Flexible flushing tube for medical catheter

By designing an irrigation tube including a flexible tube and a pull wire, the problem in the prior art that it is difficult to guide the irrigation fluid to the distal end of the medical catheter is solved, and a more efficient irrigation effect is achieved.

CN119326493APending Publication Date: 2025-01-21BIOSENSE WEBSTER (ISRAEL) LTD
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Patent Information

Application Number
CN202410963958.4
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2024-06-18
Filing Date
2024-07-18
Publication Date
2025-01-21

AI Technical Summary

Technical Problem

Existing flushing elements are not effective when delivering flushing fluid to the distal end of the medical catheter, and failing to effectively direct the fluid to the selected area, resulting in insufficient flushing effect.

Method used

An irrigation tube is designed that includes a flexible tube extending along a longitudinal axis from a proximal end to a distal end, the puller wire deflecting the distal end radially outward from the longitudinal axis, and an orifice located distally The side ends are used to guide irrigation fluid.

Benefits of technology

With this design, irrigation fluid can be more precisely directed to selected areas, improving irrigation effectiveness and enhancing cooling and lubrication of the distal end of the medical catheter.

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Abstract

The disclosed technology includes an irrigation tube for a medical catheter. 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 the distal end of the irrigation tube radially outward from the longitudinal axis. The irrigation tube may include an aperture proximate the distal end of the flexible tube, the aperture configured to direct irrigation fluid outwardly from the irrigation tube such that irrigation fluid is directed substantially by the pull wire in a deflecting direction.
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Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 514,494 (Agent File No.: BIO6817USPSP1–253757.000352), previously filed on July 19, 2023, which is hereby incorporated by reference in its entirety. Technical Field

[0003] The present invention relates generally to medical devices, and particularly to medical catheters having irrigation features, and further, but not exclusively, to medical catheters including flexible irrigation tubes configured to provide irrigation to electrodes. Background Art

[0004] Arrhythmias, such as atrial fibrillation (AF), occur when an area of ​​cardiac tissue abnormally conducts electrical signals to adjacent tissue. This disrupts the normal cardiac cycle and causes an irregular heartbeat. Certain procedures are used to treat arrhythmias, including surgically disrupting the source of the signal causing the arrhythmia and disrupting the conduction pathways for such signals. By selectively ablating cardiac tissue through the application of energy via a catheter, it is sometimes possible to stop or alter the propagation of unwanted electrical signals from one part of the heart to another.

[0005] Many current ablation methods in the art utilize radiofrequency (RF) electrical energy to heat tissue.RF ablation can have certain risks associated with thermal heating that can result in tissue charring, burning, steam bursts, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistulas.

[0006] Cryoablation is an alternative to RF ablation that generally reduces the thermal risks associated with RF ablation. However, manipulating a cryoablation device and selectively applying cryoablation is generally more challenging than RF ablation; therefore, cryoablation is not feasible in certain anatomical geometries that can be reached by electroablation devices.

[0007] Some ablation methods use irreversible electroporation (IRE) to ablate cardiac tissue using a non-thermal ablation method. IRE delivers short pulses of high voltage to tissue and generates irreversible cell membrane permeabilization. It has been previously proposed in the patent literature to use a multi-electrode probe to deliver IRE energy to tissue. Examples of systems and devices configured for IRE ablation are disclosed in U.S. Patent Publications 2021 / 0169550A1, 2021 / 0169567A1, 2021 / 0169568A1, 2021 / 0161592A1, 2021 / 0196372A1, 2021 / 0177503A1, and 2021 / 0186604A1, each of which is incorporated herein by reference and attached to the appendix of this document.

[0008] Ablation procedures, as well as other procedures utilizing electrodes (e.g., electrophysiological mapping), may result in thrombosis due to the geometry of the end effector, and in some cases, local temperature increases near the electrodes. Therefore, many existing ablation and mapping catheters include a flushing element that is configured to deliver a flushing fluid to an area near the electrode or generally to the distal end of the end effector. For example, some existing ablation catheters are configured to deliver saline to an area near the electrode via a flushing hub disposed near the proximal end of the end effector. Unfortunately, many existing flushing elements are unable to effectively deliver flushing fluid to the distal end of the end effector. In addition, many existing flushing elements are unable to accurately guide flushing fluid to a selected area. Therefore, there is a need in the art for a flushing element that increases the effectiveness of the flushing provided by the flushing element. Summary of the invention

[0009] According to one example of the present invention, a flushing tube for a medical catheter is provided. The flushing tube may include a flexible tube extending from a proximal end to a distal end along a longitudinal axis. The flushing tube may include a pull wire attached to the flexible tube, the pull wire being configured to deflect at least the distal end of the flushing tube radially outward from the longitudinal axis. The flushing tube may include an orifice near the distal end of the flexible tube, the orifice being configured to guide flushing fluid outward from the flushing tube, so that the flushing fluid is generally guided in the deflected direction by the pull wire.

[0010] The disclosed technology 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 ridges configured to bend radially outward from the longitudinal axis. The medical probe may include a plurality of electrodes, each of the plurality of electrodes being attached to a ridge of the plurality of ridges. The medical probe may include an irrigation tube disposed between the plurality of ridges 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 of the irrigation tube to direct irrigation fluid to an inwardly facing surface of an electrode of the plurality of electrodes.

[0011] Additional features, functionality, and applications of the disclosed technology are discussed in greater detail herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 is a schematic illustration of a medical system including a medical probe having electrodes according to the disclosed technology;

[0013] Figure 2 is a schematic illustration showing a perspective view of a medical probe having electrodes in a deployed state according to the disclosed technology;

[0014] Figure 3A is a schematic illustration showing a side view of a distal tip of a medical probe according to the disclosed technology;

[0015] Figure 3B is a schematic illustration showing a top view of a distal tip of a medical probe according to the disclosed technology, with ridges and electrodes omitted for purposes of clarity of illustration;

[0016] Figure 4A is a schematic illustration showing a side view of an exemplary irrigation tube having an orifice according to the disclosed technology;

[0017] Figure 4B is a schematic illustration showing a side view of another exemplary irrigation tube having an orifice according to the disclosed technology;

[0018] Figure 4C is a schematic illustration showing a side view of another exemplary irrigation tube having an orifice according to the disclosed technology;

[0019] Figure 4D is a schematic illustration showing a side view of another exemplary irrigation tube having an orifice according to the disclosed technology;

[0020] Figure 4E is a schematic illustration showing a cross-sectional view of another flushing tube having an orifice according to the disclosed technology;

[0021] Figure 5Ais a schematic illustration showing a side view of an exemplary irrigation tube having an elastic element and a pull cord according to the disclosed technology;

[0022] Figure 5B is a schematic illustration showing a side view of another exemplary irrigation tube having an elastic element and a draw cord according to the disclosed technology;

[0023] Figure 5C is a schematic illustration showing a side view of another exemplary irrigation tube having an elastic element and a draw cord according to the disclosed technology; and

[0024] Figure 6 is a schematic illustration showing a perspective view of a medical probe according to the disclosed technology. DETAILED DESCRIPTION

[0025] As discussed above, existing irrigation techniques are limited in their capabilities and therefore generally fail to achieve their intended results (e.g., cooling or lubricating a specific area near the distal end of a medical catheter). Examples of the technology described herein provide an irrigation tube for a medical catheter that is movable and / or manipulable. In some examples, the irrigation tube includes a flexible tube extending along an axis, a manipulation mechanism coupled to the flexible tube and configured to radially deflect the distal end of the flexible tube outward and / or to slide the flexible tube longitudinally, and an orifice near the distal end of the flexible tube. In some examples, the orifice is configured to direct irrigation fluid from the irrigation tube generally outward to an area or position indicated by the manipulation mechanism. The disclosed technology allows physicians to more accurately guide irrigation fluid, thereby improving their ability to effectively perform ablation or mapping procedures.

[0026] The following detailed description should be read in conjunction with the accompanying drawings, in which the same elements are labeled the same in different drawings. The accompanying drawings (not necessarily drawn to scale) depict selected examples and are not intended to limit the scope of the invention. The detailed description illustrates the principles of the invention by way of example and not by way of limitation. This description will clearly enable those skilled in the art to prepare and use the invention, and describes several embodiments, adaptations, variations, alternatives, and uses of the invention, including the best modes currently believed to be implemented in the invention.

[0027] As used herein, the term "about" or "approximately" for any numerical value or range indicates a suitable dimensional tolerance that allows a collection of parts or components to achieve its intended purpose as described herein. More specifically, "about" or "approximately" may refer to a range of ±20% of the value of the recited value, for example, "about 90%" may refer to a range of values ​​from 71% to 110%. In addition, as used herein, the terms "patient", "receptor", "user" and "subject" refer to any human or animal subject, and are not intended to limit the system or method to human use, but the use of the subject invention in human patients represents a preferred embodiment. Similarly, the term "proximal" refers to a position closer to an operator or physician, while "distal" refers to a position farther away from an operator or physician.

[0028] As discussed herein, the vasculature of a "patient," "recipient," "user," and "subject" can be that of a human or any animal. It should be understood that the animal can be of any suitable type, including, but not limited to, a mammal, a veterinary animal, a livestock animal, or a pet animal, etc. For example, the animal can be a laboratory animal (e.g., a rat, dog, pig, monkey, etc.) that is specifically selected to have certain characteristics similar to those of a human. It should be understood that the subject can be, for example, any suitable human patient.

[0029] As discussed herein, a "physician" may include a physician, surgeon, technician, scientist, operator, or any other individual or delivery instrumentation associated with delivering a multi-electrode catheter for treating drug-refractory atrial fibrillation to a subject.

[0030] As discussed herein, when referring to the devices and corresponding systems of the present disclosure, the term "ablation" refers to components and structural features configured to reduce or prevent the generation of unstable cardiac signals in cells by utilizing non-thermal energy (such as reversible or irreversible electroporation (IRE), interchangeably referred to as pulsed electric fields (PEF) and pulsed field ablation (PFA) in the present disclosure) or thermal energy (such as radiofrequency (RF) ablation or cryoablation). "Ablation" as used throughout the present disclosure, when referring to the devices and corresponding systems of the present disclosure, refers to thermal ablation or non-thermal ablation of cardiac tissue for certain conditions, including but not limited to arrhythmias, atrial flutter ablation, pulmonary vein isolation, supraventricular tachycardia ablation, and ventricular tachycardia ablation. The term "ablation" also includes known methods, devices, and systems for achieving various forms of body tissue ablation as understood by those skilled in the relevant art.

[0031] As discussed herein, the terms "tubular" and "tube" should be interpreted broadly and are not limited to structures that are perfect cylinders or have a completely circular cross-section or a uniform cross-section throughout their length. For example, tubular structures are often illustrated as structures that are substantially perfect cylinders. However, tubular structures may have tapered or curved outer surfaces without departing from the scope of the present disclosure.

[0032] Figure 1 An exemplary catheter-based electrophysiological mapping and ablation system 10 is shown. The system 10 includes a plurality of catheters that are inserted into a chamber or vascular structure of a heart 12 by a physician 24 through the vascular system of a patient 23 via the skin. Typically, a delivery sheath catheter is inserted into the left atrium or right atrium near a desired location in the heart 12. Then, a plurality of catheters may be inserted into the delivery sheath catheter to reach the desired location. The plurality of catheters may include a catheter dedicated to sensing intracardiac electrogram (IEGM) signals, a catheter dedicated to ablation, and / or a catheter dedicated to both sensing and ablation. An exemplary catheter 14 configured for sensing IEGM is illustrated herein. The physician 24 brings the distal end of the catheter 14 (i.e., the end effector 28) into contact with the heart wall for sensing a target site in the heart 12. In this case, the end effector 28 has been depicted as a basket catheter 28; however, the end effector 28 may take other forms (e.g., it may take the form of a balloon catheter). For ablation, physician 24 similarly brings the distal end of ablation catheter 14 to the target site for ablation.

[0033] The catheter 14 is an exemplary catheter that includes one (preferably multiple) electrodes 26 that are optionally distributed on a plurality of ridges 22 at 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 that includes three magnetic coils for sensing three-dimensional (3D) position and orientation. The catheter 14 may include a handle 630 located at its proximal end.

[0034] A combination of magnetic-based position sensors and force sensors may be operated with a positioning pad 25 that includes a plurality of magnetic coils 32 configured to generate a magnetic field in a predetermined workspace. The real-time position of the basket catheter 28 of the catheter 14 may be tracked based on the magnetic field generated using the positioning pad 25 and sensed by the magnetic-based position sensor. Details of magnetic-based position sensing technology are described in U.S. Patents 5,391,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, 6,892,091, each of which is incorporated herein by reference and attached to the appendix of this document.

[0035] The system 10 includes one or more electrode patches 38 positioned in contact with the skin of the patient 23 to establish a position reference for impedance-based tracking of the positioning pad 25 and the electrodes 26. For impedance-based tracking, current is directed toward the electrodes 26 and sensed at the electrode skin patches 38 so that the position of each electrode can be triangulated via the electrode patches 38. Details of impedance-based position tracking techniques are described in U.S. 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 and is attached as an appendix to this document.

[0036] Recorder 11 displays electrograms 21 captured using surface ECG electrodes 18 and intracardiac electrograms (IEGMs) captured using electrodes 26 of catheter 14. Recorder 11 may include pacing capabilities for pacing the cardiac rhythm and / or may be electrically connected to a separate pacemaker.

[0037] The system 10 may include an ablation energy generator 50 adapted to conduct ablation energy to one or more electrodes at the distal end of a catheter configured for ablation. The energy generated by the ablation energy generator 50 may include, but is not limited to, radio frequency (RF) energy or pulsed field ablation (PFA) energy (including monopolar or bipolar high voltage DC pulses that may be used to achieve irreversible electroporation (IRE)), or a combination thereof.

[0038] The patient interface unit (PIU) 30 is an interface configured to establish electrical communication between catheters, electrophysiology equipment, a power source, and a workstation 55 for controlling the operation of the system 10. The electrophysiology equipment of the system 10 may include, for example, multiple catheters, positioning pads 25, surface ECG electrodes 18, electrode patches 38, ablation energy generator 50, and recorder 11. Optionally and preferably, the PIU 30 additionally includes processing capabilities for enabling real-time calculation of the position of the catheter and for performing ECG calculations.

[0039] The workstation 55 includes a memory, a processor unit with a memory or storage device loaded with appropriate operating software, and a user interface capability. The workstation 55 can provide multiple functions, optionally including: (1) three-dimensional (3D) modeling of the endocardial anatomy and rendering the model or anatomical map 20 for display on the display device 27; (2) displaying the activation sequence (or other data) compiled from the recorded electrograms 21 on the display device 27 as representative visual markers or images superimposed on the rendered anatomical map 20; (3) displaying the real-time position and orientation of multiple catheters within the heart chamber; and (5) displaying areas of interest on the display device 27, such as where ablation energy has been applied. A commercial product embodying elements of the system 10 can be CARTO TM The 3 system was purchased from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618, USA.

[0040] Figure 2 is a schematic illustration showing a perspective view of a basket catheter 28 having electrodes 26 attached to spines 22, the spines being shown in a deployed state, such as by being pushed out of a tubular shaft lumen at the distal end of an insertion tube, in accordance with the disclosed technology. Figure 2 As shown, the basket catheter 28 includes a plurality of flexible ridges 22 formed at the ends of a tubular shaft 62 extending along the longitudinal axis 60 of the catheter 14 and connected at the two ends. The ridges 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, thereby causing the basket catheter 28 to leave the insertion tube and transition from a collapsed state to an expanded state. In the expanded state, the ridges 22 form a generally spherical shape. The ridges 22 can have an elliptical (e.g., circular) or rectangular (which can appear flat) cross-section and contain a flexible elastic material (e.g., a shape memory alloy such as nickel titanium, also known as nitinol) forming a strut. The basket catheter 28 can be connected to the rest of the catheter 14 by a coupler 15 positioned between the tubular shaft 62 and the basket catheter 28.

[0041] Physician 24 may place basket catheter 28 in contact with tissue to perform an ablation procedure and / or a mapping procedure. When ablation energy is output by electrode 26, electrode 26 and nearby tissue may begin to heat. To help dissipate the heat generated by electrode 26 and / or to prevent thrombosis, the disclosed technology may include an irrigation tube 100 configured to pass a fluid 101 (see Figure 3A ) is delivered to the vicinity of the electrodes 26 to provide a cooling effect thereto, as will be described in greater detail herein. The irrigation tube 100 may include a flexible tube extending along a longitudinal axis from a proximal end 104 to a distal end 106, and as Figure 3A As shown, the irrigation tube 100 includes an orifice 102. In some examples, the irrigation tube 100 may include a flexible biocompatible material. In some examples, the orifice 102 may be configured as a single orifice. In some examples, the orifice 102 may be configured as a plurality of orifices. In some examples, the orifice 102 is defined in the side wall of the tube 100. In some examples, the orifice 102 is defined in the distal end of the tube 100. In some examples, a combination of orifices 102 defined in the side wall and the distal end of the tube 100 may be used. Figure 2 As shown, an irrigation tube 100 extends distally from the distal end of the tubular shaft 62 and the coupler 15 and is at least partially positioned within the spherical shape of the spine 22 when the spine is in the expanded state.

[0042] In some examples, the irrigation tube 100 may carry one or more marker bands 130 to help the physician 24 identify the orientation of the tube 100 under fluoroscopic examination. Each marker band includes a metal ring with sufficient radiopacity. The marker bands 130 can be placed along any portion of the irrigation tube 100, provided that they do not contact any electrode 26. In some examples, the connecting band used to connect the pull wire 108 to the tube 100 (discussed in more detail below) can optionally be radiopaque for the same purpose.

[0043] Figure 3A is a schematic illustration showing a side view of a basket catheter 28, with an irrigation tube 100 depicted in both solid and dashed lines to illustrate exemplary movement thereof. Movement of the irrigation tube 100 may be performed to position the irrigation tube 100 so that the orifices 102 may direct irrigation fluid 101 to the inwardly facing surface of a particular electrode 26 or a particular group of electrodes 26.

[0044] like Figure 3A As shown, the irrigation tube 100 can be actuated to slide longitudinally along the longitudinal axis 60 to a distal-most position 1001 ( Figure 3A28). For example, the irrigation tube 100 can slide from the proximal end of the ridge 22 to the distal end of the ridge 22. Alternatively, the initial position and / or extended position of the irrigation tube 100 can be between the proximal end and the distal end of the ridge 28. In the most distal position 1001, a gap 103 is formed between the irrigation tube 100 and the ridge 22 along the longitudinal axis 60 so that the irrigation tube 100 does not contact the ridge 22. In the most distal position, the gap 103 can be about 0.25 millimeters (mm). In other examples, the gap can be any value, such as, for example, about 1 mm, 2 mm, 5 mm, 10 mm, etc., depending on the specific application.

[0045] Also like Figure 3A As depicted, the irrigation tube 100 can be actuated to deflect radially outward from the longitudinal axis 60 to a deflected position 1002 via a steering mechanism. In some examples, the steering mechanism can also or alternatively be used to actuate the tube 100 to slide longitudinally (as described in the preceding paragraphs). In some examples, the steering mechanism can include a pull wire 108 (in FIG. 5A to FIG. 5C ), the pull wire deflects at least the distal end 106 of the irrigation tube 100 radially outward from the longitudinal axis and is discussed in more detail below. Figure 3A In the illustrative example shown, when the irrigation tube 100 is deflected to the right to the deflected position 1002, the distal end of the irrigation tube 100 is directed in the direction of the deflection toward the inwardly facing surface of one or more electrodes 26. When the irrigation tube 100 is deflected, the orifice 102 generally directs the irrigation fluid 101 in the direction of the deflection to achieve the desired cooling effect at the electrode 26. Although the irrigation tube 100 is shown as being deflected to the right 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.

[0046] In other examples, and as Figure 3B As illustrated, the irrigation tube 100 may be configured to deflect in only a single direction to a rotational position 1003 and configured to be rotated relative to the basket assembly 28 by the physician 24 (e.g., see Figure 3B 24. In other words, the irrigation tube 100 can be deflected and then the physician 24 can rotate the irrigation tube 100 to orient the irrigation tube 100 in a desired direction. In some examples, the irrigation tube 100 can be configured to deflect radially outward so that the 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.

[0047] FIG. 4A to FIG. 4E is a schematic illustration showing a side view of an exemplary orifice configuration. As will be appreciated, the orifice configuration may be modified without departing from the spirit and scope of the disclosed technology. FIG. 4A to FIG. 4E Other ways to configure the orifice 102 are different from those depicted in FIG. Figure 4E As illustrated, the irrigation tube 100 may include a lumen 112 extending at least partially through the irrigation tube, which may direct the irrigation fluid along the length of the irrigation tube toward the orifice 102. The size of the lumen 112 may be set for a desired flow rate to ensure that a sufficient amount of irrigation fluid is delivered for a particular application. Similarly, the size of the orifice 102 may be set for a desired flow rate. In this way, a sufficient amount of fluid may be delivered to a desired location at a sufficient speed. In addition, the orifice 102 may be configured to direct fluid in a particular direction rather than just generally outward.

[0048] refer to Figure 4A In the example 100A of FIG. 1 , the apertures 102 may form a row along a 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 outwardly from the distal end 106.

[0049] like Figure 4B As shown in example 100B in FIG. 1 , the orifices 102 may be arranged in a row down one side of the distal end 106. In this example, most of the irrigation fluid 101 is directed rightward out of the orifices 102, which causes the irrigation tube to oscillate its position, for example, between a first position and a second position.

[0050] like Figure 4C As illustrated in example 100C in FIG. 1 , the orifice 102 may extend along the circumference of the distal end 106, extending down a portion of the tube 100, which allows for additional lateral fluid flow relative to, for example, example 100A. The distal end of the tube 100 may also be blocked to further promote lateral fluid flow and prevent longitudinal flow.

[0051] refer to Figure 4D In example 100D, the orifice 102 may extend along the entire circumference of the tube 100, thereby allowing the fluid 101 to pass through the orifice 102 in all directions along the length of the tube 100. In this way, the irrigation tube 100 may be configured to deliver irrigation fluid along a greater length of the basket assembly 28.

[0052] Figure 4E 100E is a cross-sectional view (cut relative to a plane perpendicular to the longitudinal axis 60). As shown in the figure, similar to Figure 3BAs depicted, the orifices 102 may also be configured to cause the irrigation tube 100 to rotationally oscillate about the longitudinal axis 60 when the irrigation fluid 101 passes through the orifices. For example, the orifices 102 may be defined in one quadrant of the tube 100 such that the irrigation fluid 101 flows out of the tube 100 in an inward radial direction toward the longitudinal axis 60 (i.e., deflecting the tube 100 away from the undeflected position 1001) and in a tangential direction perpendicular to the radial direction (i.e., having a propulsive effect that rotates the tube 100 about the longitudinal axis 60).

[0053] Now go to FIG. 5A to FIG. 5C , present schematic illustrations showing side views of exemplary irrigation tube 100 configurations. In these figures, various examples of pull wire 108 and resilient element 110 arrangements are used to manipulate the irrigation tube 100 to deflect at least the distal end 106 radially outward from the longitudinal axis 60 and return the irrigation tube 100 to a position aligned with the longitudinal axis 60, respectively. The pull wire 108 and resilient element 110 may be made of a biocompatible material, such as nitinol, cobalt chromium, titanium, stainless steel, a biocompatible polymer, or other suitable material.

[0054] In some examples, the pull wire 108 extends from an inner portion of the distal end 106 along the inner wall of the tube 100 and passes through the proximal end 104 to connect with the deflection drive actuator 632 (described in more detail below). In some examples, the pull wire can be connected to the distal end 106 on the outer wall of the distal end. In some examples, an adhesive can be used to connect the pull wire 108 to the tube 100. In some examples, a mechanical process can be used to connect them. However, any suitable positioning arrangement and connection method can be used according to the disclosed technology.

[0055] In some examples, the elastic element 110 extends from the distal end 106 and terminates at the proximal end 104 of the tube 100. The elastic element 110 can be attached to or embedded in any suitable location in the tube 100. In some examples, the elastic element 110 can include an elongated rod. In some examples, the elastic element 110 can include a spring 120, such as a coil spring (e.g., a spring) wrapped around the tube 100. Figure 5C In some examples, the tube 100 itself may be made of a resilient material so that the irrigation tube 100 may return to a position aligned with the longitudinal axis 60 .

[0056] like Figure 5A As shown, 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 mounted to the distal end 106, the distal end points radially to the left or right from the longitudinal axis 60 (e.g., see Figure 3AIn order to bias the tube 100 back to its original position, the elastic element 110 can be attached to the tube 100 or embedded therein, as described above. In the illustrated example, the element 110 is opposite to the pull wire 108, but other positions are also possible. The pull wire 108 and the elastic element 110 work together to ensure accurate positioning of the distal end 106 so that the irrigation fluid 101 can be delivered to the desired location or area.

[0057] Figure 5B Another example of the construction of the pull wire 108 and the elastic element 110 is shown. In this example, two pull wires 108 are connected on opposite sides of the tube 100, wherein the elastic element 110 is fixed to the tube 100 between the wires 108. With this arrangement, pulling one of the pull wires 108 causes the distal end 106 to rotate in a specific direction. By way of example, the left pull wire 108 may be connected to the tube 100 so as to tilt the distal end 106 to the left when pulled, and the right pull wire 108 may be connected to the tube 100 so as to tilt the distal end 106 to the right when pulled. Therefore, when in use, multiple pull wires 108 can facilitate a more customized placement of the distal end 106.

[0058] Figure 5C Still another example of a tube 100 having a pull wire 108 and an elastic element 110 is shown. This example is similar to Figure 5A The example shown differs in that a coil spring 120 is used as the resilient element 110. Although similar in function to the previously described examples, as will be appreciated by those skilled in the art, the different structural elements may provide their own unique functional advantages. For example, using a coil spring 120 extending around the tube 100, the pull wire 108 may be guided 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 even when the pull wire 10 is pulled.

[0059] Figure 66 is a schematic diagram of a perspective view of the catheter 14, wherein the middle portion of the shaft 62 is cut away for the purpose of illustration. In addition, as will be understood, for the sake of clarity, the components are not necessarily shown in scale. As shown, the handle 630 is connected to the tubular shaft 62 at its proximal end. The handle 630 may include a deflection drive actuator 632 and a flushing fluid conduit 640. The conduit 640 is in fluid communication with the flushing tube 100 to guide the flushing fluid 101 to the flushing tube under the control of the physician 24. The pull wire 108 extending through the tubular shaft 62 has a proximal end connected to the deflection drive actuator 632. Similar to the connection of the pull wire to the tube 100, any appropriate coupling technology can be adopted. When the deflection drive actuator 632 is actuated (i.e., actuated by the physician 24), the pull wire 108 can be pulled and the flushing tube 100 is deflected radially outward from the longitudinal axis 60. If more than one pull wire 108 is attached to the irrigation tube 100, actuating the deflection drive actuator 632 in a first direction may cause the irrigation tube 100 to deflect in the first direction, while actuating the deflection drive actuator 632 in a second direction may cause the irrigation tube 100 to deflect in the second direction. In some examples, the deflection drive actuator may be twisted to wrap the proximal end of the pull wire 108 around it, thereby causing actuation of the pull wire, which manipulates and / or deflects the irrigation tube 100 in the manner described above. However, other forms of actuation may also be employed, such as, but not limited to, a slider that selectively pulls and pushes the pull wire 108 to effect deflection of the tube 100.

[0060] The disclosed technology described herein can be further understood according to the following terms:

[0061] Item 1: An irrigation tube for a medical catheter, the irrigation tube comprising: a flexible tube extending from a proximal end to a distal end along a longitudinal axis; a pull wire attached to the flexible tube, the pull wire being configured to deflect at least the distal end of the flexible tube radially outward from the longitudinal axis; and an orifice proximal to the distal end of the flexible tube, the orifice being configured to direct irrigation fluid outward from the irrigation tube such that the irrigation fluid is generally directed in the deflected direction by the pull wire.

[0062] Clause 2: The irrigation tube of clause 1, comprising a flexible biocompatible material.

[0063] Clause 3: According to the irrigation tube described in Clause 1 or Clause 2, the pull wire is configured to be attached to the handle of the ablation catheter, the handle includes a deflection drive actuator connected to the proximal end of the pull wire, and the deflection drive actuator is configured to actuate the pull wire to deflect the irrigation tube.

[0064] Clause 4: The irrigation tube of any one of clauses 1 to 3, further comprising a resilient element configured to return the irrigation tube to a position aligned with the longitudinal axis.

[0065] Clause 5: The irrigation tube of Clause 4, wherein the resilient element comprises an elongated rod attached to the irrigation tube.

[0066] Clause 6: The irrigation tube of Clause 4, the elastic element comprising a spring attached to the irrigation tube.

[0067] Clause 7: The irrigation tube of any one of clauses 1 to 3, wherein the irrigation tube is made of a resilient material such that the irrigation tube is configured to return to a position aligned with the longitudinal axis.

[0068] Clause 8: The irrigation tube of any one of clauses 1 to 7, wherein the irrigation tube is further configured to slide longitudinally relative to the plurality of ridges of the ablation catheter from a proximal end of the plurality of ridges to a distal end of the plurality of ridges.

[0069] Clause 9: The irrigation tube of any one of clauses 1 to 8, the aperture being configured to direct the irrigation fluid toward an electrode.

[0070] Clause 10: The irrigation tube of any of clauses 1 to 9, the orifice being configured to cause the irrigation tube to oscillate between a first position and a second position when the irrigation fluid passes through the orifice.

[0071] Clause 11: The irrigation tube of any of clauses 1 to 9, the aperture being configured to rotationally oscillate the irrigation tube about the longitudinal axis when the irrigation fluid passes through the aperture.

[0072] Item 12: A medical probe comprising: a tubular shaft extending along a longitudinal axis; a plurality of ridges configured to bend radially outward from the longitudinal axis; a plurality of electrodes, each of the plurality of electrodes being attached to a ridge of the plurality of ridges; and an irrigation tube disposed between the plurality of ridges and extending distally from a distal end of the tubular shaft, at least a portion of the irrigation tube being configured to deflect radially outward from the longitudinal axis of the irrigation tube to direct irrigation fluid to an inwardly facing surface of an electrode of the plurality of electrodes.

[0073] Clause 13: The medical probe according to Clause 12, wherein the irrigation tube comprises a flexible biocompatible material.

[0074] Clause 14: The medical probe of clause 12 or clause 14, the irrigation tube being steerable such that a distal end of the irrigation tube can be moved to direct the irrigation fluid toward the electrode of the plurality of electrodes.

[0075] Clause 15: The medical probe of any one of clauses 12 to 14, further comprising a pull wire attached to the irrigation tube, the pull wire configured to manipulate the irrigation tube.

[0076] Clause 16: The medical probe of clause 15, further comprising a handle attached to the proximal end of the tubular shaft, the handle further comprising a deflection drive actuator connected to the proximal end of the pull wire, the deflection drive actuator being configured to actuate the pull wire to manipulate the irrigation tube.

[0077] Clause 17: The medical probe of any one of clauses 12 to 16, further comprising a resilient element configured to return the irrigation tube to a position aligned with the longitudinal axis.

[0078] Clause 18: The medical probe of Clause 17, wherein the elastic element comprises an elongated rod attached to the irrigation tube.

[0079] Clause 19: The medical probe of Clause 17, wherein the elastic element comprises a spring attached to the irrigation tube.

[0080] Clause 20: The medical probe of any of clauses 12 to 19, wherein the irrigation tube is further configured to slide longitudinally along the longitudinal axis from a proximal end of the plurality of ridges to a distal end of the plurality of ridges.

[0081] Clause 21: The medical probe of Clause 20, wherein in a distal-most position of the irrigation tube, a gap is formed between the irrigation tube and the plurality of ridges such that the irrigation tube is not in contact with the plurality of ridges.

[0082] Clause 22: The medical probe of clause 21, wherein the gap is approximately 0.25 mm.

[0083] Clause 23: The medical probe of any one of clauses 12 to 16 and 20 to 22, wherein the irrigation tube is made of a resilient material such that the irrigation tube is configured to return to a position aligned with the longitudinal axis.

[0084] Clause 24: The medical probe of any of clauses 12 to 23, the irrigation tube comprising an orifice configured to direct the irrigation fluid toward the electrode of the plurality of electrodes.

[0085] Clause 25: The medical probe of clause 24, the orifice configured to cause the irrigation tube to oscillate between a first position and a second position when the irrigation fluid passes through the orifice.

[0086] Clause 26: The medical probe of Clause 24, the aperture being configured to rotationally oscillate the irrigation tube about the longitudinal axis when the irrigation fluid passes through the aperture.

[0087] Clause 27: The medical probe of any one of clauses 12 to 26, wherein the irrigation tube is configured to deflect radially outwardly such that a distal end of the irrigation tube maintains a distance of at least about 0.25 mm from the electrode.

[0088] Clause 28: The medical probe of any of clauses 12 to 27, the plurality of ridges being configured to transition between a collapsed state and an expanded state.

[0089] Clause 29: The medical probe of clause 28, wherein the plurality of ridges form a generally spherical shape when in the expanded state.

[0090] Clause 30: The medical probe of clause 29, wherein the irrigation tube is at least partially positioned within the spherical shape when the plurality of ridges are in the expanded state.

[0091] The above embodiments are cited by way of example, and the present invention is not limited by what is specifically shown and described above. On the contrary, the scope of the present invention includes combinations and sub-combinations of the various features described above, as well as variations and modifications thereof, which will occur to those skilled in the art upon reading the above description, and which are not disclosed in the prior art.

Claims

1. A flushing tube for a medical catheter, the flushing 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; and An orifice is proximate the distal end of the flexible tube, the orifice being configured to direct irrigation fluid outwardly from the irrigation tube such that the irrigation fluid is directed generally in the deflected direction by the puller 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, the resilient element comprising an elongated rod attached to the irrigation tube.

4. The irrigation tube of claim 2, the elastic element comprising a spring attached to the irrigation tube.

5. The flushing tube according to claim 1, wherein: The irrigation tube is made of 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, the orifice being configured to direct the irrigation fluid toward an electrode.

7. The irrigation tube of claim 1, the orifice being configured to cause the irrigation tube to oscillate between a first position and a second position when the irrigation fluid passes through the orifice.

8. The irrigation tube of claim 1, the orifice being configured to rotationally oscillate the irrigation tube about the longitudinal axis when the irrigation fluid passes through the orifice.

9. A medical probe, comprising: a tubular shaft extending along a longitudinal axis; a plurality of ridges configured to curve radially outward from the longitudinal axis; a plurality of electrodes, each electrode of the plurality of electrodes being attached to a ridge of the plurality of ridges; and an irrigation tube disposed between the plurality of ridges and extending distally from a distal end of the tubular shaft, at least a portion of the irrigation tube being configured to deflect radially outward from the longitudinal axis of the irrigation tube to direct irrigation fluid to an inwardly facing surface of an electrode of the plurality of electrodes.

10. The medical probe of claim 9, the irrigation tube being steerable such that a distal end of the irrigation tube can be moved to direct the irrigation fluid toward the electrode 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 manipulate the irrigation tube.

12. The medical probe of claim 11, further comprising a handle attached to the proximal end of the tubular shaft, the handle further comprising a deflection drive actuator connected to the proximal end of the pull wire, the deflection drive actuator being configured to actuate the pull wire to manipulate 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 according to claim 9, wherein: The irrigation tube is further configured to slide longitudinally along the longitudinal axis from a proximal end of the plurality of ridges to a distal end of the plurality of ridges.

15. The medical probe according to claim 14, wherein: In the distal-most position of the irrigation tube, a gap is formed between the irrigation tube and the plurality of ridges such that the irrigation tube is not in contact with the plurality of ridges.

16. The medical probe according to claim 9, wherein: The irrigation tube is made of a resilient material such that the irrigation tube is configured to return to a position aligned with the longitudinal axis.

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

18. The medical probe of claim 17, the orifice being configured to cause the irrigation tube to oscillate between a first position and a second position when the irrigation fluid passes through the orifice.

19. The medical probe of claim 17, the orifice being configured to rotationally oscillate the irrigation tube about the longitudinal axis when the irrigation fluid passes through the orifice.

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

Citation Information

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