Medical device with irrigation manifold

Abstract

The disclosed techniques include directing irrigation fluid to an irrigation manifold for an end effector of a medical device. The irrigation manifold includes a housing and a diverter extending along a longitudinal axis and connected to irrigation tubes, respectively. The end effector includes sheaths each defining an irrigation conduit connected to the irrigation manifold to allow an irrigation fluid flow to be uniformly distributed through the sheath.

Description

Technical Field

[0001] The present technology relates generally to medical devices, and particularly to medical probes having electrodes, and further, but not exclusively, to medical probes suitable for inducing irreversible electroporation (IRE) of cardiac tissue. Background Art

[0002] 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.

[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, burning, steam bursts, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistulas.

[0004] 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.

[0005] 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 constructed 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.

[0006] When using IRE ablation, irrigation is required to ensure that thrombosis does not occur. However, ensuring uniform irrigation around the electrode is a challenge. Therefore, improved techniques are needed to evenly distribute the irrigation fluid flow around each electrode. Summary of the invention

[0007] According to the disclosed technology, a flushing manifold for a medical device is provided. The flushing manifold may include a housing extending along a longitudinal axis, defining a housing lumen and a housing conduit offset from the housing lumen, the housing conduit being configured to be connected to a mainline flushing tube. The flushing manifold may include a diverter defining a diverter lumen connected to the housing to define a flushing chamber. The diverter may include a first shaft nested within the housing lumen. The diverter may include a diverter ring defining a plurality of diverter conduits radially arranged around the longitudinal axis and connected to a distal end of the housing. Each diverter conduit is configured to be connected to a diverter flushing tube that directs fluid to an end effector of the medical device.

[0008] According to the disclosed technology, an end effector for a medical device is further provided. The end effector may include a flushing manifold, at least one ridge and an actuator rod. The flushing manifold extends along a longitudinal axis and may include a housing and a diverter. The housing defines a housing lumen and a housing conduit. The diverter defines a diverter lumen, is connected to the housing to define a flushing chamber, and defines at least one diverter conduit. The fluid is configured to flow into the flushing chamber via the housing conduit and to flow out of the flushing chamber via at least one diverter conduit. At least one ridge is connected to the flushing manifold at the proximal end of the at least one ridge, and is configured to bend radially outward from the longitudinal axis and move between an expanded configuration and a collapsed configuration. At least one diverter conduit is configured to guide fluid along at least one ridge. The actuator rod passes through the housing lumen and the diverter lumen and is connected to the distal end of at least one ridge. The actuator rod is configured to move at least one ridge between an expanded configuration and a collapsed configuration. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Figure 1 is a schematic illustration of a medical system including a medical device according to the disclosed technology, the distal end of the medical system including a medical probe having electrodes;

[0010] Figure 2 is a schematic illustration showing a perspective view of an end effector of a medical device in an expanded configuration according to the disclosed technology;

[0011] Figure 3 is a schematic illustration showing a perspective view of an end effector 100 according to the disclosed technology, with the sleeve, coil and ring removed for clarity;

[0012] Figure 4 is a schematic illustration showing a detailed perspective view of a distal end of a spine frame according to the disclosed technology;

[0013] Figure 5is a schematic illustration showing a detailed perspective view of a proximal end of an end effector according to the disclosed technology, with the cannula removed;

[0014] Figure 6 is a schematic illustration of an exploded view of a flush manifold, a mainline flush pipe, and a diverter flush pipe according to the disclosed technology;

[0015] Figure 7 is a schematic illustration showing a perspective view of a proximal end of an end effector shown in cross-section to illustrate certain features in accordance with the disclosed technology;

[0016] Figure 8 is to show the relative Figure 2 Schematic illustration of a cross-sectional view of the proximal end of the end effector cut along line 8-8 in FIG.

[0017] Fig. 9 is a diagram showing the relative Figure 2 A schematic illustration of a cross-sectional view of the proximal end of the end effector cut along line 9-9 in FIG. 1 ; and

[0018] Fig.10 is a diagram showing the relative Figure 3 Schematic illustration of a cross-sectional view of the proximal end of the end effector cut along line 10-10. DETAILED DESCRIPTION

[0019] The following detailed description should be read in conjunction with the accompanying drawings, in which the same elements in different drawings are labeled the same. The accompanying drawings (not necessarily drawn to scale) depict selected examples and are not intended to limit the scope of the present disclosure. The detailed description illustrates the principles of the disclosed technology 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 disclosed technology, and describes several embodiments, adaptations, variations, alternative forms and uses of the disclosed technology, including what is currently believed to be the best way to implement the disclosed technology.

[0020] 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 the purpose it is intended to achieve 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 technology 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.

[0021] 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.

[0022] As discussed herein, an "operator" may include a physician, surgeon, technician, scientist, or any other individual or delivery instrumentation associated with delivering a multi-electrode catheter for treating drug-refractory atrial fibrillation to a subject.

[0023] As discussed herein, when referring to the devices and corresponding systems of the present disclosure, the term "ablation" refers to components and structural features that are configured to reduce or prevent the generation of unstable cardiac signals in cells by utilizing non-thermal energy (such as irreversible electroporation (IRE)), which are interchangeably referred to as pulsed electric fields (PEF) and pulsed field ablation (PFA) in the present disclosure. "Ablation" as used throughout the present disclosure, when referring to the devices and corresponding systems of the present disclosure, refers to 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.

[0024] As discussed herein, the terms "bipolar" and "monopolar" when used to refer to ablation protocols describe ablation protocols that differ in current paths and electric field distribution. "Bipolar" refers to an ablation protocol that utilizes a current path between two electrodes as described below, both electrodes being positioned at a treatment site; the current density and electric flux density at each of the two electrodes are generally approximately equal. "Monopolar" refers to an ablation protocol that utilizes a current path between two electrodes as described below, wherein one electrode having a high current density and a high electric flux density is positioned at the treatment site, and a second electrode having a relatively lower current density and a lower electric flux density is positioned away from the treatment site.

[0025] As discussed herein, the terms "tubular," "tube," and "shaft" 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 / shaft structures are generally illustrated as structures that are substantially perfect cylinders. However, tubular / shaft structures may have tapered or curved outer surfaces without departing from the scope of the present disclosure.

[0026] The present disclosure relates to systems, methods or uses and devices for performing IRE ablation of cardiac tissue to treat arrhythmias. Ablation energy is typically provided to cardiac tissue by a distal portion of a catheter that can deliver ablation energy along the tissue to be ablated. Some example catheters include a three-dimensional structure at the distal portion and are configured to apply ablation energy from various electrodes positioned on the three-dimensional structure. Fluoroscopy can be used to visualize ablation procedures incorporating such example catheters.

[0027] Ablation of cardiac tissue to correct a malfunctioning heart using the application of thermal techniques such as radiofrequency (RF) energy and cryoablation is a well-known procedure. Typically, in order to successfully ablate using thermal techniques, it is necessary to measure cardiac electrode potentials at various locations of the myocardium. In addition, temperature measurements during ablation provide data that can achieve ablation efficacy. Typically, for ablation procedures using thermal ablation, electrode potentials and temperatures are measured before, during, and after the actual ablation. RF methods may have the risk of causing tissue charring, burns, steam bursts, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistulas. Cryoablation is an alternative to RF ablation that can reduce some of 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 electrical ablation devices.

[0028] The present disclosure may include electrodes configured for irreversible electroporation (IRE), RF ablation, and / or cryoablation. Throughout the present disclosure, IRE may be referred to interchangeably as pulsed electric field (PEF) ablation and pulsed field ablation (PFA). IRE as discussed in the present disclosure is a non-thermal cell death technique that can be used for ablation of atrial arrhythmias. In order to ablate using IRE / PEF, biphasic voltage pulses are applied to destroy the cellular structure of the myocardium. Biphasic pulses are non-sinusoidal and can be tuned to target cells based on the electrophysiology of the cells. In contrast, in order to ablate using RF, a sinusoidal voltage waveform is applied to generate heat at the treatment area, heating all cells in the treatment area indiscriminately. Therefore, IRE has the ability to avoid adjacent heat-sensitive structures or tissues, which will have benefits in reducing possible complications known to be affected by ablation or separation modalities. In addition or alternatively, monophasic pulses can be used.

[0029] Electroporation can be induced by applying a pulsed electric field across biological cells to cause holes to be reversibly (temporarily) or irreversibly (permanently) produced in the cell membrane. When a pulsed electric field is applied, the cell has a transmembrane electrostatic potential that is elevated above the static potential. When the transmembrane electrostatic potential remains below the threshold potential, electroporation is reversible, which means that the hole can be closed when the applied pulsed electric field is removed, and the cell can self-repair and survive. If the transmembrane electrostatic potential is elevated above the threshold potential, electroporation is irreversible and the cell becomes permanently permeable. Therefore, the cell dies due to the loss of homeostasis and usually dies by apoptosis. Typically, different types of cells have different threshold potentials. For example, cardiac cells have a threshold potential of approximately 500V / cm, while for bones, the threshold potential is 3000V / cm. These differences in threshold potentials allow IRE to selectively target tissues based on the threshold potential.

[0030] The technology disclosed herein includes systems and methods for applying electrical signals from catheter electrodes positioned near myocardial tissue to generate ablation energy to ablate myocardial tissue. In some examples, the system and method can effectively ablate targeted tissue by inducing irreversible electroporation. In some examples, the system and method can effectively induce reversible electroporation as part of a diagnostic procedure. Reversible electroporation occurs when the electricity applied by the electrode is lower than the electric field threshold of the target tissue that allows cell repair. Reversible electroporation does not kill cells, but allows physicians to view the effects of reversible electroporation on electrical activation signals near the target location. Exemplary systems and methods for reversible electroporation are disclosed in U.S. Patent Publication 2021 / 0162210, the entire contents of which are incorporated herein by reference.

[0031] The effectiveness of pulsed electric field and its induction of reversible electroporation and / or irreversible electroporation may be affected by the physical parameters of the system and the biphasic pulse parameters of the electrical signal. The physical parameters may include electrode contact area, electrode spacing, electrode geometry, etc. The examples proposed herein generally include physical parameters suitable for effectively inducing reversible electroporation and / or irreversible electroporation. The biphasic pulse parameters of the electrical signal may include voltage amplitude, pulse duration, pulse phase delay, pulse delay, total application time, energy delivered, etc. In some examples, the parameters of the electrical signal may be adjusted to induce both reversible and irreversible electroporation given the same physical parameters. Examples of various ablation systems and methods including IRE are presented in U.S. Patent Publications 2021 / 0169550A1, 2021 / 0169567A1, 2021 / 0169568A1, 2021 / 0161592A1, 2021 / 0196372A1, 2021 / 0177503A1, and 2021 / 0186604A1, the entire contents of each of which are incorporated herein by reference.

[0032] refer to Figure 1 , which shows an example catheter-based electrophysiological mapping and ablation system 10. 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 example medical device / probe, such as a catheter 14, configured for sensing IEGM is illustrated herein. The physician 24 brings the distal end of the catheter 14 (i.e., in this case, the basket assembly 28) into contact with the heart wall for sensing a target site in the heart 12. The catheter 14 with a distal basket assembly may be referred to as a basket catheter. For ablation, the physician 24 would similarly bring the distal end of the ablation catheter to the target site for ablation.

[0033] The catheter 14 is an exemplary catheter that includes one and preferably a plurality of electrodes 26, optionally distributed on a plurality of spines 104 at a basket assembly 28 and configured to sense IEGM signals. The catheter 14 may additionally include a position sensor embedded in or near the basket assembly 28 for tracking the position and orientation of the basket assembly 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.

[0034] The magnetic-based position sensor can operate 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 assembly 28 of the catheter 14 can be tracked based on the magnetic field generated by 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.

[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. Patents 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182, each of which is incorporated herein by reference.

[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, a positioning pad 25, surface ECG electrodes 18, electrode patches 38, an ablation energy generator 50, and a recorder 11. Optionally and preferably, the PIU 30 additionally includes processing capabilities for enabling real-time calculation of the position of the catheter and for performing ECG calculations.

[0039] Workstation 55 includes memory, a processor unit with memory or storage loaded with appropriate operating software, and user interface capabilities. Workstation 55 can provide multiple functions, optionally including: (1) three-dimensional (3D) modeling of endocardial anatomy and rendering of the model or anatomical map 20 for display on display device 27; (2) displaying on display device 27 an activation sequence (or other data) compiled from recorded electrograms 21 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 on display device 27 sites of interest, such as where ablation energy has been applied. A commercial product embodying elements of system 10 may be CARTO TM 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 medical device 14 (such as a medical probe) having an electrode 26. The medical device 14 includes an end effector 100 at its distal end 28. The end effector 100 in the presently described example takes the form of a basket assembly including at least one spine 104. The spine 104 may have an elliptical (e.g., circular) or rectangular (which may appear flat) cross-section and include a flexible, resilient material (e.g., a shape memory alloy such as nickel titanium, also known as Nitinol) forming struts.

[0041] The end effector 100 is connected to the rest of the medical probe 14 via an elongated shaft 200. The elongated shaft 200 may be tubular in form and flexible, with certain portions being more flexible than other portions. For example, the end portion may be made more flexible than the rest to allow for easy deflection of the end effector 100. The elongated shaft 200 may be formed of a flexible, biocompatible, electrically insulating material such as a polyamide-polyether (Pebax) copolymer, polyethylene terephthalate (PET), polyurethane, polyimide, polyparaxylene, silicone, and the like. In some examples, the insulating material may include a biocompatible polymer, including, but not limited to: polyetheretherketone (PEEK), polyglycolic acid (PGA), poly(lactic-glycolic acid) copolymer (PLGA), polycaprolactone (PCL), poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV), poly-L-lactide, polydioxanone, polycarbonate, and polyanhydride, wherein the proportions of certain polymers are selected to control the extent of the inflammatory response.

[0042] In some examples, such as in Figure 3 As seen in the figure, the spine 104 can be integrally formed with the distal hub (referred to herein as the crown 108) to form an integral / unitary spine frame 102. In other examples, the frame 102 can be formed from a plurality of spines 104 and crowns 108 that are formed separately and connected together. The frame 104 can be formed from planar or cylindrical tubular stock using any suitable method. For example, the frame 102 can be formed by cutting, laser cutting, stamping, etc.

[0043] The non-invasive ring 114 and the coil 116 are connected to the crown 108. In some examples, the coil 116 may include a single axis sensor (SAS). In other examples, the coil 116 may include a dual axis sensor (DAS) or a three axis sensor (TAS). The coil 116 may include a conductive material wound into a coil or a coil formed as a flexible circuit. The coil 116 may include an electrical lead for conducting the current induced on the coil to the patient interface unit 30. As will be known, by attaching the coil 116 to the distal end of the end effector 100, the position of the distal end can be detected. In this way, the physician 24 can more accurately determine the position of the distal end of the end effector 100 before applying ablation energy to the tissue.

[0044] An insulating material (referred to herein as a sheath 106) is disposed over each ridge. Each sheath 106 is used to enhance the non-invasiveness of the end effector 100, to protect the subject from sharp edges, and for flushing purposes as described in more detail below. The sheath 106 may comprise a polymer. For example, the sheath 106 may be formed of a flexible, biocompatible, electrically insulating material such as a polyamide-polyether (Pebax) copolymer, polyethylene terephthalate (PET), polyurethane, polyimide, polyparaxylene, silicone, and the like. In some examples, the insulating material may include a biocompatible polymer, including, but not limited to, polyetheretherketone (PEEK), polyglycolic acid (PGA), poly(lactic-glycolic acid) copolymer (PLGA), polycaprolactone (PCL), poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV), poly-L-lactide, polydioxanone, polycarbonate, and polyanhydride, wherein the proportions of certain polymers are selected to control the extent of the inflammatory response. Furthermore, while the sheath 106 is shown as being tubular in these figures, the sheath 106 may be shaped, scalloped, ribbed, ridged, concave, convex, or otherwise configured such that the overall profile of the sheath 106 produces the physical and / or mechanical properties required of the end effector 100 as mentioned above, such as rigidity and flexure along multiple axes. In addition, a flexible sleeve 146 is disposed between the proximal end of the end effector 100 and the irrigation manifold 120 ( Figure 3 ), which will be discussed in more detail below.

[0045] The spine 104 is movable between an expanded configuration and a collapsed configuration. The elongated shaft 200 connects the end effector 100 to a handle, which the operator 24 can manipulate in use. An actuator rod 202 is connected to the crown 108 to facilitate expansion and collapse of the spine 104. For example, the rod 202 can translate along the longitudinal axis A1 to expand / collapse the spine 104. In the expanded configuration ( Figure 2 ) and collapsed configurations, one or more ridges 104 may be bent radially outward from the longitudinal axis A1. When the elongated shaft 200 is not bent, the ridges 104, the elongated shaft 200, and the actuator rod 202 are arranged generally along the longitudinal axis A1.

[0046] Figure 3 1 is a schematic illustration showing a perspective view of the end effector 100 with the sleeve 146, coil 116 and ring 114 removed for clarity. As shown, the frame 102 has a distal end 102A (including the crown 108) and a proximal end 102B. The proximal end 102B is connected to the irrigation manifold 120, which directs an irrigation flow 300 therethrough via a fluid source 302 coupled to the mainline irrigation tube 140 and described in more detail below.

[0047] Figure 4 1 is a schematic illustration showing a detailed perspective view of the distal end 102A of the frame. As shown, the actuator rod 202 extends within a lumen in the crown 108, and the ring 114 connects the actuator rod 202 to the crown 108 via a locking notch 110 defined in the crown 108. The actuator rod 202 also defines a lumen 204 that is coaxial with the longitudinal axis A1, through which various medical devices (such as a mapping catheter or guidewire) can extend when in use.

[0048] Continue to refer Figure 4 , a pair of openings can be seen in the sheath 106 extending its length. Specifically, each sheath 106 defines a ridge channel 106A and an irrigation conduit 106B separated by a sheath wall 106C. Each ridge channel 106A and irrigation conduit 106B can span the entire length of the sheath 106. The ridge 104 extends from the crown 108 through the ridge channel 106A and terminates at a ridge proximal end 112 ( Figure 5 ) at the ridge 104. Irrigation conduit 106B directs fluid along ridge 104 and is described in more detail below.

[0049] Figure 5 is a schematic illustration showing a detailed perspective view of the proximal end of end effector 100 . Figure 6 is a schematic illustration of an exploded view of the flush manifold 120, the mainline flush pipe 140, and the diverter flush pipe 142. In addition to the above, reference is made to Figure 5 and Figure 6 , the distal end 112 of the ridge 104 is connected to a ridge coupler 118, which is shaped to adapt to the shape of the distal end 112. The ridge coupler 118 is connected to an irrigation manifold 120, which is designed to evenly distribute irrigation fluid 300 in the area where the end effector 100 is positioned within the patient 23. The irrigation manifold 120 includes a manifold housing 122 and an irrigation diverter 128 that are connected together and extend along the longitudinal axis A1. Although shown as separate components, in some examples, the housing 122 and the diverter 128 may be formed integrally. Therefore, in some examples, the term "connected" may also be considered to refer to "integrated." When connected, the housing 122 and the diverter 128 define a flush chamber 144 ( Figures 7 to 10 ), which is discussed in more detail below.

[0050] Figure 7 is a schematic illustration showing a perspective view of the proximal end of end effector 100 shown in cross-section to illustrate certain features of the disclosed technology. Figure 8 is shown relative to Figure 2 Schematic illustration of a cross-sectional view of the proximal end of end effector 100 cut along line 8-8 in FIG. Fig. 9 is shown relative to Figure 2 Schematic illustration of a cross-sectional view of the proximal end of end effector 100 cut along line 9-9 in FIG. Fig.10 is shown relative to Figure 3 Schematic illustration of a cross-sectional view of the proximal end of end effector 100 cut along line 10-10 in FIG.

[0051] refer to Figures 5 to 10 The manifold housing 122 is generally cylindrical in form and defines a housing cavity 124 and a hollow portion (relative to Figure 8 and Fig. 9 The housing lumen 124 is parallel or coaxial with the longitudinal axis A1. The housing conduit 126 connected to the mainline flushing tube 140 is axially offset from the housing lumen. Figures 6 to 8 As particularly seen in FIG. 1 , the housing conduit 126 is formed in the proximal wall of the housing 122 adjacent the hollow portion.

[0052] In addition to the above, the irrigation diverter 128 is generally cylindrical in form. The irrigation diverter 128 includes a first diverter shaft 130, a diverter ring 132, and a second diverter shaft 136, all of which are axially aligned along the longitudinal axis A1, wherein a diverter lumen 138 is defined through the irrigation diverter. The first diverter shaft 130 and the second diverter shaft 136 are disposed on opposite sides of the diverter ring 132 along the longitudinal axis A1. As shown in Figure 5 and Figures 7 to 9 As particularly shown in FIG. 1 , the ridge coupler 130 surrounds the second diverter shaft 136 to connect thereto.

[0053] As in Figures 7 to 9 , the first diverter shaft 130 is nested within the housing lumen 124. The diverter ring 132 has a larger outer diameter than the first diverter shaft 130 and the second diverter shaft 136 and defines one or more diverter conduits 134 that are radially disposed about and extend along the longitudinal axis A1 and are spaced apart around the circumference of the diverter ring 132. In other words, the diverter conduits 134 are laterally offset from the longitudinal axis A1 and extend parallel to the longitudinal axis.

[0054] A lip 132A is also formed in the outer surface of the diverter ring 132. Figures 7 to 9As can be seen in particular in the drawings, the lip nests with the inner annular surface of the manifold housing 122. Thus, due to the respective nesting of the first diverter shaft 130 and the diverter ring 132 with the manifold housing 122, the space created therebetween forms a flushing chamber 144 in the form of an annular shape. The flushing chamber 144 fluidly connects the mainline flushing tube 140 with the diverter conduit and is discussed in more detail below. In addition, due to the axially aligned lumens 124, 138 and the annular form of the flushing chamber 144, the actuator rod 202 is able to pass through the lumens 124, 138 and extend at least partially through the elongated shaft 200.

[0055] Now the main reference Figures 5 to 10 , each shunt conduit 134 is connected to a shunt irrigation tube 142. More specifically, the proximal end of each shunt irrigation tube 142 can be inserted into the corresponding shunt conduit 134 so that the shunt irrigation tube 142 extends away from the irrigation manifold 120 and toward the distal end of the end effector 100. Figure 6 As can be seen in detail in FIG. 1 , the diverter flushing tubes 142 are oriented parallel to each other and parallel to the longitudinal axis A1. The diverter flushing tubes 142 are disposed radially outside the ridge coupling 118 ( Figure 5 and Figures 7 to 9 ). In other words, the diverter flush tube 142 is spaced farther from the longitudinal axis A1 than the distance of the ridge coupler 118 from the longitudinal axis (ie, the radius of the ridge coupler 118). Figure 5 , the diverter flush tube 142 surrounds the ridge coupler 118 and the second diverter shaft 136 .

[0056] Continue to refer Figures 5 to 10 , the diverter flushing pipe 142 can be classified into two pipe groups. Specifically, the diverter flushing pipe 142 includes a first diverter flushing pipe 142A and a second diverter flushing pipe 142B. Figure 5 As best seen in FIG. 1 , the diverter conduits 134 are generally grouped into groups of three, and the second diverter flush tube 142B is sandwiched between two adjacent first diverter flush tubes 142A. Thus, in the disclosed example, the ratio of first diverter flush tubes 142A to second diverter flush tubes 142B is 2:1, but other ratios may be employed without departing from the spirit and scope of the present disclosure.

[0057] As in Figure 5 and Fig. 9 As specifically shown in FIG. 1 , the distal end of each first shunt irrigation tube 142A is connected to / received by the irrigation conduit 106B of the corresponding sheath 106. This connection creates a continuous fluid path from the irrigation chamber 144 to the irrigation conduit 106B. Figure 3As schematically illustrated by dashed lines 300 in FIG. 1 , flushing fluid 300 from a fluid source 302 is directed through the mainline flushing tube 140, into the flushing manifold 120 (specifically, the flushing chamber 144), through each first diverter flushing tube 142 (for purposes of schematic illustration, in FIG. 1 ). Figure 3 Only one path is shown), enters each irrigation catheter 106B, and exits into the patient 23 through the electrode 26 disposed on each ridge 104 or proximal to the electrode.

[0058] In the examples described herein, the electrodes 26 may be configured to deliver ablative energy (IRE and / or RF) to tissue in the heart 12. In addition to using the electrodes 26 to deliver ablative energy, the electrodes 26 may also be used to determine the position of the end effector 100 and / or measure physiological properties, such as local surface potentials at corresponding locations on tissue in the heart 12. The electrodes 26 may be biased such that a larger portion of the electrodes 26 faces outward from the end effector 100, such that the electrodes 26 deliver a greater amount of electrical energy outwardly away from the end effector 100 (i.e., toward the heart 12 tissue) rather than inwardly toward the end effector 100.

[0059] Examples of materials ideally suited for forming electrode 26 include gold, platinum, and palladium (and their respective alloys). These materials also have high thermal conductivity, which allows minimal heat generated on the tissue (i.e., by the ablative energy delivered to the tissue) to be conducted through the electrode to the back side of the electrode (i.e., the portion of the electrode on the inside of the ridge), and then to the blood pool in the heart 12.

[0060] The electrode 26 may be provided with one or more outlets 26A ( Figure 2 ), the one or more outlets passing through or in close proximity to the electrode. In use, as irrigation fluid 300 passes through irrigation conduit 106B, a portion of the fluid 300 is allowed to exit through outlet 26A, so that irrigation is provided directly at each electrode 26. In some examples, some of the irrigation fluid 300 may continue all the way down sheath 106 past the distal-most electrode 26 and exit proximal to ring 114 (see Figure 4 For reference). In other examples, the ring 114 or another element may be configured to occlude the distal end of the irrigation catheter 106 to block fluid flow, or be adjustable to selectively allow fluid flow away from the distal end as desired by the physician 24.

[0061] Now specific reference Figure 5 , Figure 7 and Figure 8, the distal end of each second shunt flush tube 142B is not received by the flushing catheter 106B. Instead, the second shunt flush tube 142B terminates outside the catheter 106B so that the flushing fluid 300 is delivered directly into the patient 23 in use, rather than first being directed through the catheter. In the illustrated example, the distal end of the second shunt flush tube 142B terminates near the proximal end of the sheath 106 along the longitudinal axis A1. Figure 8 As depicted, irrigation fluid 300 entering the irrigation chamber 144 is directed through the second diverter irrigation tube 142B in addition to being directed through the first diverter irrigation tube 142A to provide irrigation near the proximal end of the end effector 100. In some examples, the second diverter irrigation tube 142B may be omitted.

[0062] As exemplified in the foregoing, the irrigation manifold 120 and shunt tube 142 and irrigation conduit 106B formed in sheath 106 enable irrigation to be evenly distributed around electrode 26 while providing a means of providing irrigation directly within patient 23. As should be appreciated, the presently disclosed technology may be modified in various ways without departing from the spirit and scope of the present disclosure.

[0063] The disclosed technology described herein can be further understood according to the following terms:

[0064] Item 1. A flushing manifold for a medical device, the flushing manifold comprising: a shell extending along a longitudinal axis, defining a shell lumen and a shell conduit offset from the shell lumen, the shell conduit being configured to be connected to a mainline flushing tube; and a diverter defining a diverter lumen, connected to the shell to define a flushing chamber, and comprising: a first shaft nested within the shell lumen; a diverter ring defining a plurality of diverter conduits radially arranged around the longitudinal axis and connected to a distal end of the shell, each diverter conduit being configured to be connected to a diverter flushing tube that directs fluid to an end actuator of the medical device.

[0065] Clause 2. The flush manifold of clause 1, wherein the flush chamber is annular in form.

[0066] Clause 3. The flush manifold of any of clauses 1 to 2, the diverter ring defining a lip that nests with an inner annular surface of the housing.

[0067] Clause 4. The flushing manifold of any of Clauses 1 to 3, the plurality of diverter conduits being spaced apart around a circumferential periphery of the diverter ring.

[0068] Clause 5. The flushing manifold of any one of clauses 1 to 4, the flow diverter further comprising a second shaft, the first shaft and the second shaft being disposed on opposite sides of the flow diverter ring.

[0069] Item 6. A flushing system for a medical device, the flushing system comprising: a flushing manifold, the flushing manifold comprising: a shell, the shell defining a shell conduit and extending along a longitudinal axis; and a diverter, the diverter being connected to the shell to define an annular flushing chamber and defining a plurality of diverter conduits; a main line flushing tube, the main line flushing tube being connected to the shell conduit and being configured to be connected to a fluid source; and a plurality of diverter flushing tubes, each diverter flushing tube being connected to a corresponding diverter conduit, the plurality of diverter flushing tubes being configured to direct fluid to an end effector of the medical device.

[0070] Clause 7. The irrigation system of Clause 6, further comprising the end effector comprising a plurality of ridges disposed about the longitudinal axis, each ridge comprising a proximal end connected to the irrigation manifold.

[0071] Clause 8. According to the flushing system of Clause 7, the end actuator also includes a plurality of sheaths, each sheath defining: a ridge channel, the ridge channel receiving a corresponding ridge among the plurality of ridges; and a flushing catheter, the flushing catheter receiving a corresponding shunt flushing tube among the plurality of shunt flushing tubes.

[0072] Clause 9. According to the flushing system of Clause 8, the multiple shunt flushing tubes include a first shunt flushing tube and a second shunt flushing tube, each first shunt flushing tube is received by the flushing conduit of a corresponding sheath among the multiple sheaths, and each second shunt flushing tube includes a distal end arranged outside the multiple sheaths.

[0073] Clause 10. The flushing system of Clause 9, wherein each second diverter flushing tube is sandwiched by adjacent first diverter flushing tubes.

[0074] Clause 11. The irrigation system of any of clauses 8 to 10, each ridge channel and each irrigation conduit spanning the entire length of each sheath.

[0075] Clause 12. The irrigation system of Clause 11, further comprising a ring connected to the distal ends of the plurality of ridges, the ring occluding the distal end of each irrigation conduit.

[0076] Clause 13. The irrigation system of Clause 11, further comprising a ring connected to the distal ends of the plurality of ridges, the ring being configured to allow the fluid to exit the distal end of each irrigation catheter.

[0077] Clause 14. An irrigation system according to any one of clauses 7 to 13, further comprising at least one electrode connected to each ridge, at least a portion of the plurality of diverter irrigation tubes being configured to direct the fluid through at least one outlet defined in or proximal to the at least one electrode.

[0078] Clause 15. The irrigation system of any one of clauses 9 to 11, further comprising at least one electrode connected to each sheath, each first diverter irrigation tube being configured to direct the fluid through a corresponding irrigation conduit of the sheath to the at least one electrode.

[0079] Clause 16. The irrigation system of Clause 15, further comprising an outlet defined in or disposed proximal to each of the at least one electrode.

[0080] Clause 17. An end effector for a medical device, the end effector comprising:

[0081] a flushing manifold extending along a longitudinal axis and comprising:

[0082] A shell, the shell defining a shell lumen and a shell conduit; and a diverter, the diverter defining a diverter lumen, connected to the shell to define a flush chamber, and defining at least one diverter conduit, wherein a fluid is configured to flow into the flush chamber via the shell conduit and to flow out of the flush chamber via the at least one diverter conduit; at least one ridge, the at least one ridge being connected to the flush manifold at a proximal end of the at least one ridge and being configured to bend radially outward from the longitudinal axis and move between an expanded configuration and a collapsed configuration, the at least one diverter conduit being configured to guide the fluid along the at least one ridge; an actuator rod, the actuator rod passing through the shell lumen and the diverter lumen and connected to the distal end of the at least one ridge, the actuator rod being configured to move the at least one ridge between the expanded configuration and the collapsed configuration.

[0083] Clause 18. The end effector of Clause 17, wherein the at least one ridge is integrally formed from the tube stock material.

[0084] Clause 19. The end effector of any of Clauses 17-18, further comprising a distal hub integral with the at least one ridge, the actuator rod being connected to the distal hub.

[0085] Clause 20. The end effector of any one of Clauses 17 to 19, further comprising a ridge coupler shaped to couple the proximal end of the at least one ridge to the shunt.

[0086] Clause 21. The end effector of clause 20, wherein the ridge coupler surrounds at least a portion of the diverter.

[0087] Clause 22. An end effector according to any one of clauses 20 to 21, further comprising at least one diverter flushing tube connected to the at least one diverter conduit and arranged outside the ridge connector in a radial direction.

[0088] Clause 23. The end effector of any one of clauses 17 to 22, further comprising at least one electrode connected to the at least one ridge, the at least one electrode comprising an outlet configured to allow the fluid to exit through the outlet.

[0089] Clause 24. The end actuator according to any one of clauses 17 to 23, further comprising at least one sheath, wherein the at least one sheath defines: a ridge channel, the ridge channel receiving the at least one ridge; and an irrigation catheter connected to the at least one shunt catheter.

[0090] Clause 25. The end effector of Clause 24, wherein the at least one sheath comprises a wall separating the ridge channel from the irrigation conduit.

[0091] Clause 26. The end effector of any one of Clauses 17 to 25, wherein the actuator rod defines an actuator rod lumen coaxial with the longitudinal axis.

[0092] Clause 27. The end effector of any of Clauses 17 to 26, the actuator rod being configured to translate along the longitudinal axis, the translation being configured to move the at least one ridge between the expanded configuration and the collapsed configuration.

[0093] Clause 28. The end effector of any one of Clauses 17 to 27, wherein the housing conduit and the at least one diverter conduit are laterally offset from the longitudinal axis and extend parallel to the longitudinal axis.

[0094] The above examples are cited by way of example, and the disclosed technology is not limited to what is specifically shown and described above. On the contrary, the scope of the disclosed technology 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 manifold for a medical device, the flushing manifold comprising: a housing extending along a longitudinal axis defining a housing lumen and a housing conduit offset from the housing lumen, the housing conduit being configured to couple with a mainline flushing tube; and A flow diverter defining a flow diverter lumen connected to the housing to define a flushing chamber, and comprising: a first shaft, the first shaft being nested in the inner cavity of the housing; A shunt ring defines a plurality of shunt conduits radially disposed about the longitudinal axis and connected to the distal end of the housing, each shunt conduit being configured to connect to a shunt flush tube that directs fluid to an end effector of the medical device.

2. The flushing manifold of claim 1, wherein the flushing chamber is annular in form. 3 . The flush manifold of claim 1 , said diverter ring defining a lip that nests with an inner annular surface of said housing.

4. The flushing manifold of claim 1, the plurality of diverter conduits being spaced apart around a circumferential perimeter of the diverter ring.

5. The flush manifold of claim 1, said flow diverter further comprising a second shaft, said first shaft and said second shaft being disposed on opposite sides of said flow diverter ring.

6. A flushing system for a medical device, the flushing system comprising: A flushing manifold, the flushing manifold comprising: a housing defining a housing conduit and extending along a longitudinal axis; and a flow divider connected to the housing to define an annular flushing chamber, and defining a plurality of shunt conduits; a mainline flush pipe connected to the housing conduit and configured to be connected to a fluid source; and A plurality of shunt irrigation tubes are provided, each shunt irrigation tube being connected to a respective shunt catheter, the plurality of shunt irrigation tubes being configured to direct fluid to an end effector of the medical device.

7. The irrigation system of claim 6, further comprising the end effector comprising a plurality of ridges disposed about the longitudinal axis, each ridge comprising a proximal end connected to the irrigation manifold.

8. The irrigation system of claim 7, wherein the end effector further comprises a plurality of sheaths, each sheath defining: a ridge channel that receives a corresponding ridge of the plurality of ridges; and An irrigation conduit receives a corresponding one of the plurality of shunt irrigation tubes.

9. The flushing system of claim 8, wherein the plurality of shunt flushing tubes include a first shunt flushing tube and a second shunt flushing tube, each first shunt flushing tube being received by the flushing conduit of a corresponding sheath among the plurality of sheaths, and each second shunt flushing tube including a distal end disposed outside the plurality of sheaths.

10. The flushing system of claim 9, wherein each second diverter flushing tube is sandwiched by adjacent first diverter flushing tubes.

11. The irrigation system of claim 8, each ridge channel and each irrigation conduit spanning the entire length of each sheath.

12. The irrigation system of claim 11, further comprising a ring connected to the distal ends of the plurality of ridges, the ring occluding the distal end of each irrigation conduit.

13. The irrigation system of claim 7, further comprising at least one electrode connected to each ridge, at least a portion of the plurality of diverter irrigation tubes being configured to direct the fluid through at least one outlet defined in or proximal to the at least one electrode.

14. The irrigation system of claim 9, further comprising at least one electrode connected to each sheath, each first shunt irrigation tube being configured to direct the fluid through a corresponding irrigation conduit of the sheath to the at least one electrode.

15. The irrigation system of claim 14, further comprising an outlet defined in or disposed proximal to each of the at least one electrode.

16. An end effector for a medical device, the end effector comprising: a flushing manifold extending along a longitudinal axis and comprising: a housing defining a housing lumen and a housing conduit; and a flow diverter defining a flow diverter lumen, connected to the housing to define a flush chamber, and defining at least one flow diverter conduit, wherein fluid is configured to flow into the flush chamber via the housing conduit and out of the flush chamber via the at least one flow diverter conduit; at least one ridge connected to the irrigation manifold at a proximal end of the at least one ridge and configured to flex radially outward from the longitudinal axis and move between an expanded configuration and a collapsed configuration, the at least one diverter conduit configured to direct the fluid along the at least one ridge; An actuator rod passes through the housing lumen and the shunt lumen and is connected to the distal end of the at least one ridge, the actuator rod being configured to move the at least one ridge between the expanded configuration and the collapsed configuration.

17. The end effector of claim 16, further comprising at least one electrode connected to said at least one ridge, said at least one electrode comprising an outlet configured to allow said fluid to exit therethrough.

18. The end effector of claim 16, further comprising at least one sheath, the at least one sheath defining: a ridge channel receiving the at least one ridge; and An irrigation catheter is connected to the at least one shunt catheter.

19. The end effector of claim 18, said at least one sheath comprising a wall separating said ridge channel from said irrigation conduit.

20. The end effector of claim 16, said housing conduit and said at least one diverter conduit being laterally offset from said longitudinal axis and extending parallel to said longitudinal axis.

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