Systems and methods of active endoventricular cardiac assist

Abstract

The present disclosure relates to system, kits and methods for providing active cardiovascular assist. Specifically, the present disclosure relates to an endoventricular inflatable or expandable chamber inserted in the left ventricle, configured to assist in blood ejection synchronous or asynchronous with the cardiac cycle.

Description

SYSTEMS AND METHODS OF ACTIVE ENDO VENTRICULAR CARDIAC ASSISTBACKGROUND

[0001] The present disclosure is directed to system, kits and methods for providing active cardiovascular assist. Specifically, the present disclosure is directed to an endoventricular inflatable chamber inserted in the left ventricle, configured to assist in blood ejection synchronous or asynchronous with the cardiac cycle.

[0002] Chronic heart failure (CHF) is a worldwide growing major public health issue, having a huge social and economic impact. It is estimated that almost 30 million people are currently living with CHF worldwide, with an expected growth of about 50% by 2030. Patients affected by CHF have a progressively worsening quality of life and usually require frequent hospital admissions to manage HF exacerbations. More than 50% of patients die within five years of diagnosis, with an enormous burden to healthcare systems. CHF social cost derives from the impact that the disease has on the patient (frequent hospital admissions, loss of workforce) and on their family members that frequently become primary caregivers and on the community. In the US it is estimated that the costs related to the loss of work and household productivity is of $8.2 billion / year ($12.3 billion / year by 2030).

[0003] Guidelines directed medical therapy (GDMT) is usually more effective in the early stages of CHF and large capitals have been invested in the last few years to develop new CHF drugs with encouraging results (5,6). However in the advanced stages of CHF the impact of GDMT is limited. Unfortunately there is a large population of patients who are in the advanced stages of CHF (over 2 millions in Europe and the United States of America) for whom pharmacological therapies alone are no longer sufficient. The treatment of symptoms in progressive heart failure involves therefore a balance of the right medications and, in some cases, the use of devices that help the heart to beat and contract properly (i.e Pacemaker / Cardiac Resynchronization Therapy). Nevertheless, very few specific solutions directly addressing CHF are available as the disease progresses. Consequently, many advanced stage NYHA (New York Heart Association) lib and III patients face a therapeutic gap and decline towards the terminal stage (NYHA IV) where only very invasive and highly expensive lifesaving treatments are available. Some patients undergo major open-heart surgery, very few have a heart transplant (not feasible for people over age 70, representing 80% of HF patients), some are dependent onimplantable left ventricular assist devices (LVADs) or total artificial hearts that presents several severe complications, very poor quality of life and a short life expectancy, and staggering healthcare costs.

[0004] Traditional surgical therapies, based on restoration or replacement of the contractile function of the left ventricle are limited to specifically selected patients due to high invasiveness and related complications. In the last decade LVADs has emerged as an alternative to conventional surgery as bridge therapy to heart transplant or as destination therapy. Nowadays, the dischargeable LVADs available on the market (i.e. HeartMate 3, Abbott Cardiovascular, Plymouth, MN, US and Jarvik 2000, Artech, New York, NY) are obsolete, require surgery, and are burdened by high rate of complications (gastro-intestinal bleeding, haemolysis, external driveline infections, etc) that heavily decrease the quality of life and the prognosis of the patient. Available LVADs consist of a suction pump, implanted on the apex of the LV and a reinfusion vascular prosthesis, sutured on the ascending aorta, providing a circulatory support by mean of a continuous blood flow, instead of a physiologically pulsed flow. More recently, transcatheter approaches have been developed such as, for example, the Revivent TC procedure (Bioventrix, Inc.) which offers a solution for transcatheter ventricular restoration, but still show complexities and is limited to a small subset of patients with aneurysms, and the Parachute (Cardiokinetix, Inc., now abandoned due to unsatisfactory clinical data) that was initially designed to partition and exclude the akinetic or aneurysmal apical portion of the LV developing as a post-ischemic complication, while restoring the original shape of the apex.

[0005] To address some of these issues, ventricular assist devices were approved as a temporary method to support cardiac function until cardiac transplantation could be completed. Typical ventricular assist devices are mainly used as a bridge to cardiac transplant for patients awaiting a donor heart. Additionally or alternatively, cardiac assistance systems are also configured to provide additional cardiac output in patients who exhibit insufficient cardiac output. Ventricular assist devices are available as right ventricular, biventricular, or left ventricular assist devices (LVAD), with LVAD becoming the most commonly implanted device to support patient cardiac function and circulation while awaiting transplant.

[0006] Specifically with regard to LVADs, there is a range of issues and shortcomings affecting the technology. These devices entail an elevated risk of infections, often stemming from the percutaneous driveline, and the need for anticoagulation therapy, which can lead tosevere bleeding complications. Additionally, thrombosis, stroke, and device malfunctions, including mechanical failures, are persistent concerns, necessitating vigilant monitoring. LVADs can also engender hemolysis and anemia, with patients having to contend with external components, limited mobility due to battery constraints, and the complexity of implantation surgery.

[0007] The proposed systems, methods and compositions aim to address the above-identified shortcomings.SUMMARY

[0008] In an exemplary implementation, provided herein is a system for an active endoventricular cardiac assist comprising: an endoventricular inflatable chamber, adapted, sized and configured to be accommodated in a left ventricle (LV) of a subject in need thereof; a subcutaneous control module; and an endocatheter in communication with the endoventricular inflatable chamber, and the subcutaneous control module, wherein the subcutaneous control module is operable to cause the endoventricular inflatable chamber to transition between an inflated configuration and an deflated configuration, synchronous or asynchronous with a cardiac cycle.

[0009] In another exemplary implementation, provided herein is a method of implanting a system for an active endoventricular cardiac assist, implemented in a system comprising an endoventricular inflatable chamber, adapted, sized and configured to be accommodated in a left ventricle (LV) of a subject in need thereof, and to contain a predetermined blood volume; a subcutaneous control module; and an endocatheter in communication with the endoventricular inflatable chamber, and the subcutaneous control module, wherein the subcutaneous control module is operable to cause the endoventricular inflatable chamber to transition between an inflated configuration and an deflated configuration synchronous or asynchrnous with a cardiac cycle the method comprising: identifying a cephalic or a subclavian veni; inserting a guidewire into the identified vein; advancing the guidewire through the identified vein into superior vena cava, right atrium, crossing tricuspid valve, reaching the apex of the right ventricle; advancing a transeptal catheter over the guidewire; Using the transseptal catheter, perforating a mid-apical portion of the interventricular septum; removing the transeptal catheter, leaving the guidewire; advancing a delivery catheter over the guidewire into the left ventricle; removing the guidewire;advancing a folded endoventricular inflatable chamber coupled to the endocatheter through the delivery catheter into the left ventricle; unfolding the endoventricular inflatable chamber in the left ventricle; and coupling the endocatheter to the subcutaneous control module.

[0010] In yet another exemplary implementation, provided herein is a kit comprising: an endoventricular inflatable chamber, adapted, sized and configured to be accommodated in a left ventricle (LV) of a subject in need thereof; a subcutaneous control module; an endocatheter wherein the subcutaneous control module is operable to cause the endoventricular inflatable chamber to transition between an inflated configuration and an deflated configuration synchronous with a cardiac cycle; optionally, packaging; and optionally, instructions, the kit configured when assembled to form a system for an active endoventricular cardiac assist.BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The system, kits and methods for providing active cardiovascular assist disclosed herein will become apparent from the following detailed description when read in conjunction with the figures, which are exemplary, not limiting, and in which:

[0012] FIG. 1, is a schematic illustrating the system components;

[0013] FIG. 2, is a schematic illustrating of the insertion of the chamber;

[0014] FIG.s 3 is a schematic illustration of the subcutaneous control module components;

[0015] FIG.s 4 is a schematic illustration of the charging module;

[0016] FIG.s 5 is a schematic illustration of the cardiac assist chamber in the LV; and

[0017] FIG. 6A and 6B, illustrate two implementations of a mechanically expandable chamber system.

[0018] While the disclosure of the system, kits and methods of an endoventricular inflatable chamber inserted in the left ventricle, configured to assist in blood ejection synchronous or asynchronous with the cardiac cycle, disclosed herein, is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be further described in detail herein below. It should be understood, however, that the intention is not to limit the disclosure to the particular exemplary implementations described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives.DETAILED DESCRIPTION

[0019] Provided herein are exemplary implementations of systems, kits and methods for providing active cardiovascular assist. Specifically, provided herein are exemplary implementations of systems and kits having an endoventricular inflatable or expandable chamber inserted (implanted) in the left ventricle either transseptally or transapically, configured to assist in blood ejection, cardiac output (CO), mean arterial pressure (MAP), coronary flow (CF) and pulse pressure (PP) either synchronous, or asynchronous with the cardiac cycle.

[0020] As indicated, and in response to the impending health challenge associated with the increase in incidence, prevalence and mortality of CHF, provided herein is a cutting-edge medical technology designed to enhance cardiac function. This approach harnesses advanced "smart materials" and minimally invasive transcatheter techniques, offering a viable strategy to delay disease progression, extend life expectancy, and reduce healthcare expenditure burdens.

[0021] In an exemplary implementation, provided herein is a new generation of devices, configured to increase the cardiac function of patients. The technology uses an endoventricular inflatable chamber, developed using "smart materials", or non-rigid robotic actuators, having the ability to change the chamber shape actively during the cardiac cycle, when subjected to an electrical voltage. The inflatable chamber, once implanted inside the left ventricle (LV), improves cardiac function indirectly, and consequently systemic perfusion. In an exemplary implementation, the device is adapted, sized and configured to be implanted via a transcatheter, offering substantially less invasive alternative to conventional surgical techniques.

[0022] In another exemplary implementation, provided herein is an mechanically expandable chamber, coupled to an actuator operable to expand and contract the expandable chamber mechanically using a catheter inserted into the left ventricle either transseptally, or transapically, with an ectuator configured to transition the expandable chamber from a collapsed or contracted configuration, to an expanded configuration, again synchronously or asynchronously with the cardiac cycle.

[0023] The disclosed technology is operable to delay disease progression as much as possible and consequently the need for radical treatments (in synergy with optimal medical therapy) such as the implantation of intracorporeal ventricular assist devices or heart transplantation, providing a longer life expectancy and at the same time reducing the costs for healthcare.

[0024] Intelligent materials possess the ability to actively change their shape, based on the application of electrical voltage. Such technologies include dielectric elastomers (ED) and non- rigid electrohydraulic actuators (e.g., Peano-HASEL). The latter couple electrostatic energy to hydraulic energy to obtain a force similar to that of a human muscle, it can then return to the original spatial configuration when the electrical stimulus ceases. They are constructed using an elastomeric shell, partially covered by a pair of electrodes in opposite position, containing a dielectric liquid. The forces resulting from the application of voltage pressurize the liquid, generating a conformational change caused by the hydraulic force. In an exemplary implementation, the inflatable chamber or components thereof are formed using non-rigid electrohydraulic actuators.

[0025] In another exemplary implementation, the device is firmly fixed to the ventricular apex by means of endocardial anchors (see e.g., 105i, FIG. 5). Its dual function is to reduce the functional volume of the LV, occupying its apex, as well as to generate a passive propulsion using the resiliency of the inflatable or expandable chamber (see e.g., FIG. 6A, 6B), which is operable to collect the residual contractility of the basal-mid segments and transfer its energy to the overlying blood mass.Definitions:

[0026] In the context of the disclosure, the term “resilient apical membrane” refers to the ability of the membrane coupled to the apical side of the inflatable chamber, to deform readily upon the application of pressure, as well as its ability to generally spring back to its original shape when such pressure is removed. Moreover, the term “resilient”, in the context of the disclosure means that so long as the resilient apical membrane has not returned to its unconstrained original shape, it will exert a biasing force in the direction of the applied pressure constraining the resilient apical membrane.

[0027] As used herein, the term “synchronous” refers to pacing, or actuation of the inflatable or expandable chamber, in which information about a sensed activity in one or more cardiac chambers is used to determine the timing of impulse generation by the control module. As used herein, the term “asynchronous pacing” refers to pacing in which impulse generation by the control module occurs at a fixed rate, independent of underlying cardiac activity.

[0028] The term “coupled”, including its various forms such as “operably coupling”, "coupling" or "couplable", refers to and comprises any direct or indirect, structural coupling, connection or attachment, or adaptation or capability for such a direct or indirect structural or operational coupling, connection or attachment, including integrally formed components and components which are coupled via or through another component or by the forming process. Indirect coupling may involve coupling through an intermediary member or adhesive, or abutting and otherwise resting against, whether frictionally or by separate means without any physical connection.

[0029] In addition, for the purposes of the present disclosure, directional or positional terms such as "top", "bottom", "upper," "lower," "side," "front," "frontal," "forward," "rear," "rearward," "back," "trailing," "above," "below," "left," "right," "radial ," "vertical," "upward," "downward," "outer," "inner," "exterior," "interior," "intermediate,", “apical”, “basal”, etc., are merely used for convenience in describing the various exemplary implementations of the present disclosure.

[0030] Likewise, the term "engage" and various forms thereof, when used with reference to an engaging element, for example in the engagement of the inflatable or expandable chamber 100 by anchor(s) 105i, refers in an exemplary implementation to the application of any forces that tend to hold inflatable or expandable chamber 100 and LV wall together against inadvertent or undesired separating forces (e.g., such as may be introduced during the pulsatile blood flow through the replaced structural cardiac valve). It is to be understood, however, that engagement does not require in all cases an interlocking connection that is maintained against every conceivable type or magnitude of separating force. Further, the term "engaging element" refers in another exemplary implementation, to one or a plurality of coupled components, at least one of which is configured for releasably engaging another element.

[0031] In the context of the disclosure, the term “subcutaneously,” when used to describe implanting a device (e.g., control module, lead body, electrode(s), etc.), means implanting the device beneath the skin but above layers of skeletal muscle tissue, rib bones, and costal cartilage. The subcutaneously implanted device is typically positioned under or partially within the subcutaneous tissue. When the term “subcutaneous” is used to characterize the entire implantable medical system, the term means that most of the operating components of the system (e.g., the pulse generator, shocking electrodes, optional sensing electrodes, lead bodies) or each and everyone of the operating components is beneath the skin, but above layers of skeletal muscle tissue, rib bones, and costal cartilage.

[0032] The term "transseptal" refers to the access to the LV, which, starting from a peripheral cephalic or a subclavian vein, ascends in an exemplary implementation up to the superior vena cava down to the right atrium. In the case of the endoventricular inflatable or expandable chamber, it is also necessary to reach the left atrium via an opening, which is created, with interventional methods, in the interventricular septum between the two atria. In this manner, damage, that is to say the perforation of the left ventricle associated with the transapical procedure, which affords access from the ventricular side to the LV, is prevented.

[0033] Conversely, the term “transapical” and its derivatives “transapically” involves a direct surgical approach through the apex of the left ventricle. In the case of the endoventricular inflatable or expandable chamber, the method is performed via a small incision in the chest wall. By providing direct access to the left ventricle - transapical insertion allows for optimal positioning of the endoventricular inflatable or expandable chamber, designed to improve cardiac output and hemodynamic parameters such as mean arterial pressure, coronary flow, and pulse pressure. In certain exemplary implementations, this approach is used in patients with complex anatomy or peripheral vascular disease that precludes transfemoral (transseptal) access.

[0034] Both the transseptal and transapical techniques are tailored in an exemplary implementation to patient-specific needs.

[0035] The terms “first,” “second,” and the like, herein do not denote any order, quantity, or importance, but rather are used to denote one element from another. The terms “a”, “an” and “the” herein do not denote a limitation of quantity, and are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The suffix “(s)” as used herein is intended to include both the singular and the plural of the term that it modifies, thereby including one or more of that term (e.g., anchor(s) 2022p includes one or more anchor).

[0036] Reference throughout the specification to “one exemplary implementation”, “another exemplary implementation”, “an exemplary implementation”, and so forth, means that a particular element (e.g., step, feature, structure, and / or characteristic) described in connection with the exemplary implementation is included in at least one exemplary implementation described herein, and may or may not be present in other exemplary implementations. Inaddition, it is to be understood that the described elements may be combined in any suitable manner in the various exemplary implementations.

[0037] In the context of the disclosure, the term "operable" means the system and / or the device, or a certain element or step is / are fully functional, sized, adapted and calibrated, comprise elements for, and meet applicable operability requirements to perform a recited function when activated, coupled, implemented, actuated, effected, or realized. In relation to systems, the term "operable" means the system is fully functional and calibrated, having the necessary elements, as well as the mechanisms for, and meets applicable operability requirements to perform a recited function when executed by a subject in need thereof.

[0038] The term “control module,” “processor” or “processing circuitry” may generally refer to any of the foregoing logic circuitry, alone or in combination with other logic circuitry, or any other equivalents. When implemented in software, the functionality ascribed to the systems and devices described in this disclosure may be embodied as instructions on a computer-readable medium such as RAM, ROM, NVRAM, EEPROM, FLASH memory, magnetic media, optical media, or the like. The instructions may be executed to support one or more aspects of the functionality described in this disclosure, f implemented in software, the techniques described in this disclosure may be stored on or transmitted over as one or more instructions or code on a computer-readable medium. Computer-readable media may include non-transitory computer data storage media, which may be any available media that can be accessed by one or more computers or one or more processors to retrieve instructions, code and / or data structures for implementation of the techniques described in this disclosure. By way of example, and not limitation, such data storage media can comprise RAM, ROM, EEPROM, CD-ROM or other optical disk storage, magnetic disk storage, or other magnetic storage devices, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer. The code may be executed by one or more processors, such as one or more DSPs, general-purpose microprocessors, ASICs, FPGAs, or other equivalent integrated or discrete logic circuitry. Accordingly, the term “control module” or “processor,” as used herein may refer to any of the foregoing structure or any other structure suitable for implementation of the techniques described herein. In addition, in some aspects, the functionality described herein may be provided within dedicated hardware and / or softwaremodules configured for encoding and decoding, or incorporated in a combined codec. In addition, the techniques could be fully implemented in one or more circuits or logic elements.

[0039] The term “fluid communication” is used throughout this description to indicate a certain type of relative arrangement and allows, but does not require, a fluid to actually be flowing at any given time between the features which are described as being in fluid communication.

[0040] A more complete understanding of the system, kits and methods for providing active cardiovascular assist, can be obtained by reference to the accompanying drawings. These figures (also referred to herein as “FIG.”) are merely schematic representations based on convenience and the ease of demonstrating the present disclosure, and are, therefore, not intended to indicate relative size, scale and dimensions of the devices or components thereof, and / or to define or limit the scope of the exemplary implementations. Although specific terms are used in the following description for the sake of clarity, these terms are intended to refer only to the particular structure of the exemplary implementations selected for illustration in the drawings, and are not intended to define or limit the scope of the disclosure. In the drawings and the following description below, it is to be understood that like numeric designations refer to components of like function.

[0041] In an exemplary implementation (see e.g., FIG. 5), the active endoventricular cardiac assist device 100 is implanted trough a transapical or an atrial or ventricular- transseptal puncture. Anchoring of the active endoventricular cardiac assist can be performed at the level of the LV 501 Apex 504 and / or at the apical portion of the LV circumferentially. The active endoventricular cardiac assist device is operable to inflate and expand its volume during systole and decrease it during diastole (in other synchronous with cardiac cycle) but can do also the opposite (in other synchronous with cardiac cycle). Furthermore, the hydraulic pressure generated by the actuators during the active phase (systole) is configured to be sufficient to counteract the intracavitary LV systolic pressure allowing the resilient membrane expansion to a plane or convex surface.

[0042] Further, in an exemplary implementation, the active endoventricular cardiac assist device is connected to a subcutaneous controller and battery that can synchronize the inflation / deflation (expansion / contraction) with the cardiac cycle. The active endoventricular cardiac assist device is filled in an exemplary implementation with saline, hydrogel, or another similarly biocompatible fluid that is expandable based on the electricity received. Accordingly,and as illustrated in FIG.s 1-5, provided herein is system 10 for active endoventricular cardiac assist comprising: endoventricular inflatable chamber 100, adapted, sized and configured to be accommodated in left ventricle (LV) 501 of subject in need thereof 500; subcutaneous control module 200; and endocatheter 110 in (e.g., fluid) communication with endoven trie ular inflatable chamber 100, and subcutaneous control module 200, wherein subcutaneous control module 200 is operable to cause endoventricular inflatable chamber 100 to transition between inflated configuration and deflated configuration, synchronous or asynchronous with subject in need thereof’ s 500 cardiac cycle. In another exemplary implementation, endoventricular inflatable chamber 100 can be single for LV 501, or RV 502 (in this case not transseptally inserted), or can be for both LV 501 and RV 502 connected by an interventricular system (not shown).

[0043] Endoventricular inflatable chamber 100 used in systems 10 and kits 30 (not shown) disclosed, for implementing methods provided, defines conical body 101 having circular lip 1000 (see e.g., FIG. 5) and apex 1001, endoventricular inflatable chamber 100 further comprises: resilient membrane 102 coupled to circular lip 1000, configured to transition between deflated configuration, and inflated configuration during cardiac cycle; plurality of sensors and electrodes 103i, disposed on inflatable endoventricular inflatable chamber 100, operable to sense cardiac cycle; and inlet port 1002, disposed at apex 1001 of endoventricular inflatable chamber 100, in fluid communication with subcutaneous control module 200.

[0044] Endoventricular inflatable chamber 100, 600 (see e.g., FIG. 6A, 6B) is adapted, sized and configured to increase the LV stroke volume (SV) acting on the LV end ventricular systolic (LVESV) and diastolic volume (LVEDV) based the following formula:SV=LVEDV-LVESV (EQU1) where Stroke volume (SV) is the amount of blood ejected by the left ventricle (LV) of the heart during each contraction or heartbeat (in ml / beat), representing the volume of blood pumped out of the LV into the aorta and subsequently into systemic circulation; Left Ventricular End Systolic Volume (LVESV), is the volume of blood remaining in the left ventricle at the end of systole (or the LV contraction); and Left Ventricular’ End Diastolic Volume (LVEDV) is the volume of blood present in the left ventricle at the end of diastole (or the LV is relaxation), filling with blood from the left atrium.

[0045] Accordingly, endoventricular inflatable or expandable chamber 100, 600, is (each) adapted, sized and configured to be inserted and anchored (see e.g., 105j, FIG. 5) inside LV 501 occupying the LV basal space and change its (the chamber) shape and volume throughout the cardiac cycle by inflating (expanding) and deflating (contracting / collapsing) causing membrane 102 (in the case of the inflatable chamber 100) to concave and convex, or expandable chamber 600 to expand and contract accordingly. Consequently, in the deflated configuration, resilient membrane 102 is configured to form a concave cavity within endoventricular inflatable chamber 100 sized to accommodate predetermined blood volume, of between about 5ml and about 60 ml. Similarly, in the inflated configuration, resilient membrane 102 is configured to form a plane, or a convex surface across circular lip 1000 of endoventricular inflatable chamber 100.

[0046] Assuming in an exemplary implementation, that endoventricular inflatable chamber 100 has a resting volume in diastole of Vo and an active volume in systole of Vi, SV will change according to the following formula:SVi=(LVEDV-Vo)-(LVESV-Vi) (EQU2) where Vi>Vo

[0047] Turning now to FIG.s 6A, and 6B describing a system for an active endoventricular cardiac assist comprising: an endoventricular expanable chamber 600, adapted, sized and configured to be accommodated in a left ventricle (LV) 501 of a subject’s heart in need thereof; external control module (400, not shown, comprised e.g., of subcutaneous control module 200 and charging module 300); and an endocatheter 110 in communication with the endoventricular expandable chamber 600, and the external control module 400, wherein the external control module 400 is operable to cause the endoventricular expandable chamber 600 to transition between an expanded configuration and an default contracted or collapsed configuration, synchronous or asynchronous with a cardiac cycle.

[0048] Using the systems disclosed herein and in another exemplary implementation, the system is configured to increase SV1 by between about 10% and about 75%, or between about 25% and about 65%, for example, between about 40% and about 60%.

[0049] In another exemplary implementation, reducing LV functional volume using the devices, systems and methods disclosed herein, generates SV “passive” improvement together with an active propulsion generated by the small material forming apical membrane 102, and / orlip 1000, or with expandable chamber 600, improving cardiac efficiency, a key driver to enhance overall cardiac function.

[0050] The systems, kits and methods provided are therefore able to treat a wider slice of patients in need thereof, for example, and in an implementation, those with a pre-operative iLVESV<60 mL / m2. Therefore, in an exemplary implementation, the kits disclosed comprise three different sizes of endo ventricular’ inflatable or expandable chamber 100, 600, to be implanted in mild, moderate and severely dilated ventricles. Typically, an excessive reduction of LV volume would cause a restrictive condition thus potentially negatively affecting LV filling and the ability to determine the decrease in the stroke volume. Currently, suggested indication to left ventricular remodelling surgery include pre-operative, initial LVESV>60 ml / m2.Preoperative LVESV is usually carefully evaluated, to avoid the selection of patients with small ventricles for which the likelihood for diastolic function worsening is high, since an excessive reduction of LV volume would cause a low-output syndrome. Final initial LVEDV target is configured to be between about 50 and about 60 ml / m2, in order to provide a SV >40 ml / m2.

[0051] In an exemplary implementation, endoventricular inflatable or expandable chamber 100, 600, is made of a resilient material that configured to expand itself together expansion of the LV and RV. The battery is rechargeable. The assist device presents a partially compressible (more robust) scaffold that lies on the endoventricular wall of the LV to resist dilatation preventing dilatation in an opposite direction to what is requested. The basal portion of the device is expandable and can be made of small materials, named also soft robots that can modify shape and volume based on the electrical power that it is applied to them. The smart material can be linear over the wall and / or with a spiral form from the apex to the base mimicking the natural shape of heart muscle fibers.

[0052] In yet another exemplary implementation, as illustrated in FIG.s 1, and 4, subcutaneous control module 200 comprises: reservoir 210 containing liquid 2100 (e.g., saline, hydrogel) in fluid communication with endocatheter 110; pumping means 220, in fluid communication with reservoir 210, pumping means operable to pump in liquid 2100 in reservoir 210 into endoventricular inflatable chamber 100, and pump out liquid 2100 from endoventricular’ inflatable chamber 100 synchronously or asynchronously with cardiac cycle. Also illustrated schematically, is subcutaneous transceiver 260; power storage module 230; and at least one processor 250, in communication with pumping means 220, subcutaneous transceiver 260, andeach of plurality of sensors and electrodes 103i, the at least one processor being in further communication with non-transitory memory device storing thereon processor-readable media with set of executable instructions configured, when executed, to cause at least one processor 250 to: using plurality of sensors and electrodes 103i disposed on inflatable endoventricular inflatable chamber 100, and upon sensing contraction of LV 501, pump in liquid 2100 from reservoir 210 into endoventricular inflatable chamber 100; and using plurality of sensors and electrodes 103i disposed on inflatable endoventricular inflatable chamber 100, and upon sensing expansion of LV 501, pump out liquid from endoventricular inflatable chamber 100, into reservoir 210. Moreover, subcutaneous control module 200 further comprises at least one sensor 245 for detecting at least one physiological parameter associated with the cardiac cycle, and wherein the set of executable instructions is further configured, when executed by at least one processor 250, to adjust the timing and operation of endoventricular inflatable chamber 100 based on the detected parameter. That parameter can be, for example, an ecocardiographic or a haemodynamic parameter, or a parameter comprising one or more of the foregoing.

[0053] The pumping means used in the systems and devices disclosed herein can be, for example, pulsatile pumps and continuous-flow pumps. Pulsatile pumps, utilize pneumatic drivers to create alternating positive and negative pressures. These pressures shuttle air between positive and negative pressures to pump liquid to and from the inflatable endoventricular chamber. This type of pump relies on external pneumatic components, including air compressors and valves, to generate the necessary actuation forces. Additionally, or alternatively; continuous-flow pumps can use rotary propulsion mechanisms such as axial or centrifugal flow designs. These pumps are typically powered by electromagnetic or hydrodynamic forces rather than pneumatics. In certain exemplary implementations, the pumping means used is a pulsatile pump, a continuous flow pump or a pump comprising one or more of the foregoing.

[0054] Alternatively, system for an active endoventricular cardiac assist comprising: an endoventricular expanable chamber 600, adapted, sized and configured to be accommodated in a left ventricle (LV) of a subject’s heart in need thereof; an external control module 400; and an endocatheter 110 in communication with the endoventricular expandable chamber 600, and the external control module 400, wherein the external control module 400 is operable to cause the endoventricular expandable chamber 600 to transition between an expanded configuration and an default contracted, or collapsed configuration, synchronous or asynchronous with a cardiaccycle, wherein the endocatheter 110 further comprises an actuator 620, operable to mechanically expand the endoventricular expanable chamber 600, which additionally comprises covering 630 (see e.g., FIG. 6B).

[0055] Turning now to FIG. 6A, and in an exemplary implementation, the endoventricular expandable chamber can be a cuboctahedron having between 2 and 8 rings 650, for example, between 3 and 6 rings or 4-5 rings, with between 6 and 24 scissors (or fulcrum junctions 651), whereby nodes’ 652 length will depend on the rings / scissors combination used. Also illustrated are joints 653 allowing articulating motion of nodes 652. Alternatively, in yet another exemplary implementation, and as illustrated in FIG. 6B, the endoventricular expandable chamber 600 can comprise endocatheter 110 having a proximal end 1101 coupled to external control module 400 and a distal end 611 and expandable chamber 600. The expandable chamber 600 has a distal end 601, a proximal end 602, and defining a longitudinal axis (XL6OO), and is configured to transition between a collapsed position where the expandable chamber 600 is either enclosed within the endocatheter 110 or extends from the distal end 611 of endocatheter 110, and an expanded position where the expandable chamber 600 extends from the distal end 611 of the endocatheter 110. The expandable chamber 600 comprises a plurality of tines 603i each coupled to each other, made of a resilient material, such as, for example, nitinol, or stainless steel.

[0056] In an exemplary implementation, the echocardiographic parameters can be used to evaluate various aspects of the cardiac cycle, for example; systolic and diastolic function, preload, afterload, and overall cardiac performance, and can be for example the ejection fraction (EF) and fractional shortening (FS), gauging left ventricular systolic function. End-diastolic volume (EDV) and end-systolic volume (ESV) quantifying preload and afterload, respectively. Cardiac output (CO), as derived from stroke volume (SV) and heart rate (HR), indicating overall cardiac performance. Mitral valve E / A ratio and isovolumetric relaxation time (IVRT) for evaluating diastolic function, with deceleration time (DT) providing additional diastolic data. Likewise, Aortic velocity time integral (VTI) can be used to calculate stroke volume (SV) and cardiac output non-invasively.

[0057] In another exemplary implementation, the hemodynamic parameters can be used to measure and sense the forces and flow of blood within the cardiovascular system during the cardiac cycle, and can be, for example; Blood pressure (bp), represented as systolic and diastolic pressures, quantifying the force exerted by blood against arterial walls; Hear! rate (HR) in beatsper minute, with cardiac output (CO) combined with stroke volume (SV) and HR to indicate the heart's capacity to meet circulatory demands (stress situations). Likewise, Systemic vascular resistance (SVR) and pulmonary vascular resistance (PVR) are used in an example, to assess resistance faced by the left and right ventricles, respectively. Mean arterial pressure (MAP) can be used to gauge average arterial pressure, and central venous pressure (CVP) indicating right heart preload. Also, Pulse pressure (PP) can be used captures the difference between systolic and diastolic pressures, and cardiac index (CI) normalizes CO to body surface area.

[0058] Also illustrated schematically, is secondary coil 240, operable to provide wireless communication with, for example, charging module 300 (see e.g., FIG. 3). Accordingly, system 10 further comprises charging module 300, wherein charging module 300, as illustrated schematically in FIG.s 1, and 3 comprise power source 310; external transceiver 340; and at least one processor 330, in communication with power source 310, and external transceiver 340, at least one processor 330 being in further communication with non-transitory memory device storing thereon processor-readable media with set of executable instructions configured, when executed, to cause at least one processor 330 to: using external transceiver 340, programming executable instructions stored on non-transitory memory device in communication with at least one processor 250 included with subcutaneous control module 200; downloading data generated and stored on non-transitory memory device in communication with at least one processor 250 included with subcutaneous control module 200; and using power source 310, coupled to primary coil 320, wirelessly recharging power storage module 230 in subcutaneous control module. In addition, subcutaneous transceiver 260 is operable to receive instructions from external transceiver 340 via wireless communication coil (and associated module) 320 and to transmit data to external transceiver 340, related to the operation and performance of the system.

[0059] In an exemplary implementation, the actuator used for linearly biasing the guidewire against the expandable chamber, can be for example a push-pull solenoid actuator, which, when energized, the solenoid's coil creates an electromagnetic field that pulls the guidewire thereby expanding and contracting the expandable endoventricular chamber 600. In another exemplary implementation, the actuator can be a standard linear solenoid with a pushrod mechanism coupled to the guidewire, a pneumatic cylinder with a directional valve, a piezoelectric actuator, a hydraulic cylinder, or a specialized "HASEL" actuator as described herein, providing a low power consumption and linear motion in a compact package.

[0060] In an exemplary implementation, the electrical energy will be provided by the power source implanted, for example, in a subcutaneous abdominal pocket, and be wirelessly rechargeable to ensure long-term operation. As illustrated system 10 will also include control electronics and electrodes to provide synchronised actuation, optimally coupled with physiological contraction. A synchronization module included with the system and kits provided, allows for correct shape modification according to the heart cycle phase. For example, a Pacemaker-like technology can be used.

[0061] Now returning to FIG.s 1 , 2, and 5, endocatheter 110 used in the systems and kits disclosed herein, and implanted using the methods disclosed, comprises: lumen 1100, in fluid communication with inlet port 1002 of endoven tricular inflatable chamber 100; and plurality of electrical leads 1103p (not shown), in communication with at least one processor 250 and corresponding sensor 103i of plurality of sensors 103i disposed on endoventricular inflatable chamber 100.

[0062] In an exemplary implementation, the systems disclosed are implanted using the methods provided. For example, a dedicated technology to implant the device in the LV through a transseptal puncture is used, for example, using a specific steerable endocatheter 1 10 , combined with deployment of anchors 105j within the apical myocardium 504 to fix endoventricular inflatable chamber 100 firmly.

[0063] Accordingly, provided herein is a method of implanting a system for an active endoventricular cardiac assist, implemented using the systems disclosed herein, the method comprising: identifying a cephalic or a subclavian veni; inserting a guidewire into the identified vein; advancing the guidewire through the identified vein into superior vena cava 506 (see e.g., FIG. 5), right atrium 502, crossing tricuspid valve 5020, reaching the apex 5022 of the right ventricle 502; advancing a transseptal catheter over the guidewire; while using the transseptal catheter, perforating a mid- apical portion of the interventricular septum 503; removing the transseptal catheter, leaving the guidewire; advancing a delivery catheter over the guidewire into the left ventricle 501; removing the guidewire; advancing a folded endoventricular inflatable chamber 100 coupled to the endocatheter 110 through the delivery catheter 120 (not shown) into the left ventricle 501; unfolding the endoventricular inflatable chamber 100 in the left ventricle 501; and coupling the (proximal end 1105) of endocatheter 110 to the subcutaneous control module 200 (see e.g., FIG. 1). In an exemplary implementation the method further comprisesplacing the subcutaneous control module 200 subcutaneously at the right chest in the proximity of the right clavicle.

[0064] Likewise and in yet another exemplary implementation, provided herein is a kit comprising: an endoventricular inflatable chamber 100 or 600, adapted, sized and configured to be accommodated in a left ventricle (LV) of a subject in need thereof; a subcutaneous (or external) control module 200, 400; an endocatheter 110 wherein the subcutaneous control module or external control module is operable to cause the endoventricular inflatable or expandable chamber 100, 600 to transition between an inflated or expanded configuration and an deflated or collapsed configuration synchronous with a cardiac cycle; optionally, packaging; and optionally, instructions, the kit configured when assembled to form the systems disclosed herein. The kit further comprising charging module 300.

[0065] Alternatively, and in an exemplary implementation the external control 400 module used in conjunction with the expandable endoventricular chamber 600 can comprise: a guidewire 620 (see e.g., FIG. 6A) coupled to (in other words, nested within), the endocatheter 110; the actuator (not shown, see e.g., equivalent to pumping means 220) operable to bias the guidewire 620 against the endoventricular expandable chamber 600, and bias the guidewire 620 away from the endoventricular expandable chamber 600 synchronously or asynchronously with the cardiac cycle; a transceiver 340; a power storage module 230; and at least one processor , in communication with the actuator , the transceiver, and each of a plurality of sensors and electrodes disposed on the endoventricular expanable chamber, the at least one processor 250 being in further communication with a non-transitory memory device storing thereon a processor-readable media with a set of executable instructions configured, when executed, to cause the at least one processor 250 to: using a plurality of sensors (no shown) disposed on the expandable endoventricular expandable chamber 600, and upon sensing a contraction of the LV, bias the guidewire 620 against the endoventricular expandable chamber; and using the plurality of sensors disposed on the expandable endoventricular expandable chamber 600, and upon sensing an expansion of the LV, bias the guidewire away from the endoventricular expandable chamber.

[0066] Accordingly and in an exemplary implementation, provided herein is a system for an active endoventricular cardiac assist comprising: an endoventricular inflatable chamber, adapted, sized and configured to be accommodated in a left ventricle (LV) of a subject in need thereofheart; a subcutaneous control module; and an endocatheter in communication with the endoventricular inflatable chamber, and the subcutaneous control module, wherein the subcutaneous control module is operable to cause the endoventricular inflatable chamber to transition between an inflated configuration and an deflated configuration, synchronous or asynchronous with a cardiac cycle, wherein (i) the endoventricular inflatable chamber defines a conical body having a circular lip and an apex, the endoventricular inflatable chamber further comprises: a resilient membrane coupled to the circular lip, configured to transition between the deflated configuration, and the inflated configuration during the cardiac cycle; a plurality of sensors and electrodes, disposed on the inflatable endoventricular inflatable chamber, operable to sense the cardiac cycle; and an inlet port, disposed at the apex of the endoventricular inflatable chamber, in fluid communication with the subcutaneous control module, (ii) the subcutaneous control module comprises: a reservoir containing a liquid in fluid communication with the endocatheter; a pumping means, in fluid communication with the reservoir, the pumping means operable to pump in the liquid in the reservoir into the endoventricular inflatable chamber, and pump out the liquid from the endoventricular inflatable chamber synchronously or asynchronously with the cardiac cycle; a subcutaneous transceiver; a power storage module; and at least one processor, in communication with the pumping means, the subcutaneous transceiver, and each of the plurality of sensors and electrodes, the at least one processor being in further communication with a non-transitory memory device storing thereon a processor-readable media with a set of executable instructions configured, when executed, to cause the at least one processor to: using the plurality of sensors disposed on the inflatable endoventricular inflatable chamber, and upon sensing a contraction of the LV, pump in the liquid from the reservoir into the endoven trie ular inflatable chamber; and using the plurality of sensors disposed on the inflatable endoventricular inflatable chamber, and upon sensing an expansion of the LV, pump out the liquid from the endoventricular inflatable chamber, into the reservoir, as well as (iii) a charging module (iv) the charging module comprises: a power source; an external transceiver; and at least one processor, in communication with the power source, and the external transceiver, the at least one processor being in further communication with a non-transitory memory device storing thereon a processor-readable media with a set of executable instructions configured, when executed, to cause the at least one processor to: using the external transceiver, programming the executable instructions stored on the non-transitory memory device incommunication with the at least one processor included with the subcutaneous control module; downloading data generated and stored on the non-transitory memory device in communication with the at least one processor included with the subcutaneous control module; and using the power source, recharging the power storage module in the subcutaneous control module, wherein (v) the endocatheter comprises: a lumen, in fluid communication with the inlet port of the endoventricular inflatable chamber; and a plurality of electrical leads, in communication with the at least one processor and a corresponding sensor of the plurality of sensors disposed on the endoventricular inflatable chamber, wherein (vi) the endoventricular inflatable chamber further comprises a plurality of anchors, sized and configured to engage a wall portion of the LV, wherein (vii) in the deflated configuration, the resilient membrane is configured to form a concave cavity within the endoventricular inflatable chamber sized to accommodate the predetermined blood volume, and (viii) in the inflated configuration, the resilient membrane is configured to form a plane, or a convex surface across the circular lip of the endoventricular inflatable chamber, wherein (ix) the subcutaneous control module further comprises at least one sensor for detecting at least one physiological parameter associated with the cardiac cycle, and wherein the set of executable instructions is further configured, when executed by the at least one processor, to perform the step of adjusting the timing and operation of the endoventricular inflatable chamber based on the detected parameter, (x) the at least one parameter is ecocardiographic or hemodynamic parameter, or a parameter comprising one or more of the foregoing, and wherein (xi) the subcutaneous transceiver is operable to receive instructions from the external transceiver and to transmit data to the external transceiver, related to the operation and performance of the system.

[0067] In another exemplary implementation, provided herein is a method of implanting a system for an active endoventricular cardiac assist, implemented in a system comprising an endoventricular inflatable chamber, adapted, sized and configured to be accommodated in a left ventricle (LV) of a subject in need thereof, and to contain a predetermined blood volume; a subcutaneous control module; and an endocatheter in communication with the endoventricular inflatable chamber, and the subcutaneous control module, wherein the subcutaneous control module is operable to cause the endoventricular inflatable chamber to transition between an inflated configuration and an deflated configuration synchronous or asynchrnous with a cardiac cycle the method comprising: identifying a cephalic or a subclavian veni; inserting a guidewireinto the identified vein; advancing the guidewire through the identified vein into superior vena cava, right atrium, crossing tricuspid valve, reaching the apex of the right ventricle; advancing a transseptal catheter over the guidewire; using the transseptal catheter, perforating a mid-apical portion of the interventricular septum; removing the transseptal catheter, leaving the guidewire; advancing a delivery catheter over the guidewire into the left ventricle; removing the guidewire; advancing a folded endoventricular inflatable chamber coupled to the endocatheter through the delivery catheter into the left ventricle; unfolding the endoventricular inflatable chamber in the left ventricle; and coupling the endocatheter to the subcutaneous control module, wherein (xii) the endoventricular inflatable chamber defines a conical body having an apex, and a circular lip, the endoventricular inflatable chamber further comprises: a resilient apical membrane coupled to the circular lip, configured to transition between the deflated configuration, and the inflated configuration during the cardiac cycle; a plurality of sensors and electrodes, disposed on the inflatable endoventricular inflatable chamber, operable to sense the cardiac cycle; and an inlet port, disposed at the conical apex, in fluid communication with the subcutaneous control module, (xiii) the subcutaneous control module comprises: a reservoir containing a liquid in fluid communication with the endocatheter; a pumping means, in fluid communication with the reservoir, the pumping means operable to pump in the liquid in the reservoir into the endoventricular inflatable chamber, and pump out the liquid from the endoventricular inflatable chamber synchronous with the cardiac cycle; a subcutaneous transceiver; a power storage module; and at least one processor, in communication with the pumping means, the subcutaneous transceiver, and each of the plurality of sensors, the at least one processor being in further communication with a non-transitory memory device storing thereon a processor- readable media with a set of executable instructions configured, when executed, to cause the at least one processor to: using the plurality of sensors disposed on the inflatable endoventricular inflatable chamber, and upon sensing a contraction of the LV, pump in the liquid from the reservoir into the endoventricular inflatable chamber; and using the plurality of sensors disposed on the inflatable endoventricular inflatable chamber, and upon sensing an expansion of the LV, pump out the liquid from the endoventricular inflatable chamber, into the reservoir, and (xiv) a charging module, (xv) the charging module comprises: a power source; a external transceiver; and at least one processor, in communication with the power source, and the external transceiver, the at least one processor being in further communication with a non-transitory memory devicestoring thereon a processor-readable media with a set of executable instructions configured, when executed, to cause the at least one processor to: using the external transceiver, program the executable instructions stored on the non-transitory memory device in communication with the at least one processor included with the subcutaneous control module; download data generated and stored on the non-transitory memory device in communication with the at least one processor included with the subcutaneous control module; and using the power source, recharge the power source included with the subcutaneous control module, the method further comprising (xvi) : using the charging module, adjusting the ejection-accommodation according to ecocardiographic and / or hemodynamic parameters, and (xvii) placing the subcutaneous control module subcutaneously at the right chest in the proximity of the right clavicle.

[0068] In yet another exemplary implementation, provided herein is a kit comprising: an endoventricular inflatable chamber, adapted, sized and configured to be accommodated in a left ventricle (LV) of a subject in need thereof; a subcutaneous control module; an endocatheter wherein the subcutaneous control module is operable to cause the endoventricular inflatable chamber to transition between an inflated configuration and an deflated configuration synchronous with a cardiac cycle; optionally, packaging; and optionally, instractions, the kit configured when assembled to form a system for an active endoventricular cardiac assist, wherein (xviii) the endoventricular inflatable chamber defines a conical body having an apex, and a circular lip, the endoventricular inflatable chamber further comprises: a resilient apical membrane coupled to the circular lip, configured to transition between the deflated configuration, and the inflated configuration during the cardiac cycle; a plurality of sensors and electrodes, disposed on the inflatable endoventricular inflatable chamber, operable to sense the cardiac cycle; and an inlet port, disposed at the conical apex, wherein (xix) the subcutaneous control module comprises: a reservoir containing a liquid; a pumping means, operable to pump in the liquid in the reservoir into the endoventricular inflatable chamber, and pump out the liquid from the endoventricular inflatable chamber synchronous with the cardiac cycle; a subcutaneous transceiver; a power storage module; and at least one processor, in communication with the pumping means, the subcutaneous transceiver, and each of the plurality of sensors, the at least one processor being in further communication with a non-transitory memory device storing thereon a processor-readable media with a set of executable instructions configured, when executed, to cause the at least one processor to: using the plurality of sensors disposed on theinflatable endoventricular inflatable chamber, and upon sensing a contraction of the LV, pump in the liquid from the reservoir into the endoventricular inflatable chamber; and using the plurality of sensors disposed on the inflatable endoventricular inflatable chamber, and upon sensing an expansion of the LV, pump out the liquid from the endoventricular inflatable chamber, into the reservoir, and (xx) a charging module, and (xxi) the charging module comprises: a power source; a external transceiver; and at least one processor, in communication with the power source, and the external transceiver, the at least one processor being in further communication with a non- transitory memory device storing thereon a processor-readable media with a set of executable instructions configured, when executed, to cause the at least one processor to: using the external transceiver, programming the executable instructions stored on the non-transitory memory device in communication with the at least one processor included with the subcutaneous control module; downloading data generated and stored on the non-transitory memory device in communication with the at least one processor included with the subcutaneous control module; and using the power source, recharging the power source included with the subcutaneous control module.

[0069] In an even yet another exemplary implementation, provided herein is a system for an active endoventricular cardiac assist comprising: an endoventricular expanable chamber, adapted, sized and configured to be accommodated in a left ventricle (LV) of a subject in need thereof’s heart in need thereof; an external control module; and an endocatheter in communication with the endoventricular’ expandable chamber, and the external control module, wherein the external control module is operable to cause the endoventricular expandable chamber to transition between an expanded configuration and an default configuration, synchronous or asynchronous with a cardiac cycle, wherein (xxii) the endocatheter further comprises an actuator, operable to mechanically expand the endoventricular expanable chamber, and (xxiii) a covering, such as a balloon made of a biocompatible material, or a mesh both made of, for example, polyurethane, nylon, polyethylene terephthalate (PET), thermoplastic elastomers (TPE), silicone, or the like, wherein (xxiv) the endoventricular expandable chamber comprises a cuboctahedron having between 2 and 8 rings, with between 6 and 24 scissors, or (xxv) of an expandable balloon, operable to expand upon mechanical actuation by the actuator (xxvi), the endoventricular expanable chamber, and the endocatheter are configured to be inserted and operated transapically, or transseptally, and wherein (xxvii) the external control modulecomprises; a guidewire coupled to the endocatheter; the actuator operable to bias the guidewire against the endoventricular expandable chamber, and bias the guidewire away from the endoventricular expandable chamber synchronously or asynchronously with the cardiac cycle; a transceiver; a power storage module; and at least one processor, in communication with the actuator , the transceiver, and each of a plurality of sensors and electrodes disposed on the endoventricular expanable chamber, the at least one processor being in further communication with a non-transitory memory device storing thereon a processor-readable media with a set of executable instructions configured, when executed, to cause the at least one processor to: using the plurality of sensors disposed on the expandable endoventricular expandable chamber, and upon sensing a contraction of the LV, bias the guidewire against the endoventricular expandable chamber; and using the plurality of sensors disposed on the expandable endoventricular expandable chamber, and upon sensing an expansion of the LV, bias the guidewire away from the endoventricular expandable chamber.

[0070] While in the foregoing specification the system, kits and methods for providing active cardiovascular assist, described herein have been described in relation to certain exemplary implementations, and many details are set forth for purpose of illustration, it will be apparent to those skilled in the art that the disclosure of the alignment methods, implementable using the systems disclosed herein are susceptible to additional implementations and that certain of the details described in this specification and as are more fully delineated in the following claims can be varied considerably without departing from the basic principles disclosed herein.

Claims

What is claimed:1.A system for an active endoventricular cardiac assist comprising; a) an endoventricular inflatable chamber, adapted, sized and configured to be accommodated in a left ventricle (LV) of a subject in need thereof; b) a subcutaneous control module; and c) an endocatheter in communication with the endoventricular inflatable chamber, and the subcutaneous control module, wherein the subcutaneous control module is operable to cause the endoventricular inflatable chamber to transition between an inflated configuration and an deflated configuration, synchronous or asynchronous with a cardiac cycle.2.The system of claim 1, wherein the endoventricular inflatable chamber defines a conical body having a circular lip and an apex, the endoventricular inflatable chamber further comprises: a) a resilient membrane coupled to the circular lip, configured to transition between the deflated configuration, and the inflated configuration during the cardiac cycle; b) a plurality of sensors and electrodes, disposed on the inflatable endoventricular inflatable chamber, operable to sense the cardiac cycle; and c) an inlet port, disposed at the apex of the endoventricular inflatable chamber, in fluid communication with the subcutaneous control module.

3. The system of claim 2, wherein the subcutaneous control module comprises: a) a reservoir containing a liquid in fluid communication with the endocatheter; b) a pumping means, in fluid communication with the reservoir, the pumping means operable to pump in the liquid in the reservoir into the endoventricular inflatable chamber, and pump out the liquid from the endoventricular inflatable chamber synchronously or asynchronously with the cardiac cycle; c) a subcutaneous transceiver; d) a power storage module; ande) at least one processor, in communication with the pumping means, the subcutaneous transceiver, and each of the plurality of sensors and electrodes, the at least one processor being in further communication with a non-transitory memory device storing thereon a processor-readable media with a set of executable instructions configured, when executed, to cause the at least one processor to: using the plurality of sensors disposed on the inflatable endoventricular inflatable chamber, and upon sensing a contraction of the LV, pump in the liquid from the reservoir into the endoventricular inflatable chamber; and using the plurality of sensors disposed on the inflatable endoventricular inflatable chamber, and upon sensing an expansion of the LV, pump out the liquid from the endoventricular inflatable chamber, into the reservoir. The system of claim 3, further comprising a charging module. The system of claim 4, wherein the charging module comprises: a) a power source; b) an external transceiver; and c) at least one processor, in communication with the power source, and the external transceiver, the at least one processor being in further communication with a non-transitory memory device storing thereon a processor- readable media with a set of executable instructions configured, when executed, to cause the at least one processor to: using the external transceiver, programming the executable instructions stored on the non-transitory memory device in communication with the at least one processor included with the subcutaneous control module; downloading data generated and stored on the non-transitory memory device in communication with the at least one processor included with the subcutaneous control module; and using the power source, recharging the power storage module in the subcutaneous control module. The system of claim 2, wherein the endocatheter comprises:a) a lumen, in fluid communication with the inlet port of the endoventricular inflatable chamber; and b) a plurality of electrical leads, in communication with the at least one processor and a corresponding sensor of the plurality of sensors disposed on the endoventricular inflatable chamber.

7. The system of claim 2, wherein the endoventricular inflatable chamber further comprises a plurality of anchors, sized and configured to engage a wall portion of the LV.

8. The system of claim 2, wherein, in the deflated configuration, the resilient membrane is configured to form a concave cavity within the endoventricular inflatable chamber sized to accommodate the predetermined blood volume.9.The system of claim 2, wherein, in the inflated configuration, the resilient membrane is configured to form a plane, or a convex surface across the circular lip of the endoventricular inflatable chamber.

10. The system of claim 2, wherein the subcutaneous control module further comprises at least one sensor for detecting at least one physiological parameter associated with the cardiac cycle, and wherein the set of executable instructions is further configured, when executed by the at least one processor, to perform the step of adjusting the timing and operation of the endoventricular inflatable chamber based on the detected parameter.

11. The system of claim 10, wherein the at least one parameter is ecocardiographic or hemodynamic parameter, or a parameter comprising one or more of the foregoing.

12. The system of claim 5, wherein the subcutaneous transceiver is operable to receive instructions from the external transceiver and to transmit data to the external transceiver, related to the operation and performance of the system.

13. A method of implanting a system for an active endoventricular cardiac assist, implemented in a system comprising an endoventricular inflatable chamber, adapted, sized and configured to be accommodated in a left ventricle (LV) of a subject in need thereof, and to contain a predetermined blood volume; a subcutaneous control module; and an endocatheter in communication with the endoventricular inflatable chamber, and the subcutaneous control module, wherein the subcutaneous control module is operable to cause the endoventricular inflatable chamber to transition between an inflatedconfiguration and an deflated configuration synchronous or asynchrnous with a cardiac cycle the method comprising: a) identifying a cephalic or a subclavian veni; b) inserting a guidewire into the identified vein; c) advancing the guidewire through the identified vein into superior vena cava, right atrium, crossing tricuspid valve, reaching the apex of the right ventricle; d) advancing a transseptal catheter over the guidewire; e) Using the transseptal catheter, perforating a mid-apical portion of the interventricular septum; f) removing the transseptal catheter, leaving the guidewire; g) advancing a delivery catheter over the guidewire into the left ventricle; h) removing the guide wire; i) advancing a folded endoventricular inflatable chamber coupled to the endocatheter through the delivery catheter into the left ventricle; j) unfolding the endoventricular inflatable chamber in the left ventricle; and k) coupling the endocatheter to the subcutaneous control module.

14. The method of claim 13, wherein the endoventricular inflatable chamber defines a conical body having an apex, and a circular lip, the endoventricular inflatable chamber further comprises: a) a resilient apical membrane coupled to the circular lip, configured to transition between the deflated configuration, and the inflated configuration during the cardiac cycle; b) a plurality of sensors and electrodes, disposed on the inflatable endoventricular inflatable chamber, operable to sense the cardiac cycle; and c) an inlet port, disposed at the conical apex, in fluid communication with the subcutaneous control module.

15. The method of claim 14, wherein the subcutaneous control module comprises: a) a reservoir containing a liquid in fluid communication with the endocatheter;b) a pumping means, in fluid communication with the reservoir, the pumping means operable to pump in the liquid in the reservoir into the endoventricular inflatable chamber, and pump out the liquid from the endoventricular inflatable chamber synchronous with the cardiac cycle; c) a subcutaneous transceiver; d) a power storage module; and e) at least one processor, in communication with the pumping means, the subcutaneous transceiver, and each of the plurality of sensors, the at least one processor being in further communication with a non-transitory memory device storing thereon a processor-readable media with a set of executable instructions configured, when executed, to cause the at least one processor to: using the plurality of sensors disposed on the inflatable endoventricular inflatable chamber, and upon sensing a contraction of the LV, pump in the liquid from the reservoir into the endoventricular inflatable chamber; and using the plurality of sensors disposed on the inflatable endoventricular inflatable chamber, and upon sensing an expansion of the LV, pump out the liquid from the endoventricular inflatable chamber, into the reservoir.

16. The method of claim 15, further comprising a charging module.

17. The system of claim 16, wherein the charging module comprises: a) a power source; b) a external transceiver; and c) at least one processor, in communication with the power source, and the external transceiver, the at least one processor being in further communication with a non-transitory memory device storing thereon a processor- readable media with a set of executable instructions configured, when executed, to cause the at least one processor to: using the external transceiver, program the executable instructions stored on the non-transitory memory device in communication with the at least one processor included with the subcutaneous control module;download data generated and stored on the non-transitory memory device in communication with the at least one processor included with the subcutaneous control module; and using the power source, recharge the power source included with the subcutaneous control module.

18. The method of claim 17, further comprising: using the charging module, adjusting the ejection-accommodation according to ecocardiographic and / or hemodynamic parameters19. The method of claim 13, further comprising placing the subcutaneous control module subcutaneously at the right chest in the proximity of the right clavicle.

20. A kit comprising: a) an endoventricular inflatable chamber, adapted, sized and configured to be accommodated in a left ventricle (LV) of a subject in need thereof; b) a subcutaneous control module; c) an endocatheter wherein the subcutaneous control module is operable to cause the endoventricular inflatable chamber to transition between an inflated configuration and an deflated configuration synchronous with a cardiac cycle; d) optionally, packaging; and e) optionally, instructions, the kit configured when assembled to form a system for an active endoventricular cardiac assist.

21. The kit of claim 20, wherein endoventricular inflatable chamber defines a conical body having an apex, and a circular lip, the endoventricular inflatable chamber further comprises: a) a resilient apical membrane coupled to the circular lip, configured to transition between the deflated configuration, and the inflated configuration during the cardiac cycle; b) a plurality of sensors and electrodes, disposed on the inflatable endoventricular inflatable chamber, operable to sense the cardiac cycle; and c) an inlet port, disposed at the conical apex.

22. The kit of claim 20, wherein the subcutaneous control module comprises:a) a reservoir containing a liquid; b) a pumping means, operable to pump in the liquid in the reservoir into the endoventricular inflatable chamber, and pump out the liquid from the endoventricular inflatable chamber synchronous with the cardiac cycle; c) a subcutaneous transceiver; d) a power storage module; and e) at least one processor, in communication with the pumping means, the subcutaneous transceiver, and each of the plurality of sensors, the at least one processor being in further communication with a non-transitory memory device storing thereon a processor-readable media with a set of executable instructions configured, when executed, to cause the at least one processor to: using the plurality of sensors disposed on the inflatable endoventricular inflatable chamber, and upon sensing a contraction of the LV, pump in the liquid from the reservoir into the endoventricular inflatable chamber; and using the plurality of sensors disposed on the inflatable endoventricular inflatable chamber, and upon sensing an expansion of the LV, pump out the liquid from the endoventricular inflatable chamber, into the reservoir.

23. The kit of claim 22, further comprising a charging module.

24. The kit of claim 23, wherein the charging module comprises: a) a power source; b) a external transceiver; and c) at least one processor, in communication with the power source, and the external transceiver, the at least one processor being in further communication with a non-transitory memory device storing thereon a processor- readable media with a set of executable instructions configured, when executed, to cause the at least one processor to: using the external transceiver, programming the executable instructions stored on the non-transitory memory device in communication with the at least one processor included with the subcutaneous control module;downloading data generated and stored on the non-transitory memory device in communication with the at least one processor included with the subcutaneous control module; and using the power source, recharging the power source included with the subcutaneous control module.

25. A system for an active endoventricular cardiac assist comprising: a) an endoventricular expanable chamber, adapted, sized and configured to be accommodated in a left ventricle (LV) of a subject in need thereof; b) an external control module; and c) an endocatheter in communication with the endoventricular expandable chamber, and the external control module, wherein the external control module is operable to cause the endoventricular expandable chamber to transition between an expanded configuration and an default configuration, synchronous or asynchronous with a cardiac cycle.

26. The system of claim 25, wherein the endocatheter further comprises an actuator, operable to mechanically expand the endoventricular expanable chamber.

27. The system of claim 25, wherein the endoventricular expanable chamber further comprises a covering.

28. The system of claim 26, wherein the endoventricular expandable chamber comprises a cuboctahedron having between 2 and 8 rings, with between 6 and 24 scissors.

29. The system of claim 28, wherein the endoventricular expanable chamber is comprised of an expandable balloon, operable to expand upon mechanical actuation by the actuator.

30. The system of claim 26, wherein the endoventricular expanable chamber, and the endocatheter are configured to be inserted and operated transapically, or trans septally.

31. The system of claim 2, wherein the external control module comprises: a) a guidewire coupled to the endocatheter; b) the actuator operable to bias the guidewire against the endoventricular expandable chamber, and bias the guidewire away from the endoventricular expandable chamber synchronously or asynchronously with the cardiac cycle;c) a transceiver; d) a power storage module; and e) at least one processor, in communication with the actuator , the transceiver, and each of a plurality of sensors and electrodes disposed on the endoventricular expanable chamber, the at least one processor being in further communication with a non-transitory memory device storing thereon a processor- readable media with a set of executable instructions configured, when executed, to cause the at least one processor to:- using the plurality of sensors disposed on the expandable endoventricular expandable chamber, and upon sensing a contraction of the LV, bias the guidewire against the endoventricular expandable chamber; and- using the plurality of sensors disposed on the expandable endoventricular expandable chamber, and upon sensing an expansion of the LV, bias the guidewire away from the endoventricular expandable chamber.

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