Cardiovascular implant device for guiding flow

Abstract

A cardiovascular implant device includes an annular body, one or more anchoring members, and a diversion assembly. The annular body includes a central flow tube extending from an inflow end to an outflow end and a flow path extending through the central flow tube. The one or more anchoring members extend outwardly from the annular body and are configured to secure the cardiovascular implant device to a tissue wall. The diversion assembly is positioned to align blood flow out of the cardiovascular implant device with a natural flow pattern of blood in the right atrium such that the blood flow out of the cardiovascular implant device is combined with the natural flow pattern of blood in the right atrium.

Description

[0001] Cross-reference to related applications This application claims the benefit of U.S. Provisional Application No. 63 / 387,917, filed December 16, 2022, and entitled “CARDIOVASCULAR IMPLANT DEVICES FOR DIRECTING FLOW,” the disclosure of which is hereby incorporated by reference in its entirety. Background Art

[0002] The present disclosure relates to cardiovascular implant devices, and more particularly to cardiovascular implant devices for directing flow.

[0003] Cardiovascular implant devices can be positioned in natural flow paths within the cardiovascular system or can be used to create artificial flow paths. For example, a shunt device can be positioned in the heart to divert blood between the left and right atria to reduce pressure in the left atrium. The left atrium may experience elevated pressure due to abnormal heart conditions caused by age and / or disease. For example, a shunt device can be used to treat patients with heart failure (also known as congestive heart failure). A shunt device can be positioned in the inter-atrial septal wall between the left and right atria to divert blood from the left atrium to the right atrium, thereby reducing pressure in the left atrium. Summary of the Invention

[0004] In one embodiment, a cardiovascular implant device includes an annular body, one or more anchoring members, and a flow guide assembly. The annular body includes a central flow tube extending from an inflow end to an outflow end, and a flow path extending through the central flow tube. The one or more anchoring members extend outward from the annular body and are configured to secure the cardiovascular implant device to a tissue wall. The flow guide assembly is positioned to align blood flow out of the cardiovascular implant device with a natural blood flow pattern in the right atrium, such that blood flow out of the cardiovascular implant device merges with the natural blood flow pattern in the right atrium.

[0005] In another example, a cardiovascular implant device includes an annular body and one or more anchoring members. The annular body includes a central flow tube extending from an inflow end to an outflow end and a flow path extending through the central flow tube. The one or more anchoring members extend outward from the annular body and are configured to secure the cardiovascular implant device to a tissue wall. The central flow tube includes a curved portion adjacent to the outflow end, the curved portion being curved to align blood flow out of the cardiovascular implant device with a natural blood flow pattern in the right atrium, thereby combining blood flow out of the cardiovascular implant device with the natural blood flow pattern in the right atrium.

[0006] In another example, a cardiovascular implant device includes an annular body, one or more anchoring members, and a fin. The annular body includes a central flow tube extending from an inflow end to an outflow end and a flow path extending through the central flow tube. The one or more anchoring members extend outward from the annular body and are configured to secure the cardiovascular implant device to a tissue wall. The fin is connected to the annular body at the outflow end of the central flow tube. The fin is tilted to align blood flow out of the cardiovascular implant device with the natural blood flow pattern in the right atrium, so that blood flow out of the cardiovascular implant device merges with the natural blood flow pattern in the right atrium.

[0007] In another example, a cardiovascular implant device is configured to be attached adjacent to an opening in a tissue wall between the right atrium and the left atrium of a heart. The cardiovascular implant device includes an anchoring member configured to secure the cardiovascular implant device to the tissue wall, a flexible joint connected to the anchoring member, and a tab connected to the flexible joint. The tab is tilted to align blood flow out of the opening with the natural flow pattern of blood in the right atrium, such that blood flow out of the perforation merges with the natural flow pattern of blood in the right atrium.

[0008] In another example, a cardiovascular implant device includes an annular body and one or more anchoring members. The annular body includes: a central flow tube extending from an inflow end to an outflow end, the central flow tube including a guide wall connected to a radially inner surface of the central flow tube; and a flow path extending through the central flow tube and defined by the guide wall. The one or more anchoring members extend outward from the annular body and are configured to secure the cardiovascular implant device to a tissue wall. The guide wall is positioned to direct blood flow through the central flow tube of the cardiovascular implant device such that blood flow out of the cardiovascular implant device aligns with and integrates with the natural flow pattern of blood in the right atrium.

[0009] In another example, a cardiovascular implant device includes an annular body and one or more anchoring members. The annular body includes a central flow tube extending from an inflow end to an outflow end and a flow path extending through the central flow tube. The one or more anchoring members extend outward from the annular body and are configured to secure the cardiovascular implant device to a tissue wall. The cardiovascular implant device further includes a shaft extending longitudinally through the central flow tube and a set of blades extending radially around the shaft. The blades are positioned to direct blood flow through the central flow tube of the cardiovascular implant device so that blood flow out of the cardiovascular implant device is aligned with and integrated with the natural flow pattern of blood in the right atrium.

[0010] In another example, a cardiovascular implant device includes an annular body and one or more anchoring members. The annular body includes a central flow tube extending from an inflow end to an outflow end and a flow path extending through the central flow tube. The one or more anchoring members extend outward from the annular body and are configured to secure the cardiovascular implant device to a tissue wall. The central flow tube includes an adjustable portion adjacent to the outflow end. The adjustable portion is adjustable between one or more expanded configurations and compressed configurations and is adjustable to align blood flow out of the cardiovascular implant device with a natural blood flow pattern in the right atrium, such that blood flow out of the cardiovascular implant device combines with the natural blood flow pattern in the right atrium.

[0011] In another example, a cardiovascular implant device includes an annular body and one or more anchoring members. The annular body includes a central flow tube extending from an inflow end to an outflow end and a flow path extending through the central flow tube. The one or more anchoring members extend outward from the annular body and are configured to secure the cardiovascular implant device to a tissue wall. The central flow tube is configured to be tilted relative to the tissue wall. The central flow tube is tilted to align blood flow out of the cardiovascular implant device with a natural blood flow pattern in the right atrium, such that blood flow out of the cardiovascular implant device merges with the natural blood flow pattern in the right atrium. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Anatomy of the heart H and vasculature V Figure 1 is a diagram of the heart and vascular system.

[0013] Figure 2 is a schematic cross-sectional view of the heart.

[0014] Heart H flow pattern Figure 3A is a first schematic diagram illustrating modeled hemodynamic flow patterns in the heart.

[0015] Figure 3B is a second schematic diagram illustrating modeled hemodynamic flow patterns in the heart.

[0016] Figure 4A is a first schematic diagram illustrating modeled hemodynamic flow patterns in a heart with a septal shunt device.

[0017] Figure 4B is a second schematic diagram illustrating modeled hemodynamic flow patterns in a heart with a septal shunt device.

[0018] Devices 100 and 100A Figure 5 is a schematic cross-sectional view of a heart showing a first example of a cardiovascular implant device positioned in the atrial septum and including a curved portion.

[0019] Figure 6 is a schematic cross-sectional view of the atrial septum illustrating a second example of a cardiovascular implant device positioned in the atrial septum and including an internal curvature.

[0020] Device 200 Figure 7 is a schematic cross-sectional view of a heart showing a third example of a cardiovascular implant device positioned in the atrial septum and comprising a flap.

[0021] Device 300 Figure 8A is a schematic cross-sectional illustration of a heart showing a fourth example of a cardiovascular implant device positioned adjacent to a shunt in the atrial septum.

[0022] Figure 8B is an enlarged side view of a fourth example of a cardiovascular implant device.

[0023] Device 400 Figure 9 is a schematic cross-sectional illustration of a heart showing a fifth example of a cardiovascular implant device including an inner guide wall positioned in the atrial septum.

[0024] Device 500 Figure 10A is a schematic cross-sectional illustration of a heart showing a sixth example of a cardiovascular implant device positioned in the atrial septum and comprising internal leaflets.

[0025] Figure 10B is an enlarged schematic cross-sectional view of the atrial septum showing details of a sixth example of a cardiovascular implant device.

[0026] Devices 600 and 600A Figure 11 is a schematic cross-sectional illustration of a heart showing a seventh example of a cardiovascular implant device positioned in the atrial septum and including an adjustable portion.

[0027] Figure 12A is an enlarged schematic diagram of the adjustable portion of FIG. 10 in a compressed configuration.

[0028] Figure 12B is an enlarged schematic diagram of the adjustable portion of FIG. 10 in an expanded configuration.

[0029] Figure 13 is a schematic cross-sectional view of the atrial septum illustrating an eighth example of a cardiovascular implant device positioned in the atrial septum and comprising a varying inner diameter.

[0030] Device 700 Figure 14is a schematic cross-sectional illustration of a heart showing a ninth example of a cardiovascular implant device positioned in the atrial septum and comprising an angled central flow tube. DETAILED DESCRIPTION

[0031] Anatomy of the heart H and vasculature V ( Figure 1-2 ) Figure 1 is a schematic diagram of the heart H and vascular system V. Figure 2 is a schematic cross-sectional view of the heart H. Figure 1-2 Will be discussed together. Figure 1-2 Shows the heart H, vasculature V, right atrium RA, right ventricle RV, left atrium LA, left ventricle LV, superior vena cava SVC, inferior vena cava IVC, tricuspid valve TV ( Figure 1 Shown in), pulmonary valve PV ( Figure 1 Displayed in), pulmonary artery PA ( Figure 1 Displayed in the middle), pulmonary vein PVS, mitral valve MV, aortic valve AV ( Figure 1 Shown in), aortic AT ( Figure 1 Shown in the middle), coronary sinus CS ( Figure 2 Shown in), Tepexis valve BV ( Figure 2 Shown in), atrial septum IS ( Figure 2 fossa ovalis (shown in the middle) and fossa ovalis ( Figure 2 (displayed in the).

[0032] The heart H is a human heart that receives blood from and delivers blood to the vasculature V. The heart H includes four chambers: the right atrium RA, the right ventricle RV, the left atrium LA, and the left ventricle LV.

[0033] The right side of the heart H, including the right atrium RA and right ventricle RV, receives deoxygenated blood from the vasculature V and pumps the blood to the lungs. Blood flows into the right atrium RA from the superior vena cava SVC, inferior vena cava IVC, and coronary sinus CS.

[0034] The majority of blood flows into the right atrium RA from the superior vena cava (SVC) and inferior vena cava (IVC), which are offset from one another. Due to the offset of the main incoming blood flow from the superior vena cava (SVC) and inferior vena cava (IVC), a natural flow vortex (right-sided flow vortex) develops in the right atrium RA. This allows a significant portion of the blood from the right atrium RA to pass through the right atrium RA and enter the right ventricle RV by direct flow. The right-sided flow vortex in the right atrium RA preserves the kinetic energy and momentum of the main blood flow entering the right atrium RA and allows a significant portion of blood to naturally transfer from the right atrium RA to the right ventricle RV without any contribution to the flow from the pumping action of the right atrium RA. As the right atrium RA contracts, it also pumps the remaining portion of the incoming blood that did not flow directly through the tricuspid valve (TV) into the right ventricle RV. The blood enters the right ventricle RV and then flows through the pulmonary valve PV into the pulmonary artery PA. While maintaining a direct inflow from the right atrium RA, blood entering the right ventricle RV also forms a natural flow vortex (right ventricular flow vortex) within the right ventricle RV. This naturally redirects the blood entering the right ventricle RV to the pulmonary artery PA via direct flow, without requiring the right ventricle RV to perform significant work in pumping the blood. The remaining blood not delivered to the pulmonary artery PA via the pulmonary valve PV via direct flow is pumped by the contraction of the right ventricle RV. From the pulmonary artery PA, the blood flows into smaller arteries, which deliver deoxygenated blood to the lungs via the pulmonary circulatory system. The lungs can then oxygenate the blood.

[0035] The left side of the heart H (including the left atrium LA and the left ventricle LV) receives oxygenated blood from the lungs and provides blood flow to the body. Blood flows from the pulmonary veins PVS into the left atrium LA. The offset of the right and left pulmonary veins PVS also promotes the formation of a natural flow vortex (left flow vortex) in the left atrium LA, which helps maintain momentum and minimize work as the blood passes through the left atrium LA to the mitral valve MV. The direct flow as described above and the pumping action of the left atrium LA pushes the blood through the mitral valve MV into the left ventricle LV. When the blood enters the left ventricle LV, a natural flow vortex (left ventricular flow vortex) is formed in the left ventricle LV, which naturally redirects the flow toward the left ventricular outflow portion of the aortic valve AV so that it can be efficiently pumped by the left ventricle LV through the aortic valve AV into the aorta AT. From the aorta AT, blood flows into the arteries, which deliver the oxygenated blood to the body via the systemic circulatory system.

[0036] In addition, the right atrium RA receives blood from the coronary sinus CS. The coronary sinus CS collects deoxygenated blood from the myocardium and delivers it to the right atrium RA. The valve of tepecis BV is a semicircular fold of tissue at the opening of the coronary sinus CS in the right atrium RA. The coronary sinus CS surrounds the heart H and extends along the bottom of the left atrium LA, just above the mitral valve MV. Figure 2As shown in , the coronary sinus CS has an increasing diameter as it approaches the right atrium RA. The coronary sinus CS also surrounds a portion of the right atrium RA posteriorly before entering the right atrium RA via the ostium of the coronary sinus CS, which is located lateral and dorsal to the ostium of the tricuspid valve TV and medial to the entry point of the inferior vena cava IVC. Due to its proximity to the inferior vena cava IVC, blood entering the right atrium RA from the coronary sinus CS is naturally entrained with the larger inflow from the inferior vena cava IVC, forming a natural flow vortex (the right-sided flow vortex) in the right atrium RA, which naturally redirects the inflow toward the tricuspid valve TV.

[0037] The atrial septum IS and fossa ovalis FS are also Figure 2 Shown in Figure 1. The atrial septum (IS) is the wall separating the right atrium (RA) from the left atrium (LA). The fossa ovale (FS) is an indentation in the atrial septum (IS) in the right atrium (RA). At birth, a congenital structure called the foramen ovale is located in the atrial septum (IS). The foramen ovale is an opening in the atrial septum (IS) that closes shortly after birth to form the fossa ovale (FS). The foramen ovale acts as a functional shunt in utero, allowing blood, primarily from the inferior vena cava (IVC) and coronary sinus (CS), to move from the right atrium (RA) to the left atrium (LA) and subsequently circulate through the body. This is necessary in utero because the lungs are located in a sac of fluid and do not oxygenate the blood. Instead, they receive oxygenated blood from the mother. Oxygenated blood from the mother flows from the placenta through the umbilical vein into the inferior vena cava (IVC) and enters the inferior vena cava (IVC) via a natural shunt called the ductus venosus. Oxygenated blood moves through the inferior vena cava (IVC) to the right atrium (RA). The opening of the inferior vena cava (IVC) in the right atrium RA is positioned to direct oxygenated blood through the right atrium RA and then into the left atrium LA through a second natural shunt called the foramen ovale, along with entrained deoxygenated blood from the coronary sinus CS. The left atrium LA can then pump the mixed oxygenated and deoxygenated blood into the left ventricle LV, which pumps the mixed oxygenated and deoxygenated blood to the aorta AT and the systemic circulation. This allows the pulmonary circulatory system to be bypassed in utero. Some deoxygenated blood, primarily from the superior vena cava (SVC), is pumped through the right heart, where it also bypasses the lungs and re-enters the aorta AT via a third natural shunt called the ductus arteriosus. After birth, breathing expands the lungs, blood begins to circulate through the lungs for oxygenation, and the three natural shunts close. Closure of the foramen ovale forms the fossa ovale FS.

[0038] A shunt device can be positioned in the heart H to divert blood between the left atrium LA and the right atrium RA. The left atrium LA has a higher pressure and lower compliance than the right atrium RA, while the right atrium RA has a lower pressure and higher compliance than the left atrium LA. The left atrium LA may experience increased pressure due to abnormal heart disease. It is speculated that patients with increased pressure in the left atrium LA may benefit from reduced pressure in the left atrium LA. A shunt device can be used in these patients to divert blood from the left atrium LA to the right atrium RA to reduce the blood pressure in the left atrium LA, which reduces the systolic preload on the left ventricle LV. The reduced pressure in the left atrium LA further relieves back pressure on the pulmonary circulation, reducing the risk of pulmonary edema. The reduced back pressure in the pulmonary circulation also reduces pulmonary artery PA pressure, which may damage the small arteries leading to the lungs, leading to pulmonary hypertension. The increased pulmonary artery pressure may also cause pressure overload in the right ventricle RV, thereby damaging the right ventricle RV and potentially leading to right-sided heart failure.

[0039] For example, shunt devices can be used to treat patients with heart failure (also known as congestive heart failure). In patients with heart failure, the hearts are unable to pump blood as well as they should. Heart failure can affect the right and / or left side of the heart. Diastolic heart failure (also known as heart failure with preserved ejection fraction) is heart failure that occurs when the left ventricle is stiff (less compliant), making it difficult for it to relax properly and fill with blood. This leads to an increase in end-diastolic pressure, which in turn causes increased pressure in the left atrium (LA). There are very few, if any, effective treatments available for diastolic heart failure. Other examples of abnormal heart conditions that lead to increased pressure in the left atrium (LA) are systolic dysfunction of the left ventricle (LV) and certain forms of congenital heart and valve disease.

[0040] A septal shunt (also called an interatrial shunt or transseptal shunt) is positioned in the atrial septum (IS) to divert blood directly from the left atrium (LA) to the right atrium (RA). Typically, a septal shunt is positioned in the fossa ovalis (FS), a thin region of tissue in the atrial septum (IS) where the two atria share a common wall. If the pressure in the right atrium (RA) exceeds that in the left atrium (LA), a septal shunt allows blood to flow primarily from the right atrium (RA) to the left atrium (LA). Alternatively, a shunt may be a left atrium-to-coronary sinus (LA-CS) shunt, positioned in the tissue wall between the left atrium (LA) and the coronary sinus (CS), where the two structures are in close proximity as the CS crosses the epicardium-covered atrioventricular groove. A left atrium-to-coronary sinus shunt moves blood from the left atrium (LA) into the coronary sinus (CS), which then delivers blood to the right atrium (RA) via the ostium of the coronary sinus (CS), which may have a tepexis valve (BV). The coronary sinus CS is compliant and can rapidly expand in response to an increase in volume, for example, if the left subclavian vein drains into the coronary sinus CS. Similarly, when a left atrium to coronary sinus shunt device is used, the coronary sinus CS can act as an additional compliant chamber. In general, shunt devices can potentially affect the natural flow patterns in the vessels and / or chambers of the heart H. These flow patterns will be discussed below with respect to Figures 3A-4B Discuss in more detail.

[0041] Heart H flow pattern ( Figures 3A-4B ) Figure 3A is a first schematic diagram illustrating the modeled hemodynamic flow pattern in the heart H. Figure 3B is a second schematic diagram illustrating the modeled hemodynamic flow pattern in the heart H. Figure 4A is a first schematic diagram illustrating modeled hemodynamic flow patterns in a heart H with a septal shunt device. Figure 4B is a second schematic diagram illustrating modeled hemodynamic flow patterns in a heart H with a septal shunt device. Figures 3A-4B The heart H, right atrium RA, left atrium LA, superior vena cava SVC, inferior vena cava IVC and coronary sinus CS are shown. Figure 3A and 4A The tricuspid valve TV, pulmonary vein PVS, and mitral valve MV are also shown.

[0042] Figure 3A and 4A Computational fluid dynamics model representing the right and left atria. The anatomical geometry was generated from segmented and averaged computed tomography (CT) data from pre-implantation patients. The shunt geometry (included in Figure 4A) are actually added to the model. A computational mesh consisting of polyhedral elements is created on the geometry, and boundary conditions are applied in the form of flow waves at the inlets (pulmonary veins PVS, inferior vena cava IVC, superior vena cava SVC, and coronary sinus CS) and pressure waves at the outlets (mitral valve MV and tricuspid valve TV planes). Blood is modeled with a density of 1050 kg / m 3 A Newtonian viscous fluid with a viscosity of 0.0035 Pascal-seconds (Pa·s) was used. A k-ε (k-ε) Reynolds Averaged Navier-Stokes (RANS) turbulence model was employed in a separated flow solver, with time and space discretized to first- and second-order accuracy, respectively. Multiple cardiac cycles were modeled to remove any initial transients and fully implement periodic flow characteristics. Flow visualization was achieved by generating streamlines at different time instances during the cardiac cycle using post-processing tools available in the CFD software. Figure 3A and 4A Velocity streamlines at specific moments during the cardiac cycle are shown.

[0043] Figures 3A-4B Modeled velocity streamlines representing the hemodynamic flow patterns in the heart H are shown. Figure 3A and 4A The heart H is shown oriented with the right atrium RA on the right side of the drawing and the left atrium LA on the left side of the drawing. Figure 3A and 4A This is a lower view of the heart H. Figure 3B and 4B The heart H is shown oriented with the right atrium RA on the left side of the drawing and the left atrium LA on the right side of the drawing. Figure 3B and 4B It is a superior view of the heart H.

[0044] A natural flow pattern of blood flow exists within the heart H and helps move blood through the heart H and into the vasculature connected to the heart H in a manner that maximizes the preservation of blood flow momentum and kinetic energy. The natural flow pattern of blood moving through the arteries and veins is generally spiral in nature (a helical flow pattern). The natural flow pattern of blood moving through the chambers of the heart H is generally vortex in nature (a vortex flow pattern).

[0045] Figure 3A Modeled hemodynamic flow patterns existing in the right atrium RA and the left atrium LA of the heart H are shown. Figure 3B Modeled hemodynamic flow patterns present in the right atrium RA, superior vena cava SVC, inferior vena cava IVC, and coronary sinus CS are shown. Figures 3A-3BThis diagram shows the natural flow pattern formed in the heart H (including the right atrium RA and left atrium LA), which is determined not only by the anatomical structure of the heart H but also by the deviation of the inflowing blood into the chambers of the heart H. When the heart H is viewed from the right side (right sagittal view), a clockwise right-sided flow vortex forms in the right atrium RA, and a counterclockwise left-sided flow vortex forms in the left atrium LA. The right-sided flow vortex in the right atrium RA is the natural flow pattern of blood flow in the right atrium RA. The left-sided flow vortex in the left atrium LA is the natural flow pattern of blood flow in the left atrium LA. Figures 3A-3B The modeled hemodynamic flow patterns shown in represent the intracardiac flow patterns of a structurally normal heart.

[0046] Blood flows into the right atrium (RA) from the superior vena cava (SVC), inferior vena cava (IVC), and coronary sinus (CS). The openings of the superior and inferior vena cava in the right atrium (RA) are offset so that blood flowing from the superior and inferior vena cava (SVC) into the right atrium (RA) does not collide with each other. Due to their orientation and physical proximity, the coronary sinus (CS) flow is entrained into the inferior vena cava (IVC) flow. Blood flowing through the superior vena cava (SVC) and inferior vena cava (IVC) has a spiral flow pattern. Most of the blood in the right atrium (RA) enters the right atrium (RA) through the inferior vena cava (IVC), and blood flowing from the inferior vena cava (IVC) into the right atrium (RA) is directed toward the top of the right atrium (RA). This spiral flow pattern of blood flowing from the inferior vena cava (IVC) into the right atrium (RA) contributes to the formation of a clockwise, right-sided flow vortex in the right atrium (RA) (when viewing the heart from the right side). Blood entering the right atrium (RA) from the superior vena cava (SVC) flows along the atrial septum toward the tricuspid valve (TV). The spiral flow pattern of the blood flowing from the superior vena cava SVC into the right atrium RA helps the blood flow to naturally combine with the clockwise right-sided flow vortex formed in the right atrium RA by the blood flow from the inferior vena cava IVC, which is combined by the coronary sinus CS flow. A small amount of blood flows from the coronary sinus CS into the right atrium RA. The flow flowing through the coronary sinus CS will have a spiral flow pattern. The spiral flow pattern of the blood leaving the coronary sinus CS will naturally combine with the inferior vena cava IVC flow and the right-sided flow vortex in the right atrium RA. Figures 3A-3B The right-sided flow vortex in the right atrium RA is shown with velocity streamlines labeled RVF.

[0047] The right-sided flow vortex formed in the right atrium RA helps blood flow through the right atrium RA, through the tricuspid valve TV, into the right ventricle, through the pulmonary valve, and into the pulmonary artery. The right heart is an inefficient pump and may function more like a pipe. The right-sided flow vortex formed in the right heart helps maintain kinetic energy and momentum as blood moves from the superior vena cava (SVC) and inferior vena cava (IVC) through the right heart and into the pulmonary artery, even when the right heart provides minimal or no pumping. This is particularly important for maintaining right heart output, which must match left heart output, during periods of high output and heart rate during exercise. The right-sided flow vortex formed in the right atrium RA helps move blood from the right atrium RA, through the tricuspid valve TV, and into the right ventricle with minimal loss of momentum and kinetic energy. Blood is ejected from the right atrium RA, through the right ventricle, out the right ventricular outflow tract, through the pulmonary valve, and into the pulmonary artery. Due to the right-sided flow vortex of the right atrium RA and right ventricle RV and the anatomical constraints of the right heart, approximately 50% of the blood will flow into the pulmonary artery without the right heart having to do any pumping.Right heart contraction enhances the flow of residual blood through the right heart.

[0048] Blood flows from the pulmonary veins PVS into the left atrium LA. There are four pulmonary veins PVS that flow into the left atrium LA. The blood flowing through the pulmonary veins PVS has a spiral flow pattern. The deviation of the spiral flow of blood flowing from the pulmonary veins PVS into the left atrium LA helps to form a counterclockwise left flow vortex in the left atrium LA (when viewing the heart from the right). The left flow vortex in the left atrium LA directs the flow toward the mitral valve MV. Figure 3A The left-side flow vortex in the left atrium LA is shown with velocity streamlines labeled LVF.

[0049] It is hypothesized that if the intracardiac blood flow pattern in heart H (including the right-sided flow vortex in the right atrium RA and the left-sided flow vortex in the left atrium LA) is disrupted, blood flow from the superior vena cava (SVC) and inferior vena cava (IVC) through the right atrium RA, through the right ventricle, and into the pulmonary artery, and from the pulmonary vein through the left atrium LA, through the left ventricle, and into the aorta, becomes less efficient, placing an increased mechanical workload on the respective ventricles. This is particularly important in failing hearts, where the ability to increase the workload of the myocardium is impaired. Disruption of the intracardiac blood flow pattern in heart H (including the right-sided flow vortex in the right atrium RA and the left-sided flow vortex in the left atrium LA) can occur for various reasons. For example, the anatomy of heart H may change with patient age. This can affect the offset between the ostium of the superior vena cava (SVC) and the ostium of the inferior vena cava (IVC). As the anatomy of the heart H changes, blood flow entering the right atrium RA from the superior vena cava (SVC) and from the inferior vena cava (IVC) may conflict, disrupting the natural formation of the right-sided flow vortex in the right atrium RA. In another example, the right atrium RA may enlarge in heart failure patients with or without atrial fibrillation. Enlargement of the right atrium RA may also disrupt the right-sided flow vortex formed in the right atrium RA. Similarly, the left atrium LA may enlarge in heart failure patients with or without atrial fibrillation. Enlargement of the left atrium LA may also disrupt the left-sided flow vortex formed in the left atrium LA. Furthermore, patients with a patent foramen ovale (a natural atrial septal shunt) or a secundum atrial septal defect (STAD) resulting from incomplete closure of the patent foramen ovale may not experience the expected intracardiac blood flow pattern (including the right-sided flow vortex in the right atrium RA and the left-sided flow vortex in the left atrium LA) that is generated during atrial filling. It has been shown that closure of a secundum atrial septal defect with an altered right atrial non-single-vortex flow pattern restored a predominantly single-vortex flow pattern after the atrial septal defect was occluded.

[0050] When the right-sided flow vortex in the right atrium RA changes, blood loses momentum and energy, and the right heart must pump harder to move blood from the right atrium RA to the right ventricle and pulmonary artery. This is because the right-sided flow vortex contributes less to blood movement through the right heart. Similarly, when the left-sided flow vortex in the left atrium LA changes, the left heart must pump harder to move blood from the left atrium LA to the left ventricle and aorta. This is because the left-sided flow vortex contributes less to blood movement through the left heart. Furthermore, as the intracardiac flow pattern in the heart H (including the right-sided flow vortex in the right atrium RA and the left-sided flow vortex in the left atrium LA) changes due to age or disease, turbulent areas may develop in the flow pattern of the heart H, potentially leading to a loss of fluid dynamics, inefficiency, and thus reduced flow. This can increase susceptibility to right and / or left heart failure (inability to pump enough blood to meet the body's oxygen needs) because the heart H must work harder to move the same amount of blood through it. Additional stress is placed on the heart H as more work is required to regenerate the lost momentum naturally maintained by the intracardiac flow patterns in the heart H (comprising the right-sided flow vortex in the right atrium RA and the left-sided flow vortex in the left atrium LA).

[0051] Alterations in the intracardiac flow pattern alter the energetics of the heart. The heart H is uniquely designed to maximize efficiency by conserving the kinetic energy and momentum of blood flow, thereby minimizing the work required to propagate blood into, between, and out of the chambers. Anything that disrupts the intracardiac flow pattern in the heart H (including the right-sided flow vortex in the right atrium RA and the left-sided flow vortex in the left atrium LA) can reduce the efficiency of the heart H's energetics due to potential energy loss, making it more difficult for the heart H to accomplish its task of propagating blood into, between, and out of the chambers. Anything that disrupts the intracardiac flow pattern through the heart H (including the right-sided flow vortex in the right atrium RA and the left-sided flow vortex in the left atrium LA) can increase the amount of work the heart H must perform, prolong transit time through the heart H, and make it more difficult for the heart H to eject blood. This is particularly problematic for people experiencing heart failure, as disruption of the intracardiac flow pattern through the heart H (including the right-sided flow vortex in the right atrium RA and the left-sided flow vortex in the left atrium LA) can exacerbate heart failure.

[0052] Figure 4A Modeled hemodynamic flow patterns present in the right atrium RA and left atrium LA of heart H when a conventional septal shunt device (e.g., one without any additional flow directing or regulating features) is positioned between the right atrium RA and the left atrium LA are shown. Figure 4BThe modeled hemodynamic flow patterns present in the right atrium RA, superior vena cava SVC, inferior vena cava IVC, coronary sinus CS and left atrium LA when a conventional septal shunt device is positioned between the right atrium RA and the left atrium LA are presented. Figures 4A-4B In the schematic diagram shown in , a conventional septal shunt device has been modeled in the atrial septum between the right atrium RA and the left atrium LA to allow blood to be shunted directly from the left atrium LA to the right atrium RA.

[0053] like Figures 4A-4B As shown in FIG, when a conventional septal shunt device is positioned in the atrial septum between the right atrium RA and the left atrium LA, blood is ejected from the left atrium LA into and through the right atrium RA. Figures 4A-4B The blood jet is shown in FIG. 1 with velocity streamlines marked J. The blood jet in the right atrium RA destroys the right flow vortex in the right atrium RA. When the blood jet passes through the right atrium RA, two independent flow vortices are formed in the right atrium RA. Figures 4A-4B The first flow vortex is shown with the velocity streamlines labeled RVF1 and the second flow vortex is shown with the velocity streamlines labeled RVF2. The left flow vortex in the left atrium LA is also disrupted. The conventional septal shunt device is not aligned with the left flow vortex in the left atrium LA, but the pressure difference between the right atrium RA and the left atrium LA causes the blood in the left atrium LA to move out of the left flow vortex and into the right atrium RA through the septal shunt device. Figures 4A-4B The velocity streamlines labeled DFP in FIG. 4 illustrate a disrupted left-side flow vortex in the left atrium LA. This disruption of the right-side flow vortex in the right atrium RA and the left-side flow vortex in the left atrium LA may also result in a loss of vortex formation in the right ventricle RV and the left ventricle LV, and will cause the heart H to have to work harder to pump blood through its respective ventricle and, over time, may lead to the development or worsening of heart failure.

[0054] Specifically, when observing the right heart, conventional septal shunt devices can cause severe disruption to the right-sided flow vortex in the right atrium RA as the blood jet passes through the right atrium RA. It is hypothesized that this disruption to the right-sided flow vortex in the right atrium RA may lead to or aggravate right heart failure. Disruption to the right-sided flow vortex in the right atrium RA means a loss of momentum and kinetic energy in the blood flowing naturally or efficiently from the right atrium RA into the right ventricle and pulmonary artery. In order to move blood from the right atrium RA into the right ventricle and pulmonary artery, the right heart must pump blood harder. This increased work required of the right heart may lead to or aggravate right heart failure and place a severe load on the less efficient right heart during periods of exercise where the heart rate is high and the diastolic hyperemia is short.

[0055] Will refer to Figure 5-14Several examples of features of cardiovascular implant devices, including several shunt devices, in accordance with the presently disclosed technology are described. Figure 5-14 Each of the cardiovascular implant device examples shown in the FIGURES comprises several substantially similar components that share the same names and are described in the FIGURES. Figure 5-14 Each of the shared reference numerals in an incremental manner is identified between (e.g., Figure 5-6 Comprising cardiovascular implant devices 100 and 100A; Figure 7 comprising a cardiovascular implant device 200; Figures 8A-8B comprising a cardiovascular implant device 300; Figure 9 comprising a cardiovascular implant device 400; Figures 10A-10B comprising a cardiovascular implant device 500; Figure 11-13 including cardiovascular implant devices 600 and 600A; and Figure 14 For ease of discussion, Figure 5-14 The details of some components of the cardiovascular implant device examples shown in FIG may not be repeated in each of the following sections, but it should be understood that Figure 5-14 The cardiovascular implant device examples shown in the may include all or any combination of the components and features described herein. Figure 5-14 Although depicted as separate examples, cardiovascular implant devices according to the presently disclosed technology may generally include any combination of the following features.

[0056] The cardiovascular implant devices described herein, i.e., cardiovascular implant devices 100, 100A, 200, 300, 400, 500, 600, 600A, 700, can be formed in a variety of ways, for example, by connecting individual wires together to form a mesh or lattice, braiding, cutting from a sheet and subsequently rolling or otherwise forming into the shape of the cardiovascular implant device, molding, cutting from a cylindrical tube (e.g., from a nitinol tube), other ways, or a combination of these ways. All or a portion of cardiovascular implant devices 100, 100A, 200, 300, 400, 500, 600, 600A, 700 can be made of a flexible metal, metal alloy, polymer, or other suitable material. Examples of metals and metal alloys that can be used include, but are not limited to, nitinol (nickel titanium alloy) and other shape memory materials, elgiloy, and stainless steel, but other metals and elastic or flexible non-metallic materials can be used to manufacture cardiovascular implant devices 100, 100A, 200, 300, 400, 500, 600, 600A, 700 or their component parts. All or a portion of cardiovascular implant devices 100, 100A, 200, 300, 400, 500, 600, 600A, 700 can be integrally formed from any of these materials. These materials can allow cardiovascular implant device 100, 100A, 200, 300, 400, 500, 600, 600A, 700 to be compressed to a smaller size and then, when the compressive force is released, cardiovascular implant device 100, 100A, 200, 300, 400, 500, 600, 600A, 700 can self-expand back to the pre-compressed shape. Cardiovascular implant device 100, 100A, 200, 300, 400, 500, 600, 600A, 700 can expand back to a pre-compressed shape due to the material properties of cardiovascular implant device 100, 100A, 200, 300, 400, 500, 600, 600A, 700 and / or cardiovascular implant device 100, 100A, 200, 300, 400, 500, 600, 600A, 700 can expand, for example, by expansion or expansion of another device positioned within the respective cardiovascular implant device. For example, cardiovascular implant device 100, 100A, 200, 300, 400, 500, 600, 600A, 700 can be compressed so that cardiovascular implant device 100, 100A, 200, 300, 400, 500, 600, 600A, 700 can fit into a delivery catheter. The cardiovascular implant devices 100, 100A, 200, 300, 400, 500, 600, 600A, 700 may also be made of other materials and may expand and collapse in different ways, for example, mechanically expandable, balloon expandable, self-expanding, or a combination of these.In yet other examples, one of cardiovascular implant devices 100, 100A, 200, 300, 400, 500, 600, 600A, 700 is non-expandable.

[0057] Devices 100 and 100A ( Figure 5-6 ) Figure 5 FIG is a schematic cross-sectional view of a heart H showing a cardiovascular implant device 100 positioned in the atrial septum IS and including a curved portion 130. Figure 5 As shown in FIG, cardiovascular implant device 100 includes an annular body 102 including struts 103, a central flow tube 104, and a flow path 106; and an anchoring member 108. Central flow tube 104 includes an inflow end 110, an outflow end 112, and a flow surface 114. Central flow tube 104 further includes a straight portion 120 and a curved portion 130. Figure 5 Also shown are the heart H, right atrium RA, left atrium LA, superior vena cava SVC, inferior vena cava IVC, tricuspid valve TV, pulmonary vein PVS, mitral valve MV, and atrial septum IS. Figure 5 Further displayed are the right atrial vortex RVF, tissue wall plane TWP, tricuspid valve plane TVP, outer diameter OD, axis AX1 and angle α1.

[0058] The cardiovascular implant device 100 is an implantable device for use in the cardiovascular system. The cardiovascular implant device 100 is configured to be implanted in a blood vessel or chamber of the heart H. In the example shown, the cardiovascular implant device 100 is a diversion device for diverting blood from one blood vessel or chamber to another blood vessel or chamber. Specifically, Figure 5 , cardiovascular implant device 100 is positioned in the atrial septum IS. In other examples, cardiovascular implant device 100 may be positioned in any other tissue wall between adjacent chambers and / or blood vessels of heart H (or cardiovascular system). Cardiovascular implant device 100 may be delivered into the cardiovascular system via a catheter (i.e., transcatheter delivery) or may be surgically placed using transcatheter or surgical procedures known in the art.

[0059] The annular body 102 is the main body of the cardiovascular implant device 100. The annular body 102 may be expandable. The annular body 102 is generally cylindrical and tubular in cross-section, but may have a variety of different shapes and sizes. The annular body 102 may be pressed against or pressed into the tissue wall at the implant site or configured (or extended) around the anatomical structure of the cardiovascular system to set and maintain the position of the cardiovascular implant device 100. In some examples, for example, Figure 5, annular body 102 can be formed from a plurality of struts 103. Struts 103 can form a lattice or grid of annular body 102 and define openings therein. In such examples, annular body 102 can be a stent framework structure for supporting a graft material that directs flow through cardiovascular implant device 100. In other examples, annular body 102 can be solidly formed.

[0060] The annular body 102 can be positioned in a perforation in a tissue wall to hold the tissue wall open around the annular body 102 so that blood can flow between blood vessels or chambers of the heart H through the cardiovascular implant device 100. Figure 5 , the annular body 102 is positioned in a perforation in the atrial septum IS between the left atrium LA and the right atrium RA, allowing blood to flow from the left atrium LA to the right atrium RA through the cardiovascular implant device 100. In some examples, the struts 103 of the annular body 102 form a cage sufficient to hold the tissue wall open around the annular body 102. In other examples, the material forming the annular body 102 is strong enough to hold the tissue wall open around the annular body 102.

[0061] Annular body 102 has an outer diameter OD. Outer diameter OD is the diameter of annular body 102 as measured from the exterior surface of cardiovascular implant device 100. Outer diameter OD is configured to be approximately the same size as the diameter of a perforation in a tissue wall into which cardiovascular implant device 100 will be implanted, enabling annular body 102 to fit within the perforation. Outer diameter OD can have any size, allowing cardiovascular implant device 100 to be sized to suit a variety of patient conditions and / or anatomies. In some examples, outer diameter OD can also vary along the length of annular body 102 based on the overall shape or profile of annular body 102.

[0062] The annular body 102 includes a central flow tube 104, which serves as a conduit for directing flow through the cardiovascular implant device 100. The central flow tube 104 surrounds a flow path 106. The flow path 106 is an opening extending through the central flow tube 104, so that the cardiovascular implant device 100 is open at each opposite end. The flow path 106 is the path through which blood flows or is directed through the cardiovascular implant device 100. The central flow tube 104 includes a flow surface 114, which is configured to be a flow contact surface when the cardiovascular implant device 100 is implanted in a blood vessel or chamber of the heart H. The flow surface 114 is the radially inner surface of the central flow tube 104. The flow path 106 through the central flow tube 104 is defined by the flow surface 114.

[0063] The profile of the central flow tube 104 and the flow path 106 may be straight, curved, a combination of straight sections and curved sections, or any other suitable shape, as will be described in more detail below. In some examples, the profile of the central flow tube 104 and the flow path 106 may be defined by or identical to the profile of the annular body 102 (e.g., as shown in FIG. Figure 5 In other examples, the profile of the central flow tube 104 and the flow path 106 may be independent of or different from the profile of the annular body 102 (e.g., as shown in FIG. Figure 6 ). Similarly, the cross-sectional shape or profile of the central flow tube 104 and the annular body 102 can be the same, such as circular, oval, etc. Alternatively, the central flow tube 104 and the annular body 102 can have different cross-sectional shapes. For example, the annular body 102 can have a circular cross-section, and the central flow tube 104 can have an oval cross-section. Furthermore, the cross-sectional shape of the central flow tube 104 and / or the annular body can also vary along the length of either. The cross-sectional shape of the central flow tube 104 can be selected at various points along its length (e.g., at the outflow end 112) to influence the flow direction.

[0064] The central flow tube 104 (and the flow path 106 therein) extends from an inflow end 110 and an outflow end 112. The inflow end 110 may be the end of the central flow tube 104 that is relatively upstream of the outflow end 112 with respect to blood flow through the cardiovascular implant device 100 when the cardiovascular implant device 100 is implanted in a blood vessel or chamber of the heart H, as indicated by Figure 5 . Accordingly, outflow end 112 is the end of central flow tube 104 that is relatively downstream of inflow end 110 with respect to blood flow through cardiovascular implant device 100 when cardiovascular implant device 100 is implanted in a blood vessel or chamber of heart H, as indicated by Figure 5 Indicated by the arrow F in Figure 5 In the example shown in FIG, the inflow end 110 is positioned on the left atrium side of the atrial septum IS, and the outflow end 112 is positioned downstream on the right atrium side of the atrial septum IS, so that blood can flow from the left atrium LA to the right atrium RA through the flow path 106. Figure 5, the inflow end 110 may be substantially flush with the left atrial side of the atrial septum IS, while in some instances, the outflow end 112 may be spaced apart from the right atrial side of the atrial septum IS within the right atrium RA (i.e., the cardiovascular implant device 100 may extend further into the right atrium RA at the outflow end 112 than into the left atrium LA at the inflow end 110). In other instances, the inflow end 110 or the outflow end 112, or both, may be flush with or spaced apart from the respective sides of the tissue wall. Although the inflow end 110 is defined as being relatively upstream of the outflow end 112, it should be understood that other actual locations of the inflow end 110 or the outflow end 112 are possible, depending on the location at which the cardiovascular implant device 100 is implanted. The central flow tube 104 may have any suitable length as measured from the inflow end 110 to the outflow end 112. For example, central flow tube 104 can be designed to have a length that approximates the thickness of atrial septum IS or another tissue wall in which cardiovascular implant device 100 is positioned. In other examples, central flow tube 104 can be longer or shorter than the thickness of atrial septum IS or another tissue wall.

[0065] In general, the central flow tube 104 can be formed from any suitable material for forming a tubular structure surrounding the flow path 106. For example, all or a portion of the central flow tube 104 can be formed from a graft material. The graft material can be a synthetic material, such as woven polyester or polytetrafluoroethylene (PTFE), a biomaterial, a metallic material, or other materials, to name a few non-limiting examples. The central flow tube 104 formed from a graft material can be supported within the cardiovascular implant device 100 by the struts 103 of the annular body 102. In such examples, the central flow tube 104 can be attached to the struts 103 of the annular body 102 by any suitable attachment means, such as by suturing, gluing, tying, etc. In other examples, the central flow tube 104 can be rigidly formed with the annular body 104.

[0066] One or more anchoring members 108 extend outwardly from the annular body 102. When the cardiovascular implant device 100 is implanted in the body, the anchoring members 108 hold the cardiovascular implant device 100 in place in the tissue wall. The anchoring member 108 may take any suitable form for securing the cardiovascular implant device 100 to the tissue wall. In some instances, the anchoring member 108 may be one or more arms. In other instances, the anchoring member 108 may be a flange or annular lip configured to have a diameter that is larger than the diameter of the perforation or opening in which the cardiovascular implant device 100 is positioned, so as to prevent the cardiovascular implant device 100 from sliding through the perforation or opening. In some instances, the anchoring member 108 may bend toward the tissue wall, or alternatively, may remain flush against the tissue wall. Figure 5, the cardiovascular implant device 100 can include one or more anchoring members 108 extending from one end of the central flow tube 104. Specifically, the cardiovascular implant device 100 can include an anchoring member 108 adjacent to the inflow end 110. In other examples, the cardiovascular implant device 100 can include an anchoring member 108 adjacent to the outflow end 112. In still other examples, the cardiovascular implant device 100 can include anchoring members 108 at both the inflow end 110 and the outflow end 112.

[0067] like Figure 5 As shown in FIG, the central flow tube 104 includes a straight portion 120 and a curved portion 130. The straight portion 120 is the first portion or segment of the central flow tube 104. Figure 5 In the example shown in FIG, the straight portion 120 is adjacent to the inflow end 110 and extends from the inflow end to capture blood flowing into the cardiovascular implant device 100. The length of the straight portion 120 is sized to span the perforation in the tissue wall in which the cardiovascular implant device 100 is configured to be positioned. The curved portion 130 is a second portion or segment of the central flow tube 104. The curved portion 130 is connected to the straight portion 120. Figure 5 In the example shown in FIG, the curved portion 130 is adjacent to the outflow end 112 and extends from the outflow end to the straight portion 120. That is, when the cardiovascular implant device 100 is implanted in the tissue wall, the curved portion 130 is a relatively downstream portion of the central flow tube 104, and the straight portion 120 is a relatively upstream portion of the central flow tube 104 relative to the direction of blood flow through the cardiovascular implant device. The curved portion 130 may be continuous with the straight portion 120. The curved portion 130 and the straight portion 120 are connected in a continuous manner. Figure 5 however, it should be understood that the curved portion 130 and the straight portion 120 can have any relative length with respect to each other.

[0068] The curved portion 130 is a flow guide component of the cardiovascular implant device 100. The curved portion 130 is positioned to guide blood flow out of the cardiovascular implant device 100 in a specific direction. More specifically, the curved portion 130 is curved to guide blood flow out of the cardiovascular implant device 100 in a specific direction. Figure 5As shown in FIG, curved portion 130 is configured to curve toward the tricuspid valve plane TVP (a plane containing the annular region of the tricuspid valve TV) upon positioning of cardiovascular implant device 100. Thus, curved portion 130 is configured to direct flow from cardiovascular implant device 100 toward tricuspid valve plane TVP. Curved portion 130 defines a turn in flow path 106. When cardiovascular implant device 100 is implanted in the interatrial septum IS, the turn aligns the portion of flow path 106 at outflow end 112 with the natural flow pattern in the right atrium RA. Axis AX1 drawn longitudinally through outflow end 112 (which approximates the longitudinal axis aligned with blood flow out of central flow tube 104) forms an angle α1 with a tissue wall plane TWP of the tissue wall (e.g., the interatrial septum IS) in which cardiovascular implant device 100 is configured to be positioned. Tissue wall plane TWP is a vertical reference plane defined by the tissue wall and, therefore, will be substantially perpendicular to the flow path 106 where it passes through the tissue wall. In some examples, the angle α1 is between zero and seventy-five degrees (0°-75°).

[0069] Since curved portion 130 is adjacent to outflow end 112, curved portion 130 is configured to face right atrium RA or partially extend into right atrium RA when cardiovascular implant device 100 is implanted in atrial septum IS. Protrusion of curved portion 130 into right atrium RA can be minimized so that curved portion 130 protrudes only into right atrium RA enough to secure cardiovascular implant device 100 in place in atrial septum IS.

[0070] Once the cardiovascular implant device 100 is implanted in the cardiovascular system (e.g., Figure 5 In the atrial septum IS or another tissue wall shown in FIG, circulating blood passes through the flow path 106 of the cardiovascular implant device 100. Figure 5 In the example shown in FIG. 1 , blood flows from the left atrium LA through the flow path 106 and into the right atrium RA. As blood flows out of the cardiovascular implant device 100, the curved portion 130 aligns the blood flow with the natural blood flow pattern in the right atrium RA, so that the blood flow out of the cardiovascular implant device 100 merges with the natural blood flow pattern in the right atrium RA. More specifically, the curved portion 130 aligns the blood flow out of the cardiovascular implant device 100 with the natural vortex flow pattern (i.e., the right-sided flow vortex) of the blood in the right atrium RA (i.e., the right-sided flow vortex). Figure 5 (indicated by the schematic streamlines labeled RVF in the figure). Figure 5As shown by arrow F in FIG, blood flow exiting cardiovascular implant device 100 is directed in a tortuous path along the right atrial side of the atrial septum IS and toward the tricuspid valve plane TVP, rather than exiting through the right atrium RA and cutting or otherwise disrupting the natural vortex flow pattern. In this way, blood flow exiting cardiovascular implant device 100 can combine with blood flowing downward along the atrial septum IS and merge into the right atrial vortex.

[0071] Cardiovascular implant device 100 (including curved portion 130) can minimize or potentially enhance the natural flow patterns localized to the site of implantation of cardiovascular implant device 100 in heart H. When cardiovascular implant device 100 is implanted in the atrial septum IS, blood flowing from the left atrium LA to the right atrium RA through cardiovascular implant device 100 can be less disruptive to the natural rotational (e.g., vortex) flow patterns in the right atrium RA because the flow exiting cardiovascular implant device 100 is aligned with the natural vortex flow pattern, compared to conventional septal shunt devices, which can cause blood flow to eject through the right atrium. Aligning the flow exiting cardiovascular implant device 100 with the natural flow patterns in the chambers or vessels of heart H using curved portion 130 minimizes any disruption to the natural flow patterns that might otherwise be caused by implanting conventional shunt devices without directional components. Furthermore, aligning the flow exiting cardiovascular implant device 100 can potentially mitigate flow reductions or enhance baseline flow due to pathophysiological or other causes. Thus, the cardiovascular implant device 100 can maintain the kinetic energy of cardiovascular blood flow, which in turn reduces the required cardiac work and improves cardiac efficiency. These hemodynamic effects can potentially improve patient outcomes after receiving the cardiovascular implant device 100 because the cardiovascular implant device 100 can be more effective and potentially safer.

[0072] Figure 6 FIG is a schematic cross-sectional view of the atrial septum IS, showing a cardiovascular implant device 100A positioned in the atrial septum IS and including an inner curved portion 130A. Figure 6 As shown in FIG, cardiovascular implant device 100A includes an annular body 102A including struts 103A, a central flow tube 104A, and a flow path 106A; and an anchoring member 108A. Central flow tube 104A includes an inflow end 110A, an outflow end 112A, and a flow surface 114A. Central flow tube 104A further includes a straight portion 120A and a curved portion 130A. Figure 6 Also shown are the right atrium RA, left atrium LA, and atrial septum IS. Figure 6 Further shown are the tissue wall plane TWP, outer diameter OD, axis AX1 and angle α1.

[0073] The cardiovascular implant device 100A has the same Figure 5The structure, design, and function of the cardiovascular implant device 100 are generally similar to those described above, but the cardiovascular implant device 100A includes an inner curved portion 130A. Figure 5 Compared to the curved portion 130 shown in FIG, the curved portion 130A is formed inside the annular body 102 so that the curved portion 130A and the outflow end 112A do not significantly extend (if at all) beyond the tissue wall in which the cardiovascular implant device 100A is implanted. Thus, the cardiovascular implant device 100A includes an anchoring member 108 adjacent to both the inflow end 110A and the outflow end 112A. Figure 6 As shown in FIG, the central flow tube 104A and the annular body 102A do not have the same profile. The central flow tube 104A has a curved profile through the curved portion 130A, but the annular body 102 has a straight profile. In other words, the curvature of the curved portion 130A is not reflected by the outer diameter OD.

[0074] Device 200 ( Figure 7 ) Figure 7 is a schematic cross-sectional view of a heart H showing a cardiovascular implant device 200 positioned in the atrial septum IS and including a flap 240. Figure 7 As shown in FIG, cardiovascular implant device 200 includes an annular body 202 including struts 203, a central flow tube 204, and a flow path 206; and an anchoring member 208. Central flow tube 204 includes an inflow end 210, an outflow end 212, and a flow surface 214. Cardiovascular implant device 200 further includes a tab 240, a flexible joint 242, and a stopper 244. Figure 7 Also shown are the heart H, right atrium RA, left atrium LA, superior vena cava SVC, inferior vena cava IVC, tricuspid valve TV, pulmonary vein PVS, mitral valve MV, and atrial septum IS. Figure 7 Further displayed are the right atrial vortex RVF, tissue wall plane TWP, tricuspid valve plane TVP, outer diameter OD, axis AX2, axis LX2 and angle α2.

[0075] The cardiovascular implant device 200 is an implantable device for use in the cardiovascular system. The cardiovascular implant device 200 is configured to be implanted in a blood vessel or chamber of the heart H. In the example shown, the cardiovascular implant device 200 is a diversion device for diverting blood from one blood vessel or chamber to another blood vessel or chamber. Specifically, Figure 7, cardiovascular implant device 200 is positioned in the atrial septum IS. In other examples, cardiovascular implant device 200 may be positioned in any other tissue wall between adjacent chambers and / or blood vessels of heart H (or cardiovascular system). Cardiovascular implant device 200 may be delivered into the cardiovascular system via a catheter (i.e., transcatheter delivery) or may be surgically placed using transcatheter or surgical procedures known in the art.

[0076] The annular body 202 is the main body of the cardiovascular implant device 200. The annular body 202 can be expandable. The annular body 202 is generally cylindrical and tubular in cross section, but can have a variety of different shapes and sizes. The annular body 202 can be pressed against or pressed into the tissue wall at the implant site or configured (or extended) around the anatomical structure of the cardiovascular system to set and maintain the position of the cardiovascular implant device 200. In some examples, for example, Figure 7 , annular body 202 can be formed from a plurality of struts 203. Struts 203 can form a lattice or grid of annular body 202 and define openings therein. In such examples, annular body 202 can be a stent framework structure for supporting a graft material that directs flow through cardiovascular implant device 200. In other examples, annular body 202 can be solidly formed.

[0077] The annular body 202 can be positioned in a perforation in a tissue wall to hold the tissue wall open around the annular body 202 so that blood can flow between blood vessels or chambers of the heart H through the cardiovascular implant device 200. Figure 7 , the annular body 202 is positioned in a perforation in the atrial septum IS between the left atrium LA and the right atrium RA, allowing blood to flow from the left atrium LA to the right atrium RA through the cardiovascular implant device 200. In some examples, the struts 203 of the annular body 202 form a cage sufficient to hold the tissue wall open around the annular body 202. In other examples, the material forming the annular body 202 is strong enough to hold the tissue wall open around the annular body 202.

[0078] Annular body 202 has an outer diameter OD. Outer diameter OD is the diameter of annular body 202 as measured from the exterior surface of cardiovascular implant device 200. Outer diameter OD is configured to be approximately the same size as the diameter of a perforation in a tissue wall into which cardiovascular implant device 200 will be implanted, enabling annular body 202 to fit within the perforation. Outer diameter OD can have any size, allowing cardiovascular implant device 200 to be sized to suit a variety of patient conditions and / or anatomies. In some examples, outer diameter OD can also vary along the length of annular body 202 based on the overall shape or profile of annular body 202.

[0079] The annular body 202 includes a central flow tube 204, which serves as a conduit for directing flow through the cardiovascular implant device 200. The central flow tube 204 surrounds a flow path 206. The flow path 206 is an opening extending through the central flow tube 204, so that the cardiovascular implant device 200 is open at each opposite end. The flow path 206 is the path through which blood flows or is directed through the cardiovascular implant device 200. The central flow tube 204 includes a flow surface 214, which is configured to be a flow contact surface when the cardiovascular implant device 200 is implanted in a blood vessel or chamber of the heart H. The flow surface 214 is the radially inner surface of the central flow tube 204. The flow path 206 through the central flow tube 204 is defined by the flow surface 214.

[0080] The profile of the central flow tube 204 and the flow path 206 may be straight, curved, a combination of straight sections and curved sections, or any other suitable shape. In some examples, the profile of the central flow tube 204 and the flow path 206 may be defined by or identical to the profile of the annular body 202 (e.g., as shown in FIG. Figure 5 In other examples, the profile of the central flow tube 204 and the flow path 206 may be independent of or different from the profile of the annular body 202 (e.g., as shown in FIG. Figure 6 ). Similarly, the cross-sectional shape or profile of the central flow tube 204 and the annular body 202 can be the same, such as circular, oval, etc. Alternatively, the central flow tube 204 and the annular body 202 can have different cross-sectional shapes. For example, the annular body 202 can have a circular cross-section, and the central flow tube 204 can have an oval cross-section. Furthermore, the cross-sectional shape of the central flow tube 204 and / or the annular body can also vary along the length of either. The cross-sectional shape of the central flow tube 204 can be selected at various points along its length (e.g., at the outflow end 212) to influence the flow direction.

[0081] The central flow tube 204 (and the flow path 206 therein) extends from an inflow end 210 and an outflow end 212. The inflow end 210 may be the end of the central flow tube 204 that is relatively upstream of the outflow end 212 with respect to blood flow through the cardiovascular implant device 200 when the cardiovascular implant device 200 is implanted in a blood vessel or chamber of the heart H, as indicated by Figure 7 . Accordingly, the outflow end 212 is the end of the central flow tube 204 that is relatively downstream of the inflow end 210 with respect to the blood flow through the cardiovascular implant device 200 when the cardiovascular implant device 200 is implanted in a blood vessel or chamber of the heart H, as indicated by Figure 7 Indicated by the arrow F in Figure 7In the example shown in FIG, the inflow end 210 is positioned on the left atrium side of the atrial septum IS, and the outflow end 212 is positioned downstream on the right atrium side of the atrial septum IS, so that blood can flow from the left atrium LA to the right atrium RA through the flow path 206. Figure 7 , the inflow end 210 may be substantially flush with the left atrial side of the atrial septum IS, while in some instances, the outflow end 212 may be spaced apart from the right atrial side of the atrial septum IS within the right atrium RA (i.e., the cardiovascular implant device 200 may extend further into the right atrium RA at the outflow end 212 than into the left atrium LA at the inflow end 210). In other instances, the inflow end 210, the outflow end 212, or both may be flush with or spaced apart from the respective sides of the tissue wall. Although the inflow end 210 is defined as being relatively upstream of the outflow end 212, it should be understood that other actual locations of the inflow end 210 or the outflow end 212 are possible, depending on the location at which the cardiovascular implant device 200 is implanted. The central flow tube 204 may have any suitable length as measured from the inflow end 210 to the outflow end 212. For example, central flow tube 204 can be designed to have a length that approximates the thickness of the atrial septum IS or another tissue wall in which cardiovascular implant device 200 is positioned. In other examples, central flow tube 204 can be longer or shorter than the thickness of the atrial septum IS or another tissue wall.

[0082] In general, the central flow tube 204 can be formed from any suitable material for forming a tubular structure surrounding the flow path 206. For example, all or a portion of the central flow tube 204 can be formed from a graft material. The graft material can be a synthetic material, such as woven polyester or polytetrafluoroethylene (PTFE), a biomaterial, a metallic material, or other materials, to name a few non-limiting examples. The central flow tube 204 formed from a graft material can be supported within the cardiovascular implant device 200 by the struts 203 of the annular body 202. In such examples, the central flow tube 204 can be attached to the struts 203 of the annular body 202 by any suitable attachment means, such as by suturing, gluing, tying, etc. In other examples, the central flow tube 204 can be rigidly formed with the annular body 204.

[0083] One or more anchoring members 208 extend outwardly from the annular body 202. When the cardiovascular implant device 200 is implanted in the body, the anchoring members 208 hold the cardiovascular implant device 200 in place in the tissue wall. The anchoring member 208 may take any suitable form for securing the cardiovascular implant device 200 to the tissue wall. In some instances, the anchoring member 208 may be one or more arms. In other instances, the anchoring member 208 may be a flange or annular lip configured to have a diameter larger than the diameter of the perforation or opening in which the cardiovascular implant device 200 is positioned, so as to prevent the cardiovascular implant device 200 from sliding out of the perforation or opening. In some instances, the anchoring member 208 may bend toward the tissue wall, or alternatively, may remain flush against the tissue wall. Figure 7 , cardiovascular implant device 200 can include one or more anchoring members 208 extending from one end of central flow tube 204. Specifically, cardiovascular implant device 200 can include anchoring members 208 adjacent to inflow end 210. In other examples, cardiovascular implant device 200 can include anchoring members 208 adjacent to outflow end 212. In still other examples, cardiovascular implant device 200 can include anchoring members 208 at both inflow end 210 and outflow end 212.

[0084] like Figure 7 As shown in , the cardiovascular implant device 200 includes a flap 240. The flap 240 is connected to the annular body 202 adjacent to the outflow end 212 of the central flow tube 204. In some examples, the flap 240 is sized and shaped to resemble a door or cover that would be mounted on one end of the cardiovascular implant device 200. In other examples, the flap 240 may have any suitable size and shape. In some examples, the flap 240 is solidly formed from a relatively flexible but impermeable material. In other examples, the periphery of the flap 240 is formed from a wire frame, and the impermeable cloth is stretched over the wire frame. For example, the wire frame may be formed from Nitinol (nickel titanium alloy) or a similar shape memory material. In yet other examples, all or a portion of the flap 240 may be formed from a biological material such as pericardium.

[0085] The flap 240 is connected to the annular body 202 via a flexible joint 242. The flap 240 can be positioned relative to the annular body 202 at the flexible joint 242. That is, the flap 240 can be pivoted at the flexible joint 242 to be positioned at different angles. In some examples, the flexible joint 242 is a hinge. In other examples, the flexible joint 242 is a piece of flexible material that connects the flap 240 to the annular body 202 or extends between the flap and the annular body. In still other examples, the flexible joint 242 can be any suitable flexible attachment mechanism. The cardiovascular implant device 200 may also include a stopper 244 adjacent to the flexible joint 242, which is used to prevent the flap 240 from moving beyond a maximum opening angle. For example, when there is a high-pressure flow through the cardiovascular implant device 200, the stopper 244 can prevent the flap 240 from completely flipping open (moving 180°).

[0086] The fin 240 is a flow diversion component of the cardiovascular implant device 200. The fin 240 is positioned or positionable to direct blood flow out of the cardiovascular implant device 200 in a specific direction. More specifically, the fin 240 is tilted to direct blood flow out of the cardiovascular implant device 200 in a specific direction. The fin 240 is positioned so that it is tilted toward the longitudinal axis LX2 passing through the central flow tube 204 (i.e., the axis AX2 of the fin 240 intersects the axis LX2). Figure 7 As shown in FIG, the flap 240 is configured to be inclined toward the tricuspid valve plane TVP (a plane containing the annular region of the tricuspid valve TV) by positioning the cardiovascular implant device 200, and thus directs blood flow from the cardiovascular implant device 200 toward the tricuspid valve plane TVP. Figure 5 In the curved portion 130 shown in FIG, flap 240 blocks the direction of blood flow out of cardiovascular implant device 200, forcing the blood flow to turn. When cardiovascular implant device 200 is implanted in the atrial septum IS, flap 240 is positioned to align blood flow out of cardiovascular implant device 200 with the natural flow pattern in the right atrium RA. Axis AX2 of flap 240 (which is generally parallel to the flow path of blood out of central flow tube 204 and can therefore be used to approximate the longitudinal axis aligned with the blood flow out of central flow tube 204) forms an angle α2 with a tissue wall plane TWP of the tissue wall (e.g., atrial septum IS) in which cardiovascular implant device 200 is configured to be positioned. Tissue wall plane TWP is a vertical reference plane defined by the tissue wall and is therefore generally perpendicular to the flow path 206 where it passes through the tissue wall. In some examples, angle α2 is between zero and seventy-five degrees (0°-75°).

[0087] Because flap 240 is attached to annular body 202 adjacent to outflow end 212, flap 240 is configured to extend partially into the right atrium RA when cardiovascular implant device 200 is implanted in interatrial septum IS. Flap 240 extends at an angle α2 relative to tissue wall plane TWP. In some examples, flap 240, when attached to annular body 202, is biased open at angle α2 to facilitate flow through and out of cardiovascular implant device 200. In other examples, flap 240 may be configured to open and close to a certain extent based on the pressure differential between the left atrium LA and the right atrium RA. In such examples, when there is a greater pressure differential between the left atrium LA and the right atrium RA, flow through cardiovascular implant device 200 may force flap 240 to open further, allowing greater flow through cardiovascular implant device 200. Flap 240 may be configured such that angle α2 is a maximum opening angle based on desired flow characteristics out of cardiovascular implant device 200. The maximum opening angle is set by stop 244.

[0088] Once the cardiovascular implant device 200 is implanted in the cardiovascular system (e.g., Figure 7 In the atrial septum IS or another tissue wall shown in FIG, circulating blood passes through the flow path 206 of the cardiovascular implant device 200. Figure 7 In the example shown in FIG, blood flows from the left atrium LA through the flow path 206 and into the right atrium RA. As blood flows out of the cardiovascular implant device 200, the flaps 240 align the blood flow with the natural blood flow pattern in the right atrium RA, so that the blood flow out of the cardiovascular implant device 200 merges with the natural blood flow pattern in the right atrium RA. More specifically, the flaps 240 align the blood flow out of the cardiovascular implant device 200 with the natural vortex flow pattern (i.e., the right-sided flow vortex) of the blood in the right atrium RA ( Figure 7 (indicated by the schematic streamlines labeled RVF in the figure). Figure 7 As shown by arrow F in FIG, blood flow exiting cardiovascular implant device 200 is directed in a tortuous path along the right atrial side of the atrial septum IS and toward the tricuspid valve plane TVP, rather than exiting through the right atrium RA and cutting or otherwise disrupting the natural vortex flow pattern. In this way, blood flow exiting cardiovascular implant device 200 can combine with blood flowing downward along the atrial septum IS and merge into the right atrial vortex.

[0089] Cardiovascular implant device 200 (including fins 240) can minimize or potentially enhance the disruption of natural flow patterns localized to the site of implantation of cardiovascular implant device 200 in heart H. When cardiovascular implant device 200 is implanted in the atrial septum IS, blood flowing from the left atrium LA to the right atrium RA through cardiovascular implant device 200 can be less disruptive to the natural rotational (e.g., vortex) flow pattern in the right atrium RA because the flow exiting cardiovascular implant device 200 is aligned with the natural vortex flow pattern, compared to conventional septal shunt devices, which can cause blood flow to eject through the right atrium. Using fins 240 to align the flow exiting cardiovascular implant device 200 with the natural flow pattern in a chamber or vessel of heart H minimizes any disruption to the natural flow pattern that might otherwise be caused by implanting a conventional shunt device without a directional component. Furthermore, aligning the flow exiting cardiovascular implant device 200 can potentially mitigate flow reduction or enhance baseline flow due to pathophysiological or other causes. Thus, the cardiovascular implant device 200 can maintain the kinetic energy of cardiovascular blood flow, which in turn reduces the required cardiac work and improves cardiac efficiency. These hemodynamic effects can potentially improve patient outcomes after receiving the cardiovascular implant device 200 because the cardiovascular implant device 200 can be more effective and potentially safer.

[0090] Device 300 ( Figures 8A-8B ) Figure 8A is a schematic cross-sectional view of a heart H showing a cardiovascular implant device 300 positioned adjacent to a shunt S in the atrial septum IS. Figure 8B is an enlarged side view of cardiovascular implant device 300. Figure 8A and 8B We will discuss them together. Figures 8A-8B As shown in FIG, cardiovascular implant device 300 includes an anchoring member 335, a tab 340, a flexible joint 342, and a stopper 344. Figure 8A Also shown are the heart H, right atrium RA, left atrium LA, superior vena cava SVC, inferior vena cava IVC, tricuspid valve TV, pulmonary vein PVS, mitral valve MV, and atrial septum IS. Figure 8A Further shown are the flow diverter S, the flow path SFP, the right atrial vortex RVF, the tissue wall plane TWP, the tricuspid valve plane TVP, the axis AX3, the axis LX3 and the angle α3.

[0091] The cardiovascular implant device 300 is an implantable device for use in the cardiovascular system. The cardiovascular implant device 300 is configured to be implanted in a blood vessel or chamber of the heart H. In the illustrated example, the cardiovascular implant device 300 is a flow diversion device independent of a shunt device, a stent device, or other implantable device. Specifically, as Figure 8A, cardiovascular implant device 300 is positioned adjacent to a shunt S in the atrial septum IS. In other examples, cardiovascular implant device 300 can be positioned adjacent to a perforation or opening in any other tissue wall between adjacent chambers and / or vessels of the heart H (or cardiovascular system). Shunt S is a non-implanted shunt between the left atrium LA and the right atrium RA that is formed by resecting tissue from the atrial septum IS to create an opening. In some examples, tissue can be resected to create shunt S by applying radiofrequency (RF) or other energy. Cardiovascular implant device 300 can be delivered into the cardiovascular system via a catheter (i.e., transcatheter delivery) or can be surgically placed using transcatheter or surgical procedures known in the art.

[0092] like Figure 8A As shown in , the shunt flow path SFP is an opening extending through the tissue wall, wherein the shunt S is formed so that the shunt S is open at each opposite end. The shunt flow path SFP is the path through which blood flows or is directed through the shunt S. Figure 8A In the example shown in FIG, the shunt flow path SFP spans the atrial septum IS and extends from the left atrium LA to the right atrium RA.

[0093] like Figures 8A-8B As shown in , the cardiovascular implant device 300 includes a flap 340. The flap 340 is connected to the anchoring member 335. In some examples, the size and shape of the flap 340 are set to be similar to a door or cover that will be installed on one end of the shunt S. In other examples, the flap 340 can have any suitable size and shape. In some examples, the flap 340 is solidly formed of a relatively flexible but impermeable material. In other examples, the periphery of the flap 340 is formed by a wire frame, and the impermeable cloth is stretched over the wire frame. For example, the wire frame can be formed of Nitinol (nickel titanium alloy) or a similar shape memory material. In yet other examples, all or a portion of the flap 340 can be formed of a biological material such as pericardium.

[0094] The anchoring member 335 is configured to secure the cardiovascular implant device 300 (including the fins 340) to the tissue wall. The anchoring member 335 may further include fasteners or other attachment mechanisms for anchoring the cardiovascular implant device 300 to the tissue wall. Figure 8A In the example shown in FIG, the anchoring member 335 secures the cardiovascular implant device 300 to the right atrial side of the atrial septum IS. The anchoring member 335 is positioned adjacent to the shunt S. More specifically, the anchoring member 335 is positioned above the shunt S relative to the orientation of the heart H when the human is upright, such that the flap 340 extends downwardly over the shunt S. In other examples, the anchoring member 335 can be positioned anywhere around the shunt S.

[0095] The flap 340 is connected to the anchoring member 335 via a flexible joint 342. The flap 340 can be positioned relative to the shunt S at the flexible joint 342. That is, the flap 340 can be pivoted at the flexible joint 342 and positioned at different angles. In some examples, the flexible joint 342 is a hinge. In other examples, the flexible joint 342 is a flexible material piece that connects the flap 340 to the anchoring member 335 or extends between the flap and the anchoring member. In still other examples, the flexible joint 342 can be any suitable flexible attachment mechanism. The cardiovascular implant device 300 may also include a stopper 344 adjacent to the flexible joint 342, which is used to prevent the flap 340 from moving beyond a maximum opening angle. For example, when there is a high-pressure flow through the shunt S, the stopper 344 can prevent the flap 340 from completely flipping open (moving 180°).

[0096] The fin 340 is a flow guide component of the cardiovascular implant device 300. The fin 340 is positioned or positionable to direct blood flow out of the shunt S in a specific direction. More specifically, the fin 340 is tilted to direct blood flow out of the shunt S in a specific direction. The fin 340 is positioned so that it is tilted toward the longitudinal axis LX3 passing through the shunt S (i.e., the axis AX3 of the fin 340 intersects the axis LX3). Figure 8A As shown in FIG, flap 340 is configured, through the positioning of cardiovascular implant device 300, to be tilted toward the tricuspid valve plane TVP (a plane containing the annular region of the tricuspid valve TV), thereby directing blood flow from shunt S toward the tricuspid valve plane TVP. Wing 340 blocks the direction of blood flow exiting shunt S, forcing the blood flow to turn. When cardiovascular implant device 300 is implanted in the atrial septum IS, flap 340 is positioned to align blood flow exiting shunt S with the natural flow pattern in the right atrium RA. Axis AX3 of flap 340 (which is generally parallel to the flow path of blood exiting shunt S and can therefore be used to approximate the longitudinal axis aligned with blood flow exiting shunt S) forms an angle α3 with a tissue wall plane TWP of the tissue wall to which cardiovascular implant device 300 is configured to be attached (e.g., the atrial septum IS). The tissue wall plane TWP is a vertical reference plane defined by the tissue wall and will therefore be substantially perpendicular to the diversion flow path SFP where it passes through the tissue wall. In some examples, the angle α3 is between zero and seventy-five degrees (0°-75°).

[0097] Because the flap 340 is attached to the anchoring member 335, the flap 340 is configured to extend partially into the right atrium RA when the cardiovascular implant device 300 is attached to the right atrial side of the atrial septum IS. The flap 340 extends at an angle α3 relative to the tissue wall plane TWP. In some examples, the flap 340 is biased open at the angle α3 when attached to the anchoring member 335 to facilitate flow through and out of the shunt S. In other examples, the flap 340 may be configured to open and close to a certain extent based on the pressure differential between the left atrium LA and the right atrium RA. In such examples, when there is a greater pressure differential between the left atrium LA and the right atrium RA, flow through the shunt S may force the flap 340 to open further, allowing greater flow through the shunt S. The flap 340 may be configured so that the angle α3 is the maximum opening angle based on the desired flow characteristics out of the shunt S. The maximum opening angle is set by the stop member 344.

[0098] Once the cardiovascular implant device 300 is implanted in the cardiovascular system (e.g., Figure 8A In the atrial septum IS or another tissue wall shown in FIG, the circulating blood passes through the shunt flow path SFP of the shunt member S. Figure 8A In the example shown in FIG, blood flows from the left atrium LA through the flow path SFP and into the right atrium RA. As the blood flows out of the shunt S, the flap 340 aligns the blood flow with the natural blood flow pattern in the right atrium RA, so that the blood flow out of the shunt S merges with the natural blood flow pattern in the right atrium RA. More specifically, the flap 340 aligns the blood flow out of the shunt S with the natural vortex flow pattern (i.e., the right flow vortex) of the blood in the right atrium RA (i.e., the right flow vortex). Figure 8A (indicated by the schematic streamlines labeled RVF in the figure). Figure 8A As shown by arrows F in FIG, blood flow exiting the shunt S is directed in a tortuous path along the right atrial side of the atrial septum IS and toward the tricuspid valve plane TVP, rather than exiting through the right atrium RA and cutting or otherwise disrupting the natural vortex flow pattern. In this way, blood flow exiting the shunt S can combine with blood flowing downward along the atrial septum IS and merge into the right atrial vortex.

[0099] Cardiovascular implant device 300 (including fins 340) can minimize or potentially enhance the natural flow patterns localized to the site of implantation of cardiovascular implant device 300 in heart H. When cardiovascular implant device 300 is implanted in the atrial septum IS, blood flowing from the left atrium LA to the right atrium RA through shunt S can be less disruptive to the natural rotational (e.g., vortex) flow patterns in the right atrium RA because the flow exiting shunt S is aligned with the natural vortex flow pattern, compared to conventional septal shunt devices, which can cause blood flow to eject through the right atrium. Aligning the flow exiting shunt S with the natural flow patterns in the chambers or vessels of heart H using fins 340 minimizes any disruption to the natural flow patterns that might otherwise result from implantation of conventional shunt devices without directional components. Furthermore, aligning the flow exiting shunt S can potentially mitigate flow reductions or enhance baseline flow due to pathophysiological or other causes. Thus, cardiovascular implant device 300 can maintain the kinetic energy of cardiovascular blood flow, which in turn reduces the required cardiac work and improves cardiac efficiency. These hemodynamic effects can potentially improve patient outcomes after receiving cardiovascular implant device 300, as cardiovascular implant device 300 can be more effective and potentially safer.

[0100] In addition, as from Figure 7-8B As will be apparent from the above, flaps such as flap 240 or flap 340 can be used as a modification to a shunt device (e.g., cardiovascular implant device 200) or as a standalone flow-directing feature (e.g., cardiovascular implant device 300). This allows flaps 240, 340 to have a multifunctional feature that can be used for both patients who are about to undergo a shunt device placement procedure and patients who are actually undergoing a non-device shunt procedure.

[0101] Device 400 ( Figure 9 ) Figure 9 is a schematic cross-sectional view of a heart H showing a cardiovascular implant device 400 positioned in the atrial septum IS and including an inner guide wall 450. Figure 9 As shown in FIG, cardiovascular implant device 400 includes an annular body 402 including struts 403, a central flow tube 404, and a flow path 406; and an anchoring member 408. Central flow tube 404 includes an inflow end 410, an outflow end 412, and a flow surface 414. Cardiovascular implant device 400 further includes a guide wall 450 and a spiral flow path 452. Figure 9 Also shown are the heart H, right atrium RA, left atrium LA, superior vena cava SVC, inferior vena cava IVC, tricuspid valve TV, pulmonary vein PVS, mitral valve MV, and atrial septum IS. Figure 9 Further displayed are the right atrial vortex RVF, tissue wall plane TWP, tricuspid valve plane TVP, outer diameter OD, axis AX4 and angle α4.

[0102] The cardiovascular implant device 400 is an implantable device for use in the cardiovascular system. The cardiovascular implant device 400 is configured to be implanted in a blood vessel or chamber of the heart H. In the example shown, the cardiovascular implant device 400 is a diversion device for diverting blood from one blood vessel or chamber to another blood vessel or chamber. Specifically, Figure 9 , cardiovascular implant device 400 is positioned in the atrial septum IS. In other examples, cardiovascular implant device 400 may be positioned in any other tissue wall between adjacent chambers and / or blood vessels of heart H (or cardiovascular system). Cardiovascular implant device 400 may be delivered into the cardiovascular system via a catheter (i.e., transcatheter delivery) or may be surgically placed using transcatheter or surgical procedures known in the art.

[0103] The annular body 402 is the main portion of the cardiovascular implant device 400. The annular body 402 may be expandable. The annular body 402 is generally cylindrical and tubular in cross-section, but may have a variety of different shapes and sizes. The annular body 402 may be pressed against or pressed into the tissue wall at the implant site or configured (or extended) around the anatomical structure of the cardiovascular system to set and maintain the position of the cardiovascular implant device 400. In some examples, for example, Figure 9 , annular body 402 can be formed from a plurality of struts 403. Struts 403 can form a lattice or grid of annular body 402 and define openings therein. In such examples, annular body 402 can be a stent framework structure for supporting a graft material that directs flow through cardiovascular implant device 400. In other examples, annular body 402 can be rigidly formed.

[0104] The annular body 402 can be positioned in a perforation in a tissue wall to hold the tissue wall open around the annular body 402 so that blood can flow between blood vessels or chambers of the heart H through the cardiovascular implant device 400. Figure 9 In the example shown in , the annular body 402 is positioned in a perforation in the atrial septum IS between the left atrium LA and the right atrium RA, allowing blood to flow from the left atrium LA to the right atrium RA through the cardiovascular implant device 400. In some examples, the struts 403 of the annular body 402 form a cage sufficient to hold the tissue wall open around the annular body 402. In other examples, the material forming the annular body 402 is strong enough to hold the tissue wall open around the annular body 402.

[0105] Annular body 402 has an outer diameter OD. Outer diameter OD is the diameter of annular body 402 as measured from the exterior surface of cardiovascular implant device 400. Outer diameter OD is configured to be approximately the same size as the diameter of a perforation in a tissue wall into which cardiovascular implant device 400 will be implanted, enabling annular body 402 to fit within the perforation. Outer diameter OD can have any size, allowing cardiovascular implant device 400 to be sized to suit a variety of patient conditions and / or anatomies. In some examples, outer diameter OD can also vary along the length of annular body 402 based on the overall shape or profile of annular body 402.

[0106] The annular body 402 includes a central flow tube 404, which serves as a conduit for directing flow through the cardiovascular implant device 400. The central flow tube 404 surrounds a flow path 406. The flow path 406 is an opening extending through the central flow tube 404, so that the cardiovascular implant device 400 is open at each opposite end. The flow path 406 is the path through which blood flows or is directed through the cardiovascular implant device 400. The central flow tube 404 includes a flow surface 414, which is configured to be a flow contact surface when the cardiovascular implant device 400 is implanted in a blood vessel or chamber of the heart H. The flow surface 414 is the radially inner surface of the central flow tube 404. The flow path 406 through the central flow tube 404 is defined by the flow surface 414.

[0107] The profile of the central flow tube 404 and the flow path 406 can be straight, curved, a combination of straight sections and curved sections, or any other suitable shape. In some examples, the profile of the central flow tube 404 and the flow path 406 can be defined by or identical to the profile of the annular body 402 (e.g., as shown in FIG. Figure 5 In other examples, the profile of the central flow tube 404 and the flow path 406 may be independent of or different from the profile of the annular body 402 (e.g., as shown in FIG. Figure 6 ). Similarly, the cross-sectional shape or profile of the central flow tube 404 and the annular body 402 can be the same, such as circular, oval, etc. Alternatively, the central flow tube 404 and the annular body 402 can have different cross-sectional shapes. For example, the annular body 402 can have a circular cross-section, and the central flow tube 404 can have an oval cross-section. Furthermore, the cross-sectional shape of the central flow tube 404 and / or the annular body can also vary along the length of either. The cross-sectional shape of the central flow tube 404 can be selected at various points along its length (e.g., at the outflow end 412) to influence the flow direction.

[0108] The central flow tube 404 (and the flow path 406 therein) extends from an inflow end 410 and an outflow end 412. The inflow end 410 may be the end of the central flow tube 404 that is relatively upstream of the outflow end 412 with respect to blood flow through the cardiovascular implant device 400 when the cardiovascular implant device 400 is implanted in a blood vessel or chamber of the heart H, as indicated by Figure 9 . Accordingly, outflow end 412 is the end of central flow tube 404 that is relatively downstream of inflow end 410 relative to blood flow through cardiovascular implant device 400 when cardiovascular implant device 400 is implanted in a blood vessel or chamber of heart H, as indicated by Figure 9 Indicated by the arrow F in Figure 9 In the example shown in FIG, the inflow end 410 is positioned on the left atrium side of the atrial septum IS, and the outflow end 412 is positioned downstream on the right atrium side of the atrial septum IS, so that blood can flow from the left atrium LA to the right atrium RA through the flow path 406. Figure 9 , the inflow end 410 may be substantially flush with the left atrial side of the atrial septum IS, while in some instances, the outflow end 412 may be spaced apart from the right atrial side of the atrial septum IS within the right atrium RA (i.e., the cardiovascular implant device 400 may extend further into the right atrium RA at the outflow end 412 than into the left atrium LA at the inflow end 410). In other instances, the inflow end 410, the outflow end 412, or both, may be flush with or spaced apart from the respective sides of the tissue wall. Although the inflow end 410 is defined as being relatively upstream of the outflow end 412, it should be understood that other actual locations of the inflow end 410 or the outflow end 412 are possible, depending on the location at which the cardiovascular implant device 400 is implanted. The central flow tube 404 may have any suitable length as measured from the inflow end 410 to the outflow end 412. For example, central flow tube 404 can be designed to have a length that approximates the thickness of the atrial septum IS or another tissue wall in which cardiovascular implant device 400 is positioned. In other examples, central flow tube 404 can be longer or shorter than the thickness of the atrial septum IS or another tissue wall.

[0109] In general, the central flow tube 404 can be formed from any suitable material for forming a tubular structure surrounding the flow path 406. For example, all or a portion of the central flow tube 404 can be formed from a graft material. The graft material can be a synthetic material, such as woven polyester or polytetrafluoroethylene (PTFE), a biomaterial, a metallic material, or other materials, to name a few non-limiting examples. The central flow tube 404 formed from a graft material can be supported within the cardiovascular implant device 400 by the struts 403 of the annular body 402. In such examples, the central flow tube 404 can be attached to the struts 403 of the annular body 402 by any suitable attachment means, such as by suturing, gluing, tying, etc. In other examples, the central flow tube 404 can be rigidly formed with the annular body 404.

[0110] One or more anchoring members 408 extend outwardly from the annular body 402. When the cardiovascular implant device 400 is implanted in the body, the anchoring members 408 hold the cardiovascular implant device 400 in place in the tissue wall. The anchoring member 408 may take any suitable form for securing the cardiovascular implant device 400 to the tissue wall. In some instances, the anchoring member 408 may be one or more arms. In other instances, the anchoring member 408 may be a flange or annular lip configured to have a diameter larger than the diameter of the perforation or opening in which the cardiovascular implant device 400 is positioned, so as to prevent the cardiovascular implant device 400 from sliding out of the perforation or opening. In some instances, the anchoring member 408 may bend toward the tissue wall, or alternatively, may remain flush against the tissue wall. Figure 9 , cardiovascular implant device 400 may include one or more anchoring members 408 extending from one end of central flow tube 404. Specifically, cardiovascular implant device 400 may include anchoring members 408 adjacent to inflow end 410. In other examples, cardiovascular implant device 400 may include anchoring members 408 adjacent to outflow end 412. In still other examples, cardiovascular implant device 400 may include anchoring members 408 at both inflow end 410 and outflow end 412.

[0111] like Figure 9 As shown in FIG, the cardiovascular implant device 400 includes a guide wall 450. The guide wall 450 is a spiral wall. In some examples, the guide wall 450 is spiral-shaped. The guide wall 450 is connected to the flow surface 414 of the central flow tube 404 (i.e., the radially inner surface of the central flow tube 404). Specifically, the guide wall 450 is circumferentially attached to the flow surface 414. Because the cardiovascular implant device 400 is Figure 9 It is shown in cross section, so Figure 9Only a portion of the guide wall 450 (one side or half relative to the central flow tube 404) is depicted, and the connecting portion is cut away. The guide wall 450 extends from the inflow end 410 to the outflow end 412 inside the central flow tube 404. Figure 9 In the diagram, the interior of the central flow tube 404 is schematically illustrated by dashed and solid lines, with guide walls 450 encircling the interior like a slide from the inflow end 410 to the outflow end 412. Due to the helical nature of the guide walls 450, the flow path 406 extending through the central flow tube 404 is also a helical flow path 452. The helical shape of the helical flow path 452 is defined by the arrangement of the guide walls 450 within the central flow tube 404.

[0112] Typically, the structures within the interior of the central flow tube 404, including the guide wall 450, can be configured to be collapsible or can have physical dimensions sized to avoid interference with other components when the cardiovascular implant device 400 is to be delivered using a catheter. Surgical delivery scenarios may not have the same size-related limitations for implementing the guide wall 450.

[0113] The guide wall 450 is a flow guide component of the cardiovascular implant device 400. More specifically, the guide wall 450 is arranged and positioned to guide blood flow through the central flow tube 404 and direct the blood flow out of the cardiovascular implant device 400 in a specific direction. The guide wall 450 is positioned to prevent the blood flow through the central flow tube 404 from flowing in a straight path through the cardiovascular implant device 400. Instead, the blood flowing through the central flow tube 404 flows through the spiral flow path 452. Figure 9 As shown in FIG, the guide wall 450 is configured to guide blood flow from the cardiovascular implant device 400 toward the tricuspid valve plane TVP (a plane containing the annular region of the tricuspid valve TV). When the cardiovascular implant device 400 is implanted in the atrial septum IS, the guide wall 450 is positioned so that the blood flow out of the cardiovascular implant device 400 is aligned with the natural flow pattern in the right atrium RA. Figure 9 As shown in FIG, axis AX4 is the longitudinal axis aligned with blood flow exiting central flow tube 404. Axis AX4 forms an angle α4 with a tissue wall plane TWP of the tissue wall (e.g., interatrial septum IS) in which cardiovascular implant device 400 is configured to be positioned. Tissue wall plane TWP is a vertical reference plane defined by the tissue wall and, therefore, will be substantially perpendicular to flow path 406 where it passes through the tissue wall. Angle α4 can be considered the exit angle of blood exiting cardiovascular implant device 400. In some examples, angle α4 is between zero and seventy-five degrees (0°-75°).

[0114] Once the cardiovascular implant device 400 is implanted into the cardiovascular system (e.g., Figure 9In the atrial septum IS or another tissue wall shown in FIG, circulating blood passes through the flow path 406 of the cardiovascular implant device 400. Figure 9 In the example shown in FIG, blood flows from the left atrium LA through the flow path 406 (the spiral flow path 452) and into the right atrium RA. As the blood flows through the cardiovascular implant device 400, the guide walls 450 guide the blood flow so that the blood flow exiting the cardiovascular implant device 400 aligns with and merges with the natural flow pattern of blood in the right atrium RA. The guide walls 450 may also impart a rotational velocity to the blood flow through the flow path 406 to help align the flow. More specifically, the guide walls 450 guide the blood flow through the cardiovascular implant device 400 so that the blood flow exiting the cardiovascular implant device 400 aligns with and merges with the natural vortex flow pattern of blood in the right atrium RA (i.e., the right-sided flow vortex) (in FIG. Figure 9 (indicated by the schematic streamlines labeled RVF in the figure) are aligned and combined. Figure 9 As shown by arrows F in FIG, blood flow exiting cardiovascular implant device 400 is directed in a tortuous path along the right atrial side of the atrial septum IS and toward the tricuspid valve plane TVP, rather than exiting through the right atrium RA and cutting or otherwise disrupting the natural vortex flow pattern. In this way, blood flow exiting cardiovascular implant device 400 can combine with blood flowing downward along the atrial septum IS and merge into the right atrial vortex.

[0115] Cardiovascular implant device 400 (including guide wall 450) can minimize or potentially enhance the disruption of natural flow patterns localized to the site of implantation of cardiovascular implant device 400 in heart H. When cardiovascular implant device 400 is implanted in the atrial septum IS, blood flowing from the left atrium LA to the right atrium RA through cardiovascular implant device 400 can be less disruptive to the natural rotational (e.g., vortex) flow pattern in the right atrium RA because the flow exiting cardiovascular implant device 400 is aligned with the natural vortex flow pattern, compared to conventional septal shunt devices, which can cause blood flow to eject through the right atrium. Using guide wall 450 to align the flow exiting cardiovascular implant device 400 with the natural flow pattern in a chamber or vessel of heart H minimizes any disruption to the natural flow pattern that might otherwise be caused by implanting a conventional shunt device without a directional component. Furthermore, aligning the flow exiting cardiovascular implant device 400 can potentially mitigate flow reduction or enhance baseline flow due to pathophysiological or other causes. Thus, cardiovascular implant device 400 can maintain the kinetic energy of cardiovascular blood flow, which in turn reduces the required cardiac work and improves cardiac efficiency. These hemodynamic effects can potentially improve patient outcomes after receiving cardiovascular implant device 400 because cardiovascular implant device 400 can be more effective and potentially safer.

[0116] Device 500 ( Figures 10A-10B ) Figure 10A is a schematic cross-sectional view of a heart H showing a cardiovascular implant device 500 positioned in an atrial septum IS and comprising an internal leaflet 560. Figure 10B is an enlarged schematic cross-sectional view of the atrial septum IS showing details of cardiovascular implant device 500. Figure 10A and 10B We will discuss them together. Figures 10A-10B As shown in FIG, cardiovascular implant device 500 includes an annular body 502 including struts 503, a central flow tube 504, and a flow path 506; and an anchoring member 508. Central flow tube 504 includes an inflow end 510, an outflow end 512, and a flow surface 514. Cardiovascular implant device 500 further includes blades 560 and a shaft 562. Each blade 560 includes a root portion 564 and a tip portion 566. Figures 10A-10B The right atrium RA, left atrium LA, and atrial septum IS are shown. Figure 10A Also shown are the heart H, superior vena cava SVC, inferior vena cava IVC, tricuspid valve TV, pulmonary veins PVS, and mitral valve MV. Figures 10A-10B Further shown are the tissue wall plane TWP, outer diameter OD, axis AX5 and angle α5. Figure 10A Also demonstrated are right atrial vortex flow (RVF) and tricuspid valve plane (TVP).

[0117] The cardiovascular implant device 500 is an implantable device for use in the cardiovascular system. The cardiovascular implant device 500 is configured to be implanted in a blood vessel or chamber of the heart H. In the example shown, the cardiovascular implant device 500 is a diversion device for diverting blood from one blood vessel or chamber to another blood vessel or chamber. Specifically, Figures 10A-10B , cardiovascular implant device 500 is positioned in the atrial septum IS. In other examples, cardiovascular implant device 500 may be positioned in any other tissue wall between adjacent chambers and / or blood vessels of heart H (or cardiovascular system). Cardiovascular implant device 500 may be delivered into the cardiovascular system via a catheter (i.e., transcatheter delivery) or may be surgically placed using transcatheter or surgical procedures known in the art.

[0118] The annular body 502 is the main portion of the cardiovascular implant device 500. The annular body 502 may be expandable. The annular body 502 is generally cylindrical and tubular in cross-section, but may have a variety of different shapes and sizes. The annular body 502 may be pressed against or pressed into the tissue wall at the implant site or configured (or extended) around the anatomical structure of the cardiovascular system to set and maintain the position of the cardiovascular implant device 500. In some examples, for example, Figures 10A-10B, annular body 502 can be formed from a plurality of struts 503. Struts 503 can form a lattice or grid of annular body 502 and define openings therein. In such examples, annular body 502 can be a stent framework structure for supporting a graft material that directs flow through cardiovascular implant device 500. In other examples, annular body 502 can be rigidly formed.

[0119] The annular body 502 can be positioned in a perforation in a tissue wall to hold the tissue wall open around the annular body 502 so that blood can flow between blood vessels or chambers of the heart H through the cardiovascular implant device 500. Figures 10A-10B In the example shown in , the annular body 502 is positioned in a perforation in the atrial septum IS between the left atrium LA and the right atrium RA, allowing blood to flow from the left atrium LA to the right atrium RA through the cardiovascular implant device 500. In some examples, the struts 503 of the annular body 502 form a cage sufficient to hold the tissue wall open around the annular body 502. In other examples, the material forming the annular body 502 is strong enough to hold the tissue wall open around the annular body 502.

[0120] Annular body 502 has an outer diameter OD. Outer diameter OD is the diameter of annular body 502 as measured from the exterior surface of cardiovascular implant device 500. Outer diameter OD is configured to be approximately the same size as the diameter of a perforation in a tissue wall into which cardiovascular implant device 500 will be implanted, enabling annular body 502 to fit within the perforation. Outer diameter OD can have any size, allowing cardiovascular implant device 500 to be sized to suit a variety of patient conditions and / or anatomies. In some examples, outer diameter OD can also vary along the length of annular body 502 based on the overall shape or profile of annular body 502.

[0121] The annular body 502 includes a central flow tube 504, which serves as a conduit for directing flow through the cardiovascular implant device 500. The central flow tube 504 surrounds a flow path 506. The flow path 506 is an opening extending through the central flow tube 504, so that the cardiovascular implant device 500 is open at each opposite end. The flow path 506 is the path through which blood flows or is directed through the cardiovascular implant device 500. The central flow tube 504 includes a flow surface 514, which is configured to be a flow contact surface when the cardiovascular implant device 500 is implanted in a blood vessel or chamber of the heart H. The flow surface 514 is the radially inner surface of the central flow tube 504. The flow path 506 through the central flow tube 504 is defined by the flow surface 514.

[0122] The profile of the central flow tube 504 and the flow path 506 can be straight, curved, a combination of straight sections and curved sections, or any other suitable shape. In some examples, the profile of the central flow tube 504 and the flow path 506 can be defined by or identical to the profile of the annular body 502 (e.g., as shown in FIG. Figure 5 In other examples, the profile of the central flow tube 504 and the flow path 506 may be independent of or different from the profile of the annular body 502 (e.g., as shown in FIG. Figure 6 ). Similarly, the cross-sectional shape or profile of the central flow tube 504 and the annular body 502 can be the same, such as circular, oval, etc. Alternatively, the central flow tube 504 and the annular body 502 can have different cross-sectional shapes. For example, the annular body 502 can have a circular cross-section, and the central flow tube 504 can have an oval cross-section. Furthermore, the cross-sectional shape of the central flow tube 504 and / or the annular body can also vary along the length of either. The cross-sectional shape of the central flow tube 504 can be selected at various points along its length (e.g., at the outflow end 512) to influence the flow direction.

[0123] The central flow tube 504 (and the flow path 506 therein) extends from an inflow end 510 and an outflow end 512. The inflow end 510 can be the end of the central flow tube 504 that is relatively upstream of the outflow end 512 with respect to blood flow through the cardiovascular implant device 500 when the cardiovascular implant device 500 is implanted in a blood vessel or chamber of the heart H, as indicated by Figures 10A-10B . Accordingly, outflow end 512 is the end of central flow tube 504 that is relatively downstream of inflow end 510 relative to blood flow through cardiovascular implant device 500 when cardiovascular implant device 500 is implanted in a blood vessel or chamber of heart H, as indicated by Figures 10A-10B Indicated by the arrow F in Figures 10A-10B In the example shown in FIG, the inflow end 510 is positioned on the left atrium side of the atrial septum IS, and the outflow end 512 is positioned downstream on the right atrium side of the atrial septum IS, so that blood can flow from the left atrium LA to the right atrium RA through the flow path 506. Figures 10A-10B, the inflow end 510 may be substantially flush with the left atrial side of the atrial septum IS, while in some instances, the outflow end 512 may be spaced apart from the right atrial side of the atrial septum IS within the right atrium RA (i.e., the cardiovascular implant device 500 may extend further into the right atrium RA at the outflow end 512 than into the left atrium LA at the inflow end 510). In other instances, the inflow end 510, the outflow end 512, or both may be flush with or spaced apart from the respective sides of the tissue wall. Although the inflow end 510 is defined as being relatively upstream of the outflow end 512, it should be understood that other actual locations of the inflow end 510 or the outflow end 512 are possible, depending on the location at which the cardiovascular implant device 500 is implanted. The central flow tube 504 may have any suitable length as measured from the inflow end 510 to the outflow end 512. For example, central flow tube 504 can be designed to have a length that approximates the thickness of the atrial septum IS or another tissue wall in which cardiovascular implant device 500 is positioned. In other examples, central flow tube 504 can be longer or shorter than the thickness of the atrial septum IS or another tissue wall.

[0124] In general, the central flow tube 504 can be formed from any suitable material for forming a tubular structure surrounding the flow path 506. For example, all or a portion of the central flow tube 504 can be formed from a graft material. The graft material can be a synthetic material, such as woven polyester or polytetrafluoroethylene (PTFE), a biomaterial, a metallic material, or other materials, to name a few non-limiting examples. The central flow tube 504 formed from a graft material can be supported within the cardiovascular implant device 500 by the struts 503 of the annular body 502. In such examples, the central flow tube 504 can be attached to the struts 503 of the annular body 502 by any suitable attachment means, such as by suturing, gluing, tying, etc. In other examples, the central flow tube 504 can be rigidly formed with the annular body 504.

[0125] One or more anchoring members 508 extend outwardly from the annular body 502. When the cardiovascular implant device 500 is implanted in the body, the anchoring members 508 hold the cardiovascular implant device 500 in place in the tissue wall. The anchoring member 508 may take any suitable form for securing the cardiovascular implant device 500 to the tissue wall. In some instances, the anchoring member 508 may be one or more arms. In other instances, the anchoring member 508 may be a flange or annular lip configured to have a diameter that is larger than the diameter of the perforation or opening in which the cardiovascular implant device 500 is positioned, so as to prevent the cardiovascular implant device 500 from sliding through the perforation or opening. In some instances, the anchoring member 508 may be bent toward the tissue wall, or alternatively, may remain flush against the tissue wall. Figures 10A-10B, cardiovascular implant device 500 can include one or more anchoring members 508 extending from one end of central flow tube 504. Specifically, cardiovascular implant device 500 can include anchoring members 508 adjacent to inflow end 510. In other examples, cardiovascular implant device 500 can include anchoring members 508 adjacent to outflow end 512. In still other examples, cardiovascular implant device 500 can include anchoring members 508 at both inflow end 510 and outflow end 512.

[0126] like Figures 10A-10B As shown in , cardiovascular implant device 500 includes blades 560 connected to a shaft 562. Shaft 562 extends longitudinally through central flow tube 504. In some examples, shaft 562 is attached to central flow tube 504 by extension of wires or other attachment mechanisms at inflow end 510 and outflow end 512, or at other locations along the length of central flow tube 504. Generally, the structures within central flow tube 504 (including blades 560 and shaft 562) can be configured to be collapsible or can have physical dimensions that are sized to avoid interference with other components when cardiovascular implant device 500 is to be delivered using a catheter. Surgical delivery examples may not have the same size-related limitations for implementing blades 560.

[0127] The blades 560 extend radially around the shaft 562. Each of the blades 560 includes a corresponding root portion 564 and a tip portion 566. The root portion 564 is the proximal portion of the blade 560 adjacent to the shaft 562. The tip portion 566 is the distal portion of the blade 560. Each of the blades 560 extends radially from the root portion 564 to the tip portion 566 (or radially from the shaft 562 toward the flow surface 514). The tip portion 566 may be spaced apart from the flow surface 514.

[0128] The blades 560 may be arranged in one or more groups of blades 560 along the length of the shaft 562. The blades 560 may also be arranged in one or more rings around the shaft 562. That is, although Figures 10A-10B A single set of blades 560 is shown, but other examples may include multiple sets of blades 560 arranged in separate rings. In one example, one set of blades 560 is a stator (i.e., the blades 560 are stationary). In another example, one set of blades 560 is a rotor (i.e., the blades 560 are rotatable). In such an example, shaft 562 may include a concentric stationary shaft and a rotatable portion to which blades 560 are connected. The selection of stators, rotors, or a combination of stators and rotors for blades 560 may be based on the desired flow characteristics of blood flowing through cardiovascular implant device 500.

[0129] The blades 560 are flow guide components of the cardiovascular implant device 500. More specifically, the blades 560 are arranged and positioned to guide blood flow through the central flow tube 504 and to guide the blood flow out of the cardiovascular implant device 500 in a specific direction. Figure 10A As shown in FIG, the leaflets 560 are configured to direct blood flow from the cardiovascular implant device 500 toward the tricuspid valve plane TVP (a plane containing the annular region of the tricuspid valve TV). When the cardiovascular implant device 500 is implanted in the atrial septum IS, the leaflets 560 are positioned so that the blood flow out of the cardiovascular implant device 500 is aligned with the natural flow pattern in the right atrium RA. Figures 10A-10B As shown in FIG, axis AX5 is the longitudinal axis aligned with blood flow exiting central flow tube 504. Axis AX5 forms an angle α5 with a tissue wall plane TWP of the tissue wall (e.g., interatrial septum IS) in which cardiovascular implant device 500 is configured to be positioned. Tissue wall plane TWP is a vertical reference plane defined by the tissue wall and, therefore, will be substantially perpendicular to flow path 506 where it passes through the tissue wall. Angle α5 can be considered the exit angle of blood exiting cardiovascular implant device 400. In some examples, angle α5 is between zero and seventy-five degrees (0°-75°).

[0130] Once the cardiovascular implant device 500 is implanted in the cardiovascular system (e.g., Figures 10A-10B In the atrial septum IS or another tissue wall shown in FIG, circulating blood passes through the flow path 506 of the cardiovascular implant device 500. Figures 10A-10B In the example shown in FIG, blood flows from the left atrium LA through the flow path 506 and into the right atrium RA. As blood flows through the cardiovascular implant device 500, the blades 560 direct the blood flow so that the blood flow exiting the cardiovascular implant device 500 aligns with and merges with the natural flow pattern of blood in the right atrium RA. The blades 560 may also impart a rotational velocity to the blood flow through the flow path 506 to help align the flow. More specifically, the blades 560 direct the blood flow through the cardiovascular implant device 500 so that the blood flow exiting the cardiovascular implant device 500 aligns with and merges with the natural vortex flow pattern of blood in the right atrium RA (i.e., the right-sided flow vortex) ( Figure 10A (indicated by the schematic streamlines labeled RVF in the figure) are aligned and combined. Figure 10A As shown by arrows F in FIG, blood flow exiting cardiovascular implant device 500 is directed in a tortuous path along the right atrial side of the atrial septum IS and toward the tricuspid valve plane TVP, rather than exiting through the right atrium RA and cutting or otherwise disrupting the natural vortex flow pattern. In this way, blood flow exiting cardiovascular implant device 500 can combine with blood flowing downward along the atrial septum IS and merge into the right atrial vortex.

[0131] Cardiovascular implant device 500 (including vanes 560) can minimize or potentially enhance the natural flow patterns localized to the site of implantation of cardiovascular implant device 500 in heart H. When cardiovascular implant device 500 is implanted in the atrial septum IS, blood flowing from the left atrium LA to the right atrium RA through cardiovascular implant device 500 can be less disruptive to the natural rotational (e.g., vortex) flow patterns in the right atrium RA because the flow exiting cardiovascular implant device 500 is aligned with the natural vortex flow pattern, compared to conventional septal shunt devices, which can cause blood flow to eject through the right atrium. Aligning the flow exiting cardiovascular implant device 500 with the natural flow patterns in the chambers or vessels of heart H using vanes 560 minimizes any disruption to the natural flow patterns that might otherwise be caused by implanting conventional shunt devices without directional components. Furthermore, aligning the flow exiting cardiovascular implant device 500 can potentially mitigate flow reductions or enhance baseline flow due to pathophysiological or other causes. Thus, the cardiovascular implant device 500 can maintain the kinetic energy of cardiovascular blood flow, which in turn reduces the required cardiac work and improves cardiac efficiency. These hemodynamic effects can potentially improve patient outcomes after receiving the cardiovascular implant device 500 because the cardiovascular implant device 500 can be more effective and potentially safer.

[0132] Devices 600 and 100A ( Figure 11-13 ) Figure 11 is a schematic cross-sectional view of a heart H showing a cardiovascular implant device 600 positioned in an atrial septum IS and including an adjustable portion 670. Figure 12A is an enlarged schematic diagram of the adjustable portion 670 in the compressed configuration 680 . Figure 12B is an enlarged schematic diagram of the adjustable portion 670 in the expanded configuration 685. Figure 11-12B We will discuss them together. Figure 11 As shown in FIG, cardiovascular implant device 600 includes an annular body 602 including struts 603, a central flow tube 604, and a flow path 606; and an anchoring member 608. Central flow tube 604 includes an inflow end 610, an outflow end 612, and a flow surface 614. Central flow tube 604 further includes a straight portion 620 and an adjustable portion 670. Adjustable portion 670 includes accordion folds 672. Figure 11 Also shown are the heart H, right atrium RA, left atrium LA, superior vena cava SVC, inferior vena cava IVC, tricuspid valve TV, pulmonary vein PVS, mitral valve MV, and atrial septum IS. Figure 11 Further displayed are the right atrial vortex RVF, tissue wall plane TWP, tricuspid valve plane TVP, outer diameter OD, axis AX6 and angle α6. Figure 12A A compressed configuration 680 is shown, and Figure 12B An expanded configuration 685 is shown.

[0133] The cardiovascular implant device 600 is an implantable device for use in the cardiovascular system. The cardiovascular implant device 600 is configured to be implanted in a blood vessel or chamber of the heart H. In the example shown, the cardiovascular implant device 600 is a diversion device for diverting blood from one blood vessel or chamber to another blood vessel or chamber. Specifically, Figure 11 , cardiovascular implant device 600 is positioned in the atrial septum IS. In other examples, cardiovascular implant device 600 may be positioned in any other tissue wall between adjacent chambers and / or blood vessels of heart H (or cardiovascular system). Cardiovascular implant device 600 may be delivered into the cardiovascular system via a catheter (i.e., transcatheter delivery) or may be surgically placed using transcatheter or surgical procedures known in the art.

[0134] The annular body 602 is the main body of the cardiovascular implant device 600. The annular body 602 can be expandable. The annular body 602 is generally cylindrical and tubular in cross-section, but can have a variety of different shapes and sizes. The annular body 602 can be pressed against or pressed into the tissue wall at the implant site or configured (or extended) around the anatomical structure of the cardiovascular system to set and maintain the position of the cardiovascular implant device 600. In some examples, such as Figure 11 , annular body 602 can be formed from a plurality of struts 603. Struts 603 can form a lattice or grid of annular body 602 and define openings therein. In such examples, annular body 602 can be a stent framework structure for supporting a graft material that directs flow through cardiovascular implant device 600. In other examples, annular body 602 can be rigidly formed.

[0135] The annular body 602 can be positioned in a perforation in a tissue wall to hold the tissue wall open around the annular body 602 so that blood can flow between blood vessels or chambers of the heart H through the cardiovascular implant device 600. Figure 11 , the annular body 602 is positioned in a perforation in the atrial septum IS between the left atrium LA and the right atrium RA, allowing blood to flow from the left atrium LA to the right atrium RA through the cardiovascular implant device 600. In some examples, the struts 603 of the annular body 602 form a cage sufficient to hold the tissue wall open around the annular body 602. In other examples, the material forming the annular body 602 is strong enough to hold the tissue wall open around the annular body 602.

[0136] Annular body 602 has an outer diameter OD. Outer diameter OD is the diameter of annular body 602 as measured from the exterior surface of cardiovascular implant device 600. Outer diameter OD is configured to be approximately the same size as the diameter of a perforation in a tissue wall into which cardiovascular implant device 600 will be implanted, enabling annular body 602 to fit within the perforation. Outer diameter OD can have any size, allowing cardiovascular implant device 600 to be sized to suit a variety of patient conditions and / or anatomies. In some examples, outer diameter OD can also vary along the length of annular body 602 based on the overall shape or profile of annular body 602.

[0137] The annular body 602 includes a central flow tube 604, which serves as a conduit for directing flow through the cardiovascular implant device 600. The central flow tube 604 surrounds a flow path 606. The flow path 606 is an opening extending through the central flow tube 604, so that the cardiovascular implant device 600 is open at each opposite end. The flow path 606 is the path through which blood flows or is directed through the cardiovascular implant device 600. The central flow tube 604 includes a flow surface 614, which is configured to be a flow contact surface when the cardiovascular implant device 600 is implanted in a blood vessel or chamber of the heart H. The flow surface 614 is the radially inner surface of the central flow tube 604. The flow path 606 through the central flow tube 604 is defined by the flow surface 614.

[0138] The profile of the central flow tube 604 and the flow path 606 can be straight, curved, a combination of straight sections and curved sections, or any other suitable shape. In some examples, the profile of the central flow tube 604 and the flow path 606 can be defined by or identical to the profile of the annular body 602 (e.g., as shown in FIG. Figure 5 In other examples, the profile of the central flow tube 604 and the flow path 606 may be independent of or different from the profile of the annular body 602 (e.g., as shown in FIG. Figure 6 ). Similarly, the cross-sectional shape or profile of the central flow tube 604 and the annular body 602 can be the same, such as circular, oval, etc. Alternatively, the central flow tube 604 and the annular body 602 can have different cross-sectional shapes. For example, the annular body 602 can have a circular cross-section, and the central flow tube 604 can have an oval cross-section. Furthermore, the cross-sectional shape of the central flow tube 604 and / or the annular body can also vary along the length of either. The cross-sectional shape of the central flow tube 604 can be selected at various points along its length (e.g., at the outflow end 612) to influence the flow direction.

[0139] The central flow tube 604 (and the flow path 606 therein) extends from an inflow end 610 and an outflow end 612. The inflow end 610 can be the end of the central flow tube 604 that is relatively upstream of the outflow end 612 with respect to blood flow through the cardiovascular implant device 600 when the cardiovascular implant device 600 is implanted in a blood vessel or chamber of the heart H, as indicated by Figure 11 . Accordingly, outflow end 612 is the end of central flow tube 604 that is relatively downstream of inflow end 610 relative to blood flow through cardiovascular implant device 600 when cardiovascular implant device 600 is implanted in a blood vessel or chamber of heart H, as indicated by Figure 11 Indicated by the arrow F in Figure 11 In the example shown in FIG, the inflow end 610 is positioned on the left atrium side of the atrial septum IS, and the outflow end 612 is positioned downstream on the right atrium side of the atrial septum IS, so that blood can flow from the left atrium LA to the right atrium RA through the flow path 606. Figure 11 , the inflow end 610 may be substantially flush with the left atrial side of the atrial septum IS, while in some instances, the outflow end 612 may be spaced apart from the right atrial side of the atrial septum IS within the right atrium RA (i.e., the cardiovascular implant device 600 may extend further into the right atrium RA at the outflow end 612 than into the left atrium LA at the inflow end 610). In other instances, the inflow end 610, the outflow end 612, or both may be flush with or spaced apart from the respective sides of the tissue wall. Although the inflow end 610 is defined as being relatively upstream of the outflow end 612, it should be understood that other actual locations of the inflow end 610 or the outflow end 612 are possible, depending on the location at which the cardiovascular implant device 600 is implanted. The central flow tube 604 may have any suitable length as measured from the inflow end 610 to the outflow end 612. For example, central flow tube 604 can be designed to have a length that approximates the thickness of the atrial septum IS or another tissue wall in which cardiovascular implant device 600 is positioned. In other examples, central flow tube 604 can be longer or shorter than the thickness of the atrial septum IS or another tissue wall.

[0140] In general, the central flow tube 604 can be formed from any suitable material for forming a tubular structure surrounding the flow path 606. For example, all or a portion of the central flow tube 604 can be formed from a graft material. The graft material can be a synthetic material, such as woven polyester or polytetrafluoroethylene (PTFE), a biomaterial, a metallic material, or other materials, to name a few non-limiting examples. The central flow tube 604 formed from a graft material can be supported within the cardiovascular implant device 600 by the struts 603 of the annular body 602. In such examples, the central flow tube 604 can be attached to the struts 603 of the annular body 602 by any suitable attachment means, such as by suturing, gluing, tying, etc. In other examples, the central flow tube 604 can be rigidly formed with the annular body 604.

[0141] One or more anchoring members 608 extend outwardly from the annular body 602. When the cardiovascular implant device 600 is implanted in the body, the anchoring members 608 hold the cardiovascular implant device 600 in place in the tissue wall. The anchoring member 608 may take any suitable form for securing the cardiovascular implant device 600 to the tissue wall. In some instances, the anchoring member 608 may be one or more arms. In other instances, the anchoring member 608 may be a flange or annular lip configured to have a diameter that is larger than the diameter of the perforation or opening in which the cardiovascular implant device 600 is positioned, so as to prevent the cardiovascular implant device 600 from sliding through the perforation or opening. In some instances, the anchoring member 608 may bend toward the tissue wall, or alternatively, may remain flush against the tissue wall. Figure 11 , cardiovascular implant device 600 can include one or more anchoring members 608 extending from one end of central flow tube 604. Specifically, cardiovascular implant device 600 can include anchoring members 608 adjacent to inflow end 610. In other examples, cardiovascular implant device 600 can include anchoring members 608 adjacent to outflow end 612. In still other examples, cardiovascular implant device 600 can include anchoring members 608 at both inflow end 610 and outflow end 612.

[0142] like Figure 11 As shown in FIG, the center flow tube 604 includes a straight portion 620 and an adjustable portion 670. The straight portion 620 is the first portion or segment of the center flow tube 604. Figure 11In the example shown in , the straight portion 620 is adjacent to the inflow end 610 and extends from the inflow end to capture blood flowing into the cardiovascular implant device 600. The length of the straight portion 620 is sized to span the perforation in the tissue wall in which the cardiovascular implant device 600 is configured to be positioned. The adjustable portion 670 is a second portion or segment of the central flow tube 604. The adjustable portion 670 is a second portion or segment of the central flow tube 604. The adjustable portion 670 is connected to the straight portion 620. Figure 11 In the example shown in FIG, the adjustable portion 670 is adjacent to the outflow end 612 and extends from the outflow end to the straight portion 620. That is, when the cardiovascular implant device 600 is implanted in the tissue wall, the adjustable portion 670 is a relatively downstream portion of the central flow tube 604 relative to the direction of blood flow through the cardiovascular implant device, and the straight portion 620 is a relatively upstream portion of the central flow tube 604. The adjustable portion 670 may be continuous with the straight portion 620. The adjustable portion 670 is Figure 11 6 as being longer than the straight portion 620; however, it should be understood that the adjustable portion 670 and the straight portion 620 can have any relative length with respect to each other.

[0143] The adjustable portion 670 is a flexible portion of the central flow tube 604. The adjustable portion 670 is adjustable between a compressed configuration (or state) 680 and one or more expanded configurations (or states) 685. The adjustable portion 670 is similar to an accordion and includes one or more accordion pleats 672 that allow the adjustable portion 670 to expand and contract. In the compressed configuration 680, as shown in FIG. Figure 12A , the surfaces of the adjustable portion 670 are folded tightly together at the accordion pleats 672. In the expanded configuration 685, as shown Figure 12B As shown in FIG. , the accordion pleats 672 of the adjustable portion 670 are separated (ie, unfolded or pulled apart) by a certain amount, as indicated by Figure 12B For example, Figure 11 , one side of the accordion pleats 672 can be spaced further apart than the laterally opposite side of the same accordion pleats 672, allowing the adjustable portion 670 to flex. The adjustable portion 670 has a substantially infinite number of expanded configurations 685, each of which can be achieved by varying a combination of which accordion pleats 672 are spaced apart or compressed, which side of the accordion pleats 672 are spaced apart or compressed, and how much the accordion pleats 672 are spaced apart or compressed. It will be appreciated that Figure 12BOnly one such expanded configuration 685 is shown, and many other expanded configurations 685 are possible. A specific embodiment of the adjustable portion 670 can limit its degree of expansion by adjusting the number, size, and / or spacing of the accordion pleats 672 in the design. The possible expanded states 685 of the adjustable portion 670 can be selected based on the desired characteristics of the flow exiting the cardiovascular implant device 600. In some examples, the adjustable portion 670 (or a portion of the annular body 602 that provides support at the adjustable portion 670) is formed from an elastic material to accommodate expansion and contraction of the adjustable portion 670. For example, the elastic material can be a cobalt-chromium alloy.

[0144] The adjustable portion 670 is a flow diversion component of the cardiovascular implant device 600. The adjustable portion 670 is positioned or positionable to direct blood flow out of the cardiovascular implant device 600 in a specific direction. More specifically, the adjustable portion 670 is adjustable to direct blood flow out of the cardiovascular implant device 600 in a specific direction. Figure 11 As shown in FIG, adjustable portion 670 is configured to bend toward the tricuspid valve plane TVP (a plane containing the annular region of the tricuspid valve TV) upon positioning of cardiovascular implant device 600 and expansion of accordion pleats 672, such that adjustable portion 670 is in one of its one or more expanded configurations 685. Thus, adjustable portion 670 is configured to direct flow from cardiovascular implant device 600 toward the tricuspid valve plane TVP. In its one or more expanded configurations 685, adjustable portion 670 defines a turn in flow path 606. When cardiovascular implant device 600 is implanted in the interatrial septum IS, the turn aligns the portion of flow path 606 at outflow end 612 with natural flow patterns in the right atrium RA. An axis AX6 drawn longitudinally through outflow end 612 (which approximates the longitudinal axis aligned with blood flow out of central flow tube 604) forms an angle α6 with a tissue wall plane TWP of the tissue wall (e.g., the interatrial septum IS) in which cardiovascular implant device 600 is configured to be positioned. The tissue wall plane TWP is a vertical reference plane defined by the tissue wall and will therefore be substantially perpendicular to the flow path 606 where it passes through the tissue wall. In some examples, the angle α6 is between zero and seventy-five degrees (0°-75°).

[0145] Because the adjustable portion 670 is adjacent to the outflow end 612, the adjustable portion 670 is configured to face the right atrium RA or partially extend into the right atrium RA when the cardiovascular implant device 600 is implanted in the atrial septum IS. The protrusion of the adjustable portion 670 into the right atrium RA can be minimized so that the adjustable portion 670 only protrudes into the right atrium RA enough to secure the cardiovascular implant device 600 in place in the atrial septum IS. In some examples, the adjustable portion 670 is biased into the expanded configuration 685 (e.g., Figure 11 and12B ). In other examples, the adjustable portion 670 can be configured to self-expand or self-orient to a certain extent based on the pressure differential between the left atrium LA and the right atrium RA. In such examples, when there is a greater pressure differential between the left atrium LA and the right atrium RA, the flow through the cardiovascular implant device 600 can force the adjustable portion 670 to expand more to change the orientation of the outflow end 612. The adjustable portion 670 can be configured so that the angle α6 is the angle corresponding to the maximum expansion state of the adjustable portion 670. The orientation of the adjustable portion 670 in response to increased flow through the cardiovascular implant device 600 can be selected based on the desired characteristics of the flow out of the cardiovascular implant device 600.

[0146] Once the cardiovascular implant device 600 is implanted into the cardiovascular system (e.g., Figure 11 The circulatory blood then passes through the flow path 606 of the cardiovascular implant device 600. Figure 11 In the example shown in FIG, blood flows from the left atrium LA through flow path 606 and into the right atrium RA. As blood flows out of cardiovascular implant device 600, adjustable portion 670 aligns the blood flow with the natural blood flow pattern in the right atrium RA, such that the blood flow out of cardiovascular implant device 600 merges with the natural blood flow pattern in the right atrium RA. More specifically, adjustable portion 670 aligns the blood flow out of cardiovascular implant device 600 with the natural vortex flow pattern (i.e., the right-sided flow vortex) of blood in the right atrium RA ( Figure 11 (indicated by the schematic streamlines labeled RVF in the figure). Figure 11 As shown by arrows F in FIG, blood flow exiting cardiovascular implant device 600 is directed in a tortuous path along the right atrial side of the atrial septum IS and toward the tricuspid valve plane TVP, rather than exiting through the right atrium RA and cutting or otherwise disrupting the natural vortex flow pattern. In this way, blood flow exiting cardiovascular implant device 600 can combine with blood flowing downward along the atrial septum IS and merge into the right atrial vortex.

[0147] Additionally, the adjustable portion 670 is configured to be adjusted to one of one or more expanded configurations 685 shortly before or during an implantation procedure for the cardiovascular implant device 600. The accordion pleats 672 can be expanded or compressed to adjust the curvature of the adjustable portion 670 based on patient requirements, such as specific anatomy or flow conditions. In this manner, the adjustable portion 670 can have a curvature specific to the anatomy of the patient in which the cardiovascular implant device 600 will be or is implanted. In instances where the adjustable portion 670 is adjusted during the implantation procedure, the orientation of the adjustable portion 670 can be visualized in real time. For example, the orientation of the adjustable portion 670 can be visualized using fluoroscopy using radiopaque markers or contrast agents, or other visualization techniques known in the art. Furthermore, in such instances, the delivery device for the cardiovascular implant device 600 can be modified to include a guidewire and a ferrule or similar mechanism that can be releasably attached to the adjustable portion 670 to convert force from the physician's movements into folding or expanding the accordion pleats 672 to adjust the orientation of the adjustable portion 670 (i.e., select the desired expanded configuration 685). Thus, cardiovascular implant device 600 can be delivered with adjustable portion 670 in one configuration (eg, initial expanded configuration 685), and a physician can further adjust the configuration of adjustable portion 670 based on observations regarding the patient's anatomy or flow conditions.

[0148] Cardiovascular implant device 600 (including adjustable portion 670) can minimize or potentially enhance the natural flow patterns localized to the site of implantation of cardiovascular implant device 600 in heart H. When cardiovascular implant device 600 is implanted in the atrial septum IS, blood flowing from the left atrium LA to the right atrium RA through cardiovascular implant device 600 can be less disruptive to the natural rotational (e.g., vortex) flow patterns in the right atrium RA because the flow exiting cardiovascular implant device 600 is aligned with the natural vortex flow pattern, compared to conventional septal shunt devices, which can cause blood flow to eject through the right atrium. Using adjustable portion 670 to align the flow exiting cardiovascular implant device 600 with the natural flow patterns in the chambers or vessels of heart H minimizes any disruption to the natural flow patterns that might otherwise be caused by implanting conventional shunt devices without directional components. Furthermore, aligning the flow exiting cardiovascular implant device 600 can potentially mitigate flow reductions or enhance baseline flow due to pathophysiological or other causes. Thus, cardiovascular implant device 600 can maintain the kinetic energy of cardiovascular blood flow, which in turn reduces the required cardiac work and improves cardiac efficiency. These hemodynamic effects can potentially improve patient outcomes after receiving cardiovascular implant device 600 because cardiovascular implant device 600 can be more effective and potentially safer.

[0149] Furthermore, adjustable portion 670 allows cardiovascular implant device 600 to be easily adjusted for a wider range of patient anatomies and conditions. That is, a particular expanded configuration 685 of adjustable portion 670 can be selected to best suit a particular patient's anatomy or flow condition, such as a right atrial flow pattern. Furthermore, the configuration of adjustable portion 670 can be determined immediately prior to or during the implant procedure, allowing for real-time adjustments to the device based on information obtained by the physician about the patient.

[0150] Figure 13 is a schematic cross-sectional view of the atrial septum IS, showing a cardiovascular implant device 600A positioned in the atrial septum IS and comprising a varying inner diameter ID. Figure 13 As shown in FIG, cardiovascular implant device 600A includes an annular body 602A including struts 603A, a central flow tube 604A, and a flow path 606A; and an anchoring member 608A. Central flow tube 604A includes an inflow end 610A, an outflow end 612A, and a flow surface 614A. Central flow tube 604A further includes a straight portion 620A and an adjustable portion 670A. Adjustable portion 670A includes accordion pleats 672A. Figure 13 Also shown are the right atrium RA, left atrium LA, and atrial septum IS. Figure 13 Further shown are the tissue wall plane TWP, outer diameter OD, inner diameter ID, axis AX6 and angle α6.

[0151] Cardiovascular implant device 600A has the same Figure 11 Cardiovascular implant device 600 is depicted as being of generally similar structure, design, and function, but cardiovascular implant device 600A includes a varied inner diameter ID.

[0152] The central flow tube 604A has an inner diameter ID. The inner diameter ID is the diameter of the central flow tube 604A as measured to the flow surface 614A. In general, the inner diameter ID can be of any size such that the central flow tube 604A and the flow path 606A therethrough are sized to accommodate blood flow through the cardiovascular implant device 600A. Figure 13 , the inner diameter ID varies along the length of central flow tube 604A. Specifically, central flow tube 604A is tapered such that the inner diameter ID narrows toward inflow end 610A and widens toward outflow end 612A. This funnel shape can help direct blood flow out of cardiovascular implant device 600A in a desired direction. In other examples, the inner diameter ID can vary in different ways along the length of central flow tube 604A, such as tapering in opposite directions, tapering along only a portion of central flow tube 604A, etc.

[0153] Device 700 ( Figure 14 ) Figure 14 FIG is a schematic cross-sectional view of a heart H showing a cardiovascular implant device 700 positioned in the atrial septum IS and including an inclined central flow tube 704. Figure 14 As shown in FIG, cardiovascular implant device 700 includes an annular body 702 including struts 703, a central flow tube 704, and a flow path 706, and an anchoring member 708. Central flow tube 704 includes an inflow end 710, an outflow end 712, and a flow surface 714. Figure 14 Also shown are the heart H, right atrium RA, left atrium LA, superior vena cava SVC, inferior vena cava IVC, tricuspid valve TV, pulmonary vein PVS, mitral valve MV, and atrial septum IS. Figure 14 Further displayed are the right atrial vortex RVF, tissue wall plane TWP, tricuspid valve plane TVP, outer diameter OD, axis AX7 and angle α7.

[0154] The cardiovascular implant device 700 is an implantable device for use in the cardiovascular system. The cardiovascular implant device 700 is configured to be implanted in a blood vessel or chamber of the heart H. In the example shown, the cardiovascular implant device 700 is a diversion device for diverting blood from one blood vessel or chamber to another blood vessel or chamber. Specifically, Figure 14 , cardiovascular implant device 700 is positioned in the atrial septum IS. In other examples, cardiovascular implant device 700 may be positioned in any other tissue wall between adjacent chambers and / or blood vessels of heart H (or cardiovascular system). Cardiovascular implant device 700 may be delivered into the cardiovascular system via a catheter (i.e., transcatheter delivery) or may be surgically placed using transcatheter or surgical procedures known in the art.

[0155] The annular body 702 is the main body of the cardiovascular implant device 700. The annular body 702 can be expandable. The annular body 702 is generally cylindrical and tubular in cross-section, but can have a variety of different shapes and sizes. The annular body 702 can be pressed against or pressed into the tissue wall at the implant site or configured (or extended) around the anatomical structure of the cardiovascular system to set and maintain the position of the cardiovascular implant device 700. In some examples, for example, Figure 14 , annular body 702 can be formed from a plurality of struts 703. Struts 703 can form a lattice or grid of annular body 702 and define openings therein. In such examples, annular body 702 can be a stent framework structure for supporting a graft material that directs flow through cardiovascular implant device 700. In other examples, annular body 702 can be solidly formed.

[0156] The annular body 702 can be positioned in a perforation in a tissue wall to hold the tissue wall open around the annular body 702 so that blood can flow between blood vessels or chambers of the heart H through the cardiovascular implant device 700. Figure 14 In the example shown in , the annular body 702 is positioned in a perforation in the atrial septum IS between the left atrium LA and the right atrium RA, allowing blood to flow from the left atrium LA to the right atrium RA through the cardiovascular implant device 700. In some examples, the struts 703 of the annular body 702 form a cage sufficient to hold the tissue wall open around the annular body 702. In other examples, the material forming the annular body 702 is strong enough to hold the tissue wall open around the annular body 702.

[0157] Annular body 702 has an outer diameter OD. Outer diameter OD is the diameter of annular body 702 as measured from the exterior surface of cardiovascular implant device 700. Outer diameter OD is configured to be approximately the same size as the diameter of a perforation in a tissue wall into which cardiovascular implant device 700 will be implanted, enabling annular body 702 to fit within the perforation. Outer diameter OD can have any size, allowing cardiovascular implant device 700 to be sized to suit a variety of patient conditions and / or anatomies. In some examples, outer diameter OD can also vary along the length of annular body 702 based on the overall shape or profile of annular body 702.

[0158] The annular body 702 includes a central flow tube 704, which serves as a conduit for directing flow through the cardiovascular implant device 700. The central flow tube 704 surrounds a flow path 706. The flow path 706 is an opening extending through the central flow tube 704, so that the cardiovascular implant device 700 is open at each opposite end. The flow path 706 is the path through which blood flows or is directed through the cardiovascular implant device 700. The central flow tube 704 includes a flow surface 714, which is configured to be a flow contact surface when the cardiovascular implant device 700 is implanted in a blood vessel or chamber of the heart H. The flow surface 714 is the radially inner surface of the central flow tube 704. The flow path 706 through the central flow tube 704 is defined by the flow surface 714.

[0159] The profile of the central flow tube 704 and the flow path 706 can be straight, curved, a combination of straight sections and curved sections, or any other suitable shape. In some examples, the profile of the central flow tube 704 and the flow path 706 can be defined by or identical to the profile of the annular body 702 (e.g., as shown in FIG. Figure 5 In other examples, the profile of the central flow tube 704 and the flow path 706 may be independent of or different from the profile of the annular body 702 (e.g., as shown in FIG. Figure 6). Similarly, the cross-sectional shape or profile of the central flow tube 704 and the annular body 702 can be the same, such as circular, oval, etc. Alternatively, the central flow tube 704 and the annular body 702 can have different cross-sectional shapes. For example, the annular body 702 can have a circular cross-section, and the central flow tube 704 can have an oval cross-section. Furthermore, the cross-sectional shape of the central flow tube 704 and / or the annular body 702 can also vary along the length of either. The cross-sectional shape of the central flow tube 704 can be selected at various points along its length (e.g., at the outflow end 712) to influence the flow direction.

[0160] The central flow tube 704 (and the flow path 706 therein) extends from an inflow end 710 and an outflow end 712. The inflow end 710 can be the end of the central flow tube 704 that is relatively upstream of the outflow end 712 with respect to blood flow through the cardiovascular implant device 700 when the cardiovascular implant device 700 is implanted in a blood vessel or chamber of the heart H, as indicated by Figure 14 . Accordingly, outflow end 712 is the end of central flow tube 704 that is relatively downstream of inflow end 710 relative to blood flow through cardiovascular implant device 700 when cardiovascular implant device 700 is implanted in a blood vessel or chamber of heart H, as indicated by Figure 14 Indicated by the arrow F in Figure 14 In the example shown in FIG, the inflow end 710 is positioned on the left atrium side of the atrial septum IS, and the outflow end 712 is positioned downstream on the right atrium side of the atrial septum IS, so that blood can flow from the left atrium LA to the right atrium RA through the flow path 706. Figure 14 , the inflow end 710 may be substantially flush with the left atrial side of the atrial septum IS, while in some instances, the outflow end 712 may be spaced apart from the right atrial side of the atrial septum IS within the right atrium RA (i.e., the cardiovascular implant device 700 may extend further into the right atrium RA at the outflow end 712 than into the left atrium LA at the inflow end 710). In other instances, the inflow end 710, the outflow end 712, or both may be flush with or spaced apart from the respective sides of the tissue wall. Although the inflow end 710 is defined as being relatively upstream of the outflow end 712, it should be understood that other actual locations of the inflow end 710 or the outflow end 712 are possible, depending on the location at which the cardiovascular implant device 700 is implanted. The central flow tube 704 may have any suitable length as measured from the inflow end 710 to the outflow end 712. For example, central flow tube 704 can be designed to have a length that approximates the thickness of the atrial septum IS or another tissue wall in which cardiovascular implant device 700 is positioned. In other examples, central flow tube 704 can be longer or shorter than the thickness of the atrial septum IS or another tissue wall.

[0161] In general, the central flow tube 704 can be formed from any suitable material for forming a tubular structure surrounding the flow path 706. For example, all or a portion of the central flow tube 704 can be formed from a graft material. The graft material can be a synthetic material, such as woven polyester or polytetrafluoroethylene (PTFE), a biomaterial, a metallic material, or other materials, to name a few non-limiting examples. The central flow tube 704 formed from a graft material can be supported within the cardiovascular implant device 700 by the struts 703 of the annular body 702. In such examples, the central flow tube 704 can be attached to the struts 703 of the annular body 702 by any suitable attachment means, such as by suturing, gluing, tying, etc. In other examples, the central flow tube 704 can be rigidly formed with the annular body 704.

[0162] One or more anchoring members 708 extend outward from the annular body 702. When the cardiovascular implant device 700 is implanted in the body, the anchoring members 708 hold the cardiovascular implant device 700 in place within the tissue wall. The anchoring members 708 can take any suitable form for securing the cardiovascular implant device 700 to the tissue wall. In some examples, the anchoring members 708 can be one or more arms. In other examples, the anchoring members 708 can be a flange or annular lip configured to have a larger diameter than the diameter of the perforation or opening in which the cardiovascular implant device 700 is positioned, thereby preventing the cardiovascular implant device 700 from sliding through the perforation or opening. In some examples, the anchoring members 708 can bend toward the tissue wall, or alternatively, can remain flush against the tissue wall. The cardiovascular implant device 700 can include one or more anchoring members 708 extending from one or both ends of the central flow tube 704. In some examples, the cardiovascular implant device 700 can include an anchoring member 708 adjacent to the inflow end 710. In other examples, the cardiovascular implant device 700 may include an anchoring member 708 adjacent to the outflow end 712. Figure 14 In the example shown in FIG, cardiovascular implant device 700 includes anchoring members 708 at both the inflow end 710 and the outflow end 712.

[0163] like Figure 14 As shown in FIG, central flow tube 704 is positioned in cardiovascular implant device 700 such that it is configured to be tilted relative to tissue wall plane TWP. Tissue wall plane TWP is a vertical reference plane defined by the tissue wall (e.g., atrial septum IS) in which cardiovascular implant device 700 is configured to be positioned. Thus, central flow tube 704 is configured to pass through the tissue wall at a different angle than being oriented generally perpendicular to tissue wall plane TWP (e.g., as shown in FIG. Figure 5-13). Flow path 706 through central flow tube 704 is also inclined relative to the tissue wall and tissue wall plane TWP in the same manner as central flow tube 704. Therefore, central flow tube 704 is also referred to herein as "inclined central flow tube 704," and flow path 706 is also referred to herein as "inclined flow path 706." Axis AX7 is the longitudinal axis through central flow tube 704. Axis AX7 forms an angle α7 with tissue wall plane TWP. In some examples, angle α7 is between zero and seventy-five degrees (0°-75°). More typically, angle α7 may be less than approximately ninety degrees (<90°), whereas a perpendicular central flow tube would be at ninety degrees.

[0164] The inclined central flow tube 704 is a flow guide component of the cardiovascular implant device 700. The inclined central flow tube 704 is positioned to guide blood flow out of the cardiovascular implant device 700 in a specific direction. More specifically, the inclined central flow tube 704 is inclined to guide blood flow out of the cardiovascular implant device 700 in a specific direction. Figure 14 As shown in FIG, the angled central flow tube 704 (and the angled flow path 706 therein) is configured to be tilted toward the tricuspid valve plane TVP (a plane containing the annular region of the tricuspid valve TV) by the positioning of the cardiovascular implant device 700. Thus, the angled central flow tube 704 is configured to direct flow from the cardiovascular implant device 700 toward the tricuspid valve plane TVP. When the cardiovascular implant device 700 is implanted in the atrial septum IS, the angled central flow tube 704 aligns blood flow through and out of the cardiovascular implant device 700 with the natural flow pattern in the right atrium RA. Axis AX7 approximates the longitudinal axis aligned with blood flow through and out of the angled central flow tube 704. As described above, axis AX7 forms an angle α7 with the tissue wall plane TWP, such that blood flow through and out of the angled central flow tube 704 can also be described as forming an angle α7 with the tissue wall plane TWP. In some examples, angle α7 is between zero and seventy-five degrees (0°-75°).

[0165] Once the cardiovascular implant device 700 is implanted into the cardiovascular system (e.g., Figure 14 In the atrial septum IS or another tissue wall shown in FIG, circulating blood passes through the flow path 706 of the cardiovascular implant device 700. Figure 14In the example shown in FIG, blood flows from the left atrium LA through flow path 706 and into the right atrium RA. As blood flows out of the cardiovascular implant device 700, the inclined central flow tube 704 aligns the blood flow with the natural blood flow pattern in the right atrium RA, so that the blood flow out of the cardiovascular implant device 700 merges with the natural blood flow pattern in the right atrium RA. More specifically, the inclined central flow tube 704 aligns the blood flow out of the cardiovascular implant device 700 with the natural vortex flow pattern of blood in the right atrium RA (i.e., the right flow vortex) (in FIG. Figure 14 (indicated by the schematic streamlines labeled RVF in the figure). Figure 14 As shown by arrows F in FIG, blood flow exiting cardiovascular implant device 700 is directed in an oblique path along the right atrial side of the atrial septum IS and toward the tricuspid valve plane TVP, rather than exiting through the right atrium RA and cutting or otherwise disrupting the natural vortex flow pattern. In this way, blood flow exiting cardiovascular implant device 700 can combine with blood flowing downward along the atrial septum IS and merge into the right atrial vortex.

[0166] Cardiovascular implant device 700 (including angled central flow tube 704) can minimize or potentially enhance the disruption of natural flow patterns localized to the site of implantation of cardiovascular implant device 700 in heart H. When cardiovascular implant device 700 is implanted within the atrial septum IS, blood flowing from the left atrium LA to the right atrium RA through cardiovascular implant device 700 can be less disruptive to the natural rotational (e.g., vortex) flow pattern within the right atrium RA because the flow exiting cardiovascular implant device 700 is aligned with the natural vortex flow pattern, compared to conventional septal shunt devices, which can cause blood flow to eject through the right atrium. Aligning the flow exiting cardiovascular implant device 700 with the natural flow pattern within a chamber or vessel of heart H using angled central flow tube 704 minimizes any disruption to the natural flow pattern that might otherwise result from implantation of conventional shunt devices without directional components. Furthermore, aligning the flow exiting cardiovascular implant device 700 can potentially mitigate flow reductions or enhance baseline flow due to pathophysiological or other causes. Thus, the cardiovascular implant device 700 can maintain the kinetic energy of cardiovascular blood flow, which in turn reduces the required cardiac work and improves cardiac efficiency. These hemodynamic effects can potentially improve patient outcomes after receiving the cardiovascular implant device 700 because the cardiovascular implant device 700 can be more effective and potentially safer.

[0167] Any of the various systems, devices, apparatus, etc. disclosed herein may be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure their safety for use with patients, and the methods herein may include sterilizing (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) the associated systems, devices, apparatus, etc.

[0168] The therapeutic techniques, methods, steps, etc. described or proposed herein or in the references incorporated herein can be performed on living animals or on non-living simulated objects, such as cadavers, cadaver hearts, anthropomorphic pseudo-targets, simulated bodies (e.g., having simulated body parts, tissues, etc.), etc.

[0169] Discussion of possible examples The following is a non-exclusive description of possible embodiments of the invention.

[0170] A cardiovascular implant device includes an annular body, one or more anchoring members, and a flow guide assembly. The annular body includes a central flow tube extending from an inflow end to an outflow end, and a flow path extending through the central flow tube. The one or more anchoring members extend outward from the annular body and are configured to secure the cardiovascular implant device to a tissue wall. The flow guide assembly is positioned to align blood flow out of the cardiovascular implant device with the natural blood flow pattern in the right atrium, such that blood flow out of the cardiovascular implant device merges with the natural blood flow pattern in the right atrium.

[0171] The cardiovascular implant device of the preceding paragraph may optionally include additionally and / or alternatively any one or more of the following features, configurations, and / or additional components: The flow directing assembly can be configured to direct blood flow from the cardiovascular implant device toward the tricuspid valve plane in the right atrium.

[0172] The flow guide assembly may be positioned such that a longitudinal axis aligned with blood flow out of the cardiovascular implant device forms an angle of approximately zero to seventy-five degrees (0°-75°) with a vertical reference plane defined by the tissue wall.

[0173] The flow guide component may be a curved portion of the central flow tube; the curved portion may be adjacent to the outflow end; and the curved portion may be curved to align the blood flow out of the cardiovascular implant device with the natural flow pattern of blood in the right atrium, so that the blood flow out of the cardiovascular implant device is combined with the natural flow pattern of blood in the right atrium.

[0174] The flow guide component can be a fin connected to the annular body at the outflow end of the central flow tube; and the fin can be tilted to align the blood flow out of the cardiovascular implant device with the natural flow pattern of blood in the right atrium, so that the blood flow out of the cardiovascular implant device is combined with the natural flow pattern of blood in the right atrium.

[0175] The flow guide component may be a guide wall connected to the radial inner surface of the central flow tube; the flow path may be defined by the guide wall; and the guide wall may be positioned to guide blood flow through the central flow tube of the cardiovascular implant device so that the blood flow out of the cardiovascular implant device is aligned with and combined with the natural flow pattern of blood in the right atrium.

[0176] The flow guide assembly can be a set of blades extending radially around a shaft that extends longitudinally through the central flow tube; and the blades can be positioned to guide blood flow through the central flow tube of the cardiovascular implant device so that blood flow out of the cardiovascular implant device is aligned with and integrated with the natural flow pattern of blood in the right atrium.

[0177] The flow guide assembly may be an adjustable portion of the central flow tube; the adjustable portion may be adjacent to the outflow end; the adjustable portion may be adjustable between one or more expanded configurations and compressed configurations; and the adjustable portion may be adjustable to align the blood flow out of the cardiovascular implant device with the natural flow pattern of blood in the right atrium so that the blood flow out of the cardiovascular implant device combines with the natural flow pattern of blood in the right atrium.

[0178] The flow guide component can be a central flow tube; and the central flow tube can be tilted to align the blood flow out of the cardiovascular implant device with the natural blood flow pattern in the right atrium, so that the blood flow out of the cardiovascular implant device is combined with the natural blood flow pattern in the right atrium.

[0179] At least a portion of the central flow tube may be formed from a graft material.

[0180] The cardiovascular implant device can be sterile.

[0181] At least a portion of the cardiovascular implant device may be formed from a shape memory material.

[0182] A cardiovascular implant device includes an annular body and one or more anchoring members. The annular body includes a central flow tube extending from an inflow end to an outflow end and a flow path extending through the central flow tube. The one or more anchoring members extend outward from the annular body and are configured to secure the cardiovascular implant device to a tissue wall. The central flow tube includes a curved portion adjacent to the outflow end, the curved portion being curved to align blood flow out of the cardiovascular implant device with a natural blood flow pattern in the right atrium, thereby combining blood flow out of the cardiovascular implant device with the natural blood flow pattern in the right atrium.

[0183] The cardiovascular implant device of the preceding paragraph may optionally include additionally and / or alternatively any one or more of the following features, configurations, and / or additional components: The central flow tube may also include a straight portion adjacent to the inflow end, and the curved portion may be connected to the straight portion.

[0184] The straight portion can be sized to span a perforation in a tissue wall in which the cardiovascular implant device is configured to be positioned.

[0185] The curved portion can be configured to face the right atrium when the cardiovascular implant device is positioned in the atrial septum.

[0186] The curved portion can be configured to curve toward the tricuspid valve plane in the right atrium.

[0187] A longitudinal axis through the outflow end may form an angle of approximately zero to seventy-five degrees (0°-75°) with a vertical reference plane defined by the tissue wall.

[0188] The curved portion may define a turn in the flow path.

[0189] The central flow tube (including the curved portion) may be formed from a graft material.

[0190] The cardiovascular implant device can be sterile.

[0191] At least a portion of the cardiovascular implant device may be formed from a shape memory material.

[0192] A cardiovascular implant device includes an annular body, one or more anchoring members, and a fin. The annular body includes a central flow tube extending from an inflow end to an outflow end and a flow path extending through the central flow tube. The one or more anchoring members extend outward from the annular body and are configured to secure the cardiovascular implant device to a tissue wall. The fin is connected to the annular body at the outflow end of the central flow tube. The fin is tilted to align blood flow out of the cardiovascular implant device with the natural blood flow pattern in the right atrium, thereby combining blood flow out of the cardiovascular implant device with the natural blood flow pattern in the right atrium.

[0193] The cardiovascular implant device of the preceding paragraph may optionally include additionally and / or alternatively any one or more of the following features, configurations, and / or additional components: The tab may be connected to the annular body using a flexible joint, and the tab may be positioned relative to the annular body at the flexible joint.

[0194] The cardiovascular implant device may further comprise a stopper adjacent to the flexible joint, the stopper being configured to prevent the flap from moving beyond a maximum opening angle.

[0195] The fins may be positioned such that they are inclined towards a longitudinal axis passing through the central flow tube.

[0196] The flaps may be solidly formed from a flexible material, or the flaps may be formed from a wire frame and cloth stretched over the wire frame.

[0197] The flaps may be configured to extend into the right atrium.

[0198] The flaps can be configured to direct blood flow from the cardiovascular implant device toward the tricuspid valve plane in the right atrium.

[0199] The flaps may be configured to form an angle of approximately zero to seventy-five degrees (0°-75°) with a vertical reference plane defined by the tissue wall.

[0200] The cardiovascular implant device can be sterile.

[0201] At least a portion of the cardiovascular implant device may be formed from a shape memory material.

[0202] A cardiovascular implant device is configured to be attached adjacent to an opening in a tissue wall between the right and left atria of a heart. The cardiovascular implant device includes an anchoring member configured to secure the cardiovascular implant device to the tissue wall, a flexible joint connected to the anchoring member, and a tab connected to the flexible joint. The tab is tilted to align blood flow out of the opening with the natural blood flow pattern in the right atrium, such that blood flow out of the perforation merges with the natural blood flow pattern in the right atrium.

[0203] The cardiovascular implant device of the preceding paragraph may optionally include additionally and / or alternatively any one or more of the following features, configurations, and / or additional components: The tab may be positioned relative to the opening at the flexible joint.

[0204] The cardiovascular implant device may further comprise a stopper adjacent to the flexible joint, the stopper being configured to prevent the flap from moving beyond a maximum opening angle.

[0205] The flap may be positioned such that it is inclined towards a longitudinal axis passing through the opening.

[0206] The flaps may be solidly formed from a flexible material, or the flaps may be formed from a wire frame and cloth stretched over the wire frame.

[0207] The flaps may be configured to extend into the right atrium.

[0208] The flaps may be configured to direct blood flow from the opening toward the tricuspid valve plane in the right atrium.

[0209] The flaps may be configured to form an angle of approximately zero to seventy-five degrees (0°-75°) with a vertical reference plane defined by the tissue wall.

[0210] The cardiovascular implant device can be sterile.

[0211] At least a portion of the cardiovascular implant device may be formed from a shape memory material.

[0212] A cardiovascular implant device includes an annular body and one or more anchoring members. The annular body includes a central flow tube extending from an inflow end to an outflow end, the central flow tube including a guide wall connected to a radially inner surface of the central flow tube; and a flow path extending through the central flow tube and defined by the guide wall. The one or more anchoring members extend outward from the annular body and are configured to secure the cardiovascular implant device to a tissue wall. The guide wall is positioned to direct blood flow through the central flow tube of the cardiovascular implant device such that blood flow out of the cardiovascular implant device aligns with and integrates with the natural flow pattern of blood in the right atrium.

[0213] The cardiovascular implant device of the preceding paragraph may optionally include additionally and / or alternatively any one or more of the following features, configurations, and / or additional components: The guide wall may be circumferentially attached to the radially inner surface of the central flow tube.

[0214] The guide wall may be a spiral wall so that the flow path is a spiral path.

[0215] The spiral wall may extend inside the central flow tube from the inflow end to the outflow end.

[0216] The guide walls may be positioned to prevent blood flow through the central flow tube from flowing in a straight path.

[0217] The guide walls may impart a rotational velocity to the blood flow through the central flow tube.

[0218] The guide wall can be configured to direct blood flow from the cardiovascular implant device toward the tricuspid valve plane in the right atrium.

[0219] The guide wall may be positioned such that a longitudinal axis aligned with blood flow out of the cardiovascular implant device forms an angle of approximately zero to seventy-five degrees (0°-75°) with a vertical reference plane defined by the tissue wall.

[0220] The cardiovascular implant device can be sterile.

[0221] At least a portion of the cardiovascular implant device may be formed from a shape memory material.

[0222] A cardiovascular implant device includes an annular body and one or more anchoring members. The annular body includes a central flow tube extending from an inflow end to an outflow end and a flow path extending through the central flow tube. The one or more anchoring members extend outward from the annular body and are configured to secure the cardiovascular implant device to a tissue wall. The cardiovascular implant device further includes a shaft extending longitudinally through the central flow tube and a set of blades extending radially around the shaft. The blades are positioned to direct blood flow through the central flow tube of the cardiovascular implant device so that blood flow out of the cardiovascular implant device aligns with and integrates with the natural flow pattern of blood in the right atrium.

[0223] The cardiovascular implant device of the preceding paragraph may optionally include additionally and / or alternatively any one or more of the following features, configurations, and / or additional components: The blades may be arranged in a ring around the shaft.

[0224] The set of blades may be a stator.

[0225] The set of blades may be a rotor.

[0226] Each of the blades may include a root portion adjacent to the shaft and a tip portion distal to the root portion such that the blade extends radially from the shaft toward the inner surface of the central flow tube, with the tip portion spaced apart from the inner surface of the central flow tube.

[0227] The blades impart a rotational velocity to the blood flow through the central flow tube.

[0228] The leaflets can be configured to direct blood flow from the cardiovascular implant device toward the tricuspid valve plane in the right atrium.

[0229] The blades may be arranged such that a longitudinal axis aligned with blood flow out of the cardiovascular implant device forms an angle of approximately zero to seventy-five degrees (0°-75°) with a vertical reference plane defined by the tissue wall.

[0230] The cardiovascular implant device can be sterile.

[0231] At least a portion of the cardiovascular implant device may be formed from a shape memory material.

[0232] A cardiovascular implant device includes an annular body and one or more anchoring members. The annular body includes a central flow tube extending from an inflow end to an outflow end and a flow path extending through the central flow tube. The one or more anchoring members extend outward from the annular body and are configured to secure the cardiovascular implant device to a tissue wall. The central flow tube includes an adjustable portion adjacent to the outflow end. The adjustable portion is adjustable between one or more expanded and compressed configurations and is adjustable to align blood flow out of the cardiovascular implant device with a natural blood flow pattern in the right atrium, such that blood flow out of the cardiovascular implant device combines with the natural blood flow pattern in the right atrium.

[0233] The cardiovascular implant device of the preceding paragraph may optionally include additionally and / or alternatively any one or more of the following features, configurations, and / or additional components: The adjustable portion may comprise one or more accordion pleats.

[0234] The central flow tube may include an inner diameter, and the inner diameter may vary along the length of the central flow tube.

[0235] The central flow tube may further include a straight portion adjacent to the inflow end, and the adjustable portion may be connected to the straight portion.

[0236] The straight portion can be sized to span a perforation in a tissue wall in which the cardiovascular implant device is configured to be positioned.

[0237] The adjustable portion can be configured to be adjusted to one of the one or more expanded configurations prior to an implantation procedure for a cardiovascular implant device.

[0238] The adjustable portion can be configured to be adjusted to one of the one or more expanded configurations during an implantation procedure for the cardiovascular implant device.

[0239] The adjustable portion can be configured to face the right atrium when the cardiovascular implant device is positioned in the atrial septum.

[0240] The adjustable portion can be configured to bend toward a tricuspid valve plane in the right atrium when the adjustable portion is in one of the one or more expanded configurations.

[0241] A longitudinal axis through the outflow end may form an angle of approximately zero to seventy-five degrees (0°-75°) with a vertical reference plane defined by the tissue wall.

[0242] The adjustable portion may define a turn in the flow path.

[0243] The annular body at the adjustable portion may be formed of an elastic material.

[0244] The elastic material may be a cobalt-chromium alloy.

[0245] The cardiovascular implant device can be sterile.

[0246] At least a portion of the cardiovascular implant device may be formed from a shape memory material.

[0247] A cardiovascular implant device includes an annular body and one or more anchoring members. The annular body includes a central flow tube extending from an inflow end to an outflow end and a flow path extending through the central flow tube. The one or more anchoring members extend outward from the annular body and are configured to secure the cardiovascular implant device to a tissue wall. The central flow tube is configured to be tilted relative to the tissue wall. The central flow tube is tilted to align blood flow out of the cardiovascular implant device with the natural blood flow pattern in the right atrium, thereby integrating blood flow out of the cardiovascular implant device with the natural blood flow pattern in the right atrium.

[0248] The cardiovascular implant device of the preceding paragraph may optionally include additionally and / or alternatively any one or more of the following features, configurations, and / or additional components: The outflow end can be configured to be positioned on the right atrial side of the atrial septum when the cardiovascular implant device is positioned in the atrial septum.

[0249] The central flow tube can be configured to be angled toward the plane of the tricuspid valve in the right atrium.

[0250] The central flow tube can be configured to direct blood flow from the cardiovascular implant device to the tricuspid valve plane in the right atrium.

[0251] A longitudinal axis through the central flow tube may form an angle of less than ninety degrees (<90°) with a vertical reference plane defined by the tissue wall.

[0252] The angle may be between zero and seventy-five degrees (0°-75°).

[0253] At least a portion of the central flow tube may be formed from a graft material.

[0254] The cardiovascular implant device can be sterile.

[0255] At least a portion of the cardiovascular implant device may be formed from a shape memory material.

[0256] Although the present invention has been described with reference to exemplary embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements of the present invention without departing from the scope of the present invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the present invention without departing from the basic scope of the present invention. Therefore, it is intended that the present invention not be limited to the particular embodiments disclosed, but that the present invention encompass all embodiments falling within the scope of the appended claims.

Claims

1. A cardiovascular implant device, comprising: An annular body, comprising: a central flow tube extending from an inflow end to an outflow end; and a flow path extending through the central flow tube; one or more anchoring members extending outwardly from the annular body and configured to secure the cardiovascular implant device to a tissue wall; and diversion components; The flow guide component is positioned to align blood flow out of the cardiovascular implant device with a natural blood flow pattern in the right atrium, so that the blood flow out of the cardiovascular implant device combines with the natural blood flow pattern in the right atrium.

2. The cardiovascular implant device of claim 1, wherein the flow guide assembly is configured to direct the blood flow from the cardiovascular implant device toward a tricuspid valve plane in the right atrium.

3. The cardiovascular implant device of claim 1 , wherein the flow guide assembly is positioned such that a longitudinal axis aligned with the blood flow out of the cardiovascular implant device forms an angle of approximately zero to seventy-five degrees (0°-75°) with a vertical reference plane defined by the tissue wall.

4. The cardiovascular implant device according to claim 1, wherein the flow guide component is a curved portion of the central flow tube; wherein the curved portion is adjacent to the outflow end; and The curved portion is curved to align the blood flow out of the cardiovascular implant device with the natural blood flow pattern in the right atrium, so that the blood flow out of the cardiovascular implant device is combined with the natural blood flow pattern in the right atrium.

5. The cardiovascular implant device according to claim 1, wherein the flow guide assembly is a vane connected to the annular body at the outflow end of the central flow tube; and The wings are tilted to align the blood flow out of the cardiovascular implant device with the natural blood flow pattern in the right atrium, so that the blood flow out of the cardiovascular implant device combines with the natural blood flow pattern in the right atrium.

6. The cardiovascular implant device according to claim 1, wherein the flow guide component is a guide wall connected to the radial inner surface of the central flow tube; wherein the flow path is defined by the guide wall; and wherein the guide wall is positioned to guide blood flow through the central flow tube of the cardiovascular implant device such that the blood flow out of the cardiovascular implant device is aligned with and integrated with the natural flow pattern of blood in the right atrium.

7. The cardiovascular implant device according to claim 1, wherein the flow guide assembly is a set of vanes extending radially around a shaft, the shaft extending longitudinally through the central flow tube; and wherein the blades are positioned to direct blood flow through the central flow tube of the cardiovascular implant device such that the blood flow out of the cardiovascular implant device is aligned with and integrated with the natural flow pattern of blood in the right atrium.

8. The cardiovascular implant device according to claim 1, wherein the flow guide assembly is an adjustable portion of the central flow tube; wherein the adjustable portion is adjacent to the outflow end; wherein the adjustable portion is adjustable between one or more expanded and compressed configurations; and The adjustable portion is adjustable to align the blood flow out of the cardiovascular implant device with the natural blood flow pattern in the right atrium, so that the blood flow out of the cardiovascular implant device is combined with the natural blood flow pattern in the right atrium.

9. The cardiovascular implant device according to claim 1, wherein the flow guide component is the central flow tube; and The central flow tube is tilted to align the blood flow out of the cardiovascular implant device with the natural blood flow pattern in the right atrium, so that the blood flow out of the cardiovascular implant device combines with the natural blood flow pattern in the right atrium.

10. The cardiovascular implant device of claim 1, wherein at least a portion of the central flow tube is formed of a graft material.

11. The cardiovascular implant device of claim 1, wherein the cardiovascular implant device is sterile.

12. The cardiovascular implant device of claim 1, wherein at least a portion of the cardiovascular implant device is formed of a shape memory material.

13. A cardiovascular implant device configured to be attached adjacent to an opening in a tissue wall between a right atrium and a left atrium of a heart, the cardiovascular implant device comprising: an anchoring member configured to secure the cardiovascular implant device to the tissue wall; a flexible joint connected to the anchoring member; as well as A flap is connected to the flexible joint, the flap being tilted to align blood flow out of the opening with a natural blood flow pattern in the right atrium so that the blood flow out of the opening combines with the natural blood flow pattern in the right atrium.

14. The cardiovascular implant device of claim 13, wherein the tab is positionable relative to the opening at the flexible joint.

15. The cardiovascular implant device of claim 14, further comprising a stopper adjacent to the flexible joint, the stopper being configured to prevent the flap from moving beyond a maximum opening angle.

16. The cardiovascular implant device of claim 13, wherein the tab is positioned such that it is inclined toward a longitudinal axis passing through the opening.

17. The cardiovascular implant device of claim 13, wherein the flap is solidly formed of a flexible material, or wherein the flap is formed of a wire frame and cloth stretched over the wire frame.

18. The cardiovascular implant device of claim 13, wherein the flap is configured to extend into the right atrium; and wherein the flap is configured to direct the blood flow from the opening toward a tricuspid valve plane in the right atrium.

19. The cardiovascular implant device of claim 13, wherein the tab is configured to form an angle of approximately zero to seventy-five degrees (0°-75°) with a vertical reference plane defined by the tissue wall.

20. The cardiovascular implant device of claim 13, wherein the cardiovascular implant device is sterile; and wherein at least a portion of the cardiovascular implant device is formed of a shape memory material.

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