Force transducting inflatable implant system including a dual force annular transduction implant

An implant system for restoring and improving physiological intracardiac vortical flow in a human heart is provided including a dual force transducting annular implant comprising laterally extending struts transitioning into annular structural members for positioning on the atrial side of the valve annulus; an anchoring system comprising a therapeutic base plate assembly attachable to the apex of the heart; and a tether assembly comprising a tether connected between the implant and the therapeutic base plate assembly.

TECHNICAL FIELD

The present disclosure relates generally to a force transducting, structurally stabilizing, vortex orienting or steering, and functionally ventricular assisting inflatable implant within a human heart for restoring and improving physiologic vortical intracardiac flow and utilizing the re-purposed native energy and force of the atrioventricular pressure gradient, via force transduction, to restore geometric elliptical shape, healthy proportion, and proper function to the atria, the ventricles and ventricular walls, and the valvular apparatus itself.

SUMMARY

An implant system for restoring and improving physiological vortical intracardiac flow, reducing or impairing atrioventricular pressure gradient loss or regurgitation, improving or restoring ventricular elliptical geometry and function, and providing ventricular functional and structural support within an impaired human heart is provided including both a dual force transducting annular implant, comprising laterally extending struts transitioning into annular structural components for positioning and buttressing and/or anchoring on the atrial side of the valve annulus, and a vortex flow directing implant comprising an inflatable ‘member’ or bladder; an anchoring system comprising a therapeutic base plate assembly attachable to the heart; and a conduit tether or shaft assembly comprising a shaft connected between the implant and the therapeutic base plate assembly.

In some embodiments, the dual force transducting annular implant is fixed at the inflow side of a shaft in the atrium and anchored to the hearts apex. In some embodiments, the dual force transducting annular structural components on the inflow side are in contact with the annular structure. In some embodiments, the dual force transducting annular structural components stabilize the device, center the device, and mechanically connect the valve plane with the apex of the heart and thus transduct or move an increased reparative force to the annulus, the structures of the heart, the ventricles, and the ventricular walls, and aid in the geometric re-shaping of the impacted ventricle, the reverse or positive remodeling of the ventricles, the reparative strengthening of the ventricular walls, and assist the ventricle in systolic ventricular ejection thus functioning as a passive ventricular assist. By adding a constant amount of cinching force and supporting structure between the valve plane and the apex by tethering or anchoring the annulus to the apex of the heart, this becomes a passive ejection assist to aid ventricular ejection and cardiac function. In some embodiments, the annular structural components are fixed in location, in contact with, and attached to the annular structure, and/or shape and/or re-shape the valve annulus. In some embodiments, the laterally extending struts are nitinol or elastic and/or spring-based to absorb, collect, and store, energy and force in one cardiac cycle and then release, discharge, and transfer this energy and force during the subsequent cycle into the endocardium, myocardium, and epicardium via an attached apical base plate. In some embodiments, the laterally extending struts are elastic, nitinol, spring-like, and/or another expandable material designed to absorb energy and force in diastole, return energy and force in systole, and “launch” native cardiac energy and force.

In some embodiments, the dual force transducting annular implant has one or more contact points in the heart. In some embodiments, the annular structural components are positioned on the inflow side of the valve. In some embodiments, the annular structural members are nitinol, elastic, expandable, and/or rigid. In some embodiments, the annular structural members have a covering to promote endothelization.

In some embodiments, the system may further include a vortex flow directing implant that further employs the concept of force transduction and vortical flow direction. Force transduction is defined as the intentional movement and re-purposing of native energy and force from one area of the heart to another area of the heart. The movement of this energy and force can be delivered as a restoring therapy to components of the heart that have been adversely effected by pathology or cardiac insult. The design and shape of the vortex flow directing implant also enables vectoring and/or directional change of inflowing blood thereby enabling the restoration and enhancement of ventricular vortex formation. Ventricular vortex formation is critical to healthy physiologic intracardiac blood flow and overall human circulatory health. By placing the vortex flow directing implant atrioventricularly, the ‘member’ captures the forces applied by the valve leaflets and valvulo-ventricular structures driven by the atrioventricular pressure gradient. The atrioventricular pressure gradient is the source of the energy and force which is captured by the ‘member’ and transferred via the tether or shaft, and delivered to the ventricles, its structures, and the ventricular free walls via the ball jointed apical base plate and/or a fixed base plate. This delivery of re-purposed energy and force creates a restoring, reshaping, and repairing ventricular therapy by re-creating, replicating, and delivering the natural valvulo-ventricular interaction the native heart has lost due to pathology, cardiac event or insult, or structural failure. In some embodiments, the dual force transducting annular implant is detachable from the vortex flow directing implant. In some embodiments, the annular structural components control the shape of the atrium around the valve annulus. In some embodiments, the annular structural components may control the shape of the native annulus of the heart.

In some embodiments, the dual force transducting annular implant structural component defines a “D”-shape and/or saddle shape and/or circular and/or oval shape. In some embodiments, the vortex flow directing implant, acting as a force transducting implant itself by allowing the atrioventricular pressure gradient to act on the exposed surface area of the implant thereby capturing and/or harnessing its energy and force, is fluid-expanding and/or self-forming. In some embodiments, both the dual force transducting annular implant and the vortex flow directing implant, both acting as force transducting implants, and when attached to a shaft and tethered to an apical base plate then function or act as an additional or prosthetic ‘papillary muscle’ transducting and/or moving atrioventricular pressure gradient energy & force to the ventricular walls, structures, and into the ventricle itself.

DETAILED DESCRIPTION

One of the features of the healthy human heart function is proper physiological vortical intracardiac flow. During the ventricular systolic cycle, considerable forces are naturally generated and this energy and force is exerted on the closed or sealed atrioventricular valve. This filling phase occurs naturally and is powered, inside the human heart by a pressure gradient called the ‘atrioventricular pressure gradient’. The atrioventricular pressure gradient is defined as a pressure difference (or a pressure differential) that produces or generates an energy and a force within the chambers of the heart, this being naturally occurring, naturally initiated, and naturally applied. When the pressure in the atrium is greater than the pressure in the ventricle, also called the ‘diastolic’ phase or diastole, blood flows from the higher-pressure atrium into the lower pressure ventricle, causing the atrioventricular valve leaflets to open thereby allowing blood to pass. During the ejection or pumping phase, also called the ‘systolic’ phase or systole, the pressure in the atrium is exceeded by the pressure in the ventricle thereby generating a pressure differential creating an energy and force which, in turn, pushes up, onto, and against the valve leaflets and causes or effects the valve leaflets to close and seal off the ventricular chamber from the atrial chamber. The atrioventricular pressure gradient, then, is the sealing energy and force required to close the valve. The blood is then ejected from and out of the ventricle, leaving the heart through the aortic valve, and out to the human body. The ventricle, contracts toward the end of the diastolic cycle and beginning the systolic cycle. This contraction initiates the atrioventricular pressure gradient, mentioned above, that initiates this pressure, or energy and force, which ‘closes the valve leaflets’, which then seals the ventricular chamber closed. In the remaining systolic cycle, blood, under high pressure, is then ejected via muscular force aided by the healthy ventricular vortex (formed in the diastolic cycle) to complete the hemodynamic cardiac output for that particular cycle. This cardiac cycle continues throughout the human lifecycle. When the valve leaflets seal properly, the atrioventricular pressure gradient forces close the valve leaflets and maintains and provides a strong ventricular structure to contain and utilize the atrioventricular pressure gradient for hemodynamic ejection and structural heart health. The papillary muscles, attached to the chordae tendineae, exercise and pull on the ventricle and ventricular walls thus maintaining the healthy ventricular shape, the healthy ventricular free wall, and healthy ventricular function (this is natural ‘force transduction’). These native forces are delivered via the chordae tendinae and papillary muscles into the ventricular wall. This resulting valvulo-ventricular interaction keeps the ventricular structure healthy and provides the ventricle with structural support to maintain the proper elliptical ventricular geometry and functional shape. Geometric stability and ventricular function is maintained by imparting energy & force into the ventricular walls to maintain the healthy ventricle, to maintain the structures of the ventricle, to maintain the structures of the valve, and provides for dynamic proper hemodynamic ejection. During ventricular diastole, the ventricular pressure rapidly decreases. The valve opens and blood rushes from the atrium into the ventricle through the valve orifice. The valve leaflets function as a steering plane or a vectoring lever, directing ventricular flow at an angle or vector to develop and create an initial spin as illustrated inFIG. 1. Such angle may be due to the asymmetry of the valve leaflets and/or to the different shapes and sizes of the leaflets. A vortex progression results. It is believed that the inflowing blood leaving the leaflets at angle or vector is critical in the formation of ventricular vortex. The initial hemodynamic spin then begins, in which the inflowing blood, engaged by the atrioventricular pressure gradient, then engages that initial spin such that a vortex is created downstream. As the blood leaves the leaflets at vector, due to boundary layer conditions, initial spin begins in which the inflowing blood downstream is engaged (by the pressure differential or gradient) such that a vortex is created in the healthy elliptically shaped ventricle. The resulting high velocity rotational flow, now a reservoir of kinetic energy within the ventricle is believed significant to proper blood flow velocity and volume through and out of the heart. Poor or altered vector and/or ventricular dysfunction can alter the formation of the ventricular vortex and thus impact negatively intracardiac flow and output.

FIG. 2illustrates that under certain conditions, such as dilated cardiomyopathy (DCM) in which the heart becomes enlarged, the vortex and vortical flow patterns fail to properly form, geometric stability is compromised, the papillary muscles displace, and the elliptical shape is lost and, subsequently, the ventricle is unable to pump blood efficiently. Such conditions are marked by a low velocity flow, cascading symptoms such as regurgitation and annular distortion, and poor cardiac output in which the vortices are abnormal or absent and geometric distortion is present. Structures of the human heart21are illustrated inFIGS. 3 and 4and referenced below.

In accordance with the disclosed subject matter, an implant system1is illustrated inFIGS. 5-13. Implant system1may include, e.g., a dual force transduction annular implant1a, with a vortex flow directing ‘member’12, or a dual force transduction annular implant1b, without a vortex flow directing ‘member’12, that is positioned within theFIG. 3human heart21and connects, cinches and ties the annulus14of the atrioventricular valve and it's subvalvular apparatus15to the apex16and/or the ventricular wall17of the human heart via a conduit tether or shaft6and then with elastic spring-like property or spring-recoil based connection or strut3to aid in ventricular action and function by absorbing and loading the energy and force of the atrioventricular pressure gradient during one phase, diastole, and subsequently releasing it during the next phase, systole, of the cardiac cycle; absorbing and loading in one phase and releasing in the subsequent phase. This natively generated energy and force, the atrioventricular pressure gradient, is also captured, harnessed, and the transferred by the vortex flow directing ‘member’12via the tether or shaft6to the base plate9and then through that base plate9binto the ventricle17, its structures, and the ventricular free wall19.

The dual force transducting annular implant1a,1bis designed to load energy and force in the diastolic cycle and release the loaded energy and force in the following systolic cycle, effectively becoming a spring/recoil based assisting device for an impaired ventricle. The dual force transducting annular implant1atherapeutically re-directs and re-purposes this cardiac energy and force via a nitinol, elastic, or spring recoil-based strut3in addition to the native atrioventricular pressure gradient energy and force and pressure forces of the structures of theFIG. 3heart21, hemodynamic forces, muscular action, muscular forces, the valve18, valvular and subvalvular structures15, and rotational energy to effect ventricular systolic and/or diastolic function, geometric reshaping of the ventricle19, structural integrity of the ventricular free wall17, and ventricular systolic function, acting as a ventricular assist, while at the same time functioning as a support for the annulus14and/or functioning as a reshaping band, framework, or structure. The device in its entirety functions, secondarily, as a shoring-up structural support framework for the weakened or impaired human heart.

The implant1a,1bincludes a self-expanding frame2, fabricated of nitinol or any self-expanding or memory shape material.FIG. 13Strut3(or a plurality of struts) extend away from the central fixation point4, and include deployed ribs5on either side. The ribs5transition at a transition point5a, also serving as a detaching point or an elbow, into a D-Frame or circular shaped, self-expanding, self-forming or shaped, annular ring or support7. As illustrated inFIGS. 16 and 17, annular ring or support7is detachable from the ribs5at detaching point5a. As shown inFIG. 18, the annular ring7is positioned adjacent to the annulus14. As shown inFIG. 19, the ring7may be detached from the strut3, and the implant system1a,1bremoved. The remaining annular ring7conforms to an anatomical topography, e.g., annulus14. (see, e.g.,FIGS. 18,19.) Situated or placed above, in proximity to, or at the atrial annular ring14, on the inflow side of the valve18, the implant1a,1bhas a strut3, or struts, that are fixed at fixation point4onto the distal end of a multi lumen force transducting fixed tether or shaft6, transitioning into an inner fixed tether or shaft6aand an outer axially moving tether or shaft6b. The outer axially moving tether or shaft6bincludes an integrated inflatable axially adjusting balloon6c, with the whole of the tether or shaft transitioning at joint6dinto a multi lumen tube8after exiting the apex16of the heart21, in this embodiment. The tether or shaft6, in its entirety, is fixed to the apex16of the heart21by a base plate9and may include a ball joint9a, to normalize and evenly transfer force into the ventricular wall17. The multi-lumen tubing8is connected to a control unit10that adjusts the device performance via a fluid communicating system when connected, via the connection point10ato the multi lumen tube8. Control unit10is further illustrated inFIG. 10.

Dual Force Transduction Implant1a

According to a first embodiment, the dual force transduction annular implant1ahas multiple functions. A first function of dual force transduction annular implant1ais to mechanically re-connect the valve18and the subvalvular structures15with (or to) the ventricular walls17in this embodiment, by cinching the annulus14to the heart's apex16, and to deploy a nitinol, elastic, spring recoil-based, and/or externally added energy loading strut3to aid in ventricular action and function, during the cardiac cycle, by absorbing and loading the energy and force of the atrioventricular pressure gradient during one phase, diastole, and subsequently releasing it during the next phase, systole; absorbing and loading in one phase releasing in the subsequent phase. It additionally captures, harnesses, and transducts native energy and force being generated by theFIG. 3human heart21as a whole, e.g., its muscular force, hemodynamic energy, and rotational energy, on the atrial20side of the valve18, and specifically within the valve18and to transduct or move this energy and force via the shaft6to the therapeutic base plate9to be therapeutically delivered into the ventricular structures15,17,19and ventricular free walls17.

A second function of the dual force transduction annular implant1ais to restore healthy intracardiac vortical blood flow. The vortex flow directing implant ‘member’12, placed and fixed in the valve orifice, purposed to intercept, steer, direct, vector, re-vector, and channel atrial inflow thereby passing blood onto and over the valve leaflets and into the ventricle19. In positioning and fixing the vortex flow directing ‘member’ in such a way, the angle or vector at which the blood moves onto and off of the valves leaflets may be influenced, altered, or changed by increasing or decreasing the girth or inflation of the vortex flow directing ‘member’. This ability of the implant1,1ato change the vector creates a tool for the initiating, enhancing, restoring, and/or assisting of the formation of ventricular vortex under visualization such as echocardiography. Positioned atrioventricularly, the vortex flow directingFIG. 9implant12intercepts and re-vectors blood by channeling the atrial flow via and into the flow directing ribs11with the transition exiting surfaces11abeing inside the ventricle. The vortex flow directing implant is the primary instrument of force transduction as well. The exposed area of the vortex flow directing implant12is acted on by the valve's leaflets capturing, harnessing, and then re-directing the energy and force of the atrioventricular pressure gradient. The valve leaflets22supported by the entire valvulo-ventricular apparatus15, ‘grab onto and pull’ the vortex flow directing implant12during systolic cycle, capturing and re-purposing the energy and force of the atrioventricular pressure gradient, and release during the diastolic cycle; this energy and force being transducted via the shaft6, through the base plate9, and into the structures15of the ventricles19and the ventricular free walls17. Vortex flow directing implant12is further illustrated inFIG. 9.

A further function of support ring7of the dual force transduction annular implant1a,1bis to act as an annular support for the native valve annulus14as it is deployed near, to, on, or in proximity to the native valve annulus14, assisting in reforming or reshaping a dysfunctional native valve annulus, to prevent further distortion, valvular regurgitation, and/or maintain a healthy native valve18and valve annulus14.

Dual force transduction annular implant1amay include a vortex flow directing implant12, further illustrated inFIG. 9, that captures, at the line of coaptation13or at the point the valve leaflets come together on the vortex flow directing implant12, the native force of the atrioventricular pressure gradient, the valvular and subvalular structures15, and vatrioventricular pressure gradients (e.g., the difference in the systolic pressure in the ventricle19and the atrium20), as the valve leaflets22(See,FIG. 4), ‘grab onto and pull’ on the vortex flow directing implant12in systole. The valve leaflets22act on the exposed surface area in contact of the ‘member’12as the leaflets22are influenced to close by the pressure differential generated by the atrioventricular pressure gradient during the ventricular systole. This action captures the energy and force conveyed by the atrioventricular pressure gradient. This captured energy and force is then moved or transducted via the shaft6to the base plate9and into the ventricular structures15, the ventricle19, and the ventricular free wall17. This process results in the positive re-shaping of the ventricle called reverse remodeling.

The frame2, its flexible cross-section struts3, or struts transitioning into ribs5running parallel to the vortex flow directing implant12down to the atrial side20of the annular ring7, at which point they transition, forming a cinching and connecting (connecting the annulus14to the apex16) tether6, resting on or in the proximity of, and/or buttressing against the atrial side annular ring14, of the native or prosthetic valve.

The vortex flow directing implant12attached to the dual force transduction annular implant ring (See,FIG. 13) may be fixed in the valve18. The dual force transduction annular implant1ais distally fixed to the vortex flow directing implant12at the top of the shaft6. The flexible structure2and annular ring7is cinched up against, buttressed to, and/or fixed to the annulus14. During systole, the ‘grab and pull’ of the valve leaflets22, the atrioventricular pressure gradient, and the muscular action, motion, energy, and contortion of the endocardium, myocardium, and epicardium are captured by the vortex flow directing implant12(by allowing the pressure differential to act on the exposed area of the ‘member’12) while the dual force transduction annular implant1areleases its loaded energy and force. The elastic, spring recoil-based, and/or external energy is loaded, added, and then transferred together by the dual force transduction annular implant1aas it presses on the annulus14, it is now cinched, connected, and tethered to the apex, by the shaft6to the base plate9, to the apex16of the heart21. This, now, compounded energy and force, loading in diastole and releasing in systole, is delivered via the shaft6to the base plate9and therapeutically transferred into the structures15, the ventricles19, and the ventricular walls17thus restoring, assisting, or re-creating the valvulo-ventricular interaction a healthy ventricle experiences and requires.

The flow channel creating rib(s)11running at angle11aalong the surface of the vortex flow directing implant12directs or re-directs the intercepted flow of blood onto and off of the valve leaflets22, and facilitates establishment a proper vector upon entry into the ventricle19under visualization as the vector can be altered by increasing or decreasing the ‘member’12width or girth. This hemodynamic re-vector enhances, assists, restores (the missing), and/or enables the natural physiologic vector, thereby facilitating and/or enhancing the restoration of the ventricular vortex, critical to physiologic healthy intracardiac flow. The valvular and subvalvular structures15,22‘grabbing and pulling’ of the vortex flow directing implant12(allowing the pressure differential to act on the exposed area of the ‘member’12) along with the additional elastic, spring-recoil based, and/or externally added force delivered by the dual force transduction annular implant1a, in effect becomes a prosthetic, or an additional, papillary muscle23to assist the native papillary muscles23, replaces lost valvulo-ventricular interaction, which enables, repairs, and supports ventricular health, ventricular contraction, ventricular ejection, and assists in maintaining a healthy ventricular structure and ventricular wall structure, by transducting this captured native energy and force via the base plate9which then, by tether6to and contact with the apex16and ventricle19, and utilizing specific edge shapes9b, delivers this captured and harnessed natural energy and force into the ventricular walls17, thereby aiding in systolic function and inducing reverse remodeling (positive geometric reshaping) of that structure19,21.

Dual Force Transduction Annular Implant1b

According to a second embodiment, the dual force transduction annular implant1bhas several functions. The dual force transduction annular implant1bis substantially identical to dual force transduction implant1a, with the differences noted herein. In particular, dual force transduction annular implant1bdoes not include the vortex flow directing implant12. The flexible or rigid cross sectional structure3, strut, and/or struts, transitioning into ribs5, the ribs5then transitioning into a D-Frame or circular shaped, self expanding annular ring7conforming to an anatomical topography14, and cinching or connecting (mechanically connecting the annulus14to the apex16) to a nitinol, elastic, spring recoil-based, and/or externally added energy to the annulus14and/or ventricular wall17to aid or assist in ventricular function, during the cardiac cycle, by absorbing and loading energy during one phase, and subsequently releasing it during the next phase, absorbing and loading in one phase releasing in next phase. That energy and force is captured and loaded by distal implant and transferred via the tether or shaft6from the valve annulus14to the apex16. This energy and force is the transducted muscular action, muscular force, and rotational energy and force of the heart, delivered by the shaft6, to the base plate9, which then therapeutically delivers this energy and force into the ventricular structures15,19and ventricular walls17.

This cinching and connecting (connecting the annulus14to the apex16) tether or conduit6from the atrial20side of the annulus14to the apex16of the heart21creates an additional method or delivery of native energy and force capture by tethering between the annulus and apex thus assisting the native papillary muscles23, delivering additional cardiac muscular energy, compounded, into the ventricular walls17and structures via the shaft6, and the ‘ball jointed’9abase plate9during systole and diastole. The dual force transduction annular implant1b, its structure2,7, and ribs5running out and away from the fixation point4at the top of the shaft4,6, down to the atrial20side of the annular ring2, at which point they transition forming a supporting ring2,7resting and buttressing the attached device2, distal to the annular ring14, in such a manner, that during systole, the muscular motion, energy, and contortion of the endocardium, myocardium, and epicardium is captured and loaded in one phase, delivered or released in another, and this energy and force delivered via the shaft6to the ‘ball jointed’9abase plate9and therapeutically transferred9,9binto the ventricle19, the ventricular structures and ventricular walls17.

Another function of ring7of dual force transduction annular implant1bis to act as an annular support ring for the valve annulus14as it is deployed near, to, on, or in proximity to the valve annulus14assisting in reforming or re-shaping a dysfunctional valve annulus14.

The dual force transduction implant1bmay be fixed to an axially or longitudinally adjustable shaft6, which may increase the force by moving the shaft6proximally, thereby increasing the pressure of the connection14between the annular ring7and the apex16of the heart, or decrease the force by moving the shaft6distally thereby decreasing the pressure of the connection between the annular ring14and the apex16of the heart. The energy and force delivery occurs via the conduit or shaft6to the base plate9, which then transfers the energy and force into the ventricular structures15,17,19. In cinching the annulus14to the apex16, the energy and force loaded in the diastolic phase and released in the systolic phase can be adjusted by moving the tether or shaft6distally for less added force or proximally for more added force.

The fixed, ‘ball jointed’9abase plate9, with round oval cutouts9cto allow fibrous tissue in-growth for long term security, pulls the apex16upward in systole and releases the apex16in diastole and, in conjunction with the elongated therapeutic extensions9bof the base9plate extending up the sides of the ventricle9b, impart by contact, specific shape, and fixation this transducted energy into the ventricle19, inducing a physiologic response by replacing the lost valvulo-ventricular interaction, which critically supports ventricular contraction and assists in maintaining a healthy ventricular wall structure, required to maintain healthy geometric ventricular19shape.

The control unit10, illustrated inFIG. 10, above, may be used with either dual force transduction implant1aor1bor the vortex flow directing implant12and have three or more independent contained chambers10b,10c,10d, each identifiable below the skin by palpable protrusions, one palpable protrusion for chamber one10b, two palpable protrusions for chamber two10c, and three palpable protrusions for chamber three10d. A single connection point10aplaces the control unit10in communication, via the connecting multi-lumen tubing8and shaft6, with the vortex flow directing implant12, and has a needle access pad of ePTFE, any semi-porous, or non-porous material, that allows fibrous tissue in growth (the body's method of preventing infection and facilitating hemostasis). Additional compartments may be added to house, store, and/or accommodate additional sensoring equipment, power sources, data transmission equipment, or the sensors themselves.

By reference toFIGS. 9 and 10, in one of chambers10b10c10d, a sealed compartment is introduced to house a power source for sensoring nodes implanted within the device1a,1bitself, the implant system1then becoming a housing platform for these sensoring nodes. One or more lumens of the connecting multi-lumen connecting tube8may be used to connect the power source with the sensoring nodes. In one of chambers10b10c10d, fluid is introduced or removed from the integrated inflatable axial adjusting balloon6ato increase or decrease the axial positioning shaft6of the vortex flow directing implant12as reverse re-modeling occurs. In one of chambers10b10c10d, fluid is added to increase or decrease the girth of the vortex flow directing implant12. In one of chambers10b10c10d, fluid is added or removed to create crescent shaped articulation12bin the wings12aof vortex flow directing implant12, either anterior or posterior, to better vector the intercept of blood from atrium12by introducing fluid into the ‘wing’ chambers12avia a skeletal crescent beam with lumen (not shown).

With continued reference to the first embodiment,FIG. 15illustrates a novel piston25fixed to the moving portion6bof the shaft6within a cylinder24fixed to said shaft6. The piston25may be contained within the shaft6and/or within the vortex flow directing implant12that allows the sliding shaft6a, the vortex flow directing implant12and the cylinder24, to axially or longitudinally move up (arrow26) and down (arrow27) as the fluid in the vortex flow directing implant12, powered by the atrioventricular pressure gradient, rises and falls as the heart naturally cycles through diastole and systole.

During diastole, the fluid contained within the vortex flow directing implant12moves proximally (arrow27, forced by the pressure differential and/or the hemodynamic in flow to the bottom portion of the vortex flow directing implant12and then, conversely, rises distally (arrow26), under pressured force to the distal26end of the vortex flow directing implant12, during systole thereby causing the fluid contained within the vortex flow directing implant12to move with an energy and force and fill the distal portion of the vortex flow directing implant12. The cylinder24, via the two side positioned fill holes28, is then filled by fluid, under pressure and force, and drives the piston25proximally (arrow27). This novel cylinder24is housed within the inflatable vortex flow directing implant12and fixed to the distal end of the vortex flow directing implant12by the shaft6at the central fixation point4. The piston25moves independently within the cylinder24and is driven proximally (arrow27) (a) by fluid filling the ‘piston chamber bowl’29under pressure, via the two side positioned cylinder fill holes28, (b) by the fluid influenced and powered by the native systolic forces. The piston25moves the entire vortex flow directing implant12distally (arrow26), thereby creating a new, additional, and/or redirected energy and force, from the fluid's distal/proximal exchange (arrow26/arrow27), during the heart's cycle.

In an exemplary embodiment, a fluid exchange system is provided by piston25, which is operated and/or natively ‘powered’ (by the atrioventricular pressure gradient during the systolic cycle) and is a therapeutic component being driven by the heart's natural energy and force, generated, captured by vortex flow directing implant12and redirected by shaft6, delivered in a therapeutic manner, during natural diastole and systole utilizing the fluid contained and driven within the vortex flow directing implant12. The movement of the fluid housed within the vortex flow directing implant12, being driven to the distal end26of the vortex flow directing implant12during the systolic cycle, forces fluid into the cylinder fill holes28, located on each side of the cylinder24, and fills the piston chamber bowl29in the systolic cycle, and pressurizes the chamber (29) (arrow26), thereby moving the piston contained within the vortex flow directing implant12distally (arrow26), in the heart's cycle, generating a re-directed therapeutic force when transducted and/or delivered to the ventricular structures15,17,19and ventricular free walls17. The cylinder24, fixed to the implant4and the vortex flow directing implant12, in systole, raises the vortex flow directing implant12distally (arrow26), and conversely, in diastole, reverses the action (arrow27). The vortex flow directing implant12now becomes a ‘pumping piston,’ delivering an additional energy and force augmenting the valvulo-ventricular interaction15, an in effect becomes an additional papillary muscle23, delivering native energy and force, via the conduit or shaft6and via the base plate9, into the ventricular structure19and/or the ventricular free walls17. Conversely, by lowering the cylinder side fill holes28to a position30below the piston25, the reverse is achieved, e.g., in diastole the piston25is driven distally (arrow26), the vortex flow directing implant12now moves proximally (arrow27), and in systole the piston25is driven proximally (arrow27), the vortex flow directing implant12now moving distally (arrow26).

It will be appreciated that the methods and systems described above are set forth by way of example and not of limitation. Numerous variations, additions, omissions, and other modifications will be apparent to one of ordinary skill in the art. Thus, while particular embodiments have been shown and described, it will be apparent to those skilled in the art that various changes and modifications in form and details may be made therein without departing from the spirit and scope of this disclosure and are intended to form a part of the disclosure as defined by the following claims, which are to be interpreted in the broadest sense allowable by law.