Mechanical cardiac support device and methods of using same

Abstract

A pump is configured to be received within a heart. The pump has a shroud having an inlet and an outlet. An impeller is positioned within the shroud. The impeller is configured to effect flow through the shroud from the inlet to the outlet. The impeller can have a hub rotatable about a rotational axis; and a plurality of vanes extending radially from the hub.

Description

Attorney Docket No. 37759.0503P2MECHANICAL CARDIAC SUPPORT DEVICE AND METHODS OF USING SAME CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to, and the benefit of the filing date of, U.S. Provisional Application No. 63 / 698.917, filed September 25, 2024. the entirety of which is hereby incorporated by reference herein.FIELD

[0002] This disclosure relates to devices for providing cardiac support.BACKGROUND

[0003] Improvements in technology have resulted in improved acute salvage of cardiac diseases. Similarly, advancements in long term mechanical cardiac support (MCS) have somewhat offset the critical lack of donors for orthotopic cardiac transplant (OCT) byproviding options to New York Heart Association (NYHA) Class IV patients with severely- decreased left ventricle function, refractory to currently available medical and device support measures. However, a significant number of MCS candidates are not felt to be candidates for MCS implantation due to frailty, comorbidities with multi-organ dy sfunction, social issues, prior thoracic surgery or disease. While some of these patients are better served with palliative management, many of these patients could benefit from a “bridge-to- reconditioning” for possibly future definitive MCS or OCT. Accordingly, a need exists for a safe intracorporeal mechanical cardiac support system that can replace cardiac function across a range of stresses be delivered through minimally invasive surgical techniques.SUMMARY

[0004] Described herein, in various aspects, is a pump configured to be received within a heart. The pump has a shroud having an inlet and an outlet. An impeller is positioned within the shroud. The impeller is configured to effect or increase flow through the shroud from the inlet to the outlet. In use, the shroud can be configured to be received within a heart and span across an aortic valve of the heart. The impeller can have a hub rotatable about a rotational axis and a plurality of vanes extending radially outwardly from the hub.Attorney Docket No. 37759.0503P2

[0005] Also disclosed herein is a catheter comprising a portion that is positionable within a heart having a left atrium, an aorta, and a septum. The catheter comprises an elongate body having an outer surface and an inner surface defining an interior passage of the elongate body. The elongate body comprises a first portion that is configured to be positioned within a left atrium, the first portion defining at least one opening extending from the outer surface to the inner surface of the elongate body. The elongate body further comprises a second portion that is distal of the first portion and configured to be positioned in the aorta when the first portion is positioned within the left atrium, the second portion defining at least one opening extending from the outer surface to the inner surface of the elongate body. An impeller is positioned between the first portion and the second portion. The impeller is configured to effect blood flow through the elongate body from the first portion to the second portion. When the catheter is implanted, a first anchor is positioned proximal of the second portion. The first anchor is configured to inhibit movement of the second portion proximally past the aortic valve. A second anchor is positioned proximal of the first portion. The second anchor is configured to inhibit movement of the first portion of the elongate body proximally past the septum. Optionally, a third anchor can be positioned proximally of the second anchor. The third anchor is configured to inhibit movement of the first portion of the elongate body distally.

[0006] Methods of implanting the catheter are also disclosed.

[0007] Additional advantages of the invention will be set forth in part in the description that follows, and in part will be obvious from the description, or may be learned by practice of the invention. The advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.DESCRIPTION OF THE DRAWINGS

[0008] These and other features of the preferred embodiments of the invention will become more apparent in the detailed description in which reference is made to the appended drawings wherein:

[0009] FIG. 1 is a schematic diagram of a catheter, as disclosed herein, implanted in a heart.Attorney Docket No. 37759.0503P2

[0010] FIG. 2 is a schematic diagram of the catheter of FIG. 1

[0011] FIG. 3 is a schematic diagram of a system comprising the catheter of claim 1.

[0012] FIG. 4 is a schematic diagram of an exemplary of a kit for positioning the catheter.

[0013] FIG. 5 is a schematic cross-sectional view of a heart having a catheter implanted therein.

[0014] FIG. 6 is a partial perspective view of a pump of the catheter of FIG. 5 at the inlet of the pump.

[0015] FIG. 7 is a partial perspective view of the pump of the catheter of FIG. 5 at the outlet of the pump.

[0016] FIG. 8 is a perspective view of an impeller of the pump of FIG. 6.

[0017] FIG. 9 is a perspective view of modeled fluid flow across an exemplary impeller.

[0018] FIG. 10 is a side view of modeled fluid flow through an exemplary pump.

[0019] FIG. 11 is a side view of modeled fluid flow through the pump of FIG. 6.DETAILED DESCRIPTION

[0020] The present invention now will be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all embodiments of the invention are shown. Indeed, this invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. Like numbers refer to like elements throughout. It is to be understood that this invention is not limited to the particular methodology and protocols described, as such may vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present invention.

[0021] Many modifications and other embodiments of the invention set forth herein will come to mind to one skilled in the art to which the invention pertains having the benefit of the teachings presented in the foregoing description and the associated drawings. Therefore, it isAttorney Docket No. 37759.0503P2 to be understood that the invention is not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.

[0022] As used herein the singular forms “a,” “an,” and “the” can optionally include plural referents unless the context clearly dictates otherwise. For example, unless the context dictates otherwise, use of the term “an opening” can represent disclosure of embodiments having a single such opening, as well as embodiments having a plurality of such openings, and so forth.

[0023] All technical and scientific terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which this invention belongs unless clearly indicated otherwise.

[0024] As used herein, the terms “optional” or “optionally” mean that the subsequently described event or circumstance may or may not occur, and that the description includes instances where said event or circumstance occurs and instances where it does not.

[0025] As used herein, the term “at least one of’ is intended to be synonymous with “one or more of.” For example, “at least one of A, B and C” explicitly includes only A, only B, only C, and combinations of each.

[0026] Ranges can be expressed herein as from “about” one particular value, and / or to “about” another particular value. When such a range is expressed, another aspect includes from the one particular value and / or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint. Optionally, in some aspects, when values are approximated by use of the antecedent “about,” it is contemplated that values within up to 15%, up to 10%, up to 5%, or up to 1% (above or below) of the particularly stated value can be included within the scope of those aspects. Similarly, if further aspects, when values are approximated by use of “approximately,” “substantially,” and “generally, ” it is contemplated that values within up to 15%, up to 10%, up to 5%, or up to 1% (above or below) of the particularly stated value can be included within the scope of those aspects. In still further aspects, when angularAttorney Docket No. 37759.0503P2 relationships (e.g., “parallel” or “perpendicular”) are approximated by use of “approximately,” “substantially.” or “generally,” it is contemplated that angles within 15 degrees (above or below), within 10 degrees (above or below), within 5 degrees (above or below), or within 1 degree (above or below) of the stated angular relationship can be included within the scope of those aspects.

[0027] As used herein, “French” refers to a measurement of 1 / 3 of a millimeter.

[0028] As used herein, “proximal” refers to a portion of a device facing or closest to a clinician, and “distal” refers to a portion of the device facing or closest to the patient (or, in the case of a device positioned within the patient, a portion of the device facing away from or farthest aw ay from a clinician). The distal end portion of a catheter can, thus, be understood to be an insertional portion of the catheter that is the leading portion of the catheter w hen the catheter is advanced within the body of a patient as disclosed herein.

[0029] It is to be understood that unless otherwise expressly stated, it is in no way intended that any method set forth herein be construed as requiring that its steps be performed in a specific order. Accordingly, where a method claim does not actually recite an order to be followed by its steps or it is not otherwise specifically stated in the claims or descriptions that the steps are to be limited to a specific order, it is in no way intended that an order be inferred, in any respect. This holds for any possible non-express basis for interpretation, including: matters of logic with respect to arrangement of steps or operational flow; plain meaning derived from grammatical organization or punctuation; and the number or type of aspects described in the specification.

[0030] The following description supplies specific details in order to provide a thorough understanding. Nevertheless, the skilled artisan would understand that the apparatus, system, and associated methods of using the apparatus can be implemented and used without employing these specific details. Indeed, the apparatus, system, and associated methods can be placed into practice by modifying the illustrated apparatus, system, and associated methods and can be used in conjunction with any other apparatus and techniques conventionally used in the industry.

[0031] The devices described herein can be used for providing assistance to individuals suffering from severe cardiac disease. The disclosed catheter can comprise a percutaneously inserted transseptal device using a large caliber impeller to drive flow from the left atrium toAttorney Docket No. 37759.0503P2 the aorta. Advantageously, utilization of venous insertion allows for use of large catheters and devices with a much lower risk of vascular issues as compared to conventional alternatives (e.g., a ventricular assist device), especially for long-term device use, such as for several months or years at a time. In general, the abi 1 i ty to place large catheters improves the feasibility' of implanting relatively large caliber impellers, which bring various hemodynamic advantages. For instance, relatively large caliber impellers permit reduced pump speed, which imparts various mechanical advantages including increased durability, decreased shear, and decreased hemolysis and thrombosis.

[0032] Disclosed herein, and with reference to FIGS. 1-2. is an exemplary catheter 10 comprising a portion 12 that is positionable within a heart having a left atrium (LA), an aorta (AO), and a septum (IAS). The catheter 10 can comprise an elongate body 20 having an outer surface 22 and an inner surface 24 defining an interior passage 26 of the elongate body.

[0033] The elongate body 20 (referred to herein also as “the body”) can comprise a first portion 30 that is configured to be positioned within a left atrium. The first portion 30 can define at least one opening 32 extending from the outer surface 22 to the inner surface of the body 24. In some aspects, the at least one opening 32 can comprise a plurality of openings 32. In some aspects, openings 32 of the plurality of openings 32 can be spaced axially and / or circumferentially from other openings of the plurality of openings 32. In some aspects, the first portion 30 can be defined as a length of the elongate body 20 across which the opening(s) 32 are positioned.

[0034] As illustrated in FIG. 2, the elongate body 20 further comprises a second portion 34 that is distal of the first portion 30 and configured to be positioned in the aorta when the first portion 34 is positioned within the left atrium. The second portion 34 can define at least one opening 36 extending from the outer surface 22 to the inner surface 24 of the body 20. In some aspects, the second portion 34 can be defined as a length of the elongate body 20 across which the opening(s) 36 are positioned.

[0035] An impeller 40 is positioned within the interior passage 26 of the body 20 between the first portion 30 and the second portion 34. The impeller 40 is configured to effect blood flow through the elongate body 20 from the first portion 30 to the second portion 34.Accordingly, when the catheter 10 is positioned within the heart, the impeller 40 can be configured to effect blood flow from blood in the left atrium that is external to the outerAttorney Docket No. 37759.0503P2 surface 22 of the elongate body 20, through the at least one opening 32, through the interior passage 26, out the at least one opening 36, and into the aorta. In exemplary aspects, the impeller 40 can comprise a driven rotor that effects axial blood flow as described herein. In some aspects, the impeller 40 can comprise a drive shaft that couples to the driven rotor. The drive shaft can be integral to the rotor or otherwise coupled to the rotor to fix relative rotational position therebetween (e.g., via a spline, a key, or a threaded bore of the rotor). In some aspects, the impeller 40 can comprise an Archimedes screw. The impeller 40 can further comprise a motor 42 (FIG. 3) that effects rotation of the Archimedes screw. In other aspects, it is contemplated that the impeller 40 can comprise an axial flow pump. In still further aspects, it is contemplated that the impeller 40 can comprise a plurality of blades or paddles that extend radially outwardly from a central body of the impeller 40. In further exemplary aspects, and as discussed in more detail below, the impeller 40 can comprise a plurality of vanes that are configured to effect axial flow upon rotation of the plurality of vanes about a rotational axis.

[0036] Returning now to FIG. 2, a first anchor 50 is show n positioned proximal of the second portion 34 of the body 20. The first anchor 0 can be configured to inhibit movement of the second portion 34 proximally past the aortic valve. In this way, the first anchor 50 can ensure that each opening 32 is positioned within the aorta. In further aspects, the first anchor 50 can be configured to occlude blood flow through the aortic valve outside of the catheter 10 (e g., proximally, from the aorta into the left ventricle). In exemplary aspects, the first anchor 50 can comprise nitinol. In some aspects, the first anchor can comprise a plate anchor. In some optional aspects, the first anchor 50 can be structurally similar to an atrial closure device, but with the body 20 extending therethrough.

[0037] A second anchor 52 can be positioned proximal of the first portion 30 of the body 20. The second anchor 52 can be configured to inhibit movement of the first portion of the body proximally past the septum. In further aspects, the second anchor 52 can be configured to occlude blood flow through the septum. A third anchor 54 can be positioned proximally of the second anchor 52. The third anchor 54 can be configured to inhibit movement of the first portion 30 of the body 20 distally (e g., into the left ventricle). In further aspects, the third anchor 54 can be configured to occlude blood flow through the septum. In some optional aspects, the second and third anchors 52, 54 can be structurally similar to septal occluders, but with the body 20 extending therethrough. In exemplary aspects, the second and thirdAttorney Docket No. 37759.0503P2 anchors 52, 54 can comprise nitinol and / or a textile such as dacron or Gore-Tex material. By including an atrial septal anchor pair (second and third anchors 52, 54) that serves a dual purpose to anchor the catheter 10 as well as to occlude the iatrogenic atrial septal defects, thus preventing creation of an iatrogenic right-to-left shunt.

[0038] In some aspects, one or more of the first, second, or third anchors 50, 52, 54 can be a deployable anchor that is movable about and between a retracted position and a deployed position. In some aspects, one or more of the first, second, or third anchors can be non- deployable (passive) anchors. For example, such a non-deployable anchor can comprise a surface feature that inhibits movement across a surface of the patient. Such a surface feature that inhibits movement can comprise one or more radial projections or a relative increase in cross sectional diameter or other dimension of the catheter 10. In some aspects, only one of the first, second, or third anchors 50, 52, 54 is deploy able, and the others are non-deployable. For example, in some optional aspects, the second anchor 52 is a deployable anchor, and the first and third anchors 50, 54 are non-deployable. In other aspects, each of the first, second, and third anchors 50, 52, 54 is a deployable anchor. In other aspects, the second anchor 52 is deploy able, and one of the first and third anchors 50, 54 is a deploy able anchor, with the other anchor being non-deployable. For example, the second and third anchors 52. 54 can be deployable, and the first anchor 50 can be non-deployable. As further described herein, in some aspects, one or more of the first, second, and third anchors 50, 52, 54 can be configured to be self-expanding so as to form an atrial occlude / seal at the interatrial septum (IAS) to prevent migration of the device and thereby reduce intracardial shunting of blood. In some aspects, the self-expanding capability of the one or more of the first, second, and third anchors 50, 52, 54 is due to the material properties of the anchors. For instance, the selfexpanding anchors 50, 52, 54 can include nitinol or another shape-conserving material.

[0039] It can be particularly advantageous for the second anchor 52, positioned against the surface of the left aorta, to be deploy able in order to ensure that the catheter 10 is not retracted through the IAS. In exemplary' aspects, the anchors / atrial sealing elements can have self-expanding nitinol plates positioned at the interatrial septum to avoid device migration and shunting across the transseptal site.

[0040] As illustrated in FIG. 1, the body 20 can further comprise an intermediate portion 38 extending between the first portion 30 and the second portion 34. At least a portion of the impeller 40 can be positioned within the intermediate portion 38 of the body 20. In someAttorney Docket No. 37759.0503P2 aspects, an entirety of the impeller 40 can be positioned within the intermediate portion 38 of the body 20.

[0041] In some aspects, the catheter 10 can further comprise an anti -traumatic tip 60 distal of (optionally, coupled to a distal end of) the second portion 34 of the body 20. The anti -traumatic tip 60 can be configured to avoid or prevent tissue injury when the tip 60 contacts tissue within the body of the subject. Thus, it is contemplated that anti -traumatic tip 60 does not include sharp edges or other structures that are configured to penetrate or cut tissue. The anti-traumatic tip 60 can comprise, for example, a pigtail structure. In exemplary aspects, the anti-traumatic tip 60 can be flexible. The anti-traumatic tip 60 can have a rounded end. A distal end of the anti-traumatic tip 60 can extend transverse or at an angle from a longitudinal axis of the catheter. In some aspects, the anti -traumatic tip 60 can extend along a curved (e.g., arcuate) path. Optionally, the anti-traumatic tip 60 can curve at least 90 degrees and double backwardly so that the end of the tip 60 is proximal of an intermediate section of the anti-traumatic tip 60.

[0042] As illustrated in FIG. 2, in some aspects, the catheter 10 can comprise a cable portion 62 that is configured to deliver power to the impeller 40. In some aspects, the cable portion 62 can comprise a braided stainless steel sleeve 64. The braided stainless steel sleeve 64 can provide greater stiffness to the catheter 10 than a portion 65 of the cable portion 62 without the braided stainless steel sleeve 64. Accordingly, in some aspects, a distal end portion of the catheter 10 can be a flexible catheter to transition from the left atrium (LA) to the aorta (Ao), and a proximal end portion of the catheter 10 can have a greater stiffness. In some aspects, the catheter 10 can comprise gel. For example, the catheter 10 can comprise a gel-based covering (e g., a coating) that is configured to minimize risk of fracture or damage of wires. The gel-based covering can be provided over a proximal portion (e.g., some or all of the cable portion 62) of the catheter 10. In exemplary' aspects, an electrical cable 63 can be positioned within the cable portion 62 and can extend to and be electrically connected to a motor that is coupled to the impeller as further disclosed herein.

[0043] In some aspects, the catheter 10 can comprise a first radiopaque marker 66 proximate to (e.g., within 1 to 3 cm of), or secured, coupled to, or otherwise physically associated with (optionally, positioned within) the first portion 30 of the body 20. For example, the first radiopaque marker 66 can be positioned distal of the first portion 30 of the body 20 and can mark where the catheter 10 should be positioned w ithin the mitral valve.Attorney Docket No. 37759.0503P2Accordingly, with the first radiopaque marker 66 positioned at the mitral valve, the entirety of the first portion 30, and all of the opening(s) 32, can be positioned proximal of the mitral valve and entirely within the left atrium.

[0044] The catheter 10 can further comprise a second radiopaque marker 68 proximate to (e.g., within 1 to 3 cm of), or secured, coupled to, or otherwise physically associated with (optionally, positioned within) the second portion 34 of the body 20. For example, the second radiopaque marker 68 can be positioned at or in the first anchor 50. The second radiopaque marker 68 can be used to confirm that the second portion of the body 20, and all of the opening(s) 36, are entirely within the aorta.

[0045] In some aspects, the catheter can have a maximum cross sectional outer dimension (e.g., diameter) of at least 18 French, or at least 20 French, or at least 30 French. For example, in some exemplary aspects, the catheter 10 can have a maximum cross-sectional outer dimension from 18 French to 26 French, or from 18 French to 30 French. In exemplary aspects, the catheter can have a maximum outer cross-sectional dimension of about 30 French. In further aspects, the catheter can have a maximum outer cross-sectional dimension of up to 35 French, or from 20 French to 33 French. In other exemplary aspects, the catheter can have a maximum outer cross-sectional dimension of about 22 French. As should be understood in the art, it is undesirable for arterially inserted devices to have large cross- sectional outer dimensions.

[0046] In some aspects, the impeller 40 can be configured to effect a maximum flow rate of at least 5 liters per minute. In further aspects, the impeller 40 can be configured to effect a maximum flow rate of at least 6 liters per minute. In further aspects, the impeller 40 can be configured to effect a maximum flow rate of at least 7 liters per minute. In still further aspects, the impeller 40 can be configured to effect a maximum flow rate of at least 8 liters per minute. In still further aspects, the impeller 40 can be configured to effect a maximum flow rate of at least 10 liters per minute. For example, the impeller can be configured to effect a maximum flow rate from about 6 liters per minute to about 10 liters per minute, or from about 6 liters per minute to about 8 liters per minute, or from about 7 liters per minute to about 10 liters per minute. It is contemplated that the size of the body 20 and the geometry and speed of the impeller 40 can cooperate to determine the blood flow rate provided by the catheter 10.Attorney Docket No. 37759.0503P2

[0047] Referring to FIG. 3, a system 100 can comprise a power supply 102 operably coupled to the impeller 40 (for example, through electrical cable 63 and motor 42). The power supply 102 can comprise, for example, one or more batteries. Optionally, in further aspects, the system 100 can comprise a wireless charge receiver 104 that is in electrical communication with the power supply 102. The wireless charge receiver 104 can be configured to deliver power to the power supply 102. The wireless charge receiver 104 can further be configured (e.g.. sized and shaped) for receipt in a subcutaneous pocket of a patient. The system 100 can further comprise a wireless charge transmitter 106 that is configured to deliver power to the wireless charge receiver 104 (e.g., via induction). In exemplary aspects, it is contemplated that the power supply 102 can be implanted in the right chest of a subject with a cutdown to the right subclavian vein (RSCV) and make use of wireless charging techniques (e.g., inductive charging) as further disclosed herein to ensure that adequate power is available for activating the motor 42 to effect blood flow using the impeller. In alternative aspects, when the disclosed catheter is not implanted within the body of a subject, it is contemplated that the power supply 102 can remain external to the patient, with power being transmitted to the motor through the electrical cable 63, which can extend from the power supply (external to the body of the subject) to the motor 42 (positioned within the body of the subject).

[0048] In various aspects, the system 100 can comprise a controller 108 that is configured to control the speed of the impeller 40. For example, the controller 108 can be in communication with one or more sensors that are configured to detect body motion and / or breathing rate. Based on feedback from said sensors, the controller 108 can then vary the speed of the impeller 40 to provide the desired blood flow rate. For example, high movement speed and / or high breathing rate can indicate a larger required blood flow' rate than if the patient w ere at rest, and the controller 108 can cause the impeller 40 to increase blood flow upon receiving signals from sensors indicative of high movement speed and / or high breathing rate. In exemplary aspects, the controller 108 can be implanted within the body of the subject. However, in other aspects, it is contemplated that the controller 108 can be positioned external to the patient, and control signals from the controller 108 can be used to control operation of the motor 42. In exemplary' embodiments where the controller 108 is positioned within the body of the subject (e.g., through physical association with the catheter), the controller 108 can transmit electrical control signals to the motor 42 using the electrical cable 63. Optionally, in these embodiments, the controller 108 can comprise aAttorney Docket No. 37759.0503P2 receiver that is configured to receive at least one of: output signals from other sensors (e.g., breathing sensors, motion sensors, or other physiological sensors associated with the subject); or wireless input signals (e.g, BLUETOOTH or BLE signals) provided by an external computing device (e.g., a tablet or smartphone) controlled by a clinician or other healthcare provider. In use, the controller 108 can receive the signals (from physiological sensor(s) and / or an external computing device) and process the signals to determine the appropriate speed of the motor 42. Optionally, the controller 108 can comprise or be in communication with a memory that stores rotation protocols that can be selected for implementation in response to particular conditions or commands reflected or indicated by the signals received by the controller 108.

[0049] In some aspects, one or more of (optionally, each of) the power supply 102, wireless charge receiver 104, and controller 108 can be integral to the catheter 10. In other aspects, one or more of (optionally, each of) the power supply 102, wireless charge receiver 104, and controller 108 can be separate from, and coupled to the catheter 10. For example, in some aspects, a back (proximal) end of the catheter 10 can plug into the power supply 102. As further disclosed herein, an electrical cable 63 positioned within the cable portion 62 of the catheter 10 can be electrically coupled to the power supply 102.

[0050] A method of implanting the catheter 10 as described herein is disclosed. In some aspects, the catheter 10 can be positioned via auxiliary vein access. In other aspects, the catheter 10 can be installed via tunneled intra-jugular access. Accordingly, the catheter 10 can be installed via a vein.

[0051] Implantation can include a transseptal puncture performed via intracardiac echocardiography (ICE) transseptal puncture or transesophageal echocardiography guided transseptal puncture techniques.

[0052] Referring now to FIG. 4, a kit 200 can comprise one or more tools for positioning the catheter 10. A first, small sheath 110 (e.g., a 6 French sheath) can be inserted into the left atrium. The first, small sheath 110 can be exchanged for a second, larger sheath 120. This exchange can be consistent with the standard technique to progressively dilate a pathway, as is known by those skilled in the art. The second, larger sheath 120 can be a peel-away sheath. The second, larger sheath 120 can have a cross-sectional dimension (e.g., diameter) of about 24 French. In some aspects, the second, larger sheath 120 can have a cross-sectionalAttorney Docket No. 37759.0503P2 dimension from about 20 French to about 40 French, or from about 22 French to about 36 French, or about 20 French, or about 21 French, or about 22 French, or about 23 French or about 25 French, or about 25 French, or about 27 French, or about 28 French, or about 29 French, or about 30 French, or about 31 French, or about 32 French, or about 33 French, or about 34 French, or about 35 French, or about 36 French. In various optional aspects, the second, larger sheath 120 can have a length from about 40 cm to about 80 cm (e.g., about 60 cm).

[0053] A dilator 130 can be used to advance the second, larger sheath 120 into the aorta. The dilator 130 can be received through the first, small sheath 110. The dilator 130 can be inserted into the aorta via the left ventricle outflow tract (LVOT). The dilator 130 can comprise, for example, a guidewire 132 and a flexible catheter 134. In some aspects, the dilator 130 can be inserted via balloon guidance. In exemplary aspects, the dilator 130 can comprise a slightly smaller catheter 10 than the second, larger sheath 120 (e.g., 23 French flexible catheter). In this way. the dilator 130 can permit positioning of the guidewire 132 in a distal and stable location for later introduction of the second, larger sheath 120. The guidewire 132 can be sufficiently stiff to permit advancement to the aorta. Accordingly, in some exemplary aspects, the guidewire 132 can have a 0.035 inch diameter. The guidewire 132 can have an anti-traumatic tip (e.g., a J-tip).

[0054] The second, larger sheath 120 can be advanced over the dilator 130 until the second, larger sheath 120 extends into the aorta. The dilator 130 can then be removed, thereby leaving the second, larger sheath 120 in position to place the catheter 10.

[0055] The catheter 10 can be advanced through the second, larger sheath 120 until the second portion 34 of the elongate body 20 is in the aorta. The second radiopaque marker 68 can be used to confirm the position of the second portion 34. The catheter 10 can further be positioned so that the first portion 22 of the body 20 is within the left ventricle. In some aspects, the first radiopaque marker 66 can be positioned at the mitral valve to confirm that the first portion 22 of the body 20 is within the left ventricle.

[0056] The second, larger sheath 120 can be retracted, and the first anchor 50 can be deployed to secure the second portion 34 of the body 20 in the aorta. In some aspects, retraction of the second, larger sheath 120 past the first anchor 50 can cause the first anchorAttorney Docket No. 37759.0503P250 to automatically deploy. In other aspects, the first anchor 50 can be selectively deployed. The first anchor 50 can serve as an atrial occluder or seal.

[0057] The second, larger sheath 120 can be retracted to deploy the second anchor 52 on the right side of the septum. The catheter 10 can be retracted to pull the second anchor against the septum, thereby occluding blood flow through the septum from the right side. The second, larger sheath 120 can further be retracted to deploy the third anchor 54 on the left side of the septum. The third anchor 54 can occlude blood flow through the septum from the left side.

[0058] A transesophageal echocardiogram can be performed to confirm minimal shunting. The second, larger sheath 120 can then be fully removed from the patient.

[0059] The impeller 40 of the catheter 10 can be electrically coupled to the power supply 102 (for example, by an electrical cable 63 extending from the power supply 102 that is electrically coupled to a motor 42, optionally via the controller 108). The impeller 40 can then be turned on.

[0060] As further discussed herein, the wireless charge receiver 104 can be positioned in a subcutaneous pocket of the patient.

[0061] Accordingly, in various aspects, a method for positioning the catheter 10 can comprise advancing the catheter 10 through the septum to position the second portion 34 of the body 20 within the aorta and the first portion 30 of the body 20 within the left ventricle. The catheter 10 can be advanced through a sheath. Imaging can be used to determine proper positioning of the catheter 10.

[0062] The second, larger sheath 120 can be retracted to deploy the first anchor 50 to inhibit movement of the second portion 34 proximally past the aortic valve. The sheath can further be retracted to deploy the second anchor 52 inhibit movement of the first portion 30 of the elongate body 20 proximally past the septum. The sheath can further be retracted to deploy the third anchor 54 to inhibit movement of the first portion 30 of the elongate body 20 distally.

[0063] The disclosed catheter 10 can provide various advantages over conventional methods for supporting patients suffering from serious cardiac disease and in need ofAttorney Docket No. 37759.0503P2 mechanical pumping assistance, such as that of a ventricular assist device. For example, smokers are typically unable to survive with a ventricular assist device, whereas smokers can survive implantation and use of the disclosed catheter 10. Further, unlike the disclosed catheter 10, the external pump of the ventricular assist device can lead to arterial thrombosis.

[0064] Additionally, ventricular assist devices are limited by the size of the artery (which is particularly limiting for female patients), and the speed of the pump is limited, as higher speeds can damage blood cells. Therefore, ventricular assist devices have a maximum flow rate between 2.5 liters per minute and 5 liters per minute. For example, by being implantable within a vein, the disclosed catheter 10 can have a larger bore, thereby providing a substantially higher flow rate, than conventional ventricular assist devices.

[0065] Still further, by avoiding thoracic surgery, as required by a ventricular assist device, a patient has a higher likelihood of being able to receive a heart transplant later.

[0066] The disclosed catheter 10 can be configured for long-term use. For example, in some aspects, the disclosed catheter 10 can be used for the lifetime of the patient, thereby avoiding the need for a heart transplant.

[0067] Users of the disclosed catheter can include NYHA IV patients on home inotropes who are not mechanical circulatory support (MCS) candidates but may hemodynamically benefit from MCS therapy.Exemplary Pump

[0068] Referring to FIGS. 5-11, the exemplary catheter 10 can comprise a pump 300 that is receivable within the heart. For example, the pump 300 can comprise the impeller 40 (FIG. 1) as disclosed herein or an impeller 320 as further discussed below. In exemplary' aspects, the pump 300 can correspond to an exemplary' configuration of the intermediate portion 38 of the body of the catheter as further disclosed herein. The pump 300 can also comprise a shroud 310. As illustrated in FIG. 5, in some aspects, the shroud 310 can be (or can be coupled to) a portion of the elongate body 20 of the catheter 10 (FIG. 1). As illustrated in FIG. 5, in some aspects, the shroud 310 can be configured to be received within a heart and span an aortic valve of the heart. As illustrated in FIG. 6, the shroud 310 can have an inlet 312 and an outlet 314. In various aspects, the inlet 312 can be defined by at least one radial sidewall opening 316 (optionally, a plurality of circumferentially spacedAttorney Docket No. 37759.0503P2 sidewall openings). Accordingly, the pump 300 can be placed in the heart so that the inlet 312 is within the left ventricle, and the outlet 314 is within the aorta. As further shown with respect to FIG. 7, in further various aspects, the outlet 314 can be defined by at least one radial sidewall opening 318 (optionally, a plurality of circumferentially spaced sidewall openings). As illustrated in FIG. 7, in some aspects, the shroud 310 can be cylindrical. For example, the shroud 310 can have a cylindrical outer surface 319. However, other geometries of the shroud 310 (such as. for example, a frustoconical shape) are contemplated.

[0069] In use, it is contemplated that the at least one radial sidewall opening 316 of the inlet 312 can permit blood to enter the shroud 310 in a radial direction, thereby allowing for coupling a cable portion 62 to the impeller 40 / 320 through the inlet end of the shroud. Similarly, it is contemplated that the at least one radial sidewall opening 318 of the outlet 314 can permit blood to exit the shroud 310 in a radial direction, thereby avoiding interference with an anti-traumatic tip 60 that may be coupled to the outlet end of the shroud.

[0070] As discussed above, the pump 300 can include an impeller 320 that can be received within the shroud 310. As provided herein, the exemplary impeller 320 shown in FIGS. 5-11 can include any of the features previously described in reference to the impeller 40 shown in FIGS. 1-4, as well as additional features. The impeller 320 can be configured to effect or increase flow through the shroud 310 from the inlet 312 to the outlet 314. As illustrated in FIG. 6, in some aspects, the impeller 320 can comprise a hub 322 rotatable about a rotational axis 324. In some aspects, the hub 322 can have a first end 326 and a taper 328 toward the first end 326. Optionally, as shown in FIG. 6. the hub 322 can have a curved profile that converges at the first end 326. In some aspects, the first end 326 can be pointed. In other aspects, the first end 326 can be rounded. The impeller 320 can further comprise a plurality of vanes 330 extending radially outwardly from the hub 322. As illustrated in FIG. 8, each vane 330 of the plurality of vanes 330 can have a first edge 334. In some aspects, at least one vane 330 of the plurality of vanes 330 has an edge perpendicular to the rotational axis 324. Optionally, the first edges 334 of each vane 330 of the plurality of vanes 330 can extend perpendicularly or substantially perpendicularly (e.g., within 10 degrees of perpendicular) to the rotational axis 324. In other aspects, the first edges 334 can extend away from the first end 326 of the hub 322 (along the direction of blood flow).

[0071] In some optional aspects, the impeller 320 can comprise at least two vanes 330. Optionally, referring to FIG. 8, the impeller 320 can have exactly two vanes 330. In oneAttorney Docket No. 37759.0503P2 example, the impeller 320 can have only a single set 332 of circumferentially spaced vanes 330.

[0072] Referring to FIG. 9, in other aspects, the impeller 320 can comprise a plurality of sets of vanes 330, with the sets being spaced along the rotational axis 324. For example, the impeller 320 can comprise a first set 332a of circumferentially spaced vanes 330 and a second set 332b of circumferentially spaced vanes 330. The first set of vanes 332acan be spaced along the rotational axis 324 from the second set of vanes 332b. Optionally, the vanes 330 of the first set 332a of vanes 330 can have the same shape. Optionally, the vanes 330 of the second set 332b of vanes 330 can have the same shape. Optionally, the first set 332a of vanes 330 can have a shape that is different from the second set 332b of vanes 330. Optionally, the vanes 330 of the first set 332a of vanes 330 have a generally helical profile moving along the rotational axis 324. In further aspects, the vanes 330 of the second set 332b of vanes 330 have an elongate profile moving along the rotational axis 324. For example, in some aspects, the second set 332b of vanes 330 can have an airfoil profile. Optionally, the airfoil profile can comprise opposed surfaces spaced along an axis extending around a circumference of the impeller 330. In some aspects, the opposed surfaces can define a shallow taper toward a first end of the impeller 320. The airfoil profile can further comprise a second portion having a widened profile spaced from the first end of the impeller. In some aspects, both of the opposed surfaces can be arcuate with a concavity facing in the same direction. Optionally, at least two vanes 330 of the first set 332a of vanes 330 intersect a plane including the rotational axis 324, whereas no more than a single vane 330 of the second set 332b of vanes 330 intersects said plane. In some aspects, the first set of vanes 332a can have a first pitch. Optionally, the second set of vanes 332b can have profile with a second pitch that differs from the first pitch, or a profile that does not have a constant pitch. In some aspects, the first and second sets of vanes 332a, b can have the same number of vanes. In other aspects, the first and second sets of vanes 332a, b can differ in number. For example, in some aspects, the second set of vanes 332b can have a greater number of vanes than the first set of vanes 332a. In other aspects, the first set of vanes 332a can have a greater number of vanes than the second set of vanes 332b.

[0073] In some aspects, the impeller 320 can be rotated at a speed from 10.000 rpm to 100,000 rpm (e.g.. optionally, from about 30,000 rpm to 50,000 rpm). In some aspects, the impeller 320 can have a geometry that reduces hemolysis while providing for increased flowAttorney Docket No. 37759.0503P2 rate of blood through the interior passage 26 of the elongate body 20 and increase the pressure therein. FIGS. 10 and 11 illustrate modeled fluid flow of a fluid through exemplary- pumps 300. The impeller 320 of exemplary pump 300 of FIG. 11 has a comparatively larger (30 French) cross-section than the impeller 320 of exemplary pump 300 of FIG. 10. As shown, the exemplary- pump 300 of FIG. 11 demonstrated improved hemodynamics as compared to the exemplary- pump 300 of FIG. 10, including reduced shear stress. Moreover, the exemplary pump 300 of FIG. 11 can achieve flow of up to 10 liters per minute at 11.000 rprn and a 30-50 mmHg pressure head.Advantages of the Disclosed Devices, Systems, and Methods

[0074] Consistent with the above-described devices, systems, and methods, it is contemplated that the disclosure can provide a self-centering transvenous transaortic catheter with an axial flow impeller. It is further contemplated that the catheter can have a size of up to 30 French and can provide inflow in the left atrium and / or left ventricle and outflow into the ascending aorta of a subject.

[0075] In exemplary aspects, the disclosed methods can include one or more of the following steps: providing a right subclavian vein (RSCV) pocket and access with a smaller catheter and sheath; transfemoral -intracardiac echocardiography (TF-ICE) or transfemoral- transesophageal echocardiography (TF-TEE) guided transseptal puncture into a left atrium with advancement of a standard catheter and guidewire into the aorta via the mitral valve, left ventricle, and aortic valve; placing a peelaway sheath (e.g., a 55 cm 30F peelaway sheath) from the RSCV across the interatrial septum into the aorta; advancing the disclosed catheter via a sheath as disclosed herein; conducting a staged removal of the peelaway sheath, allowing for image-guided catheter positioning and atrial anchor deployment; and closing the power supply- and / or impeller of the catheter within the chest pocket.

[0076] In use, it is contemplated that the disclosed catheter can achieve one or more of the following advantages:• Using venous access, thereby allowing for very large caliber catheters with no risk of entry site related arterial complications• Larger caliber catheters allow for significant reductions in pump speed and thus:Attorney Docket No. 37759.0503P2 o Increased durability o Decreased shear o Decreased hemolysis and thrombosis• Intracorporeal design with endovenous / intracardiac approach obviates need for sternotomy and possibly anesthesia• Chest approach allows for return to normal mobility• Intracardiac anchors prevent device migration and intracardiac shunting.EXEMPLARY ASPECTS

[0077] In view of the described products, systems, and methods and variations thereof, herein below are described certain more particularly described aspects of the invention. These particularly recited aspects should not however be interpreted to have any limiting effect on any different claims containing different or more general teachings described herein, or that the “particular’7aspects are somehow limited in some way other than the inherent meanings of the language literally used therein.

[0078] Aspect 1 : A pump that is configured to be received within a heart, the pump comprising: a shroud having an inlet and an outlet; an impeller positioned within the shroud, wherein the impeller is configured to effect or increase flow through the shroud from the inlet to the outlet.

[0079] Aspect 2: The pump of aspect 1, wherein the impeller comprises: a hub rotatable about a rotational axis; and a plurality’ of vanes extending radially from the hub.

[0080] Aspect 4: The pump of aspect 2, wherein the impeller has exactly two vanes.

[0081] Aspect 5: The pump of aspect 2 or aspect 3, wherein the impeller only a single set of circumferentially spaced vanes along the rotational axis.

[0082] Aspect 5: The pump of any one of aspects 2-4, wherein the impeller comprises a first set of circumferentially spaced vanes and a second set of circumferentially spaced vanes,Attorney Docket No. 37759.0503P2 wherein the first set of circumferentially spaced vanes is spaced from the second set of circumferentially spaced vanes along the rotational axis.

[0083] Aspect 6: The pump of any one of aspects 2-5, wherein the hub has a first end and a taper toward the first end.

[0084] Aspect 7: The pump of any one of aspects 2-6, wherein the shroud is configured to be received within a heart and span an aortic valve of the heart.

[0085] Aspect 8: The pump of any one of aspects 2-7, wherein each vane of the plurality of vanes have a first edge, optionally, wherein at least one vane of the plurality of vanes has an edge perpendicular to the rotational axis.

[0086] Aspect 9: The pump of any one of aspects 2-8, wherein the inlet comprises at least one radial sidewall opening.

[0087] Aspect 10: The pump of aspect 9, wherein the at least one radial sidewall opening of the inlet comprises a plurality of circumferentially spaced sidewall openings.

[0088] Aspect 11: The pump of any one of aspects 2-10, wherein the outlet comprises at least one radial sidewall opening.

[0089] Aspect 12: The pump of aspect 11, wherein the at least one radial sidewall opening of the outlet comprises a plurality’ of circumferentially spaced sidewall openings.

[0090] Aspect 13: The pump of any one of aspects 2-12, wherein the shroud has a cy lindrical outer surface.

[0091] Aspect 14: A catheter having a portion that is positionable within a heart having a left atrium, an aorta, and a septum, the catheter comprising: an elongate body having an outer surface and an inner surface defining an interior passage of the elongate body, the elongate body comprising: a first portion that is configured to be positioned within a left atrium, the first portion defining at least one opening extending from the outer surface to the inner surface of the elongate body; and a second portion that is distal of the first portion and configured to be positioned in the aorta when the first portion is positioned within the left atrium, the second portion defining at least one opening extending from the outer surface to the inner surface of the elongate body;Attorney Docket No. 37759.0503P2 a pump as in any one of the preceding aspects, wherein the pump is configured to effect blood flow through the elongate body from the first portion to the second portion; a first anchor positioned proximal of the second portion, wherein the first anchor is configured to inhibit movement of the second portion proximally past the aortic valve; a second anchor positioned proximal of the first portion, wherein the second anchor is configured to inhibit movement of the first portion of the elongate body proximally past the septum; and optionally, a third anchor positioned proximally of the second anchor, wherein the third anchor is configured to inhibit movement of the first portion of the elongate body distally.

[0092] Aspect 15: The catheter of aspect 14, wherein the elongate body further comprises an intermediate portion extending between the first portion and the second portion, wherein at least a portion of the impeller is positioned within the intermediate portion.

[0093] Aspect 16: The catheter of aspect 14 or aspect 15, wherein the at least one opening defined by the first portion of the elongate body comprises a plurality of openings.

[0094] Aspect 17: The catheter of any one of aspects 14-16, wherein the at least one opening defined by the second portion of the elongate body comprises a plurality of openings.

[0095] Aspect 18: The catheter of any one of aspects 14-17, wherein the catheter comprises an anti-traumatic tip distal of the second portion.

[0096] Aspect 19: The catheter of any one of aspects 14-18, further comprising a cable that is configured to deliver power to the impeller.

[0097] Aspect 20: The catheter of aspect 19, wherein the cable comprises a braided stainless steel sleeve.

[0098] Aspect 21: The catheter of any one of aspects 14-20, further comprising a first radiopaque marker proximate to the first portion of the elongate body.

[0099] Aspect 22: The catheter of any one of aspects 14-21, further comprising a second radiopaque marker proximate to the second portion of the elongate body.

[0100] Aspect 23: The catheter of any one of aspects 14-22, wherein the catheter has a maximum cross sectional outer dimension from 18 French to 36 French.Attorney Docket No. 37759.0503P2

[0101] Aspect 24: The catheter of any one of aspects 14-23. wherein the catheter has a maximum cross sectional outer dimension from 22 French to 32 French.

[0102] Aspect 25: The catheter of any one of aspects 14-16-24, wherein the impeller is configured to effect a maximum flow rate of at least 5 liters per minute.

[0103] Aspect 26: A system comprising: a catheter having a portion that is positionable within a heart having a left atrium, an aorta, and a septum, the catheter comprising: an elongate body having an outer surface and an inner surface defining an interior passage of the elongate body, the elongate body comprising: a first portion that is configured to be positioned within a left atrium, the first portion defining at least one opening extending from the outer surface to the inner surface of the elongate body; and a second portion that is distal of the first portion and configured to be positioned in the aorta when the first portion is positioned within the left atrium, the second portion defining at least one opening extending from the outer surface to the inner surface of the elongate body; a pump as in any one of aspects 1-13, wherein the pump is configured to effect blood flow through the elongate body from the first portion to the second portion; a first anchor positioned proximal of the second portion, w herein the first anchor is configured to inhibit movement of the second portion proximally past the aortic valve; a second anchor positioned proximal of the first portion, wherein the second anchor is configured to inhibit movement of the first portion of the elongate body proximally past the septum; and optionally, a third anchor positioned proximally of the second anchor, wherein the third anchor is configured to inhibit movement of the first portion of the elongate body distally; and a power supply operably coupled to the impeller.

[0104] Aspect 27: The system of aspect 26, further comprising a wireless charge receiver that is in electrical communication with the power supply, wherein the wireless charge receiver is configured to deliver power to the powder supply.Attorney Docket No. 37759.0503P2

[0105] Aspect 28: The system of aspect 27, further comprising a wireless charge transmitter that is configured to deliver power to the wireless charge receiver.

[0106] Aspect 29: The system of any one of aspects 26-28, further comprising a controller that is configured to control the speed of the impeller.

[0107] Aspect 30: A method of positioning a catheter, the catheter having a portion that is positionable within a heart having a left atrium, an aorta, and a septum, the catheter comprising: an elongate body having an outer surface and an inner surface defining an interior passage of the elongate body, the elongate body comprising: a first portion that is configured to be positioned within a left atrium, the first portion defining at least one opening extending from the outer surface to the inner surface of the elongate body; and a second portion that is distal of the first portion and configured to be positioned in the aorta when the first portion is positioned within the left atrium, the second portion defining at least one opening extending from the outer surface to the inner surface of the elongate body; a pump as in any one of aspects 1-13, wherein the pump is configured to effect blood flow through the elongate body from the first portion to the second portion; a first anchor positioned proximal of the second portion, wherein the first anchor is configured to inhibit movement of the second portion proximally past the aortic valve; a second anchor positioned proximal of the first portion, wherein the second anchor is configured to inhibit movement of the first portion of the elongate body proximally past the septum; and optionally, a third anchor positioned proximally of the second anchor, wherein the third anchor is configured to inhibit movement of the first portion of the elongate body distally, the method comprising: advancing the catheter through the septum to position the second portion of the elongate body within the aorta and the first portion of the elongate body within the left ventricle.

[0108] Aspect 31: The method of aspect 30, wherein advancing the catheter comprises advancing the catheter through a sheath.Attorney Docket No. 37759.0503P2

[0109] Aspect 32: The method of aspect 31, further comprising using imaging to determine proper positioning of the catheter.

[0110] Aspect 33: The method of aspect 32, further comprising: retracting the sheath to deploy the first anchor to inhibit movement of the second portion proximally past the aortic valve; retracting the sheath to deploy the second anchor inhibit movement of the first portion of the elongate body proximally past the septum; and optionally, retracting the sheath to deploy the third anchor to inhibit movement of the first portion of the elongate body distally.

[0111] Although the foregoing invention has been described in some detail by way of illustration and example for purposes of clarity of understanding, certain changes and modifications may be practiced within the scope of the appended claims.

Claims

Attorney Docket No. 37759.0503P2CLAIMSWhat is claimed is:

1. A pump that is configured to be received within a heart, the pump comprising: a shroud having an inlet and an outlet; and an impeller positioned within the shroud, wherein the impeller is configured to effect or increase flow through the shroud from the inlet to the outlet, wherein the shroud is configured to be received within a heart and span an aortic valve of the heart.

2. The pump of claim 1, wherein the impeller comprises: a hub rotatable about a rotational axis; and a plurality of vanes extending radially outwardly from the hub.

3. The pump of claim 2, wherein the impeller has exactly two vanes.

4. The pump of claim 2, wherein the impeller has only a single set of circumferentially spaced vanes along the rotational axis.

5. The pump of claim 2, wherein the impeller comprises a first set of circumferentially spaced vanes and a second set of circumferentially spaced vanes, wherein the first and second sets of circumferentially spaced vanes are spaced along the rotational axis.

6. The pump of claim 2, wherein the hub has a first end and a taper toward the first end.

7. The pump of claim 2, wherein each vane of the plurality of vanes has a first edge, wherein at least one vane of the plurality of vanes has an edge perpendicular to the rotational axis.

8. The pump of claim 1, wherein the inlet comprises at least one radial sidewall opening.

9. The pump of claim 8, wherein the at least one radial sidew all opening of the inlet comprises a plurality of circumferentially spaced sidewall openings.

10. The pump of claim 1, wherein the outlet comprises at least one radial sidewall opening.

11. The pump of claim 10. wherein the at least one radial sidewall opening of the outlet comprises a plurality of circumferentially spaced sidewall openings.

12. The pump of claim 1, wherein the shroud has a cylindrical outer surface.Attorney Docket No. 37759.0503P213. A catheter having a portion that is positionable within a heart having a left atrium, an aorta, and a septum, the catheter comprising: an elongate body having an outer surface and an inner surface defining an interior passage of the elongate body, the elongate body comprising: a first portion that is configured to be positioned within a left atrium, the first portion defining at least one opening extending from the outer surface to the inner surface of the elongate body; and a second portion that is distal of the first portion and configured to be positioned in the aorta when the first portion is positioned within the left atrium, the second portion defining at least one opening extending from the outer surface to the inner surface of the elongate body; a pump as in any one of the preceding claims, wherein the pump is configured to effect blood flow- through the elongate body from the first portion to the second portion; a first anchor positioned proximal of the second portion, w herein the first anchor is configured to inhibit movement of the second portion proximally past the aortic valve; a second anchor positioned proximal of the first portion, wherein the second anchor is configured to inhibit movement of the first portion of the elongate body proximally past the septum.

14. The catheter of claim 13. further comprising a third anchor positioned proximally of the second anchor, wherein the third anchor is configured to inhibit movement of the first portion of the elongate body distally.

15. The catheter of claim 13, wherein the elongate body further comprises an intermediate portion extending betw een the first portion and the second portion, wherein at least a portion of the impeller is positioned within the intermediate portion.

16. The catheter of claim 13. wherein the at least one opening defined by the first portion of the elongate body comprises a plurality of openings.

17. The catheter of claim 13. wherein the at least one opening defined by the second portion of the elongate body comprises a plurality of openings.

18. The catheter of claim 13. wherein the catheter comprises an anti-traumatic tip distal of the second portion.Attorney Docket No. 37759.0503P219. The catheter of claim 13, further comprising a cable that is configured to deliver power to the impeller.

20. The catheter of claim 19. wherein the cable comprises a braided stainless steel sleeve.

21. The catheter of claim 13, further comprising a first radiopaque marker proximate to the first portion of the elongate body.

22. The catheter of claim 13. further comprising a second radiopaque marker proximate to the second portion of the elongate body.

23. The catheter of claim 13. wherein the catheter has a maximum cross sectional outer dimension from 18 French to 36 French.

24. The catheter of claim 13. wherein the catheter has a maximum cross sectional outer dimension from 22 French to 32 French.

25. The catheter of claim 13. wherein the impeller is configured to effect a maximum flow rate of at least 5 liters per minute.

26. A system comprising: a catheter having a portion that is positionable within a heart having a left atrium, an aorta, and a septum, the catheter comprising: an elongate body having an outer surface and an inner surface defining an interior passage of the elongate body, the elongate body comprising: a first portion that is configured to be positioned within a left atrium, the first portion defining at least one opening extending from the outer surface to the inner surface of the elongate body; and a second portion that is distal of the first portion and configured to be positioned in the aorta when the first portion is positioned within the left atnum, the second portion defining at least one opening extending from the outer surface to the inner surface of the elongate body; a pump as in any one of claims 1-13, wherein the pump is configured to effect blood flow through the elongate body from the first portion to the second portion; a first anchor positioned proximal of the second portion, wherein the first anchor is configured to inhibit movement of the second portion proximally past the aortic valve;Attorney Docket No. 37759.0503P2 a second anchor positioned proximal of the first portion, wherein the second anchor is configured to inhibit movement of the first portion of the elongate body proximally past the septum; and a power supply operably coupled to the impeller.

27. The system of claim 26, wherein the catheter further comprises a third anchor positioned proximally of the second anchor, wherein the third anchor is configured to inhibit movement of the first portion of the elongate body distally.

28. The system of claim 26, further comprising a wireless charge receiver that is in electrical communication with the power supply, wherein the wireless charge receiver is configured to deliver power to the power supply.

29. The system of claim 28, further comprising a wireless charge transmitter that is configured to deliver power to the wireless charge receiver.

30. The system of claim 26, further comprising a controller that is configured to control the speed of the impeller.

31. A method of positioning a catheter, the catheter having a portion that is positionable within a heart having a left atrium, an aorta, and a septum, the catheter comprising: an elongate body having an outer surface and an inner surface defining an interior passage of the elongate body, the elongate body comprising: a first portion that is configured to be positioned within a left atrium, the first portion defining at least one opening extending from the outer surface to the inner surface of the elongate body; and a second portion that is distal of the first portion and configured to be positioned in the aorta when the first portion is positioned within the left atrium, the second portion defining at least one opening extending from the outer surface to the inner surface of the elongate body; a pump as in any one of claims 1 -13, wherein the pump is configured to effect blood flow through the elongate body from the first portion to the second portion; a first anchor positioned proximal of the second portion, w herein the first anchor is configured to inhibit movement of the second portion proximally past the aortic valve;Attorney Docket No. 37759.0503P2 a second anchor positioned proximal of the first portion, wherein the second anchor is configured to inhibit movement of the first portion of the elongate body proximally past the septum, the method comprising: advancing the catheter through the septum to position the second portion of the elongate body within the aorta and the first portion of the elongate body within the left ventricle.

32. The method of claim 31, wherein advancing the catheter comprises advancing the catheter through a sheath.

33. The method of claim 32, further comprising using imaging to determine proper positioning of the catheter.

34. The method of claim 33, further comprising: retracting the sheath to deploy the first anchor to inhibit movement of the second portion proximally past the aortic valve; and retracting the sheath to deploy the second anchor inhibit movement of the first portion of the elongate body proximally past the septum.

35. The method of claim 34, wherein the catheter further comprises a third anchor positioned proximally of the second anchor, wherein the third anchor is configured to inhibit movement of the first portion of the elongate body distally, and wherein the method further comprises retracting the sheath to deploy the third anchor to inhibit movement of the first portion of the elongate body distally.

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