Multifunctional large bore access sheath

Abstract

A sheath is provided that includes an elongate body that has a proximal end and a distal end, a lumen, and a steering system. The lumen provides fluid communication between a proximal end and fenestrations disposed in left heart chamber(s) of a patient and / or in a right side chamber(s). The steering system can direct the distal end of the elongate body toward or away from cardiac anatomy. The sheath can have a large bore that optionally provides access for structural heart procedures (e.g., aspiration, incisions, ablation) and, if so used, to be simultaneously connected to or to be converted to an ECMO (or other cardiac support) procedure without removal from the patient. The sheath can be initially deployed outside the heart and then advanced across an atrial septum to unload the left side of the heart. The sheath can be integrated into a modular system for these uses.

Description

ANTMD.005WO PATENT MULTIFUNCTIONAL LARGE BORE ACCESS SHEATHINCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

[0001] This application claims priority benefit of U.S. Provisional Application No.63 / 749,862 filed January 27, 2025, which is hereby incorporated by reference in its entirety herein.BACKGROUNDField

[0002] This application is directed to medical catheters to provide drainage in mechanical cardiocirculatory support procedures and / or to provide access to perform heart procedures, such as structural heart procedures.SUMMARY

[0003] There is a need for innovations to a large bore sheath to provide access for cardiac procedures. Such a sheath may be equipped with multi-functionality. Such functions can include orienting a distal tip of the catheter to enhance blood flow therein, to improve positioning relative to heart tissue, and / or to enable the performing of procedures such as structural heart procedures. Such functions also can include providing access to provide hemodynamic cardiocirculatory support. Unique combinations of structures are needed to be able to meet these requirements.

[0004] In one embodiment, a multifunctional transeptal antegrade cardiac access system is provided. In the system, a large bore sheath is provided that has an elongate body that has a proximal end and a steerable distal segment. The large bore sheath has a 26 French size in one embodiment. Smaller or larger sizes can be provided for particular procedures and patient populations. The access system includes a lumen that extends through the elongate body of the large bore sheath. The lumen provides fluid communication between the proximal end of the elongate body and the steerable distal end. The access system includes a plurality of inflow fenestrations configured to be disposed simultaneously in a right heart chamber, e.g„ a right atrium and a left heart chamber of a patient. In variations, the inflow fenestrations can be disposed in one or more right side chambers, such as the right atrium, right ventricle, in a superior vena cava, in an inferior vena cava. In variations, the inflow fenestrations can be disposed in one or more left side chambers, such as a left atrium, a left ventricle, a pulmonaryvein. The access system includes a proximal access point. The proximal access point is configured to allow fluid communication between the lumen and an inflow branch of an ECMO system to direct blood from the plurality of inflow apertures to the ECMO system. Although an ECMO system is contemplated, the proximal access point could be configured to allow fluid communication between the lumen and an inflow branch of a pump system that provides cardiac support. In some embodiments, the proximal access point is configured to allow access to the lumen for advancing a daughter cannula configured for performing a structural heart procedure on the patient.

[0005] In another embodiment, an ECMO system is provided. The ECMO system includes a multifunctional antegrade cardiac access system, a connector, a gas exchanger, and a return cannula. The connector is configured for providing fluid communication to a lumen of the multifunctional antegrade cardiac access system through a proximal access point. The gas exchanger is configured to oxygenate blood withdrawn from a right atrium and / or a left heart chamber. The return cannula is configured to provide fluid communication between the gas exchanger and an artery of the patient.

[0006] In another embodiment, a large bore sheath is provided that includes an elongate body that has a proximal end and a distal end, a lumen, an atrial septal anchor, and a steering system. The lumen extends through the elongate body. In one embodiment, the lumen can be sized for enhanced blood flow. The lumen also can be sized to receive and permit passage of a structural heart procedure system. The lumen is sized to function as a veinous ECMO cannula. The lumen is configured to provide fluid communication between a proximal end of the elongate body and a plurality of fenestrations disposed at a distal portion of the elongate body. Fenestrations of the plurality of fenestration are simultaneously positionable in a left heart chamber of a patient and in a right atrium of the patient. In variations, the fenestrations can be in other right side chambers. In further variations, the fenestration can be in other left side chambers, e.g., the pulmonary vein. The atrial septal anchor is disposed on the elongate body such that at least one fenestration is proximal of the atrial septal anchor and at least one fenestration is disposed distal of the atrial septal anchor. The steering system is disposed through the elongate body. The steering system is configured to direct the distal end of the elongate body, e.g., toward or away from anatomy of interest. In one variation, a steering system is disposed through the distal portion of the elongate body, e.g., extending along and / orbetween the fenestrations. The distal portion thus can have a function of draining blood from a heart chamber and a second independent function of steering the distal portion. The large bore sheath is configured such that it could be used for a structural heart procedure, an electrophysiology procedure, or other procedure that could destabilize heart pumping or output and simultaneously providing pumping support while doing such a procedure or thereafter to be convertible to an ECMO (or other cardiac support) procedure without removal from the patient.

[0007] In another embodiment a method is provided. In the method, a distal end of a sheath is positioned through a veinous blood vessel and a right atrium and into a left heart chamber of a patient. A distal tip of the sheath is steered toward cardiac anatomy of interest. A structural heart procedure system is advanced antegrade through a lumen of the sheath. A structural heart procedure is performed on or through anatomy of interest using the structural heart procedure system. The procedure may be partially or fully completed. Blood is drained from the right atrium and the left heart chamber through fenestrations in a distal portion of the sheath and through the lumen. Blood could also be drained from within the IVC or the SVC or other right side chamber or through other left side chambers, e.g., a pulmonary vein or left atrial appendage. Blood drained through the fenestrations and the lumen is pumped through a blood circuit to an artery of the patient.

[0008] In another embodiment, a method is performed in which a distal end of a sheath is positioned through a veinous access site and a right atrium and into a left heart chamber of a patient. The pathway can also be through an IVC, SVC, jugular vein, subclavian vein, an axillary vein, a brachial vein, or other right side chamber, through the right atrium and into the left heart chamber or into a left side chamber. A distal tip of the sheath is steered toward cardiac anatomy of interest. A daughter cannula supporting a structural heart procedure system is advanced through a lumen of the sheath. A pacing feature incorporated into the daughter cannula is engaged with a wall of the left heart chamber. A structural heart procedure involving the structural heart procedure system is performed on or through anatomy of interest using the structural heart procedure system.

[0009] In another embodiment, a daughter cannula configured to perform a structural heart procedure on the patient is provided. The daughter cannula supports a prosthetic heart valve (or other interventional device) to be deployed in (or adjacent to) a valveannulus adjacent to at least one heart chamber. The daughter cannula may also be referred to herein as a delivery system. The daughter cannula has a distal pacing feature. A distal portion of the daughter cannula configured to extend (e.g.. is steerable) toward a heart wall to cause the distal pacing feature to contact the heart wall for pacing the heart. The distal pacing feature can include an electrode in a unipolar pacing arrangement. The distal pacing feature can include an electrode and a ground feature in a bipolar pacing arrangement. The daughter cannula can be integrated into a cardiac procedure system including any of the large bore sheaths or any of the retrograde cardiac access systems disclosed herein.

[0010] In another embodiment, a large bore sheath is provided. The large bore sheath includes: an elongate body including a proximal end and a distal end; a lumen extending through the elongate body, the lumen being sized to receive and permit passage of a structural heart procedure system and being configured to provide fluid communication between a proximal end of the elongate body and a plurality of fenestrations disposed at a distal portion of the elongate body, fenestrations of the plurality of fenestration being simultaneously positionable in a left heart chamber of a patient and in a right atrium of the patient; and a steering system disposed through the elongate body, the steering system configured to direct the distal end of the elongate body toward anatomy of interest; wherein the large bore sheath is configured to be used for a structural heart procedure and to be convertible to an ECMO procedure without removal from the patient.

[0011] In another embodiment, the large bore sheath further includes an atrial septal anchor disposed on the elongate body such that at least one fenestration is proximal of the atrial septal anchor and at least one fenestration is disposed distal of the atrial septal anchor.

[0012] In another embodiment, the atrial septal anchor includes a balloon including a radiopaque marker.

[0013] In another embodiment, the large bore sheath further includes a seal disposed in a proximal deflection portion of the elongate body and to allow access therethrough to the lumen for advancing an interventional device into the patient through a distal portion of the elongate body.

[0014] In another embodiment, the steering system is configured to position the distal end to be initially placed in a first left heart chamber and thereafter to position the distal end in a second left heart chamber.

[0015] In another embodiment, the steering system includes one or more pull wires disposed in a wall of the elongate body to steer the distal end.

[0016] In another embodiment, the steering system includes one or more pull wires disposed in a wall of the elongate body to steer the distal end, wherein the at least one fenestration disposed distal of the atrial septal anchor includes a plurality of apertures disposed about a circumference of the elongate body along a length thereof disposed adjacent to the distal end, an un-fenestrated segment disposed about the circumference, one of the one or more pull wires disposed in the un-fenestrated segment of the elongate body.

[0017] In another embodiment, the elongate body includes a distal portion disposed adjacent to the distal end, a proximal deflection portion disposed adjacent to the distal portion, and a spine disposed along a length of the distal portion.

[0018] In another embodiment, the proximal deflection portion is stiffer than the distal portion.

[0019] In another embodiment, the proximal deflection portion is a non-steerable portion of the elongate body, and the distal portion is a steerable portion of the elongate body.

[0020] In another embodiment, the spine is configured to enable the elongate body to bend in a first direction and resist bending in a different second direction.

[0021] In another embodiment, the spine is configured to allow bending along a clockwise bending path from an inferior vena cava to a left ventricle while resisting bending in a lateral directions.

[0022] In another embodiment, the spine extends along an arc length that is less than 50% of a circumference of the elongate body.

[0023] In another embodiment, the spine defines an uninterrupted portion of the elongate body along a steering axis.

[0024] In another embodiment, the distal portion includes a pattern cut distal body portion, and wherein the spine defines a non-pattem cut portion of the distal portion.

[0025] In another embodiment, the proximal deflection portion includes a slit cut pattern or a spiral cut pattern formed into the elongate body.

[0026] In another embodiment, a total length of the distal portion is sized such that the distal portion is positionable in a left atrium or a left ventricle and the proximal deflectionportion is positionable in a right atrium and across a septum when the distal end of the elongate body is positioned in the left atrium or the left ventricle.

[0027] In another embodiment, the distal portion has a total length between 10 cm and 18 cm.

[0028] In another embodiment, the proximal deflection portion has a total length between 40 cm and 80 cm.

[0029] In another embodiment, the large bore sheath further includes a decoupling mechanism between the proximal deflection portion and the distal portion, wherein the decoupling mechanism enables off-axis bending of the distal portion relative to the proximal deflection portion while maintaining torque transfer between the proximal deflection portion and the distal portion.

[0030] In another embodiment, the large bore sheath further includes a fenestration member including a circumferential member disposed between an internal and an external section of the elongate body, the circumferential member including apertures configured to form the fenestrations.

[0031] In another embodiment, the fenestration member includes a C-shaped element having longitudinal edges providing a gap therebetween, a pull wire of the steering system disposed in the gap between the longitudinal edges such that the pull wire does not cross the fenestrations.

[0032] In another embodiment, the C-shaped element includes the apertures disposed circumferentially between the longitudinal edges.

[0033] In another embodiment, the steering system includes a pull wire disposed a radial distance between an outer circumference of the circumferential member and an inner circumference of the circumferential member.

[0034] In another embodiment, the pull wire is disposed in a slit disposed through the circumferential member.

[0035] In another embodiment, an ECMO system is provided. The ECMO system includes the large bore sheath, a gas exchanger, and a connector configured to allow fluid communication between the lumen and an inflow branch of the gas exchanger.

[0036] In another embodiment, the ECMO system further includes an outflow cannula configured to connect to an outflow branch of the gas exchanger to return blood to the patient following oxygenation of the blood.

[0037] In another embodiment, a left heart chamber access system is provided. The left heart chamber access system includes, the large bore sheath and further includes a dilator and a crossing wire, the dilator having a proximal end, a distal end, an elongate dilator body disposed between the proximal end and the distal end, the elongate dilator body including a proximal portion, a distal portion, and a dilator lumen extending through the elongate dilator body, the elongate dilator body being configured to be advanced through the lumen of the large bore sheath such that the distal portion extends out of the distal end of the elongate body of the large bore sheath, the crossing wire configured to be slidably disposed in the dilator lumen.

[0038] In another embodiment, the proximal portion of the elongate dilator body includes a first stiffness and the distal portion of the elongate dilator body includes a second stiffness greater than the first stiffness, the second stiffness sufficient to expand an opening formed in an atrial septal wall by the crossing wire.

[0039] In another embodiment, the elongate dilator body is configured by shape and stiffness to induce a curvature in the large bore sheath when disposed in the lumen thereof that corresponds to the curvature from a vena cava segment adjacent to a right atrium, into the right atrium and toward a surface of a septal wall of the right atrium separating the right atrium from a left atrium.

[0040] In another embodiment, the steering system is configured to deflect the elongate body of the large bore sheath when the elongate dilator body is disposed in the lumen of the large bore sheath such that the large bore sheath has a curvature that corresponds to the curvature from a vena cava segment adjacent to a right atrium, into the right atrium and toward a surface of a septal wall of the right atrium separating the right atrium from a left atrium.

[0041] In another embodiment, a modular sheath system is provided. The modular sheath system includes the large bore sheath and a modular handle extension, wherein the large bore sheath includes a primary handle disposed at the proximal end of the elongate body, the primary handle including a first coupling portion and the modular handle extension includes a second coupling portion configured to engage the first coupling portion, the modular handleextension configured to change or supplement a function of the primary handle when coupled therewith.

[0042] In another embodiment, the primary handle includes a lumen in fluid communication with the lumen of the elongate body to enable blood to flow through the primary handle to a blood handling component.

[0043] In another embodiment, the modular handle extension includes a first branch configured to access the lumen of the elongate body of the large bore sheath through a first path and a second branch configured to access the lumen of the elongate body of the large bore sheath through a second path.

[0044] In another embodiment, the first path is aligned with a longitudinal axis of the lumen of the large bore sheath and the second path is disposed at an angle to the longitudinal axis of the lumen of the large bore sheath.

[0045] In another embodiment, the modular handle extension includes a first modular extension and further including a second modular extension of the modular handle extension.

[0046] In another embodiment, the first modular extension includes a connector for fluidly connecting the large bore sheath to an ECMO system and the second modular extension includes a first branch for fluidly connecting the large bore sheath to an ECMO system and a second branch for providing access to the lumen of the large bore sheath for an interventional tool for performing a cardiac procedure.

[0047] In another embodiment, at least one of the primary handle and the modular handle extension includes a valve configured for de-airing the large bore sheath prior to or upon connection of a device to the primary handle and the modular handle extension.

[0048] In another embodiment, the valve includes a push-button actuator to facilitate opening the valve manually.

[0049] In another embodiment, a multifunctional transeptal antegrade cardiac access system is provided. The multifunctional transeptal antegrade cardiac access system includes: a large bore sheath including an elongate body including a proximal end and a steerable distal segment; a lumen extending through the elongate body of the large bore sheath, the lumen providing fluid communication between the proximal end of the elongate body and the steerable distal segment; a plurality of inflow fenestrations configured to be disposedsimultaneously in a right atrium and a left heart chamber of a patient; and a proximal access point configured to allow fluid communication between the lumen and an inflow branch of an ECMO system to direct blood from the plurality of inflow fenestrations to the ECMO system.

[0050] In another embodiment, the proximal access point is configured to allow access to the lumen for advancing a daughter cannula configured for performing a structural heart procedure on the patient.

[0051] In another embodiment, the multifunctional transeptal antegrade cardiac access system further includes a membrane disposed at the proximal end of the elongate body configured to provide access to the lumen for an interventional device while preventing blood leak.

[0052] In another embodiment, the membrane is disposed in the proximal access point.

[0053] In another embodiment, the multifunctional transeptal antegrade cardiac access system further includes a side port disposed at the proximal end of the elongate body to allow re-wiring or flushing of the lumen.

[0054] In another embodiment, the multifunctional transeptal antegrade cardiac access system further includes a daughter cannula including a blood flow lumen and a pressure sensor configured to detect pressure in the blood flow lumen.

[0055] In another embodiment, the daughter cannula includes a cannula body including a plurality of outflow fenestrations, the cannula body including sufficient length to extend from the proximal access point through the elongate body of the large bore sheath and extending further than a distal end of the steerable distal segment.

[0056] In another embodiment, the large bore sheath includes an atrial septal anchor disposed adjacent to the steerable distal segment.

[0057] In another embodiment, the atrial septal anchor includes a balloon including a radiopaque marker.

[0058] In another embodiment, the multifunctional transeptal antegrade cardiac access system further includes one or more pull wires to activate the steerable distal segment.

[0059] In another embodiment, an ECMO system is provided. The ECMO system includes: the multifunctional transeptal antegrade cardiac access system; a connector for providing fluid communication to the lumen through the proximal access point; a gasexchanger configured to oxygenate blood withdrawn from the right atrium and / or the left heart chamber; and a return cannula configure to provide fluid communication between the gas exchanger and an artery of the patient.

[0060] In another embodiment, the return cannula includes a return cannula body including plurality of outflow fenestrations, the return cannula body including sufficient length to extend from a percutaneous vascular access site to a distal end of the return cannula body disposed in an aorta of the patient in use to supply blood.

[0061] In another embodiment, the return cannula includes a pressure sensor to detect pressure in the return cannula body.

[0062] In another embodiment, a cardiac procedure system is provided. The cardiac procedure system includes the multifunctional transeptal antegrade cardiac access system and a daughter cannula configured to perform a structural heart procedure on the patient.

[0063] In another embodiment, the daughter cannula supports a prosthetic heart valve to be deployed in a valve annulus adjacent to at least one heart chamber.

[0064] In another embodiment, the daughter cannula including a distal pacing feature disposed such as to contact a heart wall allowing pacing stimulation.

[0065] In another embodiment, the distal pacing feature includes an electrode and a ground feature to facilitate bipolar pacing.

[0066] In another embodiment, the distal pacing feature includes a single electrode configured to facilitate unipolar pacing.

[0067] In another embodiment, a method is provided. The method includes: positioning a distal end of a sheath through a veinous blood vessel and a right atrium and into a left heart chamber of a patient; steering a distal tip of the sheath toward cardiac anatomy of interest; advancing a structural heart procedure system through a lumen of the sheath; performing a structural heart procedure on or through anatomy of interest using the structural heart procedure system; draining blood from the right atrium and the left heart chamber through fenestrations in a distal portion of the sheath and through the lumen; and pumping blood drained through the fenestrations and the lumen through a blood circuit to an artery of the patient.

[0068] In another embodiment, draining blood is performed after or upon partial completion of performing the structural heart procedure.

[0069] In another embodiment, the method, further includes performing gas exchange in the blood circuit to oxygenate the blood drained through the fenestrations and the lumen.

[0070] In another embodiment, a method is provided. The method includes: positioning a distal end of a sheath through a veinous access site and a right atrium and into a left heart chamber of a patient: steering a distal tip of the sheath toward cardiac anatomy of interest; advancing a daughter cannula supporting a structural heart procedure system through a lumen of the sheath; engaging a pacing feature advanced through the veinous access site with a wall of the left heart chamber; and performing a structural heart procedure on or through anatomy of interest using the structural heart procedure system.

[0071] In another embodiment, the method, further includes: draining blood from the right atrium and the left heart chamber through fenestrations in a distal portion of the sheath and through the lumen; and pumping blood drained through the fenestrations and the lumen through a blood circuit to an artery of the patient.

[0072] In another embodiment, the pacing feature is disposed on the daughter cannula and engaging the pacing feature advanced through the veinous access site with the wall of the left heart chamber includes steering the daughter cannula from a proximal end of the daughter cannula.

[0073] In another embodiment, engaging the pacing feature advanced through the veinous access site with the wall of the left heart chamber includes providing unipolar pacing.

[0074] In another embodiment, engaging the pacing feature advanced through the veinous access site with the wall of the left heart chamber includes providing bipolar pacing.

[0075] In another embodiment, a method of draining blood from a cardiovascular system is provided. The method includes: placing a distal tip of an elongate catheter body in a veinous vessel, the elongate catheter body having a first plurality of fenestrations disposed at a distal portion and a second plurality of fenestrations disposed proximally of the first plurality of fenestrations, the elongate catheter body having a lumen therethrough; draining blood from a first veinous vessel segment adjacent to a right atrium of a heart of a patient through the first plurality of fenestrations and from a second veinous vessel segment more peripheral from the heart than the first veinous vessel segment through the second plurality of fenestrations; after draining blood from the first veinous vessel segment and the second veinous vessel segment,advancing the elongate catheter body through an atrial septal wall until the first plurality of fenestrations is disposed in a left heart chamber and the second plurality of fenestrations is disposed on a right side chamber; and draining blood from the left heart chamber through the first plurality of fenestrations and from the right side chamber through the second plurality of fenestrations.

[0076] In another embodiment, advancing the elongate catheter body through the atrial septal wall includes positioning a dilator within the lumen of the elongate catheter body until a tip portion of the dilator is distal to the distal tip of the elongate catheter body and inducing a curvature in the elongate catheter body that corresponds to a trajectory from the first veinous vessel segment, through the right atrium and to the atrial septal wall.

[0077] In another embodiment, inducing the curvature in the elongate catheter body includes allowing the dilator to assume a free state in which the dilator includes a curvature corresponding to the trajectory.

[0078] In another embodiment, inducing the curvature in the elongate catheter body includes activating a steering system to deflect the elongate catheter body from a shape suitable for draining from the first veinous vessel segment and the second veinous vessel segment to a shape corresponding to the trajectory.

[0079] In another embodiment, a dilator is provided. The dilator includes, an elongate dilator body having a proximal end, a distal end, and a lumen extending through the elongate dilator body, the elongate dilator body configured to facilitate advancement of a large bore drainage and access sheath across an atrial septal wall.

[0080] In another embodiment, the elongate dilator body includes a proximal portion with a first stiffness and a distal portion with a second stiffness greater than the first stiffness, the second stiffness sufficient to tent the atrial septal wall under a distal force or to enlarge a hole formed through the atrial septal wall.

[0081] In another embodiment, a method of accessing a cardiovascular system is included. The method includes: placing a distal tip of an elongate catheter body in the cardiovascular system of a patient, the elongate catheter body having fenestrations along a length thereof for draining blood into a lumen thereof, the lumen being disposed between the fenestrations and a primary handle disposed at a proximal end of the elongate catheter body; de-airing the lumen of the elongate catheter body; and providing fluid communication betweenthe primary handle and an ECMO system to supply blood through the primary handle to the ECMO system.

[0082] In another embodiment, a method of accessing a cardiovascular system is included. The method includes: placing a distal tip of an elongate catheter body in the cardiovascular system of a patient, the elongate catheter body having fenestrations along a length thereof for draining blood into a lumen thereof, the lumen being disposed between the fenestrations and a primary handle disposed at a proximal end of the elongate catheter body; and providing fluid communication between the primary handle and an ECMO system to supply blood through the primary handle to the ECMO system.

[0083] In another embodiment, de-airing includes opening a valve by pressing an actuator disposed on the primary handle to allow blood to flow through the primary handle, expelling air from the primary handle.

[0084] In another embodiment, the method, further includes connecting a coupling portion of a barbed hose connector with a coupling portion of the primary handle to providing fluid communication between the primary handle and the barbed hose connector.

[0085] In another embodiment, the method, further includes removing the barbed hose connector from the primary handle and thereafter coupling a coupling portion of a branched body to a coupling portion of the primary handle, providing fluid communication through a primary branch of the branched body to the lumen through the primary handle.

[0086] In another embodiment, the method, further includes coupling a coupling portion of a branched body to a coupling portion of the primary handle, providing fluid communication through a primary branch of the branched body to the lumen through the primary handle.

[0087] In another embodiment, the method, further includes advancing a procedural tool through a secondary branch of the branched body and performing a procedure with the procedural tool.

[0088] In another embodiment, the procedure includes aspirating thrombus from within the lumen of the elongate catheter body or within the patient.

[0089] In another embodiment, the procedure includes incising a valve leaflet.

[0090] In another embodiment, the procedure comprises an electrophysiology procedure.

[0091] In another embodiment, the procedure comprises an ablation procedure.

[0092] In another embodiment, the procedure comprises a ventricular fibrillation procedure.

[0093] In another embodiment, placing the distal tip of the elongate catheter body in the cardiovascular system comprises disposing at least one fenestration in a pulmonary vein, at least one fenestration in a left atrium, and at least one fenestration in a right side chamber.

[0094] In another embodiment, placing the distal tip of the elongate catheter body in the cardiovascular system comprises disposing at least one fenestration in a left ventricle, at least one fenestration in a left atrium, and at least one fenestration in a right side chamber.

[0095] In another embodiment, placing the distal tip of the elongate catheter body in the cardiovascular system comprises disposing the distal tip in or adjacent to a left atrial appendage, and further comprising advancing an aspiration catheter adjacent to or into left atrial appendage to remove matter therefrom.

[0096] In another embodiment, the procedure is performed at a same time as providing fluid communication between the primary handle and the ECMO system to supply blood through the primary handle to the ECMO system.

[0097] In another embodiment, a pathway from the branched body through the primary handle to the lumen of the elongate catheter body is provided following de-airing a lumen in the branched body.

[0098] In another embodiment, placing the distal tip of the elongate catheter body in the cardiovascular system includes disposing the distal tip in a veinous vessel adjacent to a heart, and further including advancing a dilator through the primary handle until a dilator tip is disposed distal to the distal tip of the elongate catheter body and thereafter advancing the dilator and the elongate catheter body across an atrial septum of the heart to place the distal tip in a left heart chamber.

[0099] In another embodiment, advancing the dilator through the primary handle is performed after providing fluid communication between the primary handle and the ECMO system and further including providing fluid communication between the primary handle and the ECMO system after advancing the dilator and the elongate catheter body across the atrial septum.

[0100] In another embodiment, a modular sheath system is provided. The modular sheath system includes: an elongate body including a proximal end and a distal end, a lumen extending through the elongate body, the lumen being in fluid communication with a plurality of fenestrations disposed at a distal portion of the elongate body; a primary handle coupled with the proximal end of the elongate body, the primary handle providing fluid communication therethrough to the lumen of the elongate body and having a first connection portion; and a modular extension having a second connection portion, the modular extension configured to provide fluid communication and / or access to the lumen of the elongate body when the second connection portion of the modular extension is coupled to the first connection portion of the primary handle.

[0101] n another embodiment, the primary handle includes an actuator disposed thereon to open a valve disposed in the primary handle to allow blood to flow proximally therein to flush air out of the primary handle.

[0102] In another embodiment, the modular extension includes an actuator disposed thereon to open a valve disposed in the modular extension to allow blood to flow proximally therein to flush air out of the modular extension.BRIEF DESCRIPTION OF THE DRAWINGS

[0103] Non-limiting features of some embodiments of the inventions are set forth with particularity in the claims that follow. The following drawings are for illustrative purposes only and show non-limiting embodiments. Features from different figures may be combined in several embodiments. It should be understood that the figures are not necessarily drawn to scale. Distances, angles, etc. are merely illustrative and do not necessarily bear an exact relationship to actual dimensions and layout of the devices illustrated.

[0104] FIG. 1 is a view of cardiac anatomy showing an antegrade superior path and an antegrade inferior path.

[0105] FIG. 2 shows an antegrade cardiac access system.

[0106] FIG. 2A is an enlarged schematic view of a portion of an elongate body of the antegrade cardiac access system of FIG. 2.

[0107] FIG. 3 is a cross-sectional view of the antegrade cardiac access system taken at section plane 3 - 3 showing a membrane and pull wires of the system.

[0108] FIG. 4 shows a distal portion of one variation of an antegrade cardiac access system of FIG. 1.

[0109] FIG. 4A depicts a schematic top view of an elongate body of one variation of the antegrade cardiac access system of FIG. 2.

[0110] FIG. 4B depicts a schematic side view of a deflection member of the elongate body of FIG. 4A.

[0111] FIG. 4C shows an enlarged view of a slit cut pattern of the deflection member of FIG. 4B.

[0112] FIG. 4D shows an enlarged view of a spiral cut pattern of the deflection member of FIG. 4B.

[0113] FIG. 4E is a top view of the deflection member of FIG. 4B.

[0114] FIG. 4F shows an enlarged view of a reinforcement portion of the deflection member of FIG. 4E.

[0115] FIG. 4G depicts another example deflection member with a slit cut pattern.

[0116] FIG. 4H shows another example deflection member with a spiral cut pattern.

[0117] FIG. 41 shows a top view of a fenestration member of the elongate body of FIG. 4A.

[0118] FIG. 4J shows a side view of the fenestration member of FIG. 41.

[0119] FIG. 4K shows a front view of the fenestration member of FIG. 41.

[0120] FIG. 4L shows a perspective view of the fenestration member of FIG. 41.

[0121] FIG. 5 shows one configuration of the antegrade cardiac access system showing an ECMO system coupled with the sheath of the antegrade cardiac access system of FIG. 1.

[0122] FIG. 6 shows a return cannula body that can be coupled with the ECMO system shown in FIG. 5.

[0123] FIG. 7 shows the antegrade cardiac access system used in with a structural heart procedure system disposed in a lumen of the system.

[0124] FIG. 8 shows a daughter cannula that can be used with the sheath of the cardiac access system to perform a cardiac procedure.

[0125] FIG. 9 shows a daughter cannula that can provide for rapid pacing of a heart while performing a cardiac procedure.

[0126] FIG. 10 depicts a modular handle system in a single access configuration.

[0127] FIG. 10A depicts the modular handle system of FIG. 10 in a dual access configuration.

[0128] FIGS. 10B-10E depict the modular handle system of FIG. 10 in various configurations.

[0129] FIG. 11 depicts another example modular handle system.

[0130] FIG. 11A depicts the modular handle system of FIG. 11 in a single access configuration.

[0131] FIG. 1 IB depicts the modular handle system of FIG. 11 in a dual access configuration.

[0132] FIG. 11C depicts the modular handle system of FIG. 11 in a dual access configuration with a connector attached.

[0133] FIG. 12A depicts a top view of a cannula for upper body veinous access such as axillary or trans-jugular procedures.

[0134] FIG. 12B depicts a side view of the cannula of FIG. 12A.

[0135] FIG. 12C depicts a front view of the cannula of FIG. 12A.

[0136] FIG. 12D depicts a cross-section view of the cannula of FIG. 12A.

[0137] FIG. 12E depicts a rear view of the cannula of FIG. 12A.

[0138] FIGS. 13A-13E depict a system and steps of a method for accessing a left heart chamber, e.g., after initially using a blood drainage catheter of the system in veinous vasculature.DETAILED DESCRIPTION

[0139] Reference will now be made in detail to the preferred embodiments of the disclosure, examples of which are illustrated in the accompanying drawings. While the disclosure will describe preferred embodiments, it will be understood that they are not intended to limit the disclosure to those embodiments. On the contrary, the disclosure is intended to cover alternatives, modifications, and equivalents, which may be included within the spirit and scope of the invention as defined by the appended claims.

[0140] This application is directed to innovations for sheaths that can provide many options in supporting patients with cardiac conditions. Some patients may urgently need extracorporeal membrane oxygenation (ECMO) support. Some patients on ECMO supportmay benefit most from veinous drainage for decongestion of the liver, kidney, and / or mesenteric veins. Some patients may degrade from an initial veinous drainage approach and would benefit from direct drainage of a left heart chamber. Sheaths disclosed herein can be moved from an initial veinous drainage position to a position where left side chamber can be directly drained without removing the sheath from the patient. Such a position can simultaneously drain left and right chambers. One option can be provided to drain a left atrium and left ventricle to unload the heart. Another option can be provided to drain a left atrium and left pulmonary artery to decongest the lungs and unload the heart. These right and left side approaches can be combined for a single patient interaction, allowing flexibility in support and decongestion. Also, sheaths described herein can allow access to a cardiac chamber or structure optionally for a cardiac procedure and can provide direct access for cardiac support at the same time, immediately after a cardiac procedure, or as needed. Such support can be in the form of ECMO, LAVA ECMO or pumping without oxygenation. A variety of modular components are described that enhance efficient modification of therapy approach, e.g., from support only to repositioning the sheath, and to providing access for interventional devices. This optionality makes the use of the sheaths described herein multifunctional and versatile, and streamlines care for patients who may face challenges during a procedure or in their course of treatment.

[0141] FIG. 1 shows a human heart and some of the relevant structures that come into play in cardiac procedures. FIG. 1 shows the inferior vena cava IVC and the superior vena cava SVC of the patient. These veins empty into the right atrium RA of the heart. The right atrium RA pumps blood to the right ventricle RV in a typical cardiac cycle. The right ventricle RV pumps blood through the pulmonary artery (not shown) to the lungs. Naturally oxygenated blood returns from the lungs to the left atrium LA. The left atrium LA pumps blood to the left ventricle LV, which then pumps blood to the ascending aorta. The aorta carries oxygenated blood to the systemic and cardiac arterial vasculature.

[0142] Cardiac procedures can be performed with catheters. Such procedures can include replacing or repairing heart valves, such as the mitral valve, the aortic valve, and the tricuspid valve, just to name a few. Such procedures can include aspirating or removing of mass, clot, thrombus, devices, or foreign body, or occluding the left atrial appendage as well. Many of these procedures are typically approached from the arterial vasculature, e.g., from thefemoral arteries over the aortic arch and through the aortic valve for a transcatheter aortic valve replacement procedure. It would be advantageous to approach this anatomy from a veinous access site.

[0143] FIG. 1 shows two approaches that could be used in such procedures. An antegrade superior path 90 can be provided in which access is provided by a superior peripheral veinous site. For example, the antegrade superior path 90 can be from an upper body veinous access including jugular vein, axillary vein, or other veinous access point and can extend through the superior vena cava SVC into the right atrium RA. An antegrade inferior path 94 can be provided in which access is provided by an inferior peripheral veinous site. For example, the antegrade inferior path 94 can extend from a femoral vein through the inferior vena cava IVC to the right atrium RA. These pathways are illustrated by dashed arrows. In general, the antegrade superior path 90 or the antegrade inferior path 94 would be employed, but in some cases, both are employed such as by using a snare to exteriorize a wire as part of a procedure.

[0144] FIG. 2 shows an antegrade cardiac access system 100 that can be used along either the antegrade superior path 90 or the antegrade inferior path 94. The antegrade cardiac access system 100 is a multifunctional antegrade cardiac access system, as discussed further below. The antegrade cardiac access system 100 includes a large bore sheath 104. The sheath 104 can have a suitable size, for example 26 French or more. In some cases, a smaller size could be used, e.g., 25 French, 24 French, 23 French, 22 French, 21 French, or 20 French. Larger sizes could also be used in some cases. In some embodiments, the sheath 104 can have size between 5F and 50F (e.g., 5F, 8F, 10F, 12F, 20F, 25F, 30F, 36F, ranges between such values, and the like). The sheath 104 can include an elongate body 108 that extends between the ends thereof. The elongate body 108 can extend between a proximal end 112 and a distal end 116. The distal end 116 can be a steerable distal end in some embodiments, as discussed below. The steerability can enable one mode of operation, in which the sheath 104 is used to guide an interventional device toward selected cardiac anatomy. The steerability can enable another mode of operation, in which the distal portion of the sheath 104 oriented through a steering system to position or orient a tip thereof relative to the anatomy. The proximal end of the sheath 104 can be coupled to a handle 103.

[0145] The procedures for which the multifunctional antegrade cardiac access system 100 is to be used benefit from an access pathway, which can be provided by a lumen120 disposed through the elongate body 108. The elongate body 108 can be a single access lumen device such that the only lumen for accessing blood or delivering tools through the sheath 104 is the lumen 120. In some variations, a multilumen body can be provided with some of the lumens dedicated to other functions, such as to house sensor conductors and / or steering elements within a wall thereof.

[0146] One function of the multifunctional antegrade cardiac access system 100 is to provide for draining blood from one or more chambers of the heart. As such, a plurality of inflow apertures 124 is provided in the elongate body 108. The inflow apertures 124 are also called fenestrations herein. The inflow apertures 124 can be located adjacent to the distal end 116. The inflow apertures 124 can be spread out along a distal portion of the elongate body 108. Preferably the inflow apertures 124 are numerous and evenly distributed in sections to provide for even flow around and along a length of the distal end 116. The inflow apertures 124 can be disposed within a distal length of about 25 cm, about 20cm, about 15cm, or about 10cm of the elongate body 108. FIG. 2A is an enlarged schematic view of a portion of the elongate body 108. FIG. 2A shows two circumferential rows of inflow apertures 124. The inflow apertures 124 can be arranged in any pattern, e.g., spiral about the elongate body 108, in more than two circumferential rows, or in more random patterns. In some cases, the inflow apertures 124 are arranged to be on different sides of the elongate body 108 to reduce obstruction of flow through the inflow apertures 124. In some cases, another function of the system 100 is to enable the distal portion can be oriented by a steering system, discussed below, such that the tip portion can be oriented toward or away from anatomy. This steering can be provided in the tip portion as another approach to avoiding, reducing or minimizing obstruction of the apertures 124. The inflow apertures 124 also are spaced apart such that some of the apertures are on one side of the septum S when the distal portion is advanced across the septum S into the left atrium LA or through the left atrium LA, e.g.. into the left ventricle LV. The inflow apertures 124 can enable draining blood from multiple heart chambers, e.g., a right atrium RA and a chamber of the left side of the heart. The inflow apertures 124 can be arranged to drain blood from the right atrium RA and the left atrium LA. The inflow apertures 124 can be arranged to drain blood from the right atrium RA and the left atrium left ventricle LV. The inflow apertures 124 can be arranged to drain blood from the right atrium RA, left atrium LA, and the left ventricle LV.

[0147] The antegrade cardiac access system 100 can have one or more sensors to facilitate use of the system. For example, the antegrade cardiac access system 100 can have a distal sensor 128. The distal sensor 128 can provide a signal indicative of the ambient pressure in which the distal portion of the elongate body 108 is disposed, e.g., in the left atrium LA, left atrium appendage, left pulmonary vein, right atrium, right ventricle, inferior vena cava, superior vena cava. Based on the pressure detected by the distal sensor 128 and known pressure values at corresponding locations within the vasculature system, the distal sensor 128 can be used to determine the position of the distal portion of the elongate body 108 in relation to anatomy as the elongate body 108 is advanced (e.g., whether the distal portion is in the left atrium, left atrium appendage, left pulmonary vein, right atrium, right ventricle, inferior vena cava, or superior vena cava) In one embodiment, the antegrade cardiac access system 100 only has the distal sensor 128. The antegrade cardiac access system 100 can have a proximal sensor 132. The proximal sensor 132 can be disposed proximal of some or all of the inflow apertures 124. The proximal sensor 132 can be positioned to be in the right atrium RA when the distal portion is in the heart with the septum S distal to some inflow apertures 124 and proximal to some inflow apertures 124. In one embodiment, the antegrade cardiac access system 100 only has the proximal sensor 132. The distal sensor 128 and / or the proximal sensor 132 can communicate with a controller by way of signal conductors 136 coupled with the one or more sensors. Additionally, one or more sensors can be included to be disposed on the elongate body 108 to be positioned within any one or more of the left ventricle LV, left atrium LA, right atrium RA, right ventricle RV, superior vena cava SVC, inferior vena cava IVC, or within or adjacent to other anatomical features. Any one or more of the sensors can be used to measure temperature, oxygen, pressure, hemoglobin, or any other biometric measurement.

[0148] The antegrade cardiac access system 100 can include a proximal access point 144 configured to allow fluid communication between the lumen 120 and an inflow branch of an ECMO system. FIG. 5 shows an ECMO system 152 with an inflow branch 148. The inflow branch 148 can be placed into fluid communication with the lumen 120 by use of a connector 186. The connection to the inflow branch 148 can enable blood to be directed to the ECMO system 152 from the inflow apertures 124. In some embodiments, one or more sensors can be included for sensing of the cardiac rhythm or oxygen to trigger a pulsatile ECMO flow and provide optimal perfusion. Blood flow can be modulated based on a sensedparameter (e.g., oxygen, cardiac rhythm, temperature, etc.) Tt can also electrically sense, pace, or cardiovert / defibrillate as needed. For example, the ECMO system 152 can include or be coupled with an ECG sensor 188 configured to detect the electrical activity of the heart. The output of the ECG sensor 188 can be provided to a controller operating the pump of the ECMO system 152.

[0149] The antegrade cardiac access system 100 can have a side port 162 configured to allow access to the lumen 120. The side port 162 can facilitate auxiliary steps, such as re- wiring a treatment site and / or flushing the lumen 120. The side port 162 can also be configured to allow an inflow branch of an ECMO system. This can enable the system 100 to be used to perform another procedures through the lumen 120.

[0150] Various procedures benefit from stabilizing the sheath 104. FIG. 2 shows that the antegrade cardiac access system 100 can include an atrial septal anchor 164 in the form of a balloon 165b disposed toward the distal end 116 of the elongate body 108. The balloon 165b can be inflated by a fluid (e.g.. saline, a radiopaque medium, water) similar to a Swan-Ganz balloon catheter. The atrial septal anchor 164 can be disposed in the left atrial side of the septum S. In some embodiments, the atrial septal anchor 164 can be disposed in the right atrial side of the septum S, or on both the left and right atrial side of the septum S. The atrial septal anchor 164 can include a collapsible member that can expand to contact the septum S to hold the elongate body 108 stable. The atrial septal anchor 164 can be compressed by a delivery sheath as the sheath 104 is positioned in the heart. The atrial septal anchor 164 can be configured to self-expand upon exposing the sheath 104 within the heart. In other embodiments, the atrial septal anchor 164 can include any other anchoring mechanism, e.g., barbs, tines, mesh cages, or the like.

[0151] The balloon 165b is coupled with the elongate body 108. The balloon 165b can include one or more radiopaque markers 168 to make the sheath 104 more visible when deployed. The one or more radiopaque markers 168 can be in close proximity to the balloon 165b (e.g., proximally adjacent, distally adjacent, or under the balloon 165b). The balloon 165b can take any suitable form. In one case, the balloon 165b has a central recess into which the septum S can be received to hold the sheath 104 in place at the septum S. In one embodiment, the balloon 165b is disposed only on the left atrium LA of the heart where the balloon 165b anchors the system 100 against slipping back through the septum S into the right atrium RA.

[0152] In some embodiments, the one or more radiopaque markers 168 can be disposed on the elongate body 108 between a distal set and a proximal set of fenestrations 216. The one or more radiopaque markers can be aligned with or located to indicate the position of the atrial septal anchor 164. In some embodiments, the one or more radiopaque markers 168 can have a length between 1 mm and 15 mm (e.g., between 3 mm and 10 mm, approximately 1 mm, approximately 3 mm, approximately 5 mm, approximately 7 mm, approximately 10 mm, approximately 15 mm, approximately 20 mm, ranges between such values, and the like).

[0153] The proximal end 112 can include a membrane 172 configured to seal the lumen 120 when the proximal access point 144 is not connected to another device. FIG. 3 shows that the membrane 172 can have one or more seams 172a that can separate to allow access of a device to open the lumen 120 to use at the proximal access point 144. For example, the connector 186 can be inserted through the membrane 172 to provide fluid communication between the lumen 120 and the ECMO system 152. FIG. 3 also shows the pull wire 180 described below. As shown in FIG. 3, the pull wires 180 can extend within dedicated lumens of the elongate body. The pull wires 180 and associated lumens can be positioned in an outermost layer of the elongate body 108 assembly, within an innermost layer of the elongate body 108 assembly, or within an intermediate layer of the elongate body 108 assembly. In some embodiments, the pull wires 180 can be positioned radially inward from or radially outward of the fenestration members 414 and / or deflection member 400 described below.

[0154] FIGS. 4-5 show that a steering system can be integrated into the antegrade cardiac access system 100. The steering system can include one or more, e.g., two or four pull wires 180. The pull wires 180 may also be referred to herein as wires or steering wires. The pull wires 180 can be located at opposite points, e.g., at 3 o’clock and 9 o’clock and / or at 6 o’clock and 12 o’clock. FIG. 4 shows that these wires can deflect the tip of the sheath 104 in two degrees of freedom, which can enable the tip portion to point as desired. In another embodiment, one or more wires can be provided to deflect in only one degree of freedom, e.g., to flex and extend in that direction. Another degree of freedom can be provided by clocking or counter-clocking (rotating) the system 100 about its longitudinal axis. Rotating in one direction, e.g., clockwise, can move the tip portion posteriorly. Rotating in one direction, e.g., counter-clockwise, can move the tip portion anteriorly.

[0155] The inset anatomy image in FIG. 4 shows the path of the elongate body 108 along an antegrade inferior path. As shown in FIG. 4, the elongate body 108 extends from the inferior vena cava IVC into right atrium RA and deflects (e.g., bends) rightward towards the septum S. The elongate body 108 then extends through the septum S and deflects (e.g., bends) downward toward the mitral valve annulus. In some cases, the elongate body 108 can be advanced such that it extends through the mitral valve MV to position the distal end 116 of the elongate body 108 in the left ventricle LV. In some embodiments, the tip of the sheath 104 can point straight through or even be positioned at or below the leaflets of the mitral valve MV. As shown in FIG. 4, the elongate body 108 traverses a path that may include imperfect plane alignment between the right atrium RA and the left atrium LA through the septum S. Additionally, the path can extend in a particular patient along a different plane from the vena cava (e.g., inferior vena cava IVC or superior vena cava SVC) to the septum S than from septum S to the mitral valve MV position (e.g., 15 degree or more off-set in distal section to get into the mitral valve MV).

[0156] The elongate body 108 can advantageously be constructed to enable traversal along the tortuous path shown in FIGS. 1 and 4 (e.g., the antegrade superior path and / or the antegrade inferior path to the left ventricle). Specifically, the elongate body 108 can provide high torque transfer while maintaining sufficient flexibility to traverse and bend through heart anatomy. FIG. 4A depicts a schematic view of a distal segment of the elongate body 108. As shown in FIG. 4A, the elongate body 108 can include a proximal shaft portion 110 and a distal shaft portion 111. In some embodiments, the proximal shaft portion 110 can be a push and / or torque portion of the elongate body 108, and the distal shaft portion 111 can be a steerable portion of the elongate body 108. The proximal shaft portion 110 can include one or more fenestration members 414. The distal shaft portion 111 can include a deflection member 400. The proximal shaft portion 110 can extend from the proximal end of the elongate body 108 up to or adjacent to the distal shaft portion 111. The distal shaft portion 111 can extend from or adjacent to the proximal shaft portion 110 to the distal end 116 of the elongate body 108. As shown in FIG. 4A, the deflection member 400 can be positioned at or adjacent to the distal end 116 of the elongate body 108.

[0157] As shown in FIG. 4A, the elongate body 108 can include one or more (e.g., a plurality of) sets of fenestrations 416. Each set of fenestrations 416 may include one or more(e.g., three) fenestrations 416. A first set of fenestrations 416 can be positioned adjacent a distal end 116 of the elongate body 108 (e.g., within 5 cm from the distal tip) for positioning within / near or for drainage of blood from a left heart chamber (e.g., a pulmonary vein, left ventricle, and / or left atrium). A second set of fenestrations 416 can be positioned proximal to the first set of fenestrations (e.g., within 10-15 cm from the distal tip) for positioning within / near and / or for drainage of blood from a left heart chamber (e.g.. the left atrium). For example, when the first set of fenestrations 416 is positioned at or near the left ventricle or pulmonary vein, the second set of fenestrations can be positioned within the left atrium. A third set of fenestrations 416 can be positioned proximal to the second set of fenestrations 416 for positioning within / near or for drainage of blood from a left heart chamber (e.g., right atrium, right ventricle, inferior vena cava, and / or or superior vena cava). A fourth set of fenestrations 416 can be 16 can be positioned proximal to the third set of fenestrations 416 for positioning within / near or for drainage of blood from a left heart chamber (e.g., the inferior vena cava, and / or or superior vena cava). For example, when the third set of fenestrations 416 is in the right atrium, the fourth set of fenestrations 416 can be positioned within the inferior vena cava. One or more additional sets of fenestrations (e.g., two, three, four or more) can be spaced proximal to the fourth set of fenestrations 416 for positioning at / near blood outflows of one or more organs (e.g., the liver, kidney, bowels). Accordingly, the one or more fenestrations 416 can provide simultaneous cardiac and organ decongestion (e.g., decongestion of the left side body, decongestion of multiple heart chambers, left side heart decongestion, right side heart decongestion, kidney decongestion, liver decongestion, mesenteric decongestion). Decongestion can advantageously be provided while the patient is being supported e.g., by ECMO or LAVA ECMO. In some embodiments, the axial spacing between fenestrations 416 can be uniform. In other embodiments, spacing between adjacent fenestrations 416 may be non-uniform. For example, one or more sets of fenestrations 416 can be clustered for positioning within the inferior vena cava. In some embodiments, a proximal most third or half of the elongate body may not include fenestrations 416. One or more of the sets of fenestrations described above may not be included in some embodiments.

[0158] FIG. 4B shows a schematic side view of an example deflection member 400. FIG. 4E shows a schematic top view of the deflection member 400. The deflection member 400 can advantageously provide desired flexibility and bending characteristics to thedistal shaft portion 111 to enable traversal through tortuous heart anatomy. As shown in FIG.4B, the deflection member 400 can include a proximal deflection portion 402 and a distal deflection portion 404. The deflection member 400 may additionally include a first transition portion 401 at a proximal end of the proximal deflection portion 402 and / or a second transition portion 403 between the proximal deflection portion 402 and the distal deflection portion 404.

[0159] With continued reference to FIG. 4B, the proximal deflection portion 402 can extend along a proximal region of the deflection member 400. The proximal deflection portion 402 can have a total length between 25 cm and 125 cm (e.g., approximately 25 cm, approximately 40 cm, approximately 50 cm, approximately 60 cm, approximately 70 cm, approximately 80 cm, approximately 90 cm, approximately 100 cm, approximately 125 cm, ranges between such values (e.g., between 40 cm and 80 cm), and the like). In some embodiments, the proximal deflection portion 402 can have a length within the lower end of the provided length range (e.g., about 40 cm) for trans-jugular use. In some embodiments, the proximal deflection portion 402 can have a length within the upper end of the provided length range (e.g., about 80 cm) for trans-femoral use. As shown in FIG. 4A, the proximal deflection portion 402 can include a proximal body portion 406. The proximal body portion 406 can define an elongate tubular body. The proximal body portion 406 can be constructed to have sufficient flexibility to allow bending (e.g., off-axis bending) while still ensuring high torque transfer up to the distal deflection portion 404.

[0160] In some embodiments, the proximal body portion 406 can include a patterned cut design to provide the aforementioned flexibility and torque transfer characteristics. FIG. 4C is an enlarged view of the proximal deflection portion 402 showing a pattern cut design in the proximal body portion 406, FIG. 4C shows a slit cut pattern in the proximal body portion 406, In other embodiments, the proximal body portion 406 can include a spiral cut pattern (see FIG. 4D), a helical cut pattern, other pattern types, or a combination of pattern types.. The pattern cut design can extend at least partially or entirely through a wall thickness of the proximal body portion 406 to alter the flexibility and / or torque transfer characteristics of the proximal deflection portion 402. Accordingly, the pattern cut design can be defined by negative space in a wall thickness of the proximal body portion 406. In this respect, the pattern cut design can advantageously increase the flexibility of the proximal deflection portion 402 as compared to a similarly constructed layer without a pattern cut designformed into it. The pattern cut design can advantageously enable bending of the proximal deflection portion in multiple (e.g., any) direction. The specific pattern or shape of the pattern cut design can advantageously maintain a large percentage of the torsional stiffness of a nonpatterned proximal body portion 406. In some embodiments, the pattern cut design can maintain at least 20%, at least 50%, at least 75%, at least 90%. or at least 95% of the torsional stiffness of a non-pattem cut proximal body portion 406. The pattern cut design may be formed by any suitable manufacturing technique (e.g., laser cutting, molding, 3D-printing, CNC machining, or the like).

[0161] The material forming the proximal body portion 406 can additionally or alternatively contribute to the desired flexibility and torque transfer characteristics of the proximal deflection portion 402. For example, the proximal body portion 406 can be made from one or more of a polymer, plastic, rubber, metal, ceramic, or other material. The material of the proximal body portion 406 can be chosen to provide high flexibility and high torsional stiffness.

[0162] With reference to FIG. 4E, the distal deflection portion 404 can extend along a distal region of the deflection member 400. As shown in FIG. 4E, the distal deflection portion 404 can include a distal body portion 408 and a reinforcement portion 410. The proximal body portion 406 and the reinforcement portion 410 can define an elongate tubular body. The reinforcement portion 410 may be referred to as a spine or reinforcement member. The distal deflection portion 404 can have a total length between 5 cm and 25 cm (e.g., approximately 5 cm, approximately 10 cm, approximately 11 cm, approximately 12 cm, approximately 13 cm, approximately 14 cm, approximately 15 cm, approximately 16 cm, approximately 17 cm, approximately 18 cm, approximately 25 cm, ranges between such values (e.g., between 10 cm and 18 cm), and the like).

[0163] The distal body portion 408 may be the same as or similar to and / or include one or more features of the proximal body portion 406. For example, the distal body portion 408 can include a patterned cut design. The pattern cut design can be chosen to provide desired values of flexibility and torsional stiffness. FIG. 4D is an enlarged view of the distal deflection portion 404 showing a pattern cut design in the distal body portion 408. As shown in FIG. 4D, the distal body portion 408 can include a spiral cut pattern. In other embodiments, the distal body portion 408 can include a slit cut pattern (see FIG. 4C), a helical cut pattern, other patterntypes, or a combination of pattern types. As shown in FIG. 4E, the distal deflection portion 404 can have a different pattern cut design than the proximal deflection portion 402. In some embodiments, the distal deflection portion 404 and the proximal deflection portion 402 can have the same pattern cut design. In some embodiments, distal body portion 408 may not include a pattern cut design.

[0164] With continued reference to FIG. 4E and 4F, the reinforcement portion 410 can advantageously increase the bending stiffness of at least a portion of the distal deflection portion 404 to inhibit or prevent bending of the distal deflection portion 404 along one or more directions. In this manner, the reinforcement portion 410 can advantageously enable the proximal deflection portion 404 to bend in one or more directions (e.g., a first direction) while resisting or preventing bending in a different one or more directions (e.g., a different second direction). Accordingly, the reinforcement portion 410 can enable the distal deflection portion 404 to have a preferential bending axis. In one embodiment, the reinforcement portion 410 can enable bending within a first plane while resisting bending in a substantially perpendicular plane. For example, if the reinforcement portion 410 is provided along a top side of the distal deflection portion 404, the distal deflection portion 404 may resist bending in lateral directions (e.g., left or right directions) while being more freely bendable in superior-inferior directions (e.g., upward and downward directions. With reference to the path shown in FIG. 4, the reinforcement portion 410 can be arranged such that the distal deflection portion 404 can bend in superior-inferior directions (e.g., to enable a substantially clockwise bending path) from the inferior vena cava IVC to the left ventricle LV while resisting bending in anterior-posterior directions. In this manner, the bending direction of the elongate body 108 can be more easily controlled and directed through the tortuous anatomy of the heart, thereby reducing procedure time, reducing injury risk to the patient, and improving patient outcomes.

[0165] As shown in FIG. 4E, the reinforcement portion 410 can extend along at least a portion of or the entirety of the length of the distal deflection portion 404. In embodiments in which the distal body portion 408 is pattern cut, the reinforcement portion 410 can be formed as an un-patterned or uncut portion of the distal deflection portion 404. In some embodiments, the reinforcement portion 410 can be formed as a region of increased wall thickness of the distal body portion 408. In some embodiments, the reinforcement portion 410 can be formed by a separate component (e.g., a metal or polymer strip) that is coupled to thedistal body portion 408. Tn some embodiments, the reinforcement portion 410 can be formed as a combination of any one or more the above described embodiments, or may be formed in other ways.

[0166] FIG. 4E shows the reinforcement portion 410 having a substantially rectangular or linear shape. In other embodiments, the reinforcement portion 410 can have other shapes to provide varying stiffness characteristics. For example, the reinforcement portion 410 can form a spiral or helical shape that clocks around at least a portion of the circumference of the distal body portion. In other embodiments, the reinforcement portion 410 can form a corrugated shape, a patterned shape, a curved shape, or any other shape. In various embodiments, the reinforcement portion 410 may be continuous, discontinuous, or segmented. In a continuous arrangement, the reinforcement portion 410 can provide an uninterrupted portion of the elongate body 108 along a steering axis. The arc length or width of the reinforcement portion 410 can be chosen based on the desired stiffness characteristics. For example, reinforcement portions 410 that extend along larger arc lengths of the circumference of the distal body portion 404 can provide greater bending stiffness and / or resistance to bending in more directions. In contrast, reinforcement portions 410 that extend along smaller arc lengths of the circumference of the distal body portion 404 can provide lower bending stiffness and / or resistance to bending in fewer directions. The reinforcement portion 410 can extend along an arc length that is between 0% to 99% of the circumference of the distal deflection portion 404 (e.g., approximately 5%, approximately 10%, approximately 15%, approximately 20%, approximately 25%, approximately 30%, approximately 40%, approximately 50%. approximately 75%, less than approximately 50%, ranges between such values, and the like). In some embodiments, the deflection member 400 may not include a reinforcement portion 410. In some embodiments, the proximal deflection portion 402 can include a reinforcement portion 410 (e.g., a reinforcement portion 410 with a larger arc length than in the distal deflection portion 404 to provide a lower flexibility in the proximal deflection portion 402).

[0167] As shown in FIG. 4A, the deflection member 400 can be a separate component that is integrated or assembled into the elongate body 108. In other embodiments, the deflection member 400 can be formed integrally with other layers of the elongate body 108. While the deflection member 400 is shown as a single integral component in FIGS. 4A-4E, in other embodiments, the deflection member 400 can be formed as multiple separate components. For example, the proximal deflection portion 402 and the distal deflection portion 404 can be formed as separate components that are assembled into the elongate body 108.

[0168] With reference to FIG. 4A, the first transition portion 401 can transition the proximal shaft portion 110 to the distal shaft portion 111. The second transition portion 403 can transition the proximal deflection portion 402 to the distal deflection portion 404. The first transition portion 401 and the second transition portion 403 may also be referred to herein as decoupling mechanisms. The first transition portion 401 can enable off-axis bending of the distal shaft portion 111 relative to the proximal shaft portion 110 while maintaining torque transfer between the proximal shaft portion 110 and the distal shaft portion 111 The second transition portion 403 can enable off-axis bending of the distal deflection portion 404 relative to the proximal deflection portion 402 while maintaining torque transfer between the proximal deflection portion 402 and the distal deflection portion 404. In some embodiments, the elongate body 108 may not include the first transition portion 401 or the second transition portion 403.

[0169] With continued reference to FIG. 4 and 4A, the proximal deflection portion 402 and the distal deflection portion 404 can each be sized such that when the elongate body 108 is advanced through the septum S, at least a part of the proximal deflection portion 402 is positioned within a right heart chamber (e.g., the right atrium RA) and the distal deflection portion 404 extends at least partially into a left heart chamber (e.g., the left atrium FA). The features of the proximal deflection portion 402 and the distal deflection portion 404 described above advantageously enable the distal end 116 of the elongate body 108 to be traversed through the off-plane path from the septum S, into the left atrium FA, through the mitral valve MV, and into left ventricle FV. In some embodiments, the proximal deflection portion 402 can be stiffer than the distal deflection portion 404 to control the steerable motion of the elongate body 108. For example, the proximal deflection portion 402 can be between 105% and 500% stiffer than the distal deflection portion 404 (e.g., approximately 105%, approximately 110%, approximately 125%. approximately 150%, approximately 200%, approximately 300%, approximately 400%, approximately 500%, ranges between such values, and the like). The reinforcement portion 410 in the distal deflection portion 404 can enable a stiff reaction upon clocking or counter clocking of the elongate body 108, which allows for good maneuverability of the elongate body 108 to more accurately position the distal end 116 in a specific location(e.g., the left ventricle LV). The pattern cut design in the proximal deflection portion 402 can provide flexibility and enable off axis bending while still ensuring a good torque transfer up to the distal deflection portion 404.

[0170] As shown in FIGS. 4A-4E, the deflection member 400 can include one or more fenestrations 416 to provide one or more fenestrations 416 in the distal shaft portion 111. The one or more fenestrations can be formed in, between, and / or adjacent to the proximal deflection portion 402 and / or the distal shaft portion 404. As shown in FIGS. 4A-4B, the deflection member 400 can include four fenestrations 416. In other embodiments, the deflection member 400 or the distal shaft portion 111 can include zero, one two, three, five, six, or any other number of fenestrations 416.

[0171] FIG. 4G shows another example deflection member 400A. The deflection member 400A can be the same as or similar to the deflection member 400 shown in FIG. 4A, except as described below. As shown in FIG. 4G, the deflection member 400A can include a slit cut pattern along at least a majority (e.g„ the entirety or substantial entirety) of the length of the deflection member 400A. The slit cut pattern can provide higher torque transfer and lower flexibility as compared to a spiral cut pattern. The deflection member 400A may not include a reinforcement portion 410.

[0172] FIG. 4H shows another example deflection member 400B. The deflection member 400B can be the same as or similar to the deflection member 400 shown in FIG. 4A, except as described below. As shown in FIG. 4H, the deflection member 400B can include a spiral cut pattern along at least a majority (e.g., the entirety or substantial entirety) of the length of the deflection member 400B. The spiral cut pattern can form a coil. The spiral cut pattern can provide higher flexibility with lower torque transfer as compared to a slit cut pattern. The deflection member 400B may not include a reinforcement portion 410.

[0173] FIGS. 4I-4L show an example fenestration member 414. The fenestration member 414 can include a body portion 415. One or more fenestrations 416 can be formed in the body portion 415, The one or more fenestrations 416 can be circumferentially spaced around the fenestration member 414. The fenestration member 414 shown in FIGS. 4I-4L includes three fenestrations 416. In other embodiments, the fenestration member 414 can include one, two, four, or any other number of fenestrations 416. The body portion 415 can include a pattern cut design. As shown in FIGS. 4I-4L, the body portion 415 can include a slitcut pattern. Tn other embodiments, the body portion 415 can include a spiral pattern, a helical pattern, other pattern types, a combination of pattern types, or no pattern. The pattern cut design can increase flexibility of the fenestration member 414 such that the fenestration member 414 does not undesirably stiffen the elongate body 108. The fenestration member 414 can include a slit 418. The slit 418 can extend along an entire length of the fenestration member 414. The slit 418 can be defined by longitudinal edges providing a gap therebetween. The one or more fenestrations 416 can be positioned circumferentially between the longitudinal edges. The slit 418 can enable the fenestration member 414 to be expanded at the slit 418 to be placed around and / or assembled onto a portion of the elongate body during assembly. The fenestration member 414 can include a C-shaped cross section to form a C-shaped element (see FIG. 4K). The fenestration member 414 can additionally include a coil accommodation portion 420. The coil accommodation portion 420 can be formed as a cut out or slot in the body portion 415, The coil accommodation portion can receive a portion or end of a coil. The coil accommodation portion 420 can allow to the coil to be coupled (e.g., screwed) in place for easier assembly. The coil accommodation portion 420 can ensure proper axial alignment of the coil relative to the fenestration members 414 to maintain positioning of the pull wires 180 between the fenestrations 416. The fenestration member 414 may be formed by any suitable manufacturing technique (e.g., laser cutting, molding, 3D-printing, CNC machining, or the like).

[0174] As shown in FIG. 4A, a plurality of fenestration members 414 can be spaced along the elongate body 108. The elongate body can include one, two, three, four, or any other number of fenestration members 414. The fenestration members 414 can be positioned within the proximal shaft portion 110 (e.g.. the non-steerable portion). The plurality of fenestration members 414 can define a fenestrated segment of the elongate body that extends proximally from the distal shaft portion 111. The plurality of fenestration member 414 can be aligned such that the one or more fenestrations 416 are axially aligned along a length of the elongate body 108. The axial alignment of the fenestrations 416 can allow for linear positioning of the pull wires 180 along a different axial position. Specifically, the pull wires 180 can be being positioned along an offset or different axial path, such that the pull wires 180 do not cross the fenestrations 416 (e.g., the pull wires 180 never cross the fenestrations 416).

[0175] In some embodiments, the elongate body 108 can be assembled and / or manufactured according to a method. Initially, a mandrel can be provided. Next, a liner can beapplied to mandrel to form a base layer of the elongate body 108. The liner can be made from PTFE or other suitable materials. A second layer optionally can be applied to the liner. The second layer can include a thin reflow plastic layer (e.g., PEBAX or other suitable material). Next, the one or more pull wires 180 of a steering system can be coupled to the assembly (e.g., to the second layer or mandrel). Next, one or more fenestration members 414 can be coupled to the assembly. Next, the coil can be coupled to the fenestration members 414 (e.g., coupled to coil accomodation portion 420). The deflection member 400 can be coupled to the assembly. The fenestraion members 414 and / or deflection member 400 can be disposed between an internal and an external section of the elongate body 108. Next, a top layer can be applied to the assembly (e.g., over the fenestration members 414, the deflection member 400, and the coil). The top layer can be a layer of reflow plastic. Next, a shrink layer can be applied to the top layer. In other embodiments, any one or more of the steps can be performed in any order.

[0176] FIG. 5 shows one functionality of the antegrade cardiac access system 100. When patient need requires, the proximal end 112 of the sheath 104 can be accessed. The connector 186 can be inserted into the proximal end 112 and past the membrane 172. The connector 186 has a lumen that fluidly communicates with the lumen 120. The connector 186 communicates through the inflow branch 148 to a gas exchanger 190. The gas exchanger 190 is configured to oxygenate blood withdrawn from the right atrium and / or the left heart chamber. The gas exchanger 190 communicates with the patient through a return cannula 198. The return cannula 198 can have a return cannula body 200. FIG. 6 shows a return cannula body 200 that can be coupled with the ECMO system shown in FIG. 5. The return cannula body 200 can have a blood flow lumen 204. The return cannula body 200 can have a pressure sensor 208 configured to detect pressure in the blood flow lumen. The pressure sensor 208 can confirm flow through the blood flow lumen 204 as part of controlling the ECMO system 152. Blood from the ECMO system 152 is delivered to the patient through plurality of outflow fenestrations 216. The return cannula body 200 has sufficient length to supply blood to locations in the ascending aorta, aortic arch or descending aorta. Such supply can be from a second proximal access site (different from the site the sheath 104 is advanced through) or through the elongate body 108 of the large bore sheath 104 to the aorta.

[0177] FIG. 7 shows the use of the structural heart procedure system 184. The antegrade cardiac access system 100 can be placed in the heart. The distal end 116 of the sheath104 can be placed in the left atrium LA. The structural heart procedure system 184 can be advanced through the proximal access point 144 to the left atrium LA. The structural heart procedure system 184 can be operated to perform the procedure. FIG. 8 shows a daughter cannula 240 that can be used in such a procedure. The daughter cannula 240 can be configured to fit through the system 100 to perform a structural heart procedure. In one embodiment the procedure provides for delivery of a balloon expandable heart valve. The daughter cannula 240 can have a size of 26 French and the system 100 can have a larger size configured to fit a 26 French daughter cannula 240. The daughter cannula 240 can have a lumen 244 for delivering a structural heart tool or implant. The daughter cannula 240 can have pull wires 248 to deflect the tip of the daughter cannula 240 as needed for the procedure. The deflection can be in at least in one axis. The inset image shows that the return daughter cannula 240 can deflect from the position seen in FIG. 8 to point toward the left ventricular outflow track. Such an orientation could facilitate a TAVR procedure.

[0178] Should the patient need cardiac support or cardiac unloading, the antegrade cardiac access system 100 provides access at the proximal access point 144 for deploying the ECMO system 152 to support the patient. The structural heart procedure system 184 can be removed. The connector 186 can be inserted into the proximal end 112 at the proximal access point 144 through the membrane 172.

[0179] FIG. 9 shows a daughter cannula 240A that can be used with the retrograde cardiac access system 100 to perform a cardiac procedure. The daughter cannula 240 A can be similar to the daughter cannula 240 discussed above with additional features. For example, the daughter cannula 240A can include pull wires to facilitate flexing a distal tip portion of the daughter cannula 240A, as indicated by the arrow to the right of the distal end. The daughter cannula 240A can be further positioned by rotating the body thereof at the proximal end, as discussed above and as illustrated the by second arrow further to the right of the body of the daughter cannula 240A. The daughter cannula 240A includes a lumen 244 that can facilitate a procedure. For example, a heart valve can be disposed in the lumen 244. The lumen 244 could be used to inflate a balloon upon which a heart valve can be mounted. The daughter cannula 240A also includes pacing capability so that rapid pacing can be applied to a patient’s heart using the daughter cannula 240A. The pacing can be applied to the patient using a single veinous access site that is also used for the structural heart procedure, e.g., a heart valvemounted to the daughter cannula 240A, and the large bore sheath 104. The pacing can be bipolar pacing. For example, distal pacing features 256 can be provided at the distal tip portion of the daughter cannula 240A. The distal pacing features 256 can include an active electrode and a ground electrode. The distal pacing features 256 can be in electrical communication with proximal contacts 260 by one or more leads 264 disposed through the body of the daughter cannula 240A. The proximal contacts 260 can be connected to an electric circuit and a controller configured to apply the right electrical impulse to cause the heart to rapidly beat to control, e.g., to reduce or minimize interference by blood in the chamber. FIG. 9 illustrates a bipolar pacing configuration. In a variation of the daughter cannula 240A, a unipolar pacing configuration is provided. The unipolar pacing configuration could have a single distal pacing feature. A ground can be provided outside the heart, e.g.. connected to the patients skin.

[0180] In a method, the sheath 104 can be advanced through the septum and oriented toward or through the mitral valve. Then, the daughter cannula 240A can be advanced out of the sheath 104. The pull wires can be used to steer a distal tip portion of the daughter cannula 240A. Upon steering a portion of the distal tip can be urged toward, e.g., into contact with, a wall of the heart. The inset image of FIG. 9 shows the distal pacing features 256 of the daughter cannula 240A contacting a left ventricle septal wall of the heart. Upon contacting the septal wall of the heart, the distal pacing features 256 can direct an electrical impulse into the heart to cause rapid pacing. Then a heart procedure, e.g., a transcatheter aortic valve replacement procedure can be performed at the aortic valve annulus. Similarly, the technique could be used in connection with other left heart procedures, such as a transcatheter mitral valve replacement procedure.

[0181] FIGS. 10-10E depict schematic views of an example modular handle system 1000 (also referred to as a modular sheath system). As shown in FIGS. 10-10E, the modular handle system 1000 can include a sheath 104, a primary port attachment 1004 (also referred to as a primary handle), a side port attachment 1006 (also referred to as a modular handle extension), and an introducer 1008 (also referred to as a dilator), a connector 1014, a plug 1016, and / or a valve 1018. The primary port attachment 1004 can include a primary port 1005 at the proximal end of the primary port attachment 1004. 1006. The side port attachment 1006 can include a side port 1010 and / or an adaptor port 1012. The adaptor port 1012 can define a first branch with a first path that is aligned with the longitudinal axis of the lumen of the sheath104. The side port 1010 can define a second branch with a second path that is disposed at an angle to the longitudinal axis of the lumen of the sheath 104. The introducer 1008 can be a dilator. One or more components of the modular handle system 1000 can be quickly attached or detached to allow the modular handle system to be quickly changed between a single access configuration and a dual access configuration.

[0182] FIG. 10 depicts the modular handle system 1000 in the single access configuration. When in the single access configuration, the primary port attachment 1004 can be coupled to the sheath 104 without the side port attachment 1006. In the single access configuration, the modular handle system 1000 can be used for ECMO procedures. For ECMO procedures, clinicians may prefer to not have the side port attachment 1006 coupled to the modular handle system 1000. In the single access configuration, the introducer 1008 can be advanced through the primary port 1005. In the single access configuration, the modular handle system 1000 can include a single steerable lumen.

[0183] FIG. 10A depicts the modular handle system 1000 in the dual access configuration. When in the dual access configuration, the side port attachment 1006 can be coupled to primary port attachment 1004 (e.g., to the proximal end of the primary port attachment 1004). The side port attachment 1006 can be attachable and detachable from the primary port attachment 1004 to transition the modular handle system between the single access configuration and the dual access configuration. The primary port attachment 1004 can include a first coupling portion (e.g., port 1005) for coupling to a second coupling portion of the side port attachment In some embodiments, the side port attachment 1006 can be coupled to the primary port attachment 1004 via a snap-fit connection, a threaded connection, a locking mechanism, a friction-fit connection, a latch, a securement mechanism, one or more fasteners, or any other coupling mechanism. When the side port attachment 1006 is coupled to the primary port attachment 1004, the adaptor port 1012 of the side port attachment 1006 can be in fluid communication with the primary port 1005 of the primary port attachment 1004. In the dual access configuration, the modular handle system 1000 can be used for ECMO procedures and / or cardiac intervention procedures (e.g., valve modification, leaflet modification, leaflet removal, trans-septal procedures, ablation procedures, electrophysiology procedures (e.g., an ablation procedure, a ventricular fibrillation procedure), an aspiration procedure, or other complex procedures as may create heart function instability). In one example, the primary portattachment 1004 can be used for ECMO procedures while the side port attachment 1006 is used for cardiac intervention procedures. In the dual access configuration, the modular handle system 1000 can be used for LAVA ECMO procedures. e.g., through the side port, while another procedure can be performed through the port located on the main axis of the catheter body.

[0184] In some embodiments, the primary port attachment 1004 and the side port attachment 1006 can each be multi-functional. For example, either of the primary port attachment 1004 or the side port attachment 1006 can be used for ECMO procedures or cardiac intervention procedures. One or more devices (e.g., valve modification tools, leaflet modification tools, leaflet removal tools cardiac pumps, or other devices) can be inserted through the each of the primary port attachment 1004 and the side port attachment 1006. In the dual access configuration, the modular handle system 1000 can include two or more lumens. In the dual access configuration, the introducer 1008 can be advanced through the adaptor port 1012 of the side port attachment 1006 and into the primary port 1005 of the primary port attachment 1004. In the dual access configuration, each of the primary port attachment 1004 or the side port attachment 1006 can be in fluid communication with the sheath 104.

[0185] The modular handle system 1000 can include a valve between the primary port attachment 1004, the side port attachment 1006, and / or the sheath 104. The valve can be vacuum tight to allow for any of ECMO, LAVA ECMO, and / or cardiac intervention procedures. In some embodiments, the modular handle system 1000 can include a de-airing mechanism. The de-airing mechanism can include and be operated via an actuator (e.g., a pushbutton). The actuator can enable the de-airing mechanism to be opened linearly. The de-airing mechanism can include a first opening (e.g., a small opening) for de-airing and a second opening (e.g., a large opening) for a wet-to-wet connection. The valve can include a quick connect mechanism, a snapping mechanism, and / or dedicated tubing to enable quick wet-to-wet connection with the ECMO tubing. The valve can be biased to a closed position. The valve can be locked in the open position. In some embodiments, the modular handle system 1000 can be secured to the skin of a patient via sutures.

[0186] One or more of the connector 1014, plug 1016, and / or valve 1018 can be detachably coupled to one or more of the ports 1005, 1010, 1012. One or more of the connector 1014, plug 1016, and / or valve 1018 may be referred to as modular extensions. The connector1014 can facilitate quick connection between the modular handle system 1000 and another system (e.g., an ECMO system). The connector 1014 can be a quick connector. The connector 1014 can include a barbed hose connector to connect to tubing (e.g., blood flow tubing to an ECMO system). The plug 1016 can be used to seal or plug any of the ports 1005, 1010, 1012 (e.g., if that port is not required or no longer required for a procedure, or after an interventional device has been removed from the port). The valve 1018 can enable insertion of interventional devices, deairing, and / or flushing.

[0187] FIGS. 10B-10E depict variations of the dual access configuration. FIG. 10B shows a configuration in which a valve 1018 is inserted into the port 1010 and a valve 1018 is inserted into the port 1012. FIG. 10C shows a configuration in which a plug is inserted into the port 1010 and a valve 1018 is inserted into the port 1012. FIG. 10D shows a configuration in which a plug 1016 is inserted into the port 1010 and a connector 1014 is inserted into the port 1012. FIG. 10E shows a configuration in which a connector 1014 is inserted into the port 1010 and a valve 1018 is inserted into the port 1012.

[0188] FIGS. 11-11C depict another example modular handle system 1100. The modular handle system 1100 can include any of the features of the modular handle system 1000, and vice versa, except as described below. Thus, reference numerals used to designate the various features or components of the modular handle system 1100 are identical to those used for identifying the corresponding features or components of the modular handle system 1000, except that the numerical identifier has been incremented up by one hundred. Therefore, the structure and description for the various features of the modular handle system 1000 and how it’s operated are understood to also apply to the corresponding features of the modular handle system 1100, and vice versa, except as described below.

[0189] As shown in FIGS. 11-11C, the modular handle system 1100 can include a sheath 104, a primary port attachment 1104, and side port attachment 1106. and a connector 1114, The primary port attachment 1104 can include a primary port 1105 at the proximal end of the primary port attachment 1104. The primary port attachment 1104 can include a valve coupled to the primary port 1005 and an actuator 1107 for controlling the valve. The side port attachment 1106 can include a side port 1110 and / or an adaptor port 1112. The side port attachment 1106 can include a valve coupled to side port 1110, an actuator for controlling the valve coupled to side port 1110, a valve coupled to the adaptor port 1116, and an actuator forcontrolling the valve coupled to the adaptor port 1116. Each valve can be biased to a closed position. Each of the actuators 1107 can be activated (e.g., manually activated) to open the corresponding valve coupled thereto. Each valve can be opened to provide de-airing and to allow backflow of blood into the proximal component of the modular handle system 1100. Each actuator 1007 can be a push-button, a lever, a switch, a dial, or any other manual or electronic actuator.

[0190] FIG. 11A shows a configuration of the modular handle system 1100 with the connector 1114 attached to the primary port 1105. FIG. 11B shows a configuration of the modular handle system 1100 with the side port attachment 1106 attached to the primary port 1105. FIG. 11C shows a configuration of the modular handle system 1100 with the side port attachment 1106 attached to the primary port 1105 and the connector 1114 attached to the side port 1110.

[0191] FIGS. 12A-12E depict schematic views of an example multi-lumen cannula 1200 for trans-jugular procedures. The cannula 1200 can include any one or more features of the sheath 104 described above, and can be used in the same or similar manner, and vice versa. For example, the cannula 1200 can include the deflection member and one or more fenestration members 414 to provide the described mechanical response characteristics and the desired fenestration pattern. As shown in FIG. 12A, the cannula 1200 can include a body 1201 defining a first lumen 1202 and a second lumen 1204. In other embodiments, the cannula 1200 can include additional lumens (e.g., three lumens, or more). The plurality of lumens 1202, 1204 can be oriented in an excentric arrangement (e.g., a non-concentric arrangement, a side-by-side arrangement). In some embodiments, one or more of the lumens 1202, 1204 can be differently sized from each other. As shown in FIGS12A-12B, a distal end 1202b of the first lumen 1202 can terminate proximal to the distal end 1204b of the second lumen 12O4.In some embodiments, the cannula 1200 can be steerable (e.g., via the same or similar steering system as described above). The cannula 1200 can be steerable in one, two, or more directions. In some embodiments, the cannula can include one or more fenestrations 1216 (e.g., in a proximal region). In some embodiments, the cannula 1200 can include two or more sets of fenestrations 1216 (e.g., a first and second set) that are axially spaced apart from each other. Each set of fenestrations 1216 can include one or more fenestrations 1216. A first set of fenestrations 1216 can be positioned adjacent to the distal end 1202b of the first lumen 1202. The first set offenestrations 1216 can be in fluid communication with the first lumen but not in fluid communication with the second lumen 1204. The second set of fenestrations 1216 can be positioned adjacent to the distal end 1204b of the second lumen and distal to the first set of fenestrations 1216. The second set of fenestrations 1216 can be in fluid communication with the second lumen 1204 but not in fluid communication with the first lumen 1202. For example, the second set of fenestrations 1216 can be located on a distal portion of the cannula 1200 such that the second set of fenestrations 1216 can be positioned in the left atrium LA, and the first set of fenestrations 1216 can be located on a proximal portion of the cannula 1200 such that the first set of fenestrations 1216 can be positioned in the left atrium LA or superior vena cava SVC. According to this arrangement, a steerable section of the cannula 1200 can be located distal to the second set of fenestrations 1216. For example, the first lumen 1202 can be used to carry veinous blood and the second lumen 1204 can be used to carry arterial blood. Arterial blood can be expelled from the fenestrations 1216 and / or from an opening on the longitudinal axis of the second lumen 1204 at the distal end 1204b. The fenestrations 1216 can serve to suction blood into ECMO then return blood via a distal lumen of the dual-lumen cannula 1200 in the ascending aorta. This arrangement has the advantage of facilitating treatment through a single vessel puncture.

[0192] FIGS. 13A-13D show a system 1300 and method for accessing a left heart chamber. The system 1300 can include one or more components or features of and can be used in a same or similar manner as the systems 100, 1000, 1100 described above The system 1300 can include a handle 1303 (e.g., handle 103, or a handle of modular handle systems 1000, 1100), a sheath 1304 (e.g., a large bore sheath, e.g., sheath 104, 1200), a dilator 1008 (e.g., the introducer 1008) and a crossing wire 1350

[0193] The dilator 1008 can include a proximal end 1008a, a distal end 1008b, and an elongate dilator body 1008c disposed between the proximal end 1008a and the distal end 1008b (see FIG. 10). The elongate dilator body 1008c can include a proximal portion, a distal portion, and a dilator lumen extending through the elongate dilator body 1008c, The proximal portion of the elongate dilator body 1008c can have a first stiffness and the distal portion of the elongate dilator can have a second stiffness greater than the first stiffness. The elongate dilator body 1008c can transition from the first stiffness to the second stiffness at a location that would be aligned with, e.g., within the deflection member 400, in some cases aligned withor within the proximal deflection portion 402, and in some cases aligned with or disposed within the distal deflection portion 404. In some embodiments, the transition from the first stiffness to the second stiffness is between about 0 cm and 10 cm from the distal end of the dilator body (e.g., about 0.5 cm, about 1 cm, about 3 cm, about 5 cm, about 10 cm, ranges between such values, and the like). The second stiffness can be sufficient to tent the atrial septal wall under a distal force. The second stiffness can be sufficient to expand an opening formed in an atrial septal wall by the crossing wire.

[0194] The elongate dilator body 1008c can be advanced through the lumen of the large bore sheath 1304 such that the distal portion extends out of the distal end of the elongate body of the large bore sheath 1304. As shown, the elongate dilator body 1008c can be advanced through a port aligned with the longitudinal axis of the large bore sheath 1304. The elongate dilator body 1008c is configured such that the crossing wire can be slidably disposed in the dilator lumen. In some embodiments, the elongate dilator body 1008c can have a shape and sufficient stiffness to induce a curvature in the large bore sheath 1304 when disposed in the lumen thereof. The curvature can be one that corresponds to the curvature from a vena cava segment adjacent to a right atrium, into the right atrium and toward a surface of a septal wall of the right atrium separating the right atrium from the left atrium. The stiffness of the elongate dilator body 1008c can cause the deflection member 400 and the portion of the sheath 1304 within which it is disposed to bend to this anatomical curvature. In some cases, the proximal shaft portion 110 is stiffer than the elongate dilator body 1008c such that the proximal shaft portion 110 can deflect the elongate dilator body 1008c from this curved configuration and can, in some cases, straighten the elongate dilator body 1008c as it passes through the proximal shaft portion 110. In some embodiments, the steering system of the sheath 1304 can be used to deflect the elongate body of the large bore sheath 1304 when the elongate dilator body 1008c is disposed in the lumen of the large bore sheath 1304 such that the large bore sheath 1304 has a curvature that corresponds to the curvature from a vena cava segment adjacent to a right atrium, into the right atrium and toward a surface of a septal wall of the right atrium separating the right atrium from the left atrium. In that case, the first stiffness of the elongate dilator body 1008c is selected to provide sufficient pushability such that the tip of the dilator can tent the atrial septal wall, as discussed above, and advance through it forming and / or enlarging a passage through which the sheath 1304 can be disposed.

[0195] As shown in FIG. 13 A, a connector 1314 (e.g., connector 1014, 1114) can be attached to the handle 1303 to connect the system 1300 to a pump or ECMO system. With reference to FIGS. 13A and 13B, the sheath 1304 can advanced up a veinous vessel segment (e.g., the inferior vena cava IVC) and into the right atrium RA. The configuration of FIG. 13A corresponds to an initial use position in which the sheath 1304 is placed in the vena cava. From this position, blood can be drained from the patient and the blood that is drained can flow through the connector 1314. The connector 1314 can have a barb, as shown to facilitate connection to a pump, e.g., as part of an ECMO system. This can enable blood to be withdrawn from the patient to be treated (e.g., oxygenated) to support the patient. In some cases, this position works well for a time. In some cases, a patient’s condition can deteriorate such that they would benefit from unloading on the left side of the heart. In such cases, the sheath 1304 provides the advantage of allowing a clinician to quickly move the sheath from the position of FIG. 13A to the position of FIG. 13C.

[0196] One technique of crossing from the right side chamber in FIG. 13A (the vena cava) to the left side chamber is shown in FIG. 13B. As shown in FIG. 13B, a side port attachment 1306 (e.g., side port attachment 1006, 1106) can be attached (e.g., intra-procedurally attached) to the handle 1303 to provide another port for insertion of the crossing wire 1350 and / or dilator 1008. The connection can involve de-airing the side port attachment 1306, e.g., by actuating the push-button actuator 1107 on one or more of the handle 1303 and the side port attachment 1306. In one protocol, each of the actuator 1107 is pressed to expel a small amount of blood to confirm de-airing of the handle and of each branch of the side port attachment 1306. The ECMO system can still be connected via the side port while the crossing wire 1350 and the dilator 1008. As the dilator 1008 is advanced into the sheath 1304, the curvature of the distal portion of the sheath can be induced. For example, as or after a tip portion of the sheath 1304 is positioned within the right atrium RA, curvature can be induced in the elongate body of the sheath 1304 such that the distal end of the sheath 1304 is directed towards the septum S. The distal tip of the dilator 1008 can make contact with the tissue of the septum and tent the septum S. The crossing wire 1350 can then be urged into contact with the septum and through the septum S. The curvature in the elongate body of the sheath can corresponds to a trajectory from the first veinous vessel segment, through the right atrium and to the atrial septal wall. In some embodiments, the curvature can be induced in the elongatebody of the sheath by allowing the dilator to assume a free state in which the dilator comprises a curvature corresponding to the trajectory. In some embodiments, the curvature in the elongate body of the sheath 1304 can be induced by activating a steering system to deflect the elongate body to a shape corresponding to the trajectory

[0197] The crossing wire 1350 can be a radio-frequency (RF) wire that can apply heat or energy to the septum S to create a trans-septal puncture. The crossing wire 1350 may be any wire capable of creating a trans-septal puncture, e.g., by employing sharp feature to cut the tissue of the septum or by a combination of cutting and RF energy. After a puncture is created through the septum S by the crossing wire 1350, the dilator 1008 can be advanced through the puncture to widen the puncture for the sheath 1304. After the crossing wire 1350 and / or dilator 1008 have been utilized to create and / or widen the trans-septal puncture, the crossing wire 1350 and / or dilator 1008 can be removed from the patient. After the puncture is widened by the dilator 1008, the sheath 1304 can be advanced through the trans-septal puncture and into the left atrium LA. Then, the dilator 1008 can be removed. The passage used for the dilator 1008 can be available for an interventional step. If no additional intervention is needed, a cap or plug (e.g., similar to plug 1016) can be coupled with the port aligned with the longitudinal axis of the sheath 1304. The cap or plug can then be removed as needed to reopen access for a procedural step. Additionally, the side port attachment may be intra-procedurally detached from the handle 1303 if no further interventional procedures are to be performed. The steering system can be utilized again to direct the distal end of the sheath toward or through the mitral valve and into the left ventricle LV or away from tissue around the LA. As shown in FIG. 13C, the sheath 1304 can be positioned within the heart such that one or more fenestrations 1316 are positioned at or adjacent to the mitral valve or within the left ventricle LV, one or more fenestrations 1316 are positioned within the left atrium LA, one or more fenestrations 1316 are positioned within the right atrium RA, and / or one or more fenestrations 1316 are positioned within the inferior vena cava IVC. Any one or more of the fenestrations 1316 can be used to drain blood.In some situations, as shown in FIG. 13D, the sheath 1304 can be positioned such that at least one fenestration is in or adjacent to a left ventricle, at least one fenestration is in or adjacent to a left atrium, and at least one fenestration is in or adjacent to a right side chamber. In some situations, as shown in FIG. 13E, the sheath 1304 can be positioned such that at least one fenestration is in or adjacent to a pulmonary vein(e.g., the left superior pulmonary vein LSPV), at least one fenestration is in or adjacent to a left atrium, and at least one fenestration is in or adjacent to a right side heart chamber, as shown in FIG. 13E, the distal tip of the sheath 1304 can be positioned within or rested within the pulmonary vein. As shown in FIG. 13E, multiple sets of fenestrations 1316 can be clustered within the inferior vena cava IVC. In some situations, a distal tip of the sheath 1304 can be positioned in or adjacent to a left atrial appendage and an aspiration catheter can be advanced adjacent to or into left atrial appendage to remove matter (e.g., thrombus) therefrom. Although FIGS. 13A-13C suggest that a patient can be converted from a vena cava drainage approach to a trans-septal approach to help unload the heart, in other techniques, it may be clear that a patient would benefit from left heart support and the configuration of FIG. 13C may be the starting point of the ECMO support.

[0198] While certain embodiments of the inventions have been described, these embodiments have been presented by way of example only and are not intended to limit the scope of the disclosure. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms. Furthermore, various omissions, substitutions and changes in the systems and methods described herein may be made without departing from the spirit of the disclosure. The accompanying claims and their equivalents are intended to cover such forms or modifications as would fall within the scope and spirit of the disclosure. Accordingly, the scope of the present inventions is defined only by reference to the appended claims and their equivalents.

[0199] Features, materials, characteristics, or groups described in conjunction with a particular aspect, embodiment, or example are to be understood to be applicable to any other aspect, embodiment or example described in this section or elsewhere in this specification unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and / or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and / or steps are mutually exclusive. The protection is not restricted to the details of any foregoing embodiments. The protection extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

[0200] Furthermore, certain features that are described in this disclosure in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable sub-combination. Moreover, although features may be described above as acting in certain combinations, one or more features from a claimed combination can, in some cases, be excised from the combination, and the combination may be claimed as a sub-combination or variation of a sub-combination.

[0201] Moreover, while operations may be depicted in the drawings or described in the specification in a particular order, such operations need not be performed in the particular order shown or in sequential order, or that all operations be performed, to achieve desirable results. Other operations that are not depicted or described can be incorporated in the example methods and processes. For example, one or more additional operations can be performed before, after, simultaneously, or between any of the described operations. Further, the operations may be rearranged or reordered in other implementations. Those skilled in the art will appreciate that in some embodiments, the actual steps taken in the processes illustrated and / or disclosed may differ from those shown in the figures. Depending on the embodiment, certain of the steps described above may be removed, others may be added. Furthermore, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure. Also, the separation of various system components in the implementations described above should not be understood as requiring such separation in all implementations, and it should be understood that the described components and systems can generally be integrated together in a single product or packaged into multiple products.

[0202] For purposes of this disclosure, certain aspects, advantages, and novel features are described herein. Not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, for example, those skilled in the art will recognize that the disclosure may be embodied or canned out in a manner that achieves one advantage or a group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.

[0203] Conditional language, such as “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements, and / or steps. Thus, such conditional language is not generally intended to imply that features, elements, and / or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements, and / or steps are included or are to be performed in any particular embodiment.

[0204] Conjunctive language such as the phrase “at least one of X, Y, and Z,” unless specifically stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.

[0205] Language of degree used herein, such as the terms “approximately,” “about,” “generally,” and “substantially” as used herein represent a value, amount, or characteristic close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, “generally,” and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount. As another example, in certain embodiments, the terms “generally parallel” and “substantially parallel” refer to a value, amount, or characteristic that departs from exactly parallel by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degree.

[0206] The scope of the present disclosure is not intended to be limited by the specific disclosures of preferred embodiments in this section or elsewhere in this specification and may be defined by claims as presented in this section or elsewhere in this specification or as presented in the future. The language of the claims is to be interpreted broadly based on the language employed in the claims and not limited to the examples described in the present specification or during the prosecution of the application, which examples are to be construed as non-exclusive.

[0207] Of course, the foregoing description is that of certain features, aspects, and advantages of the present invention, to which various changes and modifications can be made without departing from the spirit and scope of the present invention. Moreover, the devices described herein need not feature all of the objects, advantages, features and aspects discussed above. Thus, for example, those of skill in the art will recognize that the invention can be embodied or earned out in a manner that achieves or optimizes one advantage or a group of advantages as taught herein without necessarily achieving other objects or advantages as may be taught or suggested herein. In addition, while a number of variations of the invention have been shown and described in detail, other modifications and methods of use, which are within the scope of this invention, will be readily apparent to those of skill in the art based upon this disclosure. It is contemplated that various combinations or sub-combinations of these specific features and aspects of embodiments may be made and still fall within the scope of the invention. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the discussed apparatuses and methods.-M-

Claims

1. WHAT TS CLAIMED TS:

1. A large bore sheath, comprising:an elongate body comprising a proximal end and a distal end;a lumen extending through the elongate body, the lumen being sized to receive and permit passage of a structural heart procedure system and being configured to provide fluid communication between a proximal end of the elongate body and a plurality of fenestrations disposed at a distal portion of the elongate body, fenestrations of the plurality of fenestration being simultaneously positionable in a left heart chamber of a patient and in a right atrium of the patient; anda steering system disposed through the elongate body, the steering system configured to direct the distal end of the elongate body toward anatomy of interest; wherein the large bore sheath is configured to be used for a structural heart procedure and to be convertible to an ECMO procedure without removal from the patient.

2. The large bore sheath of Claim 1, further comprising an atrial septal anchor disposed on the elongate body such that at least one fenestration is proximal of the atrial septal anchor and at least one fenestration is disposed distal of the atrial septal anchor.

3. The large bore sheath of Claim 2, wherein the atrial septal anchor comprises a balloon comprising a radiopaque marker.

4. The large bore sheath of any one of Claims 1 to 3, further comprising a seal disposed in a proximal deflection portion of the elongate body and to allow access therethrough to the lumen for advancing an interventional device into the patient through a distal portion of the elongate body.

5. The large bore sheath of any one of Claims 1 to 4, wherein the steering system is configured to position the distal end to be initially placed in a first left heart chamber and thereafter to position the distal end in a second left heart chamber.

6. The large bore sheath of any one of Claims 1 to 5, wherein the steering system comprises one or more pull wires disposed in a wall of the elongate body to steer the distal end.

7. The large bore sheath of Claim 2, wherein the steering system comprises one or more pull wires disposed in a wall of the elongate body to steer the distal end, wherein the atleast one fenestration disposed distal of the atrial septal anchor comprises a plurality of apertures disposed about a circumference of the elongate body along a length thereof disposed adjacent to the distal end, an un-fenestrated segment disposed about the circumference, one of the one or more pull wires disposed in the un-fenestrated segment of the elongate body.

8. The large bore sheath of any one of Claims 1 to 7, wherein the elongate body comprises a distal portion disposed adjacent to the distal end, a proximal deflection portion disposed adjacent to the distal portion, and a spine disposed along a length of the distal portion.

9. The large bore sheath of Claim 8, wherein the proximal deflection portion is stiffer than the distal portion.

10. The large bore sheath of Claim 8 or 9, wherein the proximal deflection portion is a non- steerable portion of the elongate body, and the distal portion is a steerable portion of the elongate body.

11. The large bore sheath of any one of Claims 8 to 10, wherein the spine is configured to enable the elongate body to bend in a first direction and resist bending in a different second direction.

12. The large bore sheath of any one of Claims 8 to 11, wherein the spine is configured to allow bending along a clockwise bending path from an inferior vena cava to a left ventricle while resisting bending in a lateral directions.

13. The large bore sheath of any one of Claims 8 to 12, wherein the spine extends along an arc length that is less than 50% of a circumference of the elongate body.

14. The large bore sheath of any one of Claims 8 to 13, wherein the spine defines an uninterrupted portion of the elongate body along a steering axis.

15. The large bore sheath of any one of Claims 8 to 14, wherein the distal portion comprises a pattern cut distal body portion, and wherein the spine defines a non-pattern cut portion of the distal portion.

16. The large bore sheath of any one of Claims 8 to 15, wherein the proximal deflection portion comprises a slit cut pattern or a spiral cut pattern formed into the elongate body.

17. The large bore sheath of any one of Claims 8 to 16, wherein a total length of the distal portion is sized such that the distal portion is positionable in a left atrium or a left ventricle and the proximal deflection portion is positionable in a right atrium and across aseptum when the distal end of the elongate body is positioned in the left atrium or the left ventricle.

18. The large bore sheath of any one of Claims 8 to 17, wherein the distal portion has a total length between 10 cm and 18 cm.

19. The large bore sheath of any one of Claims 8 to 18, wherein the proximal deflection portion has a total length between 40 cm and 80 cm.

20. The large bore sheath of any one of Claims 8 to 19, further comprising a decoupling mechanism between the proximal deflection portion and the distal portion, wherein the decoupling mechanism enables off-axis bending of the distal portion relative to the proximal deflection portion while maintaining torque transfer between the proximal deflection portion and the distal portion.

21. The large bore sheath of any one of Claims 1 to 20, further comprising a fenestration member comprising a circumferential member disposed between an internal and an external section of the elongate body, the circumferential member comprising apertures configured to form the fenestrations.

22. The large bore sheath of Claim 21, wherein the fenestration member comprises a C-shaped element having longitudinal edges providing a gap therebetween, a pull wire of the steering system disposed in the gap between the longitudinal edges such that the pull wire does not cross the fenestrations.

23. The large bore sheath of Claim 22, wherein the C-shaped element comprises the apertures disposed circumferentially between the longitudinal edges.

24. The large bore sheath of any one of Claims 21 to 23. wherein the steering system comprises a pull wire disposed a radial distance between an outer circumference of the circumferential member and an inner circumference of the circumferential member.

25. The large bore sheath of Claim 24, wherein the pull wire is disposed in a slit disposed through the circumferential member.

26. An ECMO system, comprising the large bore sheath of any one of Claims 1 to 25, a gas exchanger, and a connector configured to allow fluid communication between the lumen and an inflow branch of the gas exchanger.

27. The ECMO system of Claim 26, further comprising an outflow cannula configured to connect to an outflow branch of the gas exchanger to return blood to the patient following oxygenation of the blood.

28. A left heart chamber access system, comprising the large bore sheath of any of Claims 1-27 and further comprising a dilator and a crossing wire, the dilator having a proximal end, a distal end, an elongate dilator body disposed between the proximal end and the distal end, the elongate dilator body comprising a proximal portion, a distal portion, and a dilator lumen extending through the elongate dilator body, the elongate dilator body being configured to be advanced through the lumen of the large bore sheath such that the distal portion extends out of the distal end of the elongate body of the large bore sheath, the crossing wire configured to be slidably disposed in the dilator lumen.

29. The left heart chamber access system of Claim 28, wherein the proximal portion of the elongate dilator body comprises a first stiffness and the distal portion of the elongate dilator body comprises a second stiffness greater than the first stiffness, the second stiffness sufficient to expand an opening formed in an atrial septal wall by the crossing wire.

30. The left heart chamber access system of Claim 28, wherein the elongate dilator body is configured by shape and stiffness to induce a curvature in the large bore sheath when disposed in the lumen thereof that corresponds to the curvature from a vena cava segment adjacent to a right atrium, into the right atrium and toward a surface of a septal wall of the right atrium separating the right atrium from a left atrium.

31. The left heart chamber access system of Claim 28, wherein the steering system is configured to deflect the elongate body of the large bore sheath when the elongate dilator body is disposed in the lumen of the large bore sheath such that the large bore sheath has a curvature that corresponds to the curvature from a vena cava segment adjacent to a right atrium, into the right atrium and toward a surface of a septal wall of the right atrium separating the right atrium from a left atrium.

32. A modular sheath system, comprising the large bore sheath of any one of Claims Ito 30 and a modular handle extension, wherein the large bore sheath comprises a primary handle disposed at the proximal end of the elongate body, the primary handle comprising a first coupling portion and the modular handle extension comprises a secondcoupling portion configured to engage the first coupling portion, the modular handle extension configured to change or supplement a function of the primary handle when coupled therewith.

33. The modular sheath system of Claim 32, wherein the primary handle comprises a lumen in fluid communication with the lumen of the elongate body to enable blood to flow through the primary handle to a blood handling component.

34. The modular sheath system of Claim 32, wherein the modular handle extension comprises a first branch configured to access the lumen of the elongate body of the large bore sheath through a first path and a second branch configured to access the lumen of the elongate body of the large bore sheath through a second path.

35. The modular sheath system of Claim 34, wherein the first path is aligned with a longitudinal axis of the lumen of the large bore sheath and the second path is disposed at an angle to the longitudinal axis of the lumen of the large bore sheath.

36. The modular sheath system of Claim 32, wherein the modular handle extension comprises a first modular extension and further comprising a second modular extension of the modular handle extension.

37. The modular sheath system of Claim 36, wherein the first modular extension comprises a connector for fluidly connecting the large bore sheath to an ECMO system and the second modular extension comprises a first branch for fluidly connecting the large bore sheath to an ECMO system and a second branch for providing access to the lumen of the large bore sheath for an interventional tool for performing a cardiac procedure.

38. The modular sheath system of Claim 32, wherein at least one of the primary handle and the modular handle extension comprises a valve configured for de-airing the large bore sheath prior to or upon connection of a device to the primary handle and the modular handle extension.

39. The modular sheath system of Claim 38, wherein the valve comprises a pushbutton actuator to facilitate opening the valve manually.

40. A multifunctional transeptal antegrade cardiac access system comprising: a large bore sheath comprising an elongate body comprising a proximal end and a steerable distal segment;a lumen extending through the elongate body of the large bore sheath, the lumen providing fluid communication between the proximal end of the elongate body and the steerable distal segment;a plurality of inflow fenestrations configured to be disposed simultaneously in a right atrium and a left heart chamber of a patient; anda proximal access point configured to allow fluid communication between the lumen and an inflow branch of an ECMO system to direct blood from the plurality of inflow fenestrations to the ECMO system.

41. The multifunctional transeptal antegrade cardiac access system of Claim 40, wherein the proximal access point is configured to allow access to the lumen for advancing a daughter cannula configured for performing a structural heart procedure on the patient.

42. The multifunctional transeptal antegrade cardiac access system of Claim 40 or 41, further comprising a membrane disposed at the proximal end of the elongate body configured to provide access to the lumen for an interventional device while preventing blood leak.

43. The multifunctional transeptal antegrade cardiac access system of Claim 42, wherein the membrane is disposed in the proximal access point.

44. The multifunctional transeptal antegrade cardiac access system of any one of Claims 40 to 43, further comprising a side port disposed at the proximal end of the elongate body to allow re-wiring or flushing of the lumen.

45. The multifunctional transeptal antegrade cardiac access system of any one of Claims 40 to 443, further comprising a daughter cannula comprising a blood flow lumen and a pressure sensor configured to detect pressure in the blood flow lumen.

46. The multifunctional transeptal antegrade cardiac access system of Claim 45, wherein the daughter cannula comprises a cannula body comprising a plurality of outflow fenestrations, the cannula body comprising sufficient length to extend from the proximal access point through the elongate body of the large bore sheath and extending further than a distal end of the steerable distal segment.

47. The multifunctional transeptal antegrade cardiac access system of any one of Claims 40 to 46, wherein the large bore sheath comprises an atrial septal anchor disposed adjacent to the steerable distal segment.

48. The multifunctional transeptal antegrade cardiac access system of Claim 47, wherein the atrial septal anchor comprises a balloon comprising a radiopaque marker.

49. The multifunctional transeptal antegrade cardiac access system of any one of Claims 40 to 48, further comprising one or more pull wires to activate the steerable distal segment.

50. An ECMO system, comprising:the multifunctional transeptal antegrade cardiac access system of any one of Claims 40 to 49;a connector for providing fluid communication to the lumen through the proximal access point;a gas exchanger configured to oxygenate blood withdrawn from the right atrium and / or the left heart chamber; anda return cannula configure to provide fluid communication between the gas exchanger and an artery of the patient.

51. The ECMO system of Claim 50, wherein the return cannula comprises a return cannula body comprising plurality of outflow fenestrations, the return cannula body comprising sufficient length to extend from a percutaneous vascular access site to a distal end of the return cannula body disposed in an aorta of the patient in use to supply blood.

52. The ECMO system of Claim 51, wherein the return cannula comprises a pressure sensor to detect pressure in the return cannula body.

53. A cardiac procedure system, comprising the multifunctional transeptal antegrade cardiac access system of any one of Claims 40 to 52 and a daughter cannula configured to perform a structural heart procedure on the patient.

54. The cardiac procedure system of Claim 53, wherein the daughter cannula supports a prosthetic heart valve to be deployed in a valve annulus adjacent to at least one heart chamber.

55. The cardiac procedure system of Claim 53 or 54, wherein the daughter cannula comprising a distal pacing feature disposed such as to contact a heart wall allowing pacing stimulation.

56. The cardiac procedure system of Claim 55, wherein the distal pacing feature comprises an electrode and a ground feature to facilitate bipolar pacing.

57. The cardiac procedure system of Claim 55 or 56, wherein the distal pacing feature comprises a single electrode configured to facilitate unipolar pacing.

58. A method comprising:positioning a distal end of a sheath through a veinous blood vessel and a right atrium and into a left heart chamber of a patient;steering a distal tip of the sheath toward cardiac anatomy of interest; advancing a structural heart procedure system through a lumen of the sheath; performing a structural heart procedure on or through anatomy of interest using the structural heart procedure system;draining blood from the right atrium and the left heart chamber through fenestrations in a distal portion of the sheath and through the lumen; and pumping blood drained through the fenestrations and the lumen through a blood circuit to an artery of the patient.

59. The method of Claim 58, wherein draining blood is performed after or upon partial completion of performing the structural heart procedure.

60. The method of Claim 58 or 59, further comprising performing gas exchange in the blood circuit to oxygenate the blood drained through the fenestrations and the lumen.

61. A method comprising:positioning a distal end of a sheath through a veinous access site and a right atrium and into a left heart chamber of a patient;steering a distal tip of the sheath toward cardiac anatomy of interest; advancing a daughter cannula supporting a structural heart procedure system through a lumen of the sheath;engaging a pacing feature advanced through the veinous access site with a wall of the left heart chamber; andperforming a structural heart procedure on or through anatomy of interest using the structural heart procedure system.

62. The method of Claim 61 further comprising:draining blood from the right atrium and the left heart chamber through fenestrations in a distal portion of the sheath and through the lumen; andpumping blood drained through the fenestrations and the lumen through a blood circuit to an artery of the patient.

63. The method of Claim 61 or 62 wherein the pacing feature is disposed on the daughter cannula and engaging the pacing feature advanced through the veinous access site with the wall of the left heart chamber comprises steering the daughter cannula from a proximal end of the daughter cannula.

64. The method of any one of Claims 61 to 63, wherein engaging the pacing feature advanced through the veinous access site with the wall of the left heart chamber comprises providing unipolar pacing.

65. The method of any one of Claims 61 to 64, wherein engaging the pacing feature advanced through the veinous access site with the wall of the left heart chamber comprises providing bipolar pacing.

66. A method of draining blood from a cardiovascular system, comprising:placing a distal tip of an elongate catheter body in a veinous vessel, the elongate catheter body having a first plurality of fenestrations disposed at a distal portion and a second plurality of fenestrations disposed proximally of the first plurality of fenestrations, the elongate catheter body having a lumen therethrough;draining blood from a first veinous vessel segment adjacent to a right atrium of a heart of a patient through the first plurality of fenestrations and from a second veinous vessel segment more peripheral from the heart than the first veinous vessel segment through the second plurality of fenestrations;after draining blood from the first veinous vessel segment and the second veinous vessel segment, advancing the elongate catheter body through an atrial septal wall until the first plurality of fenestrations is disposed in a left heart chamber and the second plurality of fenestrations is disposed on a right side chamber; and draining blood from the left heart chamber through the first plurality of fenestrations and from the right side chamber through the second plurality of fenestrations.

67. The method of Claim 66, wherein advancing the elongate catheter body through the atrial septal wall comprises positioning a dilator within the lumen of the elongate catheter body until a tip portion of the dilator is distal to the distal tip of the elongate catheter body andinducing a curvature in the elongate catheter body that corresponds to a trajectory from the first veinous vessel segment, through the right atrium and to the atrial septal wall.

68. The method of Claim 67. wherein inducing the curvature in the elongate catheter body comprises allowing the dilator to assume a free state in which the dilator comprises a curvature corresponding to the trajectory.

69. The method of Claim 67, wherein inducing the curvature in the elongate catheter body comprises activating a steering system to deflect the elongate catheter body from a shape suitable for draining from the first veinous vessel segment and the second veinous vessel segment to a shape corresponding to the trajectory.

70. A dilator, comprising an elongate dilator body having a proximal end, a distal end, and a lumen extending through the elongate dilator body, the elongate dilator body configured to facilitate advancement of a large bore drainage and access sheath across an atrial septal wall.

71. The dilator of Claim 70. wherein the elongate dilator body comprises a proximal portion with a first stiffness and a distal portion with a second stiffness greater than the first stiffness, the second stiffness sufficient to tent the atrial septal wall under a distal force or to enlarge a hole formed through the atrial septal wall.

72. A method of accessing a cardiovascular system, comprising:placing a distal tip of an elongate catheter body in the cardiovascular system of a patient, the elongate catheter body having fenestrations along a length thereof for draining blood into a lumen thereof, the lumen being disposed between the fenestrations and a primary handle disposed at a proximal end of the elongate catheter body;de-airing the lumen of the elongate catheter body; andproviding fluid communication between the primary handle and an ECMO system to supply blood through the primary handle to the ECMO system.

73. The method of Claim 72, wherein de-airing comprises opening a valve by pressing an actuator disposed on the primary handle to allow blood to flow through the primary handle, expelling air from the primary handle.

74. The method of Claim 72, further comprising connecting a coupling portion of a barbed hose connector with a coupling portion of the primary handle to providing fluid communication between the primary handle and the barbed hose connector.

75. The method of Claim 74, further comprising removing the barbed hose connector from the primary handle and thereafter coupling a coupling portion of a branched body to a coupling portion of the primary handle, providing fluid communication through a primary branch of the branched body to the lumen through the primary handle.

76. The method of Claim 72, further comprising coupling a coupling portion of a branched body to a coupling portion of the primary handle, providing fluid communication through a primary branch of the branched body to the lumen through the primary handle.

77. The method of Claim 76, further comprising advancing a procedural tool through a secondary branch of the branched body and performing a procedure with the procedural tool.

78. The method of Claim 77, wherein the procedure comprises aspirating thrombus from within the lumen of the elongate catheter body or within the patient.

79. The method of Claim 77, wherein the procedure comprises incising a valve leaflet.

80. The method of Claim 77, wherein the procedure comprises an electrophysiology procedure.

81. The method of Claim 77, wherein the procedure comprises an ablation procedure.

82. The method of Claim 77, wherein the procedure comprises a ventricular fibrillation procedure.

83. The method of Claim 77, wherein the procedure is performed at a same time as providing fluid communication between the primary handle and the ECMO system to supply blood through the primary handle to the ECMO system.

84. The method of Claim 76. wherein a pathway from the branched body through the primary handle to the lumen of the elongate catheter body is provided following de-airing a lumen in the branched body.

85. The method of Claim 72, wherein placing the distal tip of the elongate catheter body in the cardiovascular system comprises disposing the distal tip in a veinous vesseladjacent to a heart, and further comprising advancing a dilator through the primary handle until a dilator tip is disposed distal to the distal tip of the elongate catheter body and thereafter advancing the dilator and the elongate catheter body across an atrial septum of the heart to place the distal tip in a left heart chamber.

86. The method of Claim 72, wherein placing the distal tip of the elongate catheter body in the cardiovascular system comprises disposing at least one fenestration in a pulmonary vein, at least one fenestration in a left atrium, and at least one fenestration in a right side chamber.

87. The method of Claim 72, wherein placing the distal tip of the elongate catheter body in the cardiovascular system comprises disposing at least one fenestration in a left ventricle, at least one fenestration in a left atrium, and at least one fenestration in a right side chamber.

88. The method of Claim 72, wherein placing the distal tip of the elongate catheter body in the cardiovascular system comprises disposing the distal tip in or adjacent to a left atrial appendage, and further comprising advancing an aspiration catheter adjacent to or into left atrial appendage to remove matter therefrom.

89. The method of Claim 85, wherein advancing the dilator through the primary handle is performed after providing fluid communication between the primary handle and the ECMO system and further comprising providing fluid communication between the primary handle and the ECMO system after advancing the dilator and the elongate catheter body across the atrial septum.

90. A modular sheath system, comprising:an elongate body comprising a proximal end and a distal end, a lumen extending through the elongate body, the lumen being in fluid communication with a plurality of fenestrations disposed at a distal portion of the elongate body;a primary handle coupled with the proximal end of the elongate body, the primary handle providing fluid communication therethrough to the lumen of the elongate body and having a first connection portion; anda modular extension having a second connection portion, the modular extension configured to provide fluid communication and / or access to the lumen of the elongatebody when the second connection portion of the modular extension is coupled to the first connection portion of the primary handle.

91. The modular sheath system of Claim 90 wherein the primary handle comprises an actuator disposed thereon to open a valve disposed in the primary handle to allow blood to flow proximally therein to flush air out of the primary handle.

92. The modular sheath system of Claim 91, wherein the modular extension comprises an actuator disposed thereon to open a valve disposed in the modular extension to allow blood to flow proximally therein to flush air out of the modular extension.

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