Flow biasing element for conduit

Abstract

The disclosed techniques include a flow biasing element including a lumen extending along a longitudinal axis from a proximal end to a distal end of the flow biasing element. The flow biasing element may include a plurality of manifolds, each manifold including a plurality of fluid channels, each fluid channel extending from the lumen to an exterior of the flow biasing element. The flow biasing element may also include a plurality of annular ridges disposed about the lumen between the proximal end and the distal end of the flow biasing element. Each manifold of the plurality of manifolds may be disposed between adjacent annular ridges of the plurality of annular ridges.

Description

Technical Field

[0001] The present invention generally relates to medical devices, and more particularly to medical probes with irrigation, and further but not exclusively to medical probes configured to provide irrigation to electrodes. Background Art

[0002] When regions of cardiac tissue abnormally conduct electrical signals to adjacent tissue, arrhythmias such as atrial fibrillation (AF) can occur. This disrupts the normal cardiac cycle and results in an irregular heartbeat. Certain procedures are used to treat arrhythmias, including surgically disrupting the source of the arrhythmia-causing signals and disrupting the conduction pathways for such signals. Selectively ablating cardiac tissue by applying energy via a catheter can sometimes stop or alter the propagation of unwanted electrical signals from one part of the heart to another.

[0003] Many current ablation methods in the art utilize radiofrequency (RF) electrical energy to heat tissue. RF ablation can have certain risks associated with thermal heating that can result in tissue charring, burns, steam pops, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistulas.

[0004] Prior to ablating tissue, it may be desirable to map the pulmonary veins or other anatomical features. During mapping, the chance of inducing blood clots may increase. Additionally, ablation of tissue can cause a local temperature increase near the electrodes. For at least these reasons, it is desirable to provide a flushing fluid to the anatomical region being treated or mapped. Unfortunately, many existing flushing elements are designed with sharp bends or otherwise have inefficient designs that reduce the effectiveness of the cooling provided by the flushing element. Accordingly, there is a need in the art for flushing elements that increase the effectiveness of the cooling provided by the flushing element. Summary of the Invention

[0005] According to one example of the present invention, there is provided a flow biasing element including: a proximal end and a distal end; a lumen extending longitudinally along an axis from the proximal end to the distal end of the flow biasing element; a plurality of annular ridges disposed around the lumen between the proximal end and the distal end; and a plurality of manifolds, each manifold being disposed between adjacent ones of the plurality of annular ridges and including a plurality of fluid channels, and each fluid channel extending from the lumen to the exterior of the flow biasing element.

[0006] The distal end of the flow biasing element may include a distal aperture that may be configured to form a seal around an outer circumference of the end effector disposed through the lumen. The plurality of annular ridges may include a proximal annular ridge, a second annular ridge, a third annular ridge, and a distal annular ridge. The plurality of manifolds may include a first manifold disposed between the proximal annular ridge and the second annular ridge, a second manifold disposed between the second annular ridge and the third annular ridge, and a third manifold disposed between the third annular ridge and the distal annular ridge. Each of the proximal annular ridge, the second annular ridge, and the third annular ridge may include a distal surface and a proximal surface, and each of the proximal surfaces may be substantially convex, and each of the distal surfaces may be substantially concave. The distal annular ridge may include a distal surface and a proximal surface, and both the distal surface and the proximal surface of the distal annular ridge may be substantially convex. The diameter of the proximal annular ridge may be greater than the diameter of the second annular ridge, the diameter of the second annular ridge may be greater than the diameter of the third annular ridge, and the diameter of the third annular ridge may be greater than the diameter of the distal annular ridge. The flow biasing element may include an elastomeric material. The flow biasing element may include silicone.

[0007] The disclosed technique may include a catheter including: an insertion shaft extending along a longitudinal axis; an end effector disposed at a distal end of the insertion shaft; a sheath disposed around the insertion shaft; and a flow biasing element disposed at a distal end of the sheath, the flow biasing element including: a proximal end and a distal end; a lumen extending along the longitudinal axis from the proximal end to the distal end of the flow biasing element; a plurality of annular ridges disposed around the lumen between the proximal end and the distal end; and a plurality of manifolds, and each manifold may be disposed between adjacent annular ridges of the plurality of annular ridges and include a plurality of fluid channels, and each fluid channel may extend from the lumen to an exterior of the flow biasing element.

[0008] The plurality of manifolds may divert flushing fluid from the lumen to the exterior of the flow biasing element to radially distribute the flushing fluid around the end effector. The end effector may include one or more electrodes configured for tissue ablation, and the flushing fluid may cool the electrodes during ablation. The end effector may be a guide wire.

[0009] The diameter of each of the plurality of annular ridges may decrease relative to each other from the proximal end to the distal end of the flow biasing element. The plurality of annular ridges may include a proximal annular ridge, a second annular ridge, a third annular ridge, and a distal annular ridge. The plurality of manifolds may include a first manifold disposed between the proximal annular ridge and the second annular ridge, a second manifold disposed between the second annular ridge and the third annular ridge, and a third manifold disposed between the third annular ridge and the distal annular ridge.

[0010] Each of the proximal annular ridge, the second annular ridge, and the third annular ridge may include a distal surface and a proximal surface, and each of the proximal surfaces may be substantially convex, and each of the distal surfaces may be substantially concave. The distal end of the flow biasing element may include a distal aperture that may form a seal around an outer circumference of the end effector disposed through the lumen. The seal may include an elastomeric material. The seal may include silicone.

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

[0012] Figure 1 is a schematic illustration of a medical system including a medical probe in accordance with the disclosed technology;

[0013] Figure 2 is a schematic illustration showing a perspective view of a medical probe in accordance with the disclosed technology;

[0014] Figure 3A is a schematic illustration showing a perspective view of a flow biasing element in accordance with the disclosed technology;

[0015] Figure 3B is a schematic illustration showing an exploded perspective view of a flow biasing element in accordance with the disclosed technology;

[0016] Figure 3C is a schematic illustration showing an exploded side view of a flow biasing element in accordance with the disclosed technology;

[0017] Figure 3D is a schematic illustration showing a cross-sectional view of a flow biasing element in accordance with the disclosed technology;

[0018] Figure 3E is a schematic illustration showing a cross-sectional view of a flow biasing element in accordance with the disclosed technology;

[0019] Figure 4A is a schematic illustration depicting a proximal end component of a flow biasing element in accordance with the disclosed technology; and

[0020] Figure 4B is a schematic illustration depicting a collar component of a flow biasing element in accordance with the disclosed technology. DETAILED DESCRIPTION

[0021] The following detailed description should be read in conjunction with the accompanying drawings, in which like reference numerals refer to like elements in the different drawings. The drawings (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. This description will clearly enable 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 presently believed to be the best mode of carrying out the invention.

[0022] As used herein, the term "about" or "approximately" in reference to any numerical value or range indicates a suitable dimensional tolerance that allows for a collection of parts or components to achieve its intended purpose as described herein. More specifically, "about" or "approximately" can refer to a range of values of plus or minus 20% of the recited value, e.g., "about 90%" can refer to a range of values from 71% to 110%. In addition, as used herein, the terms "patient", "recipient", "user" and "subject" refer to any human or animal subject, and are not intended to limit the system or method to human use, although use of the subject invention in human patients represents a preferred embodiment. Similarly, the term "proximal" refers to a position closer to the operator or physician, while "distal" refers to a position farther from the operator or physician.

[0023] 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 mammals, veterinary animals, livestock animals or pet animals, etc. For example, the animal can be an experimental animal (e.g., rats, dogs, pigs, monkeys, etc.) specifically selected to have certain characteristics similar to humans. It should be understood that the subject can be, for example, any suitable human patient.

[0024] As discussed herein, a "physician" can include a doctor, surgeon, technician, scientist, operator, or any other individual or delivery instrument associated with delivering a multi-electrode catheter for treating drug-refractory atrial fibrillation to a subject.

[0025] 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 field (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 or non-thermal ablation of cardiac tissue for certain conditions, including but not limited to arrhythmia, atrial flutter ablation, pulmonary vein isolation, supraventricular tachycardia ablation, and ventricular tachycardia ablation. The term "ablation" also includes known methods, devices, and systems for achieving various forms of ablation of body tissue understood by those skilled in the relevant art.

[0026] As discussed herein, the terms "tubular" and "tube" should be understood broadly and are not limited to structures that are right circular cylinders or have a fully circular cross-section or a uniform cross-section along their entire length. For example, a tubular structure is typically illustrated as a structure that is substantially a right circular cylinder. However, without departing from the scope of the present disclosure, a tubular structure may have a tapered or curved outer surface.

[0027] Figure 1 An exemplary catheter-based electrophysiological mapping and ablation system 10 is shown. System 10 includes a plurality of catheters that are inserted by a physician 24 through the vascular system of a patient 23 via the skin into the chambers or vascular structures of the heart 12. Typically, a delivery sheath catheter is inserted into the left atrium or right atrium near a desired location within the heart 12. Then, a plurality of catheters may be inserted into the delivery sheath catheter in order to reach that desired location. The plurality of catheters may include catheters dedicated to sensing intracardiac electrogram (IEGM) signals, catheters dedicated to ablation, and / or catheters dedicated to both sensing and ablation. In an example of sensing IEGM signals, the physician 24 brings the distal end of catheter 14 (i.e., the end effector 200 in this case) to a target site within the heart 12. For ablation, the physician 24 similarly brings the distal end of an ablation catheter to the target site for ablation.

[0028] Catheter 14 is an exemplary catheter that includes a sheath 300 having a deflecting element 100 disposed at a distal end of the sheath 300. Catheter 14 may also include an end effector 200 that passes through the sheath 300 and the deflecting element. End effector 200 may include one or more electrodes configured to detect electrophysiological signals and / or deliver ablation energy to tissue. Catheter 14 may additionally include a magnetic-based position sensor embedded within or near end effector 200 for tracking the position and orientation of end effector 200. End effector 200 may also include one or more impedance-based electrodes disposed within or near end effector 200 for tracking the position and orientation of end effector 200. In some examples, end effector 200 is a guide wire.

[0029] The magnetic-based position sensor may operate in conjunction with a positioning pad 25 that includes a plurality of magnetic coils 32 configured to generate a magnetic field within a predefined workspace. The real-time position of end effector 200 of catheter 14 may be tracked based on the magnetic field generated by positioning pad 25 and sensed by the magnetic-based position sensor 29. The magnetic-based position sensor may be a uniaxial sensor, a biaxial sensor, or a triaxial sensor, depending on the particular configuration. Details of magnetic-based position sensing techniques are described in U.S. Pat. Nos. 5,391,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, and 6,892,091, each of which is incorporated herein by reference as if fully set forth herein.

[0030] System 10 includes one or more electrode patches 38 positioned to contact the skin of patient 23 to establish a position reference for impedance-based tracking of positioning pad 25 and electrodes 26. For impedance-based tracking, current is directed toward electrodes 26 and sensed at electrode skin patches 38 such that the position of each electrode may be triangulated via electrode patches 38. Details of impedance-based position tracking techniques are described in U.S. Pat. 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.

[0031] Recorder 11 displays the electrocardiogram 21 captured using the body surface ECG electrodes 18 and the intracardiac electrogram (IEGM) captured using the electrodes 26 of the catheter 14. Recorder 11 may include pacing capabilities for pacing the heart rhythm and / or may be electrically connected to an independent pacemaker.

[0032] System 10 may include an ablation energy generator 50 adapted to conduct ablation energy to one or more electrodes at the distal tip of a catheter configured for ablation. The energy generated by ablation energy generator 50 may include, but is not limited to, radiofrequency (RF) energy or pulsed field ablation (PFA) energy (including unipolar or bipolar high voltage DC pulses that may be used to effect irreversible electroporation (IRE)), or combinations thereof.

[0033] The patient interface unit (PIU) 30 is an interface configured to establish electrical connectivity between the catheter, electrophysiology equipment, power supply, and a workstation 55 for controlling the operation of system 10. The electrophysiology equipment of system 10 may include, for example, a plurality of catheters, positioning pads 25, body surface ECG electrodes 18, electrode patches 38, ablation energy generator 50, and recorder 11. Optionally and preferably, PIU 30 further includes processing capabilities for performing real-time calculations of the position of the catheter and for performing ECG calculations.

[0034] Workstation 55 includes a memory, a processor unit with a memory or storage device loaded with appropriate operating software, and user interface capabilities. Workstation 55 may provide a plurality of functions, optionally including: (1) performing three-dimensional (3D) modeling of the endocardial anatomy and rendering a model or anatomical map 20 for display on a display device 27; (2) displaying on the display device 27 an activation sequence (or other data) compiled from the recorded electrogram 21 as representative visual markers or images superimposed on the rendered anatomical map 20; (3) displaying the real-time position and orientation of a plurality of catheters within the heart chambers; and (5) displaying on the display device 27 sites of interest, such as where ablation energy has been applied. An article of commerce embodying the elements of system 10 may be the CARTO TM 3 System, available from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618, USA.

[0035] As Figure 2As shown, the catheter 14 may include a sheath 300. The flow diversion element 100 may be disposed at the distal end of the sheath 300. The end effector 200 may be disposed at the distal end of the insertion shaft 350. The flow diversion element 100 may be configured to radially deliver irrigation fluid around the end effector 200 and to the target anatomical region. The end effector 200 may be disposed through the flow diversion element 100, and the distal end of the flow diversion element 100 may be configured to form a seal around the circumference of the end effector 200. In some examples, the flow diversion element 100 may be disposed inside the interior of a cage catheter to provide irrigation to the electrodes of the catheter during operation.

[0036] Figures 3A to 3D The flow diversion element 100 according to the disclosed technology is depicted. As previously mentioned, and as will be described in more detail herein, the flow diversion element 100 may be configured to radially deliver fluid around the end effector and / or deliver fluid to the target anatomical region. The flow diversion element 100 may include a generally tubular lumen 150 disposed along a longitudinal axis 180 of the flow diversion element 100, as Figure 3D shown.

[0037] The flow diversion element 100 may include a plurality of manifolds 115, 125, 135. Each manifold 115, 125, 135 may include a plurality of fluid channels 157 extending from the lumen 150 to the exterior of the flow diversion element 100 (as Figure 3D shown). In some examples, each fluid channel 157 of the flow diversion element 100 extends from an internal hole 156 disposed on an inner circumference 152 of the lumen 150 to an external hole 158 disposed around an outer circumference 154 of the lumen 150. In Figures 3A to 3D the example shown, each manifold includes 24 fluid channels 157, however the number of fluid channels may vary. For example, each manifold may include 6, 12, 18, or 32 fluid channels, or any number therebetween. In some examples, the manifolds of the flow diversion element may include different numbers of fluid channels. For example, the number of fluid channels may increase from the proximal end to the distal end of the flow diversion element such that the second manifold 125 includes more fluid channels than the first manifold 115, and the third manifold 135 includes more fluid channels than the second manifold 125, or vice versa.

[0038] During operation, the end effector may be disposed through the lumen 150 of the flow biasing element 100. The distal aperture 144 disposed at the distal end 104 of the flow biasing element 100 may form a seal around the outer circumference of the end effector. When a flushing fluid (e.g., via a pump) is provided into the proximal aperture 108 disposed at the proximal end 102 of the flow biasing element 100, the flushing fluid is forced through the fluid channels 157 of the plurality of manifolds 115, 125, 135. In some examples, the flushing fluid also exits the distal aperture 144 of the flow biasing element 100. In some examples, the seal formed by the distal aperture 144 that interfaces with the outer circumference of the end effector forces the flushing fluid to flow out only through the fluid channels 157 of the plurality of manifolds 115, 125, 135. In some examples, the inner diameter of the distal aperture 144 is from about 0.010 inches to about 0.050 inches. In some examples, the inner diameter of the distal aperture 144 is about 0.045 inches. In some examples, the inner diameter of the distal aperture 144 is from about 0.255 millimeters (mm) to about 1.5 mm. In some examples, the inner diameter of the distal aperture 144 is about 1.17 mm.

[0039] In some examples, the flow biasing element 100 includes a plurality of annular ridges 110, 120, 130, 140. In some examples, the annular ridges may be arranged to direct the flushing fluid toward the end effector of the catheter. In some examples, the size (i.e., circumference, radius, and diameter) of each annular ridge decreases from the proximal annular ridge 110 to the distal annular ridge 140 such that the annular ridges taper from the proximal end 102 to the distal end 104 of the flow biasing element. The annular ridges may be flexible such that they conform to the shape of the anatomical region or anatomical lumen in which the flow biasing element is located. In some examples, the flow biasing element is formed of or otherwise includes silicone. As Figures 3A to 3D depicted, the flow biasing element 100 may include a proximal annular ridge 110, a second annular ridge 120, a third annular ridge 130, and a distal annular ridge 140 disposed along the longitudinal axis 180 of the flow biasing element 100 from the proximal end 102 to the distal end 104.

[0040] In some examples, each annular ridge includes a proximal surface and a distal surface. For example, proximal annular ridge 110 includes proximal surface 112 and distal surface 114, second annular ridge 120 includes proximal surface 122 and distal surface 124, third annular ridge 130 includes proximal surface 132 and distal surface 134, and distal annular ridge 140 includes a proximal surface and a distal surface. In some examples, each annular ridge is substantially conical. In some examples, each proximal surface of the annular ridges can be substantially convex, and each distal surface of the distal surfaces can be substantially concave. In some examples, the distal surfaces 114, 124, 134 of proximal annular ridge 110, second annular ridge 120, and third annular ridge 130 can be substantially concave, and the distal surface of distal annular ridge 140 can be substantially flat. In some examples, the distal surface of distal annular ridge 140 can be substantially convex.

[0041] In some examples, the proximal surface of each annular ridge (e.g., 112, 122, 132) tapers toward the proximal end 102 of the flow diverter element 100 such that the proximal surface is angled relative to the longitudinal axis 180 of the flow diverter element 100. The angled proximal surface can facilitate removal of the flow diverter element 100 from the target anatomical region and through the sheath 300.

[0042] In some examples, the distal surface of each annular ridge (e.g., 114, 124, 134) tapers toward the proximal end 102 of the flow diverter element, providing a distal surface angled relative to the longitudinal axis 180 of the flow diverter element 100. The angles of the proximal surface and the distal surface can be approximately equal. In some examples, adjacent annular ridges have some overlap. For example, the spacing between second annular ridge 120 and third annular ridge 130 can be set such that when viewed at an angle transverse to the longitudinal axis 180 (as Figure 3C shown), a portion of the distal surface 124 of second annular ridge 120 overlaps a portion of the proximal surface 132 of third annular ridge 130.

[0043] In some examples, each of the plurality of manifolds 115, 125, 135 may be disposed between adjacent annular ridges. For example, the outer hole 158 of the fluid passage 157 of the first manifold 115 is disposed between the proximal annular ridge 110 and the second annular ridge 120, the outer hole 158 of the fluid passage 157 of the second manifold 125 is disposed between the second annular ridge 120 and the third annular ridge 130, and the outer hole 158 of the fluid passage 157 of the third manifold 135 is disposed between the third annular ridge 130 and the distal annular ridge 140. In some examples, the outer hole 158 of the fluid passage 157 of each manifold is disposed on the distal surface of the annular ridge. For example, the outer hole 158 of the fluid passage 157 of the first manifold 115 is disposed on the distal surface 114 of the proximal annular ridge 110, the outer hole 158 of the fluid passage 157 of the second manifold 125 is disposed on the distal surface 124 of the second annular ridge 120, and the outer hole 158 of the fluid passage 157 of the third manifold 135 is disposed on the distal surface 134 of the third annular ridge 130.

[0044] In some examples, the fluid passage 157 extends outwardly from the lumen at an angle Φ away from the longitudinal axis. The angle Φ may be a predetermined angle sufficient to direct the flushing fluid discharged from the fluid passage of the manifold out of the plurality of outer holes such that the fluid is directed radially about the longitudinal axis 180 (as Figure 3E depicted). As a non-limiting example, the angle Φ may be about 15°, 20°, 25°, 30°, 35°, 40°, 45°, 60°, 75°, 85°, or any other suitable angle for a particular application.

[0045] Although the flow diverter element 100 is illustrated in the drawings as having four annular ridges, other examples of the flow diverter element 100 may include more or fewer annular ridges. For example, the flow diverter element may include three, four, five, or six annular ridges. In some examples, the number of manifolds is one less than the number of annular ridges (i.e., if the number of annular ridges equals n, then the number of manifolds equals n - 1). In some examples, the flow diverter element 100 is formed by injection molding.

[0046] In some examples, the annular ridge extends outwardly from the lumen at an angle θ away from the longitudinal axis. The angle θ may be a predetermined angle sufficient to redirect the flushing fluid discharged from the fluid passage of the manifold out of the plurality of outer holes such that the fluid is directed generally transverse to the longitudinal axis 180 (as Figure 3E depicted). In some examples, the angle θ may direct the fluid toward an electrode disposed on the end effector. As a non-limiting example, the angle θ may be about 15°, 20°, 25°, 30°, 35°, 40°, 45°, 60°, 75°, 85°, or any other suitable angle for a particular application.

[0047] AsFigure 3D As depicted, the distal end of the lumen 150 may include a flange 103. When the insertion shaft of the catheter (e.g., the insertion shaft 350 as Figure 2 depicted) is received by the proximal aperture 108 and disposed into the distal end of the lumen 150 of the flow diversion element 100, the flange 103 may be disposed to abut the distal end of the insertion shaft of the catheter.

[0048] In some examples, the proximal end 102 of the flow diversion element 100 includes a bellows 105. Corrugations 106 may be provided for attaching the flow diversion element 100 to the distal end of a sheath (e.g., the sheath 300 as Figure 2 depicted). Attaching the flow diversion element 100 to the distal end of the sheath may include placing the distal end of the sheath over the bellows 105, then placing the electrode 165 over the outer circumference of the sheath, and securing the sheath to the flow diversion element by coupling a collar 160 over both the electrode 165 and the distal end of the sheath. The electrode 165 may be configured for non-contact intracardiac electrogram signal sensing. As Figure 4A depicted, the bellows 105 disposed at the proximal end 102 of the flow diversion element may include a channel 107 disposed through one or more of the corrugations. The channel 107 may be aligned with a slot (e.g., Figure 4B the slot 164 depicted in Figure 3C ) in the collar to provide space for a lead to connect to the non-contact electrode (e.g.,

[0049] Figure 4B The collar 160 component of the flow diversion element 100 is depicted. In some examples, the collar includes a slot 164 that is aligned with a channel (e.g., the channel 107 as Figure 4A depicted) disposed through the corrugations at the proximal end of the flow diversion element to provide space for a lead to connect to the non-contact electrode (e.g., Figure 3C the electrode 165 depicted in

[0050] The disclosed techniques herein may be further understood in accordance with the following clauses:

[0051] Clause 1: A bias flow element, the bias flow element comprising: a proximal end and a distal end; a lumen extending longitudinally along an axis from the proximal end of the bias flow element to the distal end; a plurality of annular ridges disposed around the lumen between the proximal end and the distal end; and a plurality of manifolds, each manifold disposed between adjacent ones of the plurality of annular ridges and including a plurality of fluid channels, each fluid channel extending from the lumen to the exterior of the bias flow element.

[0052] Clause 2: The bias flow element according to Clause 1, wherein the distal end includes a distal aperture configured to form a seal around an outer circumference of an end effector disposed through the lumen.

[0053] Clause 3: The bias flow element according to Clause 1 or 2, wherein the plurality of annular ridges includes a proximal annular ridge, a second annular ridge, a third annular ridge, and a distal annular ridge.

[0054] Clause 4: The bias flow element according to Clause 3, wherein the plurality of manifolds includes a first manifold disposed between the proximal annular ridge and the second annular ridge, a second manifold disposed between the second annular ridge and the third annular ridge, and a third manifold disposed between the third annular ridge and the distal annular ridge.

[0055] Clause 5: The bias flow element according to Clause 4, wherein each of the proximal annular ridge, the second annular ridge, and the third annular ridge includes a distal surface and a proximal surface, wherein each of the proximal surfaces is substantially convex, and each of the distal surfaces is substantially concave.

[0056] Clause 6: The bias flow element according to Clause 5, wherein the distal annular ridge includes a distal surface and a proximal surface, wherein the distal surface and the proximal surface of the distal annular ridge are substantially convex.

[0057] Clause 7: The bias flow element according to Clause 3, wherein the diameter of the proximal annular ridge is greater than the diameter of the second annular ridge, the diameter of the second annular ridge is greater than the diameter of the third annular ridge, and the diameter of the third annular ridge is greater than the diameter of the distal annular ridge.

[0058] Clause 8: The bias flow element according to any one of Clauses 1 to 7, wherein the bias flow element comprises an elastomeric material.

[0059] Clause 9: The bias flow element according to Clause 8, wherein the bias flow element comprises silicone.

[0060] Clause 10: A catheter, the catheter comprising: an insertion shaft extending along a longitudinal axis; an end effector disposed at a distal end of the insertion shaft; a sheath surrounding the insertion shaft; and a flow diversion element disposed at a distal end of the sheath, the flow diversion element including: a proximal end and a distal end; a lumen extending along the longitudinal axis from the proximal end to the distal end of the flow diversion element; a plurality of annular ridges disposed around the lumen between the proximal end and the distal end; and a plurality of manifolds, each manifold disposed between adjacent ones of the plurality of annular ridges and including a plurality of fluid channels, each fluid channel extending from the lumen to the exterior of the flow diversion element.

[0061] Clause 11: The catheter according to Clause 10, wherein the plurality of manifolds divert flushing fluid from the lumen to the exterior of the flow diversion element to radially distribute the flushing fluid around the end effector.

[0062] Clause 12: The catheter according to Clause 11, wherein the end effector includes one or more electrodes configured for tissue ablation, and wherein the flushing fluid cools the electrodes during ablation.

[0063] Clause 13: The catheter according to Clause 11, wherein the end effector is a guide wire.

[0064] Clause 14: The catheter according to any one of Clauses 10 to 13, wherein the diameter of each of the plurality of annular ridges decreases relative to each other from the proximal end to the distal end of the flow diversion element.

[0065] Clause 15: The catheter according to any one of Clauses 10 to 14, wherein the plurality of annular ridges includes a proximal annular ridge, a second annular ridge, a third annular ridge, and a distal annular ridge.

[0066] Clause 16: The catheter according to Clause 15, wherein the plurality of manifolds includes a first manifold disposed between the proximal annular ridge and the second annular ridge, a second manifold disposed between the second annular ridge and the third annular ridge, and a third manifold disposed between the third annular ridge and the distal annular ridge.

[0067] Clause 17: The catheter according to Clause 15 or 16, wherein each of the proximal annular ridge, the second annular ridge, and the third annular ridge includes a distal surface and a proximal surface, wherein each of the proximal surfaces is substantially convex, and each of the distal surfaces is substantially concave.

[0068] Clause 18: The catheter according to any one of Clauses 10 to 17, wherein the distal end of the flow biasing element includes a distal hole that forms a seal around the outer circumference of the end effector disposed through the lumen.

[0069] Clause 19. The catheter according to Clause 18, wherein the seal comprises an elastomeric material.

[0070] Clause 20. The catheter according to Clause 19, wherein the seal comprises silicone.

[0071] The above embodiments are cited by way of example, and the present invention is not limited to what is specifically shown and described above. On the contrary, the scope of the present invention includes combinations and sub - combinations of the various features described above, as well as their variations and modifications, which will occur to those skilled in the art upon reading the above description and which are not disclosed in the prior art.

Claims

1. A flow deviation element, comprising: a proximal end and a distal end; an inner lumen extending along a longitudinal axis from the proximal end to the distal end of the flow diverting element; a plurality of annular ridges disposed about the lumen between the proximal end and the distal end; and A plurality of manifolds are each disposed between adjacent ones of the plurality of annular ridges and including a plurality of fluid passages, each fluid passage extending from the lumen to an exterior of the flow diverting element.

2. The flow deflection element according to claim 1, wherein: The distal end includes a distal aperture configured to form a seal around an outer circumference of an end effector disposed through the lumen.

3. The flow deflection element according to claim 1, wherein: The plurality of annular ridges include a proximal annular ridge, a second annular ridge, a third annular ridge, and a distal annular ridge.

4. The flow deflection element according to claim 3, wherein: The plurality of manifolds include a first manifold disposed between the proximal annular ridge and the second annular ridge, a second manifold disposed between the second annular ridge and the third annular ridge, and a third manifold disposed between the third annular ridge and the distal annular ridge.

5. The flow deflection element according to claim 4, wherein: Each of the proximal, second, and third annular ridges includes a distal surface and a proximal surface, wherein each of the proximal surfaces is substantially convex and each of the distal surfaces is substantially concave.

6. The flow deflection element according to claim 5, wherein: The distal annular ridge includes a distal surface and a proximal surface, wherein the distal surface and the proximal surface of the distal annular ridge are substantially convex.

7. The flow deflection element according to claim 3, wherein: The proximal annular ridge has a diameter greater than the second annular ridge, the second annular ridge has a diameter greater than the third annular ridge, and the third annular ridge has a diameter greater than the distal annular ridge.

8. The flow deflection element according to claim 1, wherein: The flow deflecting element comprises an elastomeric material.

9. The flow deflection element according to claim 8, wherein: The flow deflecting element includes silicone.

10. A catheter, comprising: an insertion shaft extending along a longitudinal axis; an end effector disposed at a distal end of the insertion shaft; a sheath disposed around the insertion shaft; and A flow deviation element disposed at a distal end of the sheath, the flow deviation element comprising: a proximal end and a distal end; a lumen extending along the longitudinal axis from the proximal end to the distal end of the flow diverting element; a plurality of annular ridges disposed about the lumen between the proximal end and the distal end; and A plurality of manifolds are each disposed between adjacent ones of the plurality of annular ridges and including a plurality of fluid passages, each fluid passage extending from the lumen to an exterior of the flow diverting element.

11. The catheter according to claim 10, wherein The plurality of manifolds divert irrigation fluid from the lumen to the exterior of the flow diverting element to radially distribute the irrigation fluid around the end effector.

12. The catheter according to claim 11, wherein The end effector includes one or more electrodes configured for tissue ablation, and wherein the irrigation fluid cools the electrodes during ablation.

13. The catheter according to claim 11, wherein The end effector is a guide wire.

14. The catheter according to claim 10, wherein: The diameter of each of the plurality of annular ridges decreases relative to one another from the proximal end to the distal end of the flow diverting element.

15. The catheter according to claim 10, wherein The plurality of annular ridges include a proximal annular ridge, a second annular ridge, a third annular ridge, and a distal annular ridge.

16. The catheter of claim 15, wherein: The plurality of manifolds include a first manifold disposed between the proximal annular ridge and the second annular ridge, a second manifold disposed between the second annular ridge and the third annular ridge, and a third manifold disposed between the third annular ridge and the distal annular ridge.

17. The catheter of claim 15, wherein: Each of the proximal, second, and third annular ridges includes a distal surface and a proximal surface, wherein each of the proximal surfaces is substantially convex and each of the distal surfaces is substantially concave.

18. The catheter of claim 10, wherein: The distal end of the flow diverting element includes a distal aperture that forms a seal around an outer circumference of the end effector disposed through the lumen.

19. The catheter of claim 18, wherein: The seal comprises an elastomeric material.

20. The catheter of claim 19, wherein: The seal comprises silicone.

Images