Cardiovascular implant devices for directing flow

Abstract

The cardiovascular implant device includes an annular body, one or more anchor members, and a flow directing component. 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 anchor members extend outward from the annular body and are configured to secure the cardiovascular implant device to a tissue wall. The flow directing component is positioned to align blood flow from the cardiovascular implant device with a natural flow pattern of blood in the right atrium, such that blood flow from the cardiovascular implant device merges with the natural flow pattern of blood in the right atrium.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 387,917, filed December 16, 2022, entitled "CARDIOVASCULAR IMPLANT DEVICES FOR DIRECTING FLOW," the disclosure of which is incorporated herein by reference in its entirety. [Background technology]

[0002] FIELD OF THE DISCLOSURE 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 within the natural flow path in the cardiovascular system or can be used to create an artificial flow path. For example, a shunt device can be positioned in the heart to shunt blood between the left and right atria to reduce pressure in the left atrium, which can become elevated 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 atrial septum wall between the left and right atria to shunt blood from the left atrium into the right atrium, thereby reducing pressure in the left atrium. Summary of the Invention [Means for solving the problem]

[0004] In one example, a cardiovascular implant device includes an annular body, one or more anchor members, and a flow directing component. 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 anchor members extend outward from the annular body and are configured to secure the cardiovascular implant device to a tissue wall. The flow directing component is positioned to align blood flow from the cardiovascular implant device with the natural flow pattern of blood in the right atrium, such that the flow from the cardiovascular implant device merges with the natural flow pattern of blood in the right atrium.

[0005] In another example, a cardiovascular implant device includes an annular body and one or more anchor 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 anchor 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 the outflow end, the curved portion being curved to align blood flow from the cardiovascular implant device with the natural flow pattern of blood in the right atrium, such that the blood flow from the cardiovascular implant device merges with the natural flow pattern of blood in the right atrium.

[0006] In another example, a cardiovascular implant device includes an annular body, one or more anchor members, and a flap. 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 anchor members extend outward from the annular body and are configured to secure the cardiovascular implant device to a tissue wall. The flap is connected to the annular body at the outflow end of the central flow tube. The flap is angled to align blood flow from the cardiovascular implant device with the natural flow pattern of blood in the right atrium, such that the blood flow from the cardiovascular implant device merges with the natural flow pattern of blood 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 and left atria of the heart. The cardiovascular implant device includes an anchor member configured to secure the cardiovascular implant device to the tissue wall, a flexible joint connected to the anchor member, and a flap connected to the flexible joint. The flap is angled to align blood flow from the opening with a natural blood flow pattern in the right atrium, such that blood flow from the puncture merges with the natural blood flow pattern in the right atrium.

[0008] In another example, a cardiovascular implant device includes an annular body and one or more anchor 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 anchor 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 guide blood flow through the central flow tube of the cardiovascular implant device, such that blood flow from the cardiovascular implant device aligns with and merges 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 anchor 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 anchor 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 guide blood flow through the central flow tube of the cardiovascular implant device such that blood flow from the cardiovascular implant device aligns with and merges 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 anchor 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 anchor 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 the outflow end. The adjustable portion is adjustable between one or more expanded and compressed configurations to align blood flow from the cardiovascular implant device with a natural blood flow pattern in the right atrium, such that blood flow from the cardiovascular implant device merges 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 anchor 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 anchor 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 angled relative to the tissue wall. The central flow tube is angled to align blood flow from the cardiovascular implant device with a natural blood flow pattern in the right atrium, such that blood flow from the cardiovascular implant device merges with the natural blood flow pattern in the right atrium. [Brief explanation of the drawings]

[0012] Anatomy of the Heart H and Vascular System V [Figure 1] FIG. 1 is a schematic diagram of the heart and vascular system. [Figure 2] Figure 2 is a schematic cross-sectional view of the heart. Flow patterns in the heart H [Figure 3A] FIG. 3A is a first schematic diagram illustrating modeled hemodynamic flow patterns within the heart. [Figure 3B] FIG. 3B is a second schematic diagram illustrating the modeled hemodynamic flow patterns within the heart. [Figure 4A] FIG. 4A is a first schematic diagram illustrating modeled hemodynamic flow patterns within a heart with a septal shunt device. [Figure 4B] 4B is a second schematic diagram showing modeled hemodynamic flow patterns within a heart with a septal shunt device. [Figure 5] FIG. 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. [Figure 6] 6 is a schematic cross-sectional view of the atrial septum showing a second example of a cardiovascular implant device positioned in the atrial septum and including an internal curved portion. [Figure 7] 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 including a flap. [Figure 8A] FIG. 8A is a schematic cross-sectional view of a heart showing a fourth example of a cardiovascular implant device positioned adjacent to a shunt in the atrial septum. [Figure 8B] FIG. 8B is an enlarged side view of a fourth example of a cardiovascular implant device. [Figure 9] 9 is a schematic cross-sectional view of a heart showing a fifth example of a cardiovascular implant device positioned in the interatrial septum, including an internal guide wall. [Figure 10A] FIG. 10A is a schematic cross-sectional view of a heart positioned in the atrial septum and showing a sixth example of a cardiovascular implant device with an internal blade. [Figure 10B] 10B is an enlarged schematic cross-sectional view of the atrial septum showing details of a sixth example of a cardiovascular implant device. [Figure 11] FIG. 11 is a schematic cross-sectional view of a heart showing a seventh example of a cardiovascular implant device positioned in the atrial septum and including an adjustable portion. [Figure 12A]FIG. 12A is an enlarged schematic view of the adjustable portion of FIG. 10 in a compressed configuration. [Figure 12B] FIG. 12B is an enlarged schematic view of the adjustable portion of FIG. 10 in an expanded configuration. [Figure 13] 13 is a schematic cross-sectional view of the atrial septum showing an eighth example of a cardiovascular implant device positioned in the atrial septum and including a variable inner diameter. [Figure 14] FIG. 14 is a schematic cross-sectional view of a heart showing a ninth example of a cardiovascular implant device positioned in the atrial septum and including an angled central flow tube. DETAILED DESCRIPTION OF THE INVENTION

[0013] Anatomical structure of the heart (H) and vascular system (V) (Figures 1-2) Figure 1 is a schematic diagram of the heart H and vascular system V. Figure 2 is a cross-sectional schematic diagram of the heart H. Figures 1 and 2 will be considered together. Figures 1 and 2 show the heart H, vascular system V, right atrium RA, right ventricle RV, left atrium LA, left ventricle LV, superior vena cava SVC, inferior vena cava IVC, tricuspid valve TV (shown in Figure 1), pulmonary valve PV (shown in Figure 1), pulmonary artery PA (shown in Figure 1), pulmonary veins PVS, mitral valve MV, aortic valve AV (shown in Figure 1), aorta AT (shown in Figure 1), coronary sinus CS (shown in Figure 2), Thebesian valve BV (shown in Figure 2), interatrial septum IS (shown in Figure 2), and fossa ovalis FO (shown in Figure 2).

[0014] Heart H is a human heart that receives blood from and delivers blood to vascular system V. Heart H includes four chambers: right atrium RA, right ventricle RV, left atrium LA, and left ventricle LV.

[0015] The right side of the heart H, including the right atrium RA and right ventricle RV, receives deoxygenated blood from the vascular system V and pumps the blood to the lungs. Blood flows into the right atrium RA from the superior vena cava SVC, the inferior vena cava IVC, and the coronary sinus CS.

[0016] The majority of blood flows into the right atrium (RA) from the offset superior vena cava (SVC) and inferior vena cava (IVC). The offset of the major inflows from the superior vena cava (SVC) and inferior vena cava (IVC) creates a natural flow vortex (right-handed flow vortex) within 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) via direct flow. The right-handed flow vortex within the right atrium (RA) conserves the kinetic energy and momentum of the major blood flow entering the right atrium (RA), allowing a significant portion of the blood to naturally pass from the right atrium (RA) to the right ventricle (RV) without requiring the right atrium (RA) to contribute to the flow by pumping. With contraction, the right atrium (RA) also pumps the remainder of the inflow blood not captured in the direct flow through the tricuspid valve (TV) into the right ventricle (RV). Blood flows into the right ventricle (RV) and then through the pulmonary valve (PV) into the pulmonary artery (PA). By preserving direct inflow from the right atrium (RA), blood flowing into the right ventricle (RV) also forms a natural flow vortex (right ventricular flow vortex) within the right ventricle (RV), naturally redirecting the blood flowing into the right ventricle (RV) to the pulmonary artery (PA) by direct flow without requiring the right ventricle (RV) to do any substantial work of pumping the blood. The remaining blood that is not transported to the pulmonary artery (PA) by direct flow through the pulmonary valve (PV) is pumped by contraction of the right ventricle (RV). Blood flows from the pulmonary artery (PA) into each of the small arteries, and deoxygenated blood is supplied to the lungs via the pulmonary circulation. There, the lungs can oxygenate the blood.

[0017] The left side of the heart H, including the left atrium LA and left ventricle LV, receives oxygenated blood from the lungs and provides blood flow to the body. Blood flows into the left atrium LA from the pulmonary veins PVS. The offset between the right and left pulmonary veins PVS also creates a natural flow vortex (counterclockwise flow vortex) within the left atrium LA, helping to maintain momentum and minimize work as blood passes through the left atrium LA and reaches the mitral valve MV. The direct flow described above, along with the pumping action of the left atrium LA, propels blood through the mitral valve MV and into the left ventricle LV. As blood flows into the left ventricle LV, a natural flow vortex (left ventricular flow vortex) is created within the left ventricle LV, naturally redirecting the flow toward the left ventricular outflow of the aortic valve AV, allowing the left ventricle LV to efficiently pump the flow through the aortic valve AV and into the aorta AT. Blood flows from the aorta AT into the arteries, which supply oxygenated blood to the entire body via the systemic circulatory system.

[0018] Blood is additionally received by the right atrium (RA) from the coronary sinus (CS). The coronary sinus (CS) collects deoxygenated blood from the myocardium and delivers it to the right atrium (RA). The Thebesian valve (BV) is a semicircular fold of tissue at the opening of the coronary sinus (CS) in the right atrium (RA). As shown in Figure 2, the coronary sinus (CS) wraps around the heart (H) and extends partially along and below the bottom of the left atrium (LA) and just above the mitral valve (MV). The coronary sinus (CS) increases in diameter as it approaches the right atrium (RA). The coronary sinus (CS) also wraps around a portion of the posterior part of the right atrium (RA) before entering the right atrium (RA) through the ostium of the coronary sinus (CS) lateral and posterior to the ostium of the tricuspid valve (TV) and medial to the entrance of the inferior vena cava (IVC). Blood entering the right atrium RA from the coronary sinus CS is naturally mixed with the larger inflow from the inferior vena cava IVC due to its proximity, forming a natural flow vortex in the right atrium RA (a right-handed flow vortex), which naturally redirects the inflow toward the tricuspid valve TV.

[0019] The interatrial septum (IS) and fossa ovalis (FS) are also shown in Figure 2. The interatrial septum (IS) is the wall separating the right atrium (RA) from the left atrium (LA). The fossa ovalis (FS) is a depression in the interatrial septum (IS) in the right atrium (RA). At birth, a congenital structure called the foramen ovale is located in the interatrial septum (IS). The foramen ovale is an opening in the interatrial septum (IS) that closes shortly after birth to form the fossa ovalis (FS). The foramen ovale functions 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 then circulate throughout the body. This is necessary in utero because the lungs, located in a fluid sac, do not oxygenate blood. Rather, oxygenated blood is received from the mother. Oxygenated blood from the mother flows from the placenta through the umbilical vein to the inferior vena cava (IVC) and then enters the inferior vena cava (IVC) via a natural shunt called the ductus venosus. Oxygenated blood travels 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 the oxygenated blood through the right atrium (RA) and then through a second natural shunt called the foramen ovale to the left atrium (LA), along with mixed deoxygenated blood from the coronary sinus (CS). The left atrium (LA) then pumps the mixed oxygenated and deoxygenated blood into the left ventricle (LV), which pumps the blood into the aorta (AT) and the systemic circulatory system. This allows the pulmonary circulation to be bypassed in utero. Some deoxygenated blood is pumped primarily through the superior vena cava (SVC) through the right heart, where it bypasses the lungs and re-enters the aorta (AT) through a third natural shunt called the ductus arteriosus. At 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).

[0020] A shunt device can be positioned within the heart H to shunt blood between the left atrium LA and the right atrium RA. The left atrium LA has higher pressure and lower compliance compared to the right atrium RA, and the right atrium RA has lower pressure and higher compliance than the left atrium LA. The left atrium LA may experience elevated pressure due to abnormal cardiac conditions. It has been hypothesized that patients with elevated pressure in the left atrium LA may benefit from reduced pressure in the left atrium LA. In these patients, a shunt device can be used to shunt blood from the left atrium LA to the right atrium RA, reducing blood pressure in the left atrium LA and thereby reducing systolic preload in the left ventricle LV. Reducing pressure in the left atrium LA further reduces back pressure in the pulmonary circulation, reducing the risk of pulmonary edema. Reducing back pressure in the pulmonary circulation also reduces pulmonary artery PA pressure, which can damage arterioles leading to the lungs and lead to pulmonary hypertension. Increased pulmonary artery pressure can also lead to right ventricular (RV) pressure overload, right ventricular (RV) damage, and right heart failure.

[0021] For example, shunt devices can be used to treat patients with heart failure (also known as congestive heart failure). A patient's heart cannot pump blood as well as it 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) refers to heart failure that occurs when the left ventricle is stiff (poorly compliant) and has difficulty properly relaxing and filling with blood. This leads to elevated end-diastolic pressure, which causes increased pressure in the left atrium (LA). Few, if any, effective treatments are available for diastolic heart failure. Other examples of abnormal heart conditions that cause elevated pressure in the left atrium (LA) are systolic dysfunction of the left ventricle (LV), as well as certain forms of congenital heart disease and valvular disease.

[0022] A septal shunt device (also called an atrial septal shunt device or transseptal shunt device) is positioned within the interatrial septum (IS) to shunt blood directly from the left atrium (LA) to the right atrium (RA). Typically, a septal shunt device is positioned in the fossa ovalis (FS) because this is the thinner area of ​​tissue in the interatrial septum (IS) where the two atria share a common wall. When the pressure in the right atrium (RA) exceeds the pressure in the left atrium (LA), the septal shunt device can allow blood to flow primarily from the right atrium (RA) to the left atrium (LA). The shunt device can also be a left atrium-to-coronary sinus shunt device, positioned in the tissue wall between the left atrium (LA) and the coronary sinus (CS), where these two structures are in close proximity as the coronary sinus (CS) passes through the atrioventricular groove covered by the epicardium. A left atrium-to-coronary sinus shunt device moves blood from the left atrium (LA) into the coronary sinus (CS), which then delivers it to the right atrium (RA) through the ostium of the coronary sinus (CS), a natural ostium of the coronary sinus (CS) that may contain the Thebesian valve (BV). The coronary sinus (CS) is malleable and can rapidly enlarge in response to increased volume, such as when the left subclavian vein drains into the coronary sinus (CS). Similarly, the coronary sinus (CS) can act as an additional compliance chamber when using a left atrium-to-coronary sinus shunt device. In general, shunt devices can affect the natural flow patterns of the vessels and / or chambers of the heart (H). These flow patterns are discussed in more detail below with reference to Figures 3A-4B.

[0023] Flow patterns in the cardiac H (Figures 3A-4B) FIG. 3A is a first schematic diagram illustrating a modeled hemodynamic flow pattern within a heart H. FIG. 3B is a second schematic diagram illustrating a modeled hemodynamic flow pattern within a heart H. FIG. 4A is a first schematic diagram illustrating a modeled hemodynamic flow pattern within a heart H having a septal shunt device. FIG. 4B is a second schematic diagram illustrating a modeled hemodynamic flow pattern within a heart H having a septal shunt device. FIGS. 3A-4B show the heart H, the right atrium RA, the left atrium LA, the superior vena cava SVC, the inferior vena cava IVC, and the coronary sinus CS. FIGS. 3A and 4A also show the tricuspid valve TV, the pulmonary veins PVS, and the mitral valve MV.

[0024] Figures 3A and 4A represent computational fluid dynamics models of the right and left atria. The anatomical geometry was generated by segmenting and averaging computed tomography (CT) data from the patient before implantation. The shunt geometry (included in Figure 4A) was virtually added to the model. A computational mesh consisting of multifaceted cells was created on the geometry, and boundary conditions were applied in the form of flow waveforms 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 was circulated at a density of 1050 kg / m3. 3 The flow was modeled as a Newtonian viscous fluid with a viscosity of 0.0035 Pascal seconds (Pa s). A K-epsilon (k-ε) Reynolds-averaged Navier-Stokes (RANS) turbulence model was utilized with a segregated fluid solver discretized to first-order and second-order accuracy in time and space, respectively. Multiple cardiac cycles were modeled to remove any initial transients and achieve fully cyclic flow characteristics. Using post-processing tools available in the CFD software, the flow was visualized by generating streamlines at different times during the cardiac cycle. Figures 3A and 4A show the flow velocity lines at specific instants during the cardiac cycle.

[0025] 3A-4B show modeled flow velocity lines representing hemodynamic flow patterns within heart H. FIGS. 3A and 4A show heart H facing the right atrium RA on the right side of the figure, and heart H facing the left atrium LA on the left side of the figure. FIGS. 3A and 4A are views from below heart H. FIGS. 3B and 4B show heart H facing the right atrium RA on the left side of the figure, and heart H facing the left atrium LA on the right side of the figure. FIGS. 3B and 4B are top views of heart H.

[0026] Natural flow patterns of blood exist within the heart H to help move blood through the heart H and into the vascular system connected to the heart H in a manner that maximizes the conservation of momentum and kinetic energy of the blood flow. The natural flow patterns for blood moving through the arteries and veins are typically spiral in nature (spiral flow pattern). The natural flow patterns for blood moving through each chamber of the heart H are typically vortex in nature (vortex flow pattern).

[0027] FIG. 3A shows modeled hemodynamic flow patterns as they exist within the right atrium RA and left atrium LA of heart H. FIG. 3B shows modeled hemodynamic flow patterns as they exist within the right atrium RA, superior vena cava SVC, inferior vena cava IVC, and coronary sinus CS. FIGS. 3A-3B represent natural flow patterns formed within heart H, including the right atrium RA and left atrium LA, based on the anatomical structure of heart H as well as the offset of blood inflow into the chambers of heart H. When heart H is viewed from the right side (right sagittal view), a clockwise rightward flow vortex is formed within the right atrium RA, and a counterclockwise leftward flow vortex is formed within the left atrium LA. The rightward flow vortex within the right atrium RA is connected to the right atrium RA. Counterclockwise flow vortex in the left atrium LA is the natural flow pattern of blood in the left atrium LA. The modeled hemodynamic flow patterns shown in Figures 3A-3B represent the intracardiac flow patterns for a structurally normal heart.

[0028] Blood enters the right atrium RA from the superior vena cava (SVC), the inferior vena cava (IVC), and the coronary sinus (CS). The openings of the superior vena cava (SVC) and the inferior vena cava (IBC) in the right atrium RA are offset to prevent blood flowing into the right atrium RA from the superior vena cava (SVC) and the inferior vena cava (IVC). Due to their orientation and physical proximity, the flow of the coronary sinus CS is entrained within the flow of the inferior vena cava (IVC). Blood flowing through the superior vena cava (SVC) and the inferior vena cava (IVC) has a spiral flow pattern. Most of the blood in the right atrium RA flows into the right atrium RA through the inferior vena cava (IVC), and blood flowing into the right atrium RA from the inferior vena cava (IVC) is directed toward the top of the right atrium RA. The spiral flow pattern of blood flowing from the inferior vena cava (IVC) into the right atrium RA helps form a clockwise vortex within the right atrium RA (when viewed from the right side of the heart). Blood flowing from the superior vena cava (SVC) into the right atrium (RA) flows along the interatrial septum toward the tricuspid valve (TV). The spiral flow pattern of blood flowing from the superior vena cava (SVC) into the right atrium (RA) naturally merges with the clockwise vortex formed in the right atrium (RA) by blood flow from the inferior vena cava (IVC), which merges with flow from the coronary sinus (CS). A small amount of blood flows from the coronary sinus (CS) into the right atrium (RA). The flow through the coronary sinus (CS) has a spiral flow pattern. The spiral flow pattern of blood emerging from the coronary sinus (CS) naturally merges with the flow from the inferior vena cava (IVC) and with the rightward vortex in the right atrium (RA). The rightward vortex in the right atrium (RA) is indicated by the flow velocity line labeled RVF in Figures 3A and 3B.

[0029] The rightward flow vortex formed within the right atrium RA helps blood move through the right atrium RA, through the tricuspid valve TV, into the right ventricle, and through the pulmonary valve into the pulmonary artery. The right heart is an inefficient pump and can act more like a conduit. The rightward flow vortex formed within the right heart helps conserve 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 minimal or no pumping action is provided by the right heart. This is particularly important during periods of high power output and high heart rate during exercise to maintain right cardiac output, which must match left cardiac output. The rightward flow vortex formed within the right atrium RA helps blood move from the right atrium RA through the tricuspid valve TV and into the right ventricle with minimal loss of momentum and kinetic energy. Blood flows from the right atrium RA through the right ventricle, exits the right ventricular outflow tract, and flows through the pulmonary valve into the pulmonary artery. Due to the rightward flow vortex of the right atrium (RA) and right ventricle (RV) and the anatomical constraints of the right heart, approximately 50% of the blood flows into the pulmonary arteries without requiring pumping by the right heart. Right heart contraction enhances the flow of residual blood through the right heart.

[0030] Blood flows into the left atrium LA from the pulmonary veins PVS. There are four pulmonary veins PVS that flow into the left atrium LA. Blood flowing through the pulmonary veins PVS has a spiral flow pattern. The offset of the spiral flow of blood flowing from the pulmonary veins PVS into the left atrium LA helps to form a counterclockwise (when viewing the heart from the right side) leftward flow vortex within the left atrium LA. The leftward flow vortex within the left atrium LA guides the flow toward the mitral valve MV. The leftward flow vortex within the left atrium LA is indicated in Figure 3A by the flow velocity line labeled LVF.

[0031] It is hypothesized that if the intracardiac blood flow pattern of the heart H (including the right-handed vortex in the right atrium RA and the left-handed vortex in the left atrium LA) is disrupted, the flow of blood from the superior vena cava SVC and inferior vena cava IVC (from the vena cava) through the right atrium RA to the right ventricle and into the pulmonary artery, and the flow of blood from the pulmonary veins through the left atrium LA to the left ventricle and into the aorta, will be less efficient, increasing the mechanical load on the corresponding ventricles. This is particularly serious in an already dysfunctional heart, which has a reduced ability to increase myocardial work. Disruptions in the intracardiac blood flow pattern of the heart H (including the right-handed vortex in the right atrium RA and the left-handed vortex in the left atrium LA) can occur for a variety of reasons. For example, the anatomy of the heart H can change with patient age, which may affect the offset between the openings of the superior vena cava SVC and the inferior vena cava IVC. Blood flow from the superior vena cava (SVC) into the right atrium (RA) and blood flow from the inferior vena cava (IVC) into the right atrium (RA) can collide when the anatomy of the heart (H) changes, disrupting the natural formation of a rightward flow vortex within the right atrium (RA). In another example, the right atrium (RA) can enlarge in patients with heart failure, regardless of whether atrial fibrillation is present. The enlargement of the right atrium (RA) can also disrupt the rightward flow vortex that forms within the right atrium (RA). Similarly, the left atrium (LA) can enlarge in patients with heart failure, regardless of whether atrial fibrillation is present. The enlargement of the left atrium (LA) can disrupt the leftward flow vortex that forms within the left atrium (LA). Additionally, patients with a patent foramen ovale (a native atrial septal shunt) or an ostium secundum atrial septal defect due to incomplete closure of the patent foramen ovale may not have the expected intracardiac blood flow pattern (including a rightward flow vortex in the right atrium RA and a leftward flow vortex in the left atrium LA), including the expected flow vortices that are generated during atrial filling. Occlusion of an ostium secundum atrial septal defect, which alters the non-single vortex flow pattern in the right atrium, has been shown to revert to a predominantly single vortex flow pattern after closure of the atrial septal defect.

[0032] When the rightward flow vortex in the right atrium RA changes, blood momentum and energy are lost, and the right heart must pump harder to move blood from the right atrium RA into the right ventricle and into the pulmonary artery. This is because the rightward flow vortex contributes less to blood movement through the right heart. Similarly, when the leftward flow vortex in the left atrium LA changes, the left heart must pump harder to move blood from the left atrium LA into the left ventricle and into the aorta. This is because the leftward flow vortex contributes less to blood movement through the left heart. Furthermore, when the intracardiac flow pattern of the heart H (including the rightward flow vortex in the right atrium RA and the leftward flow vortex in the left atrium LA) changes due to aging or disease, regions of turbulence can develop in the flow pattern of the heart H, potentially creating fluid dynamic losses that lead to inefficiencies that result in reduced flow. This can increase the likelihood of right and / or left heart failure (the inability to pump enough blood to meet the body's oxygen needs) because the heart H must work more to move the same amount of blood through the heart H. The additional effort required to recreate the lost momentum naturally conserved by the heart H's intracardiac flow patterns (including a right-handed vortex in the right atrium RA and a left-handed vortex in the left atrium LA) places an additional burden on the heart H.

[0033] Changes in intracardiac flow patterns change intracardiac energy. Heart H is uniquely designed to maximize efficiency by conserving blood flow kinetic energy and momentum, thereby minimizing the effort required to propagate blood into, between, and out of its chambers. Anything that disrupts the intracardiac flow patterns within heart H (including right-handed flow vortices in the right atrium RA and left-handed flow vortices in the left atrium LA) can reduce the energy efficiency of heart H due to loss of potential energy, making it more difficult for heart H to do its job of propagating blood into, between, and out of its chambers. Anything that disrupts the intracardiac flow patterns through heart H (including right-handed flow vortices in the right atrium RA and left-handed flow vortices in the left atrium LA) can increase heart H's effort and lengthen transit time through heart H, further making it more difficult for heart H to pump blood. This is particularly problematic for people experiencing heart failure, which can be exacerbated due to disturbances in the intracardiac flow patterns through the heart H, including right-handed flow vortices in the right atrium RA and left-handed flow vortices in the left atrium LA.

[0034] 4A shows modeled hemodynamic flow patterns present in the right atrium RA and left atrium LA of a heart H when a conventional septal shunt device (e.g., a septal shunt device without any additional flow directing or regulating functions) is positioned between the right atrium RA and left atrium LA. FIG. 4B shows 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 left atrium LA. A conventional septal shunt device is modeled in the atrial septum between the right atrium RA and left atrium LA, shown schematically in FIGS. 4A-4B, to shunt blood directly from the left atrium LA to the right atrium RA.

[0035] As shown in FIGS. 4A-4B, when a conventional septal shunt device is positioned in the atrial septum between the right atrium RA and the left atrium LA, blood spurts from the left atrium LA into the right atrium RA and crosses the right atrium RA. The blood spurt is indicated by the flow velocity line labeled J in FIGS. 4A-4B. The blood spurt in the right atrium RA disrupts the clockwise flow vortex in the right atrium RA. As the blood spurts across the right atrium RA, two separate flow vortices are formed in the right atrium RA. The first flow vortex is indicated by the flow velocity line labeled RVF1 in FIGS. 4A-4B, and the second flow vortex is indicated by the flow velocity line labeled RVF2. There is also a disturbance of the counterclockwise flow vortex in the left atrium LA. Although conventional septal shunt devices are not aligned with the left atrium LA's left-handed flow vortex, the pressure difference between the right atrium RA and the left atrium LA causes blood in the left atrium LA to exit the left-handed flow vortex and move through the septal shunt device into the right atrium RA. The disturbed left-handed flow vortex in the left atrium LA is shown in Figures 4A-4B by the flow velocity lines labeled DFP. This disturbance of the right-handed flow vortex in the right atrium RA and the left-handed flow vortex in the left atrium LA can also lead to a loss of vortex formation in the right ventricle RV and left ventricle LV, requiring the heart H to work harder to pump blood through their respective chambers, which over time can lead to the onset or worsening of heart failure.

[0036] Specifically, when considering the right heart, conventional septal shunt devices significantly disrupt the rightward flow vortex in the right atrium RA as blood is ejected across the right atrium RA. It is hypothesized that disruption of the rightward flow vortex in the right atrium RA can cause or worsen right heart failure. Disruption of the rightward flow vortex in the right atrium RA means that the momentum and kinetic energy of blood flowing naturally or efficiently from the right atrium RA to the right ventricle and pulmonary artery is lost. To move blood from the right atrium RA to the right ventricle and pulmonary artery, the right heart must work harder to pump blood. This increased effort required by the right heart can cause or worsen right heart failure, placing a heavy load on the less efficient right heart during periods of exercise, resulting in a higher heart rate and shorter diastolic filling time.

[0037] Some example features of cardiovascular implant devices (including some shunt devices) according to the technology of the present disclosure are described with reference to Figures 5-14. Each example cardiovascular implant device shown in Figures 5-14 includes several generally similar components that share the same name and are identified by shared reference numbers that increase progressively between each of Figures 5-14 (e.g., Figures 5-6 include cardiovascular implant devices 100 and 100A, Figure 7 includes cardiovascular implant device 200, Figures 8A-8B include cardiovascular implant device 300, Figure 9 includes cardiovascular implant device 400, Figures 10A-10B include cardiovascular implant device 500, Figures 11-13 include cardiovascular implant devices 600 and 600A, and Figure 14 includes cardiovascular implant device 700). For ease of discussion, details of some components of the example cardiovascular implant device shown in Figures 5-14 may not be repeated in each of the following sections, but it should be understood that the example cardiovascular implant device shown in Figures 5-14 can include all or any combination of the components and features described herein. In addition, although illustrated in Figures 5-14 as separate examples, cardiovascular implant devices according to the technology of the present disclosure can generally include any combination of the following features:

[0038] The cardiovascular implant devices 100, 100A, 200, 300, 400, 500, 600, 600A, 700 described herein can be formed in a variety of ways, such as by connecting individual wires together to form a mesh or lattice, braiding, cutting from a sheet and then rolling or otherwise forming into the shape of the cardiovascular implant device, casting, cutting from a cylindrical tube (e.g., cutting from a Nitinol tube), other methods, or combinations thereof. All or a portion of the cardiovascular implant devices 100, 100A, 200, 300, 400, 500, 600, 600A, 700 can be made from a flexible metal, metal alloy, polymer, or other suitable material. Examples of metals and metal alloys that may be used include, but are not limited to, Nitinol (nickel-titanium alloy) and other shape memory materials, Elgiloy, and stainless steel, although other metals and elastic or malleable non-metallic materials can be used in fabricating cardiovascular implant devices 100, 100A, 200, 300, 400, 500, 600, 600A, 700, or their components. All or a portion of cardiovascular implant devices 100, 100A, 200, 300, 400, 500, 600, 600A, 700 may be monolithically formed from any of these materials. These materials can allow the cardiovascular implant device 100, 100A, 200, 300, 400, 500, 600, 600A, 700 to be compressed to a small size, and then, when the compressive force is released, the cardiovascular implant device 100, 100A, 200, 300, 400, 500, 600, 600A, 700 can self-expand and return to its pre-compression shape.The cardiovascular implant devices 100, 100A, 200, 300, 400, 500, 600, 600A, 700 can expand and return to their pre-compressed shape due to the material properties of the cardiovascular implant devices 100, 100A, 200, 300, 400, 500, 600, 600A, 700, and / or the cardiovascular implant devices 100, 100A, 200, 300, 400, 500, 600, 600A, 700 can be expandable, for example, by inflation or expansion of another device positioned within the corresponding cardiovascular implant device. For example, the cardiovascular implant devices 100, 100A, 200, 300, 400, 500, 600, 600A, 700 can be compressed so that the cardiovascular implant devices 100, 100A, 200, 300, 400, 500, 600, 600A, 700 can fit within a delivery catheter. The cardiovascular implant devices 100, 100A, 200, 300, 400, 500, 600, 600A, 700 can also be made from other materials and can be expandable and collapsible in various manners, such as mechanically expandable, balloon expandable, self-expandable, or combinations thereof. In yet other examples, some of the cardiovascular implant devices 100, 100A, 200, 300, 400, 500, 600, 600A, 700 are not expandable.

[0039] Devices 100 and 100A (Figures 5-6) FIG. 5 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). As shown in FIG. 5, the cardiovascular implant device (100) includes an annular body (102) including struts (103), a central flow tube (104), and a flow channel (106), and an anchor member (108). The central flow tube (104) includes an inflow end (110), an outflow end (112), and a flow surface (114). The central flow tube (104) further includes a straight portion (120) and a curved portion (130). FIG. 5 also shows the heart (H), the right atrium (RA), the left atrium (LA), the superior vena cava (SVC), the inferior vena cava (IVC), the tricuspid valve (TV), the pulmonary veins (PVS), the mitral valve (MV), and the atrial septum (IS). FIG. 5 further shows the right atrial vortex (RVF), the tissue wall (TWP), the tricuspid valve plane (TVP), the outer diameter (OD), the axis (AX1), and the angle (α1).

[0040] The cardiovascular implant device 100 is an implantable device for use within the cardiovascular system. The cardiovascular implant device 100 is configured to be implanted within a blood vessel or chamber of the heart H. In the illustrated example, the cardiovascular implant device 100 is a flow directing shunt device for shunting blood from one blood vessel or chamber to another. Specifically, as shown in FIG. 5 , the cardiovascular implant device 100 is positioned within the interatrial septum IS. In other examples, the cardiovascular implant device 100 may be positioned in any other tissue wall between adjacent chambers and / or blood vessels of the heart H (or cardiovascular system). The cardiovascular implant device 100 can be delivered into the cardiovascular system via a catheter (i.e., transcatheter delivery) or surgically positioned using transcatheter or surgical procedures known in the art.

[0041] The annular body 102 is the main body portion 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 wide variety of different shapes and sizes. The annular body 102 may press against or into a tissue wall at the implantation site to set and maintain the position of the cardiovascular implant device 100, or may be positioned (or extend) around an anatomical structure of the cardiovascular system. In some examples, for example, as shown in FIG. 5 , the annular body 102 may be formed with a plurality of struts 103. The struts 103 may form a lattice or mesh of the annular body 102 and define openings therein. In such examples, the annular body 102 may be a stent framework for supporting graft material that guides flow through the cardiovascular implant device 100. In other examples, the annular body 102 may be integrally formed.

[0042] The annulus 102 can be positioned within a puncture in a tissue wall to hold the tissue wall open around the annulus 102 so that blood can flow between the vessels or chambers of the heart H through the cardiovascular implant device 100. In the example shown in FIG. 5 , the annulus 102 is positioned within a puncture in the interatrial septum IS between the left atrium LA and the right atrium RA so that blood can 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 annulus 102 form a type of cage sufficient to hold the tissue wall open around the annulus 102. In other examples, the material integrally forming the annulus 102 is sufficient to hold the tissue wall open around the annulus 102.

[0043] The annular body 102 has an outer diameter OD. The outer diameter OD is the diameter of the annular body 102 measured relative to the outer surface of the cardiovascular implant device 100. The outer diameter OD is configured to be approximately the same size as the diameter of the puncture in the tissue wall into which the cardiovascular implant device 100 is to be implanted, so that the cardiovascular implant device 100 can fit within the puncture. The outer diameter OD can have any size, such that the cardiovascular implant device 100 is sized to suit a variety of different patient conditions and / or anatomies. In some examples, the outer diameter OD can also vary along the length of the annular body 102 based on the overall shape or configuration of the annular body 102.

[0044] The annular body 102 includes a central flow tube 104 that functions as a conduit for guiding flow through the cardiovascular implant device 100. The central flow tube 104 surrounds a flow path 106. The flow path 106 is an opening that extends through the central flow tube 104 such that the cardiovascular implant device 100 is open at each opposing end. The flow path 106 is a path along which blood flows or is directed through the cardiovascular implant device 100. The central flow tube 104 includes a flow surface 114 configured to be a flow contact surface when the cardiovascular implant device 100 is implanted in a vessel or chamber of the heart H. The flow surface 114 is a 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.

[0045] The outer shapes of the central flow tube 104 and the flow channels 106 can be straight, curved, a combination of straight and curved sections, or any other suitable shape, as described in more detail below. In some examples, the outer shapes of the central flow tube 104 and the flow channels 106 can be defined by or the same as the outer shape of the annular body 102 (e.g., as shown in FIG. 5 ). In other examples, the outer shapes of the central flow tube 104 and the flow channels 106 can be independent of or different from the outer shape of the annular body 102 (e.g., as shown in FIG. 6 ). Similarly, the cross-sectional shapes or outer shapes of the central flow tube 104 and the annular body 102 can be the same, e.g., circular, elliptical, 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 elliptical cross-section. Furthermore, the cross-sectional shapes of the central flow tube 104 and / or the annular body can also vary along either length. The cross-sectional shape of the central flow tube 104 may be selected at various points along its length, such as at the outlet end 112, to affect the flow direction.

[0046] The central flow tube 104 (and the flow passage 106 therein) extends from an inflow end 110 and an outflow end 112. The inflow end 110 can be the end of the central flow tube 104 that is relatively upstream of the outflow end 112 with respect to the flow of blood through the cardiovascular implant device 100, as represented by arrow F in FIG. 5 , when the cardiovascular implant device 100 is implanted in a vessel or chamber of the heart H. Thus, the outflow end 112 is the end of the central flow tube 104 that is relatively downstream of the inflow end 110 with respect to the flow of blood through the cardiovascular implant device 100, as represented by arrow F in FIG. 5 , when the cardiovascular implant device 100 is implanted in a vessel or chamber of the heart H. In the example shown in FIG. 5 , the inflow end 110 is positioned on the left atrial side of the atrial septum IS, and the outflow end 112 is positioned downstream of the right atrial side of the atrial septum IS, such that blood can flow from the left atrium LA to the right atrium RA through the flow passage 106. As shown in FIG. 5 , the inflow end 110 may be essentially flush with the left atrial side of the atrial septum IS, whereas 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, either the inflow end 110 or the outflow end 112, or both, may be flush with or spaced apart from the corresponding side of the tissue wall. While the inflow end 110 is defined as being relatively upstream from 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 where the cardiovascular implant device 100 is implanted. The central flow tube 104 may have any suitable length measured from the inflow end 110 to the outflow end 112. For example, the central flow tube 104 can be designed to have a length that approximates the thickness of the atrial septum IS or another tissue wall in which the cardiovascular implant device 100 is positioned. In other examples, the central flow tube 104 can be longer or shorter than the thickness of the atrial septum IS or another tissue wall.

[0047] In general, the central flow tube 104 may be formed of 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 may be formed of a graft material. The graft material may be a synthetic material such as woven polyester or polytetrafluoroethylene (PTFE), a biological material, a metallic material, or other material, to name a few non-limiting examples. The central flow tube 104 formed of a graft material may be supported within the cardiovascular implant device 100 by the struts 103 of the annular body 102. In such an example, the central flow tube 104 may be attached to the struts 103 of the annular body 102 by any suitable attachment means, such as suturing, gluing, tying, etc. In other examples, the central flow tube 104 may be integrally formed with the annular body 104.

[0048] One or more anchor members 108 extend outward from the annular body 102. The anchor members 108 hold the cardiovascular implant device 100 in place within the tissue wall when the cardiovascular implant device 100 is implanted within the body. The anchor members 108 can take any suitable form for securing the cardiovascular implant device 100 to the tissue wall. In some examples, the anchor members 108 can be one or more arms. In other examples, the anchor members 108 can be a flange or annular lip configured to have a diameter larger than the diameter of the puncture or opening in which the cardiovascular implant device 100 is positioned to prevent the cardiovascular implant device 100 from slipping through the puncture or opening. In some examples, the anchor members 108 can bend toward the tissue wall or, alternatively, lie flush against the tissue wall. As shown in FIG. 5 , the cardiovascular implant device 100 can include one or more anchor members 108 extending from one end of the central flow tube 104. Specifically, the cardiovascular implant device 100 may include an anchor member 108 adjacent the inflow end 110. In other examples, the cardiovascular implant device 100 may include an anchor member 108 adjacent the outflow end 112. In yet other examples, the cardiovascular implant device 100 may include anchor members 108 at both the inflow end 110 and the outflow end 112.

[0049] As shown in FIG. 5 , the central flow tube 104 includes a straight portion 120 and a curved portion 130. The straight portion 120 is a first portion or segment of the central flow tube 104. In the example shown in FIG. 5 , the straight portion 120 is adjacent to and extends from the inflow end 110 to capture blood flowing into the cardiovascular implant device 100. The length of the straight portion 120 is sized to span the puncture 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. In the example shown in FIG. 5 , the curved portion 130 is adjacent to and extends from the outflow end 112 to the straight portion 120. That is, 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 100 when implanted in a tissue wall. The curved portion 130 may be continuous with the straight portion 120. Although the curved portion 130 and the straight portion 120 are shown in FIG. 5 as having similar lengths, it should be understood that the curved portion 130 and the straight portion 120 may have any relative lengths with respect to one another.

[0050] The curved portion 130 is a flow-directing component of the cardiovascular implant device 100. The curved portion 130 is positioned to direct blood flow from the cardiovascular implant device 100 in a particular direction. More specifically, the curved portion 130 is curved to direct blood flow from the cardiovascular implant device 100 in a particular direction. As shown in FIG. 5 , the curved portion 130 is configured by positioning the cardiovascular implant device 100 so that it curves toward the tricuspid valve plane TVP (a plane containing the annulus of the tricuspid valve TV). Therefore, the curved portion 130 is configured to direct flow from the cardiovascular implant device 100 toward the tricuspid valve plane TVP. The curved portion 130 defines a bend in the flow path 106. When the cardiovascular implant device 100 is implanted in the atrial septum IS, the bend aligns a portion of the flow path 106 at the outflow end 112 with the natural flow pattern in the right atrium RA. An axis AX1 extending longitudinally through the outflow end 112 (approximating a longitudinal axis aligned with blood flow from the central flow tube 104) forms an angle α1 with a tissue wall plane TWP of the tissue wall (e.g., the atrial septum IS) in which the cardiovascular implant device 100 is configured to be positioned. The tissue wall plane TWP is a vertical reference plane defined by the tissue wall and is therefore approximately perpendicular to the flow path 106 across the tissue wall. In some examples, the angle α1 is between 0 and 75 degrees (0°-75°).

[0051] Because the curved portion 130 is adjacent the outflow end 112, the curved portion 130 is configured to face or partially extend into the right atrium RA when the cardiovascular implant device 100 is implanted in the interatrial septum IS. Protrusion of the curved portion 130 into the right atrium RA can be minimized so that the curved portion 130 protrudes only sufficiently into the right atrium RA to secure the cardiovascular implant device 100 in place within the interatrial septum IS.

[0052] When the cardiovascular implant device 100 is implanted in the cardiovascular system (e.g., the interatrial septum IS as shown in FIG. 5 , or another tissue wall), circulating blood passes through the flow channel 106 of the cardiovascular implant device 100. In the example shown in FIG. 5 , blood flows from the left atrium LA through the flow channel 106 into the right atrium RA. As blood exits the cardiovascular implant device 100, the curved portion 130 aligns the flow of blood with the natural flow pattern of the right atrium RA so that the flow of blood from the cardiovascular implant device 100 merges with the natural flow pattern of the right atrium RA. More specifically, the curved portion 130 aligns the flow of blood from the cardiovascular implant device 100 with the natural vortex flow pattern of blood (i.e., a right-handed flow vortex) in the right atrium RA (shown in FIG. 5 by the schematic flow lines labeled RVF). As shown by arrow F in Figure 5, blood flow from the cardiovascular implant device 100 is directed in a curved path along the right atrial side of the interatrial septum IS toward the tricuspid valve plane TVP, rather than ejecting across the right atrium RA and cutting or otherwise disrupting the natural vortex flow pattern. In this way, blood flow from the cardiovascular implant device 100 can merge with blood flowing downward along the interatrial septum IS and enter the right atrial vortex.

[0053] The cardiovascular implant device 100, including the curved portion 130, can minimize disruption to, or potentially enhance, the natural flow pattern local to the site where the cardiovascular implant device 100 is implanted in the heart H. When the cardiovascular implant device 100 is implanted in the interatrial septum IS, blood flowing from the left atrium LA to the right atrium RA through the cardiovascular implant device 100 can lessen interference with the natural rotational (e.g., vortex) flow pattern in the right atrium RA because, in contrast to conventional septal shunt devices that may spurt blood flow across the right atrium, the flow from the cardiovascular implant device 100 is aligned with the natural vortex flow pattern. Utilizing the curved portion 130 to align the flow from the cardiovascular implant device 100 with the natural flow pattern within the chambers or vessels of the heart H minimizes any disruption to the natural flow pattern that may result from the implantation of a conventional shunt device without a directional component. Furthermore, aligning flow from the cardiovascular implant device 100 may also potentially mitigate reduced flow due to pathophysiology or other causes or enhance basal flow. As a result, the cardiovascular implant device 100 may preserve the kinetic energy of blood flow in the cardiovascular system, which may reduce cardiac work requirements and improve cardiac efficiency. These hemodynamic effects may potentially improve patient outcomes after receiving the cardiovascular implant device 100, as the cardiovascular implant device 100 may be more effective and potentially safer.

[0054] FIG. 6 is a schematic cross-sectional view of the atrial septum IS, showing a cardiovascular implant device 100A positioned therein and including an internal curved portion 130A. As shown in FIG. 6, the cardiovascular implant device 100A includes a strut 103A, a central flow tube 104A, an annular body 102A including a flow channel 106A, and an anchor member 108A. The central flow tube 104A includes an inflow end 110A, an outflow end 112A, and a flow face 114A. The central flow tube 104A further includes a straight portion 120A and a curved portion 130A. FIG. 6 also shows the right atrium RA, the left atrium LA, and the atrial septum IS. FIG. 6 further shows the tissue wall surface TWP, the outer diameter OD, the axis AX1, and the angle α1.

[0055] The cardiovascular implant device 100A has a structure, design, and function generally similar to the cardiovascular implant device 100 described above with reference to FIG. 5, except that the cardiovascular implant device 100A includes an internal curved portion 130A. Compared to the curved portion 130 shown in FIG. 5, the curved portion 130A is formed internally within the annular body 102 such that the curved portion 130A and the outflow end 112A do not extend substantially, if at all, beyond the tissue wall into which the cardiovascular implant device 100A is implanted. As such, the cardiovascular implant device 100A includes anchor members 108 adjacent the inflow end 110A and the outflow end 112A. As shown in FIG. 6, the central flow tube 104A and the annular body 102A do not have the same outer shape. The central flow tube 104A has a curved outer shape through the curved portion 130A, while the annular body 102 has a straight outer shape. In other words, the curvature of curved portion 130A is not reflected by the outer diameter OD.

[0056] Device 200 (Figure 7) FIG. 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). As shown in FIG. 7, the cardiovascular implant device (200) includes an annular body (202) including struts (203), a central flow tube (204), and a flow channel (206), and an anchor member (208). The central flow tube (204) includes an inflow end (210), an outflow end (212), and a flow face (214). The cardiovascular implant device (200) further includes a flap (240), a flexible joint (242), and a stopper (244). FIG. 7 also shows the heart (H), the right atrium (RA), the left atrium (LA), the superior vena cava (SVC), the inferior vena cava (IVC), the tricuspid valve (TV), the pulmonary veins (PVS), the mitral valve (MV), and the atrial septum (IS). FIG. 7 further shows the right atrial vortex (RVF), the tissue wall (TWP), the tricuspid valve plane (TVP), the outer diameter (OD), the axis (AX2), the axis (LX2), and the angle (α2).

[0057] The cardiovascular implant device 200 is an implantable device for use within the cardiovascular system. The cardiovascular implant device 200 is configured to be implanted within a blood vessel or chamber of the heart H. In the illustrated example, the cardiovascular implant device 200 is a flow directing shunt device for shunting blood from one blood vessel or chamber to another. Specifically, as shown in FIG. 7 , the cardiovascular implant device 200 is positioned within the interatrial septum IS. In other examples, the cardiovascular implant device 200 may be positioned in any other tissue wall between adjacent chambers and / or blood vessels of the heart H (or cardiovascular system). The cardiovascular implant device 200 can be delivered into the cardiovascular system via a catheter (i.e., transcatheter delivery) or surgically positioned using transcatheter or surgical procedures known in the art.

[0058] The annular body 202 is the main body portion of the cardiovascular implant device 200. The annular body 202 may be expandable. The annular body 202 is generally cylindrical and tubular in cross section, but may have a wide variety of different shapes and sizes. The annular body 202 may press against or into a tissue wall at the implantation site to set and maintain the position of the cardiovascular implant device 200, or may be positioned (or extend) around an anatomical structure of the cardiovascular system. In some examples, for example, as shown in FIG. 7 , the annular body 202 may be formed with a plurality of struts 203. The struts 203 may form a lattice or mesh of the annular body 202 and define openings therein. In such examples, the annular body 202 may be a stent framework for supporting graft material that guides flow through the cardiovascular implant device 200. In other examples, the annular body 202 may be integrally formed.

[0059] The annulus 202 can be positioned within a puncture in a tissue wall to hold the tissue wall open around the annulus 202 so that blood can flow between blood vessels or chambers of the heart H through the cardiovascular implant device 200. In the example shown in FIG. 7 , the annulus 202 is positioned within a puncture in the interatrial septum IS between the left atrium LA and the right atrium RA so that blood can 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 annulus 202 form a type of cage sufficient to hold the tissue wall open around the annulus 202. In other examples, the material integrally forming the annulus 202 is sufficient to hold the tissue wall open around the annulus 202.

[0060] The annular body 202 has an outer diameter OD. The outer diameter OD is the diameter of the annular body 202 measured relative to the outer surface of the cardiovascular implant device 200. The outer diameter OD is configured to be approximately the same size as the diameter of the puncture in the tissue wall into which the cardiovascular implant device 200 is to be implanted, so that the cardiovascular implant device 202 can fit within the puncture. The outer diameter OD may have any size such that the cardiovascular implant device 200 is sized to suit a variety of different patient conditions and / or anatomies. In some examples, the outer diameter OD may also vary along the length of the annular body 202 based on the overall shape or configuration of the annular body 202.

[0061] The annular body 202 includes a central flow tube 204 that functions as a conduit for guiding flow through the cardiovascular implant device 200. The central flow tube 204 surrounds a flow path 206. The flow path 206 is an opening that extends through the central flow tube 204 such that the cardiovascular implant device 200 is open at each opposing end. The flow path 206 is a path along which blood flows or is directed through the cardiovascular implant device 200. The central flow tube 204 includes a flow face 214 configured to be a flow contact surface when the cardiovascular implant device 200 is implanted in a vessel or chamber of the heart H. The flow face 214 is a radially inner surface of the central flow tube 204. The flow path 206 through the central flow tube 204 is defined by the flow face 214.

[0062] The outer shapes of the central flow tube 204 and the flow channels 206 can be straight, curved, a combination of straight and curved sections, or any other suitable shape. In some examples, the outer shapes of the central flow tube 204 and the flow channels 206 can be defined by or the same as the outer shape of the annular body 202 (e.g., as shown in FIG. 5 ). In other examples, the outer shapes of the central flow tube 204 and the flow channels 206 can be independent of or different from the outer shape of the annular body 202 (e.g., as shown in FIG. 6 ). Similarly, the cross-sectional shape or outer shape of the central flow tube 204 and the annular body 202 can be the same, e.g., circular, elliptical, 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 elliptical cross-section. Furthermore, the cross-sectional shapes of the central flow tube 204 and / or the annular body can also vary along either length. The cross-sectional shape of the central flow tube 204 may be selected at various points along its length, such as at the outlet end 212, to affect the flow direction.

[0063] The central flow conduit 204 (and the flow path 206 therein) extends from an inflow end 210 and an outflow end 212. The inflow end 210 can be the end of the central flow conduit 204 that is relatively upstream of the outflow end 212 with respect to the flow of blood through the cardiovascular implant device 200, as represented by arrow F in FIG. 7 , when the cardiovascular implant device 200 is implanted in a vessel or chamber of the heart H. Thus, the outflow end 212 is the end of the central flow conduit 204 that is relatively downstream of the inflow end 210 with respect to the flow of blood through the cardiovascular implant device 200, as represented by arrow F in FIG. 7 , when the cardiovascular implant device 200 is implanted in a vessel or chamber of the heart H. In the example shown in FIG. 7 , the inflow end 210 is positioned on the left atrial side of the atrial septum IS, and the outflow end 212 is positioned downstream of the right atrial side of the atrial septum IS, such that blood can flow from the left atrium LA to the right atrium RA through the flow path 206. As shown in FIG. 7 , the inflow end 210 may be essentially flush with the left atrial side of the atrial septum IS, whereas 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, either the inflow end 210 or the outflow end 212, or both, may be flush with or spaced apart from the corresponding side of the tissue wall. While the inflow end 210 is defined as being relatively upstream from 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 where the cardiovascular implant device 200 is implanted. The central flow tube 204 may have any suitable length measured from the inflow end 210 to the outflow end 212. For example, the 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 the cardiovascular implant device 200 is positioned. In other examples, the central flow tube 204 can be longer or shorter than the thickness of the atrial septum IS or another tissue wall.

[0064] In general, the central flow tube 204 may be formed of 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 may be formed of a graft material. The graft material may be a synthetic material such as woven polyester or polytetrafluoroethylene (PTFE), a biological material, a metallic material, or other material, to name a few non-limiting examples. The central flow tube 204 formed of a graft material may be supported within the cardiovascular implant device 200 by the struts 203 of the annular body 202. In such an example, the central flow tube 204 may be attached to the struts 203 of the annular body 202 by any suitable attachment means, such as suturing, gluing, tying, etc. In other examples, the central flow tube 204 may be integrally formed with the annular body 204.

[0065] One or more anchor members 208 extend outward from the annular body 202. The anchor members 208 hold the cardiovascular implant device 200 in place within the tissue wall when the cardiovascular implant device 200 is implanted within the body. The anchor members 208 can take any suitable form for securing the cardiovascular implant device 200 to the tissue wall. In some examples, the anchor members 208 can be one or more arms. In other examples, the anchor members 208 can be a flange or annular lip configured to have a diameter larger than the diameter of the puncture or opening in which the cardiovascular implant device 200 is positioned so that the cardiovascular implant device 200 cannot slip through the puncture or opening. In some examples, the anchor members 208 can bend toward the tissue wall or, alternatively, lie flush against the tissue wall. As shown in FIG. 7 , the cardiovascular implant device 200 can include one or more anchor members 208 extending from one end of the central flow tube 204. Specifically, the cardiovascular implant device 200 may include an anchor member 208 adjacent the inflow end 210. In other examples, the cardiovascular implant device 200 may include an anchor member 208 adjacent the outflow end 212. In yet other examples, the cardiovascular implant device 200 may include anchor members 208 at both the inflow end 210 and the outflow end 212.

[0066] As shown in FIG. 7 , the cardiovascular implant device 200 includes a flap 240. The flap 240 is connected to the annular body 202 adjacent the outflow end 212 of the central flow tube 204. In some examples, the flap 240 is sized and shaped to fit over the end of the cardiovascular implant device 200, like a door or cover. In other examples, the flap 240 can have any suitable size and shape. In some examples, the flap 240 is integrally formed from a relatively flexible but impermeable material. In other examples, the periphery of the flap 240 is formed from a wire frame, and an impermeable fabric is stretched over the wire frame. For example, the wire frame can be formed from nitinol (nickel-titanium alloy) or a similar shape-memory material. In still other examples, all or a portion of the flap 240 can be formed from a biological material, such as pericardium.

[0067] The flap 240 is connected to the annular body 202 by a flexible joint 242. The flap 240 is positionable relative to the annular body 202 at the flexible joint 242. That is, the flap 240 can pivot 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 flexible piece of material connecting or extending between the flap 240 and the annular body 202. In still other examples, the flexible joint 242 can be any suitable flexible attachment mechanism. The cardiovascular implant device 200 can also include a stopper 244 adjacent the flexible joint 242 to prevent the flap 240 from moving beyond a maximum opening angle. For example, the stopper 244 can prevent the flap 240 from fully opening (moving 180°) when there is high-pressure flow through the cardiovascular implant device 200.

[0068] The flap 240 is a flow-directing component of the cardiovascular implant device 200. The flap 240 is positioned or positionable to direct blood flow from the cardiovascular implant device 200 in a particular direction. More specifically, the flap 240 is angled to direct blood flow from the cardiovascular implant device 200 in a particular direction. The flap 240 is positioned to be angled toward the longitudinal axis LX2 through the central flow tube 204 (i.e., the axis AX2 of the flap 240 intersects with the axis LX2). As shown in FIG. 7 , the flap 240 is configured by positioning the cardiovascular implant device 200 so that it is angled toward the tricuspid valve plane TVP (the plane containing the annulus of the tricuspid valve TV) and accordingly directs blood flow from the cardiovascular implant device 200 toward the tricuspid valve plane TVP. Similar to the curved portion 130 shown in FIG. 5, the flap 240 obstructs the direction of blood flow from the cardiovascular implant device 200, forcing the blood flow to change direction. When the cardiovascular implant device 200 is implanted in the atrial septum IS, the flap 240 is positioned to align the blood flow from the cardiovascular implant device 200 with the natural flow pattern of the right atrium RA. The axis AX2 of the flap 240 (which is generally parallel to the flow path of blood from the central flow conduit 204 and thus may be used to approximate a longitudinal axis aligned with the flow of blood from the central flow conduit 204) forms an angle α2 with the tissue wall surface TWP of the tissue wall (e.g., the atrial septum IS) in which the cardiovascular implant device 200 is configured to be positioned. The tissue wall surface TWP is a vertical reference plane defined by the tissue wall, and is therefore generally perpendicular to the flow path 206 across the tissue wall. In some examples, the angle α2 is between 0 and 75 degrees (0°-75°).

[0069] The flap 240 is attached to the annular body 202 adjacent the outflow end 212, so that the flap 240 is configured to extend partially into the right atrium RA when the cardiovascular implant device 200 is implanted in the atrial septum IS. The flap 240 extends at an angle α2 relative to the tissue wall surface TWP. In some examples, the flap 240 is biased to open at the angle α2 when attached to the annular body 202 to promote flow through and out of the cardiovascular implant device 200. In other examples, the flap 240 may be configured to open and close to some extent based on the pressure difference between the left atrium LA and the right atrium RA. In such examples, when the pressure difference between the left atrium LA and the right atrium RA increases, flow through the cardiovascular implant device 200 can force the flap 240 to open more, allowing greater flow to pass through the cardiovascular implant device 200. The flap 240 may be configured such that the angle α2 is a maximum opening angle based on the desired flow characteristics from the cardiovascular implant device 200. The maximum opening angle is set by a stopper 244 .

[0070] When the cardiovascular implant device 200 is implanted in the cardiovascular system (e.g., the interatrial septum IS as shown in FIG. 7 , or another tissue wall), circulating blood passes through the flow channel 206 of the cardiovascular implant device 200. In the example shown in FIG. 7 , blood flows from the left atrium LA through the flow channel 206 and into the right atrium RA. As blood exits the cardiovascular implant device 200, the flap 240 aligns the flow of blood with the natural flow pattern of the right atrium RA so that the flow of blood from the cardiovascular implant device 200 merges with the natural flow pattern of the right atrium RA. More specifically, the flap 240 aligns the flow of blood from the cardiovascular implant device 200 with the natural vortex flow pattern of blood (i.e., a right-handed flow vortex) in the right atrium RA (shown in FIG. 7 by the schematic flow lines labeled RVF). As shown by arrow F in Figure 7, blood flow from the cardiovascular implant device 200 ejects across the right atrium RA and is directed in a curved path along the right atrial side of the interatrial septum IS toward the tricuspid valve plane TVP, rather than cutting or otherwise disrupting the natural vortex flow pattern. In this way, blood flow from the cardiovascular implant device 200 can merge with blood flowing downward along the interatrial septum IS and enter the right atrial vortex.

[0071] The cardiovascular implant device 200, including the flap 240, can minimize disruption to, or potentially enhance, the natural flow pattern local to the site where the cardiovascular implant device 200 is implanted in the heart H. When the cardiovascular implant device 200 is implanted in the interatrial septum IS, blood flowing from the left atrium LA to the right atrium RA through the cardiovascular implant device 200 can lessen interference with the natural rotational (e.g., vortex) flow pattern in the right atrium RA because, in contrast to conventional septal shunt devices that may eject blood flow across the right atrium, the flow from the cardiovascular implant device 200 is aligned with the natural vortex flow pattern. Utilizing the flap 240 to align the flow from the cardiovascular implant device 200 with the natural flow pattern within a chamber or vessel of the heart H minimizes any disruption to the natural flow pattern that may result from the implantation of a conventional shunt device without a directional component. Furthermore, aligning flow from the cardiovascular implant device 200 may also potentially mitigate reduced flow due to pathophysiology or other causes or enhance basal flow. As a result, the cardiovascular implant device 200 may preserve the kinetic energy of blood flow in the cardiovascular system, which may reduce the required cardiac work and improve cardiac efficiency. These hemodynamic effects may potentially improve patient outcomes after receiving the cardiovascular implant device 200, as the cardiovascular implant device 200 may be more effective and potentially safer.

[0072] Device 300 (FIGS. 8A-8B) FIG. 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). FIG. 8B is an enlarged side view of the cardiovascular implant device 300. FIGS. 8A and 8B are considered together. As shown in FIGS. 8A-8B, the cardiovascular implant device 300 includes an anchor member 335, a flap 340, a flexible joint 342, and a stopper 344. FIG. 8A also shows the heart (H), the right atrium (RA), the left atrium (LA), the superior vena cava (SVC), the inferior vena cava (IVC), the tricuspid valve (TV), the pulmonary veins (PVS), the mitral valve (MV), and the atrial septum (IS). FIG. 8A further shows the shunt (S), the flow path (SFP), the right atrial vortex (RVF), the tissue wall (TWP), the tricuspid valve plane (TVP), the axis (AX3), the axis (LX3), and the angle (α3).

[0073] The cardiovascular implant device 300 is an implantable device for use within the cardiovascular system. The cardiovascular implant device 300 is configured to be implanted within a blood vessel or chamber of the heart H. In the illustrated example, the cardiovascular implant device 300 is a flow directing device that is independent of a shunt device, stent device, or other implantable device. Specifically, as shown in FIG. 8A , the cardiovascular implant device 300 is positioned adjacent to a shunt S in the atrial septum IS. In other examples, the cardiovascular implant device 300 may be positioned adjacent to a puncture or opening in any other tissue wall between adjacent chambers and / or vessels of the heart H (or cardiovascular system). The shunt S is a shunt (non-implanted) between the left atrium LA and the right atrium RA, formed by ablation of tissue from the atrial septum IS to create an opening. In some examples, tissue can be ablated to create the shunt S by application of radiofrequency (RF) energy or other energy. The 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.

[0074] As shown in Figure 8A, the shunt flow path SFP is an opening extending through a tissue wall in which a shunt S is formed such that the shunt S is open at each opposing end. The shunt flow path SFP is a path through which blood flows or is directed through the shunt S. In the example shown in Figure 8A, the shunt flow path SFP spans the interatrial septum IS and extends from the left atrium LA to the right atrium RA.

[0075] As shown in FIGS. 8A-8B, the cardiovascular implant device 300 includes a flap 340. The flap 340 is connected to an anchor member 335. In some examples, the flap 340 is sized and shaped like a door or cover that fits over one end of the shunt S. In other examples, the flap 340 may have any suitable size and shape. In some examples, the flap 340 is integrally formed of a relatively flexible but impermeable material. In other examples, the periphery of the flap 340 is formed from a wire frame, and an impermeable fabric 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 still other examples, all or a portion of the flap 340 may be formed from a biological material, such as pericardium.

[0076] The anchor member 335 is configured to secure the cardiovascular implant device 300, including the flap 340, to a tissue wall. The anchor member 335 may further include a fastener or other attachment mechanism for securing the cardiovascular implant device 300 to the tissue wall. In the example shown in FIG. 8A , the anchor member 335 secures the cardiovascular implant device 300 to the right atrial side of the interatrial septum IS. The anchor member 335 is positioned adjacent to the shunt S. More specifically, the anchor member 335 is positioned above the shunt S relative to the orientation of the heart H when the person is upright, so that the flap 340 extends downward over the shunt S. In other examples, the anchor member 335 may be positioned anywhere around the shunt S.

[0077] The flap 340 is connected to the anchor member 335 by a flexible joint 342. The flap 340 is positionable relative to the shunt S at the flexible joint 342. That is, the flap 340 can pivot at the flexible joint 342 to be positioned at different angles. In some examples, the flexible joint 342 is a hinge. In other examples, the flexible joint 342 is a flexible piece of material connecting or extending between the flap 340 and the anchor member 335. In still other examples, the flexible joint 342 can be any suitable flexible attachment mechanism. The cardiovascular implant device 300 can also include a stopper 344 adjacent the flexible joint 342 to prevent the flap 340 from moving beyond a maximum opening angle. For example, the stopper 344 can prevent the flap 340 from fully opening (moving 180°) when there is high pressure flow through the shunt S.

[0078] The flap 340 is a flow-directing component of the cardiovascular implant device 300. The flap 340 is positioned or positionable to direct the flow of blood from the shunt S in a particular direction. More specifically, the flap 340 is angled to direct the flow of blood from the shunt S in a particular direction. The flap 340 is positioned to be angled toward the longitudinal axis LX3 through the shunt S (i.e., the axis AX3 of the flap 340 intersects the axis LX3). As shown in FIG. 8A , the flap 340 is configured by positioning the cardiovascular implant device 300 so that it is angled toward the tricuspid valve plane TVP (the plane containing the annulus of the tricuspid valve TV) and accordingly directs the flow of blood from the shunt S toward the tricuspid valve plane TVP. The flap 340 obstructs the direction of blood flow from the shunt S, causing the blood flow to have to change direction. When the cardiovascular implant device 300 is implanted in the atrial septum IS, the flap 340 is positioned to align blood flow from the shunt S with the natural flow pattern of the right atrium RA. The axis AX3 of the flap 340 (which is generally parallel to the flow path of blood from the shunt S and thus may be used to approximate a longitudinal axis aligned with blood flow from the shunt S) forms an angle α3 with the tissue wall plane TWP of the tissue wall (e.g., the atrial septum IS) to which the cardiovascular implant device 300 is configured to be attached. The tissue wall plane TWP is a vertical reference plane defined by the tissue wall, and is therefore generally perpendicular to the shunt flow path SFP across the tissue wall. In some examples, the angle α3 is between 0 and 75 degrees (0°-75°).

[0079] Because the flap 340 is attached to the anchor 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 surface TWP. In some examples, the flap 340 is biased to open at the angle α3 when attached to the anchor 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 some extent based on the pressure difference between the left atrium LA and the right atrium RA. In such examples, when the pressure difference between the left atrium LA and the right atrium RA increases, flow through the shunt S can force the flap 340 to open more, allowing greater flow to pass through the shunt S. The flap 340 may be configured such that the angle α3 is a maximum opening angle based on the desired flow characteristics from the shunt S. The maximum opening angle is set by a stopper 344.

[0080] When the cardiovascular implant device 300 is implanted in the cardiovascular system (e.g., the interatrial septum IS as shown in FIG. 8A , or another tissue wall), circulating blood passes through the flow path SFP of the shunt S. In the example shown in FIG. 8A , blood flows from the left atrium LA through the flow path SFP into the right atrium RA. As blood exits the shunt S, the flap 340 aligns the blood flow with the natural flow pattern of the right atrium RA so that the flow of blood from the shunt S merges with the natural flow pattern of the right atrium RA. More specifically, the flap 340 aligns the flow of blood from the shunt S with the natural vortex flow pattern of blood (i.e., a rightward flow vortex) in the right atrium RA (shown in FIG. 8A by the schematic flow lines labeled RVF). As shown by arrow F in Figure 8A, blood flow from shunt S is directed in a curved path along the right atrial side of the interatrial septum IS toward the tricuspid valve plane TVP, rather than ejecting across the right atrium RA and cutting or otherwise disrupting the natural vortex flow pattern. In this way, blood flow from shunt S can merge with blood flowing downward along the interatrial septum IS and enter the right atrial vortex.

[0081] The cardiovascular implant device 300, including the flap 340, can minimize disruption to, or potentially enhance, the natural flow pattern local to the site where the cardiovascular implant device 300 is implanted in the heart H. When the cardiovascular implant device 300 is implanted in the atrial septum IS, blood flowing from the left atrium LA to the right atrium RA through the shunt S can lessen interference with the natural rotational (e.g., vortex) flow pattern in the right atrium RA because, in contrast to conventional septal shunt devices that may jet blood flow across the right atrium, the flow from the shunt S is aligned with the natural vortex flow pattern. Utilizing the flap 340 to align the flow from the shunt S with the natural flow pattern within the chambers or vessels of the heart H minimizes any disruption to the natural flow pattern that may result from the implantation of a conventional shunt device without a directional component. Furthermore, aligning the flow from the shunt S may also potentially mitigate reduced flow due to pathophysiology or other causes or enhance basal flow. As a result, the cardiovascular implant device 300 can preserve the kinetic energy of blood flow in the cardiovascular system, which can reduce the required cardiac work and improve cardiac efficiency. These hemodynamic effects can potentially improve patient outcomes after receiving the cardiovascular implant device 300, as the cardiovascular implant device 300 can be more effective and potentially safer.

[0082] 7-8B together, a flap such as flap 240 or flap 340 may be utilized as a modification to a shunt device (e.g., cardiovascular implant device 200) or as a stand-alone flow directing feature (e.g., cardiovascular implant device 300), making flaps 240, 340 a versatile feature that can be used in both patients undergoing procedures that place a shunt device and in patients undergoing shunt procedures that do not otherwise utilize a device.

[0083] Device 400 (Figure 9) FIG. 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 internal guide wall 450. As shown in FIG. 9, the cardiovascular implant device 400 includes an annular body 402 including struts 403, a central flow tube 404, and a flow channel 406, and an anchor member 408. The central flow tube 404 includes an inflow end 410, an outflow end 412, and a flow surface 414. The cardiovascular implant device 400 further includes a guide wall 450 and a spiral flow channel 452. FIG. 9 also shows the heart (H), the right atrium (RA), the left atrium (LA), the superior vena cava (SVC), the inferior vena cava (IVC), the tricuspid valve (TV), the pulmonary veins (PVS), the mitral valve (MV), and the atrial septum (IS). FIG. 9 further shows the right atrial vortex (RVF), the tissue wall (TWP), the tricuspid valve plane (TVP), the outer diameter (OD), the axis (AX4), and the angle (α4).

[0084] The cardiovascular implant device 400 is an implantable device for use within the cardiovascular system. The cardiovascular implant device 400 is configured to be implanted within a blood vessel or chamber of the heart H. In the illustrated example, the cardiovascular implant device 400 is a flow directing shunt device for shunting blood from one blood vessel or chamber to another. Specifically, as shown in FIG. 9 , the cardiovascular implant device 400 is positioned within the interatrial septum IS. In other examples, the cardiovascular implant device 400 may be positioned in any other tissue wall between adjacent chambers and / or blood vessels of the heart H (or cardiovascular system). The cardiovascular implant device 400 can be delivered into the cardiovascular system via a catheter (i.e., transcatheter delivery) or surgically positioned using transcatheter or surgical procedures known in the art.

[0085] The annular body 402 is the main body 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 wide variety of different shapes and sizes. The annular body 402 may press against or into a tissue wall at the implantation site to set and maintain the position of the cardiovascular implant device 400, or may be positioned (or extend) around an anatomical structure of the cardiovascular system. In some examples, for example, as shown in FIG. 9 , the annular body 402 may be formed with a plurality of struts 403. The struts 403 may form a lattice or mesh of the annular body 402 and define openings therein. In such examples, the annular body 402 may be a stent framework for supporting graft material that guides flow through the cardiovascular implant device 400. In other examples, the annular body 402 may be integrally formed.

[0086] The annulus 402 can be positioned within a puncture in a tissue wall to hold the tissue wall open around the annulus 402 so that blood can flow between blood vessels or chambers of the heart H through the cardiovascular implant device 400. In the example shown in FIG. 9 , the annulus 402 is positioned within a puncture in the interatrial septum IS between the left atrium LA and the right atrium RA so that blood can 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 annulus 402 form a type of cage sufficient to hold the tissue wall open around the annulus 402. In other examples, the material integrally forming the annulus 402 is sufficient to hold the tissue wall open around the annulus 402.

[0087] The annular body 402 has an outer diameter OD. The outer diameter OD is the diameter of the annular body 402 measured relative to the outer surface of the cardiovascular implant device 400. The outer diameter OD is configured to be approximately the same size as the puncture diameter of the tissue wall into which the cardiovascular implant device 400 is to be implanted, so that the cardiovascular implant device 402 can fit within the puncture. The outer diameter OD may have any size such that the cardiovascular implant device 400 is sized to suit a variety of different patient conditions and / or anatomies. In some examples, the outer diameter OD may also vary along the length of the annular body 402 based on the overall shape or configuration of the annular body 402.

[0088] The annular body 402 includes a central flow tube 404 that functions as a conduit for guiding flow through the cardiovascular implant device 400. The central flow tube 404 surrounds a flow path 406. The flow path 406 is an opening that extends through the central flow tube 404 such that the cardiovascular implant device 400 is open at each opposing end. The flow path 406 is a path along which blood flows or is directed through the cardiovascular implant device 400. The central flow tube 404 includes a flow surface 414 configured to be a flow contact surface when the cardiovascular implant device 400 is implanted in a 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.

[0089] The outer shapes of the central flow tube 404 and the flow channels 406 can be straight, curved, a combination of straight and curved sections, or any other suitable shape. In some examples, the outer shapes of the central flow tube 404 and the flow channels 406 can be defined by or the same as the outer shape of the annular body 402 (e.g., as shown in FIG. 5 ). In other examples, the outer shapes of the central flow tube 404 and the flow channels 406 can be independent of or different from the outer shape of the annular body 402 (e.g., as shown in FIG. 6 ). Similarly, the cross-sectional shape or outer shape of the central flow tube 404 and the annular body 402 can be the same, e.g., circular, elliptical, 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 elliptical cross-section. Furthermore, the cross-sectional shapes of the central flow tube 404 and / or the annular body can also vary along either length. The cross-sectional shape of the central flow tube 404 may be selected at various points along its length, such as at the outlet end 412, to affect the flow direction.

[0090] 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 can be the end of the central flow tube 404 that is relatively upstream of the outflow end 412 with respect to the flow of blood through the cardiovascular implant device 400, as represented by arrow F in FIG. 9 , when the cardiovascular implant device 400 is implanted in a vessel or chamber of the heart H. Therefore, the outflow end 412 is the end of the central flow tube 404 that is relatively downstream of the inflow end 410 with respect to the flow of blood through the cardiovascular implant device 400, as represented by arrow F in FIG. 9 , when the cardiovascular implant device 400 is implanted in a vessel or chamber of the heart H. In the example shown in FIG. 9 , the inflow end 410 is positioned on the left atrial side of the atrial septum IS, and the outflow end 412 is positioned downstream of the right atrial side of the atrial septum IS, such that blood can flow from the left atrium LA to the right atrium RA through the flow path 406. As shown in FIG. 9 , the inflow end 410 may be essentially flush with the left atrial side of the atrial septum IS, whereas 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, either the inflow end 410 or the outflow end 412, or both, may be flush with or spaced apart from the corresponding side of the tissue wall. While the inflow end 410 is defined as being relatively upstream from 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 where the cardiovascular implant device 400 is implanted. The central flow tube 404 may have any suitable length measured from the inflow end 410 to the outflow end 412. For example, the 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 the cardiovascular implant device 400 is positioned. In other examples, the central flow tube 404 can be longer or shorter than the thickness of the atrial septum IS or another tissue wall.

[0091] In general, the central flow tube 404 may be formed of 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 may be formed of a graft material. The graft material may be a synthetic material such as woven polyester or polytetrafluoroethylene (PTFE), biological material, metallic material, or other material, to name a few non-limiting examples. The central flow tube 404 formed of a graft material may be supported within the cardiovascular implant device 400 by the struts 403 of the annular body 402. In such an example, the central flow tube 404 may be attached to the struts 403 of the annular body 402 by any suitable attachment means, such as suturing, gluing, tying, etc. In other examples, the central flow tube 404 may be integrally formed with the annular body 404.

[0092] One or more anchor members 408 extend outward from the annular body 402. The anchor members 408 hold the cardiovascular implant device 400 in place within the tissue wall when the cardiovascular implant device 400 is implanted within the body. The anchor members 408 can take any suitable form for securing the cardiovascular implant device 400 to the tissue wall. In some examples, the anchor members 408 can be one or more arms. In other examples, the anchor members 408 can be a flange or annular lip configured to have a diameter larger than the diameter of the puncture or opening through which the cardiovascular implant device 400 is positioned so that the cardiovascular implant device 400 cannot slip through the puncture or opening. In some examples, the anchor members 408 can bend toward the tissue wall or, alternatively, lie flush against the tissue wall. As shown in FIG. 9 , the cardiovascular implant device 400 can include one or more anchor members 408 extending from one end of the central flow tube 404. Specifically, the cardiovascular implant device 400 can include an anchor member 408 adjacent the inflow end 410. In other examples, the cardiovascular implant device 400 can include an anchor member 408 adjacent the outflow end 412. In yet other examples, the cardiovascular implant device 400 can include anchor members 408 at both the inflow end 410 and the outflow end 412.

[0093] As shown in FIG. 9 , 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 helical. 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 shown in cross section in FIG. 9 , only a portion of the guide wall 450 (one side or half transverse to the central flow tube 404) is shown in FIG. 9 , and the connecting portion is cut away. The guide wall 450 extends from the inflow end 410 to the outflow end 412 within the interior of the central flow tube 404. As schematically shown in FIG. 9 by the dashed and solid lines within the interior of the central flow tube 404, the guide wall 450 annularly surrounds the interior in a sliding manner from the inflow end 410 to the outflow end 412. Due to the spiral nature of the guide walls 450, the flow path 406 extending through the central flow tube 404 is also a spiral flow path 452. The spiral shape of the spiral flow path 452 is defined by the placement of the guide walls 450 within the central flow tube 404.

[0094] In general, the internal structure of the central flow tube 404, including the guide wall 450, may be configured to be collapsible or have physical dimensions sized to avoid interference with other components when the cardiovascular implant device 400 is delivered using a catheter. Surgical delivery examples may not have the same size-related limitations for implementing the guide wall 450.

[0095] The guide wall 450 is a flow-directing 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 blood flow from the cardiovascular implant device 400 in a particular direction. The guide wall 450 is positioned to prevent blood flow through the central flow tube 404 from flowing in a straight path through the cardiovascular implant device 400. Instead, blood flowing through the central flow tube 404 flows through a spiral flow path 452. As shown in FIG. 9 , the guide wall 450 is configured to direct blood flow from the cardiovascular implant device 400 toward the tricuspid valve plane TVP (the plane containing the annulus of the tricuspid valve TV). When the cardiovascular implant device 400 is implanted in the atrial septum IS, the guide wall 450 is positioned to align blood flow from the cardiovascular implant device 400 with the natural flow pattern of the right atrium RA. As shown in FIG. 9 , axis AX4 is a longitudinal axis aligned with the flow of blood from central flow tube 404. Axis AX4 forms an angle α4 with a tissue wall plane TWP of a tissue wall (e.g., the atrial septum IS) in which cardiovascular implant device 400 is configured to be positioned. The tissue wall plane TWP is a vertical reference plane defined by the tissue wall, and is therefore approximately perpendicular to the flow path 406 across the tissue wall. Angle α4 can be considered an exit angle for blood exiting cardiovascular implant device 400. In some examples, angle α4 is between 0 and 75 degrees (0°-75°).

[0096] When the cardiovascular implant device 400 is implanted in the cardiovascular system (e.g., the interatrial septum IS as shown in FIG. 9 , or another tissue wall), circulating blood passes through the flow channel 406 of the cardiovascular implant device 400. In the example shown in FIG. 9 , blood flows from the left atrium LA through the flow channel 406 (spiral flow channel 452) and into the right atrium RA. As blood flows through the cardiovascular implant device 400, the guide wall 450 guides the blood flow so that the flow of blood from the cardiovascular implant device 400 aligns with and merges with the natural flow pattern of blood in the right atrium RA. The guide wall 450 can also impart a rotational velocity to the blood flow through the flow channel 406 to aid in flow alignment. More specifically, the guide wall 450 guides blood flow through the cardiovascular implant device 400, aligning and merging the blood flow from the cardiovascular implant device 400 with the natural vortex flow pattern (i.e., right-handed flow vortex) of blood in the right atrium RA (shown in FIG. 9 by the schematic flow lines labeled RVF). As shown by arrow F in FIG. 9, the blood flow from the cardiovascular implant device 400 jets across the right atrium RA and is directed in a curved path along the right atrial side of the atrial septum IS toward the tricuspid valve plane TVP, rather than cutting or otherwise disrupting the natural vortex flow pattern. In this way, the blood flow from the cardiovascular implant device 400 can merge with blood flowing downward along the atrial septum IS and flow into the right atrial vortex.

[0097] The cardiovascular implant device 400, including the guide wall 450, can minimize disruption to, or potentially enhance, the natural flow pattern local to the site where the cardiovascular implant device 400 is implanted in the heart H. When the cardiovascular implant device 400 is implanted in the interatrial septum IS, blood flowing from the left atrium LA to the right atrium RA through the cardiovascular implant device 400 can lessen interference with the natural rotational (e.g., vortex) flow pattern in the right atrium RA because, in contrast to conventional septal shunt devices that may jet blood flow across the right atrium, the flow from the cardiovascular implant device 400 is aligned with the natural vortex flow pattern. Utilizing the guide wall 450 to align the flow from the cardiovascular implant device 400 with the natural flow pattern within the chambers or vessels of the heart H minimizes any disruption to the natural flow pattern that may result from the implantation of a conventional shunt device without a directional component. Furthermore, aligning flow from the cardiovascular implant device 400 may also potentially mitigate reduced flow due to pathophysiology or other causes or enhance basal flow. As a result, the cardiovascular implant device 400 may preserve the kinetic energy of blood flow in the cardiovascular system, which may reduce cardiac work requirements and improve cardiac efficiency. These hemodynamic effects may potentially improve patient outcomes after receiving the cardiovascular implant device 400, as the cardiovascular implant device 400 may be more effective and potentially safer.

[0098] Device 500 (FIGS. 10A-10B) FIG. 10A is a schematic cross-sectional view of a heart H showing a cardiovascular implant device 500 positioned in the atrial septum IS and including an internal blade 560. FIG. 10B is an enlarged schematic cross-sectional view of the atrial septum IS, showing details of the cardiovascular implant device 500. FIGS. 10A and 10B will be considered together. As shown in FIGS. 10A-10B, the cardiovascular implant device 500 includes an annular body 502 including struts 503, a central flow tube 504, and a flow channel 506, and an anchor member 508. The central flow tube 504 includes an inflow end 510, an outflow end 512, and a flow face 514. The 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. FIGS. 10A-10B show the right atrium RA, the left atrium LA, and the atrial septum IS. Figure 10A also shows 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 show the tissue wall plane TWP, outer diameter OD, axis AX5, and angle α5. Figure 10A also shows the right atrial vortex RVF and tricuspid valve plane TVP.

[0099] The cardiovascular implant device 500 is an implantable device for use within the cardiovascular system. The cardiovascular implant device 500 is configured to be implanted within a blood vessel or chamber of the heart H. In the illustrated example, the cardiovascular implant device 500 is a flow directing shunt device for shunting blood from one blood vessel or chamber to another. Specifically, as shown in FIGS. 10A-10B , the cardiovascular implant device 500 is positioned within the interatrial septum IS. In other examples, the cardiovascular implant device 500 may be positioned in any other tissue wall between adjacent chambers and / or blood vessels of the heart H (or cardiovascular system). The cardiovascular implant device 500 can be delivered into the cardiovascular system via a catheter (i.e., transcatheter delivery) or surgically positioned using transcatheter or surgical procedures known in the art.

[0100] The annular body 502 is the main body portion of the cardiovascular implant device 500. The annular body 502 can be expandable. The annular body 502 is generally cylindrical and tubular in cross section, but can have a wide variety of different shapes and sizes. The annular body 502 can press against or into a tissue wall at the implantation site to set and maintain the position of the cardiovascular implant device 500, or can be positioned (or extend) around an anatomical structure of the cardiovascular system. In some examples, for example, as shown in FIGS. 10A-10B , the annular body 502 can be formed with a plurality of struts 503. The struts 503 can form a lattice or mesh of the annular body 502 and define openings therein. In such examples, the annular body 502 can be a stent framework for supporting graft material that guides flow through the cardiovascular implant device 500. In other examples, the annular body 502 can be integrally formed.

[0101] The annular body 502 can be positioned within a puncture in a tissue wall to hold the tissue wall open around the annular body 502 so that blood can flow between the vessels or chambers of the heart H through the cardiovascular implant device 500. In the example shown in FIGS. 10A-10B , the annular body 502 is positioned within a puncture in the interatrial septum IS between the left atrium LA and the right atrium RA so that blood can 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 type of cage sufficient to hold the tissue wall open around the annular body 502. In other examples, the material integrally forming the annular body 502 is sufficient to hold the tissue wall open around the annular body 502.

[0102] The annular body 502 has an outer diameter OD. The outer diameter OD is the diameter of the annular body 502 measured relative to the outer surface of the cardiovascular implant device 500. The outer diameter OD is configured to be approximately the same size as the diameter of the puncture in the tissue wall into which the cardiovascular implant device 500 is to be implanted, so that the cardiovascular implant device 502 can fit within the puncture. The outer diameter OD can have any size, such that the cardiovascular implant device 500 is sized to suit a variety of different patient conditions and / or anatomies. In some examples, the outer diameter OD can also vary along the length of the annular body 502 based on the overall shape or configuration of the annular body 502.

[0103] The annular body 502 includes a central flow tube 504 that functions as a conduit for guiding flow through the cardiovascular implant device 500. The central flow tube 504 surrounds a flow path 506. The flow path 506 is an opening that extends through the central flow tube 504 such that the cardiovascular implant device 500 is open at each opposing end. The flow path 506 is a path along which blood flows or is directed through the cardiovascular implant device 500. The central flow tube 504 includes a flow surface 514 configured to be a flow contact surface when the cardiovascular implant device 500 is implanted in a vessel or chamber of the heart H. The flow surface 514 is a 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.

[0104] The outer shapes of the central flow tube 504 and the flow channels 506 can be straight, curved, a combination of straight and curved sections, or any other suitable shape. In some examples, the outer shapes of the central flow tube 504 and the flow channels 506 can be defined by or the same as the outer shape of the annular body 502 (e.g., as shown in FIG. 5 ). In other examples, the outer shapes of the central flow tube 504 and the flow channels 506 can be independent of or different from the outer shape of the annular body 502 (e.g., as shown in FIG. 6 ). Similarly, the cross-sectional shape or outer shape of the central flow tube 504 and the annular body 502 can be the same, e.g., circular, elliptical, 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 elliptical cross-section. Furthermore, the cross-sectional shapes of the central flow tube 504 and / or the annular body can also vary along either length. The cross-sectional shape of the central flow tube 504 may be selected at various points along its length, such as at the outlet end 512, to affect the flow direction.

[0105] The central flow conduit 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 conduit 504 that is relatively upstream of the outflow end 512 with respect to the flow of blood through the cardiovascular implant device 500, as represented by arrow F in FIGS. 10A-10B , when the cardiovascular implant device 500 is implanted in a vessel or chamber of the heart H. Thus, the outflow end 512 is the end of the central flow conduit 504 that is relatively downstream of the inflow end 510 with respect to the flow of blood through the cardiovascular implant device 500, as represented by arrow F in FIGS. 10A-10B , when the cardiovascular implant device 500 is implanted in a vessel or chamber of the heart H. 10A-10B, the inflow end 510 is positioned on the left atrial side of the atrial septum IS, and the outflow end 512 is positioned downstream on the right atrial side of the atrial septum IS, such that blood can flow from the left atrium LA to the right atrium RA through the flow path 506. As shown in FIGS. 10A-10B, the inflow end 510 can be essentially flush with the left atrial side of the atrial septum IS, whereas in some examples, the outflow end 512 can 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 can 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 examples, either the inflow end 510 or the outflow end 512, or both, can be flush with or spaced apart from the corresponding side of a tissue wall. Although the inflow end 510 is defined as being relatively upstream from the outflow end 512, it should be understood that other actual locations of the inflow end 510 or outflow end 512 are possible depending on the location where the cardiovascular implant device 500 is implanted. The central flow tube 504 can have any suitable length measured from the inflow end 510 to the outflow end 512. For example, the 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 the cardiovascular implant device 500 is positioned. In other examples, the central flow tube 504 can be longer or shorter than the thickness of the atrial septum IS or another tissue wall.

[0106] In general, the central flow tube 504 may be formed of 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 may be formed of a graft material. The graft material may be a synthetic material such as woven polyester or polytetrafluoroethylene (PTFE), a biological material, a metallic material, or other material, to name a few non-limiting examples. The central flow tube 504 formed of a graft material may be supported within the cardiovascular implant device 500 by the struts 503 of the annular body 502. In such an example, the central flow tube 504 may be attached to the struts 503 of the annular body 502 by any suitable attachment means, such as suturing, gluing, tying, etc. In other examples, the central flow tube 504 may be integrally formed with the annular body 504.

[0107] One or more anchor members 508 extend outward from the annular body 502. The anchor members 508 hold the cardiovascular implant device 500 in place within the tissue wall when the cardiovascular implant device 500 is implanted within the body. The anchor members 508 can take any suitable form for securing the cardiovascular implant device 500 to the tissue wall. In some examples, the anchor members 508 can be one or more arms. In other examples, the anchor members 508 can be a flange or annular lip configured to have a diameter larger than the diameter of the puncture or opening through which the cardiovascular implant device 500 is positioned so that the cardiovascular implant device 500 cannot slip through the puncture or opening. In some examples, the anchor members 508 can bend toward the tissue wall or, alternatively, lie flush against the tissue wall. As shown in FIGS. 10A-10B , the cardiovascular implant device 500 can include one or more anchor members 508 extending from one end of the central flow tube 504. Specifically, the cardiovascular implant device 500 can include an anchor member 508 adjacent the inflow end 510. In other examples, the cardiovascular implant device 500 can include an anchor member 508 adjacent the outflow end 512. In yet other examples, the cardiovascular implant device 500 can include anchor members 508 at both the inflow end 510 and the outflow end 512.

[0108] As shown in FIGS. 10A-10B , the cardiovascular implant device 500 includes blades 560 connected to a shaft 562. The shaft 562 extends longitudinally through a central flow tube 504. In some examples, the shaft 562 is attached to the central flow tube 504 by wire extensions or other attachment mechanisms at the inflow end 510 and outflow end 512, or at other locations along the length of the central flow tube 504. In general, the internal structure of the central flow tube 504, including the blades 560 and the shaft 562, can be configured to be foldable or have physical dimensions sized to avoid interference with other components when the cardiovascular implant device 500 is delivered using a catheter. Surgical delivery examples may not have the same size-related limitations for implementing the blades 560.

[0109] 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 a proximal portion of the blade 560 adjacent the shaft 562. The tip portion 566 is a distal portion of the blade 560. Each of the blades 560 extends radially from the root portion 564 to the tip portion 566 (or from the shaft 562 toward the flow surface 514). The tip portion 566 may be spaced from the flow surface 514.

[0110] The blades 560 may be arranged in one or more sets of blades 560 along the length of the shaft 562. The blades 560 may also be arranged in ring(s) around the shaft 562. That is, while FIGS. 10A-10B show one set of blades 560, other examples may include multiple sets of blades 560 arranged in separate rings. In one example, the set of blades 560 is a stator (i.e., the blades 560 are stationary). In another example, the set of blades 560 is a rotor (i.e., the blades 560 can rotate). In such examples, the shaft 562 may include a concentric fixed shaft and a rotatable portion to which the blades 560 are connected. The stator, rotor, or combination of stator and rotor sets of blades 560 may be selected based on the desired flow characteristics of blood flowing through the cardiovascular implant device 500.

[0111] The blades 560 are flow-directing 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 direct blood flow from the cardiovascular implant device 500 in a particular direction. As shown in FIG. 10A , the blades 560 are configured to direct blood flow from the cardiovascular implant device 500 toward the tricuspid valve plane TVP (a plane containing the annulus of the tricuspid valve TV). When the cardiovascular implant device 500 is implanted in the atrial septum IS, the blades 560 are positioned to align blood flow from the cardiovascular implant device 500 with the natural flow pattern of the right atrium RA. As shown in FIGS. 10A-10B , the axis AX5 is a longitudinal axis aligned with the flow of blood from the central flow tube 504. The axis AX5 forms an angle α5 with the tissue wall plane TWP of the tissue wall (e.g., the atrial septum IS) in which the cardiovascular implant device 500 is configured to be positioned. The tissue wall plane TWP is a vertical reference plane defined by the tissue wall and is therefore approximately perpendicular to the flow path 506 that crosses the tissue wall. The angle α5 can be considered an exit angle for blood exiting the cardiovascular implant device 400. In some examples, the angle α5 is between zero and seventy-five degrees (0°-75°).

[0112] When the cardiovascular implant device 500 is implanted in the cardiovascular system (e.g., the interatrial septum IS as shown in FIGS. 10A-10B , or another tissue wall), circulating blood passes through the flow channel 506 of the cardiovascular implant device 500. In the example shown in FIGS. 10A-10B , blood flows from the left atrium LA through the flow channel 506 to the right atrium RA. As blood flows through the cardiovascular implant device 500, the blades 560 guide the blood flow so that the flow of blood from the cardiovascular implant device 500 aligns with and merges with the natural flow pattern of blood in the right atrium RA. The blades 560 can also impart a rotational velocity to the blood flow through the flow channel 506 to aid in flow alignment. More specifically, the blades 560 guide the flow of blood through the cardiovascular implant device 500, aligning and merging the flow of blood from the cardiovascular implant device 500 with and into the natural vortex flow pattern (i.e., right-handed flow vortex) of blood in the right atrium RA (shown in FIG. 10A by the schematic flow lines labeled RVF). As shown by arrow F in FIG. 10A, the flow of blood from the cardiovascular implant device 500 jets across the right atrium RA and is directed in a curved path along the right atrial side of the atrial septum IS toward the tricuspid valve plane TVP, rather than cutting or otherwise disrupting the natural vortex flow pattern. In this way, the flow of blood from the cardiovascular implant device 500 can merge with blood flowing downward along the atrial septum IS and flow into the right atrial vortex.

[0113] The cardiovascular implant device 500, including the blade 560, can minimize disruption to, or potentially enhance, the natural flow pattern local to the site where the cardiovascular implant device 500 is implanted in the heart H. When the cardiovascular implant device 500 is implanted in the interatrial septum IS, blood flowing from the left atrium LA to the right atrium RA through the cardiovascular implant device 500 can lessen interference with the natural rotational (e.g., vortex) flow pattern in the right atrium RA because, in contrast to conventional septal shunt devices that may jet blood flow across the right atrium, the flow from the cardiovascular implant device 500 is aligned with the natural vortex flow pattern. Utilizing the blade 560 to align the flow from the cardiovascular implant device 500 with the natural flow pattern within the chambers or vessels of the heart H minimizes any disruption to the natural flow pattern that may result from the implantation of a conventional shunt device without a directional component. Furthermore, aligning flow from the cardiovascular implant device 500 may also potentially mitigate reduced flow due to pathophysiology or other causes or enhance basal flow. As a result, the cardiovascular implant device 500 may preserve the kinetic energy of blood flow in the cardiovascular system, which may reduce the required cardiac work and improve cardiac efficiency. These hemodynamic effects may potentially improve patient outcomes after receiving the cardiovascular implant device 500, as the cardiovascular implant device 500 may be more effective and potentially safer.

[0114] Devices 600 and 100A (Figures 11 to 13) FIG. 11 is a schematic cross-sectional view of a heart H showing a cardiovascular implant device 600 positioned in the interatrial septum IS and including an adjustable portion 670. FIG. 12A is an enlarged schematic view of the adjustable portion 670 in a compressed configuration 680. FIG. 12B is an enlarged schematic view of the adjustable portion 670 in an expanded configuration 685. FIGS. 11-12B will be considered together. As shown in FIG. 11, the cardiovascular implant device 600 includes a toroidal body 602 including struts 603, a central flow tube 604, and a flow channel 606, and an anchor member 608. The central flow tube 604 includes an inflow end 610, an outflow end 612, and a flow face 614. The central flow tube 604 further includes a straight portion 620 and an adjustable portion 670. The adjustable portion 670 includes an accordion-like fold 672. Figure 11 also shows the heart H, right atrium RA, left atrium LA, superior vena cava SVC, inferior vena cava IVC, tricuspid valve TV, pulmonary veins PVS, mitral valve MV, and interatrial septum IS. Figure 11 also shows the right atrial vortex RVF, tissue wall surface TWP, tricuspid valve surface TVP, outer diameter OD, axis AX6, and angle α6. Figure 12A shows the compressed configuration 680, and Figure 12B shows the expanded configuration 685.

[0115] The cardiovascular implant device 600 is an implantable device for use within the cardiovascular system. The cardiovascular implant device 600 is configured to be implanted within a blood vessel or chamber of the heart H. In the illustrated example, the cardiovascular implant device 600 is a flow directing shunt device for shunting blood from one blood vessel or chamber to another. Specifically, as shown in FIG. 11 , the cardiovascular implant device 600 is positioned in the interatrial septum IS. In other examples, the cardiovascular implant device 600 may be positioned in any other tissue wall between adjacent chambers and / or blood vessels of the heart H (or cardiovascular system). The cardiovascular implant device 600 can be delivered into the cardiovascular system via a catheter (i.e., transcatheter delivery) or surgically positioned using transcatheter or surgical procedures known in the art.

[0116] The annular body 602 is the main body portion 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 wide variety of different shapes and sizes. The annular body 602 can press against or into a tissue wall at the implantation site to set and maintain the position of the cardiovascular implant device 600, or can be positioned (or extend) around an anatomical structure of the cardiovascular system. In some examples, for example, as shown in FIG. 11 , the annular body 602 can be formed with a plurality of struts 603. The struts 603 can form a lattice or mesh of the annular body 602 and define openings therein. In such examples, the annular body 602 can be a stent framework for supporting graft material that guides flow through the cardiovascular implant device 600. In other examples, the annular body 602 can be integrally formed.

[0117] The annular body 602 can be positioned within a puncture in a tissue wall to hold the tissue wall open around the annular body 602 so that blood can flow between the vessels or chambers of the heart H through the cardiovascular implant device 600. In the example shown in FIG. 11 , the annular body 602 is positioned within a puncture in the interatrial septum IS between the left atrium LA and the right atrium RA so that blood can 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 type of cage sufficient to hold the tissue wall open around the annular body 602. In other examples, the material integrally forming the annular body 602 is sufficient to hold the tissue wall open around the annular body 602.

[0118] The annular body 602 has an outer diameter OD. The outer diameter OD is the diameter of the annular body 602 measured relative to the outer surface of the cardiovascular implant device 600. The outer diameter OD is configured to be approximately the same size as the diameter of the puncture in the tissue wall into which the cardiovascular implant device 600 is to be implanted, so that the cardiovascular implant device 602 can fit within the puncture. The outer diameter OD can have any size, such that the cardiovascular implant device 600 is sized to suit a variety of different patient conditions and / or anatomies. In some examples, the outer diameter OD can also vary along the length of the annular body 602 based on the overall shape or configuration of the annular body 602.

[0119] The annular body 602 includes a central flow tube 604 that functions as a conduit for guiding flow through the cardiovascular implant device 600. The central flow tube 604 surrounds a flow path 606. The flow path 606 is an opening that extends through the central flow tube 604 such that the cardiovascular implant device 600 is open at each opposing end. The flow path 606 is a path along which blood flows or is directed through the cardiovascular implant device 600. The central flow tube 604 includes a flow face 614 configured to be a flow contact surface when the cardiovascular implant device 600 is implanted in a vessel or chamber of the heart H. The flow face 614 is a radially inner surface of the central flow tube 604. The flow path 606 through the central flow tube 604 is defined by the flow face 614.

[0120] The outer shapes of the central flow tube 604 and the flow channels 606 can be straight, curved, a combination of straight and curved sections, or any other suitable shape. In some examples, the outer shapes of the central flow tube 604 and the flow channels 606 can be defined by or the same as the outer shape of the annular body 602 (e.g., as shown in FIG. 5 ). In other examples, the outer shapes of the central flow tube 604 and the flow channels 606 can be independent of or different from the outer shape of the annular body 602 (e.g., as shown in FIG. 6 ). Similarly, the cross-sectional shape or outer shape of the central flow tube 604 and the annular body 602 can be the same, e.g., circular, elliptical, 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 elliptical cross-section. Furthermore, the cross-sectional shapes of the central flow tube 604 and / or the annular body can also vary along either length. The cross-sectional shape of the central flow tube 604 may be selected at various points along its length, such as at the outlet end 612, to affect the flow direction.

[0121] 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 the flow of blood through the cardiovascular implant device 600, as represented by arrow F in FIG. 11 , when the cardiovascular implant device 600 is implanted in a vessel or chamber of the heart H. Thus, the outflow end 612 is the end of the central flow tube 604 that is relatively downstream of the inflow end 610 with respect to the flow of blood through the cardiovascular implant device 600, as represented by arrow F in FIG. 11 , when the cardiovascular implant device 600 is implanted in a vessel or chamber of the heart H. In the example shown in FIG. 11 , the inflow end 610 is positioned on the left atrial side of the atrial septum IS, and the outflow end 612 is positioned downstream of the right atrial side of the atrial septum IS, such that blood can flow from the left atrium LA to the right atrium RA through the flow path 606. As shown in FIG. 11 , the inflow end 610 may be essentially flush with the left ventricular side of the atrial septum IS, whereas 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, either the inflow end 610 or the outflow end 612, or both, may be flush with or spaced apart from the corresponding side of the tissue wall. While the inflow end 610 is defined as being relatively upstream from 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 where the cardiovascular implant device 600 is implanted. The central flow tube 604 may have any suitable length measured from the inflow end 610 to the outflow end 612. For example, the 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 the cardiovascular implant device 600 is positioned. In other examples, the central flow tube 604 can be longer or shorter than the thickness of the atrial septum IS or another tissue wall.

[0122] In general, the central flow tube 604 may be formed of 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 may be formed of a graft material. The graft material may be a synthetic material such as woven polyester or polytetrafluoroethylene (PTFE), a biological material, a metallic material, or other material, to name a few non-limiting examples. The central flow tube 604 formed of a graft material may be supported within the cardiovascular implant device 600 by the struts 603 of the annular body 602. In such an example, the central flow tube 604 may be attached to the struts 603 of the annular body 602 by any suitable attachment means, such as suturing, gluing, tying, etc. In other examples, the central flow tube 604 may be integrally formed with the annular body 604.

[0123] One or more anchor members 608 extend outward from the annular body 602. The anchor members 608 hold the cardiovascular implant device 600 in place within the tissue wall when the cardiovascular implant device 600 is implanted within the body. The anchor members 608 can take any suitable form for securing the cardiovascular implant device 600 to the tissue wall. In some examples, the anchor members 608 can be one or more arms. In other examples, the anchor members 608 can be a flange or annular lip configured to have a diameter larger than the diameter of the puncture or opening through which the cardiovascular implant device 600 is positioned so that the cardiovascular implant device 600 cannot slip through the puncture or opening. In some examples, the anchor members 608 can bend toward the tissue wall or, alternatively, lie flush against the tissue wall. As shown in FIG. 11 , the cardiovascular implant device 600 can include one or more anchor members 608 extending from one end of the central flow tube 604. Specifically, the cardiovascular implant device 600 can include an anchor member 608 adjacent the inflow end 610. In other examples, the cardiovascular implant device 600 can include an anchor member 608 adjacent the outflow end 612. In yet other examples, the cardiovascular implant device 600 can include anchor members 608 at both the inflow end 610 and the outflow end 612.

[0124] As shown in FIG. 11 , the central flow conduit 604 includes a straight portion 620 and an adjustable portion 670. The straight portion 620 is a first portion or segment of the central flow conduit 604. In the example shown in FIG. 11 , the straight portion 620 is adjacent to and extends from the inflow end 610 to capture blood flowing into the cardiovascular implant device 600. The length of the straight portion 620 is sized to span a puncture in a 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 conduit 604. The adjustable portion 670 is a second portion or segment of the central flow conduit 604. The adjustable portion 670 is connected to the straight portion 620. In the example shown in FIG. 11 , the adjustable portion 670 is adjacent to and extends from the outflow end 612 to the straight portion 620. That is, adjustable portion 670 is a relatively downstream portion of central flow conduit 604, and straight portion 620 is a relatively upstream portion of central flow conduit 604, relative to the direction of blood flow through cardiovascular implant device 600 when implanted in a tissue wall. Adjustable portion 670 may be continuous with straight portion 620. Although adjustable portion 670 is shown in FIG. 11 as being longer than straight portion 620, it should be understood that adjustable portion 670 and straight portion 620 may have any relative lengths with respect to one another.

[0125] Adjustable portion 670 is a flexible portion of central flow tube 604. Adjustable portion 670 is adjustable between a compressed configuration (or state) 680 and one or more expanded configurations (or states) 685. Adjustable portion 670 is accordion-like and includes one or more accordion folds 672 that allow for expansion and contraction of adjustable portion 670. In compressed configuration 680, as shown in FIG. 12A, the surfaces of adjustable portion 670 are tightly folded together at accordion folds 672. In expanded configuration 685, as shown in FIG. 12B, the accordion folds 672 of adjustable portion 670 are separated (i.e., deployed or pulled apart) by the same amount, as indicated by the double-headed arrow in FIG. 12B. For example, as shown in FIG. 11 , one side of an accordion-like fold 672 can be separated more than the laterally opposite side of the same accordion-like fold 672 so that the adjustable portion 670 curves. The adjustable portion 670 has an essentially infinite number of expansion configurations 685, each of which can be achieved by varying combinations of which of the accordion-like folds 672 are separated or compressed, which sides of the accordion-like folds 672 are separated or compressed, and the degree to which the accordion-like folds 672 are separated or compressed. Of course, only one such expansion configuration 685 is shown in FIG. 12B , and many other expansion configurations 685 are possible. Depending on the particular implementation of the adjustable portion 670, how much it expands can be limited by adjusting the number, size, and / or spacing of the accordion-like folds 672 in the design. The possible expansion states 685 of the adjustable portion 670 can be selected based on the desired characteristics of the outflow from the cardiovascular implant device 600. In some examples, the adjustable portion 670 (or the portion of the annular body 602 that provides support for the adjustable portion 670) is formed of a resilient material to accommodate the expansion and contraction of the adjustable portion 670. For example, the resilient material can be a cobalt chromium alloy.

[0126] The adjustable portion 670 is a flow-directing component of the cardiovascular implant device 600. The adjustable portion 670 is positioned or positionable to direct blood flow from the cardiovascular implant device 600 in a particular direction. More specifically, the adjustable portion 670 is adjustable to direct blood flow from the cardiovascular implant device 600 in a particular direction. As shown in FIG. 11 , the adjustable portion 670 is configured to curve toward the tricuspid valve plane TVP (a plane containing the annulus of the tricuspid valve TV) depending on the positioning of the cardiovascular implant device 600 and the expansion of the accordion fold 672, thereby placing the adjustable portion 670 in one of its one or more expanded configurations 685. Therefore, the adjustable portion 670 is configured to direct flow from the cardiovascular implant device 600 toward the tricuspid valve plane TVP. In its one or more expanded configurations 685, the adjustable portion 670 defines a bend in the flow path 606. When the cardiovascular implant device 600 is implanted in the atrial septum IS, the bend aligns a portion of the flow path 606 at the outflow end 612 with the natural flow pattern in the right atrium RA. An axis AX6 extending longitudinally through the outflow end 612 (approximating a longitudinal axis aligned with blood flow from the central flow tube 604) forms an angle α6 with a tissue wall plane TWP of the tissue wall (e.g., the atrial septum IS) in which the 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 is therefore approximately perpendicular to the flow path 606 across the tissue wall. In some examples, the angle α6 is between 0 and 75 degrees (0°-75°).

[0127] Because the adjustable portion 670 is adjacent to the outflow end 612, the adjustable portion 670 is configured to face or partially extend into the right atrium RA when the cardiovascular implant device 600 is implanted in the atrial septum IS. The adjustable portion 670's protrusion into the right atrium RA can be minimized so that the adjustable portion 670 protrudes only sufficiently into the right atrium RA to secure the cardiovascular implant device 600 in place within the atrial septum IS. In some examples, the adjustable portion 670 is biased to an expanded configuration 685 (e.g., the configuration shown in FIGS. 11 and 12B ). In other examples, the adjustable portion 670 can be configured to self-expand or self-orient to some extent based on the pressure difference between the left atrium LA and the right atrium RA. In such examples, when the pressure difference between the left atrium LA and the right atrium RA increases, flow through the cardiovascular implant device 600 can force the adjustable portion 670 to expand more, changing the orientation of the outflow end 612. The adjustable portion 670 can be configured such that the angle α6 is the angle that corresponds to the maximum expansion state of the adjustable portion 670. The orientation of the adjustable portion 670 in response to increasing flow through the cardiovascular implant device 600 can be selected based on the desired characteristics of the outflow from the cardiovascular implant device 600.

[0128] When the cardiovascular implant device 600 is implanted in the cardiovascular system (e.g., the interatrial septum IS as shown in FIG. 11 , or another tissue wall), circulating blood passes through the flow channel 606 of the cardiovascular implant device 600. In the example shown in FIG. 11 , blood flows from the left atrium LA through the flow channel 606 and into the right atrium RA. As blood exits the cardiovascular implant device 600, the adjustable portion 670 aligns the flow of blood with the natural flow pattern of the right atrium RA so that the flow of blood from the cardiovascular implant device 600 merges with the natural flow pattern of the right atrium RA. More specifically, the adjustable portion 670 aligns the flow of blood from the cardiovascular implant device 600 with the natural vortex flow pattern of blood (i.e., a right-handed flow vortex) in the right atrium RA (shown in FIG. 11 by the schematic flow lines labeled RVF). As shown by arrow F in Figure 11, blood flow from the cardiovascular implant device 600 is directed in a curved path along the right atrial side of the interatrial septum IS toward the tricuspid valve plane TVP, rather than ejecting across the right atrium RA and cutting or otherwise disrupting the natural vortex flow pattern. In this way, blood flow from the cardiovascular implant device 600 can merge with blood flowing downward along the interatrial septum IS and flow into the right atrial vortex.

[0129] Additionally, the adjustable portion 670 is configured to be adjusted to one of one or more expanded configurations 685 immediately prior to or during the implantation procedure of the cardiovascular implant device 600. The accordion folds 672 can be deployed or compressed to adjust the curvature of the adjustable portion 670 based on patient requirements, such as specific anatomical or flow conditions. In this manner, the adjustable portion 670 can have a curvature configured specifically for the patient in whom the cardiovascular implant device 600 will or will be implanted. In instances in which 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. Additionally, a delivery device for cardiovascular implant device 600, in such an example, may be modified to include a guidewire and snare or similar mechanism removably attachable to adjustable portion 670 to transmit force from the physician's movements to fold or unfold accordion-like fold 672 and adjust the orientation of adjustable portion 670 (i.e., to select a desired expanded configuration 685). Thus, cardiovascular implant device 600 may be delivered with adjustable portion 670 in one configuration (e.g., initial expanded configuration 685), and the physician may further adjust the configuration of adjustable portion 670 based on observations regarding the patient's anatomical or flow conditions.

[0130] The cardiovascular implant device 600, including the adjustable portion 670, can minimize disruption of, or potentially enhance, the natural flow pattern local to the site where the cardiovascular implant device 600 is implanted in the heart H. When the cardiovascular implant device 600 is implanted in the interatrial septum IS, blood flowing from the left atrium LA to the right atrium RA through the cardiovascular implant device 600 can lessen interference with the natural rotational (e.g., vortex) flow pattern in the right atrium RA because, in contrast to conventional septal shunt devices that may spurt blood flow across the right atrium, the flow from the cardiovascular implant device 600 is aligned with the natural vortex flow pattern. Utilizing the adjustable portion 670 to align the flow from the cardiovascular implant device 600 with the natural flow pattern within a chamber or vessel of the heart H minimizes any disruption to the natural flow pattern that may result from the implantation of a conventional shunt device without a directional component. Furthermore, aligning flow from the cardiovascular implant device 600 may also potentially mitigate reduced flow due to pathophysiology or other causes or enhance basal flow. As a result, the cardiovascular implant device 600 may preserve the kinetic energy of blood flow in the cardiovascular system, which may reduce the required cardiac work and improve cardiac efficiency. These hemodynamic effects may potentially improve patient outcomes after receiving the cardiovascular implant device 600, as the cardiovascular implant device 600 may be more effective and potentially safer.

[0131] Furthermore, the adjustable portion 670 may allow the cardiovascular implant device 600 to be easily adjustable for a wider range of patient anatomies and conditions. That is, a particular expansion configuration 685 of the adjustable portion 670 may be selected to be optimal for a particular patient's anatomical or flow conditions, such as right atrial flow patterns. Furthermore, the configuration of the adjustable portion 670 may be determined immediately before or during the implantation procedure, thereby allowing real-time adjustments to be made to the device based on information obtained by the physician about the patient.

[0132] FIG. 13 is a schematic cross-sectional view of the atrial septum IS, showing a cardiovascular implant device 600A positioned therein and including a variable inner diameter ID. As shown in FIG. 13, the cardiovascular implant device 600A includes a strut 603A, a central flow tube 604A, an annular body 602A including a flow channel 606A, and an anchor member 608A. The central flow tube 604A includes an inflow end 610A, an outflow end 612A, and a flow face 614A. The central flow tube 604A further includes a straight portion 620A and an adjustable portion 670A. The adjustable portion 670A includes an accordion-like fold 672A. FIG. 13 also shows the right atrium RA, the left atrium LA, and the atrial septum IS. FIG. 13 further shows the tissue wall surface TWP, the outer diameter OD, the inner diameter ID, the axis AX6, and the angle α6.

[0133] Cardiovascular implant device 600A has a generally similar structure, design, and function to cardiovascular implant device 600 described above with reference to FIG. 11, except that cardiovascular implant device 600A includes a variable inner diameter ID.

[0134] The central flow conduit 604A has an inner diameter ID. The inner diameter ID is the diameter of the central flow conduit 604A measured relative to the flow face 614A. Generally, the inner diameter ID can be any size such that the central flow conduit 604A and the flow path 606A therethrough are dimensioned to accommodate the flow of blood through the cardiovascular implant device 600A. In the example shown in FIG. 13 , the inner diameter ID varies along the length of the central flow conduit 604A. Specifically, the central flow conduit 604A is tapered such that the inner diameter ID is narrower toward the inflow end 610A and wider toward the outflow end 612A. This funnel shape can help direct the flow of blood from the cardiovascular implant device 600A in a desired direction. In other examples, the inner diameter ID can vary differently along the length of the central flow conduit 604A, such as tapering in opposite directions or tapering along only a portion of the central flow conduit 604A.

[0135] Device 700 (Figure 14) Figure 14 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 angled central flow tube (704). As shown in Figure 14, the cardiovascular implant device (700) includes an annular body (702) including struts (703), a central flow tube (704), and a flow channel (706), and anchor members (708). The central flow tube (704) includes an inflow end (710), an outflow end (712), and a flow surface (714). Figure 14 also shows the heart (H), the right atrium (RA), the left atrium (LA), the superior vena cava (SVC), the inferior vena cava (IVC), the tricuspid valve (TV), the pulmonary veins (PVS), the mitral valve (MV), and the atrial septum (IS). Figure 14 further shows the right atrial vortex (RVF), the tissue wall (TWP), the tricuspid valve surface (TVP), the outer diameter (OD), the axis (AX7), and the angle (α7).

[0136] The cardiovascular implant device 700 is an implantable device for use within the cardiovascular system. The cardiovascular implant device 700 is configured to be implanted within a blood vessel or chamber of the heart H. In the illustrated example, the cardiovascular implant device 700 is a flow directing shunt device for shunting blood from one blood vessel or chamber to another. Specifically, as shown in FIG. 14 , the cardiovascular implant device 700 is positioned within the interatrial septum IS. In other examples, the cardiovascular implant device 700 may be positioned in any other tissue wall between adjacent chambers and / or blood vessels of the heart H (or cardiovascular system). The cardiovascular implant device 700 can be delivered into the cardiovascular system via a catheter (i.e., transcatheter delivery) or surgically positioned using transcatheter or surgical procedures known in the art.

[0137] The annular body 702 is the main body portion 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 wide variety of different shapes and sizes. The annular body 702 can press against or into a tissue wall at the implantation site to set and maintain the position of the cardiovascular implant device 700, or can be positioned (or extend) around the anatomical structure of the cardiovascular system. In some examples, for example, as shown in FIG. 14 , the annular body 702 can be formed with a plurality of struts 703. The struts 703 can form a lattice or mesh of the annular body 702 and define openings therein. In such examples, the annular body 702 can be a stent framework for supporting graft material that guides flow through the cardiovascular implant device 700. In other examples, the annular body 702 can be integrally formed.

[0138] The annular body 702 can be positioned within a puncture in a tissue wall to hold the tissue wall open around the annular body 702 so that blood can flow between the vessels or chambers of the heart H through the cardiovascular implant device 700. In the example shown in FIG. 14 , the annular body 702 is positioned within a puncture in the interatrial septum IS between the left atrium LA and the right atrium RA so that blood can 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 type of cage sufficient to hold the tissue wall open around the annular body 702. In other examples, the material integrally forming the annular body 702 is sufficient to hold the tissue wall open around the annular body 702.

[0139] The annular body 702 has an outer diameter OD. The outer diameter OD is the diameter of the annular body 702 measured relative to the outer surface of the cardiovascular implant device 700. The outer diameter OD is configured to be approximately the same size as the puncture diameter of the tissue wall into which the cardiovascular implant device 700 is implanted so that the cardiovascular implant device 702 can fit within the puncture. The outer diameter OD can have any size such that the cardiovascular implant device 700 is sized to suit a variety of different patient conditions and / or anatomies. In some examples, the outer diameter OD can also vary along the length of the annular body 702 based on the overall shape or configuration of the annular body 702.

[0140] The annular body 702 includes a central flow tube 704 that functions as a conduit for guiding flow through the cardiovascular implant device 700. The central flow tube 704 surrounds a flow path 706. The flow path 706 is an opening that extends through the central flow tube 704 such that the cardiovascular implant device 700 is open at each opposing end. The flow path 706 is a path along which blood flows or is directed through the cardiovascular implant device 700. The central flow tube 704 includes a flow surface 714 configured to be a flow contact surface when the cardiovascular implant device 700 is implanted in a vessel or chamber of the heart H. The flow surface 714 is a 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.

[0141] The outer shapes of the central flow tube 704 and the flow channels 706 can be straight, curved, a combination of straight and curved sections, or any other suitable shape. In some examples, the outer shapes of the central flow tube 704 and the flow channels 706 can be defined by or the same as the outer shape of the annular body 702 (e.g., as shown in FIG. 5 ). In other examples, the outer shapes of the central flow tube 704 and the flow channels 706 can be independent of or different from the outer shape of the annular body 702 (e.g., as shown in FIG. 6 ). Similarly, the cross-sectional shape or outer shape of the central flow tube 704 and the annular body 702 can be the same, e.g., circular, elliptical, 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 elliptical cross-section. Furthermore, the cross-sectional shapes of the central flow tube 704 and / or the annular body 702 can also vary along either length. The cross-sectional shape of the central flow tube 704 may be selected at various points along its length, such as at the outlet end 712, to affect the flow direction.

[0142] The central flow conduit 704 (and the flow passage 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 conduit 704 that is relatively upstream of the outflow end 712 with respect to the flow of blood through the cardiovascular implant device 700, as represented by arrow F in FIG. 14 , when the cardiovascular implant device 700 is implanted in a vessel or chamber of the heart H. Thus, the outflow end 712 is the end of the central flow conduit 704 that is relatively downstream of the inflow end 710 with respect to the flow of blood through the cardiovascular implant device 700, as represented by arrow F in FIG. 14 , when the cardiovascular implant device 700 is implanted in a vessel or chamber of the heart H. In the example shown in FIG. 14 , the inflow end 710 is positioned on the left atrial side of the atrial septum IS, and the outflow end 712 is positioned downstream of the right atrial side of the atrial septum IS, such that blood can flow from the left atrium LA to the right atrium RA through the flow passage 706. As shown in FIG. 14 , the inflow end 710 may be essentially flush with the left atrial side of the atrial septum IS, whereas 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, either the inflow end 710 or the outflow end 712, or both, may be flush with or spaced apart from the corresponding side of the tissue wall. While the inflow end 710 is defined as being relatively upstream from 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 where the cardiovascular implant device 700 is implanted. The central flow tube 704 may have any suitable length measured from the inflow end 710 to the outflow end 712. For example, the 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 the cardiovascular implant device 700 is positioned. In other examples, the central flow tube 704 can be longer or shorter than the thickness of the atrial septum IS or another tissue wall.

[0143] In general, the central flow tube 704 may be formed of 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 may be formed of a graft material. The graft material may be a synthetic material such as woven polyester or polytetrafluoroethylene (PTFE), a biological material, a metallic material, or other material, to name a few non-limiting examples. The central flow tube 704 formed of a graft material may be supported within the cardiovascular implant device 700 by the struts 703 of the annular body 702. In such an example, the central flow tube 704 may be attached to the struts 703 of the annular body 702 by any suitable attachment means, such as suturing, gluing, tying, etc. In other examples, the central flow tube 704 may be integrally formed with the annular body 704.

[0144] One or more anchor members 708 extend outward from the annular body 702. The anchor members 708 hold the cardiovascular implant device 700 in place within the tissue wall when the cardiovascular implant device 700 is implanted within the body. The anchor members 708 can take any suitable form for securing the cardiovascular implant device 700 to the tissue wall. In some examples, the anchor members 708 can be one or more arms. In other examples, the anchor members 708 can be flanges or annular lips configured to have a diameter larger than the diameter of the puncture or opening in which the cardiovascular implant device 700 is positioned so that the cardiovascular implant device 700 cannot slip through the puncture or opening. In some examples, the anchor members 708 can bend toward the tissue wall or, alternatively, lie flush against the tissue wall. The cardiovascular implant device 700 can include one or more anchor 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 anchor member 708 adjacent the inflow end 710. In other examples, the cardiovascular implant device 700 can include an anchor member 708 adjacent the outflow end 712. In the example shown in FIG. 14 , the cardiovascular implant device 700 includes anchor members 708 at both the inflow end 710 and the outflow end 712.

[0145] As shown in FIG. 14 , the central flow tube 704 is positioned within the cardiovascular implant device 700 so that it is configured to be angled relative to the tissue wall surface TWP. The tissue wall surface TWP is a vertical reference plane defined by the tissue wall (e.g., the atrial septum IS) on which the cardiovascular implant device 700 is configured to be positioned. Thus, rather than being oriented approximately perpendicular to the tissue wall surface TWP (e.g., as illustrated by the example devices shown in FIGS. 5-13 ), the central flow tube 704 is configured to traverse the tissue wall at a different angle. The flow channels 706 passing through the central flow tube 704 are also angled relative to the tissue wall and the tissue wall surface TWP in the same manner as the central flow tube 704. Therefore, the central flow tube 704 is also referred to herein as the “angled central flow tube 704,” and the flow channels 706 are also referred to herein as the “angled flow channels 706.” Axis AX7 is a longitudinal axis passing through the central flow tube 704. Axis AX7 forms an angle α7 with tissue wall TWP. In some instances, angle α7 is between 0 and 75 degrees (0°-75°). More typically, angle α7 can be less than about 90 degrees (<90°), while a vertical central flow tube is 90 degrees.

[0146] The angled central flow conduit 704 is a flow-directing component of the cardiovascular implant device 700. The angled central flow conduit 704 is positioned to direct the flow of blood from the cardiovascular implant device 700 in a particular direction. More specifically, the angled central flow conduit 704 is angled to direct the flow of blood from the cardiovascular implant device 700 in a particular direction. As shown in FIG. 14 , the angled central flow conduit 704 (and the angled flow passages 706 therein) is configured by positioning the cardiovascular implant device 700 so that it is angled toward the tricuspid valve plane TVP (the plane containing the annulus of the tricuspid valve TV). Therefore, the angled central flow conduit 704 is configured to direct the 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 conduit 704 aligns the flow of blood through and out of the cardiovascular implant device 700 with the natural flow pattern in the right atrium RA. Axis AX7 approximates a longitudinal axis aligned with the flow of blood through and exiting angled central flow tube 704. As described above, axis AX7 forms an angle α7 with tissue wall surface TWP, such that the flow of blood through and exiting angled central flow tube 704 may be described as forming an angle α7 with tissue wall surface TWP. In some examples, angle α7 is between zero and seventy-five degrees (0°-75°).

[0147] When the cardiovascular implant device 700 is implanted in the cardiovascular system (e.g., the interatrial septum IS as shown in FIG. 14 , or another tissue wall), circulating blood passes through the flow channel 706 of the cardiovascular implant device 700. In the example shown in FIG. 14 , blood flows from the left atrium LA through the flow channel 706 and into the right atrium RA. As blood exits the cardiovascular implant device 700, the angled central flow tube 704 aligns the flow of blood with the natural flow pattern of the right atrium RA so that the flow of blood from the cardiovascular implant device 700 merges with the natural flow pattern of the right atrium RA. More specifically, the angled central flow tube 704 aligns the flow of blood from the cardiovascular implant device 700 with the natural vortex flow pattern (i.e., right-handed flow vortex) of blood in the right atrium RA (shown in FIG. 14 by the schematic flow lines labeled RVF). As shown by arrow F in Figure 14, blood flow from the cardiovascular implant device 700 is directed in an angled path along the right atrial side of the interatrial septum IS toward the tricuspid valve plane TVP, rather than ejecting across the right atrium RA and cutting or otherwise disrupting the natural vortex flow pattern. In this way, blood flow from the cardiovascular implant device 700 can merge with blood flowing downward along the interatrial septum IS and flow into the right atrial vortex.

[0148] The cardiovascular implant device 700, including the angled central flow tube 704, can minimize disruption to, or potentially enhance, the natural flow pattern local to the site where the cardiovascular implant device 700 is implanted in the heart H. When the cardiovascular implant device 700 is implanted in the atrial septum IS, blood flowing from the left atrium LA to the right atrium RA through the cardiovascular implant device 700 can lessen interference with the natural rotational (e.g., vortex) flow pattern in the right atrium RA because, in contrast to conventional septal shunt devices that may jet blood flow across the right atrium, the flow from the cardiovascular implant device 700 is aligned with the natural vortex flow pattern. Utilizing the angled central flow tube 704 to align the flow from the cardiovascular implant device 700 with the natural flow pattern within the chambers or vessels of the heart H minimizes any disruption to the natural flow pattern that may result from the implantation of a conventional shunt device without a directional component. Furthermore, aligning flow from the cardiovascular implant device 700 can also potentially mitigate reduced flow due to pathophysiology or other causes or enhance basal flow. As a result, the cardiovascular implant device 700 can preserve the kinetic energy of blood flow in the cardiovascular system, which can reduce required cardiac work and improve cardiac efficiency. These hemodynamic effects can potentially improve patient outcomes after receiving the cardiovascular implant device 700, as the cardiovascular implant device 700 can be more effective and potentially safer.

[0149] Any of the various systems, devices, apparatus, etc. of the present disclosure can be sterilized (e.g., by heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can include sterilization (e.g., by heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of the relevant systems, devices, apparatus, etc.

[0150] The treatment techniques, methods, steps, etc., as described or suggested herein, or as described or suggested in the documents incorporated herein, may be performed on live animals or on non-biological simulations, such as cadavers, cadaver hearts, anthropomorphic ghosts, simulators (e.g., in which body parts, tissues, etc. are simulated), etc.

[0151] Description of Possible Implementations The following is a non-exclusive description of possible embodiments of the present invention.

[0152] The cardiovascular implant device includes an annular body, one or more anchor members, and a flow directing component. 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 anchor members extend outward from the annular body and are configured to secure the cardiovascular implant device to a tissue wall. The flow directing component is positioned to align blood flow from the cardiovascular implant device with a natural flow pattern of blood in the right atrium, such that blood flow from the cardiovascular implant device merges with the natural flow pattern of blood in the right atrium.

[0153] The cardiovascular implant device of the preceding paragraph may optionally, additionally and / or alternatively include any one or more of the following features, configurations and / or additional components.

[0154] The flow directing component can be configured to direct the flow of blood from the cardiovascular implant device toward the tricuspid valve plane of the right atrium.

[0155] The flow directing component can be positioned so that its longitudinal axis aligned with the flow of blood from 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.

[0156] The flow directing component can be a curved portion of the central flow tube, which can be adjacent to the outflow end, and which can be curved to align the flow of blood from the cardiovascular implant device with the natural flow pattern of blood in the right atrium, so that the flow of blood from the cardiovascular implant device merges with the natural flow pattern of blood in the right atrium.

[0157] The flow directing component can be a flap connected to the annulus at the outflow end of the central flow tube, and the flap can be angled to align the flow of blood from the cardiovascular implant device with the natural flow pattern of blood in the right atrium, so that the flow of blood from the cardiovascular implant device merges with the natural flow pattern of blood in the right atrium.

[0158] The flow directing component may be a guide wall connected to the radially 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 the flow of blood through the central flow tube of the cardiovascular implant device so that the flow of blood from the cardiovascular implant device aligns with and merges with the natural flow pattern of blood in the right atrium.

[0159] The flow directing component may be a set of blades extending radially around a shaft extending longitudinally through the central flow tube, and the blades may be positioned to guide the flow of blood through the central flow tube of the cardiovascular implant device so that the flow of blood from the cardiovascular implant device aligns with and merges with the natural flow pattern of blood in the right atrium.

[0160] The flow directing component can be an adjustable portion of the central flow tube, the adjustable portion can be adjacent the outflow end, the adjustable portion can be adjustable between one or more expanded and compressed configurations, and the adjustable portion can be adjustable to align the flow of blood from the cardiovascular implant device with the natural flow pattern of blood in the right atrium so that the flow of blood from the cardiovascular implant device merges with the natural flow pattern of blood in the right atrium.

[0161] The flow directing component can be a central flow tube that can be angled to align the flow of blood from the cardiovascular implant device with the natural flow pattern of blood in the right atrium, so that the flow of blood from the cardiovascular implant device merges with the natural flow pattern of blood in the right atrium.

[0162] At least a portion of the central flow tube may be formed by the graft material.

[0163] The cardiovascular implant device is sterilizable.

[0164] At least a portion of the cardiovascular implant device may be formed from a shape memory material.

[0165] The cardiovascular implant device includes an annular body and one or more anchor 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 anchor 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 the outflow end, the curved portion being curved to align blood flow from the cardiovascular implant device with the natural flow pattern of blood in the right atrium, such that the blood flow from the cardiovascular implant device merges with the natural flow pattern of blood in the right atrium.

[0166] The cardiovascular implant device of the preceding paragraph may optionally, additionally and / or alternatively include any one or more of the following features, configurations and / or additional components.

[0167] The central flow tube may further include a straight portion adjacent the inlet end, and the curved portion may be connectable to the straight portion.

[0168] The straight portion can be sized to span a puncture in a tissue wall within which the cardiovascular implant device is configured to be positioned.

[0169] The curved portion can be configured to face the right atrium when the cardiovascular implant device is positioned within the atrial septum.

[0170] The curved portion can be configured to curve toward the tricuspid valve plane of the right atrium.

[0171] A longitudinal axis through the outflow end can form an angle of approximately zero to seventy-five degrees (0°-75°) with a vertical reference plane defined by the tissue wall.

[0172] The curved portion may define a bend in the flow path.

[0173] A central flow tube including a curved portion may be formed by the graft material.

[0174] The cardiovascular implant device is sterilizable.

[0175] At least a portion of the cardiovascular implant device may be formed from a shape memory material.

[0176] The cardiovascular implant device includes an annular body, one or more anchor members, and a flap. 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 anchor members extend outward from the annular body and are configured to secure the cardiovascular implant device to a tissue wall. The flap is connected to the annular body at the outflow end of the central flow tube. The flap is angled to align blood flow from the cardiovascular implant device with the natural flow pattern of blood in the right atrium, such that the blood flow from the cardiovascular implant device merges with the natural flow pattern of blood in the right atrium.

[0177] The cardiovascular implant device of the preceding paragraph may optionally, additionally and / or alternatively include any one or more of the following features, configurations and / or additional components.

[0178] The flap may be connectable to the annular body at a flexible joint, and the flap may be positionable relative to the annular body at the flexible joint.

[0179] The cardiovascular implant device may further include a stop adjacent the flexible joint to prevent the flap from moving beyond a maximum opening angle.

[0180] The flaps may be positioned so as to be angled toward a longitudinal axis through the central flow tube.

[0181] The flaps can be integrally formed of flexible material, or the flaps can be formed of a wire frame and fabric stretched over the wire frame.

[0182] The flap may be configured to extend into the right atrium.

[0183] The flap can be configured to direct blood flow from the cardiovascular implant device toward the tricuspid valve plane of the right atrium.

[0184] The flap can 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.

[0185] The cardiovascular implant device is sterilizable.

[0186] At least a portion of the cardiovascular implant device may be formed from a shape memory material.

[0187] The cardiovascular implant device is configured to be attached adjacent to an opening in a tissue wall between the right and left atria of the heart. The cardiovascular implant device includes an anchor member configured to secure the cardiovascular implant device to the tissue wall, a flexible joint connected to the anchor member, and a flap connected to the flexible joint. The flap is angled to align blood flow from the opening with the natural flow pattern of blood in the right atrium, such that blood flow from the puncture merges with the natural flow pattern of blood in the right atrium.

[0188] The cardiovascular implant device of the preceding paragraph may optionally, additionally and / or alternatively include any one or more of the following features, configurations and / or additional components.

[0189] The flap may be positionable relative to the opening of the flexible joint.

[0190] The cardiovascular implant device may further include a stop adjacent the flexible joint to prevent the flap from moving beyond a maximum opening angle.

[0191] The flap may be positioned so as to be angled toward the longitudinal axis through the opening.

[0192] The flaps can be integrally formed of flexible material, or the flaps can be formed of a wire frame and fabric stretched over the wire frame.

[0193] The flap may be configured to extend into the right atrium.

[0194] The flap can be configured to direct blood flow from the opening toward the tricuspid valve plane of the right atrium.

[0195] The flap can 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.

[0196] The cardiovascular implant device is sterilizable.

[0197] At least a portion of the cardiovascular implant device may be formed from a shape memory material.

[0198] The cardiovascular implant device includes an annular body and one or more anchor 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 anchor 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 guide blood flow through the central flow tube of the cardiovascular implant device, such that blood flow from the cardiovascular implant device aligns with and merges with the natural flow pattern of blood in the right atrium.

[0199] The cardiovascular implant device of the preceding paragraph may optionally, additionally and / or alternatively include any one or more of the following features, configurations and / or additional components.

[0200] The guide wall may be circumferentially attached to the radially inner surface of the central flow tube.

[0201] The guide wall may be a spiral wall so that the flow path is a spiral path.

[0202] The spiral wall may extend from the inlet end to the outlet end within the interior of the central flow tube.

[0203] The guide walls may be positioned to prevent blood flow through the central flow tube from flowing in a straight path.

[0204] The guide walls are capable of imparting a rotational velocity to the flow of blood through the central flow tube.

[0205] The guide wall can be configured to direct blood flow from the cardiovascular implant device toward the tricuspid valve plane of the right atrium.

[0206] The guide wall can be positioned so that its longitudinal axis aligned with the flow of blood from 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.

[0207] The cardiovascular implant device is sterilizable.

[0208] At least a portion of the cardiovascular implant device may be formed from a shape memory material.

[0209] The cardiovascular implant device includes an annular body and one or more anchor members. The annular body includes a central flow tube extending from the inflow end to the outflow end and a flow path extending through the central flow tube. The one or more anchor 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 guide blood flow through the central flow tube of the cardiovascular implant device, such that blood flow from the cardiovascular implant device aligns with and merges with the natural flow pattern of blood in the right atrium.

[0210] The cardiovascular implant device of the preceding paragraph may optionally, additionally and / or alternatively include any one or more of the following features, configurations and / or additional components.

[0211] The blades may be arranged in a ring around the shaft.

[0212] A set of blades may be a stator.

[0213] A set of blades may be a rotor.

[0214] Each of the blades may include a root portion adjacent the shaft and a tip portion distal to the root portion, whereby the blade extends radially from the shaft toward the inner surface of the central flow tube and the tip portion is spaced from the inner surface of the central flow tube.

[0215] The blades are capable of imparting a rotational velocity to the blood flowing through the central flow tube.

[0216] The blades can be configured to direct blood flow from the cardiovascular implant device toward the tricuspid valve plane of the right atrium.

[0217] The blades may be positioned so that their longitudinal axes, aligned with the flow of blood from the cardiovascular implant device, form an angle of approximately zero to seventy-five degrees (0°-75°) with a vertical reference plane defined by the tissue wall.

[0218] The cardiovascular implant device is sterilizable.

[0219] At least a portion of the cardiovascular implant device may be formed from a shape memory material.

[0220] The cardiovascular implant device includes an annular body and one or more anchor 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 anchor 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 the outflow end. The adjustable portion is adjustable between one or more expanded and compressed configurations to align blood flow from the cardiovascular implant device with a natural blood flow pattern in the right atrium, such that blood flow from the cardiovascular implant device merges with the natural blood flow pattern in the right atrium.

[0221] The cardiovascular implant device of the preceding paragraph may optionally, additionally and / or alternatively include any one or more of the following features, configurations and / or additional components.

[0222] The adjustable portion may include one or more accordion folds.

[0223] The central flow tube can include an inner diameter, which can vary along the length of the central flow tube.

[0224] The central flow tube may further include a straight portion adjacent the inlet end, the adjustable portion being connectable to the straight portion.

[0225] The straight portion can be sized to span a puncture in a tissue wall within which the cardiovascular implant device is configured to be positioned.

[0226] The adjustable portion can be configured to be adjusted to one of one or more expanded configurations prior to an implantation procedure of the cardiovascular implant device.

[0227] The adjustable portion can be configured to be adjusted to one of one or more expanded configurations during an implantation procedure of the cardiovascular implant device.

[0228] The adjustable portion can be configured to face the right atrium when the cardiovascular implant device is positioned within the atrial septum.

[0229] The adjustable portion can be configured to curve toward the tricuspid valve plane of the right atrium when the adjustable portion is in one of the one or more expanded configurations.

[0230] A longitudinal axis through the outflow end can form an angle of approximately zero to seventy-five degrees (0°-75°) with a vertical reference plane defined by the tissue wall.

[0231] The adjustable portion can define a bend in the flow path.

[0232] The collar in the adjustable portion may be formed from a resilient material.

[0233] The resilient material may be a cobalt chromium alloy.

[0234] The cardiovascular implant device is sterilizable.

[0235] At least a portion of the cardiovascular implant device may be formed from a shape memory material.

[0236] The cardiovascular implant device includes an annular body and one or more anchor 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 anchor 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 angled relative to the tissue wall. The central flow tube is angled to align blood flow from the cardiovascular implant device with a natural blood flow pattern in the right atrium, such that blood flow from the cardiovascular implant device merges with the natural blood flow pattern in the right atrium.

[0237] The cardiovascular implant device of the preceding paragraph may optionally, additionally and / or alternatively include any one or more of the following features, configurations and / or additional components.

[0238] 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 within the atrial septum.

[0239] The central flow tube may be configured to be angled toward the tricuspid valve plane of the right atrium.

[0240] The central flow tube can be configured to direct blood flow from the cardiovascular implant device toward the tricuspid valve plane of the right atrium.

[0241] A longitudinal axis through the central flow tube can form an angle of less than 90 degrees (<90°) with a vertical reference plane defined by the tissue wall.

[0242] The angle can be between 0 and 75 degrees (0° to 75°).

[0243] At least a portion of the central flow tube may be formed by the graft material.

[0244] The cardiovascular implant device is sterilizable.

[0245] At least a portion of the cardiovascular implant device may be formed from a shape memory material.

[0246] Although the present invention has been described with reference to illustrative embodiments, those skilled in the art will recognize that various modifications may be made and that equivalents may be substituted for components without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope thereof. Therefore, it is not intended that the invention be limited to the particular embodiments disclosed, but it is intended that the invention include all examples falling within the scope of the appended claims.

Claims

1. 1. A cardiovascular implant device comprising: A ring-shaped body, a central flow tube extending from an inlet end to an outlet end; and an annulus including a flow path extending through the central flow tube; one or more anchor members extending outward from the annular body and configured to secure the cardiovascular implant device to a tissue wall; a flow directing component; A cardiovascular implant device, wherein the flow directing component is positioned to align the flow of blood from the cardiovascular implant device with the natural flow pattern of blood in the right atrium, such that the flow of blood from the cardiovascular implant device merges with the natural flow pattern of blood in the right atrium.

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

3. 10. The cardiovascular implant device of claim 1, wherein the flow directing component is positioned such that a longitudinal axis aligned with the flow of blood from 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 flow directing element is a curved portion of the central flow tube; the curved portion is adjacent the outflow end; 2. The cardiovascular implant device of claim 1, wherein the curved portion is curved to align the flow of blood from the cardiovascular implant device with the natural flow pattern of blood in the right atrium, such that the flow of blood from the cardiovascular implant device merges with the natural flow pattern of blood in the right atrium.

5. the flow directing element is a flap connected to the annulus at the outlet end of the central flow tube; 2. The cardiovascular implant device of claim 1, wherein the flap is angled to align the flow of blood from the cardiovascular implant device with the natural flow pattern of blood in the right atrium, such that the flow of blood from the cardiovascular implant device merges with the natural flow pattern of blood in the right atrium.

6. the flow directing element is a guide wall connected to the radially inner surface of the central flow tube; the flow path is defined by the guide wall; 2. The cardiovascular implant device of claim 1, wherein the guide wall is positioned to guide blood flow through the central flow tube of the cardiovascular implant device such that the flow of blood from the cardiovascular implant device aligns with and merges with the natural flow pattern of the blood in the right atrium.

7. the flow directing component being a set of blades extending radially around a shaft extending longitudinally through the central flow tube; 2. The cardiovascular implant device of claim 1, wherein the blades are positioned to guide blood flow through the central flow tube of the cardiovascular implant device such that the flow of blood from the cardiovascular implant device aligns with and merges with the natural flow pattern of the blood in the right atrium.

8. the flow directing component is an adjustable portion of the central flow tube; the adjustable portion is adjacent the outflow end; the adjustable portion is adjustable between one or more expanded and compressed configurations; 10. The cardiovascular implant device of claim 1, wherein the adjustable portion is adjustable to align the flow of blood from the cardiovascular implant device with the natural flow pattern of the blood in the right atrium, such that the flow of blood from the cardiovascular implant device merges with the natural flow pattern of the blood in the right atrium.

9. the flow directing component is the central flow tube; 2. The cardiovascular implant device of claim 1, wherein the central flow tube is angled to align the flow of blood from the cardiovascular implant device with the natural flow pattern of blood in the right atrium, such that the flow of blood from the cardiovascular implant device merges with the natural flow pattern of blood in the right atrium.

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

13. 1. A cardiovascular implant device configured to be attached adjacent an opening in a tissue wall between the right atrium and the left atrium of a heart, comprising: an anchor member configured to secure the cardiovascular implant device to the tissue wall; a flexible joint connected to the anchor member; a flap connected to the flexible joint, the flap angled to align blood flow from the opening with a natural flow pattern of blood in the right atrium, such that the blood flow from the opening meets the natural flow pattern of blood in the right atrium.

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

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

16. The cardiovascular implant device of claim 13 , wherein the flap is positioned so as to be angled toward the longitudinal axis through the opening.

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

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

19. The cardiovascular implant device of claim 13 , wherein the flap 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. 14. The cardiovascular implant device of claim 13, wherein the cardiovascular implant device is sterilized and at least a portion of the cardiovascular implant device is formed from a shape memory material.

Images