Flow diverter for catheter

Abstract

To provide a flow diverter for a catheter.SOLUTION: The disclosed technology includes a flow diverter comprising a lumen extending along a longitudinal axis from a proximal end to a distal end of the flow diverter. The flow diverter can comprise a plurality of manifolds, each manifold comprising a plurality of fluid passageways, each fluid passageway extending from the lumen to an exterior of the flow diverter. The flow diverter can further comprise a plurality of annular ridges disposed around the lumen between the proximal end and the distal end of the flow diverter. Each manifold of the plurality of manifolds can be disposed between adjacent annular ridges of the plurality of annular ridges.SELECTED DRAWING: Figure 3A

Description

Technical Field

[0001] The present invention generally relates to medical devices, and more particularly to medical probes involving perfusion, and still more particularly to medical probes configured to provide perfusion to electrodes, but is not limited thereto.

Background Art

[0002] Cardiac arrhythmias such as atrial fibrillation (AF) occur when regions of cardiac tissue abnormally transmit electrical signals to adjacent tissue. This disrupts the normal cardiac cycle and causes asynchronous rhythms. Some specific procedures that exist for treating arrhythmias include surgically destroying the source of the signals causing the arrhythmia and destroying the conduction pathways of such signals. It is sometimes possible to stop or alter the propagation of unwanted electrical signals from one part of the heart to another by selectively ablating cardiac tissue by applying energy via a catheter.

[0003] 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 carbonization, burning, steam popping, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistulas.

Summary of the Invention

Problems to be Solved by the Invention

[0004] Before ablating tissue, it may be desirable to map the pulmonary vein or other anatomical features. During mapping, there is an increased chance of inducing a thrombus. Further, ablation of tissue can cause a local temperature rise near the electrode. For at least these reasons, it is desirable to provide a perfusion fluid to the anatomical area being treated or mapped. Unfortunately, many existing perfusion elements are designed with sharp curves or other inefficient designs that can reduce the effectiveness of the cooling provided by the perfusion element. Accordingly, there is a need in the art for a perfusion element that enhances the effectiveness of the cooling provided by the perfusion element.

Means for Solving the Problems

[0005] According to an embodiment of the technology of the present disclosure, there is provided a diverter comprising a proximal end and a distal end, a lumen extending from the proximal end to the distal end of the diverter along a longitudinal axis, 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 annular ridges of the plurality of annular ridges and capable of comprising a plurality of fluid passages, each fluid passage being capable of extending from the lumen to the outside of the diverter.

[0006] The distal end of the flow diverter can comprise a distal opening, which can be configured to form a seal around the outer periphery of an end effector disposed through the lumen. The plurality of annular ridges can comprise a proximal annular ridge, a second annular ridge, a third annular ridge, and a distal annular ridge. The plurality of manifolds can comprise 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 can include a distal surface and a proximal surface, each of the proximal surfaces can be substantially convex, and each of the distal surfaces can be substantially concave. The distal annular ridge can comprise a distal surface and a proximal surface, and both the distal surface and the proximal surface of the distal annular ridge can be substantially convex. The diameter of the proximal annular ridge can be greater than the diameter of the second annular ridge, the diameter of the second annular ridge can be greater than the diameter of the third annular ridge, and the diameter of the third annular ridge can be greater than the diameter of the distal annular ridge. The flow diverter can comprise an elastomeric material. The flow diverter can comprise silicone.

[0007] The disclosed technique can include 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 disposed around the insertion shaft, and a flow diverter disposed at a distal end of the sheath, the flow diverter having 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 diverter, 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 comprising a plurality of fluid passages, each fluid passage being capable of extending from the lumen to the exterior of the flow diverter.

[0008] The plurality of manifolds can divert the irrigation fluid from the lumen to the exterior of the diverter and radially distribute the irrigation fluid around the end effector. The end effector can comprise one or more electrodes configured for tissue ablation, and the irrigation fluid can cool the electrodes during ablation. The end effector can be a guide wire.

[0009] The diameter of each of the plurality of annular ridges may decrease relative to each other distally from the proximal end of the diverter. The plurality of annular ridges can comprise a proximal annular ridge, a second annular ridge, a third annular ridge, and a distal annular ridge. The plurality of manifolds can comprise 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 can comprise a distal surface and a proximal surface, each of the proximal surfaces can be substantially convex, and each of the distal surfaces can be substantially concave. The distal end of the diverter can comprise a distal opening, and the distal opening can form a seal around the outer periphery of the end effector disposed through the lumen. The seal can comprise an elastomeric material. The seal can comprise 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

Figure 2

Figure 3A

Figure 3B

Figure 3C

Figure 3D

Figure 3E

Figure 4A

Figure 4B

DETAILED DESCRIPTION OF THE INVENTION

[0013] The following detailed description should be read with reference to the drawings, and like elements in different drawings are given the same number. The drawings are not necessarily to scale, show selected embodiments, and are not intended to limit the scope of the present invention. The detailed description is by way of example and not limitation, and illustrates the principles of the present invention. This description enables those skilled in the art to make and use the present invention and describes some embodiments, adaptations, variations, alternatives, and uses of the present invention, including what is currently considered to be the best mode for practicing the present invention.

[0014] As used herein, the term "about" or "substantially" with respect to any numerical value or range indicates a reasonable dimensional tolerance that allows a component or collection thereof to function for the intended purpose described herein. More specifically, "about" or "substantially" can refer to a range of values that are ±20% of the recited value. For example, "about 90%" can refer to a range of values from 71% to 110%. Additionally, as used herein, the terms "patient", "host", "user", and "subject" refer to any human or animal subject, and while the use of the present 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" indicates the position closer to the operator or physician, while "distal" indicates the position farther from the operator or physician.

[0015] As contemplated herein, the vasculature of a "patient", "host", "user", and "subject" can be that of a human or any animal. It should be understood that the animal can be of any of a variety of applicable types, including, but not limited to, mammals, veterinary animals, livestock animals, or pet animals. By way of example, the animal can be a laboratory animal (e.g., rat, dog, pig, monkey, etc.) that is specifically selected to have certain properties similar to humans. It should be understood that the subject can be, for example, any applicable human patient.

[0016] As contemplated herein, a "physician" can include a physician, surgeon, technician, scientist, operator, or any other individual or delivery device associated with the delivery of a multi-electrode catheter for the treatment of drug-refractory atrial fibrillation to a subject.

[0017] As discussed herein, the terms "ablating" or "ablation," when referring to the devices and corresponding systems of the present disclosure, are used interchangeably throughout the present disclosure with pulsed electric fields (PEF) and pulsed field ablation (PFA) to refer to non-thermal energies such as reversible electroporation or irreversible electroporation (IRE), or thermal energies such as radiofrequency (RF) ablation or cryoablation, and are used to refer to components and structural features configured to reduce or prevent the generation of irregular cardiac signals within cells. When referring to the devices and corresponding systems of the present disclosure, ablating or ablation is used throughout the present disclosure with reference to thermal or non-thermal ablation of cardiac tissue in certain conditions including, but not limited to, arrhythmia, atrial fibrillation ablation, pulmonary vein isolation, supraventricular tachycardia ablation, and ventricular tachycardia ablation. The terms "ablating" or "ablation" also include known methods, devices, and systems for achieving various forms of body tissue ablation, as understood by those of ordinary skill in the art.

[0018] As discussed herein, the terms "tubular" and "tube" are to be construed broadly and are not limited to a straight cylindrical structure, or a structure with a strictly circular cross-section, or a structure with a uniform cross-section throughout its length. For example, a tubular structure is generally illustrated as a substantially straight 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 shows an exemplary catheter-based electrophysiology mapping and ablation system 10. System 10 includes a plurality of catheters that are percutaneously inserted by a physician 24 into a chamber or vascular structure of the heart 12 through the vasculature of a patient 23. Typically, a delivery sheath catheter is inserted into the left or right atrium near a desired location in the heart 12. Thereafter, a plurality of catheters can 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. In an example of sensing IEGM signals, the physician 24 moves the distal tip of catheter 14 (i.e., in this case, the end effector 200) to a target site within the heart 12. For ablation, the physician 24 similarly moves the distal end of the ablation catheter to a target site for ablation.

[0020] Catheter 14 is an exemplary catheter that includes a sheath 300 that includes a diverter 100 disposed at the distal end of the sheath 300. Catheter 14 can further include an end effector 200 that passes through the sheath 300 and the diverter. The 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 the end effector 200 to track the position and orientation of the end effector 200. The end effector 200 can further include one or more impedance-based electrodes disposed within or near the end effector 200 to track the position and orientation of the end effector 200. In some examples, the end effector 200 is a guide wire.

[0021] Magnetic base position sensors can operate with a position pad 25 that includes a plurality of magnetic coils 32 configured to generate a magnetic field within a predetermined working volume. The real-time position of the end effector 200 of the catheter 14 can be tracked based on the magnetic field generated by the position pad 25 and sensed by the magnetic base position sensor 29. The magnetic base position sensor can be a uniaxial sensor, a biaxial sensor, or a triaxial sensor depending on the particular configuration. Details of the magnetic base position sensing technique are described in U.S. Patent Nos. 5,391,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, and 6,892,091, each of which is incorporated herein by reference as if fully set forth herein.

[0022] System 10 includes one or more electrode patches 38 disposed for skin contact on patient 23 to establish position referencing of position pad 25 and impedance-based tracking of electrodes 26. For impedance-based tracking, current is directed to electrodes 26 and sensed at electrode skin patches 38, whereby the position of each electrode can be triangulated via electrode patches 38. Details of the impedance-based position tracking technique 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.

[0023] Recorder 11 displays an electrogram 21 captured by body surface ECG electrodes 18 and an intracardiac electrogram (IEGM) captured by electrodes 26 of catheter 14. Recorder 11 may include pacing capabilities for pacing the rhythm of the heart and / or may be electrically connected to an independent pacer.

[0024] System 10 may include an ablation energy generator 50 adapted to deliver ablation energy to one or more of the electrodes at the distal tip of a catheter configured to ablate. The energy generated by ablation energy generator 50 may include radiofrequency (RF) energy or pulsed-field ablation (PFA) energy, or combinations thereof, including unipolar or bipolar high voltage DC pulses such that they can be used to effect irreversible electroporation (IRE), but are not limited thereto.

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

[0026] The workstation 55 includes a memory, a processor unit having a memory or storage device loaded with appropriate operating software, and user interface functions. The workstation 55 optionally provides a plurality of functions including: (1) modeling the endocardial anatomical structure in three dimensions (3D) and rendering it to display a model or anatomical map 20 on the display device 27; (2) displaying on the display device 27, in a representative visual display or image overlaid on the rendered anatomical map 20, an activation sequence (or other data) compiled from the recorded electrogram 21; (3) displaying the real-time position and orientation of a plurality of catheters within the heart chamber; and (5) displaying on the display device 27 a site of interest such as a location where ablation energy is being applied. One commercially available product embodying the elements of the system 10 is available as the CARTO (trademark) 3 system, marketed by Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618, USA.

[0027] As shown in FIG. 2, the catheter 14 can include a sheath 300. The shunt 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 shunt 100 may be configured to deliver irrigation fluid radially around the end effector 200 to a target anatomical region. The end effector 200 may be provided through the shunt 100, and the distal end of the shunt 100 may be configured to form a seal around the outer periphery of the end effector 200. In some examples, the shunt 100 is provided inside a basket catheter and can provide irrigation to the electrodes of the catheter during operation.

[0028] Figures 3A-3D illustrate a diverter 100 according to the techniques of the present disclosure. As described above and as will be described in more detail herein, the diverter 100 can be configured to deliver fluid radially around an end effector and / or to a target anatomical region. The diverter 100 can include a substantially tubular lumen 150 provided along a longitudinal axis 180 of the diverter 100, as shown in FIG. 3D.

[0029] The diverter 100 can include a plurality of manifolds 115, 125, 135. Each manifold 115, 125, 135 may include a plurality of fluid passages 157 (such as those shown in FIG. 3D) extending from the lumen 150 to the exterior of the diverter 100. In some examples, each fluid passage 157 of the diverter 100 extends from an internal opening 156 provided on an inner circumference 152 of the lumen 150 to an external opening 158 provided around an outer circumference 154 of the lumen 150. In the example shown in FIGS. 3A-3D, each manifold includes 24 fluid passages 157, although the number of fluid passages may be varied. For example, each manifold may include 6, 12, 18, or 32 fluid passages, or any number therebetween. In some examples, the manifolds of the diverter may include different numbers of fluid passages. For example, the number of fluid passages may increase from the proximal end to the distal end of the diverter such that the second manifold 125 includes more fluid passages than the first manifold 115 and the third manifold 135 includes more fluid passages than the second manifold 125, or vice versa.

[0030] During operation, the end effector can be provided through the lumen 150 of the diverter 100. The distal opening 144 provided at the distal end 104 of the diverter 100 can form a seal around the outer periphery of the end effector. When perfusion fluid is supplied (e.g., by a pump) into the proximal opening 108 provided at the proximal end 102 of the diverter 100, the perfusion fluid is forced through the fluid passages 157 of the plurality of manifolds 115, 125, 135. In some examples, the perfusion fluid also exits from the distal opening 144 of the diverter 100. In some embodiments, the seal created by the distal opening 144 that interacts with the outer periphery of the end effector pushes the perfusion fluid only through the fluid passages 157 of the plurality of manifolds 115, 125, 135. In some examples, the inner diameter of the distal opening 144 is from about 0.010 inches to about 0.050 inches. In some examples, the inner diameter of the distal opening 144 is about 0.045 inches. In some examples, the inner diameter of the distal opening 144 is from about 0.255 millimeters (mm) to about 1.5 mm. In some examples, the inner diameter of the distal opening 144 is about 1.17 mm.

[0031] In some examples, the diverter 100 includes a plurality of annular ridges 110, 120, 130, 140. In some examples, the annular ridges can be provided to direct the perfusion fluid towards 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 towards the distal annular ridge 140 such that the annular ridges taper from the proximal end 102 to the distal end 104 of the diverter. The annular ridges can be flexible to conform to the shape of the anatomical region or anatomical lumen in which the diverter is provided. In some examples, the diverter is formed from silicone or otherwise includes silicone. As shown in FIGS. 3A - 3D, the diverter 100 can 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 diverter 100 from the proximal end 102 to the distal end 104.

[0032] In some embodiments, each annular ridge comprises a proximal surface and a distal surface. For example, proximal annular ridge 110 comprises proximal surface 112 and distal surface 114, second annular ridge 120 comprises proximal surface 122 and distal surface 124, third annular ridge 130 comprises proximal surface 132 and distal surface 134, and distal annular ridge 140 comprises a proximal surface and a distal surface. In some examples, each annular ridge is substantially conical. In some examples, each of the proximal surfaces of the annular ridges may be substantially convex, and each of the distal surfaces may 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 may be substantially concave, and the distal surface of distal annular ridge 140 may be substantially flat. In some examples, the distal surface of distal annular ridge 140 may be substantially convex.

[0033] In some examples, each proximal surface of the annular ridges (e.g., 112, 122, 132) tapers towards the proximal end 102 of the shunt 100 such that the proximal surface makes an angle with the longitudinal axis 180 of the shunt 100. The angled proximal surface can facilitate removal of the shunt 100 through the sheath 300 from the target anatomical region.

[0034] In some examples, the distal surface of each annular ridge (e.g., 114, 124, 134) tapers towards the proximal end 102 of the shunt and provides a distal surface at an angle with respect to the longitudinal axis 180 of the shunt 100. The angles of the proximal and distal surfaces may be approximately equal. In some examples, some overlap is provided between adjacent annular ridges. For example, the spacing between second annular ridge 120 and third annular ridge 130 may be provided such that 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 when viewed at an angle transverse to the longitudinal axis 180 (as shown in FIG. 3C).

[0035] In some examples, each of the plurality of manifolds 115, 125, 135 can be provided between adjacent annular ridges. For example, the external opening 158 of the fluid passage 157 of the first manifold 115 is provided between the proximal annular ridge 110 and the second annular ridge 120, and the external opening 158 of the fluid passage 157 of the second manifold 135 is provided between the second annular ridge 120 and the third annular ridge 130, and the external opening 158 of the fluid passage 157 of the third manifold 125 is provided between the third annular ridge 130 and the distal annular ridge 140. In some examples, the external opening 158 of the fluid passage 157 of each manifold is provided on the distal surface of the annular ridge. For example, the external opening 158 of the fluid passage 157 of the first manifold 115 is provided on the distal surface 114 of the proximal annular ridge 110, the external opening 158 of the fluid passage 157 of the second manifold 135 is provided on the distal surface 124 of the second annular ridge 120, and the external opening 158 of the fluid passage 157 of the third manifold 125 is provided on the distal surface 134 of the third annular ridge 130.

[0036] In some examples, the fluid passage 157 extends outwardly from the lumen at an angle Φ away from the longitudinal axis. The angle Φ can be a predetermined angle sufficient to direct the perfusion fluid discharged from the fluid passage of the manifold outwardly from the plurality of external openings such that the fluid is directed substantially radially about the longitudinal axis 180 (as shown in FIG. 3E). As a non-limiting example, the angle θ can be approximately 15°, 20°, 25°, 30°, 35°, 40°, 45°, 60°, 75°, 85°, or any other angle suitable for a particular application.

[0037] The diverter 100 is illustrated in a figure having four annular ridges, but other examples of the diverter 100 can include more or fewer annular ridges. For example, the diverter can 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 is equal to n, the number of manifolds is equal to n - 1). In some examples, the diverter 100 is formed by injection molding.

[0038] In some examples, the annular ridge extends outwardly from the lumen at an angle θ away from the longitudinal axis. The angle θ can be a predetermined angle sufficient to redirect the perfusion fluid discharged from the fluid passage of the manifold and direct it outwardly from the plurality of external openings such that the fluid is directed substantially across the longitudinal axis 180 (as shown in FIG. 3E). In some examples, the angle θ can direct the fluid to the electrodes provided on the end effector. By way of non-limiting example, the angle θ can be approximately 15°, 20°, 25°, 30°, 35°, 40°, 45°, 60°, 75°, 85°, or any other angle suitable for a particular application.

[0039] As shown in FIG. 3D, the distal end of the lumen 150 can include a ledge 103. The ledge 103 can be provided to abut the distal end of the insertion shaft when the insertion shaft of the catheter (e.g., the insertion shaft 350 as shown in FIG. 2) is received by the proximal opening 108 and provided within the distal end of the lumen 150 of the diverter 100.

[0040] In some examples, the proximal end 102 of the diverter 100 includes a corrugated tube 105. The corrugated portion 106 may be provided for attaching the diverter 100 to the distal end of a sheath (e.g., the sheath 300 shown in FIG. 2). Attachment of the diverter 100 to the distal end of the sheath can include placing the distal end of the sheath over the corrugated tube 105, then placing the electrode 165 over the outer periphery of the sheath, and securing the sheath to the diverter by coupling a collar 160 over both the electrode 165 and the distal end of the sheath. The electrode 165 can be configured for non-contact intracardiac electrogram signal sensing. As shown in FIG. 4A, the corrugated tube 105 provided at the proximal end 102 of the diverter may include a channel 107 provided through one or more of the waveforms. The channel 107 may be aligned with a slot provided within the collar (e.g., the slot 164 depicted in FIG. 4B) and provide a space for connecting a lead wire to a non-contact electrode (e.g., the electrode 165 depicted in FIG. 3C).

[0041] Figure 4B shows the color 160 component of the shunt 100. In some embodiments, the color provides a channel (e.g., channel 107 shown in FIG. 4A) that aligns through the waveform portion at the proximal end of the shunt to provide a space for the lead wire to connect to a non-contact electrode (e.g., electrode 165 shown in FIG. 3C). The color 160 may further include a hole 162 for receiving the lead wire. The lead wire may be connected to, for example, a treatment coil or electrode (not shown) provided near or below the electrode 165. The treatment coil or electrode can be configured, for example, for position sensing, delivery of ablation energy, or detection of electrophysiological signals.

[0042] The techniques of the present disclosure described herein can be further understood in accordance with the following clauses.

[0043] Clause 1: A shunt comprising a deck having a proximal end and a distal end, a lumen extending from the proximal end to the distal end of the shunt along a longitudinal axis, 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 annular ridges of the plurality of annular ridges and comprising a plurality of fluid passages, each fluid passage extending from the lumen to the exterior of the shunt.

[0044] Clause 2: The shunt of clause 1, wherein the distal end comprises a distal opening configured to form a seal around the outer periphery of an end effector disposed through the lumen.

[0045] Clause 3: The shunt of clause 1 or 2, wherein the plurality of annular ridges comprises a proximal annular ridge, a second annular ridge, a third annular ridge, and a distal annular ridge.

[0046] Clause 4: The diverter according to Clause 3, comprising a plurality of manifolds including 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.

[0047] Clause 5: The diverter according to Clause 4, wherein each of the proximal annular ridge, the second annular ridge, and the third annular ridge has a distal surface and a proximal surface, each of the proximal surfaces is substantially convex, and each of the distal surfaces is substantially concave.

[0048] Clause 6: The diverter according to Clause 5, wherein the distal annular ridge has a distal surface and a proximal surface, and both the distal surface and the proximal surface of the distal annular ridge are substantially convex.

[0049] Clause 7: The diverter according to Clause 3, wherein the diameter of the proximal annular ridge is larger than the diameter of the second annular ridge, the diameter of the second annular ridge is larger than the diameter of the third annular ridge, and the diameter of the third annular ridge is larger than the diameter of the distal annular ridge.

[0050] Clause 8: The diverter according to any one of Clauses 1 to 7, wherein the diverter includes an elastomeric material.

[0051] Clause 9: The diverter according to Clause 8, wherein the diverter includes silicone.

[0052] Clause 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 diverter disposed at a distal end of the sheath, the diverter having a proximal end and a distal end, a lumen extending along the longitudinal axis from the proximal end to the distal end of the diverter, 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 having a plurality of fluid passages, each fluid passage extending from the lumen to the exterior of the diverter.

[0053] Clause 11: The catheter according to Clause 10, wherein the plurality of manifolds divert a perfusate fluid from the lumen to the exterior of the diverter and radially distribute the perfusate fluid around the end effector.

[0054] Clause 12: The catheter according to Clause 11, wherein the end effector comprises one or more electrodes configured for tissue ablation and the perfusate fluid cools the electrodes during ablation.

[0055] Clause 13: The catheter according to Clause 11, wherein the end effector is a guide wire.

[0056] 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 diverter.

[0057] 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.

[0058] Clause 16: The catheter according to clause 15, comprising a first manifold disposed between a proximal annular bulge and a second annular bulge, a second manifold disposed between the second annular bulge and a third annular bulge, and a third manifold disposed between the third annular bulge and a distal annular bulge.

[0059] Clause 17: The catheter according to clause 15 or 16, wherein each of the proximal annular bulge, the second annular bulge, and the third annular bulge has a distal surface and a proximal surface, each of the proximal surfaces is substantially convex, and each of the distal surfaces is substantially concave.

[0060] Clause 18: The distal end of the shunt has a distal opening, and the distal opening forms a seal around the outer periphery of an end effector disposed through the lumen, the catheter according to any one of clauses 10 to 17.

[0061] Clause 19: The catheter according to clause 18, wherein the seal comprises an elastomeric material.

[0062] Clause 20: The catheter according to clause 19, wherein the seal comprises silicone.

[0063] The above embodiments are cited as examples, and the present invention is not limited to those specifically illustrated and described in this specification above. Rather, the scope of the present invention includes both various combinations of the features described herein heretofore and their partial combinations, as well as those variations and modifications thereof that would be contemplated by those skilled in the art upon reading the above description and that are not disclosed in the prior art.

[0064] 〔Embodiment〕 (1) A shunt, comprising a proximal end and a distal end, a lumen extending from the proximal end to the distal end of the shunt along a longitudinal axis, a plurality of annular bulges disposed around the lumen between the proximal end and the distal end, A plurality of manifolds, each manifold being disposed between adjacent annular ridges of the plurality of annular ridges and including a plurality of fluid passages, each fluid passage extending from the lumen to the outside of the diverter; and a plurality of manifolds. (2) The diverter according to embodiment 1, wherein the distal end includes a distal opening configured to form a seal around an outer periphery of an end effector disposed through the lumen. (3) The diverter according to embodiment 1, wherein the plurality of annular ridges includes a proximal annular ridge, a second annular ridge, a third annular ridge, and a distal annular ridge. (4) The diverter according to embodiment 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. (5) The diverter according to embodiment 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, each of the proximal surfaces being substantially convex and each of the distal surfaces being substantially concave.

[0065] (6) The diverter according to embodiment 5, wherein the distal annular ridge includes a distal surface and a proximal surface, both the distal surface and the proximal surface of the distal annular ridge being substantially convex. (7) The diverter according to embodiment 3, wherein the diameter of the proximal annular ridge is larger than the diameter of the second annular ridge, the diameter of the second annular ridge is larger than the diameter of the third annular ridge, and the diameter of the third annular ridge is larger than the diameter of the distal annular ridge. (8) The diverter according to embodiment 1, wherein the diverter includes an elastomeric material. (9) The diverter according to embodiment 8, wherein the diverter includes silicone. (10) A catheter, an insertion shaft extending along a longitudinal axis, An end effector disposed at the distal end of the insertion shaft; A sheath disposed around the insertion shaft; A diverter disposed at the distal end of the sheath, the diverter having a proximal end and a distal end; A proximal end and a distal end; A lumen extending along the longitudinal axis from the proximal end to the distal end of the diverter; A plurality of annular ridges disposed around the lumen between the proximal end and the distal end; A plurality of manifolds, each manifold being disposed between adjacent ones of the plurality of annular ridges and having a plurality of fluid passages, each fluid passage extending from the lumen to the exterior of the diverter, the diverter including the plurality of manifolds.

[0066] (11) The catheter according to embodiment 10, wherein the plurality of manifolds divert the irrigation fluid from the lumen to the exterior of the diverter and radially distribute the irrigation fluid around the end effector. (12) The catheter according to embodiment 11, wherein the end effector includes one or more electrodes configured for tissue ablation, and the irrigation fluid cools the electrodes during ablation. (13) The catheter according to embodiment 11, wherein the end effector is a guide wire. (14) The catheter according to embodiment 10, wherein the diameter of each of the plurality of annular ridges decreases from the proximal end to the distal end of the diverter. (15) The catheter according to embodiment 10, wherein the plurality of annular ridges includes a proximal annular ridge, a second annular ridge, a third annular ridge, and a distal annular ridge.

[0067] (16) The catheter according to embodiment 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. (17) The catheter according to embodiment 15, wherein each of the proximal annular ridge, the second annular ridge, and the third annular ridge has a distal surface and a proximal surface, each of the proximal surfaces is substantially convex, and each of the distal surfaces is substantially concave. (18) The catheter according to embodiment 10, wherein the distal end of the diverter has a distal opening that forms a seal around the outer periphery of the end effector disposed through the lumen. (19) The catheter according to embodiment 18, wherein the seal comprises an elastomeric material. (20) The catheter according to embodiment 19, wherein the seal comprises silicone.

Claims

1. A shunt, comprising: a proximal end and a distal end; a lumen extending along a longitudinal axis from the proximal end to the distal end of the shunt; a plurality of annular ridges disposed around the lumen between the proximal end and the distal end; a plurality of manifolds, each manifold being disposed between adjacent ones of the plurality of annular ridges and comprising a plurality of fluid passages, each fluid passage extending from the lumen to the exterior of the shunt.

2. The shunt according to claim 1, wherein the distal end comprises a distal opening configured to form a seal around an outer periphery of an end effector disposed through the lumen.

3. The shunt according to claim 1, wherein the plurality of annular ridges includes a proximal annular ridge, a second annular ridge, a third annular ridge, and a distal annular ridge.

4. The shunt according to claim 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.

5. The shunt according to claim 4, wherein each of the proximal annular ridge, the second annular ridge, and the third annular ridge comprises a distal surface and a proximal surface, each of the proximal surfaces being substantially convex and each of the distal surfaces being substantially concave.

6. The shunt according to claim 5, wherein the distal annular ridge comprises a distal surface and a proximal surface, both the distal surface and the proximal surface of the distal annular ridge being substantially convex.

7. The shunt according to claim 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.

8. The shunt according to claim 1, wherein the shunt comprises an elastomeric material.

9. The shunt according to claim 8, wherein the shunt comprises 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. A diverter disposed at the distal end of the sheath, having a proximal end and a distal end, a lumen extending along the longitudinal axis from the proximal end to the distal end of the diverter, a plurality of annular ridges disposed around the lumen between the proximal end and the distal end, a plurality of manifolds, each manifold being disposed between adjacent annular ridges of the plurality of annular ridges and having a plurality of fluid passages, each fluid passage extending from the lumen to the outside of the diverter, and a diverter including the plurality of manifolds. A catheter comprising: **Claim 11** The catheter according to claim 10, wherein the plurality of manifolds divert the perfusion fluid from the lumen to the outside of the diverter and radially distribute the perfusion fluid around the end effector. **Claim 12** The catheter according to claim 11, wherein the end effector includes one or more electrodes configured for tissue ablation, and the perfusion fluid cools the electrodes during ablation. **Claim 13** The catheter according to claim 11, wherein the end effector is a guide wire. **Claim 14** The catheter according to claim 10, 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 diverter. **Claim 15** The catheter according to claim 10, wherein the plurality of annular ridges includes a proximal annular ridge, a second annular ridge, a third annular ridge, and a distal annular ridge. **Claim 16** The catheter according to claim 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. **Claim 17** The catheter according to claim 15, wherein each of the proximal annular ridge, the second annular ridge, and the third annular ridge has a distal surface and a proximal surface, each of the proximal surfaces is substantially convex, and each of the distal surfaces is substantially concave. **Claim 18** The catheter according to claim 10, wherein the distal end of the diverter has a distal opening, and the distal opening forms a seal around the outer periphery of the end effector disposed through the lumen. **Claim 19** The catheter according to claim 18, wherein the seal comprises an elastomeric material. **Claim 20** The catheter according to claim 19, wherein the seal comprises silicone.

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