WO2025184111A1

WO2025184111A1 - Restoration of atrial flow pattern

Info

Publication number: WO2025184111A1
Application number: PCT/US2025/017241
Authority: WO
Inventors: Anthony Ciro VRBA; Farzad AZIMPOUR; Atiya Makhdoom AHMAD; Arvin T. Chang
Original assignee: Edwards Lifesciences Corp
Current assignee: Edwards Lifesciences Corp
Priority date: 2024-02-26
Filing date: 2025-02-25
Publication date: 2025-09-04
Anticipated expiration: 2026-08-26

Abstract

A vortex inducer for inducing a vortical blood flow pattern within a right atrium includes an anchor and a vortex inducing member connected to the anchor. The vortex inducing member is shaped for redirecting the flow of blood into the right atrium for inducing a more vortical blood flow pattern within the right atrium and thereby increasing the efficiency of the heart.

Description

RESTORATION OF ATRIAL FLOW PATTERN

CROSS REFERENCE TO RELATED APPLICATION(S)

[0001] This application claims the benefit of U.S. Patent No. 63/557,935, filed February 26, 2024, the disclosure of which is hereby expressly incorporated by reference herein in its entirety for all purposes.

BACKGROUND

[0002] The present disclosure relates to blood flow, and in particular, to blood flow within the heart.

[0003] The heart delivers oxygenated blood to the body. Deoxygenated blood is pumped from the right side of the heart to the lungs, where it becomes oxygenated. From the lungs, oxygenated blood flows back to the left side of the heart, which pumps the oxygenated blood throughout the body. The oxygenated blood flow provides needed oxygen to the body. Anatomic structural or positional changes to the heart and/or the blood vessels leading to and arising from the heart (due to age-related changes or other structural imposition) can affect the heart’s ability to deliver the requisite amount of oxygenated blood to metabolically demanding tissue and end organs. It would be beneficial to improve blood flow when such changes occur.

SUMMARY

[0004] An implantable device for inducing a vortical blood flow pattern within a right atrium includes a stent sized for placement in an inferior vena cava or a superior vena cava and a vortex inducing member coupled to the stent. The vortex inducing member is shaped for enhancing the vortical blood flow pattern within the right atrium.

[0005] A vortex inducer for inducing a vortical blood flow pattern within a right atrium includes a first stent for placement in an inferior vena cava, a second stent for placement in a superior vena cava, and a pivot member connected to the first stent and the second stent and shaped for inducing the vortical blood flow pattern within the right atrium.

[0006] A vortex inducer for inducing a vortical blood flow pattern within a right atrium includes a first stent, a second stent, and a two-piece pivot member connected to the first stent and the second stent. The two-piece pivot member includes a straight member connected to the first stent, a curved member connected to the second stent, and a pivot connector between the straight member and the curved member. The curved member is rotatable at the pivot connector to establish an offset between a superior vena cava and an inferior vena cava.

[0007] A vortex inducer for inducing a vortical blood flow pattern within a right atrium includes a first stent, a second stent, and a curved threaded rod connected to the first stent and the second stent. The threaded rod is twistable to establish an offset between a superior vena cava and an inferior vena cava.

[0008] A vortex inducer for inducing a vortical blood flow pattern within a right atrium includes a first inflatable tube and a first inflatable protruding element connected to an interior surface of the first inflatable tube. The first inflatable protruding element is configured to deflect blood flow through a superior vena cava or an inferior vena cava to induce a vortical flow pattern. [0009] A vortex inducer for inducing a vortical blood flow pattern within a right atrium includes a body and an electric ion flow motor housed in the body. The device is configured to induce an ionic gradient adjacent a superior vena cava or an inferior vena cava to induce a vortical flow pattern.

[0010] A vortex inducer for inducing a vortical blood flow pattern within a right atrium includes a stent and a compartment circumferentially connected to an interior surface of the stent at an open upstream end of the compartment, the compartment having a hole. The compailment is configured to deflect blood flow through a superior vena cava or an inferior vena cava into the right atrium to induce a vortical flow pattern.

[0011] A vortex inducer for inducing a vortical blood flow pattern within a right atrium includes a body having a hole and an inflatable balloon positioned around the body. The body is configured to seal against the inflatable balloon to deflect blood flow through a superior vena cava or an inferior vena cava to induce a vortical flow pattern.

[0012] A vortex inducer for inducing a vortical blood flow pattern within a right atrium includes an occlusion device and a hole within the occlusion device. The occlusion device is circumferentially connectable to an interior surface of a superior vena cava or an inferior vena cava to induce a vortical flow pattern.

[0013] A vortex inducer for inducing a vortical blood flow pattern within a right atrium includes a first stent, a second stent, a first disc circumferentially connected to an interior surface of the first stent and having a first timed aperture, and a second disc circumferentially connected to an interior surface of the second stent and having a second timed aperture. The first timed aperture and the second timed aperture arc timed to open and close to induce blood flow through a superior vena cava or an inferior vena cava into a vortical flow pattern.

[0014] A vortex inducer for inducing a vortical blood flow pattern within a right atrium includes a first band positionable around a superior vena cava and a second band positionable around an inferior vena cava. The first band and the second band are adjustable in diameter to establish an offset between the superior vena cava and the inferior vena cava.

[0015] A method for inducing a vortical blood flow pattern within a right atrium includes advancing a vortex inducer into a superior vena cava and/or an inferior vena cava and deploying the vortex inducer for altering a flow of blood into the right atrium for inducing a vortical flow pattern.

[0016] An implantable device for inducing a vortical blood flow pattern within the right atrium includes an anchor member sized for placement adjacent a blood vessel entering the right atrium and a vortex inducing member coupled to the anchor. The vortex inducing member is shaped for redirecting the flow of blood into the right atrium, thereby enhancing the vortical blood flow pattern within the right atrium.

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] FIG. 1 is a. schematic diagram of a heart and vasculature.

[0018] FIG. 2 is a cross-sectional schematic view of the heart.

[0019] FIG. 3 is a schematic diagram illustrating modeled hemodynamic flow patterns in the heart.

[0020] FIG. 4A is a schematic view of a first example of a vortex inducer, having two stents connected by a two-piece pivot member, in an undeployed position.

[0021] FIG. 4B is a schematic view of the first example of the vortex inducer, having two stents connected by the two-piece pivot member, in a deployed position.

[0022] FIG. 5A is a schematic view of a first example of a flow pattern indicator.

[0023] FIG. 5B is a schematic view of a second example of a flow pattern indicator.

[0024] FIG. 6A is a schematic view of a second example of a vortex inducer, having two stents connected by a threaded rod, in an undeployed position. [0025] FIG. 6B is a schematic view of the second example of the vortex inducer, having two stents connected by the threaded rod, in a deployed position.

[0026] FIG. 7 is a schematic view of a third example of a vortex inducer having two stents with curved protruding elements.

[0027] FIG. 8 is a schematic view of a fourth example of a vortex inducer having a single stent with a pointed protruding element.

[0028] FIG. 9A is a schematic view of a fifth example of a vortex inducer, having two stents with adjustable deflectors, in an undeployed position.

[0029] FIG. 9B is a schematic view of the fifth example of the vortex inducer, having two stents with adjustable deflectors, in a deployed position.

[0030] FIG. 10A is a schematic view of a seventh example of a vortex inducer, having two inflatable tubes with inflatable protruding elements, in an undeployed position.

[0031] FIG. 10B is a schematic view of a seventh example of a vortex inducer, having two inflatable tubes with inflatable protruding elements, in a deployed position.

[0032] FIG. 11A is a schematic view of an eighth example of a vortex inducer having a device with two opposing motors and two holes.

[0033] FIG. 1 IB is a schematic view of a ninth example of a vortex inducer having a serpentine device with two opposing motors and two holes.

[0034] FIG. 12 is a schematic view of a tenth example of a vortex inducer having two connected stents with compartments having holes.

[0035] FIG. 13 is a schematic view of an eleventh example of a vortex inducer having an inflatable balloon around a device with a hole.

[0036] FIG. 14 is a schematic view of a twelfth example of a vortex inducer having two grafts with offset holes.

[0037] FIG. I5A is a schematic view of a thirteenth example of a vortex inducer having two stents with discs having timed apertures, showing a first aperture open and a second aperture closed.

[0038] FIG. 15B is a schematic view of the thirteenth example of the vortex inducer having two stents with discs having timed apertures, showing the first aperture closed and the second aperture open. [0039] FIG. 16 is a schematic view of a fourteenth example of a vortex inducer having two stents with nozzles.

[0040] FIG. 17 is a schematic cross-sectional view of a fifteenth example of a vortex inducer having two stents with threading.

[0041] FIG. 18A is a schematic view of a sixteenth example of a vortex inducer, having exterior bands, in an undeployed position.

[0042] FIG. 18B is a schematic view of the sixteenth example of the vortex inducer, having the exterior band, in a deployed position.

[0043] FIG. 19A is a schematic view of a seventeenth example of a vortex inducer, having a large-celled stent, in an undeployed position.

[0044] FIG. 19B is a schematic view of the seventeenth example of the vortex inducer, having the large-celled stent, in a deployed position.

[0045] FIG. 20A is a schematic view of an eighteenth example of a vortex inducer, having a large-celled stent with a adjustable deflector, in an undeployed position.

[0046] FIG. 20B is a schematic view of the eighteenth example of the vortex inducer, having a large-celled stent with the adjustable deflector, in a deployed position.

DETAILED DESCRIPTION

[0047] In a healthy heart, blood enters the right atrium from the caval veins (inferior vena cava and superior vena cava) in a generally clockwise vortex formation. The posterior wall of the right atrium and the inferior vena cava play an important role in helping to form the vortex. The vortical rotation of blood flow within the right atrium reduces the energy required to move blood during filling and emptying. This mechanism also leads to more efficient transfer of flow and energy to the right ventricle.

[0048] In general, the present disclosure describes devices and methods for creating a more well-defined vortical blood flow pattern within the right atrium. This may be achieved by reestablishing an offset between or redirecting blood flow from one or both caval veins. The resulting adjustment to the blood flow pattern in the right atrium decreases the effort required to fill the right ventricle and thereby increases the efficiency of right ventricular performance, placing less stress on the heart. [0049] FIG. 1 is a schematic diagram of heart H and vasculature V. FIG. 2 is a cross- sectional schematic view of heart H. FIGS. 1 and 2 will be discussed together. FIGS. 1-2 show heart H, vasculature V, right atrium RA, right ventricle RV, left atrium LA, left ventricle LV, interatrial septum IS (shown in FIG. 2), superior vena cava SVC, inferior vena cava IVC, tricuspid valve TV (shown in FIG. 1), pulmonary valve PV (shown in FIG. 1), pulmonary artery PA (shown in FIG. 1), pulmonary veins PVS, mitral valve MV, aortic valve AV (shown in FIG. 1), aorta AT (shown in FIG. 1), coronary sinus CS (shown in FIG. 2), and thebesian valve BV (shown in FIG. 2).

[0050] Heart H is a human heart that receives blood from and delivers blood to vasculature V. Heart H includes four chambers: right atrium RA, right ventricle RV, left atrium LA, and left ventricle LV. Inter-atrial septum IS is the wall that separates right atrium RA from left atrium LA. The right side of heart H, including right atrium RA and right ventricle RV, receives deoxygenated blood from vasculature V and pumps the blood to the lungs. Blood flows into right atrium RA from superior vena cava SVC, inferior vena cava IVC, and coronary sinus CS.

[0051] Blood flows into right atrium RA from the superior vena cava SVC and the inferior vena cava IVC, which are offset from one another. Due to the offset of the major entry blood flows from superior vena cava SVC and inferior vena cava IVC, a natural flow vortex occurs in right atrium RA (a right-sided flow vortex). This allows a substantial portion of blood from the right atrium RA to enter right ventricle RV by direct flow (i.e., without requiring additional pumping by the heart). The right- sided flow vortex in right atrium RA preserves kinetic energy and momentum of the major blood flows entering right atrium RA and allows a substantial portion of blood to naturally pass from right atrium RA to right ventricle RV without any contribution to flow needed from the pumping action of right atrium RA.

[0052] With contraction, right atrium RA also pumps the residual portion of the entering blood not caught in the direct flow through tricuspid valve TV into right ventricle RV. The blood enters right ventricle RV and then flows through pulmonary valve PV into pulmonary artery PA. With preservation of direct inflow from right atrium RA, blood entering right ventricle RV also forms a natural flow vortex (a right- ventricular flow vortex) in right ventricle RV, which naturally re-directs blood entering right ventricle RV to pulmonary artery PA by direct flow without requiring right ventricle RV to perform substantial work of pumping blood. Residual blood that is not transported to pulmonary artery PA via pulmonary valve PV by direct flow is pumped by the contraction of right ventricle RV. The blood flows from pulmonary artery PA into smaller arteries that deliver the deoxygenated blood to the lungs via the pulmonary circulatory system. The lungs can then oxygenate the blood.

[0053] The left side of heart H, including left atrium LA and left ventricle LV, receives oxygenated blood from the lungs and provides blood flow to the body. Blood flows into left atrium LA from pulmonary veins PVS. There are four pulmonary veins PVS that flow into left atrium LA. The offset of the right and left pulmonary veins PVS also leads to the formation of a natural flow vortex in left atrium LA (left-sided flow vortex), which helps maintain momentum and minimize work as the blood traverses left atrium LA to mitral valve MV. Direct flow, as described above, and the pumping action of left atrium LA propels the blood through mitral valve MV into left ventricle LV. As the blood enters left ventricle LV, a natural flow vortex (a left-ventricular flow vortex) forms in left ventricle LV, which redirects flow naturally towards the left ventricular outflow of aortic valve AV so that it can be efficiently pumped by left ventricle LV through aortic valve AV into aorta AT. The blood flows from aorta AT into arteries that deliver the oxygenated blood to the body via the systemic circulatory system.

[0054] Blood is additionally received in right atrium RA from coronary sinus CS. Coronary sinus CS collects deoxygenated blood from the heart muscle and delivers it to right atrium RA. Thebesian valve BV is a semicircular fold of tissue at the opening of coronary sinus CS in right atrium RA. Coronary sinus CS is wrapped around heart H and runs in part along and beneath the floor of left atrium LA right above mitral valve MV, as shown in FIG. 2. Coronary sinus CS has an increasing diameter as it approaches right atrium RA. Coronary sinus CS also wraps around a portion of right atrium RA posteriorly before in enters right atrium RA via the ostium of coronary sinus CS lateral and posterior to an orifice of tricuspid valve TV, and medial to inferior vena cava IVC entry point. Due to its proximity to inferior vena cava IVC, blood entering right atrium RA from coronary sinus CS is naturally entrained into the larger inflow from inferior vena cava IVC forming the natural flow vortex (right-sided flow vortex) in right atrium RA, which naturally redirects the inflows towards tricuspid valve TV.

[0055] The hearts of patients with heart failure do not pump blood as well as they should. Heart failure can affect the right side and/or the left side of the heart. Heart failure and other cardiac conditions can disrupt the natural vortical flow pattern of blood moving through right atrium RA. [0056] FIG. 3 is a schematic diagram illustrating modeled hemodynamic flow patterns in heart H. FIG. 3 shows heart H, right atrium RA, left atrium LA, superior vena cava SVC, inferior vena cava IVC, coronary sinus CS, and right-sided flow vortex RVF. FIG. 3 shows modeled velocity stream lines representing hemodynamic flow patterns in heart H. FIG. 3 is a superior view of heart H and shows heart H oriented with right atrium RA on a left side of the figure and left atrium LA on a right side of the figure.

[0057] Natural flow patterns of blood flow exist in heart H and help move blood through heart H and into the vasculature connected to heart H in a way that maximizes preservation of blood flow momentum and kinetic energy. The natural flow pattern for blood moving through arteries and veins is typically helical in nature (helical flow patterns). The natural flow pattern for blood moving through the chambers of heart H is typically vortical in nature (vortical flow patterns).

[0058] FIG. 3 shows modeled hemodynamic flow patterns that exist in right atrium RA, superior vena cava SVC, inferior vena cava IVC, and coronary sinus CS. FIG. 3 represents natural flow patterns that are formed in heart H, including right atrium RA and left atrium LA, based on the offset inflows of blood into the chambers of heart H in addition to the anatomical structure of heart H. When looking at heart H from the right side (the right sagittal view), a clockwise rightsided flow vortex is formed in right atrium RA and a counter-clockwise left- sided flow vortex is formed in left atrium LA. The right-sided flow vortex in right atrium RA is the natural flow pattern of blood flow in right atrium RA. The left-sided flow vortex in left atrium LA is the natural flow pattern of blood flow in left atrium LA. The modeled hemodynamic flow patterns shown in FIG. 3 represent intra-cardiac flow patterns for a structurally normal heart.

[0059] Blood flows enter the right atrium RA from superior vena cava SVC, inferior vena cava IVC, and coronary sinus CS. The superior vena cava opening and the inferior vena cava opening in right atrium RA are offset so that the blood flowing into right atrium RA from superior vena cava SVC and inferior vena cava IVC do not collide with each other. Due to its orientation and physical proximity, coronary sinus CS flow is entrained into inferior vena cava IVC flow. The blood flowing through superior vena cava SVC and inferior vena cava IVC has a helical flow pattern. A majority of the blood in right atrium RA enters right atrium RA through inferior vena cava IVC, and the blood flowing from inferior vena cava IVC into right atrium RA is pointed towards the top of right atrium RA. The helical flow pattern of the blood flowing into right atrium RA from inferior vena cava IVC helps to form a clockwise right-sided flow vortex in right atrium RA (when looking at the heart from the right side). The flow of blood entering right atrium RA from superior vena cava SVC will flow along the inter-atrial septum and towards tricuspid valve TV. The helical flow pattern of the blood flowing from superior vena cava SVC into right atrium RA helps the flow of blood naturally join with the clockwise right-sided flow vortex formed in right atrium RA by the flow of blood from inferior vena cava IVC, which is joined by coronary sinus CS flow. A small amount of blood flows into right atrium RA from coronary sinus CS. The flow flowing through coronary sinus CS will have a helical flow pattern. The helical flow pattern of the blood exiting coronary sinus CS will naturally join with inferior vena cava IVC flow and the right-sided flow vortex in right atrium RA. The right-sided flow vortex in right atrium RA is shown with velocity stream lines labeled RVF in FIG. 3.

[0060] The right-sided flow vortex formed in right atrium RA helps the blood flow through right atrium RA, through tricuspid valve TV, into the right ventricle, through the pulmonary valve, and into the pulmonary artery. The right heart is an inefficient pump and can act more like a conduit. The right-sided flow vortex formed in the right heart helps to preserve kinetic energy and the momentum of blood flow as it moves from superior vena cava SVC and inferior vena cava IVC (the Vena Cavae) through the right heart and into the pulmonary artery, even with minimal to no pumping being provided by the right heart. This is especially important for maintaining right heart output, which must match left heart output, during periods of high output and heart rates during exercise. The right-sided flow vortex formed in right atrium RA helps to move the blood from right atrium RA through tricuspid valve TV and into the right ventricle with minimal loss of momentum and kinetic energy. The blood shoots from right atrium RA through the right ventricle, out the right ventricular outflow tract, through the pulmonary valve, and into the pulmonary artery. Approximately 50% of the blood will flow into the pulmonary artery without any pumping required by the right heart because of the right-sided flow vortices of right atrium RA and right ventricle RV and anatomical constraints of the right heart. Right heart contraction enhances the flow of residual blood through the right heart.

[0061] It is hypothesized that if the intra-cardiac blood flow patterns in heart H (including right-sided flow vortex in right atrium RA) are disrupted, blood flow from superior vena cava SVC and inferior vena cava IVC (the Vena Cavae), through right atrium RA, through the right ventricle, and into the pulmonary artery, and blood flow from the pulmonary veins, through the left atrium LA, through the left ventricle, and into the aorta become less efficient and place increased mechanical workloads on the respective ventricles. This is especially important in already failing hearts, where the ability to increase the workload of the heart muscle is impaired. Disruptions in the intra-cardiac blood flow patterns in heart H (including right-sided flow vortex in right atrium RA) can happen for a variety of reasons. For example, the anatomy of heart H can change as patients age. This can affect the offset between the opening of superior vena cava SVC and the opening of inferior vena cava IVC. The blood flow entering right atrium RA from superior vena cava SVC and the blood flow entering right atrium RA from inferior vena cava IVC can collide as the anatomy of heart H changes, which disrupts the natural formation of the right-sided flow vortex in right atrium RA.

[0062] When the right-sided flow vortex in right atrium RA changes, momentum and energy of the blood flow are lost and the right heart needs to pump harder to move the blood from right atrium RA into the right ventricle and the pulmonary artery. This is due to the right-sided flow vortex contributing less to the movement of blood through the right heart. Further, as the intra-cardiac flow patterns in heart H (including right-sided flow vortex in right atrium RA) change due to age or disease, areas of turbulence can be created in the flow patterns of heart H and there can be a loss of fluid dynamics leading to inefficiencies that could lead to diminished flow. This can increase the susceptibility of the right heart to fail (the inability to pump enough blood to meet the body’s oxygen demands), as heart H has to do more work to move the same amount of blood through heart H. More work is needed to recreate the lost momentum naturally preserved by the intra-cardiac flow patterns in heart H (including right-sided flow vortex in right atrium RA), putting additional strain on heart H.

[0063] Changes in intra-cardiac flow patterns change intra-cardiac energetics. Heart H is uniquely designed to maximize efficiency by preserving the kinetic energy and momentum of blood flow, thus minimizing the work needed to propagate the blood flow into the chambers, between the chambers, and out of the chambers. Anything that disrupts the intra-cardiac flow patterns in heart H (including right-sided flow vortex in right atrium RA) can reduce the efficiency of the energetics of heart H due to a loss of potential energy, which makes it more difficult for heart H to do its job of propagating blood into, between, and out of the chambers. Anything that disrupts the intra-cardiac flow patterns through heart H (including right-sided flow vortex in right atrium RA) can increase the amount of work heart H has to do, prolong transit times through heart H, and makes it more difficult for heart H to eject blood. This is especially problematic for people experiencing heart failure, as heart failure can be exacerbated due to disruptions in the intra-cardiac flow patterns through heart H (including right-sided flow vortex in right atrium).

[0064] FIG. 4A is a schematic view of vortex inducer 10, having stents 12 and 14 connected by two-piece pivot member 16, in an undeployed position. FIG. 4B is a schematic view of vortex inducer 10, having stents 12 and 14 connected by two-piece pivot member 16, in a deployed position. FIGS. 4A and 4B will be discussed together. Heart H is shown in cross-section, and vortex inducer 10 is not shown in cross-section. Heart H includes superior vena cava SVC, inferior vena cava IVC, and right atrium RA. Vortex inducer 10 includes stent 12, stent 14, two- piece pivot member 16, connector 18, and connector 20. Two-piece pivot member 16 includes straight member 22, curved member 24, and pivot connector 26. Also shown in FIGS. 4A and 4B are first axis Al and second axis A2. FIG. 4B further shows offset O, flow Fl, and flow F2.

[0065] Vortex inducer 10 is an implantable device. Vortex inducer 10 has stent 12 at a first end and stent 14 at a second end. Stent 12 is positioned inside the superior vena cava SVC, and stent 14 is positioned inside the inferior vena cava IVC. Stents 12 and 14 are preferably selfexpanding stents; however, balloon expandable stents may also be used. Two-piece pivot member 16 is a vortex inducing member connected, or coupled, to stent 12 and stent 14. As such, two- piece pivot member 16 is positioned between superior vena cava SVC and inferior vena cava IVC adjacent right atrium RA. A first end of two-piece pivot member 16 is connected to stent 12 via connector 18, and a second end of two-piece pivot member 16 is connected to stent 14 via connector 20. Connectors 18 and 20 are rigid spiked connectors that may be annular. Connectors 18 and 20 include spikes, protrusions, or any other suitable member that enhances frictional engagement with superior vena cava SVC and inferior vena cava IVC, respectively. In alternate examples, connector 18 and/or connector 20 is not included and two-piece pivot member 16 is connected to stent 12 and stent 14 by any suitable connector.

[0066] Straight member 22 of two-piece pivot member 16 is connected to stent 12 via connector 18. Straight member 22 is a rigid rod-like portion of two-piece pivot member 16. Straight member 22 may include a skirt (not shown) at an end of straight member 22 adjacent stent 12 to promote tissue ingrowth into the interior wall of superior vena cava SVC. Curved member 24 of two-piece pivot member 16 is connected to stent 14 via connector 20. Curved member 24 is a rigid curved portion of two-piece pivot member 16. Pivot connector 26 connects straight member 22 to curved member 24. As such, pivot connector 26 is between straight member 22 and curved member 24. Curved member 24 is pivotable, or rotatable, about straight member 22 at pivot connector 26. Pivot connector 26 may be a ratchet mechanism or any other suitable adjustable connector.

[0067] Vortex inducer 10 is used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, causing a turbulent flow pattern from superior vena cava SVC and inferior vena cava IVC. First axis Al is the central axis of superior vena cava SVC, and second axis A2 is the central axis of inferior vena cava IVC. As seen in Fig. 4A, first axis Al is in alignment with second axis A2. In an undeployed state, stent 12 is positioned in superior vena cava SVC. Stent 12 is deployed in superior vena cava SVC by expanding stent 12 within superior vena cava SVC, frictional engagement with the interior wall of superior vena cava SVC fixing stent 12 in place. As such, the first end of vortex inducer 10, or an end of straight member 22, is anchored to superior vena cava SVC. Two-piece pivot member 16 connects stent 12 and stent 14. Stent 14 is positioned in inferior vena cava IVC in an undeployed position, as shown in FIG. 4A. Curved member 24 is rotated about straight member 22 at pivot connector 26, rotating stent 14 about straight member 22 and stent 12 to achieve a preferred orientation. The preferred orientation of two-piece pivot member 16 establishes offset O between superior vena cava SVC and inferior vena cava IVC, as shown in FIG. 4B. Curved member 24 is rotated until the preferred orientation is achieved. Connector 18 holds stent 12 and straight member 22 in place within superior vena cava SVC to prevent stent 12 and straight member 22 from spinning within superior vena cava SVC due to torsion as curved member 24 is rotated. Straight member 22 including a skirt further prevents movement of stent 12 and straight member 22 within superior vena cava SVC over time. Once vortex inducer 10 is in the preferred orientation, stent 14 is deployed in inferior vena cava IVC by expanding stent 14, frictional engagement with the interior wall of inferior vena cava IVC fixing stent 14 in place. As such, the second end of vortex inducer 10, or end of curved member 24, is anchored to inferior vena cava IVC. Pivot connector 26 is locked in place, locking the positions of straight member 22 and curved member 24 of two-piece pivot member 16 in place. Connectors 18 and 20 ensure that two-piece pivot member 16 stays connected to stent 12 and stent 14 in the same locations on stent 12 and stent 14, respectively. Thus, vortex inducer 10 fixes inferior vena cava IVC in place relative to superior vena cava SVC. As seen in FIG. 4B, deployed vortex inducer 10 has established offset O between first axis Al and second axis A2, or between superior vena cava SVC and inferior vena cava IVC.

[0068] Flow Fl is blood flow from superior vena cava SVC, and flow F2 is blood flow from inferior vena cava IVC. As seen in FIG. 4B, flow Fl from superior vena cava SVC flows into right atrium RA. Flow F2 from inferior vena cava IVC flows out of inferior vena cava IVC in a direction opposite flow Fl due to offset O between superior vena cava SVC and inferior vena cava IVC. Flow F2 curls around and joins with flow Fl into right atrium RA. Flow Fl and flow F2 enter right atrium RA in a vortical flow pattern.

[0069] Vortex inducer 10 can be used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, resulting in colliding, turbulent flow that causes increased workloads on heart H, reduces efficiency of heart H, and could lead to diminished flow from heart H. Vortex inducer 10 redirects flow Fl and flow F2 to induce a vortical blood flow pattern within right atrium RA. Two-piece pivot member 16 of vortex inducer 10 reestablishes offset O between superior vena cava SVC and inferior vena cava IVC to alter the inflowing streams from superior vena cava SVC and inferior vena cava IVC to right atrium RA to reestablish, or enhance, a vortical flow pattern. Because two-piece pivot member 16 is adjustable at pivot connector 26, optimal positioning of inferior vena cava IVC with respect to superior vena cava SVC can be achieved. As vortex inducer 10 improves the blood flow patterns to transform the atypical, turbulent flow into vortical flow, less effort is required to fill right ventricle RV, increasing efficiency of right ventricular performance. Blood flow momentum and kinetic energy are preserved, maintaining the output of heart H. As such, the workload on heart H is reduced, placing less stress on heart H and reducing the susceptibility of failure of heart H.

[0070] FIG. 5 A is a schematic view of flow pattern indicator 116A. FIG. 5B is a schematic view of flow pattern indicator 116B. FIGS. 5A and 5B will be discussed together. Heart H is shown in cross-section, and vortex inducers 100A and 100B are only partially shown. Heart H includes superior vena cava SVC, inferior vena cava IVC, and right atrium RA. Vortex inducer 100A, shown in FIG. 5A, includes stent 112A, stent 114A, and flow pattern indicator 116A. Vortex inducer 100B, shown in FIG. 5B, includes stent 112B, stent 114B, and flow pattern indicator 116B, which includes heads 118B. Also shown in FIGS. 5A and 5B are flow Fl and flow F2. [0071] Vortex inducers 100A and 100B are only partially shown to demonstrate the positioning of flow pattern indicators 116A and 116B. Vortex inducers 100A and 100B have stents 112A and 112B positioned in superior vena cava SVC and stents 114A and 114B positioned in inferior vena cava IVC, respectively. Stents 112A and 112B are similar in structure and function to stent 12 described with respect to FIGS. 4A and 4B. Stents 114A and 114B are similar in structure and function to stent 14 described with respect to FIGS. 4A and 4B. Vortex inducers 100A and 100B also contain any suitable part (not shown) to deflect and/or induce flow into a vortical flow pattern within the right atrium RA, such as two-piece pivot member 16 or any other part shown in FIGS. 6A-19B. Flow pattern indicator 116A is connected to the ends of stents 112A and 114A adjacent right atrium RA. Flow pattern indicators 116A and 116B comprise ribbon-like flagella, such as macro flagella. First ends of flow pattern indicators 116A and 116B are connected to first stent 112A or 112B or second stent 114A or 114B. Ends of stents 112 A, 112B, 114A, and 114B may each have one flagellum or a plurality of flagella connected around pail or an entire circumference of end of stents 112A, 112 A, 114A, and 114B. Flow Fl is blood flow from superior vena cava SVC, and flow F2 is blood flow from inferior vena cava IVC. The flagella making up flow pattern indicators 116A and 116B have second ends that change position to align with flow Fl and flow F2, respectively. In alternate examples, flow pattern indicators 116A and 116B may comprise any suitable component(s) that change position to align with flow Fl and flow F2, respectively. Flow pattern indicators 116A and 116B are radiopaque. Flow pattern indicator 116B has heads 118B, each head 118B being attached to a flagellum of flow pattern indicator 116B. One or more flagella may include head 118B . Each head 118B is radiopaque. Head 118B further improves visualization of the flagella of flow pattern indicators 116B.

[0072] Vortex inducers 100A and 100B are used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, causing a turbulent flow pattern from superior vena cava SVC and inferior vena cava IVC. Flow pattern indicators 116A and 116B identify whether vortex inducers 100 A and 100B have been deployed at a preferred orientation. The preferred orientation re-establishes vortical flow from superior vena cava SVC and inferior vena cava IVC. Flagella of flow pattern indicators 116A and 116B, and heads 118B of flow pattern indicator 116B, can be viewed using ultrasound or fluoroscopy to confirm whether flow Fl and flow F2 are moving in the desired vortical pattern before and/or after deploying vortex inducers 100A and 100B. If flow pattern indicators 116A and 116B are moving consistent with a vortical flow pattern, flow Fl and flow F2 are moving in the desired vortical flow pattern. If flow pattern indicators 116A and 116B arc not moving consistent with a vortical flow pattern, flow Fl and flow F2 are not moving in the desired vortical flow pattern. Vortex inducers 100A and 100B can be adjusted until the desired vortical flow is achieved. Flow pattern indicators 116A and 116B provide an indicator of blood flow while deploying and/or adjusting vortex inducers 100A and 100B, respectively. Flow pattern indicators 116A and 116B provide visual confirmation of a vortical flow pattern into right atrium RA.

[0073] FIG. 6A is a schematic view of vortex inducer 200, having stents 212 and 214 connected by threaded rod 216, in an undeployed position. FIG. 6B is a schematic view of vortex inducer 200, having stents 212 and 214 connected by threaded rod 216, in a deployed position. FIGS. 6A and 6B will be discussed together. Heart H is shown in cross-section, and vortex inducer 200 is not shown in cross-section. Heart H includes superior vena cava SVC, inferior vena cava IVC, and right atrium RA. Vortex inducer 200 includes stent 212, stent 214, and threaded rod 216. Also shown in FIGS. 6A and 6B are first axis A10 and second axis A20. FIG. 6B further shows offset O, flow Fl, and flow F2.

[0074] Vortex inducer 200 has stent 212 at a first end and stent 214 at a second end. Stent 212 is positioned inside superior vena cava SVC, and stent 214 is positioned inside inferior vena cava IVC. Stents 212 and 214 are self-expanding stents. Threaded rod 216 is connected to stent 212 and stent 214 such that threaded rod 216 is between stent 212 and 214. As such, threaded rod 216 is positioned between superior vena cava SVC and inferior vena cava IVC adjacent right atrium RA. Threaded rod 216 is a curved, or bowed, rod that is threaded on both ends. Each end of threaded rod 216 has an end portion with a threaded inner diameter that accepts the middle portion of the threaded rod, which has a threaded outer diameter. Threaded rod 216 may include a locking mechanism to prevent threaded rod 216 from threading, or twisting, within end portions of threaded rod 216. The first end of threaded rod 216, the portion of threaded rod 216 with a threaded inner diameter, is fixed in place on stent 212. The second end of threaded rod 216, the portion of threaded rod 216 with a threaded inner diameter, is fixed in place on stent 214. As a result, threaded rod 216 produces tension between stent 212 and stent 214. In alternate examples, only one end of threaded rod 216 may be threaded.

[0075] Vortex inducer 200 is used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, causing a turbulent flow pattern from superior vena cava SVC and inferior vena cava IVC. First axis A10 is the central axis of superior vena cava SVC, and second axis A20 is the central axis of inferior vena cava IVC. As seen in FIG. 6A, first axis A10 is in alignment with second axis A20. Stent 212 is deployed in superior vena cava SVC by expanding stent 212 within superior vena cava SVC, frictional engagement with the interior wall of superior vena cava SVC fixing stent 212 in place. Stent 214 is deployed in inferior vena cava IVC by expanding stent 214 within inferior vena cava IVC, frictional engagement with the interior wall of inferior vena cava IVC fixing stent 214 in place. As seen in FIG. 6A, vortex inducer 200 is in an undeployed position when stent 212 of vortex inducer 200 is initially deployed, superior vena cava SVC and inferior vena cava IVC being in alignment. Threaded rod 216 is rotated, or the middle portion of threaded rod 216 is twisted within the end portions, to deploy vortex inducer 200. Because threaded rod 216 is curved and fixed between stent 212 and stent 214 to cause tension, twisting, or threading, threaded rod 216 changes the alignment between stent 212 and stent 214, creating offset O between stent 212 and stent 214. As a result, offset O is formed between superior vena cava SVC and inferior vena cava IVC. Threaded rod 216 is rotated to a degree that creates an offset between superior vena cava SVC and inferior vena cava IVC. Threaded rod 216 is adjusted, or rotated, until the desired offset between superior vena cava SVC and inferior vena cava IVC is achieved. Threaded rod 216 can be twisted using a wire connected to threaded rod 216 that twists threaded rod 216 as the wire is pulled. Alternatively, threaded rod 216 can be twisted using a ratchet or any other suitable tool. As seen in FIG. 6B, deployed vortex inducer 200 has established offset O between first axis A 10 and second axis A20, or superior vena cava SVC and inferior vena cava IVC. Once desired offset O is achieved, threaded rod 216 can be locked in place.

[0076] Flow Fl is blood flow from superior vena cava SVC, and flow F2 is blood flow from inferior vena cava IVC. As seen in FIG. 6B, flow Fl from superior vena cava SVC flows into right atrium RA. Flow F2 from inferior vena cava IVC flows out of inferior vena cava IVC in a direction opposite flow Fl due to offset O between superior vena cava SVC and inferior vena cava IVC. Flow F2 curls around and joins with flow Fl into right atrium RA. Flow Fl and flow F2 enter right atrium RA in a vortical flow pattern. Any suitable flow pattern indicator, such as 116A or 116B described with respect to FIGS. 5A and 5B, can be used to confirm whether the offset caused by vortex inducer 200 is producing the desired vortical flow pattern. [0077] Vortex inducer 200 can be used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, resulting in colliding, turbulent flow that causes increased workloads on heart H, reduces efficiency of heart H, and could lead to diminished flow from heart H. Vortex inducer 200 redirects flow Fl and flow F2 to induce a vortical blood flow pattern within right atrium RA. Threaded rod 216 of vortex inducer 200 reestablishes offset O between superior vena cava SVC and inferior vena cava IC to alter the inflowing streams from superior vena cava SVC and inferior vena cava IVC to right atrium RA to reestablish, or enhance, a vortical flow pattern. Because threaded rod 216 is threaded to be adjustable, optimal positioning of inferior vena cava IVC with respect to superior vena cava SVC can be achieved. As vortex inducer 200 improves the blood flow patterns to transform the atypical, turbulent flow into vortical flow, less effort is required to fill right ventricle RV, increasing efficiency of right ventricular performance. Blood flow momentum and kinetic energy are preserved, maintaining the output of heart H. As such, the workload on heart H is reduced, placing less stress on heart H and reducing the susceptibility of failure of heart H.

[0078] FIG. 7 is a schematic view of vortex inducer 300 having two stents 312 and 314 with curved protruding elements 316 and 318, respectively. Heart H is shown in cross-section, and vortex inducer 300 is not shown in cross-section. Heart H includes superior vena cava SVC, inferior vena cava IVC, and right atrium RA. Vortex inducer 300 includes stent 312, stent 314, protruding element 316, and protruding element 318. Also shown in FIG. 7 are flow Fl and flow F2.

[0079] Vortex inducer 300 has stent 312 at a first end and stent 314 at a second end. Stent 312 is positioned inside superior vena cava SVC, and stent 314 is positioned inside inferior vena cava IVC. Stents 312 and 314 are self-expanding stents. Protruding element 316 is a vortex inducing member positioned within a lumen of stent 312 and connected to an interior surface of stent 312. Protruding element 318 is a vortex inducing member positioned within a lumen of stent 314 and connected to an interior surface of stent 314. Protruding element 318 may be radially opposite protruding element 316, or 180 degrees from protruding element 316, as shown in FIG. 7. As such, protruding element 318 is positioned in an opposing orientation to protruding element 316. Protruding elements 316 and 318 extend along less than 180 degrees of the inner diameters of stents 312 and 314, respectively. As seen in FIG. 7, stent 312 with protruding element 316 is like a mirror image of stent 314 with protruding element 318. Protruding elements 316 and 318 are anchored to stents 312 and 314 to reshape the interior of superior vena cava SVC and inferior vena cava IVC, respectively. Protrading elements 316 and 318 arc bumps or rounded protrusions extending from the interior surfaces of stents 312 and 314, respectively. Protruding elements 316 and 318 may be solid or hollow. Vortex inducer 300 can include two separate stents 312 and 314, as shown in FIG. 7, or stents 312 and 314 can comprise a single stent that spans from superior vena cava SVC to inferior vena cava IVC.

[0080] Vortex inducer 300 is used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, causing a turbulent flow pattern from superior vena cava SVC and inferior vena cava IVC. In an undeployed state, stent 312 is positioned in superior vena cava SVC. Stent 312 is adjusted to position protruding element 316 in the desired location within superior vena cava SVC. Subsequently, stent 312 is deployed in superior vena cava SVC by expanding stent 312 within superior vena cava SVC, frictional engagement with the interior wall of superior vena cava SVC fixing stent 312 in place. In an undeployed state, stent 314 is positioned in inferior vena cava IVC. Stent 314 is adjusted to position protruding element 318 in the desired location within inferior vena cava IVC, opposite protruding element 316. Next, stent 314 is deployed in inferior vena cava IVC by expanding stent 314 within inferior vena cava IVC, frictional engagement with the interior wall of inferior vena cava IVC fixing stent 314 in place. Flow Fl is blood flow from superior vena cava SVC, and flow F2 is blood flow from inferior vena cava IVC. Protruding element 316 acts as a deflecting feature to distort flow Fl in superior vena cava SVC. Protruding element 318 acts as a deflecting feature to distort flow F2 in inferior vena cava IVC. As protruding element 316 is positioned opposite protruding element 318, flow Fl and flow F2 are deflected in opposing directions, aiding in vortex formation.

[0081] As seen in FIG. 7, flow Fl in superior vena cava SVC is forced around protrading element 316 to flow from superior vena cava SVC into right atrium RA. Flow F2 in inferior vena cava IVC is forced around protruding element 318, flowing out of inferior vena cava IVC in a direction opposite flow Fl. Flow F2 curls around and joins with flow Fl into right atrium RA. Flow Fl and flow F2 enter right atrium RA in a vortical flow pattern. Any suitable How pattern indicator, such as 116A or 116B described with respect to FIGS. 5A and 5B, can be used to confinn whether the positioning of vortex inducer 300 is producing the desired vortical flow pattern. [0082] Vortex inducer 300 can be used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, resulting in colliding, turbulent flow that causes increased workloads on heart H, reduces efficiency of heart H, and could lead to diminished flow from heart H. Vortex inducer 300 redirects flow Fl and flow F2 to induce a vortical blood flow pattern within right atrium RA. Protruding elements 316 and 318 of vortex inducer 300 alter the inflowing streams from superior vena cava SVC and inferior vena cava IVC to right atrium RA to reestablish, or enhance, a vortical flow pattern. Protruding elements 316 and 318 are on opposing sides to mimic an offset between superior vena cava SVC and inferior vena cava IVC in the area through which flow Fl and flow F2 exit superior vena cava SVC and inferior vena cava IVC, respectively. As vortex inducer 300 improves the blood flow patterns to transform the atypical, turbulent flow into vortical flow, less effort is required to fill right ventricle RV, increasing efficiency of right ventricular performance. Blood flow momentum and kinetic energy are preserved, maintaining the output of heart H. As such, the workload on heart H is reduced, placing less stress on heart H and reducing the susceptibility of failure of heart H.

[0083] FIG. 8 is a schematic view of vortex inducer 400 having single stent 412 with pointed protruding element 414. Heart H is shown in cross-section, and vortex inducer 400 is not shown in cross-section. Heart H includes superior vena cava SVC, inferior vena cava IVC, and right atrium RA. Vortex inducer 400 includes stent 412 and protruding element 414. Also shown in FIG. 8 are flow Fl and flow F2.

[0084] Vortex inducer 400 has stent 412 positioned inside and extending between superior vena cava SVC and inferior vena cava IVC. Stent 412 is a self-expanding stent. Protruding element 414 is a vortex inducing member positioned with a lumen of stent 412 and connected to an interior surface of stent 412 opposite, or 180 degrees from, right atrium RA. As seen in FIG. 8, protruding element 414 is an angular' bump or pointed protrusion extending from the interior surface of stent 412 between superior vena cava SVC and inferior vena cava IVC. Protruding element 414 may be solid or hollow. Flow Fl is blood flow from superior vena cava SVC, and flow F2 is blood flow from inferior vena cava IVC. Protruding element 414 angles the inner diameter of superior vena cava SVC where flow Fl exits superior vena cava SVC toward right atrium RA. Protruding element 414 angles the inner diameter of inferior vena cava IVC where flow F2 exits inferior vena cava IVC toward right atrium RA. [0085] Vortex inducer 400 is used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, causing a turbulent flow pattern from superior vena cava SVC and inferior vena cava IVC. In an undeployed state, stent 412 is positioned in superior vena cava SVC and inferior vena cava IVC such that stent 412 spans from superior vena cava SVC to inferior vena cava IVC. Stent 412 is adjusted to position protruding element 414 in the desired location across from right atrium RA. Subsequently, stent 412 is deployed in superior vena cava SVC and inferior vena cava IVC, frictional engagement with the interior wall of superior vena cava SVC and inferior vena cava IVC fixing stent 412 in place. Protruding element 414 acts as a deflecting feature to distort flow Fl in superior vena cava SVC and flow F2 in inferior vena cava IVC. Protruding element 414 has a surface off which flow Fl is directed toward right atrium RA and a surface off which flow F2 is directed toward right atrium RA to join with flow Fl . As such, protruding element 414 is deflecting both flow Fl and flow F2 toward right atrium RA, aiding in vortex formation.

[0086] As seen in FIG. 8, flow Fl in superior vena cava SVC is forced between superior vena cava SVC and protruding element 414, toward and into right atrium RA. Flow F2 in inferior vena cava IVC is forced between inferior vena cava IVC and protruding element 414, toward and into right atrium RA. Flow Fl and flow F2 join together as flow Fl and flow F2 enter right atrium RA in a vortical flow pattern. Any suitable flow pattern indicator, such as 116A or 116B described with respect to FIGS. 5A and 5B, can be used to confirm whether the positioning of vortex inducer 400 is producing the desired vortical flow pattern.

[0087] Vortex inducer 400 can be used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, resulting in colliding, turbulent flow that causes increased workloads on heart H, reduces efficiency of heart H, and could lead to diminished flow from heart H. Vortex inducer 400 redirects flow Fl and flow F2 to induce a vortical blood flow pattern within right atrium RA. Protruding element 414 of vortex inducer 400 alters the inflowing streams from superior vena cava SVC and inferior vena cava IVC to right atrium RA to reestablish, or enhance, a vortical flow pattern. Because protruding element 414 is between superior vena cava SVC and inferior vena cava IVC, only a single stent 412 and a single protruding element 414 are required to affect flow Fl and flow F2. As vortex inducer 400 improves the blood flow patterns to transform the atypical, turbulent flow into vortical flow, less effort is required to fill right ventricle RV, increasing efficiency of right ventricular performance. Blood flow momentum and kinetic energy are preserved, maintaining the output of heart H. As such, the workload on heart H is reduced, placing less stress on heart H and reducing the susceptibility of failure of heart H.

[0088] FIG. 9A is a schematic view of vortex inducer 500, having two stents 512 and 514 with adjustable deflectors 516 and 518, respectively, in an undeployed position. FIG. 9B is a schematic view of vortex inducer 500, having stents 512 and 514 with adjustable deflectors 516 and 518, respectively, in a deployed position. FIGS. 9A and 9B will be discussed together. Heart H is shown in cross-section, and vortex inducer 500 is not shown in cross-section. Heart H includes superior vena cava SVC, inferior vena cava IVC, and right atrium RA. Vortex inducer 500 includes stent 512, stent 514, adjustable deflector 516, and adjustable deflector 518. Also shown in FIG. 9B are flow Fl and flow F2.

[0089] Vortex inducer 500 has stent 512 at a first end and stent 514 at a second end. Stent 512 is positioned inside superior vena cava SVC, and stent 514 is positioned inside inferior vena cava IVC. Stents 512 and 514 are self-expanding stents. Adjustable deflector 516 is a vortex inducing member connected to an interior surface of stent 512, above right atrium RA. Adjustable deflector 518 is a vortex inducing member connected to an interior surface of stent 514 such that adjustable deflector 518 is radially opposite adjustable deflector 516, or 180 degrees from adjustable deflector 516. As such, adjustable deflector 518 is opposing adjustable deflector 516, below right atrium RA, and adjustable deflectors 516 and 518 are at least partially positioned within a lumen of stents 512 and 514, respectively. Adjustable deflectors 516 and 518 can be connected to interior surfaces of stents 512 and 514, respectively, via a hinge having a joint. Alternatively, adjustable deflectors 516 and 518 can be connected to interior surfaces of stents 512 and 514, respectively, via sutures that form a pivoting joint. As seen in FIGS. 9A and 9B, stent 512 with adjustable deflector 516 is like a mirror image of stent 514 with adjustable deflector 518. Adjustable deflectors 516 and 518 are tunable levers that can be adjusted to reshape the interior of superior vena cava SVC and inferior vena cava IVC, respectively. Adjustable deflectors 516 and 518 may be contoured to deflect fluid. Adj ustable deflectors 516 and 518 extend from the interior surfaces of stents 512 and 514, respectively. Adjustable deflectors 516 and 518 are adjustable at the connection points between adjustable deflectors 516 and 518 and stents 512 and 514, respectively. Adjustable deflectors 516 and 518 will generally deflect in the direction of fluid flow. Adjustable deflectors 516 and 518 may be nitinol-based such that they are adjustable, or deflectable, depending on flow velocity through stents 512 and 514. For example, adjustable deflectors 516 and 518 may deflect more with a higher blood flow rate through stents 512 and 514. Vortex inducer 500 can include two separate stents 512 and 514, as shown in FIGS. 9A and 9B, or stents 512 and 514 can comprise a single stent that spans from superior vena cava SVC to inferior vena cava IVC.

[0090] Vortex inducer 500 is used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, causing a turbulent flow pattern from superior vena cava SVC and inferior vena cava IVC. In an undeployed state, stent 512 is positioned in superior vena cava SVC. Stent 512 is adjusted to position adjustable deflector 516 in the desired location within superior vena cava SVC. Subsequently, stent 512 is deployed in superior vena cava SVC by expanding stent 512 within superior vena cava SVC, frictional engagement with the interior wall of superior vena cava SVC fixing stent 512 in place. In an undeployed state, stent 514 is positioned in inferior vena cava IVC. Stent 514 is adjusted to position adjustable deflector 518 in the desired location within inferior vena cava IVC, opposite adjustable deflector 516. Next, stent 514 is deployed in inferior vena cava IVC by expanding stent 514 within inferior vena cava IVC, frictional engagement with the interior wall of inferior vena cava IVC fixing stent 514 in place. As seen in FIG. 9A, vortex inducer 500 is in an undeployed position when adjustable deflector 516 is positioned as close to stent 512 as possible, and adjustable deflector 518 is positioned as close to stent 514 as possible. Adjustable deflectors 516 and 518 can be adjusted up to 180 degrees. Flow Fl is blood flow from superior vena cava SVC, and flow F2 is blood flow from inferior vena cava IVC. Adjustable deflector 516 is adjustable to adjust, or distort, flow Fl in superior vena cava SVC. Adjustable deflector 518 is adjustable to adjust, or distort, flow F2 in inferior vena cava IVC. As adjustable deflector 516 is positioned opposite adjustable deflector 518, flow Fl and flow F2 can be deflected in opposing directions, aiding in vortex formation. Adjustable deflectors 516 and 518 are tuned based on blood flow characteristics within superior vena cava SVC and inferior vena cava IVC to achieve the desired vortical flow pattern.

[0091] Once adjustable deflectors 516 and 518 have been adjusted to optimal positions, adjustable deflectors 516 and 518 are locked in place. For example, adjustable deflectors 516 and 518 may be tethered to one or more sutures that act as pull wire(s). By pulling the tension on the pull wire(s) during implantation, the deflection of adjustable deflectors 516 and 518 is adjusted. The pull wire(s) can be locked, or set in position, with a cinch-type mechanism. Alternatively, adjustable deflectors 516 and 518 may be locked in place via a travel-limit mechanical tab once adjustable deflectors 516 and 518 have deflected to the maximum amount due to flow pressure. Alternatively, adjustable deflectors 516 and 518 may be tethered together, such as via one or more sutures, during implantation so that their motion is connected and opposing. For example, when adjustable deflector 516 is in a deployed position, adjustable deflector 518 is in an undeployed position, and when adjustable deflector 516 is in an undeployed position, adjustable deflector 518 is in a deployed position. In such an embodiment, adjustable deflectors 516 and 518 could also be deflectors that span the entirety of superior vena cava SVC and inferior vena cava IVC, respectively, when in a deployed position. When adjustable deflectors 516 and 518 are shaped to span the entirety of superior vena cava SVC and inferior vena cava IVC, respectively, adjustable deflectors 516 and 518 can be shaped to occlude the entirety of superior vena cava SVC and inferior vena cava IVC, respectively, to impede some or all flow through superior vena cava SVC and interior vena cava IVC, respectively.

[0092] Adjustable deflectors 516 and 518 are adjusted away from stents 512 and 514, respectively, to deploy vortex inducer 500. Adjustable deflectors 516 and 518 are adjusted about 90 degrees from stents 512 and 514, respectively. As seen in FIG. 9B, flow F 1 from superior vena cava SVC flows into right atrium RA. Flow F2 from inferior vena cava IVC flows out of inferior vena cava IVC in a direction opposite flow Fl. Flow F2 curls around and joins with flow Fl into right atrium RA. Flow Fl and F2 enter right atrium RA in a vortical flow pattern. Adjustable deflectors 516 and 518 are adjusted based on the blood flow characteristics to achieve the desired direction of flow to yield a vortical flow pattern. Any suitable flow pattern indicator, such as 116A or 116B described with respect to FIGS. 5 A and 5B, can be used to confirm whether the positioning of vortex inducer 500 is producing the desired vortical flow pattern.

[0093] Vortex inducer 500 can be used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, resulting in colliding, turbulent flow that causes increased workloads on heart H, reduces efficiency of heart H, and could lead to diminished flow from heart H. Vortex inducer 500 redirects flow Fl and flow F2 to induce a vortical blood flow pattern within right atrium RA. Adjustable deflectors 516 and 518 of vortex inducer 500 alter the inflowing streams from superior vena cava SVC and inferior vena cava IVC to right atrium RA to reestablish, or enhance, a vortical flow pattern. Adjustable deflectors 516 and 518 are on opposing sides to mimic an offset between superior vena cava SVC and inferior vena cava IVC in the area through which flow Fl and flow F2 exit superior vena cava SVC and inferior vena cava IVC, respectively. Because adjustable deflectors 516 and 518 are adjustable, optimal positioning can be achieved to yield optimal flow Fl from inferior vena cava IVC and flow F2 from superior vena cava SVC. As vortex inducer 500 improves the blood flow patterns to transform the atypical, turbulent flow into vortical flow, less effort is required to fill right ventricle RV, increasing efficiency of right ventricular performance. Blood flow momentum and kinetic energy are preserved, maintaining the output of heart H. As such, the workload on heart H is reduced, placing less stress on heart H and reducing the susceptibility of failure of heart H.

[0094] FIG. 10A is a schematic view of vortex inducer 700, having inflatable tubes 712 and 714 with inflatable protruding elements 716 and 718, in an undeployed position. FIG. 10B a schematic view of vortex inducer 700, having inflatable tubes 712 and 714 with inflatable protruding elements 716 and 718, in a deployed position. FIGS. 10A and 10B will be discussed together. Heart H is shown in cross-section, and vortex inducer 700 is not shown in cross-section. Heart H includes superior vena cava SVC, inferior vena cava IVC, and right atrium RA. Vortex inducer 700 includes inflatable tube 712, inflatable tube 714, inflatable protruding element 716, and inflatable protruding element 718. Also shown in FIG. 10B are flow Fl and flow F2.

[0095] Vortex inducer 700 has inflatable tube 712 at a first end and inflatable tube 714 at a second end. Inflatable tube 712 is positioned inside superior vena cava SVC, and inflatable tube 714 is positioned inside inferior vena cava IVC. Inflatable tubes 712 and 714 may be cylindrical tube-like balloons, or any other suitable inflatable protruding element. Inflatable protruding element 716 is a vortex inducing member positioned within an lumen of and connected to an interior surface, or inner diameter, of inflatable tube 712. Inflatable protruding element 718 is a vortex inducing member positioned within a lumen of and connected to an interior surface, or inner diameter, of inflatable tube 714 such that inflatable protruding element 718 is radially opposite inflatable protruding element 716, or 180 degrees from inflatable protruding element 716. As such, inflatable protruding element 716 is positioned in an opposing orientation to inflatable protruding element 716. As seen in FIGS. 10A and 10B, inflatable tube 712 with inflatable protruding element 716 is like a mirror image of tube 714 with inflatable protruding element 718. Inflatable protruding elements 716 and 718 may be balloons, or any other suitable inflatable protruding element. In alternate examples, inflatable tubes 712 and 714 may instead be stents, such as those described above with respect to FIGS. 4A-9.

[0096] Vortex inducer 700 is used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, causing a turbulent flow pattern from superior vena cava SVC and inferior vena cava IVC. Inflatable protruding elements 716 and 718 are anchored to inflatable tubes 712 and 714 to reshape the interior of superior vena cava SVC and inferior vena cava IVC. Inflatable tubes 712 and 714 and inflatable protruding elements 716 and 718 are deflated when vortex inducer 700 is in an undeployed position, as seen in FIG. 10A. Inflatable tubes 712 and 714 and inflatable protruding elements 716 and 718 are inflated when vortex inducer 700 is in a deployed position. Inflatable tubes 712 and 714 and inflatable protruding elements 716 and 718 may be inflated or deflated via a catheter (not shown) attached to inflatable tubes 712 and 714 and/or protruding elements 716 and 718 when vortex inducer 700 is in an undeployed position. When inflatable tubes 712 and 714 are inflated, inflatable tubes 712 and 714 are held in place against interior surfaces of superior vena cava SVC and inferior vena cava IVC, respectively, and have cylindrical spaces that extend through the centers. When inflatable protruding elements 716 and 718 are inflated, inflatable protruding elements 716 are bumps or rounded protrusions extending from the interior surfaces of inflatable tubes 712 and 714, respectively. The inflatable protruding elements 716 and 718 asymmetrically obstruct about half of the interior of inflatable tubes 712 and 714 in superior vena cava SVC and inferior vena cava IVC, respectively, when inflatable protruding elements 716 and 718 are fully inflated. Vortex inducer 700 mimics the offset between superior vena cava SVC and inferior vena cava IVC to induce vortical flow. Vortex inducer 700 can include two separate inflatable tubes 712 and 714, as shown in FIG. 10A, or inflatable tubes 712 and 714 can comprise a single tube that spans from superior vena cava SVC to inferior vena cava IVC.

[0097] In an undeployed state, inflatable tube 712 is positioned in superior vena cava SVC. Inflatable tube 712 is adjusted to position inflatable protruding element 316 in the desired location within superior vena cava SVC. Subsequently, inflatable tube 712 is deployed in superior vena cava SVC by inflating inflatable tube 712 within superior vena cava SVC, frictional engagement with the interior wall of superior vena cava SVC fixing inflatable tube 712 in place. In an undeployed state, inflatable tube 714 is positioned in inferior vena cava IVC. Inflatable tube 714 is adjusted to position inflatable protruding element 718 in the desired location within inferior vena cava IVC, opposite inflatable protruding element 716. Next, inflatable tube 714 is deployed in inferior vena cava IVC by inflating inflatable tube 714 within inferior vena cava IVC, frictional engagement with the interior wall of inferior vena cava IVC fixing inflatable tube 714 in place.

[0098] Once inflatable tubes 712 and 714 are fixed in plate, inflatable protruding elements 716 and 718 are inflated to deploy vortex inducer 700, as seen in FIG. 10B. Flow Fl is blood flow from superior vena cava SVC, and flow F2 is blood flow from inferior vena cava IVC. Inflatable protruding element 716 acts as a deflecting feature to distort flow Fl in superior vena cava SVC. Inflatable protruding element 718 acts as a deflecting feature to distort flow F2 in inferior vena cava IVC. As inflatable protruding element 716 is positioned opposite inflatable protruding element 718, flow Fl and flow F2 are deflected in opposing directions, aiding in vortex formation. The level of inflation, or pressure, of inflatable protruding elements 716 and 718 can be adjusted to adjust deflection. As such, inflatable protruding elements 716 and 718 are fully or less than fully inflated based on blood flow characteristics within superior vena cava SVC and inferior vena cava IVC to achieve the desired vortical flow pattern. Once inflatable protruding elements 716 and 718 have reached the desired amount of pressure, or inflation, inflatable protruding elements 716 and 718 are no longer inflated. Inflatable tube 712, inflatable tube 714, inflatable protruding element 716, and inflatable protruding element 718 may each include a one-way valve to accept fluid for inflation and prevent such fluid from exiting once a conduit is removed. Conduits from a fluid source (not shown) may attach to one-way valves to deliver fluid to or remove fluid from inflatable tube 712, inflatable tube 714, inflatable protruding element 716, and inflatable protruding element 718, respectively.

[0099] As seen in FIG. 10B, flow F2 in inferior vena cava IVC is forced around inflatable protruding element 718 to flow from inferior vena cava IVC into right atrium RA. Flow Fl in superior vena cava SVC is forced around inflatable protruding element 716, flowing out of superior vena cava SVC in a direction opposite flow F2. Flow Fl curls around and joins with flow F2 into right atrium RA. Flow Fl and flow F2 enter right atrium RA in a vortical flow pattern. Any suitable flow pattern indicator, such as 116A or 116B described with respect to FIGS. 5A and 5B, can be used to confirm whether the positioning of vortex inducer 700 is producing the desired vortical flow pattern.

[0100] Vortex inducer 700 can be used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, resulting in colliding, turbulent flow that causes increased workloads on heart H, reduces efficiency of heart H, and could lead to diminished flow from heart H. Vortex inducer 700 redirects flow Fl and flow F2 to induce a vortical blood flow pattern within right atrium RA. Inflatable protruding elements 716 and 718 of vortex inducer 700 alter the inflowing streams from superior vena cava SVC and inferior vena cava IVC to right atrium RA to reestablish, or enhance, a vortical flow pattern. Inflatable protruding elements 716 and 718 are on opposing sides to mimic an offset between superior vena cava SVC and inferior vena cava IVC in the area through which flow Fl and flow F2 exit superior vena cava SVC and inferior vena cava IVC, respectively. Inflatable protruding elements 716 and 718 can be adjusted to achieve the desired vortical flow patten. As vortex inducer 700 improves the blood flow patterns to transform the atypical, turbulent flow into vortical flow, less effort is required to fill right ventricle RV, increasing efficiency of right ventricular performance. Blood flow momentum and kinetic energy are preserved, maintaining the output of heart H. As such, the workload on heart H is reduced, placing less stress on heart H and reducing the susceptibility of failure of heart H.

[0101] FIG. 11 A is a schematic view of vortex inducer 800 having body 812 with opposing holes 814 and 816 and motors 818 and 820. FIG. 1 IB is a schematic view of vortex inducer 900 having a serpentine body 912 with opposing holes 914 and 916 and motors 918 and 920. FIGS. 11A and 11B will be discussed together. Heart H is shown in cross-section, and vortex inducers 800 and 900 are not shown in cross-section. Heart H includes superior vena cava SVC, inferior vena cava IVC, and right atrium RA. Vortex inducer 800 includes body 812, hole 814, hole 816, motor 818, and motor 820. Vortex inducer 900 includes body 912, hole 914, hole 916, motor 918, and motor 920. Also shown in FIGS. 11 A and 1 IB are flow Fl and flow F2.

[0102] Vortex inducer 800, shown in FIG. 11A, has body 812 positioned inside and extending between superior vena cava SVC and inferior vena cava IVC. In the example shown, body 812 extends from superior vena cava SVC. In alternate examples, body 812 may extend from inferior vena cava IVC. In the example shown, body 812 is a straight catheter, a distal end of the catheter being shown in FIG. 11A. Body 812 could have a proximal end (not shown) that plugs into a wall for acute management of patients in a hospital. In alternate examples, body 812 may be a catheter with a different shape, a fully implantable device, or any other suitable device or body. Body 812 can be fixed in place within superior vena cava SVC and inferior vena cava IVC via an expandable frame, such as a stent or balloon, within superior vena cava SVC and/or inferior vena cava IVC and around body 812. Body 812 includes two axially opposing holes 814 and 816. Holes 814 and 816 arc spaces that extend radially through body 812. Hole 814 is at least partially within superior vena cava SVC, and hole 816 is at least partially within inferior vena cava IVC. Motors 818 and 820 are housed in body 812. Motor 818 is adjacent hole 814, and motor 820 is adjacent hole 816. Motors 818 and 820 are independent and opposing electric ion flow motors. Motors 818 and 820 induce an ion gradient through holes 814 and 816, respectively. The ion gradient, or electrical charge differences, is created via negatively charged proteins to drive opposing motors 818 and 820. Flow Fl is blood flow from superior vena cava SVC, and flow F2 is blood flow from inferior vena cava IVC. Flow Fl is sucked into hole 814, and flow F2 is sucked into hole 816, as a result of the ion gradient. Flow Fl is sucked through hole 814 in a first direction, and flow F2 is sucked through hole 816 in a second direction that is opposite the first direction.

[0103] Vortex inducer 800 is used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, causing a turbulent flow pattern from superior vena cava SVC and inferior vena cava IVC. Body 812 is positioned in superior vena cava SVC and inferior vena cava IVC such that body 812 spans from superior vena cava SVC to inferior vena cava IVC. Body 812 may drop down from superior vena cava SVC or may extend up from inferior vena cava IVC. Body 812 is positioned such that hole 814 is at least partially within superior vena cava SVC and hole 816 is at least partially within inferior vena cava IVC. An expandable frame may be deployed to hold body 812 in place. Motors 818 and 820 are activated to induce opposing ionic gradients at holes 814 and 816, respectively. As seen in FIG. 11 A, flow F2 is sucked from inferior vena cava IVC through hole 816 and into right atrium RA. Flow Fl is sucked from superior vena cava SVC through hole 814 to flow out of superior vena cava SVC in a direction opposite to flow F2. Flow Fl curls around and joins with flow F2, where flow Fl is then sucked through hole 816, along with flow F2, and into right atrium RA. Flow Fl and flow F2 enter right atrium RA in a vortical flow pattern. Any suitable flow pattern indicator, such as 116A or 116B described with respect to FIGS. 5A and 5B, can be used to confinn whether the positioning of vortex inducer 800 is producing the desired vortical flow pattern.

[0104] Vortex inducer 900 has the same structure and function as vortex inducer 800; however, body 912 has a serpentine shape at the distal end instead of having a straight body at the distal end like body 812. As such, holes 914 and 916 and motors 918 and 920 are slightly offset. Flow Fl and flow F2 moving through body 912 may form an S-like shape between motor 918 and motor 920. The serpentine shape of body 912 further enhances the vortex of flow Fl and flow F2 formed by vortex inducer 900.

[0105] Vortex inducers 800 and 900 can be used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, resulting in colliding, turbulent flow that causes increased workloads on heart H, reduces efficiency of heart H, and could lead to diminished flow from heart H. Vortex inducers 800 and 900 redirect flow Fl and flow F2 to induce a vortical blood flow pattern within right atrium RA. Holes 814 and 816 and motors 818 and 820 of vortex inducer 800, and holes 914 and 916 and motors 918 and 920 of vortex inducer 900, alter the inflowing streams from superior vena cava SVC and inferior vena cava IVC to right atrium RA to reestablish, or enhance, a vortical flow pattern. Further, the serpentine shape of vortex inducer 900 allows for easier vortex formation, mimicking an offset between superior vena cava SVC and inferior vena cava IVC. As vortex inducer 900 improves the blood flow patterns to transform the atypical, turbulent flow into vortical flow, less effort is required to fill right ventricle RV, increasing efficiency of right ventricular performance. Blood flow momentum and kinetic energy are preserved, maintaining the output of heart H. As such, the workload on heart H is reduced, placing less stress on heart H and reducing the susceptibility of failure of heart H.

[0106] FIG. 12 is a schematic view of vortex inducer 1000 having connected stents 1012 and 1014 with compartments 1016 and 1018 having holes 1020 and 1022, respectively. Heart H is shown in cross-section, and vortex inducer 1000 is not shown in cross-section. Heart H includes superior vena cava SVC, inferior vena cava IVC, and right atrium RA. Vortex inducer 1000 includes stent 1012, stent 1014, compartment 1016, and compartment 1018, including hole 1020 and hole 1022, respectively. Also shown in FIG. 12 are first flow Fl and flow F2.

[0107] Vortex inducer 1000 has stent 1012 at a first end and stent 1014 at a second end. Stent 1012 is positioned inside superior vena cava SVC, and stent 1014 is positioned inside inferior vena cava IVC. Stents 1012 and 1014 are self-expanding stents. Compartment 1016 is a vortex inducing member at least partially positioned within a lumen of and circumferentially connected to an interior surface of stent 1012 at an open upstream end of compartment 1016. The open upstream end of compartment 1016 is within superior vena cava SVC. Compartment 1016 mostly covers superior vena cava SVC. A closed downstream end of compartment 1016 extends beyond superior vena cava SVC. Compartment 1018 is a vortex inducing member at least partially positioned within a lumen of and circumferentially connected to an interior surface of stent 1014 at an open upstream end of compartment 1018. The open upstream end of compartment 1018 is within inferior vena cava IVC. Compartment 1018 mostly covers inferior vena cava IVC. A closed downstream end of compailment 1018 extends beyond inferior vena cava IVC. The closed downstream end of compartment 1018 may contact the closed downstream end of compartment 1016. Vortex inducer 1000 may include struts that extend between stent 1012 and 1014 to keep the positioning of compartment 1016 relative to compartment 1018 the same. Compartments 1016 and 1018 may be pear-shaped. Compartments 1016 and 1018 may have small apertures or any other suitable characteristic that allows a small amount of blood flow to pass between compartments 1016 and 1018. Compartment 1016 has hole 1020, which is an opening through compartment 1016, positioned adjacent right atrium RA. Compartment 1018 has hole 1022, which is an opening through compartment 1018, positioned adjacent right atrium RA. As such, hole 1020 axially opposes hole 1022, and hole 1020 is in radial alignment with hole 1022. Compartments 1016 and 1018 may include contoured ramps connected internally or externally to compartments 1016 and 1018 to drive flow toward holes 1020 and 1022, respectively. Vortex inducer 1000 can include two separate stents 1012 and 1014, as shown in FIG. 12, or stents 1012 and 1014 can comprise a single stent that spans from superior vena cava SVC to inferior vena cava IVC. Further, compartment 1016 and compartment 1018 can be two separate compartments 1016 and 1018 as shown in FIG. 12, or compartments 1016 and 1018 can comprise a single compartment that spans from stent 1012 to stent 1014 and includes holes 1020 and 1022.

[0108] Vortex inducer 1000 is used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, causing a turbulent flow pattern from superior vena cava SVC and inferior vena cava IVC. Stent 1012 is positioned in superior vena cava SVC. Stent 1012 is adjusted to position compartment 1016 in the desired location within superior vena cava SVC. Subsequently, stent 1012 is deployed in superior vena cava SVC by expanding stent 1012 within superior vena cava SVC, frictional engagement with the interior wall of superior vena cava SVC fixing stent 1012 in place. Once stent 1012 is deployed, the circumference of the open upstream end of compartment 1016 is sealed against the interior surface of superior vena cava SVC. In an undeployed state, stent 1014 is positioned in inferior vena cava IVC. Stent 1014 is adjusted to position compartment 1018 in the desired location within inferior vena cava IVC. Next, stent 1014 is deployed in inferior vena cava IVC by expanding stent 1014 within inferior vena cava IVC, frictional engagement with the interior wall of inferior vena cava IVC fixing stent 1014 in place. Once stent 1014 is deployed, the circumference of the open upstream end of compartment 1018 is scaled against the interior surface of inferior vena cava IVC. Flow Fl is blood flow from superior vena cava SVC, and flow F2 is blood flow from inferior vena cava IVC. Compartments 1016 and 1018 are contoured to drive flow Fl and flow F2 toward holes 1020 and 1022, respectively, and into right atrium RA. Thus, compartment 1016 acts as a ramp to direct flow Fl in superior vena cava SVC into compartment 1016, through hole 1020, and into right atrium RA. Compartment 1018 acts as ramp to direct flow F2 in inferior vena cava IVC into compartment 1018, through hole 1022, and into right atrium RA.

[0109] As seen in FIG. 12, flow Fl in superior vena cava SVC is forced into compartment 1016 because compartment 1016 is sealed against the interior surface of superior vena cava SVC. Flow Fl is then deflected and forced through hole 1020, by the closed downstream end of compartment 1016 and hole 1020, and into right atrium RA. Flow F2 in inferior vena cava IVC is forced into compartment 1018 because compartment 1018 is sealed against the interior surface of inferior vena cava IVC. Flow F2 is then deflected and forced through hole 1022, by the closed downstream end of compartment 1018 and hole 1022, and into right atrium RA. As such, flow Fl and flow F2 are forced into right atrium RA. Flow Fl and flow F2 enter right atrium RA in a vortical flow pattern. Any suitable flow pattern indicator, such as 116A or 116B described with respect to FIGS. 5A and 5B, can be used to confirm whether the positioning of vortex inducer 1000 is producing the desired vortical flow pattern.

[0110] Vortex inducer 1000 can be used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, resulting in colliding, turbulent flow that causes increased workloads on heart H, reduces efficiency of heart H, and could lead to diminished flow from heart H. Vortex inducer 1000 redirects flow Fl and flow F2 to induce a vortical blood flow pattern within right atrium RA. Compartments 1016 and 1018 and holes 1020 and 1022 of vortex inducer 1000 alter the inflowing streams from superior vena cava SVC and inferior vena cava IVC to right atrium RA to reestablish, or enhance, a vortical flow pattern. Compartments 1016 and 1018 and holes 1020 and 1022 decrease the area through which flow Fl and flow F2 exit superior vena cava SVC and inferior vena cava IVC, respectively, holes 1022 and 1022 acting as outlets that direct flow Fl and flow F2 directly into right atrium RA. As vortex inducer 1000 improves the blood flow patterns to transform the atypical, turbulent flow into vortical flow, less effort is required to fill right ventricle RV, increasing efficiency of right ventricular performance. Blood flow momentum and kinetic energy are preserved, maintaining the output of heart H. As such, the workload on heart H is reduced, placing less stress on heart H and reducing the susceptibility of failure of heart H.

[0111] FIG. 13 is a schematic view of vortex inducer 1100 having inflatable balloon 1112 around body 1114 with hole 1116. Heart H is shown in cross-section, and vortex inducer 1100 is not shown in cross-section. Heart H includes superior vena cava SVC, inferior vena cava IVC, and right atrium RA. Vortex inducer 1100 includes inflatable balloon 1112 and body 1114, which includes space 1115 and hole 1116. Also shown in FIG. 13 are flow Fl and flow F2.

[0112] Vortex inducer 1100 has inflatable balloon 1112 positioned around body 1114 in inferior vena cava IVC. Balloon 1112 is a ring-like inflatable balloon 1112. As such, balloon 1112 has an axial opening extending through a center of balloon 1112. Body 1114 is positioned to extend through the axial opening in balloon 1112 and extend from inferior vena cava IVC into superior vena cava SVC. Balloon 1112 seals against an interior surface of inferior vena cava IVC and an exterior surface of body 1114. In the example shown, body 1114 extends from inferior vena cava IVC. In alternate examples, body 1114 may extend from superior vena cava SVC into inferior vena cava IVC. Body 1114 is hollow such that space 1115 is within body 1114. Body 1114 is cylindrical, having an open proximal end and a closed distal end. Body 1114 may be a catheter, a fully implantable device, or any other suitable device or body. Body 1114 includes hole 1116. Hole 1116 is an opening through body 1114, extending from space 1115 within body 1114 to an exterior of body 1114. Hole 1116 extends radially through body 1114 adjacent the closed distal end of body 1114 and is in alignment with right atrium RA.

[0113] Vortex inducer 1100 is used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, causing a turbulent flow pattern from superior vena cava SVC and inferior vena cava IVC. Balloon 1112 is positioned in inferior vena cava IVC in a deflated state. Body 1114 is inserted into inferior vena cava IVC, through balloon 1112, and into superior vena cava SVC. Body 1114 is adjusted to position hole 1116 in the desired location, in alignment with right atrium RA. Subsequently, vortex inducer 1100 is deployed by inflating balloon 1112 within inferior vena cava IVC, fixing balloon 1112 and body 1114 in place. Once balloon 1112 is inflated, balloon 1112 is sealed against the interior surface of inferior vena cava IVC and the exterior surface of body 1114. As such, balloon 1112 sandwiches body 1114 in place within inferior vena cava IVC. Flow Fl is blood flow from superior vena cava SVC, and flow F2 is blood flow from inferior vena cava TVC. Flow Fl is forced into right atrium RA, flow Fl being blocked by balloon 1112. Flow F2 is forced into space 1115 within body 1114 at the open proximal end of body 1114, flow F2 being blocked by balloon 1112. Flow F2 is deflected by the closed distal end of body 114, flow F2 being directed from space 1115 within body 1114 through hole 1116 and into right atrium RA. Flow Fl and flow F2 join together upon entering right atrium RA, aiding in vortex formation.

[0114] As seen in FIG. 13, flow Fl in superior vena cava SVC is forced into right atrium RA because balloon 1112 is sealed against the interior surface of inferior vena cava IVC. Flow Fl is being blocked by balloon 1112 such that right atrium RA is the only place for flow Fl to travel. As such, flow Fl is deflected into right atrium RA. Flow F2 in inferior vena cava IVC is forced into space 1115 within body 1114 because balloon 1112 is sealed against the interior surface of inferior vena cava IVC and the exterior surface of body 1114. Flow F2 is blocked by balloon 1112 such that space 1115 within body 1114 is the only place for flow F2 to travel. Flow F2 is then deflected by the closed distal end of body 1114 through hole 1116 and into right atrium RA. As such, flow Fl and flow F2 are forced into right atrium RA. Flow Fl and flow F2 join while entering right atrium RA, forming a vortical flow pattern. Any suitable flow pattern indicator, such as 116A or 116B described with respect to FIGS. 5A and 5B, can be used to confirm whether the positioning of vortex inducer 1100 is producing the desired vortical flow pattern.

[0115] Vortex inducer 1100 can be used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, resulting in colliding, turbulent flow that causes increased workloads on heart H, reduces efficiency of heart H, and could lead to diminished flow from heart H. Vortex inducer 1100 redirects flow Fl and flow F2 to induce a vortical blood flow pattern within right atrium RA. Body 1114 and balloon 1112 alter the inflowing streams from superior vena cava SVC and inferior vena cava IVC to right atrium RA to reestablish, or enhance, a vortical flow pattern. Balloon 1112 forces flow F2 to exit body 1114 at hole 1116, which re-directs flow F2. Hole 1116 acts as an outlet that directs flow F2 directly into right atrium RA to join with flow Fl in a vortical flow pattern. As vortex inducer 1100 improves the blood flow patterns to transform the atypical, turbulent flow into vortical flow, less effort is required to fill right ventricle RV, increasing efficiency of right ventricular performance. Blood flow momentum and kinetic energy are preserved, maintaining the output of heart H. As such, the workload on heart H is reduced, placing less stress on heart H and reducing the susceptibility of failure of heart H.

[0116] FIG. 14 is a schematic view of vortex inducer 1200 having occlusion devices 1212 and 1214 with offset holes 1216 and 1218. Heart H is shown in cross-section, and vortex inducer 1200 is not shown in cross-section. Heart H includes superior vena cava SVC, inferior vena cava IVC, and right atrium RA. Vortex inducer 1200 includes occlusion device 1212 and occlusion device 1214, which include hole 1216 and hole 1218, respectively. Also shown in FIG. 14 are flow Fl and flow F2.

[0117] Vortex inducer 1200 has occlusion device 1212 at a first end and occlusion device 1214 at a second end. Occlusion devices 1212 and 1214 may be grafts, may be any other suitable device supported by a graft or a stent, or may be any other suitable device supported by any other suitable support. Occlusion device 1212 is positioned inside superior vena cava SVC, occlusion device 1212 extending radially across superior vena cava SVC. In this embodiment, occlusion device 1212 is planar and perpendicular to superior vena cava SVC. In alternate embodiments, occlusion device may be any suitable shape and at any suitable angle to superior vena cava SVC. Occlusion device 1212 is circumferentially connected to an interior surface of superior vena cava SVC such that occlusion device 1212 is sealed against the interior surface of superior vena cava SVC. Occlusion device 1214 is positioned inside inferior vena cava IVC, occlusion device 1214 extending radially across inferior vena cava IVC. In this embodiment, occlusion device 1214 is planar and perpendicular to inferior vena cava IVC. In alternate embodiments, occlusion device may be any suitable shape and at any suitable angle to inferior vena cava IVC. Occlusion device 1214 is circumferentially connected to an interior surface of inferior vena cava IVC such that occlusion device 1214 is sealed against the interior surface of inferior vena cava IVC. Occlusion device 1212 has hole 1216, which is an opening through occlusion device 1212. Occlusion device 1214 has hole 1218, which is an opening through occlusion device 1214. Hole 1216 axially and radially opposes hole 1218.

[0118] Vortex inducer 1200 is used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, causing a turbulent flow pattern from superior vena cava SVC and inferior vena cava IVC. Occlusion device 1212 is surgically transplanted into superior vena cava SVC, and occlusion device 1214 is surgically transplanted into inferior vena cava IVC. Occlusion devices 1212 and 1214 are fixed in place, or anchored to superior vena cava SVC and inferior vena cava IVC, at the circumferences of occlusion devices 1212 and 1214, respectively. Hole 1216 is formed in occlusion device 1212, and hole 1218 is formed in occlusion device 1214.

[0119] Flow Fl is blood flow from superior vena cava SVC, and flow F2 is blood flow from inferior vena cava IVC. As seen in FIG. 14, flow Fl is forced through hole 1216, flow Fl being otherwise blocked by occlusion device 1212. Flow Fl from superior vena cava SVC flows through hole 1216 into right atrium RA. Flow F2 is forced through hole 1218, flow F2 otherwise being blocked by occlusion device 1214. Flow F2 from inferior vena cava IVC flows out of inferior vena cava IVC through hole 1218 in a direction opposite flow Fl. Flow F2 curls around and joins with flow Fl into right atrium RA. Flow Fl and flow F2 enter right atrium RA in a vortical flow pattern. Any suitable flow pattern indicator, such as 116A or 116B described with respect to FIGS. 5A and 5B, can be used to confirm whether the positioning of vortex inducer 1200 is producing the desired vortical flow pattern.

[0120] Vortex inducer 1200 can be used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, resulting in colliding, turbulent flow that causes increased workloads on heart H, reduces efficiency of heart H, and could lead to diminished flow from heart H. Vortex inducer 1200 redirects How Fl and flow F2 to induce a vortical blood flow pattern within right atrium RA. Occlusion devices 1212 and 1214 of vortex inducer 1200 alter the inflowing streams from superior vena cava SVC and inferior vena cava IVC to right atrium RA to reestablish, or enhance, a vortical flow pattern. Holes 1216 and 1218 are on opposing sides to mimic an offset between superior vena cava SVC and inferior vena cava IVC in the area through which flow Fl and flow F2 exit superior vena cava SVC and inferior vena cava IVC, respectively. As vortex inducer 1200 improves the blood flow patterns to transform the atypical, turbulent flow into vortical flow, less effort is required to fill right ventricle RV, increasing efficiency of right ventricular performance. Blood flow momentum and kinetic energy are preserved, maintaining the output of heart H. As such, the workload on heart H is reduced, placing less stress on heart H and reducing the susceptibility of failure of heart H.

[0121] FIG. 15A is a schematic view of vortex inducer 1300 having stents 1312 and 1314 with discs 1316 and 1318 having timed apertures 1320 and 1322, respectively, showing aperture 1320 open and aperture 1322 closed. FIG. 15B is a schematic view of vortex inducer 1300 having stents 1312 and 1314 with discs 1316 and 1318 having timed apertures 1320 and 1322, showing aperture 1320 closed and aperture 1322 open. FIGS. 15A and 15B will be discussed together. Heart H is shown in cross-section, and vortex inducer 1300 is not shown in cross-section. Heart H includes superior vena cava SVC, inferior vena cava IVC, and right atrium RA. Vortex inducer 1300 includes stent 1312 and stent 1314, which include disc 1316 and disc 1318, respectively. Disc 1316 has timed aperture 1320, and disc 1318 has timed aperture 1322. FIG. 15A also shows flow Fl, and FIG. 15B shows flow F2.

[0122] Vortex inducer 1300 has stent 1312 at a first end and stent 1314 at a second end. Stent 1312 is positioned inside superior vena cava SVC, and stent 1314 is positioned inside inferior vena cava IVC. Stents 1312 and 1314 are self-expanding stents. Disc 1316 is positioned with a lumen of and circumferentially connected to an interior surface of stent 1312, disc 1316 extending radially across stent 1312. Disc 1316 is planar- and perpendicular to stent 1312. Disc 1318 is partially positioned within a lumen of and circumferentially connected to an interior surface of stent 1314, disc 1318 extending radially across stent 1314. Disc 1318 is planar- and perpendicular to stent 1314. Disc 1316 has timed aperture 1320, which is an opening through disc 1316 that is timed to open and close. Disc 1318 has timed aperture 1322, which is an opening through disc 1318 that is timed to open and close. Timed aperture 1320 axially opposes timed aperture 1322. Timed aperture 1320 is timed to alternate between a closed position and an open position with timed aperture 1322. As such, when timed aperture 1320 is open, timed aperture 1322 is closed, as shown in FIG. 15 A. When timed aperture 1322 is open, timed aperture 1320 is closed, as shown in FIG. 15B. Vortex inducer 1300 can include two separate stents 1312 and 1314, as shown in FIGS. 15A and 15B, or stents 1312 and 1314 can comprise a single stent that spans from superior vena cava SVC to inferior vena cava IVC.

[0123] Vortex inducer 1300 is used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, causing a turbulent flow pattern from superior vena cava SVC and inferior vena cava IVC. In an undeployed state, stent 1312 is positioned in superior vena cava SVC. Subsequently, stent 1312 is deployed in superior vena cava SVC by expanding stent 1312 within superior vena cava SVC, frictional engagement with the interior wall of superior vena cava SVC fixing stent 1312 in place. Once stent 1312 is deployed, the circumference of disc 1316 is sealed against the interior surface of superior vena cava SVC. In an undeployed state, stent 1314 is positioned in inferior vena cava IVC. Next, stent 1314 is deployed in inferior vena cava IVC by expanding stent 1314 within inferior vena cava IVC, frictional engagement with the interior wall of inferior vena cava IVC fixing stent 1314 in place. Once stent 1314 is deployed, the circumference of disc 1318 is scaled against the interior surface of inferior vena cava IVC.

[0124] Flow Fl is blood flow from superior vena cava SVC, and flow F2 is blood flow from inferior vena cava IVC. As seen in FIG. 15A, when timed aperture 1320 is in an open position, flow Fl in superior vena cava SVC is forced through timed aperture 1320 because disc 1316 is sealed to the interior surface of stent 1312, which is sealed against the interior surface of superior vena cava SVC. Flow Fl is then forced into right atrium RA, as disc 1318 has closed timed aperture 1322. Flow F2 in inferior vena cava IVC does not flow past disc 1318 because disc 1318 is sealed to the interior surface of stent 1314, which is sealed to the interior surface of inferior vena cava IVC, and disc 1318 has closed timed aperture 1322. As seen in FIG. 15B, when timed aperture 1322 is in an open position, flow F2 in inferior vena cava IVC is forced through timed aperture 1322 because disc 1318 is sealed to the interior surface of stent 1314, which is sealed against the interior surface of inferior vena cava IVC. Flow F2 is then forced into right atrium RA, as disc 1316 has closed timed aperture 1320. Flow Fl in superior vena cava SVC does not flow past disc 1316 because disc 1316 is sealed to the interior surface of stent 1312, which is sealed to the interior surface of superior vena cava SVC, and disc 1316 has closed timed aperture 1320. As such, flow Fl and flow F2 are forced into right atrium RA in an alternating pattern, either flow Fl entering right atrium RA from superior vena cava SVC or flow F2 entering right atrium RA from inferior vena cava IVC. Flow Fl and flow F2 mix in a vortical flow pattern such that flow Fl and flow F2 enter right atrium RA in a vortical flow pattern. Any suitable flow pattern indicator, such as 116A or 116B described with respect to FIGS. 5A and 5B, can be used to confirm whether the positioning of vortex inducer 1300 is producing the desired vortical flow pattern. In alternate examples, timed aperture 1322 remains closed such that only flow Fl enters right atrium RA, or timed aperture 1320 remains closed such that only flow F2 enters right atrium RA. In further alternate examples, either disc 1318 does not include timed aperture 1322, or disc 1316 does not include timed aperture 1320.

[0125] Vortex inducer 1300 can be used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, resulting in colliding, turbulent flow that causes increased workloads on heart H, reduces efficiency of heart H, and could lead to diminished flow from heart H. Vortex inducer 1300 redirects flow Fl and flow F2 to induce a vortical blood flow pattern within right atrium RA. Discs 1316 and 1318 of vortex inducer 1300 alter the inflowing streams from superior vena cava SVC and inferior vena cava IVC to right atrium RA to reestablish, or enhance, a vortical flow pattern. Timed apertures 1320 and 1322 in discs 1316 and 1318, respectively, alternate between which of timed apertures 1320 and 1322 is open such that blood flow does not flow through superior vena cava SVC and inferior vena cava VC and into right atrium RA at the same time. As such, flow Fl and flow F2 are prevented from colliding and causing turbulent flow. As vortex inducer 1300 improves the blood flow patterns to transform the atypical, turbulent flow into vortical How, less effort is required to fill right ventricle RV, increasing efficiency of right ventricular performance. Blood flow momentum and kinetic energy are preserved, maintaining the output of heart H. As such, the workload on heart H is reduced, placing less stress on heart H and reducing the susceptibility of failure of heart H.

[0126] FIG. 16 is a schematic view of vortex inducer 1400 having stents 1412 and 1414 with nozzles 1416 and 1418. Heart H is shown in cross-section, and vortex inducer 1400 is not shown in cross-section. Heart H includes superior vena cava SVC, inferior vena cava IVC, and right atrium RA. Vortex inducer 1400 includes stent 1412, stent 1414, nozzle 1416, and nozzle 1418. Also shown in FIG. 16 are flow Fl and flow F2.

[0127] Vortex inducer 1400 has stent 1412 at a first end and stent 1414 at a second end. Stent 1412 is positioned inside superior vena cava SVC, and stent 1414 is positioned inside inferior vena cava IVC. Stents 1412 and 1414 are self-expanding stents. Nozzle 1416 is a vortex inducing member partially positioned within a lumen of and circumferentially connected to an interior surface of stent 1412 at an upstream end of nozzle 1416. The upstream end of nozzle 1416 is within superior vena cava SVC. A downstream end of nozzle 1416 extends beyond superior vena cava SVC and is offset from superior vena cava SVC. The upstream end and the downstream end of nozzle 1416 are open to allow flow between the upstream end and the downstream end. Nozzle 1416 is angled toward right atrium RA. Nozzle 1418 is a vortex inducing member partially positioned within a lumen of and circumferentially connected to an interior surface of stent 1414 at an upstream end of nozzle 1418. The upstream end of nozzle 1418 is within inferior vena cava IVC. A downstream end of nozzle 1418 extends beyond inferior vena cava IVC and is offset from inferior vena cava IVC. The upstream end and the downstream end of nozzle 1418 are open to allow flow between the upstream end and the downstream end. Nozzle 1418 is angled toward right atrium RA. Nozzles 1416 and 1418 each decrease in diameter from an upstream end to a downstream end. Nozzles 1416 and 1418 are adjustable by adjusting, or twisting, stents 1412 and 1414, respectively, to adjust the positions of the downstream ends of nozzles 1416 and 1418, respectively, to achieve the desired flow pattern. Stents 1412 and 1414, nozzles 1416 and 1418, and/or the delivery system used to place stents 1412 and 1414 can include radiopaque markers such that the operator can orientate the nozzles 1416 and 1418 to the proper position prior to and during the delivery procedure. Alternatively, stents 1412 and 1414, nozzles 1416 and 1418, and/or the delivery system used to place stents 1412 and 1414 can include materials or material structures that are visible using echocardiography, which can be utilized prior to and during the delivery procedure to ensure proper orientation of nozzles 1416 and 1418. For example, if adjustment is needed, the delivery system, such as a catheter, can recapture and twist stent 1412 or 1414 to reorient nozzle 1416 or 1418, respectively, and redeploy stent 1412 or 1414. Nozzle 1416 axially opposes nozzle 1418. Vortex inducer 1400 can include two separate stents 1412 and 1414, as shown in FIG. 16, or stents 1412 and 1414 can comprise a single stent that spans from superior vena cava SVC to inferior vena cava IVC.

[0128] Vortex inducer 1400 is used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, causing a turbulent flow pattern from superior vena cava SVC and inferior vena cava IVC. In an undeployed state, stent 1412 is positioned in superior vena cava SVC. Stent 1412 is adjusted to position nozzle 1416 in the desired location within superior vena cava SVC. Subsequently, stent 1412 is deployed in superior vena cava SVC by expanding stent 1412 within superior vena cava SVC, frictional engagement with the interior wall of superior vena cava SVC fixing stent 1412 in place. Once stent 1412 is deployed, the circumference of the upstream end of nozzle 1416 is sealed against the interior surface of superior vena cava SVC. In an undeployed state, stent 1414 is positioned in inferior vena cava IVC. Stent 1414 is adjusted to position nozzle 1418 in the desired location within inferior vena cava IVC. Next, stent 1414 is deployed in inferior vena cava IVC by expanding stent 1414 within inferior vena cava IVC, frictional engagement with the interior wall of inferior vena cava IVC fixing stent 1414 in place. Once stent 1414 is deployed, the circumference of the upstream end of nozzle 1418 is sealed against the interior surface of inferior vena cava IVC. Flow Fl is blood flow from superior vena cava SVC, and flow F2 is blood flow from inferior vena cava IVC. Once stents 1412 and 1414 are implanted, nozzles 1416 and 1418 can be twisted to adjust the angle of nozzles 1416 and 1418, respectively, to achieve the desired offset of flow Fl and flow F2. Nozzles 1416 and 1418 are shaped to deflect flow Fl and flow F2 through nozzles, respectively, and into right atrium RA.

[0129] As seen in FIG. 16, flow Fl in superior vena cava SVC is forced into nozzle 1416 because nozzle 1416 is sealed against the interior surface of superior vena cava SVC. Flow Fl is then forced through nozzle 1416 and into right atrium RA. Flow F2 in inferior vena cava IVC is forced into nozzle 1418 because nozzle 1418 is sealed against the interior surface of inferior vena cava IVC. Flow F2 is then forced through nozzle 1418 and into right atrium RA. As such, flow Fl and flow F2 are forced into right atrium RA. Flow Fl and flow F2 enter right atrium RA in a vortical flow pattern. Any suitable flow pattern indicator, such as 116A or 116B described with respect to FIGS. 5A and 5B, can be used to confirm whether the positioning of vortex inducer 1400 is producing the desired vortical flow pattern.

[0130] Vortex inducer 1400 can be used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, resulting in colliding, turbulent flow that causes increased workloads on heart H, reduces efficiency of heart H, and could lead to diminished flow from heart H. Vortex inducer 1400 redirects flow Fl and flow F2 to induce a vortical blood flow pattern within right atrium RA. Nozzles 1416 and 1418 of vortex inducer 1400 alter the inflowing streams from superior vena cava SVC and inferior vena cava IVC to right atrium RA to reestablish, or enhance, a vortical flow pattern. Nozzles 1416 and 1418 decrease the area through which flow Fl and flow F2 exit superior vena cava SVC and inferior vena cava IVC, respectively, acting as outlets that direct flow Fl and flow F2 directly into right atrium RA. As vortex inducer 1400 improves the blood flow patterns to transform the atypical, turbulent flow into vortical flow, less effort is required to fill right ventricle RV, increasing efficiency of right ventricular performance. Blood flow momentum and kinetic energy are preserved, maintaining the output of heart H. As such, the workload on heart H is reduced, placing less stress on heart H and reducing the susceptibility of failure of heart H.

[0131] FIG. 17 is a schematic cross-sectional view of vortex inducer 1500 having stents 1512 and 1514 with threading 1516 and 1518, respectively. Heart H is shown in cross-section, and vortex inducer 1500 is not shown in cross-section. Heart H includes superior vena cava SVC, inferior vena cava IVC, and right atrium RA. Vortex inducer 1500 includes stent 1512, stent 1514, threading 1516, and threading 1518. Also shown in FIG. 17 are flow Fl and flow F2. [0132] Vortex inducer 1500 has stent 1512 at a first end and stent 1514 at a second end. Stent 1512 is positioned inside superior vena cava SVC, and stent 1514 is positioned inside inferior vena cava IVC. Stents 1512 and 1514 are self-expanding stents. Threading 1516 is a vortex inducing member at least partially positioned within a lumen of and connected to the interior surface of stent 1512. Threading 1516 extends along the interior surface of stent 1512, twisting in a helical pattern toward right atrium RA. Threading 1518 is a vortex inducing member at least partially positioned with a lumen of and connected to an interior surface of stent 1514. Threading 1518 extends along the interior surface of stent 1514, twisting in a helical pattern toward right atrium RA. As such, threading 1516 opposes threading 1518, threading 1516 and 1518 having opposite helical patterns. Threading 1516 and threading 1518 may be macro threads, or any other suitable fabric or part that forms a helical structure on the interior surfaces of stent 1512 and stent 1514, respectively. Threading 1516 and threading 1518 are anchored to stents 1512 and 1514 to reshape the interior of superior vena cava SVC and inferior vena cava IVC, respectively. Vortex inducer 1500 can include two separate stents 1512 and 1514, as shown in FIG. 17, or stents 1512 and 1514 can comprise a single stent that spans from superior vena cava SC to inferior vena cava IVC.

[0133] Vortex inducer 1500 is used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, causing a turbulent flow pattern from superior vena cava SVC and inferior vena cava IVC. In an undeployed state, stent 1512 is positioned in superior vena cava SVC. Stent 1512 is adjusted to position threading 1516 in the desired location within superior vena cava SVC. Subsequently, stent 1512 is deployed in superior vena cava SVC by expanding stent 1512 within superior vena cava SVC, frictional engagement with the interior wall of superior vena cava SVC fixing stent 1512 in place. In an undeployed state, stent 1514 is positioned in inferior vena cava IVC. Stent 1514 is adjusted to position threading 1518 in the desired location within inferior vena cava IVC, opposite threading 1516. Next, stent 1514 is deployed in inferior vena cava IVC by expanding stent 1514 within inferior vena cava IVC, frictional engagement with the interior wall of inferior vena cava IVC fixing stent 1514 in place. Flow Fl is blood flow from superior vena cava SVC, and flow F2 is blood flow from inferior vena cava IVC. Threading 1516 acts as a deflecting feature to distort flow Fl in superior vena cava SVC. Threading 1518 acts as a deflecting feature to distort flow F2 in inferior vena cava IVC. Threading 1516 and threading 1518 deflect flow into right atrium RA. As threading 1516 is positioned opposite threading 1518, flow Fl and flow F2 are deflected into helical flow in opposing directions, aiding in vortex formation. In alternate examples, threading 1516 and threading 1518 can be surgically connected to the interior surface of superior vena cava SVC and the interior surface of inferior vena cava IVC, respectively, such that vortex inducer 1500 does not include stents 1512 and 1514.

[0134] As seen in FIG. 17, flow Fl travels through superior vena cava SVC along threading 1512 and into right atrium RA. Threading 1512 forces flow Fl into a vortical flow pattern. Flow F2 travels through inferior vena cava IVC along threading 1512 and into right atrium RA. Threading 1512 forces flow F2 into a vortical flow pattern. Flow Fl and flow F2 join and enter right atrium RA in a vortical flow pattern. Any suitable flow pattern indicator, such as 116A or 116B described with respect to FIGS. 5A and 5B, can be used to confirm whether the positioning of vortex inducer 1500 is producing the desired vortical flow pattern.

[0135] Vortex inducer 1500 can be used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, resulting in colliding, turbulent flow that causes increased workloads on heart H, reduces efficiency of heart H, and could lead to diminished flow from heart H. Vortex inducer 1500 redirects flow Fl and flow F2 to induce a vortical blood flow pattern within right atrium RA. Threading 1516 and threading 1518 of vortex inducer 1500 are spirals to alter the inflowing streams from superior vena cava SVC and inferior vena cava IVC to right atrium RA to reestablish, or enhance, a vortical flow pattern. As vortex inducer 1500 improves the blood flow patterns to transform the atypical, turbulent flow into vortical flow, less effort is required to fill right ventricle RV, increasing efficiency of right ventricular performance. Blood flow momentum and kinetic energy are preserved, maintaining the output of heart H. As such, the workload on heart H is reduced, placing less stress on heart H and reducing the susceptibility of failure of heart H.

[0136] FIG. 18A is a schematic view of vortex inducer 1600, having exterior band 1612 and exterior band 1614, in an undeployed position. FIG. 18B is a schematic view of vortex inducer 1600, having exterior bands 1612 and 1614, in a deployed position. FIGS. 18A and 18B will be discussed together. Heart H is shown in cross-section, and vortex inducer 1600 is not shown in cross-section. Heart H includes superior vena cava SVC, inferior vena cava IVC, and right atrium RA. Vortex inducer 1600 includes exterior band 1612 having mechanism 1613 and exterior band 1614 having mechanism 1615. Also shown in FIG. 18A are flow Fl and flow F2. [0137] Vortex inducer 1600 comprises exterior band 1612, which has mechanism 1613 connected to exterior band 1612, and exterior band 1614, which has mechanism 1615 connected to exterior band 1614. Exterior band 1612 is positioned around an outer surface of superior vena cava SVC. Exterior band 1614 is positioned around an outer surface of inferior vena cava IVC. As such, exterior band 1612 opposes exterior band 1614. Exterior bands 1612 and 1614 are positioned such that mechanism 1613 opposes mechanism 1615. Exterior bands 1612 and 1614 are adjustable in diameter. Mechanisms 1613 and 1615 are features that decrease the diameter of exterior band 1612 and exterior band 1614, respectively. Mechanisms 1613 and 1615 may be a ratchet mechanism, making exterior bands 1612 and 1614 similar- to a cable tie, or any other suitable feature.

[0138] Vortex inducer 1600 is used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, causing a turbulent flow pattern from superior vena cava SVC and inferior vena cava IVC. Exterior bands 1612 and 1614 are positioned around the exteriors of superior vena cava SVC and inferior vena cava IVC to reshape the interior of superior vena cava SVC and inferior vena cava IVC, respectively. As seen in FIG. 18A, when vortex inducer 1600 is in an undeployed position, exterior band 1612 and exterior band 1614 are positioned loosely against exterior surfaces of superior vena cava SVC and inferior vena cava IVC, respectively. When vortex inducer 1600 is deployed, exterior band 1612 and exterior band 1614 are tightened, as seen in FIG. 18B, fixing exterior bands 1612 and 1614 in place. Mechanism 1613 is engaged to tighten exterior band 1612, and mechanism 1615 is engaged to tighten exterior band 1614. When exterior band 1612 is tightened, the portion of superior vena cava SVC within exterior band 1612 decreases in diameter, the side opposite mechanism 1613 being forced inward. When exterior band 1614 is tightened, the portion of inferior vena cava IVC within exterior band 1614 decreases in diameter, the side opposite mechanism 1615 being forced inward. Mechanisms 1613 and 1615 may also include a distribution rod, plate, or any other suitable mechanism that prevents the outer surfaces of superior vena cava SVC and inferior vena cava IVC from being deformed in the areas around mechanisms 1613 and 1615, respectively. The portion of superior vena cava SVC with a decreased diameter is offset from the portion of inferior vena cava IVC with a decreased diameter. As such, the interior geometry of superior vena cava SVC and inferior vena cava IVC is reshaped to reestablish an offset between superior vena cava SVC and inferior vena cava IVC. [0139] Flow Fl is blood flow from superior vena cava SVC, and flow F2 is blood flow from inferior vena cava IVC. As seen in FIG. 18B, flow Fl travels through the portion of superior vena cava SVC within exterior band 1612 and having a decreased diameter and into right atrium RA. Flow F2 travels through the portion of inferior vena cava IVC within exterior band 1614 and having a decreased diameter, flowing out of inferior vena cava IVC in a direction opposite flow Fl. Flow F2 curls around and joins with flow Fl into right atrium RA. Exterior bands 1612 and 1614 distort flow Fl and flow F2 such that flow Fl and flow F2 enter right atrium RA in a vortical flow pattern. Any suitable flow pattern indicator, such as 116A or 116B described with respect to FIGS. 5A and 5B, can be used to confirm whether the positioning of vortex inducer 1600 is producing the desired vortical flow pattern.

[0140] Vortex inducer 1600 can be used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, resulting in colliding, turbulent flow that causes increased workloads on heart H, reduces efficiency of heart H, and could lead to diminished flow from heart H. Vortex inducer 1600 redirects flow Fl and flow F2 to induce a vortical blood flow pattern within right atrium RA. Exterior bands 1612 and 1614 of vortex inducer 1600 alter the inflowing streams from superior vena cava SVC and inferior vena cava IVC to right atrium RA to reestablish, or enhance, a vortical flow pattern. Exterior bands 1612 and 1614 decrease the area through which flow Fl and flow F2 exit superior vena cava SVC and inferior vena cava IVC from the exterior, simplifying the deployment procedure. Further, the areas through which flow Fl and flow F2 exit superior vena cava SVC and inferior vena cava IVC are on opposing sides to form an offset between superior vena cava SVC and inferior vena cava IVC in the area through which flow F 1 and flow F2 exit superior vena cava SVC and inferior vena cava IVC, respectively. As vortex inducer 1600 improves the blood flow patterns to transform the atypical, turbulent flow into vortical flow, less effort is required to fill right ventricle RV, increasing efficiency of right ventricular performance. Blood flow momentum and kinetic energy are preserved, maintaining the output of heart H. As such, the workload on heart H is reduced, placing less stress on heart H and reducing the susceptibility of failure of hear t H.

[0141] FIG. 19A is a schematic view of vortex inducer 1700, having large-celled stent 1712, in an undeployed position. FIG. 20B is a schematic view of vortex inducer 1700, having large-celled stent 1712, in a deployed position. FIGS. 19A and 19B will be discussed together. Heart H is shown in cross-section, and vortex inducer 1700 is not shown in cross-section. Heart H includes superior vena cava SVC, inferior vena cava IVC, and right atrium RA. Vortex inducer 1700 includes large-celled stent 1712. Also shown in FIG. 19B arc flow Fl and flow F2.

[0142] Vortex inducer 1700 has stent 1712 positioned inside inferior vena cava IVC. Stent 1712 is a large-celled stent. Large-celled stent 1712 can have varied size cells and/or cell arrangements that cause stent 1712 to expand in a non-uniform way. Large-celled stent 1712 is adjustable to achieve a desired geometry of inferior vena cava IVC. Vortex inducer 1700 can comprise single stent 1712, as shown in FIG. 19A, positioned in inferior vena cava IVC or superior vena cava SVC. Alternatively, vortex inducer 1700 can comprise a single stent that spans from superior vena cava SVC to inferior vena cava IVC and includes varied cell shapes and/or arrangements adjacent superior vena cava SVC and/or inferior vena cava IVC. Alternatively, vortex inducer 1700 can comprise two stents, a first stent being positioned in inferior vena cava IVC and a second stent being positioned in superior vena cava SVC.

[0143] Vortex inducer 1700 is used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, causing a turbulent flow pattern from superior vena cava SVC and inferior vena cava IVC. Stent 1712 is positioned within inferior vena cava IVC to reshape the geometry of inferior vena cava IVC. In an undeployed state, stent 1712 is positioned in inferior vena cava IVC, as seen in FIG. 19A. Stent 1712 could also be positioned in superior vena cava SVC. When vortex inducer 1700 is in an undeployed position, stent 1712 is positioned loosely against the interior surface of inferior vena cava IVC. When vortex inducer 1700 is deployed, stent 1712 is deployed in inferior vena cava IVC by expanding stent 1712 within inferior vena cava IVC, as seen in FIG. 19B. When stent 1712 is deployed, frictional engagement with the interior wall of inferior vena cava IVC fixes stent 1712 in place. As stent 1712 is deployed, stent 1712 becomes non-uniform and pushes out against interior surface of inferior vena cava IVC, changing the geometry of inferior vena cava IVC. As such, when stent 1712 is expanded, the portion of inferior vena cava IVC that contains stent 1712 changes shape. For example, inferior vena cava IVC may increase in diameter as stent 1712 pushes against the interior surface of inferior vena cava IVC. As seen in FIG. 19B, deployed stent 1712 changes the geometry of inferior vena cava IVC such that inferior vena cava IVC is no longer in alignment with superior vena cava SVC. The portion of inferior vena cava IVC that has changed geometry (e.g. increased in diameter) is offset from superior vena cava SVC. Stent 1712 is expanded based on blood flow characteristics within superior vena cava SVC and inferior vena cava IVC. Expanded stent 1712 is locked in place. The geometry of inferior vena cava IVC is reshaped to reestablish an offset between superior vena cava SVC and inferior vena cava IVC.

[0144] Flow Fl is blood flow from superior vena cava SVC, and flow F2 is blood flow from inferior vena cava IVC. As seen in FIG. 19B, flow Fl from superior vena cava SVC flows into right atrium RA. Flow F2 from inferior vena cava IVC flows out of inferior vena cava IVC in a direction opposite flow Fl. Flow F2 curls around and joins with flow Fl into right atrium RA. Flow Fl and F2 enter right atrium RA in a vortical flow pattern. Stent 1712 changes the geometry of inferior vena cava IVC to distort flow F2 based on the blood flow characteristics to achieve the desired vortical flow pattern. Any suitable flow pattern indicator, such as 116A or 116B described with respect to FIGS. 5 A and 5B, can be used to confirm whether the positioning of vortex inducer 1700 is producing the desired vortical flow pattern.

[0145] Vortex inducer 1700 can be used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, resulting in colliding, turbulent flow that causes increased workloads on heart H, reduces efficiency of heart H, and could lead to diminished flow from heart H. Vortex inducer 1700 redirects flow F2 to induce a vortical blood flow pattern within right atrium RA. Large-celled stent 1712 alters the inflowing stream from inferior vena cava IVC to right atrium RA to reestablish a vortical flow pattern. Large-celled stent 1712 changes the geometry of inferior vena cava IVC to mimic an offset between superior vena cava SVC and inferior vena cava IVC in the area through which flow Fl and flow F2 exit superior vena cava SVC and inferior vena cava IVC, respectively. As vortex inducer 1700 improves the blood flow patterns to transform the atypical, turbulent flow into vortical flow, less effort is required to fill right ventricle RV, increasing efficiency of right ventricular performance. Blood flow momentum and kinetic energy are preserved, maintaining the output of heart H. As such, the workload on heart H is reduced, placing less stress on heart H and reducing the susceptibility of failure of heart H.

[0146] FIG. 20A is a schematic view of vortex inducer 1800, having stent 1812 with adjustable deflectorl814, in an undeployed position. FIG. 20B is a schematic view of vortex inducer 1800, having stent 1812 with adjustable deflector 1814, in a deployed position. FIGS. 20A and 20B will be discussed together. Heart H is shown in cross-section and vortex inducer 1800 is not shown in cross-section. Heart H includes superior vena cava SVC, inferior vena cava IVC, and right atrium RA. Vortex inducer 1800 includes stent 1812 and adjustable deflector 1814. Also shown in FIG. 9B arc flow Fl and flow F2.

[0147] Vortex inducer 1800 has stent 1812 positioned inside inferior vena cava IVC. Stent 1812 is a large-celled stent. Large-celled stent 1812 can have varied size cells and/or cell arrangements that cause stent 1812 to expand in a non-uniform way. Adjustable deflector 1814 is a vortex inducing member at least partially positioned within a lumen of and connected to an interior surface of stent 1812, below right atrium RA. Adjustable deflector 1814 can be connected to interior surface of stent 1812, respectively, via a hinge having a joint. Alternatively, adjustable deflector 1814 can be connected to the interior surface of stent 1812 via suture(s) that form a pivoting joint. Adjustable deflector 1814 is a tunable lever that can be adjusted to reshape the interior of inferior vena cava IVC, respectively. Adjustable deflector 1814 may be contoured to deflect fluid. Adjustable deflector 1814 extends from the interior surface of stent 1812. Adjustable deflector 1814 is adjustable at the connection points between adjustable deflector 1814 and stent 1812. Adjustable deflector 1814 will generally deflect in the direction of fluid flow. Adjustable deflector 1814 may be nitinol-based such that adjustable deflector 1814 is adjustable, or deflectable, depending on flow velocity through stent 1812. For example, adjustable deflector 1814 may deflect more with a higher blood flow rate through stent 1812. Vortex inducer 1800 can comprise single stent 1812 with a single adjustable deflector 1814, as shown in FIG. 20A, positioned in inferior vena cava IVC or superior vena cava SVC. Alternatively, vortex inducer 1800 can comprise a single stent that spans from superior vena cava SVC to inferior vena cava IVC and includes a first adjustable deflector adjacent superior vena cava SVC and a second adjustable deflector adjacent inferior vena cava IVC. Alternatively, vortex inducer 1800 can comprise two stents that each have an adjustable deflector, a first stent being positioned in inferior vena cava IVC and a second stent being positioned in superior vena cava SVC.

[0148] Vortex inducer 1800 is used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, causing a turbulent flow pattern from superior vena cava SVC and inferior vena cava IVC. In an undeployed state, stent 1812 is positioned in inferior vena cava IVC, as shown in FIG. 20A. Stent 1812 could also be positioned in superior vena cava SVC. Stent 1812 is adjusted to position adjustable deflector 1814 in the desired location within inferior vena cava IVC. Subsequently, stent 1812 is deployed in inferior vena cava IVC by expanding stent 1812 within inferior vena cava IVC. When stent 1812 is deployed, frictional engagement with the interior wall of inferior vena cava IVC fixes stent 1812 in place. As stent 1812 is deployed, stent 1812 becomes non-uniform and pushes out against interior surface of inferior vena cava IVC, changing the geometry of inferior vena cava IVC. As such, when stent 1812 is expanded, the portion of inferior vena cava IVC that contains stent 1812 changes shape. For example, inferior vena cava IVC may increase in diameter as stent 1812 pushes against the interior surface of inferior vena cava IVC. As seen in FIG. 20B, deployed stent 1812 changes the geometry of inferior vena cava IVC such that inferior vena cava IVC is no longer in alignment with superior vena cava SVC. The portion of inferior vena cava IVC that has changed geometry (e.g. increased in diameter) is offset from the superior vena cava SVC. Stent 1812 is expanded based on blood flow characteristics within superior vena cava SVC and inferior vena cava IVC. The geometry of inferior vena cava IVC is reshaped to reestablish an offset between superior vena cava SVC and inferior vena cava IVC.

[0149] As seen in FIG. 20A, when vortex inducer 1800 is in an undeployed position, adjustable deflector 1814 is positioned as close to stent 1812 as possible. Adjustable deflector 1814 can be adjusted up to 180 degrees. Flow Fl is blood flow from superior vena cava SVC, and flow F2 is blood flow from inferior vena cava IVC. Adjustable deflector 1814 is adjustable to adjust, or distort, flow F2 in inferior vena cava IVC, aiding in vortex formation. Adjustable deflector 1814 is tuned based on blood flow characteristics within superior vena cava SVC and inferior vena cava IVC to achieve the desired vortical flow pattern.

[0150] Once adjustable deflector 1814 has been adjusted to an optimal position, adjustable deflector 1814 is locked in place. For example, adjustable deflector 1814 may be tethered to one or more sutures that act as pull wire(s). By pulling the tension on the pull wire(s) during the implant procedure, the deflection of adjustable deflector 1814 is adjusted. The pull wire(s) can be locked, or set in position, with a cinch-type mechanism. Alternatively, adjustable deflector 1814 may be locked in place via a travel-limit mechanical tab once adjustable deflector 1814 has deflected to the maximum amount due to flow pressure. In some embodiments, adjustable deflector 1814 could also be a deflector that spans the entirety of inferior vena cava IVC, when in a deployed position. When adjustable deflector 1814 is shaped to span the entirety of inferior vena cava IVC adjustable deflector 1814 can be shaped to occlude the entirety of inferior vena cava IVC to impede some or all flow through interior vena cava IVC, respectively. [0151] Adjustable deflector 1814 is adjusted away from stent 1812 when deploying vortex inducer 1800. Adjustable deflector 1814 is adjusted about 90 degrees from stent 1812. As seen in FIG. 20B, flow Fl from superior vena cava SVC flows into right atrium RA. Flow F2 from inferior vena cava IVC flows out of inferior vena cava IVC in a direction opposite flow Fl. Flow F2 curls around and joins with flow Fl into right atrium RA. Flow Fl and F2 enter right atrium RA in a vortical flow pattern. Adjustable deflector 1814 is adjusted based on the blood flow characteristics to achieve the desired direction of flow to yield a vortical flow pattern. Any suitable flow pattern indicator, such as 116A or 116B described with respect to FIGS. 5A and 5B, can be used to confirm whether the positioning of vortex inducer 1800 is producing the desired vortical flow pattern.

[0152] Vortex inducer 1800 can be used when superior vena cava SVC and inferior vena cava IVC have shifted into alignment or into a reduced offset, resulting in colliding, turbulent flow that causes increased workloads on heart H, reduces efficiency of heart H, and could lead to diminished flow from heart H. Vortex inducer 1800 redirects flow F2 to induce a vortical blood flow pattern within right atrium RA. Large-celled stent 1812 and adjustable deflector 1814 of vortex inducer 1800 alter the inflowing stream from inferior vena cava IVC to right atrium RA to reestablish a vortical flow pattern. Large-celled stent 1812 changes the geometry of inferior vena cava IVC and adjustable deflector impedes flow through inferior vena cava IVC to mimic an offset between superior vena cava SVC and inferior vena cava IVC in the area through which flow Fl and F2 exit superior vena cava SVC and inferior vena cava IVC, respectively. Because adjustable deflector 1814 is adjustable, optimal positioning can be achieved to yield optimal flow F2 from inferior vena cava IVC. As vortex inducer 1800 improves the blood flow patterns to transform the atypical, turbulent flow into vortical flow, less effort is required to fill right ventricle RV, increasing efficiency of right ventricular’ performance. Blood flow momentum and kinetic energy are preserved, maintaining the output of heart H. As such, the workload on heart H is reduced, placing less stress on heart H and reducing the susceptibility of failure of heart H.

[0153] Vortex inducers 10, 200, 300, 400, 500, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, and/or 1800 are shaped for redirecting the flow of blood into the right atrium, thereby enhancing the vortical blood flow pattern within the right atrium and reducing stress on the heart H. All vortex inducers 10, 200, 300, 400, 500, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, and 1800 are implantable devices that are collapsible for delivery to a treatment site via a catheterization technique. A delivery catheter can be used to advance the implantable device to heart H. Further, vortex inducers 10, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, and 1800 can include any other suitable components, such as a pump, and can be used with any suitable type of anchor member(s) or mechanism(s) sized for placement adjacent a blood vessel entering the right atrium (they do not need to be mounted to a stent). For example, the anchor member may be sized for placement in a superior vena cava, an inferior vena cava, or a coronary sinus. Additionally, the anchor member may have a length sized to extend between an inferior vena cava and a superior vena cava. While vortex inducers 10, 200, 300, 400, 500, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, 1500, and 1600 have been described with respect to superior vena cava SVC and inferior vena cava IVC, vortex inducers 10, 200, 300, 400, 500, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, and 1800 can be positioned in only superior vena cava SVC or only inferior vena cava IVC. Further, vortex inducers 10, 200, 300, 400, 500, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, and 1800 can be positioned in coronary sinus CS. A decision regarding which of vortex inducers 10, 200, 300, 400, 500, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, and 1800 should be used can be made using 4-D MRI to establish how the blood is flowing within right atrium RA, which will enable determination of how the blood flow should be altered. Any suitable flow pattern indicator, such as 116A or 116B described with respect to FIGS. 5A and 5B, can be used to confirm whether the positioning of vortex inducer 10, 200, 300, 400, 500, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, or 1800 is producing the desired vortical flow pattern. If the desired vortical flow pattern has not been achieved, vortex inducers 10, 200, 300, 400, 500, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, and 1800 can be adjusted.

[0154] In another embodiment, a vortex can be induced or enhanced by increasing the flow of blood through the coronary sinus. As noted above, blood enters the right atrium from the coronary sinus. The blood flowing through coronary sinus has a generally helical flow pattern and joins with blood flow entering the right atrium from the inferior vena cava. This combination leads to the right-sided flow vortex in the right atrium. It has been found that the vortex can be enhanced by increasing the volume of blood entering the right atrium from the coronary sinus. This can be achieved by connecting the coronary sinus to higher pressure blood vessels or heart chambers such that more blood passes through the coronary sinus. For example, a shunt, conduit, or other passageway may be provided for allowing blood to enter the coronary sinus from another blood vessel, such as the pulmonary artery, right ventricle, left ventricle, aorta, pulmonary vein, or local branches of the aorta. Furthermore, as noted above, the flow rate through the coronary sinus may be increased using a pump or impeller to raise blood flow above the baseline level.

[0155] Any of the various systems, devices, apparatuses, etc. in this disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise sterilization of the associated system, device, apparatus, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.). [0156] The treatment techniques, methods, steps, etc. described or suggested herein or in references incorporated herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (e.g., with the body parts, tissue, etc. being simulated), etc.

[0157] DISCUSSION OF DETAILED EMBODIMENTS

[0158] The following are non-exclusive descriptions of possible embodiments of the present invention.

[0159] A vortex inducer for inducing a vortical blood flow pattern within a right atrium includes a vortex inducing member, which may be connected to a stent, that is configured to induce the vortical blood flow pattern within the right atrium. The vortex inducer can optionally include, additionally and/or alternatively, one or more additional features, configurations and/or additional components. For example, the vortex inducing member can be a deflector, a protruding element, a pointed protruding element, an adjustable deflector, an inflatable protruding element, a compartment, which may have a hole and an open upstream end, a twistable nozzle, and a threading. The vortex inducing member can be connected to an interior surface of the stent. The vortex inducing member can deflect blood flow through a superior vena cava or an inferior vena cava to induce the vortical blood flow pattern. A self-expanding or balloon-expandable stent may be included. A second stent with a second vortex inducing member connected to the second stent may be included. A flow pattern indicator, which may include flagella, may be connected to the stent. The flow pattern indicator may further comprises heads, each head being attached to a flagellum of the flagella. The vortex inducer may be sterilized.

[0160] A vortex inducer for inducing a vortical blood flow pattern within a right atrium includes a first stent, a second stent, and a pivot member connected to the first stent and the second stent. The vortex inducer is configured to induce the vortical blood flow pattern within the right atrium. The vortex inducer can optionally include, additionally and/or alternatively, one or more additional features, configurations and/or additional components. For example, the pivot member may be a two-piece pivot member that may include a straight member connected to the first stent, a curved member connected to the second stent, and a pivot connector between the straight member and the curved member. The curved member may be rotatable at the pivot connector to establish an offset between a superior vena cava and an inferior vena cava. A two-piece pivot connector may be rotatable to establish an offset between a superior vena cava and an inferior vena cava. A first spiked connector configured to connect the two-piece pivot member to the first stent and a second spiked connector configured to connect the two-piece pivot member to the second stent may be included. A flow pattern indicator may be connected to the first stent and/or the second stent.

[0161] A vortex inducer for inducing a vortical blood flow pattern within a right atrium includes a first inflatable tube; and a first inflatable protruding element connected to an interior surface of the first inflatable tube; wherein the first inflatable protruding element is configured to deflect blood flow through a superior vena cava or an inferior vena cava to induce a vortical flow pattern. The vortex inducer can optionally include, additionally and/or alternatively, one or more additional features, configurations and/or additional components. For example, a second inflatable tube and a second inflatable protruding element connected to an interior surface of the second inflatable tube can be included. The second inflatable protruding element is configured to deflect blood flow to induce the vortical flow pattern.

[0162] A vortex inducer for inducing a vortical blood flow pattern within a right atrium includes a body; and a first electric ion flow motor housed in the body; wherein the device is configured to induce an ionic gradient adjacent a superior vena cava or an inferior vena cava to induce a vortical flow pattern. The vortex inducer can optionally include, additionally and/or alternatively, one or more additional features, configurations and/or additional components. For example, the body may have a serpentine shape.

[0163] A method for inducing a vortical blood flow pattern within a right atrium includes positioning a vortex inducer into a superior vena cava and/or an inferior vena cava and deploying the vortex inducer. The method can optionally include, additionally and/or alternatively, one or more additional features, configurations and/or additional components. For example, the method may include establishing an offset between the superior vena cava and the inferior vena cava when the vortex inducer is deployed. The method may include deflecting flow to mimic an offset between the superior vena cava and the inferior vena cava. The method may include establishing a vortical flow pattern in the right atrium.

[0164] While the invention has been described with reference to an exemplary embodiment(s), it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope thereof. Therefore, it is intended that the invention not be limited to the particular embodiment(s) disclosed, but that the invention will include all examples falling within the scope of the appended claims.

Claims

CLAIMS:

1. An implantable device for inducing a vortical blood flow pattern within a right atrium, comprising: a stent sized for placement in an inferior or superior vena cava; and a vortex inducing member coupled to the stent, wherein the vortex inducing member is shaped for enhancing the vortical blood flow pattern within the right atrium.

2. The implantable device of claim 1, wherein the vortex inducing member is positioned within a lumen of the stent.

3. The implantable device of claim 2, wherein the vortex inducing member is connected to an interior surface of the stent.

4. The implantable device of claim 1, wherein the vortex inducing member is a deflector.

5. The implantable device of claim 1, wherein the vortex inducing member is adjustable.

6. The implantable device of claim 1, wherein the vortex inducing member is a protruding element.

7. The implantable device of claim 1, wherein the vortex inducing member is inflatable.

8. The implantable device of claim 1, wherein the vortex inducing member is a nozzle.

9. The implantable device of claim 8, wherein the nozzle is twistable.

10. The implantable device of claim 1 , wherein the vortex inducing member is a threading.

11. The implantable device of claim 1, wherein the stent is self-expandable.

12. The implantable device of claim 1, wherein the stent is balloon expandable.

13. The implantable device of claim 1, further comprising a flow pattern indicator connected to the stent.

14. The implantable device of claim 13, wherein the flow pattern indicator comprises flagella.

15. The implantable device of claim 14, wherein the implantable device is collapsible for delivery to a treatment site via a catheterization technique.

16. A vortex inducer for inducing a vortical blood flow pattern within a right atrium, the vortex inducer comprising: a first stent sized for placement in an inferior vena cava; a second stent sized for placement in a superior vena cava; and a pivot member connected to the first stent and the second stent and shaped for inducing the vortical blood flow pattern within the right atrium.

17. A vortex inducer for inducing a vortical blood flow pattern within a right atrium, the vortex inducer comprising: a first stent; a second stent; and a two-piece pivot member connected to the first stent and the second stent, the two-piece pivot member comprising: a straight member connected to the first stent; a curved member connected to the second stent; and a pivot connector between the straight member and the curved member; wherein the curved member is rotatable at the pivot connector to establish an offset between a superior vena cava and an inferior vena cava.

18. A vortex inducer for inducing a vortical blood flow pattern within a right atrium, the vortex inducer comprising: a first stent; a second stent; and a curved threaded rod connected to the first stent and the second stent; wherein the threaded rod is twistable to establish an offset between a superior vena cava and an inferior vena cava.

19. A vortex inducer for inducing a vortical blood flow pattern within a right atrium, the vortex inducer comprising: a first inflatable tube; and a first inflatable protruding element connected to an interior surface of the first inflatable tube; wherein the first inflatable protruding element is configured to deflect blood flow through a superior vena cava or an inferior vena cava to induce a vortical flow pattern.

20. The vortex inducer of claim 19, further comprising: a second inflatable tube; and a second inflatable protruding element connected to an interior surface of the second inflatable tube; wherein the second inflatable protruding element is configured to deflect blood flow to induce the vortical flow pattern.

21. A vortex inducer for inducing a vortical blood flow pattern within a right atrium, the vortex inducer comprising: a body; and an electric ion flow motor housed in the body; wherein the device is configured to induce an ionic gradient adjacent a superior vena cava or an inferior vena cava to induce a vortical flow pattern.

22. The vortex inducer of claim 21, wherein the body has a serpentine shape.

23. A vortex inducer for inducing a vortical blood flow pattern within a right atrium, the vortex inducer comprising: a stent; and a compartment circumferentially connected to an interior surface of the stent at an open upstream end of the compartment, the compartment having a hole; wherein the compartment is configured to deflect blood flow through a superior vena cava or an inferior vena cava into the right atrium to induce a vortical flow pattern.

24. A vortex inducer for inducing a vortical blood flow pattern within a right atrium, the vortex inducer comprising: a body having a hole; and an inflatable balloon positioned around the body; wherein the body is configured to seal against the inflatable balloon to deflect blood flow through a superior vena cava or an inferior vena cava to induce a vortical flow pattern.

25. A vortex inducer for inducing a vortical blood flow pattern within a right atrium, the vortex inducer comprising: an occlusion device; and a hole within the occlusion device; wherein the occlusion device is circumferentially connectable to an interior surface of a superior vena cava or an inferior vena cava to induce a vortical flow pattern.

26. A vortex inducer for inducing a vortical blood flow pattern within a right atrium, the vortex inducer comprising: a first stent; a second stent; a first disc circumferentially connected to an interior surface of the first stent and having a first timed aperture; and a second disc circumferentially connected to an interior surface of the second stent and having a second timed aperture; wherein the first timed aperture and the second timed aperture are timed to open and close to induce blood flow through a superior vena cava or an inferior vena cava into a vortical flow pattern.

27. A vortex inducer for inducing a vortical blood flow pattern within a right atrium, the vortex inducer comprising: a first band positionable around a superior vena cava; and a second band positionable around an inferior vena cava; wherein the first band and the second band are adjustable in diameter to establish an offset between the superior vena cava and the inferior vena cava.

28. An implantable device for inducing a vortical blood flow pattern within the right atrium, the implantable device comprising: an anchor member sized for placement within a blood vessel entering the right atrium; and a vortex inducing member coupled to the anchor member; wherein the vortex inducing member is shaped for redirecting the flow of blood into the right atrium, thereby enhancing the vortical blood flow pattern within the right atrium.

29. The implantable device of claim 28, wherein the anchor member is a stent.

30. The implantable device of claim 29, wherein the stent is self-expandable.

30. The implantable device of claim 29, wherein the stent is balloon expandable.

31. The implantable device of claim 28, wherein the vortex inducing member includes a deflector for redirecting the flow of blood.

32. The implantable device of claim 31, wherein the deflector is adjustable.

33. The implantable device of claim 28, wherein the vortex inducing member includes a nozzle.

34. The implantable device of claim 28, wherein the vortex inducing member includes a pump.

35. The implantable device of claim 28, wherein the anchor member is sized for placement in a superior vena cava.

36. The implantable device of claim 28, wherein the anchor member is sized for placement in an inferior vena cava.

37. The implantable device of claim 28, wherein the anchor member is sized for placement in a coronary sinus.

38. The implantable device of claim 28, wherein the anchor member has a length sized to extend between between an inferior vena cava and a superior vena cava.

39. The implantable device of claim 28, further comprising a second anchor member.

40. A system for improving the efficiency of a heart, comprising the implantable device of claim 28 and further comprising a delivery catheter for advancing the implantable device to the heart.

41. A method for inducing a vortical blood flow pattern within a right atrium, the method comprising: advancing a vortex inducer into a superior vena cava and/or an inferior vena cava; and deploying the vortex inducer for altering a flow of blood into the right atrium for inducing a vortical flow pattern.

42. A method for inducing a vortical blood flow pattern within a right atrium, the method comprising forming a conduit between a high-pressure blood vessel and a coronary sinus, wherein blood enters the coronary sinus from the high-pressure blood vessel for increasing the volume of blood flowing through the coronary sinus and into the right atrium, thereby inducing vortical blood flow.

43. A method for inducing a vortical blood flow pattern within a right atrium, the method comprising forming a conduit between a heart chamber and a coronary sinus, wherein blood enters the coronary sinus from the heart chamber for increasing the volume of blood flowing through the coronary sinus and into the right atrium, thereby inducing vortical blood flow.