A cardiovascular implant device having a flow regulator that enhances the hemodynamics of the cardiovascular system while minimizing disturbances to the hemodynamics of the cardiovascular system

Abstract

The cardiovascular implant device includes an expandable annular frame and a flow regulator. The expandable annular frame is formed from a plurality of struts and is configured to conform to the internal shape of a blood vessel or chamber of the heart when expanded within the blood vessel or chamber of the heart. The flow regulator is connected to the plurality of struts of the expandable annular frame. The flow regulator is arranged to alter the hemodynamic characteristics of the blood flow that is derived from or through the expandable annular frame and flows therethrough.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Application No. 63 / 349,824, filed on June 7, 2022, entitled "CARDIOVASCULAR IMPLANT DEVICES WITH FLOW CONDITIONERS TO MINIMIZE DISRUPTION TO AND ENHANCE CARDIOVASCULAR HEMODYNAMICS", the disclosure of which is hereby incorporated by reference in its entirety.

[0002] The present disclosure relates to cardiovascular implant devices, and more particularly to cardiovascular implant devices for minimizing disruption to and enhancing the hemodynamics of the cardiovascular system.

Background Art

[0003] A variety of medical devices can be implanted within the cardiovascular system at locations where blood will flow through or around the implanted device. For example, an artificial valve or artificial valve device can be deployed to replace a diseased or malfunctioning native valve. Also, an edge - to - edge valve repair device can be deployed at the site of the native valve to treat tricuspid regurgitation (TR) or mitral regurgitation (MR). Additionally, a stent can be deployed into the cardiovascular system to keep a stenosed blood vessel open. These implantable devices can be placed within the natural flow path inside the cardiovascular system.

Summary of the Invention

[0004] In one example, a cardiovascular implant device includes an expandable annular frame and a flow regulator. The expandable annular frame is formed from a plurality of struts and is configured to conform to the internal shape of a blood vessel or chamber of the heart when expanded inside the blood vessel or chamber of the heart. The flow regulator is connected to the plurality of struts of the expandable annular frame. The flow regulator is arranged to change the hemodynamic characteristics of the blood flow flowing through or derived from the expandable annular frame.

[0005] In another example, an artificial valve device includes an annular frame formed from a plurality of struts, a valve body attached inside the annular frame, and a flow regulator. The valve body includes a plurality of valve leaflets that control the blood flow flowing through the annular frame. The flow regulator is connected to the plurality of struts of the annular frame. The flow regulator is arranged to change the hemodynamic characteristics of the blood flow flowing through or derived from the annular frame.

[0006] In another example, an artificial valve system includes a prestent device having a frame with a bidirectional expanding diameter profile formed from a first plurality of struts, an artificial valve device configured to seat inside the prestent device, a first flow regulator, and a second flow regulator. The artificial valve device includes an annular frame formed from a second plurality of struts and a valve body attached inside the annular frame. The valve body includes a plurality of valve leaflets that control the blood flow flowing through the annular frame. The first flow regulator is connected to the first plurality of struts of the prestent device. The first flow regulator is arranged to change the first hemodynamic characteristics of the blood flow flowing through or derived from the prestent device. The second flow regulator is connected to the second plurality of struts of the artificial valve device. The second flow regulator is arranged to change the second hemodynamic characteristics of the blood flow flowing through or derived from the artificial valve device.

[0007] In another example, a cardiovascular implant device includes a body and a flow regulator connected to the body. The body is configured to be attached to one or more leaflets of a native heart valve. The body includes a central spacer and clasps extending radially outward from the central spacer. Each of the clasps includes a first arm and a second arm for gripping one or more leaflets. The flow regulator is arranged to alter the hemodynamic characteristics of the blood flow passing through the perimeter of the cardiovascular implant device.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0009] FIG. 1 is a schematic view of the heart H and the vascular system V. FIG. 1 shows the heart H, the vascular system V, the right atrium RA, the right ventricle RV, the left atrium LA, the left ventricle LV, the superior vena cava SVC, the inferior vena cava IVC, the tricuspid valve TV, the pulmonary valve PV, the pulmonary artery PA, the pulmonary veins PVS, the mitral valve MV, the aortic valve AV, the aorta AT, and the coronary sinus CS.

[0010] The heart H is a human heart that receives blood from the vascular system V and pumps blood to the vascular system V. The heart H includes four chambers, namely, the right atrium RA, the right ventricle RV, the left atrium LA, and the left ventricle LV.

[0011] The right side of the heart, including the right atrium RA and the right ventricle RV, receives oxygen-depleted 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, from the inferior vena cava IVC, and from the coronary sinus CS.

[0012] Most of the blood flows into the right atrium RA from the superior vena cava SVC and the inferior vena cava IVC, which are offset from each other. Due to the offset of the major inflow blood from the superior vena cava SVC and the inferior vena cava IVC, a natural flow vortex (a clockwise flow vortex) occurs within the right atrium RA. As a result, a significant portion of the blood from the right atrium RA can flow through the right atrium RA and directly into the right ventricle RV by a direct flow. The clockwise flow vortex within the right atrium RA conserves the kinetic energy and momentum of the major blood flow flowing into the right atrium RA, enabling a significant portion of the blood to naturally pass from the right atrium RA to the right ventricle RV without the need for a contribution from the pumping action of the right atrium RA. With contraction, the right atrium RA also pumps the remainder of the inflow blood that was not captured within the direct flow through the tricuspid valve TV into the right ventricle RV. The blood flows into the right ventricle RV and then into the pulmonary artery PA through the pulmonary valve PV. By conserving the direct inflow from the right atrium RA, the blood flowing into the right ventricle RV also forms a natural flow vortex (a vortex of the right ventricle flow) within the right ventricle RV, enabling the blood flowing into the right ventricle RV to be naturally redirected to the pulmonary artery PA by a direct flow without causing substantial work to be done by the right ventricle RV to pump the blood. The remaining blood that was not transported to the pulmonary artery PA through the pulmonary valve PV by a direct flow is pumped by the contraction of the right ventricle RV. The blood flows into the thin arteries from the pulmonary artery PA, supplying the oxygen-depleted blood to the lungs via the pulmonary circulation system. There, the lungs can supply oxygen to the blood.

[0013] The left side of the heart H, including the left atrium LA and the left ventricle LV, receives oxygenated blood from the lungs and provides blood flow to the body. Blood flows into the left atrium LA from the pulmonary veins PVS. The offset between the right pulmonary vein PVS and the left pulmonary vein PVS also forms a natural vortex (left-handed vortex) of flow within the left atrium LA, assisting in maintaining the momentum as blood passes through the left atrium LA and reaches the mitral valve MV, thereby minimizing work. Due to the direct flow as described above and the pumping action of the left atrium LA, blood is sent through the mitral valve MV into the left ventricle LV. When blood flows into the left ventricle LV, a natural vortex (vortex of left ventricle flow) is formed within the left ventricle LV, and the flow is naturally redirected towards the left ventricular outflow of the aortic valve AV, enabling the left ventricle LV to efficiently pump the flow through the aortic valve AV into the aorta AT. Blood flows from the aorta AT into each artery, thereby supplying oxygenated blood to the whole body via the systemic circulation system.

[0014] Figure 2A is a first schematic diagram illustrating the modeled blood flow dynamic flow pattern within the heart H. Figure 2B is a second schematic diagram illustrating the modeled blood flow dynamic flow pattern within the heart H. Figures 2A - 2B 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. Figure 2A shows the tricuspid valve TV, the pulmonary veins PVS, and the mitral valve MV.

[0015] Figures 2A - 2B show the modeled velocity lines representing the blood flow dynamic flow pattern within the heart H. Figure 2A shows the heart H facing the right atrium RA on the right side of the figure and the heart H facing the left atrium LA on the left side of the figure. Figure 2A is a view from the bottom of the heart H. Figure 2B shows the heart H facing the right atrium RA on the left side of the figure and the heart H facing the left atrium LA on the right side of the figure. Figure 2B is a view from the top of the heart H.

[0016] The natural flow pattern of blood exists within the heart H and assists the blood in moving through the heart H and into the vascular system connected to the heart H in a manner that maximally preserves the momentum and kinetic energy of the blood flow. The natural flow pattern for blood to move through arteries and veins is typically essentially helical (helical flow pattern). The natural flow pattern for blood to move through each chamber of the heart H is typically essentially vortical (vortex flow pattern).

[0017] Figure 2A shows a modeled blood flow dynamic flow pattern as existing within the right atrium RA and the left atrium LA of the heart H. Figure 2B shows a modeled blood flow dynamic flow pattern as existing within the right atrium RA, within the superior vena cava SVC, within the inferior vena cava IVC, and within the coronary sinus CS. Figures 2A - 2B represent the natural flow pattern formed within the heart H, including the right atrium RA and the left atrium LA, based on the offset inflow of blood to each chamber of the heart H in addition to the anatomical structure of the heart H. When viewing the heart H from the right side (right sagittal view), within the right atrium RA, a clockwise right - hand - turning vortex of blood flow is formed, and within the left atrium LA, a counterclockwise left - hand - turning vortex of blood flow is formed. The right - hand - turning vortex of blood flow within the right atrium RA is the natural flow pattern of blood flow within the right atrium RA. The left - hand - turning vortex of blood flow within the left atrium LA is the natural flow pattern of blood flow within the left atrium LA. The modeled blood flow dynamic flow pattern as shown in Figures 2A - 2B represents the intracardiac flow pattern for a structurally normal heart.

[0018] Blood is introduced into the right atrium RA from the superior vena cava SVC, from the inferior vena cava IVC, and from the coronary sinus CS. The opening of the superior vena cava in the right atrium RA and the opening of the inferior vena cava in the right atrium RA are offset so that the blood flowing into the right atrium RA from each of the superior vena cava SVC and the inferior vena cava IVC do not collide with each other. Based on its orientation and physical proximity, the flow of the coronary sinus CS is entrained into the flow of the inferior vena cava IVC. The blood flowing through the superior vena cava SVC and through the inferior vena cava IVC has a helical flow pattern. Most of the blood in the right atrium RA flows into the right atrium RA through the inferior vena cava IVC, and the blood flowing from the inferior vena cava IVC into the right atrium RA is directed towards the upper part of the right atrium RA. The helical flow pattern of the blood flowing from the inferior vena cava IVC into the right atrium RA aids in forming a clockwise rightward flow vortex (when viewing the heart from the right side) within the right atrium RA. The blood flow flowing from the superior vena cava SVC into the right atrium RA will flow towards the tricuspid valve TV along the atrial septum. The helical flow pattern of the blood flowing from the superior vena cava SVC into the right atrium RA aids in naturally joining with the clockwise rightward flow vortex formed within the right atrium RA by the blood flow from the inferior vena cava IVC, and this flow is joined by the flow of 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 will have a helical flow pattern. The helical flow pattern of the blood derived from the coronary sinus CS will be naturally joined to the flow of the inferior vena cava IVC and to the clockwise rightward flow vortex within the right atrium RA. The clockwise rightward flow vortex within the right atrium RA is shown by the velocity lines marked with RVF in FIGS. 2A - 2B.

[0019] The vortices of the rightward flow formed within the right atrium RA assist blood in flowing from the right atrium RA through the tricuspid valve TV into the right ventricle, and also assist in flowing through the pulmonary valve into the pulmonary artery. The right heart is an inefficient pump and may rather act like a conduit. The vortices of the rightward flow formed within the right heart assist in conserving the kinetic energy and momentum of the blood flow when moving from the superior vena cava SVC and inferior vena cava IVC (from the vena cava) through the right heart into the pulmonary artery, even if little or no pumping action is provided by the right heart. This is particularly important for maintaining the right heart output that must match the left heart output during periods of high power and high heart rate during exercise. The vortices of the rightward flow formed within the right atrium RA assist in moving blood from the right atrium RA through the tricuspid valve TV into the right ventricle while minimizing the 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 vortices of the rightward flow in the right atrium RA and right ventricle RV and the anatomical constraints of the right heart, approximately 50% of the blood will flow into the pulmonary artery without the need for pumping action by the right heart. Right heart contraction enhances the flow of residual blood through the right heart.

[0020] Blood flows from the pulmonary veins PVS into the left atrium LA. There are four pulmonary veins PVS that flow into the left atrium LA. The blood flowing through the pulmonary veins PVS has a helical flow pattern. The offset of the helical flow of the blood flowing from the pulmonary veins PVS into the left atrium LA assists in forming a counterclockwise leftward flow vortex within the left atrium LA (when viewing the heart from the right side). The leftward flow vortex within the left atrium LA guides the flow towards the mitral valve MV. The leftward flow vortex within the left atrium LA is shown by the velocity lines labeled LVF in Figure 2A.

[0021] Although not shown in FIGS. 2A-2B, the blood flowing from the left ventricle LV through the aorta AT can also have a characteristic helical flow pattern and a vortex flow pattern. Similar characteristic helical flow patterns and / or vortex flow patterns can also be present in other blood vessels of the heart H (e.g., the pulmonary artery PA) or in chambers (e.g., the left ventricle LV and the right ventricle RV).

[0022] When the intracardiac blood flow pattern of the heart H (including the vortex of the rightward flow in the right atrium RA and the vortex of the leftward flow in the left atrium LA) is disrupted, the blood flow that flows from the superior vena cava SVC and the inferior vena cava IVC (from the vena cava) through the right atrium RA, through the right ventricle, and into the pulmonary artery, and the blood flow that flows from the pulmonary vein through the left atrium LA, through the left ventricle, and into the aorta, are less efficient, and there is a hypothesis that they increase the mechanical load on the corresponding ventricles. This is particularly serious in a heart that has already fallen into dysfunction, such as one with a reduced ability to increase the workload of the myocardium. The disruption of the intracardiac blood flow pattern of the heart H (including the vortex of the rightward flow in the right atrium RA and the vortex of the leftward flow in the left atrium LA) can occur for various reasons. For example, the anatomical structure of the heart H can change with the age of the patient. This can affect the offset between the opening of the superior vena cava SVC and the opening of the inferior vena cava IVC. The blood flow that flows from the superior vena cava SVC into the right atrium RA and the blood flow that flows from the inferior vena cava IVC into the right atrium RA may collide when the anatomical structure of the heart H changes, thereby disturbing the natural formation of the vortex of the rightward flow in the right atrium RA. In another example, regardless of the presence or absence of atrial fibrillation, the right atrium RA may expand in heart failure patients. The expansion of the right atrium RA can also disrupt the vortex of the rightward flow formed within the right atrium RA. Similarly, regardless of the presence or absence of atrial fibrillation, the left atrium LA may expand in heart failure patients. The expansion of the left atrium LA can disrupt the vortex of the leftward flow formed within the left atrium LA. Additionally, patients with a patent foramen ovale (a natural atrial septal shunt) or patients with a secundum atrial septal defect due to incomplete closure of the patent foramen ovale may not have the expected intracardiac blood flow pattern (including the vortex of the rightward flow in the right atrium RA and the vortex of the leftward flow in the left atrium LA), including the vortices of the flow that is expected to be generated during atrial filling. The closure of a secundum atrial septal defect with a changing non-unique vortex pattern in the right atrium has been shown to return to a dominant single-vortex pattern after the closure of the atrial septal defect.

[0023] In another example, introducing an implant device such as a valve or a stent into a cardiovascular anatomical structure, and also, at or near the location where the device is implanted inside, can disrupt the natural flow patterns, such as the vortices of the rightward flow in the right atrium RA and the leftward flow in the left atrium LA, within the blood vessels and chambers of the heart H. This can be due to the mismatch (albeit a minor one) between the artificial flow path through the implanted device and the replaced natural flow path. For example, the aortic vortices and / or helical flow may be disrupted after transcatheter aortic valve replacement (TAVR). Before TAVR, the helical flow in the aorta can move the blood downstream through the aorta. After TAVR, the influence of the vortices may become more prominent, and as a result, the energy directed towards forward (downstream) movement in the aortic flow may decrease. Moreover, the blood flowing through the implanted device tends to flow along the walls of the device. If the device structure abruptly terminates at the downstream end of the device, the blood flow will immediately separate from the edge and become turbulent, thereby causing a reversal of the flow and resulting in a decrease in hemodynamic efficiency.

[0024] When the vortices of the rightward flow in the right atrium RA change, the momentum and energy of the blood flow are lost, and the right heart has to pump harder to move blood from the right atrium RA into the right ventricle and into the pulmonary artery. This is because the vortices of the rightward flow do not contribute much to the blood movement through the right heart. Similarly, when the vortices of the leftward flow in the left atrium LA change, the left heart has to pump harder to move blood from the left atrium LA into the left ventricle and into the aorta. This is because the vortices of the leftward flow do not contribute much to the blood movement through the left heart. Furthermore, when the intracardiac flow pattern of the heart H (including the vortices of the rightward flow in the right atrium RA and the vortices of the leftward flow in the left atrium LA) changes due to aging or disease, turbulent regions may occur within the flow pattern of the heart H, leading to hydrodynamic losses that result in inefficiencies causing a decrease in flow. This may increase the likelihood of right heart failure and / or left heart failure (a condition where the heart cannot pump out enough blood to meet the body's oxygen demand), because the heart H has to do more work to move the same amount of blood. To reproduce the loss of momentum naturally conserved by the intracardiac flow pattern of the heart H (including the vortices of the rightward flow in the right atrium RA and the vortices of the leftward flow in the left atrium LA), additional work is required, imposing an additional burden on the heart H. The hemodynamic efficiency of the valves within the heart H also affects the work required of the heart H. Slight changes or inefficiencies in hemodynamics, such as those caused by disease or dysfunction or by the presence of prosthetic valve devices, can lead to significant unnecessary energy consumption by the heart H when amplified by millions of beats.

[0025] Changes in the intracardiac flow pattern alter the intracardiac energy. The heart H is uniquely designed to maximize efficiency by conserving the kinetic energy and momentum of the blood flow, and thus is uniquely designed to minimize the work required to propagate the blood flow into, between, and out of the chambers. Anything that disrupts the intracardiac flow pattern within the heart H (including the vortices of the rightward flow in the right atrium RA and the vortices of the leftward flow in the left atrium LA) can reduce the energy efficiency of the heart H due to loss of potential energy, thereby making it more difficult for the heart H to do the work of propagating blood into, between, and out of the chambers. Anything that disrupts the intracardiac flow pattern through the heart H (including the vortices of the rightward flow in the right atrium RA and the vortices of the leftward flow in the left atrium LA) can increase the workload of the heart H and increase the transit time through the heart H, and further make it more difficult for the heart H to pump blood out. This is particularly a problem for people experiencing heart failure, as heart failure can worsen due to disruption of the intracardiac flow pattern through the heart H (including the vortices of the rightward flow in the right atrium RA and the vortices of the leftward flow in the left atrium LA).

[0026] Device 100 (Figs. 3A - 9E) Regarding FIGS. 3A - 4, they will be described together. FIG. 3A is a perspective view of a cardiovascular implant device 100 including a fin - type flow regulator 110. FIG. 3B is a plan view of a cardiovascular implant device 100 including a fin - type flow regulator 110. FIG. 3C is a bottom view of a cardiovascular implant device 100 including a fin - type flow regulator 110. FIG. 4 is a cross - sectional view of the heart H illustrating an exemplary placement at a non - valve site with respect to the cardiovascular implant device 100 including a fin - type flow regulator 110.

[0027] As shown in FIGS. 3A - 3C, the cardiovascular implant device 100 includes a fin - type flow regulator 110, a frame 112, a cover 114, a valve seat 116, an inflow end 118, and an outflow end 120. The frame 112 includes struts 122, an inner diameter 124, an inner surface 125, an outer diameter 126, and an outer surface 127, and defines an opening 128, a central flow path 129, and a flow axis 130. FIG. 4 also shows the device 100, the heart H, the vascular system V, the right atrium RA, the right ventricle RV, the left atrium LA, the left ventricle LV, the superior vena cava SVC, the inferior vena cava IVC, the tricuspid valve TV, the pulmonary valve PV, the pulmonary artery PA, the pulmonary veins PVS, the mitral valve MV, the aortic valve AV, the aorta AT, and the coronary sinus CS.

[0028] 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 “prestent” or docking station for supporting a valve device such as an artificial valve device. The cardiovascular implant device 100 can be delivered into the cardiovascular system via a catheter (i.e., trans - catheter delivery), or can be surgically placed using trans - catheter procedures known in the art or using surgical procedures. As shown in FIG. 4, the device 100 is disposed within the inferior vena cava IVC near the opening into the right atrium RA. That is, the device 100 is disposed at a site within the heart H where there is no natural valve (a “non - valve” site). In other examples, the device 100 can be disposed within the superior vena cava SVC. In still other examples, the device 100 can be disposed within any blood vessel or any chamber of the heart H at a non - valve site or at a site where a natural valve (e.g., aortic valve AV, mitral valve MV, pulmonary valve PV, etc.) is present. Examples of cardiovascular implant devices within valve sites will be described later with reference to FIGS. 12 - 14.

[0029] Frame 112 forms the main body of device 100. Frame 112 can be made expandable. Frame 112 can have various shapes and sizes. As shown in FIGS. 3A - 3C, frame 112 is in the form of an annular or cylindrical mesh or lattice. Frame 112 has an inner diameter 124 and an outer diameter 126. Each of the inner diameter 124 and the outer diameter 126 can vary along the length of frame 112. The inner diameter 124 is the diameter of the radially inner surface 125 of frame 112. The outer diameter 126 is the diameter of the radially outer surface 127 of frame 112. Frame 112 can have any suitable length. For example, frame 112 may be approximately the same length as a valve configured to seat within the interior of frame 112 (e.g., within seat 116). In other examples, frame 112 can be longer or shorter compared to a valve configured to seat within the interior of frame 112. Frame 112 can press against or into the tissue wall at the implantation site in order to set and maintain the position of device 100, or can be placed (or extended) around the anatomical structures of the cardiovascular system.

[0030] Frame 112 can be formed in various ways. For example, in a way of forming a mesh or lattice by connecting individual wires together, in a braiding way, in a way of rolling into the shape of frame 112 after cutting from a sheet or forming in other ways, in a molding way, in a way of cutting from a cylindrical tube (for example, in a way of cutting from a Nitinol tube), in other ways, or in combinations thereof. Frame 112 can be formed from a highly flexible metal, from a metal alloy, or from a polymer. Examples of metals and metal alloys that can be used include, but are not limited to, Nitinol and other shape memory alloys, Elgiloy, and stainless steel. However, when manufacturing frame 112, other metals, highly elastic non-metallic materials, or soft non-metallic materials can be used. All or part of frame 112 can be integrally formed from any of those materials. Those materials can enable frame 112 to be compressed to a small size, and then, when the compressive force is released, frame 112 can self-expand to return to its shape before compression. Frame 112 can expand to return to its shape before compression based on the properties of the material forming frame 112, and / or frame 112 can expand by the expansion or dilation of a device disposed inside frame 112. For example, frame 112 can be compressed so that frame 112 can fit inside a delivery catheter. Frame 112 can also be formed from other materials and can be made expandable and crushable in various ways, such as in a mechanically expandable way, a balloon-expandable way, a self-expandable way, or a combination thereof.

[0031] Frame 112 extends across between the inflow end 118 and the outflow end 120 of the cardiovascular implant device 100. The inflow end 118 can be the end of the device 100 such that when the device 100 is implanted within a blood vessel or chamber of the heart H, it is located upstream of the outflow end 120 with respect to the blood flow along the flow axis 130 represented by arrow A in FIG. 3A. Thus, the outflow end 120 is the end of the device 100 such that when the device 100 is implanted within a blood vessel or chamber of the heart H, it is located downstream of the inflow end 118 with respect to the blood flow along the flow axis 130 represented by arrow A in FIG. 3A. In the example shown in FIG. 4, the outflow end 120 is disposed in the vicinity where the inferior vena cava IVC opens into the right atrium RA, and the inflow end 118 is disposed upstream within the inferior vena cava IVC. Although the inflow end 118 is defined as being located upstream of the outflow end 120, it will be understood that other actual arrangements regarding the inflow end 118 or the outflow end 120 are possible depending on the location where the device 100 is implanted.

[0032] Frame 112 is formed from a plurality of struts 122. The struts 122 construct a lattice or mesh of the frame 112 and define an opening (or cell) 128 inside the lattice or mesh. The struts 122 can be integrally formed. In some examples, all or part of the struts 122 are integrally formed from the same material. The opening 128 extends through the frame 112 from the inner surface 125 to the outer surface 127. Each of the openings 128 is surrounded by one or more sides by the struts 122. The opening 128 can have any suitable shape or size, and this shape or size can be based on the overall shape or size of the frame 112. In the example shown in FIG. 3A, the opening 128 is rhombus-shaped and is arranged as a circumferential row around the frame 112. In other examples, the opening 128 can have any other regular or irregular, polygonal or non-polygonal shape and pattern. In some examples, some of the openings 128 can have different shapes or sizes throughout the frame 112. In some examples, some of the openings 128 can be connected to adjacent openings 128 with a gap therebetween.

[0033] The central flow path 129 is an open flow path passing through the central portion of the annular frame 112. The central flow path 129 is defined by the inner surface 125 of the frame 112. The central flow path 129 extends from the inflow end 118 to the outflow end 120, whereby the device 100 is open at both ends. Thus, the blood flowing through the device 100 and led out from the device 100 follows the central flow path 129. More specifically, the flow axis 130 is the longitudinal axis through the device 100, and along this longitudinal axis, the blood flows when the blood passes through or is guided through the device 100 (e.g., in the direction indicated by arrow A in FIG. 3A). In the example illustrated in FIG. 4 where the device 100 is implanted in the inferior vena cava IVC, the valve seated in the device 100 can open when the heart H is in diastole. Blood flows into the right atrium RA from the inferior vena cava IVC and from the superior vena cava SVC. The blood flowing in from the inferior vena cava IVC flows through the device 100 along the flow axis 130. During diastole, the blood in the right atrium RA flows into the right ventricle RV through the tricuspid valve TV. During systole of the heart H, the valve seated in the device 100 can close. The blood is prevented from flowing (i.e., flowing backward) from the right atrium RA into the inferior vena cava IVC by the valve closed in the device 100. The valve closed in the device 100 prevents the blood flowing backward through the tricuspid valve TV during systole from being pushed into the inferior vena cava IVC.

[0034] Cover 114 is a cover for one or more portions of frame 112. Cover 114 can be a cloth material, a polymer material, or other materials. For example, cover 114 can be a material that promotes ingrowth within tissue at locations where device 100 contacts adjacent tissue walls of a blood vessel or chamber of heart H. Cover 114 can also form a seal for restricting or preventing blood flow through portions of frame 112 covered by cover 114. Cover 114 can be attached to frame 112 by any suitable attachment means such as suturing, adhesion, tying, etc. Cover 114 can be shaped and arranged in various manners. In the example shown in FIG. 3A, cover 114 is adjacent to outflow end 120. In some examples, cover 114 is located in the vicinity of, or adjacent to, valve seat 116. In other examples, cover 114 can be adjacent to inflow end 118, or can be at any position or arrangement between inflow end 118 and outflow end 120. In yet other examples, device 100 does not include cover 114.

[0035] The valve seat 116 is a part of the device 100 for holding, supporting, or attaching to a valve device such as an artificial valve device. In some examples, the valve seat 116 can be part of the frame 112. In some examples, the valve seat 116 can be integrally formed with respect to the frame 112. In other examples, the valve seat 116 can be formed separately from the frame 112 and attached. The valve seat 116 can take any form such that it provides a support surface for implanting or deploying a valve inside the device 100 after the device 100 is implanted into the cardiovascular system. In the example shown in FIG. 3A, the valve seat 116 is disposed near the outflow end 120. However, it will be understood that in other examples, the valve seat 116 can be disposed at any longitudinal position along the frame 112. The valve seat 116 (and, although not shown, the valve seated within the valve seat 116) can span across a part of the central flow path 129. The valve seat 116 enables the valve to be implanted into a cardiovascular system or tissue having various strengths, sizes, and shapes. The outer profile of the device 100 (e.g., the outer surface 127 of the frame 112) can better conform to the anatomical structure of the cardiovascular system (e.g., the vascular system, tissue, heart, etc.) without applying excessive pressure to the anatomical structure. On the other hand, the valve can be firmly and securely fixed within the valve seat 116 to prevent or reduce the risk of movement or slippage.

[0036] The flow regulator 110 is in the form of fins or is a fin-type flow regulator. Each flow regulator 110 can also be referred to as a flow regulating function. The flow regulator 110 is an elongated protrusion from the frame 112. More specifically, the flow regulator 110 is connected to the frame 112 at the corresponding strut 122. The flow regulator 110 is attached by an attachment mechanism (described in more detail with reference to FIGS. 5A - 5B below) or is integrally formed with respect to a part of the frame 112 (described in more detail with reference to FIGS. 6A - 6B below).

[0037] Generally, the flow regulator 110 can take many different forms (i.e., shapes, sizes, etc.). In some examples, the flow regulator 110 can be an airfoil. The flow regulator 110 can have a symmetric or asymmetric, regular or irregular shape and can have a variable geometric shape. The physical dimensions of the flow regulator 110 (e.g., length, width, shape, cross-sectional shape, etc.) can be configured so that the flow regulator 110 does not interfere (or contact) with other parts of the device 100 or the tissue wall adjacent thereto. In other examples, the components of the device 100 (e.g., the cover 114) can be designed to conform to the perimeter of the flow regulator 110 or to allow the flow regulator 110 to pass therethrough. The physical dimensions of the flow regulator 110 can be further configured so that the flow regulator 110 can be crushed or expanded together with the expandable frame 112 (e.g., to fit inside a delivery catheter). The physical dimensions of the flow regulator 110 can be further configured so that the flow regulator 110 does not occlude the blood vessels of the chamber of the heart H into which the device 100 is implanted. That is, the length and / or width of the flow regulator 110 can be made short enough so that the flow regulator 110 does not project from the device 100 and extend across the blood vessels or chambers of the heart H to block blood flow. The physical dimensions of the flow regulator 110 can be further configured to change the hemodynamic characteristics (e.g., helicity, vorticity, velocity, turbulence, flow direction, etc.) of the blood flowing through or out of the device 100 in a particular manner.

[0038] One or more flow regulators 110 can be arranged in any suitable arrangement with respect to the frame 112 of the device 100. In some examples, the flow regulator 110 can be arranged around the periphery of the inner surface 125 of the frame 112. In some examples, the flow regulator 110 can be arranged adjacent to the inflow end 118 (as shown in FIG. 3C) and / or adjacent to the outflow end 120 (as shown in FIG. 3B). In some examples, the flow regulator 110 is connected to the strut 122 forming the first row of openings 128 adjacent to the outflow end 120. The device 100 can include any number of flow regulators 110 at any one or more of the positions described above. The position of the flow regulator 110 can be configured so that the flow regulator 110 does not interfere (or contact) with other parts of the device 100 or the tissue wall adjacent thereto. In other examples, the components of the device 100 (e.g., the cover 114) can be designed to conform around the flow regulator 110 or allow the flow regulator 110 to pass therethrough. The position of the flow regulator 110 can be further configured so that the flow regulator 110 can be crushed or expanded together with the expandable frame 112 (e.g., to fit inside a delivery catheter). The position of the flow regulator 110 can be further configured so that the flow regulator 110 does not occlude the blood vessels of the chamber of the heart H into which the device 100 is implanted. The position of the flow regulator 110 can be further configured to change the hemodynamic characteristics (e.g., helicity, vorticity, velocity, turbulence, flow direction, etc.) of the blood flowing through or out of the device 100 in a particular manner.

[0039] After the device 100 is implanted into the cardiovascular system (e.g., into the inferior vena cava IVC as shown in FIG. 4), the circulating blood passes through the device 100. As the blood flows into the device 100 along the flow axis 130, passes through the device 100, and is then led out of the device 100, the flow regulator 110 interacts with the blood flow to change or affect the hemodynamic characteristics of the flow (e.g., helicity, vorticity, velocity, turbulence, flow direction, etc.). The flow regulator 110 can interact with the blood flowing through or out of the device 100 by adding flow resistance and / or changing the direction of the blood flow, thereby preventing the reversal of the blood flow. For example, the flow regulator 110 can increase or decrease the vorticity or helicity of the flow. In some examples, the flow regulator 110 may make the flow smoother (reduce turbulence). In other examples, the flow regulator 110 can increase the turbulence in the flow. In some examples, the flow regulator 110 can change the direction of the flow. In some examples, the flow regulator 110 can align the flow with the natural vortex pattern of the blood through the blood vessels or chambers of the heart H, such as the left-handed vortex flow in the left atrium LA or the right-handed vortex flow in the right atrium RA. In other examples, the flow regulator 110 can align the flow with the natural helical flow pattern of the blood through the blood vessels or chambers of the heart H, such as the helical flow in the coronary sinus CS. The flow regulator 110 circumferentially arranged at the inlet end 118 and / or the outlet end 120 of the device 100 can reverse the blood flow toward the center of the blood vessel or chamber in the same helical direction by generating a helical flow pattern in the vicinity of the adjacent blood vessel wall or chamber wall, thereby generating a forward movement of the blood. More generally, the flow regulator 110 adjacent to the inlet end 118 can change the hemodynamic characteristics of the blood flowing through the frame 112, and the flow regulator 110 adjacent to the outlet end 120 can change the hemodynamic characteristics of the blood led out from the frame 112.

[0040] Including the flow regulator 110, the cardiovascular implant device 100 can generate hemodynamic effects that minimize disturbances to the natural flow patterns within the heart H, such as vortices of leftward flow within the left atrium LA, vortices of rightward flow within the right atrium RA, and / or helical flow within the coronary sinus CS, or enhance the natural flow patterns within the heart H. The flow regulator 110 can modify the hemodynamic characteristics of the blood flowing through or derived from the device 100 such that (a) any disturbances that would be caused by the implantable device to the natural flow pattern are minimized, (b) flow rate reductions due to pathophysiology or other causes are alleviated, and / or (c) the baseline flow rate is enhanced. As a result, the device 100 can maintain the kinetic energy of the blood flow in the cardiovascular system, thereby reducing the required heart work and improving heart efficiency. These hemodynamic effects can potentially improve the patient's outcome after receiving the cardiovascular implant device 100, making the device 100 potentially safer and more efficient. At the same time, since the flow regulator 110 can be relatively easily incorporated into the device 100 in many configurations, various modifications of the device 100 can be optimized for use in many different scenarios (e.g., with respect to the medical conditions of many different patients).

[0041] Regarding FIGS. 5A - 5B, they will be described together. FIG. 5A is an enlarged partial perspective view showing a fin - type flow regulator 140 interacting with low - flow blood flowing through the cardiovascular implant device 100. FIG. 5B is an enlarged partial perspective view showing a fin - type flow regulator 140 interacting with high - flow blood flowing through the cardiovascular implant device 100.

[0042] Figures 5A - 5B show the frame 112 (of the cardiovascular implant device 100), which includes struts 122, a fin - type flow regulator 140 including an attachment region 142, a joint 144, and a biasing member 146. Figures 5A - 5B also show an attachment angle 148 (Figure 5A), a deflection angle 149 (Figure 5B), a fin longitudinal axis 150, and a strut longitudinal axis 152 (of one corresponding strut 122).

[0043] The flow regulator 140 is an example of the fin-type flow regulator 110 as described above with reference to FIGS. 3A-4. The flow regulator 140 has one or more mounting regions 142 along its length (e.g., from the root portion to the tip portion). The mounting region 142 is the region where the flow regulator 140 is connected to the frame 112 at one of the struts 122. In some examples, the mounting region 142 can be a single point. The mounting angle 148 is formed between the fin longitudinal axis 150 of the flow regulator 140 and the strut longitudinal axis 152 of the corresponding one of the struts 122 to which the flow regulator 140 is mounted. The mounting angle 148 shown in FIG. 5A is the position of the flow regulator 140 in the non-deflected or initial state. The flow regulator 140 can be inclined radially inward from the frame 112 at the mounting angle 148. In some examples, the mounting angle 148 is 90 degrees or less. In other examples, the mounting angle 148 is greater than 90 degrees. For example, the mounting angle 148 can be selected such that the flow regulator 140 is inclined away from other components of the device 100 or such that the flow regulator 140 optimally interacts with the blood flowing through or out of the device 100. The deflection angle 149 shown in FIG. 5B is formed between the fin longitudinal axis 150 and the strut longitudinal axis 152 when the flow regulator 140 is deflected. The deflection angle 149 represents the change from the mounting angle 148. Generally, the deflection angle 149 is smaller than the mounting angle 148. The mounting angle 148 and / or the deflection angle 149 can be selected or calibrated to optimize the position of the flow regulator 140 based on a low heart rate or a high heart rate and also based on a low blood flow velocity or a high blood flow velocity.

[0044] The flow regulator 140 is attached to the frame 112 at the attachment region 142, thereby forming a joint 144 together with the corresponding portion of the frame 112. More specifically, the joint 144 is formed between the flow regulator 140 and one strut 122. The joint 144 can include any suitable attachment mechanism, such as a hinge, a flexible portion of a tissue or another material, a spring, etc. In some examples, the joint 144 is a flexible joint that easily allows deflection of the flow regulator 140. In other examples, the joint 144 is a rigid joint (e.g., when the flow regulator 140 is integrally formed with the corresponding strut 122).

[0045] The flow regulator 140 can also be biased radially inwards from the frame 112 by a biasing member 146, and the biasing member 146 can be a spring or other suitable feature for biasing the flow regulator 140. The biasing member 146 is attached to one or more struts 122. In some examples, the joint 144 and the biasing member 146 are located on the same strut 122. In other examples, the joint 144 can be located on a first strut 122, and the biasing member 146 can be attached to a second strut 122. In some such examples, the second strut 122 to which the biasing member 146 is attached can be adjacent to the first strut 122. In still other examples, the device 100 does not include the biasing member 146.

[0046] As shown in FIG. 5A, when the blood flow is low or when relatively slow blood is flowing through device 100, flow regulator 140 is positioned in the first position, i.e., in the non-deviated position. The non-deviated position is represented by mounting angle 148. As shown in FIG. 5B, when the blood flow increases or when relatively fast blood is flowing through device 100, flow regulator 140 deflects towards frame 112. The deflected flow regulator 140 is positioned at deflection angle 149, which can be a smaller angle compared to mounting angle 148. Additionally, biasing member 146 will be compressed towards frame 112.

[0047] The mounting angle 148 at joint 144 allows the initial placement of flow regulator 140 to be adjusted based on the desired hemodynamic effect. Moreover, the amount of disturbance (or change in flow) induced by flow regulator 140 on the blood flowing through or exiting device 100 can be calibrated at mounting angle 148 or by incorporating biasing member 146. Specifically, the deflection amount of flow regulator 140 in response to an increase in blood flow (or an increase in the velocity of blood flow) can be controlled by the tension of biasing member 146. Biasing member 146 can be adjusted to allow for greater or lesser deflection of flow regulator 140 based on the desired interaction between flow regulator 140 and the blood flowing through or exiting device 100. Additionally, the deflectable flow regulator 140 can have increased flexibility. These characteristics enable flow regulator 140 to be flexibly implemented within a wide variety of implantable devices to cause different hemodynamic effects, and the placement of flow regulator 140 can be adjusted for each implementation.

[0048] Regarding FIGS. 6A to 8, they will be described together. FIG. 6A is a schematic diagram showing the connection of control components to the active control type flow regulator 140'. FIG. 6B is a schematic diagram showing the electromechanical drive of the active control type flow regulator 140'. FIG. 7 is a cross-sectional view of the heart H showing an exemplary arrangement of control components for the active control type flow regulator 140'. FIG. 8 is a schematic diagram showing the control system 170 for the active control type flow regulator 140'.

[0049] FIGS. 6A to 6B show the frame 112 (of the cardiovascular implant device 100), and this frame 112 includes struts 122, a flow regulator 140' including an extension region 142', an electrical connector 160, and a control system 170. FIGS. 6A to 6B also show an extension 148', an adjustment angle 149', a fin longitudinal axis 150, and a strut longitudinal axis 152 (of one corresponding strut 122). FIG. 7 shows the cardiovascular implant device 100, and this cardiovascular implant device 100 includes an active control type flow regulator 140', an electrical connector 160, and a control system 170. FIG. 7 also shows the heart H, the vascular system V, the right atrium RA, the right ventricle RV, the left atrium LA, the left ventricle LV, the superior vena cava SVC, the inferior vena cava IVC, the tricuspid valve TV, the pulmonary valve PV, the pulmonary artery PA, the pulmonary veins PVS, the mitral valve MV, the aortic valve AV, the aorta AT, and the coronary sinus CS. FIG. 8 shows the active control type flow regulator 140', the electrical connector 160, and the control system 170, and this control system 170 includes a controller 172, a power source 174, a switch 176, a receiver 178, a transmitter 179, and a mobile device 180.

[0050] The flow regulator 140' includes the same structure and function as those described above with respect to the flow regulator 110 (FIGS. 3A to 4) and the flow regulator 140 (FIGS. 5A to 5B), except that the flow regulator 140' is electromechanically driven by the control system 170.

[0051] The flow regulator 140' can be integrally formed with one or more struts 122 of the frame 112. More specifically, the flow regulator 140' and a part of the frame 112 (one or more struts 122) to which the flow regulator 140' is connected can be integrally formed from a shape memory alloy such as nitinol. In other examples, the flow regulator 140' can be connected to the frame 112 by an electrically controllable mechanism such as a motor-driven hinge. The flow regulator 140' has one or more extension regions 142' along its length (e.g., from the root portion to the tip portion). The extension region 142' is the region where the flow regulator 140' extends from the frame 112 at one (or more) struts 122. In some examples, the flow regulator 140' extends integrally from the frame 112 at the extension region 142'.

[0052] The extension angle 148' is formed between the fin longitudinal axis 150 of the flow regulator 140' and the strut longitudinal axis 152 of one corresponding strut 122 from which the flow regulator 140' extends. The extension angle 148' illustrated in FIG. 6A is the position of the flow regulator 140' in an initial state (e.g., body temperature). The flow regulator 140' can be inclined radially inward from the frame 112 at the extension angle 148'. In some examples, the extension angle 148' is 90 degrees or less. In other examples, the extension angle 148' is greater than 90 degrees. For example, the extension angle 148' can be selected such that the flow regulator 140' is inclined away from other components of the device 100, or such that the flow regulator 140' optimally interacts with the blood flowing through or out of the device 100. Moreover, the angle of the flow regulator 140' can be controlled during electromechanical actuation of the flow regulator 140'. In some examples, the angle of the flow regulator 140' is controllable based on the preset shape of a shape memory alloy that forms at least a part of the frame 112 from which the flow regulator 140' extends. When the flow regulator 140' is electromechanically actuated, an adjustment angle 149' is formed between the fin longitudinal axis 150 and the strut longitudinal axis 152. That is, in an example where the flow regulator 140' and the corresponding part of the frame 112 are integrally formed, different adjustment angles 149' of the flow regulator 140' can be preset and stored in the shape memory alloy when the shape memory alloy is brought to its transformation temperature by applying a current to the flow regulator 140'. The adjustment angle 149' represents a change from the extension angle 148'. Generally, the adjustment angle 149' is smaller than the extension angle 148'. The extension angle 148' and / or the adjustment angle 149' can be selected or calibrated to optimize the position of the flow regulator 140' based on a low heart rate or a high heart rate, and also based on a low blood flow rate or a high blood flow rate.

[0053] The electrical connector 160 is electrically connected between the flow regulator 140' and the control system 170. As shown in FIG. 7, the electrical connector 160 extends from the device 100 through the right atrium RA and through the superior vena cava SVC. The electrical connector 160 can generally be positioned and routed through the right side of the cardiovascular system so as to avoid thick arteries such as the aorta AT and also to remain within veins such as the superior vena cava SVC and the subclavian vein (not shown). That is, although not shown in FIG. 7, the electrical connector 160 can extend from the superior vena cava SVC, through a part of the thoracic vascular system (e.g., the subclavian vein), out of the body via a puncture or incision, and further to the externally located control system 170. In other examples, the electrical connector 160 can be positioned within or along any blood vessel or chamber of the heart H that is convenient with respect to the location of the cardiovascular implant device 100. As shown in FIG. 8, the electrical connector 160 is connected to the switch 176 of the control system 170.

[0054] The control system 170 is a system consisting of each component for controlling (for example, electromechanically driving) the flow regulator 140'. The control system 170 can include a wired connection or a wireless connection between components. Moreover, all or part of the components of the control system 170 can be arranged outside the body. In one example, the control system 170 can include a receiver 178 and a transmitter 179 for the purpose of wireless communication with the mobile device 180 to send and receive signals for controlling the flow regulator 140'. In some examples, the receiver 178 and the transmitter 179 can be transceivers. In other examples, the control system 170 may not include the receiver 178, the transmitter 179, and the mobile device 180. Instead, the controller 172 can directly implement pre-specified processing instructions for controlling the flow regulator 140'. Alternatively, the control system 170 may not include the controller 172. Instead, by manually activating the switch 176, current can be supplied from the power source 174 to the flow regulator 140'.

[0055] The controller 172 is configured to implement processing instructions for controlling the operation of the flow regulator 140'. For example, the controller 172 can include one or more processors configured to implement functions and / or processing instructions for execution within the control system 170, and a computer-readable memory. In the example of one or more processors, it can include any one or more of, for example, a microprocessor, a controller, a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or other equivalent distributed logic circuits or integrated logic circuits.

[0056] The computer-readable memory of the controller 172 can be configured to store information used by the controller 172 during the operation of the control system 170. In some examples, the computer-readable memory is described as a computer-readable storage medium. In some examples, the computer-readable storage medium can include a non-transitory medium. The term "non-transitory" can indicate that the storage medium is not embodied in a carrier wave or a propagated signal. In a particular example, the non-transitory storage medium can store data that can change over time (e.g., inside a RAM or a cache). In some examples, the computer-readable memory is used to store program instructions for execution by one or more processors. In one example, the computer-readable memory is used by software or an application executed on the controller 172 to temporarily store information during program execution. The computer-readable memory can include volatile memory and non-volatile memory. Examples of volatile memory can include, for example, random access memory (RAM), dynamic random access memory (DRAM), static random access memory (SRAM), and other forms of volatile memory. Examples of non-volatile storage media can include, for example, magnetic hard disks, optical disks, flash memory, or in the form of electrically programmable memory (EPROM) or electrically erasable and programmable (EEPROM) memory.

[0057] Examples of the controller 172 can include any one or more of a microcontroller or other computer. The controller 172 can be configured to communicate with one or more components of the control system 170, including the switch 176, the receiver 178, and the transmitter 179. In the example of FIG. 8, the controller 172 is shown as being operably coupled to other components of the control system 170, but in other examples, the controller 172 can include a dedicated device that controls the flow regulator 140' by being integrated with the switch 176, the receiver 178, and the transmitter 179.

[0058] The power supply 174 supplies current to the flow regulator 140' via the electrical connector 160. In some examples, the power supply 174 can be a battery. The switch 176 is positioned between the power supply 174 and the flow regulator 140'. By activating (or switching on) the switch 176, current can flow from the power supply 174 to the flow regulator 140'. Also, by deactivating (or switching off) the switch 176, current can be prevented from flowing from the power supply 174 to the flow regulator 140'. The switch 176 can be activated or deactivated manually or by a control signal from the controller 172. For example, the switch 176 can be a metal-oxide-semiconductor field-effect transistor (MOSFET) or any other electrical switch.

[0059] Controller 172 is connected to, or includes, a receiver 178 and a transmitter 179 (or a transceiver instead of separate transmitter and receiver) for transmitting and receiving wireless signals. For example, receiver 178 can receive Bluetooth Low Energy (BLE) signals. In other examples, receiver 178 can receive Wi-Fi signals. In still other examples, receiver 178 can be a receiver for any suitable wireless signal type. Similarly, transmitter 179 can be a transmitter for any suitable wireless signal type. In some examples, receiver 178 can receive signals from mobile device 180, and transmitter 179 can transmit signals to mobile device 180.

[0060] Mobile device 180 is an access point for remotely controlling flow regulator 140’. For example, mobile device 180 can be a mobile phone, a tablet, or other device capable of communicating with controller 172 by transmitting wireless signals to receiver 178. Mobile device 180 can include a user interface (UI) for displaying control options of control system 170 to a user such as a doctor. Mobile device 180 can include a display and / or other UI members (e.g., a keyboard, buttons, a monitor, graphical control members provided at a touch-sensitive display, or other UI members). In some examples, the mobile device includes a graphical user interface (GUI) such as a graphical representation of a button for activating switch 176, including graphical representations of control options of control system 170.

[0061] During operation of the control system 170, by activating the switch 176, current can flow from the power supply 174 along the electrical connector 160 to the flow regulator 140'. The switch 176 can be activated manually or based on a signal from the controller 172. The controller 172 can send a signal based on pre - defined instructions such as settings stored internally or can receive a signal from the mobile device 180 via the receiver 178. The supplied current can deflect the flow regulator 140' to the adjustment angle 149'. In some examples, the flow regulator 140' formed from a shape - memory alloy reaches its transformation temperature and transitions to a preset shape that matches the transformation temperature. That is, as shown in FIG. 6B, the flow regulator 140' deflects from the extension angle 148' to the adjustment angle 149' based on the preset shape of the shape - memory alloy. In other examples, the supplied current drives an electrically controllable hinge or other active mechanism at the extension region 142'. On the other hand, when the switch 176 is deactivated, current is no longer supplied to the flow regulator 140', and the flow regulator 140' returns to the initial position with the extension angle 148' as shown in FIG. 6A.

[0062] After the device 100 is implanted into the cardiovascular system, the control system 170 can actively control or adjust the placement of the flow regulator 140'. That is, the amount of disturbance (or change in flow) caused by the flow regulator 140' to the blood flowing through or derived from the device 100 can be actively calibrated by changing the extension angle 148' to the adjustment angle 149' in response to the supply current from the power source 174. In this way, a user such as a physician or a patient can adjust the placement of the flow regulator 140' based on the changed medical condition without directly accessing the flow regulator 140' (e.g., via a surgical procedure or other means). For example, by adjusting the placement of the flow regulator 140' in response to the worsening of heart disease, a greater impact on hemodynamics can be achieved. Further, the control system 170 using the mobile device 180 can remotely control or adjust the placement of the flow regulator 140', thereby rationalizing the adjustment procedure regarding the placement of the flow regulator 140' or providing a user-friendly alternative for adjusting the placement of the flow regulator 140'. By forming the corresponding portions of the flow regulator 140' and the frame 112 from a shape memory alloy, active control of the flow regulator 140' is enabled by relatively small changes to the structure of the device 100.

[0063] Figures 9A through 9E will be described together. Figures 9A through 9E are enlarged perspective views of a portion of the frame 112 in the cardiovascular implant device 100, illustrating several variations of the fin-type flow regulator. The fin-type flow regulator described herein can take many different forms. Five examples are presented with reference to Figures 9A through 9E. These examples are not intended to be limiting, and other examples are possible. Figure 9A shows a flow regulator 185A attached to a portion of the frame 112, which flow regulator 185A includes flow detail features 186A. Flow regulator 185A further includes a front edge 188A and a rear edge 190A. Figure 9B shows a flow regulator 185B attached to a portion of the frame 112, which flow regulator 185B includes flow detail features 186B. Flow regulator 185B further includes a front edge 188B and a rear edge 190B. Figure 9C shows a flow regulator 185C attached to a portion of the frame 112, which flow regulator 185C includes flow detail features 186C. Flow regulator 185C further includes a front edge 188C and a rear edge 190C. Figure 9D shows a flow regulator 185D attached to a portion of the frame 112, which flow regulator 185D includes flow detail features 186D. Flow regulator 185D further includes a front edge 188D and a rear edge 190D. Figure 9E shows a flow regulator 185E attached to a portion of the frame 112, which flow regulator 185E includes flow detail features 186E. Flow regulator 185E further includes a front edge 188E and a rear edge 190E.

[0064] Each of the flow regulators 185A, 185B, 185C, 185D, and 185E can be any of the fin-type flow regulators 110 shown in FIGS. 3A to 4, the fin-type flow regulators 140 shown in FIGS. 5A to 5B, or the fin-type flow regulators 140' shown in FIGS. 6A to 8. Specifically, each of the flow regulators 185A, 185B, 185C, 185D, and 185E can be airfoil-shaped. The flow regulator 185A extends between a front edge 188A and a rear edge 190A, the flow regulator 185B extends between a front edge 188B and a rear edge 190B, the flow regulator 185C extends between a front edge 188C and a rear edge 190C, the flow regulator 185D extends between a front edge 188D and a rear edge 190D, and further, the flow regulator 185E extends between a front edge 188E and a rear edge 190E.

[0065] The flow regulator 185A includes a flow finesse feature 186A that is a front edge notch. The flow regulator 185B includes a flow finesse feature 186B that is a boundary layer fence. The flow regulator 185C includes a flow finesse feature 186C that is a front edge canine tooth. The flow regulator 185D includes a flow finesse feature 186D that is a group of vortex generators. The flow regulator 185E includes a flow finesse feature 186E that is a group of vortilons (shown in FIG. 9E by a virtual line passing through the flow regulator 185E from the side opposite the flow regulator 185E with respect to the observation plane). For example, the flow finesse features 186A, 186B, 186C, 186D, 186E can be disposed at or near the respective front edges 188A, 188B, 188C, 188D, and 188E of the corresponding flow regulators 185A, 185B, 185C, 185D, 185E. As shown in FIGS. 9A - 9C, the flow finesse features 186A, 186B, 186C are disposed along the respective front edges 188A, 188B, 188C. As shown in FIGS. 9D - 9E, the flow finesse features 186D, 186E are disposed near the respective front edges 188D, 188E. Other fin - type flow regulators can include combinations of the flow finesse features described herein. Further, the device 100 can include any combination of the flow regulators 185A, 185B, 185C, 185D, 185E and the flow finesse features 186A, 186B, 186C, 186D, 186E disposed across the entirety of the frame 112 in any suitable pattern or configuration according to the desired hemodynamic characteristics.

[0066] When the blood flow flowing through or derived from the device 100 reaches the flow regulators 185A, 185B, 185C, 185D, 185E, the flow finesse features 186A, 186B, 186C, 186D, 186E interact with such blood flow. Each of the flow finesse features 186A, 186B, 186C, 186D, 186E can generate characteristic flow effects on the blood flowing through or derived from the device 100.

[0067] Flow regulators 185A, 185B, 185C, 185D, 185E, including flow micro features 186A, 186B, 186C, 186D, 186E, provide a wider range of options and greater flexibility in designing cardiovascular implant devices that alter hemodynamic characteristics to achieve a desired hemodynamic effect on blood flowing through or out of the device. By incorporating the flow micro features 186A, 186B, 186C, 186D, 186E, or by incorporating combinations of the flow micro features 186A, 186B, 186C, 186D, 186E, the hemodynamic effect can be controlled more precisely or finely.

[0068] Device 200 (Figs. 10A - 11E) Figs. 10A - 10C will be described together. Fig. 10A is a perspective view of a cardiovascular implant device 200 including a plate - type flow regulator 210. Fig. 10B is a plan view of a cardiovascular implant device 200 including a plate - type flow regulator 210. Fig. 10C is a bottom view of a cardiovascular implant device 200 including a plate - type flow regulator 210. As shown in Figs. 10A - 10C, the cardiovascular implant device 200 includes a plate - type flow regulator 210 (collectively referred to herein by a common reference numeral) including flow regulators 210A, 210B, a frame 212, a cover 214, a valve seat 216, an inlet end 218, and an outlet end 220. The frame 212 includes struts 222, an inner diameter 224, an inner surface 225, an outer diameter 226, an outer surface 227, and defines an opening 228, a central flow path 229, and a flow axis 230. The flow regulator 210 includes a wall 232 and defines an internal flow path 234.

[0069] The cardiovascular implant device 200 includes the same structure and functions as the above - described cardiovascular implant device 100, except that the device 200 includes a plate - type flow regulator 210 instead of a fin - type flow regulator (e.g., flow regulator 110).

[0070] The flow regulator 210 is a flow plate or a plate-type flow regulator. Each individual flow regulator 210 can also be referred to as a flow regulator function. The flow regulator 210 can be a flat protrusion or a cylindrical protrusion from the frame 212. More specifically, the flow regulator 210 is connected to the frame 212 at the corresponding strut 222. In some examples, the flow regulator 210 is attached to a plurality of struts 222 along a plurality of portions of the frame 212. In some examples, the flow regulator 210 is circumferentially connected at several positions along the inner surface 225 of the frame 212. In some examples, the flow regulator 210 is continuously formed with respect to the inner surface 225 of the frame 212. The flow regulator 210 is attached by an attachment mechanism or is integrally formed with a part of the frame 212. Each plate-type flow regulator 210 can be a single member rather than a plurality of individual fin-type flow regulators.

[0071] Generally, the flow regulator 210 can take many different forms (i.e., shapes, sizes, etc.). The physical dimensions of the flow regulator 210 (e.g., length, width, shape, cross-sectional shape, etc.) can be configured so that the flow regulator 210 does not interfere (or contact) with other parts of the device 200 or the adjacent tissue wall. In other examples, components of the device 200 (e.g., the cover 214) can be designed to conform around the flow regulator 210 or allow the flow regulator 210 to pass through. The physical dimensions of the flow regulator 210 can be further configured so that the flow regulator 210 can be crushed or expanded together with the expandable frame 212 (e.g., to fit inside a delivery catheter). The physical dimensions of the flow regulator 210 can be further configured so that the flow regulator 210 does not occlude the blood vessels of the chamber of the heart H into which the device 200 is implanted. That is, the length and / or width of the flow regulator 210 can be made short enough so that the flow regulator 210 does not protrude from the device 200 and block blood flow by extending across the blood vessels or chambers of the heart H. The physical dimensions of the flow regulator 210 can be further configured to change the hemodynamic characteristics (e.g., helicity, vorticity, velocity, turbulence, flow direction, etc.) of the blood flowing through or out of the device 200 in a particular manner.

[0072] One or more flow regulators 210 can be arranged in any suitable arrangement relative to the frame 212 of the device 200. In the example shown in FIG. 10A, the device 200 includes two flow regulators, namely, a flow regulator 210A and a flow regulator 210B. In other examples, any number of flow regulators 210 can be included. The flow regulator 210 is arranged to straddle a portion of the central flow path 229 (defined by the frame 212) such that the flow regulator 210 intersects the flow axis 230 through the frame 212. In some examples, the flow regulator 210 can be arranged adjacent to the inlet end 218 (flow regulator 210A shown in FIG. 10C) and / or adjacent to the outlet end 220 (flow regulator 210B shown in FIG. 10B). In some examples, the flow regulator 210 is connected to the strut 222 that forms the first row of openings 228 adjacent to the outlet end 220. The device 200 can include any number of flow regulators 210 at any one or more of the positions described above. The position of the flow regulator 210 can be configured such that the flow regulator 210 does not interfere with other parts of the device 200 or adjacent tissue walls. In other examples, the components of the device 200 (e.g., the cover 214) can be designed to conform around the flow regulator 210 or allow the flow regulator 210 to pass through. The position of the flow regulator 210 can be further configured such that the flow regulator 210 can be crushed or expanded together with the expandable frame 212 (e.g., to conform inside a delivery catheter). The position of the flow regulator 210 can be further configured such that the flow regulator 210 does not occlude the blood vessels or chambers of the heart H into which the device 200 is implanted internally. The position of the flow regulator 210 can be further configured to change the hemodynamic characteristics (e.g., helicity, vorticity, velocity, turbulence, flow direction, etc.) of the blood flowing through or out of the device 200 in a specific manner.

[0073] Each flow regulator 210 includes a wall 232 that defines a flow path 234 therein. The flow path 234 extends through a corresponding flow regulator 210 such that blood flowing along the flow axis 230 through the central flow path 229 within the device 200 can pass through the corresponding flow regulator 210. That is, the flow path 234 extends from the upstream side to the downstream side of the corresponding flow regulator 210. The form of each flow regulator 210 can depend significantly on the configuration of the flow path 234. The flow path is at least partially surrounded by the wall 232. In some examples, the flow path 234 is a closed channel surrounded by the wall 232 (as shown in FIGS. 10A - 10C). In other examples, the flow path 234 can be continuous with an adjacent flow path 234 across a gap or space between the walls 232. The individual walls 232 can have any height (when measured relative to the flow axis 230). In some examples, the walls 232 can have the same height so as to form a flat upstream surface and / or a flat downstream surface of the flow regulator 210. In other examples, the walls 232 can protrude such that the upstream surface and / or the downstream surface of the flow regulator 210 is not flat. The flow path 234 can take many different forms (i.e., shape, size, curvature, etc.). The examples illustrated in FIGS. 10A - 10C include eight wedge-shaped flow paths 234 and one central circular flow path 234 (when observed perpendicular to the upstream or downstream side of the flow regulator 210). In other examples, any combination of the shape and size of the flow path 234 can be included throughout the flow regulator 210.

[0074] After the device 200 is implanted into the cardiovascular system, the circulating blood passes through the device 200. As the blood flows into the device 200 along the flow axis 230, passes through the device 200, and is further led out of the device 200, the blood flows through the flow path 234 of the flow regulator 210. By interacting with the blood flow, the flow regulator 210 changes or affects the hemodynamic characteristics of the flow (e.g., helicity, vorticity, velocity, turbulence, flow direction, etc.). The flow regulator 210 can interact with the blood flowing through or out of the device 200 by adding flow resistance and / or changing the direction of the blood flow, thereby preventing the reversal of the blood flow. For example, the flow regulator 210 can increase or decrease the vorticity or helicity of the flow. In some examples, the flow regulator 210 may make the flow smoother (reduce turbulence). In other examples, the flow regulator 210 can increase the turbulence in the flow. In some examples, the flow regulator 210 can change the direction of the flow. In some examples, the flow regulator 210 can align the flow with the natural vortex pattern of the blood through the blood vessels or chambers of the heart H, such as the left-handed vortex in the left atrium LA or the right-handed vortex in the right atrium RA. In other examples, the flow regulator 210 can align the flow with the natural helical flow pattern of the blood through the blood vessels or chambers of the heart H, such as the helical flow in the coronary sinus CS. The flow regulator 210 disposed at or near the inlet end 218 and / or the outlet end 220 of the device 200 can generate a helical flow pattern in the vicinity of the adjacent blood vessel wall or chamber wall, causing the blood to flow backward toward the center of the blood vessel or chamber in the same helical direction, thereby generating forward movement of the blood. More generally, the flow regulator 210 adjacent to the inlet end 218 can change the hemodynamic characteristics of the blood flowing through the frame 212, and the flow regulator 210 adjacent to the outlet end 220 can change the hemodynamic characteristics of the blood led out from the frame 212.

[0075] Similar to the above-described device 100, the cardiovascular implant device 200, including the flow regulator 210, can generate hemodynamic effects that minimize disturbances to the natural flow patterns within the heart H, such as vortices of leftward flow within the left atrium LA, vortices of rightward flow within the right atrium RA, and / or helical flow within the coronary sinus CS, or enhance the natural flow patterns within the heart H. The flow regulator 210 can modify the hemodynamic characteristics of the blood flowing through or derived from the device 200 such that (a) any disturbances that would be caused by the implantable device to the natural flow pattern are minimized, (b) flow rate reductions due to pathophysiology or other causes are alleviated, and / or (c) the baseline flow rate is enhanced. As a result, the device 200 can maintain the kinetic energy of the blood flow in the cardiovascular system, thereby reducing the required heart work and improving heart efficiency. These hemodynamic effects can potentially improve the patient outcome after receiving the cardiovascular implant device 200, making the device 200 potentially safer and more efficient. At the same time, since the flow regulator 210 can be relatively easily incorporated into the device 200 in many configurations, various modifications of the device 200 can be optimized for use in many different scenarios (e.g., with respect to the medical conditions of many different patients).

[0076] Regarding FIGS. 11A to 11E, they will be described together. FIGS. 11A to 11E are perspective views of the cardiovascular implant device 200, illustrating some modified examples of the plate-type flow regulator. The plate-type flow regulator described in this specification can take many different forms. Five examples are presented with reference to FIGS. 11A to 11E. These examples are not intended to be limiting, and other examples are also possible. FIG. 11A shows a flow regulator 285A attached to a part of the frame 212, and this flow regulator 285A includes a wall 286A that defines a flow path 288A inside. FIG. 11B shows a flow regulator 285B attached to a part of the frame 212, and this flow regulator 285B includes a wall 286B that defines a flow path 288B inside. FIG. 11C shows a flow regulator 285C attached to a part of the frame 212, and this flow regulator 285C includes a wall 286C that defines a flow path 288C inside. FIG. 11D shows a flow regulator 285D attached to a part of the frame 212, and this flow regulator 285D includes a wall 286D that defines a flow path 288D inside. FIG. 11E shows a flow regulator 285E attached to a part of the frame 212, and this flow regulator 285E includes a wall 286E that defines a flow path 288E inside.

[0077] Each of the flow regulators 285A, 285B, 285C, 285D, and 285E can be a plate-type flow regulator 210 shown in FIGS. 10A to 10C. The flow regulator 285A includes a wall 286A, and the wall 286A is in the form of connecting fins that extend in a wheel shape across the flow regulator 285A. Accordingly, the wall 286A forms a flow path 288A having a wedge-shaped cross section. The wall 286A also forms a central flow path 288A having a circular cross section. The flow regulator 285A is an example of the flow regulator 210 illustrated in FIGS. 10A to 10C. The flow regulator 285B includes a wall 286B, and the wall 286B is in the form of a grid or lattice (such as a zanker-type flow plate) of the flow path 288B. The flow regulator 285C includes a wall 286C, and the wall 286C is in the form of a connecting tube surrounding the flow path 288C. The flow regulator 285D includes a wall 286D, and the wall 286D is in the form of a wheel-shaped folded vane similar to the flow regulator 285A, except that several flow paths 288D formed by the wall 286D are bounded by additional walls 286D instead of the frame 212. Accordingly, the wall 286D forms a flow path 288D having a wedge-shaped cross section. The wall 286D also forms a central flow path 288D having a circular cross section. The flow regulator 285E includes a wall 286E, and the wall 286E is in the form of inclined tabs that form a flow path 288E between these walls 286E. The flow paths 288E are continuous with each other at the center. Other plate-type flow regulators can include combinations of walls and flow paths described herein. Further, the device 200 can include any combination of the flow regulators 285A, 285B, 285C, 285D, and 285E arranged along the frame 212 in any suitable pattern or configuration according to the desired hemodynamic characteristics.

[0078] The flow regulators 285A, 285B, 285C, 285D, 285E interact with the blood flowing through or out of the device 200 as the blood passes through the corresponding flow paths 288A, 288B, 288C, 288D, 288E. Each of the flow regulators 285A, 285B, 285C, 285D, 285E having various respective corresponding types or arrangements with respect to the walls 286A, 286B, 286C, 286D, 286E and the flow paths 288A, 288B, 288C, 288D, 288E can generate characteristic flow effects on the blood flow flowing through or out of the device 200.

[0079] Including the walls 286A, 286B, 286C, 286D, 286E and the flow paths 288A, 288B, 288C, 288D, 288E, the flow regulators 285A, 285B, 285C, 285D, 285E provide a wider range of options and greater flexibility in designing a cardiovascular implant device to change hemodynamic characteristics in order to produce a desired hemodynamic effect on the blood flowing through or out of the device. By incorporating the flow regulators 285A, 285B, 285C, 285D, 285E including the walls 286A, 286B, 286C, 286D, 286E and the flow paths 288A, 288B, 288C, 288D, 288E, or by incorporating combinations of these flow regulators 285A, 285B, 285C, 285D, 285E, the hemodynamic effect can be controlled more precisely or finely.

[0080] Device 300 (Figs. 12 - 13) Regarding FIGS. 12 and 13, they will be described together. FIG. 12 is a perspective view of a cardiovascular implant device 300 including a fin-type flow regulator 310. FIG. 13 is a cross-sectional view of the heart H illustrating an exemplary arrangement at the valve site for the cardiovascular implant device 300 including the fin-type flow regulator 310. As shown in FIGS. 12 to 13, the cardiovascular implant device 300 includes a fin-type flow regulator 310, a frame 312, a cover 314, a valve seat 316, a valve 317, an inflow end 318, and an outflow end 320. The frame 312 includes struts 322, an inner diameter 324, an inner surface 325, an outer diameter 326, and an outer surface 327, and defines an opening 328, a central flow path 329, and a flow axis 330. FIG. 13 also shows the device 300, the heart H, the right atrium RA, the right ventricle RV, the left atrium LA, the left ventricle LV, the superior vena cava SVC, the inferior vena cava IVC, the tricuspid valve TV, the pulmonary valve PV, the pulmonary artery PA, the mitral valve MV, the aortic valve AV, and the aorta AT.

[0081] Cardiovascular implant device 300 includes the same structure and function as the above-described cardiovascular implant device 100, except that the device 300 is arranged at the valve site rather than the non-valve site. For example, FIG. 13 shows that the device 300 is arranged at the site of the pulmonary valve PV within the pulmonary artery PA such that the inflow end 318 faces the right ventricle RV and the outflow end 320 is located inside the pulmonary artery PA. In other examples, the device 300 can be arranged at the aortic valve AV, at the mitral valve MV, or at other valves. The cardiovascular implant device 300 also includes various minor structural changes compared to the device 100. For example, the frame 312 has a profile that expands diametrically in both directions rather than a regular cylindrical shape, that is, it has an overall hourglass-shaped profile. The valve seat 316 is located centrally along the longitudinal axis (e.g., flow axis 330) through the cardiovascular implant device 300. The cardiovascular implant device 300 is also illustrated in FIGS. 12 and 13 as including a valve 317 supported within the valve seat 316. Compared to the cover 114 of the device 100 shown in FIG. 3A, the cover 314 extends over most of the frame 312. Moreover, although the cover 314 extends from the inflow end 318 towards the outflow end 320, the outflow end 320 is not covered by the cover 314. Among the other variations described above with reference to the device 100, it will be understood that other examples of cardiovascular implant devices can include a wide variety of frame shapes and sizes, and can also include a wide variety of positions regarding the valve seat and the cover.

[0082] The fin-type flow regulator 310 can generally include the same structure and function as the fin-type flow regulator 110 shown in FIGS. 3A-4), the fin-type flow regulator 140 shown in FIGS. 5A-5), the fin-type flow regulator 140' shown in FIGS. 6A-8, and the fin-type flow regulators 185A-185E shown in FIGS. 9A-9E. One or more flow regulators 310 can be arranged in any suitable arrangement with respect to the frame 312 of the device 300. In some examples, the flow regulator 310 can be arranged around the periphery defined by the inner diameter 324 of the inner surface 325 of the frame 312. In some examples, the flow regulator 310 can be arranged adjacent to the inlet end 318 and / or adjacent to the outlet end 320. In some examples, the flow regulator 310 is connected to the strut 322 that forms the first row of openings 328 adjacent to the outlet end 320. The device 300 can include any number of flow regulators 310 at any of the one or more positions described above. The position of the flow regulator 310 can be configured so that the flow regulator 310 does not interfere with other parts of the device 300 or with the tissue wall adjacent thereto. In other examples, the components of the device 300 (e.g., the cover 314) can be designed to conform around the flow regulator 310 or to allow the flow regulator 310 to pass therethrough. The position of the flow regulator 310 can be further configured so that the flow regulator 310 can be crushed or expanded together with the expandable frame 312 (e.g., to conform inside a delivery catheter). The position of the flow regulator 310 can be further configured so that the flow regulator 310 does not occlude the blood vessels of the chamber of the heart H into which the device 300 is implanted internally. The position of the flow regulator 310 can be further configured to change the hemodynamic characteristics (e.g., helicity, vorticity, velocity, turbulence, flow direction, etc.) of the blood flowing through or out of the device 300 in a specific manner.

[0083] After the device 300 is implanted into the cardiovascular system (e.g., into the pulmonary artery PA as shown in FIG. 13), the circulating blood passes through the device 300. When the blood flows into the device 300 along the flow axis 330, passes through the device 300, and is then led out of the device 300, the flow regulator 310 interacts with the blood flow to change or affect the hemodynamic characteristics of the flow (e.g., helicity, vorticity, velocity, turbulence, flow direction, etc.). The flow regulator 310 can interact with the blood flowing through or out of the device 300 by adding flow resistance and / or changing the direction of the blood flow, thereby preventing the reversal of the blood flow. For example, the flow regulator 310 can increase or decrease the vorticity or helicity of the flow. In some examples, the flow regulator 310 may make the flow smoother (reduce turbulence). In other examples, the flow regulator 310 can increase the turbulence in the flow. In some examples, the flow regulator 310 can change the direction of the flow. In some examples, the flow regulator 310 can align the flow with the natural vortex pattern of the blood through the blood vessels or chambers of the heart H, such as the left-handed vortex flow in the left atrium LA or the right-handed vortex flow in the right atrium RA. In other examples, the flow regulator 310 can align the flow with the natural helical flow pattern of the blood through the blood vessels or chambers of the heart H, such as the helical flow in the coronary sinus CS. The flow regulator 310 circumferentially arranged at the inlet end 318 and / or the outlet end 320 of the device 300 can reverse the blood flow in the same helical direction towards the center of the blood vessel or chamber by generating a helical flow pattern in the vicinity of the adjacent blood vessel wall or chamber wall, thereby generating a forward movement of the blood. More generally, the flow regulator 310 adjacent to the inlet end 318 can change the hemodynamic characteristics of the blood flowing through the frame 312, and the flow regulator 310 adjacent to the outlet end 320 can change the hemodynamic characteristics of the blood led out from the frame 312.

[0084] In addition to the advantages described above with respect to device 100, device 300 according to the techniques of the present disclosure can modify hemodynamic characteristics at or adjacent to the site of a replaced native heart valve. Despite being at the location where the native valve was previously located (and thus the location of the native flow regulator), the implantable device can disrupt the native flow pattern due to factors such as the size of the device, the location of the device, any contact between the device and neighboring tissue, or other factors. The flow regulator 310 incorporated into device 300 can produce a hemodynamic effect that minimizes or enhances disruption to the native flow pattern at or adjacent to the valve site.

[0085] Device 400 (FIG. 14) FIG. 14 is a perspective view of a cardiovascular implant device 400 that includes a plate-type flow regulator 410. As shown in FIG. 14, the cardiovascular implant device 400 includes a plate-type flow regulator 410 (collectively referred to herein by a common reference numeral) that includes flow regulators 410A, 410B, a frame 412, a cover 414, a valve seat 416, a valve 417, an inflow end 418, and an outflow end 420. The frame 412 includes struts 422, an inner diameter 424, an inner surface 425, an outer diameter 426, an outer surface 427, and defines an opening 428, a central flow path 429, and a flow axis 430. The flow regulator 410 includes a wall 432 and defines a flow path 434 therein.

[0086] Cardiovascular implant device 400 includes a plate-type flow regulator 410 instead of a fin-type flow regulator (e.g., flow regulator 310) as described above, and has the same structure and function as the cardiovascular implant device 300 described above. Further, the plate-type flow regulator 410 can generally include the same structure and function as the plate-type flow regulator 210 shown in FIGS. 10A-10C and the plate-type flow regulators 285A-285E shown in FIGS. 11A-11E. One or more flow regulators 410 can be arranged in any suitable arrangement with respect to the frame 412 of the device 400. In the example shown in FIG. 14, the device 400 includes two flow regulators, namely, flow regulator 410A and flow regulator 410B. In other examples, any number of flow regulators 410 can be included. The flow regulator 410 is arranged to straddle a portion of the central flow path 429 (defined by the frame 412) such that the flow regulator 410 intersects the flow axis 430 through the frame 412. In some examples, the flow regulator 410 can be arranged adjacent to the inlet end 418 (flow regulator 410A) and / or adjacent to the outlet end 420 (flow regulator 410B). In some examples, the flow regulator 410 is connected to the strut 422 that forms the first row of openings 428 adjacent to the outlet end 420. The device 400 can include any number of flow regulators 410 at any of the one or more positions described above. The position of the flow regulator 410 can be configured so that the flow regulator 410 does not interfere with other parts of the device 400 or the adjacent tissue wall. In other examples, the components of the device 400 (e.g., the cover 414) can be designed to conform to the periphery of the flow regulator 410 or allow the flow regulator 410 to pass through. The position of the flow regulator 410 can be further configured so that the flow regulator 410 can be crushed or expanded together with the expandable frame 412 (e.g., to fit inside a delivery catheter). The position of the flow regulator 410 can be further configured so that the flow regulator 410 does not block the blood vessels of the chambers of the heart H into which the device 400 is implanted internally.The position of the flow regulator 410 can be further configured to change the hemodynamic characteristics (e.g., helicity, vorticity, velocity, turbulence, flow direction, etc.) of the blood flowing through or out of the device 400 in a specific manner.

[0087] After the device 400 is implanted into the cardiovascular system, the circulating blood passes through the device 400. As the blood flows into the device 400 along the flow axis 430, passes through the device 400, and is then led out of the device 400, the blood flows through the flow path 434 of the flow regulator 410. By interacting with the blood flow, the flow regulator 410 can change or affect the hemodynamic characteristics of the flow (e.g., helicity, vorticity, velocity, turbulence, flow direction, etc.). The flow regulator 410 can interact with the blood flowing through or out of the device 400 by adding flow resistance and / or changing the direction of the blood flow, thereby preventing the reversal of the blood flow. For example, the flow regulator 410 can increase or decrease the vorticity or helicity of the flow. In some examples, the flow regulator 410 may make the flow smoother (reduce turbulence). In other examples, the flow regulator 410 can increase the turbulence in the flow. In some examples, the flow regulator 410 can change the direction of the flow. In some examples, the flow regulator 410 can align the flow with the natural vortex pattern of the blood through the blood vessels or chambers of the heart H, such as the left-handed vortex in the left atrium LA or the right-handed vortex in the right atrium RA. In other examples, the flow regulator 410 can align the flow with the natural helical flow pattern of the blood through the blood vessels or chambers of the heart H, such as the helical flow in the coronary sinus CS. The flow regulator 410 disposed at or near the inlet end 418 and / or the outlet end 420 of the device 400 can generate a helical flow pattern near the adjacent blood vessel wall or chamber wall, causing the blood to flow backward toward the center of the blood vessel or chamber in the same helical direction, thereby generating forward movement of the blood. More generally, the flow regulator 410 adjacent to the inlet end 418 can change the hemodynamic characteristics of the blood flowing through the frame 412, and the flow regulator 410 adjacent to the outlet end 420 can change the hemodynamic characteristics of the blood led out from the frame 412.

[0088] In addition to the advantages described above with respect to device 200, device 400 according to the techniques of the present disclosure can modify hemodynamic characteristics at or adjacent to the site of a replaced native heart valve. Despite being at the location where the native valve was previously located (and thus the location of the native flow regulator), the implantable device can disrupt the native flow pattern due to factors such as the size of the device, the location of the device, any contact between the device and the surrounding tissue, or other factors. The flow regulator 410 incorporated into device 400 can produce hemodynamic effects that minimize or enhance the native flow pattern disruption to the native flow pattern at or adjacent to the valve site.

[0089] Device 500 (Figs. 15A - 16B) Figs. 15A - 16B will be described together. Fig. 15A is a perspective view of a cardiovascular implant device 500 including a fin - type flow regulator 510. Fig. 15B is a plan view of a cardiovascular implant device 500 including a fin - type flow regulator 510. Fig. 15C is a bottom view of a cardiovascular implant device 500 including a fin - type flow regulator 510. Fig. 16A is a cross - sectional view of the heart H illustrating an exemplary arrangement at the valve site with respect to the cardiovascular implant device 500 including the fin - type flow regulator 510. Fig. 16B is a cross - sectional view of the heart H illustrating an exemplary arrangement at a non - valve site with respect to the cardiovascular implant device 500 including the fin - type flow regulator 510.

[0090] As shown in FIGS. 15A - 15C, the cardiovascular implant device 500 includes a fin - type flow regulator 510, a frame 512, a cover 514, a valve body 516, an inflow end 518, and an outflow end 520. The frame 512 includes struts 522, an inner diameter 524, an inner surface 525, an outer diameter 526, and an outer surface 527, and defines an opening 528, a central flow path 529, and a flow axis 530. The valve body includes valve leaflets 531. FIG. 16A also shows the device 500, the heart H, the right atrium RA, the right ventricle RV, the left atrium LA, the left ventricle LV, the superior vena cava SVC, the inferior vena cava IVC, the tricuspid valve TV, the mitral valve MV, the aortic valve AV, and the aorta AT. FIG. 16B also shows the device 500, the heart H, the vascular system V, the right atrium RA, the right ventricle RV, the left atrium LA, the left ventricle LV, the superior vena cava SVC, the inferior vena cava IVC, the tricuspid valve TV, the pulmonary valve PV, the pulmonary artery PA, the pulmonary veins PVS, the mitral valve MV, the aortic valve AV, the aorta AT, and the coronary sinus CS.

[0091] 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 valve device such as an artificial valve device. In some examples, the device 500 is deployed into the valve seat of a previously implanted stent device or into the valve seat of a docking station device (e.g., devices 100, 200, 300, 400). The cardiovascular implant device 500 can be delivered into the cardiovascular system via a catheter (i.e., transcatheter delivery), or surgically placed using transcatheter procedures known in the art or using surgical procedures. In some examples, the device 500 can be delivered and / or implanted using the same catheter or surgical procedure as that used with a stent device (e.g., devices 100, 200, 300, 400). In other examples, the device 500 can be delivered and / or implanted by a different catheter or by a different surgical procedure. The device 500 can be placed within any blood vessel or any chamber of the heart H at a location where there is no natural valve (a "non-valve" location) or at a location where a natural valve (e.g., aortic valve AV, mitral valve MV, pulmonary valve PV, etc.) is present. For example, FIG. 16A shows an exemplary placement of the device 500 at the aortic valve AV (valve location). In contrast, FIG. 16B shows an exemplary placement of the device 500 within the inferior vena cava IVC (non-valve location).

[0092] Frame 512 forms the main body of device 500. Frame 512 can be made expandable. Frame 512 can have various shapes and sizes. As shown in FIGS. 15A - 15C, for example, frame 512 is annular or cylindrical and is a mesh or lattice. Frame 512 has an inner diameter 524 and an outer diameter 526. Each of the inner diameter 524 and the outer diameter 526 can vary along the length of frame 512. The inner diameter 524 is the diameter of the radially inner surface 525 of frame 512. The outer diameter 526 is the diameter of the radially outer surface 527 of frame 512. Frame 512 can have any suitable length. For example, frame 512 may be approximately the same length as valve body 516. In other examples, frame 512 can be made longer compared to valve body 516. Frame 512 can press against or into the tissue wall at the implantation site to set and maintain the position of device 500, or can be placed around the anatomical structures of the cardiovascular system.

[0093] Frame 512 can be formed in various ways. For example, in a way that forms a mesh or lattice by connecting individual wires together, in a braided way, in a way of rolling it into the shape of frame 512 after cutting from a sheet or forming it in other ways, in a molding way, in a way of cutting from a cylindrical tube (e.g., in a way of cutting from a Nitinol tube), in other ways, or in combinations of these. Frame 512 can be formed from a highly flexible metal, from a metal alloy, or from a polymer. Examples of metals and metal alloys that can be used include, but are not limited to, Nitinol and other shape memory alloys, Elgiloy, and stainless steel. However, when manufacturing frame 512, other metals, highly elastic non-metallic materials, or soft non-metallic materials can be used. All or part of frame 512 can be integrally formed from any of those materials. Those materials can enable frame 512 to be compressed to a small size, and then, when the compressive force is released, frame 512 can self-expand to return to its shape before compression. Frame 512 can expand to return to its shape before compression based on the properties of the material forming frame 112, and / or frame 512 can expand when a device disposed inside the frame expands or extends. For example, frame 512 can be compressed so that it can fit inside a delivery catheter. Frame 512 can also be formed from other materials and can be made expandable and crushable in various ways, such as in a mechanically expandable way, a balloon-expandable way, a self-expandable way, or combinations of these.

[0094] Frame 512 extends across between the inflow end 518 and the outflow end 520 of the cardiovascular implant device 500. The inflow end 518 can be the end of the device 500 such that when the device 500 is implanted within a blood vessel or chamber of the heart H, it is located upstream of the outflow end 520 with respect to the blood flow along the flow axis 530 represented by arrow A in FIG. 15A. Thus, the outflow end 520 is the end of the device 500 such that when the device 500 is implanted within a blood vessel or chamber of the heart H, it is located downstream of the inflow end 518 with respect to the blood flow along the flow axis 530 represented by arrow A in FIG. 15A. In the example shown in FIG. 16A, the outflow end 520 is disposed inside the aorta AT, and the inflow end 518 is disposed upstream at the site of the aortic valve AV (facing the left ventricle LV). In the example shown in FIG. 16B, the outflow end 520 is disposed near where the inferior vena cava IVC opens into the right atrium RA, and the inflow end 518 is disposed upstream inside the inferior vena cava IVC. Although the inflow end 518 is defined as being located upstream of the outflow end 520, it will be understood that other actual arrangements regarding the inflow end 518 or the outflow end 520 are possible depending on the location where the device 500 is implanted.

[0095] Frame 512 is formed from a plurality of struts 522. The struts 522 construct a lattice or mesh of the frame 512 and define an opening (or cell) 528 inside the lattice or mesh. The struts 522 can be integrally formed. In some examples, all or part of the struts 522 are integrally formed from the same material. The opening 528 extends through the frame 512 from the inner surface 525 to the outer surface 527. Each of the openings 528 is surrounded by one or more sides by the struts 522. The opening 528 can have any suitable shape or size, and this shape or size can be based on the overall shape or size of the frame 512. In the example shown in FIG. 15A, the opening 528 is a combination of a hexagonal shape and a rhombic shape and is arranged as a circumferential row around the frame 512. In other examples, the opening 528 can have any other regular or irregular, polygonal or non-polygonal, shape and pattern. In some examples, some of the openings 528 can have different shapes or sizes throughout the frame 512. For example, FIG. 15A shows an opening 528 forming a first row having a hexagonal shape (adjacent to the outflow end 520) and an opening 528 forming the remaining rows having a rhombic shape and being smaller. In some examples, some of the openings 528 can be connected to adjacent openings 528 with a gap therebetween.

[0096] The central flow path 529 is an open flow path passing through the central portion of the annular frame 512. The central flow path 529 is defined by the inner surface 525 of the frame 512. The central flow path 529 extends from the inflow end 518 to the outflow end 520, whereby the device 500 is open at both ends. Thus, the blood flowing through the device 500 and being led out from the device 500 follows the central flow path 529. More specifically, the flow axis 530 is the longitudinal axis through the device 500, and along this longitudinal axis, the blood flows when the blood passes through or is guided through the device 500 (e.g., in the direction indicated by arrow A in FIG. 15A). In the example shown in FIG. 16A where the device 500 is implanted at the site of the aortic valve AV, the device 500 can be occluded when the heart H is in diastole (i.e., the valve leaflets 531 of the valve body 516 can be occluded). During diastole, the blood flows from the left atrium LA, through the mitral valve MV, and into the left ventricle LV. During systole of the heart H, the device 500 can be opened. The blood flows from the left ventricle LV, through the device 500, and along the flow axis 530 into the aorta AT. In the example shown in FIG. 16B where the device 500 is implanted in the inferior vena cava IVC, the device 500 can be opened when the heart H is in diastole. The blood flows from the inferior vena cava IVC and from the superior vena cava SVC into the right atrium RA. The blood flowing in from the inferior vena cava IVC flows through the device 500 along the flow axis 530. During diastole, the blood in the right atrium RA flows through the tricuspid valve TV into the right ventricle RV. During systole of the heart, the device 500 can be occluded. The blood is prevented from flowing (i.e., flowing backward) from the right atrium RA into the inferior vena cava IVC by the occluded device 500. The occluded device 500 prevents the blood flowing backward through the tricuspid valve TV during systole from being pushed into the inferior vena cava IVC.

[0097] Cover 514 is a cover for one or more portions of frame 512. Cover 514 can be a cloth material, a polymer material, or other materials. For example, cover 514 can be a material that promotes in-growth within tissue at locations where device 500 contacts adjacent tissue walls of blood vessels or chambers of heart H. Cover 514 can also form a seal for restricting or preventing blood flow through portions of frame 512 covered by cover 514. Cover 514 can be attached to frame 512 by any suitable attachment means such as suturing, adhesion, tying, etc. Cover 514 can be shaped and arranged in various manners. In the example shown in FIG. 15A, cover 514 is adjacent to inflow end 518. In some examples, cover 514 is located near or adjacent to an attachment region for valve body 516. In other examples, cover 514 can be adjacent to outflow end 520 or can be at any position or arrangement between inflow end 518 and outflow end 520. In still other examples, device 500 does not include cover 514.

[0098] Valve body 516 is attached inside annular frame 512. More specifically, valve body 516 is connected to inner surface 525 of frame 512. Valve body 516 includes one or more valve leaflets 531. In the examples shown in FIGS. 15A - 15C, three valve leaflets 531 are provided (i.e., a trileaflet configuration). In other examples, valve body 516 can include more or fewer valve leaflets 531. The plurality of valve leaflets 531 are flexible and crushable within frame 512 and can control blood flow through device 500.

[0099] The fin-type flow regulator 510 can generally include the same structure and function with respect to the fin-type flow regulator 110 shown in FIGS. 3A-4, the fin-type flow regulator 140 shown in FIGS. 5A-5B, the fin-type flow regulator 140' shown in FIGS. 6A-8, and the fin-type flow regulators 185A-185E shown in FIGS. 9A-9E. One or more flow regulators 510 can be arranged in any suitable arrangement with respect to the frame 512 of the device 500. In some examples, the flow regulator 510 can be arranged around the periphery of the inner surface 525 of the frame 512 defined by the inner diameter 524. In some examples, the flow regulator 510 can be arranged adjacent to the inflow end 518 (as shown in FIG. 15C) and / or adjacent to the outflow end 520 (as shown in FIG. 15B). In some examples, the flow regulator 510 is connected to the strut 522 that forms the first row of openings 528 adjacent to the outflow end 520. The device 500 can include any number of flow regulators 510 at any of the one or more positions described above. The position of the flow regulator 510 can be configured so that the flow regulator 510 does not interfere with other parts of the device 500 or the tissue wall adjacent thereto. For example, the flow regulator 510 can be arranged (or sized and shaped) so as to avoid interaction with the valve body 516 and the valve tip 531. In other examples, the components of the device 500 (e.g., the cover 514) can be designed to conform around the flow regulator 510 or to allow the flow regulator 510 to pass therethrough. The position of the flow regulator 510 can be further configured so that the flow regulator 510 can be crushed or expanded together with the expandable frame 512 (e.g., to conform inside a delivery catheter). The position of the flow regulator 510 can be further configured so that the flow regulator 510 does not occlude the blood vessels of the chamber of the heart H into which the device 500 is implanted internally. The position of the flow regulator 510 can be further configured to change the hemodynamic characteristics (e.g., helicity, vorticity, velocity, turbulence, flow direction, etc.) of the blood flowing through or out of the device 500 in a specific manner.

[0100] When the device 500 is implanted within the cardiovascular system (e.g., within the aorta AT at the aortic valve AV as shown in FIG. 16A or within the inferior vena cava IVC as shown in FIG. 16B), the circulating blood passes through the device 500. As the blood flows into the device 500 along the flow axis 530, passes through the device 500, and is then conducted out of the device 500, the flow regulator 510 interacts with the blood flow to alter or affect the hemodynamic characteristics of the flow (e.g., helicity, vorticity, velocity, turbulence, flow direction, etc.). The flow regulator 510 can interact with the blood flowing through or out of the device 500 by adding flow resistance and / or by changing the direction of the blood flow, thereby preventing reversal of the blood flow. For example, the flow regulator 510 can increase or decrease the vorticity or helicity of the flow. In some examples, the flow regulator 510 may make the flow smoother (reduce turbulence). In other examples, the flow regulator 510 can increase the turbulence within the flow. In some examples, the flow regulator 510 can change the direction of the flow. In some examples, the flow regulator 510 can align the flow with the natural vortex pattern of the blood through the vessels or chambers of the heart H, such as the left - hand - eddy of the left - hand - eddy flow within the left atrium LA or the right - hand - eddy of the right - hand - eddy flow within the right atrium RA. In other examples, the flow regulator 510 can align the flow with the natural helical flow pattern of the blood through the vessels or chambers of the heart H, such as the helical flow within the coronary sinus CS. The flow regulator 510 circumferentially disposed at or near the inlet end 518 and / or the outlet end 520 of the device 500 can cause the blood to flow backward toward the center of the vessel or chamber in the same helical direction by generating a helical flow pattern in the vicinity of the adjacent vessel wall or chamber wall, thereby generating forward movement of the blood. More generally, the flow regulator 510 adjacent to the inlet end 518 can change the hemodynamic characteristics of the blood flowing through the frame 512, and the flow regulator 510 adjacent to the outlet end 520 can change the hemodynamic characteristics of the blood conducted out of the frame 512.

[0101] In addition to the advantages described above with respect to devices 100, 300, an alternative or additional option is provided of incorporating a flow regulator directly onto a valve device (e.g., device 500), such as incorporating a flow regulator onto a prestent device or a docking station device (e.g., devices 100, 300). The flow regulator 510 incorporated onto device 500 can generate a hemodynamic effect that enhances the natural flow pattern while minimizing disruption to the natural flow pattern in a scenario where an artificial valve is implanted without a prestent or without a docking station.

[0102] Device 600 (Figs. 17A - 17C) Figs. 17A - 17C will be described together. Fig. 17A is a perspective view of a cardiovascular implant device 600 including a plate - type flow regulator 610. Fig. 17B is a plan view of the cardiovascular implant device 600 including the plate - type flow regulator 610. Fig. 17C is a bottom view of the cardiovascular implant device 600 including the plate - type flow regulator 610. As shown in Figs. 17A - 17C, the cardiovascular implant device 600 includes a plate - type flow regulator 610 (which will be generally referred to herein by a common reference numeral) including flow regulators 610A, 610B, a frame 612, a cover 614, a valve body 616, an inflow end 618, and an outflow end 620. The frame 612 includes struts 622, an inner diameter 624, an inner surface 625, an outer diameter 626, an outer surface 627, and defines an opening 628, a central flow path 629, and a flow axis 630. The valve body includes valve tips 631. The flow regulator 610 includes a wall 632 and defines a flow path 634 therein.

[0103] The cardiovascular implant device 600 includes the same structure and function as the above-described cardiovascular implant device 500, except that the device 600 includes a plate-type flow regulator 610 instead of a fin-type flow regulator (e.g., flow regulator 510). Further, the plate-type flow regulator 610 can generally include the same structure and function as the plate-type flow regulator 210 and the plate-type flow regulators 285A-285E (FIGS. 11A-11E) shown in FIGS. 10A-10C. One or more flow regulators 610 can be arranged in any suitable arrangement with respect to the frame 612 of the device 600. In the example shown in FIG. 17A, the device 600 includes two flow regulators, i.e., a flow regulator 610A and a flow regulator 610B. In other examples, any number of flow regulators 610 can be included. The flow regulator 610 is arranged to straddle a portion of the central flow path 629 (defined by the frame 612) such that the flow regulator 610 intersects the flow axis 630 through the frame 612. In some examples, the flow regulator 610 can be arranged adjacent to the inlet end 618 (flow regulator 610A shown in FIG. 17C) and / or adjacent to the outlet end 620 (flow regulator 610B shown in FIG. 17B). In some examples, the flow regulator 610 is connected to the strut 622 that forms the first row of openings 628 adjacent to the outlet end 620. The device 600 can include any number of flow regulators 610 at any one or more of the above-described positions. The position of the flow regulator 610 can be configured so that the flow regulator 610 does not interfere (or contact) with other parts of the device 600 or adjacent tissue walls. For example, the flow regulator 610 can be arranged (or sized and shaped) to avoid interaction with the valve body 616 and the valve tip 631. In other examples, the components of the device 600 (e.g., the cover 614) can be designed to conform to the periphery of the flow regulator 610 or to allow the flow regulator 610 to pass through.The position of the flow regulator 610 can be further configured such that the flow regulator 610 can be crushed or expanded together with the expandable frame 612 (e.g., to fit inside a delivery catheter). The position of the flow regulator 610 can be further configured such that the flow regulator 610 does not occlude the blood vessels or chambers of the heart H into which the device 600 is implanted. The position of the flow regulator 610 can be further configured to alter the hemodynamic characteristics (e.g., helicity, vorticity, velocity, turbulence, flow direction, etc.) of the blood flowing through or exiting from the device 600 in a particular manner.

[0104] After the device 600 is implanted into the cardiovascular system, the circulating blood is supplied through the device 600. As the blood flows into the device 600 along the flow axis 630, passes through the device 600, and is further led out of the device 600, the blood flows through the flow path 634 of the flow regulator 610. By interacting with the blood flow, the flow regulator 610 can change or affect the hemodynamic characteristics of the flow (e.g., helicity, vorticity, velocity, turbulence, flow direction, etc.). The flow regulator 610 can interact with the blood flowing through or led out of the device 600 by adding flow resistance and / or changing the direction of the blood flow, thereby preventing the reversal of the blood flow. For example, the flow regulator 610 can increase or decrease the vorticity or helicity of the flow. In some examples, the flow regulator 610 may make the flow smoother (reduce turbulence). In other examples, the flow regulator 610 can increase the turbulence in the flow. In some examples, the flow regulator 610 can change the direction of the flow. In some examples, the flow regulator 610 can align the flow with the natural vortex pattern of the blood through the blood vessels or chambers of the heart H, such as the left-handed vortex flow in the left atrium LA or the right-handed vortex flow in the right atrium RA. In other examples, the flow regulator 610 can align the flow with the natural helical flow pattern of the blood through the blood vessels or chambers of the heart H, such as the helical flow in the coronary sinus CS. The flow regulator 610 disposed at the inlet end 618 and / or the outlet end 620 of the device 600 can reverse the blood flow in the same helical direction towards the center of the blood vessel or chamber by generating a helical flow pattern in the vicinity of the adjacent blood vessel wall or chamber wall, thereby generating a forward movement of the blood. More generally, the flow regulator 610 adjacent to the inlet end 618 can change the hemodynamic characteristics of the blood flowing through the frame 612, and the flow regulator 610 adjacent to the outlet end 620 can change the hemodynamic characteristics of the blood led out from the frame 612.

[0105] In addition to the advantages described above with respect to devices 200, 400, an alternative or additional option is provided of incorporating a flow regulator directly onto a valve device (e.g., device 600), or onto a prestent device or docking station device (e.g., devices 200, 400). The flow regulator 610 incorporated onto device 600 can produce a hemodynamic effect that enhances the natural flow pattern while minimizing disruption to the natural flow pattern in a scenario where an artificial valve is implanted without a prestent or without a docking station.

[0106] Device 700 (FIG. 18) FIG. 18 is a cross-sectional view of the heart H illustrating an exemplary arrangement of a cardiovascular implant device 700 that includes a fin-type flow regulator 710. As illustrated in FIG. 18, the cardiovascular implant device 700 includes a fin-type flow regulator 710, a frame 712, an inflow end 718, and an outflow end 720. The frame 712 includes struts 722, an inner diameter 724, an inner surface 725, an outer diameter 726, an outer surface 727, and defines an opening 728, a central flow path 729, and a flow axis 730. FIG. 18 also shows device 700, heart H, right atrium RA, left atrium LA, left ventricle LV, superior vena cava SVC, mitral valve MV, aortic valve AV, and aorta AT.

[0107] 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 within a chamber of the heart H. In the illustrated example, the cardiovascular implant device 700 is a stent device. The cardiovascular implant device 700 can be delivered into the cardiovascular system via a catheter (i.e., transcatheter delivery), or can be surgically placed using transcatheter procedures known in the art or using surgical procedures. In some examples, the device 700 can be delivered and / or implanted using the same catheter or surgical procedure as that used with respect to an adjacent (or nearby) pre-stent device (e.g., devices 100, 200, 300, 400) or with respect to a valve device (e.g., devices 500, 600). In other examples, the device 700 can be delivered and / or implanted by a different catheter or by a different surgical procedure. The device 700 can be placed within any blood vessel or within any chamber of the heart H. In some examples, the device 700 is placed at a location within the heart H where there is no natural valve present (a "non-valve" location). In other examples, the device 700 is placed in the vicinity of a location where a natural valve (e.g., aortic valve AV, mitral valve MV, pulmonary valve PV, etc.) is present. For example, FIG. 18 shows an exemplary placement of the device 700 within the aorta AT.

[0108] Frame 712 forms the main body of device 700. Frame 712 can be made expandable. Frame 712 can have various shapes and sizes. As shown in FIG. 18, for example, frame 712 is annular or cylindrical and is a mesh or lattice. Frame 712 has an inner diameter 724 and an outer diameter 726. Each of the inner diameter 724 and the outer diameter 726 can vary along the length of frame 712. The inner diameter 724 is the diameter of the radially inner surface 725 of frame 712. The outer diameter 726 is the diameter of the radially outer surface 727 of frame 712. Frame 712 can have any suitable length. Frame 712 can press against or into the tissue wall at the implantation site to set and maintain the position of device 700, or can be placed (or extended) around the anatomical structures of the cardiovascular system.

[0109] Frame 712 can be formed in various ways. For example, it can be formed in a manner of forming a mesh or lattice by connecting individual wires together, in a braided manner, in a manner of rolling it into the shape of frame 712 after cutting from a sheet or forming it in other ways, in a molding manner, in a manner of cutting from a cylindrical tube (e.g., in a manner of cutting from a Nitinol tube), in other ways, or in combinations thereof. Frame 712 can be formed from a highly flexible metal, from a metal alloy, or from a polymer. Examples of metals and metal alloys that can be used include, but are not limited to, Nitinol and other shape memory alloys, Elgiloy, and stainless steel. However, when manufacturing frame 712, other metals, highly elastic non-metallic materials, or soft non-metallic materials can be used. All or part of frame 712 can be integrally formed from any of those materials. Those materials can enable frame 712 to be compressed to a small size, and then, when the compressive force is released, frame 712 can self-expand to return to its shape before compression. Frame 712 can expand to return to its shape before compression based on the properties of the material forming frame 712, and / or frame 712 can expand due to the expansion or dilation of a device disposed inside frame 712. For example, frame 712 can be compressed so that it can fit within a delivery catheter. Frame 712 can also be formed from other materials and can be made expandable and crushable in various ways, such as in a mechanically expandable manner, a balloon-expandable manner, a self-expandable manner, or a combination thereof.

[0110] Frame 712 extends across between the inflow end 718 and the outflow end 720 of the cardiovascular implant device 700. The inflow end 718 can be the end of the device 700 such that when the device 700 is implanted within a blood vessel or chamber of the heart H, it is located upstream of the outflow end 720 with respect to the blood flow along the flow axis 730 represented by arrow A in FIG. 18. Thus, the outflow end 720 is the end of the device 700 such that when the device 700 is implanted within a blood vessel or chamber of the heart H, it is located downstream of the inflow end 718 with respect to the blood flow along the flow axis 730 represented by arrow A in FIG. 18. In the example shown in FIG. 18, the outflow end 720 is disposed inside the aorta AT, and the inflow end 718 is disposed upstream and closer to the site of the aortic valve AV. Although the inflow end 718 is defined as being located upstream of the outflow end 720, it will be understood that other actual arrangements regarding the inflow end 718 or the outflow end 720 are possible depending on the location where the device 700 is implanted.

[0111] Frame 712 is formed from a plurality of struts 722. The struts 722 construct a lattice or mesh of the frame 712 and define an opening (or cell) 728 inside the lattice or mesh. The struts 722 can be integrally formed. In some examples, all or part of the struts 722 are integrally formed from the same material. The opening 728 extends through the frame 712 from the inner surface 725 to the outer surface 727. Each of the openings 728 is surrounded by one or more sides by the struts 722. The opening 728 can have any suitable shape or size, and this shape or size can be based on the overall shape or size of the frame 712. In the example shown in FIG. 18, the opening 728 is triangular and is arranged as a circumferential row around the frame 712. In other examples, the opening 728 can have any other regular or irregular, polygonal or non-polygonal shape and pattern. In some examples, some of the openings 728 can have different shapes or sizes throughout the frame 712. For example, FIG. 18 shows that the dimensions of the openings 728 are different throughout the frame 712. In some examples, some of the openings 728 can be connected to adjacent openings 728 with a gap in between.

[0112] The central flow path 729 is an open flow path passing through the central portion of the annular frame 712. The central flow path 729 is defined by the inner surface 725 of the frame 712. The central flow path 729 extends from the inflow end 718 to the outflow end 720, whereby the device 700 is open at both ends. Thus, the blood flowing through the device 700 and being led out of the device 700 follows the central flow path 729. More specifically, the flow axis 730 is the longitudinal axis through the device 700, and along this longitudinal axis, the blood flows (for example, in the direction indicated by arrow A in FIG. 18) when the blood passes through or is guided through the device 700. In the example shown in FIG. 18 where the device 700 is implanted in the aorta AT, the aortic valve AV (or an artificial valve device such as the device 500) opens during the systolic phase of the heart H. The blood flows from the left ventricle LV, through the aortic valve AV, and into the aorta AT. Inside the aorta AT, the blood flows through the device 700 along the flow axis 730.

[0113] Although not shown in FIG. 18, the device 700 can also include a cover, which can generally include the same structure and function as the covers 114, 514 described above.

[0114] The fin-type flow regulator 710 can generally include the same structure and function as the fin-type flow regulator 110 shown in FIGS. 3A-4, the fin-type flow regulator 140 shown in FIGS. 5A-5B, the fin-type flow regulator 140' shown in FIGS. 6A-8, and the fin-type flow regulators 185A-185E shown in FIGS. 9A-9E. One or more flow regulators 710 can be arranged in any suitable arrangement with respect to the frame 712 of the device 700. In some examples, the flow regulator 710 can be arranged around the periphery of the inner surface 725 of the frame 712 defined by the inner diameter 724. In some examples, the flow regulator 710 can be arranged adjacent to the inlet end 718 and / or adjacent to the outlet end 720. In some examples, the flow regulator 710 is connected to the strut 722 that forms the first row of openings 728 adjacent to the outlet end 720. The device 700 can include any number of flow regulators 710 at any of the one or more positions described above. The position of the flow regulator 710 can be configured so that the flow regulator 710 does not interfere with other parts of the device 700 or with the tissue wall adjacent thereto. In other examples, the components of the device 700 can be designed to conform around the flow regulator 710 or to allow the flow regulator 710 to pass therethrough. The position of the flow regulator 710 can be further configured so that the flow regulator 710 can be crushed or expanded together with the expandable frame 712 (e.g., to conform to the inside of a delivery catheter). The position of the flow regulator 710 can be further configured so that the flow regulator 710 does not occlude the blood vessels of the chambers of the heart H into which the device 700 is implanted internally. The position of the flow regulator 710 can be further configured to change the hemodynamic characteristics (e.g., helicity, vorticity, velocity, turbulence, flow direction, etc.) of the blood flowing through or out of the device 700 in a particular manner.

[0115] When the device 700 is implanted within the cardiovascular system (e.g., within the aorta AT as shown in FIG. 18), the circulating blood passes through the device 700. As the blood flows into the device 700 along the flow axis 730, passes through the device 700, and is then conducted out of the device 700, the flow regulator 710 interacts with the blood flow to change or affect the hemodynamic characteristics of the flow (e.g., helicity, vorticity, velocity, turbulence, flow direction, etc.). The flow regulator 710 can interact with the blood flowing through or out of the device 700 by adding flow resistance and / or changing the direction of the blood flow, thereby preventing reversal of the blood flow. For example, the flow regulator 710 can increase or decrease the vorticity or helicity of the flow. In some examples, the flow regulator 710 may make the flow smoother (reduce turbulence). In other examples, the flow regulator 710 can increase the turbulence within the flow. In some examples, the flow regulator 710 can change the direction of the flow. In some examples, the flow regulator 710 can align the flow with the natural vortex pattern of the blood through the blood vessels or chambers of the heart H, such as the vortex of the leftward flow within the left atrium LA or the vortex of the rightward flow within the right atrium RA. In other examples, the flow regulator 710 can align the flow with the natural helical flow pattern of the blood through the blood vessels or chambers of the heart H, such as the helical flow within the coronary sinus CS. The flow regulator 710 circumferentially disposed at or near the inlet end 718 and / or the outlet end 720 of the device 700 can cause the blood to flow backward toward the center of the blood vessel or chamber in the same helical direction by generating a helical flow pattern in the vicinity of the adjacent blood vessel wall or chamber wall, thereby generating forward movement of the blood. More generally, the flow regulator 710 adjacent to the inlet end 718 can change the hemodynamic characteristics of the blood flowing through the frame 712, and the flow regulator 710 adjacent to the outlet end 720 can change the hemodynamic characteristics of the blood conducted out of the frame 712.

[0116] In addition to the advantages described above with respect to devices 100, 300, by incorporating the flow regulator 710 directly onto a stent device (e.g., device 700), hemodynamic effects can be generated that minimize disruption to or enhance the natural flow pattern at any site where a stent can be implanted. To some extent, this can be at a greater variety of locations throughout the cardiovascular system (e.g., any blood vessel or chamber of the heart H) compared to valve devices or pre-stent devices / docking station devices that may have more limited uses.

[0117] Device 800 (FIG. 19) FIG. 19 is a cross-sectional view of the heart H illustrating an exemplary arrangement of a cardiovascular implant device 800 that includes a plate-type flow regulator 810. As shown in FIG. 19, the cardiovascular implant device 800 includes a plate-type flow regulator 810, a frame 812, an inflow end 818, and an outflow end 820. The frame 812 includes struts 822, an inner diameter 824, an inner surface 825, an outer diameter 826, an outer surface 827, and defines an opening 828, a central flow path 829, and a flow axis 830. The flow regulator 810 includes a wall 832 and defines a flow path 834 therein. FIG. 19 also shows the device 800, the heart H, the right atrium RA, the left atrium LA, the left ventricle LV, the superior vena cava SVC, the mitral valve MV, the aortic valve AV, and the aorta AT.

[0118] The cardiovascular implant device 800 includes the same structure and functions as the above-described cardiovascular implant device 700, except that the cardiovascular implant device 800 includes a plate-type flow regulator 810 instead of a fin-type flow regulator (e.g., flow regulator 710). In the example shown in FIG. 19, the device 800 includes one flow regulator 810. In other examples, any number of flow regulators 810 can be included. Further, the plate-type flow regulator 810 can generally include the same structure and functions as the plate-type flow regulator 210 shown in FIGS. 10A - 10C and the plate-type flow regulators 285A - 285E shown in FIGS. 11A - 11E. One or more flow regulators 810 can be arranged in any suitable arrangement with respect to the frame 812 of the device 800. The flow regulator 810 is arranged to straddle a portion of the central flow path 829 (defined by the frame 812) such that the flow regulator 810 intersects the flow axis 830 through the frame 812. In some examples, the flow regulator 810 can be arranged adjacent to the inflow end 818 and / or adjacent to the outflow end 620. In some examples, the flow regulator 810 is connected to struts 822 that form a first row of openings 828 adjacent to the outflow end 820. The device 800 can include any number of flow regulators 810 at any of the one or more positions described above. The position of the flow regulator 810 can be configured such that the flow regulator 810 does not interfere (or contact) with other parts of the device 800 or the adjacent tissue wall. In other examples, the components of the device 800 can be designed to conform around the flow regulator 810 or allow the flow regulator 810 to pass through. The position of the flow regulator 810 can be further configured such that the flow regulator 810 does not occlude the blood vessels of the chambers of the heart H into which the device 800 is implanted internally. The position of the flow regulator 810 can be further configured such that the flow regulator 810 can be crushed or expanded together with the expandable frame 812 (e.g., to fit inside a delivery catheter).The position of the flow regulator 810 can be further configured to change the hemodynamic characteristics (e.g., helicity, vorticity, velocity, turbulence, flow direction, etc.) of the blood flowing through or derived from the device 800 in a specific manner.

[0119] After the device 800 is implanted into the cardiovascular system (e.g., into the aorta AT as shown in FIG. 19), the circulating blood passes through the device 800. As the blood flows into the device 800 along the flow axis 830, passes through the device 800, and is then led out of the device 800, the blood flows through the flow path 834 of the flow regulator 810. By interacting with the blood flow, the flow regulator 810 can change or affect the hemodynamic characteristics of the flow (e.g., helicity, vorticity, velocity, turbulence, flow direction, etc.). The flow regulator 810 can interact with the blood flowing through or out of the device 800 by adding flow resistance and / or changing the direction of the blood flow, thereby preventing the reversal of the blood flow. For example, the flow regulator 810 can increase or decrease the vorticity or helicity of the flow. In some examples, the flow regulator 810 may make the flow smoother (reduce turbulence). In other examples, the flow regulator 810 can increase the turbulence in the flow. In some examples, the flow regulator 810 can change the direction of the flow. In some examples, the flow regulator 810 can align the flow with the natural vortex pattern of the blood through the blood vessels or chambers of the heart H, such as the left - hand - turning vortex in the left atrium LA or the right - hand - turning vortex in the right atrium RA. In other examples, the flow regulator 810 can align the flow with the natural helical flow pattern of the blood through the blood vessels or chambers of the heart H, such as the helical flow in the coronary sinus CS. The flow regulator 810 disposed at or near the inlet end 818 and / or the outlet end 820 of the device 800 can generate a helical flow pattern in the vicinity of the adjacent blood vessel wall or chamber wall, causing the blood to flow backward toward the center of the blood vessel or chamber in the same helical direction, thereby generating forward movement of the blood. More generally, the flow regulator 810 adjacent to the inlet end 818 can change the hemodynamic characteristics of the blood flowing through the frame 812, and the flow regulator 810 adjacent to the outlet end 820 can change the hemodynamic characteristics of the blood led out from the frame 812.

[0120] In addition to the advantages described above with respect to devices 200 and 400, by incorporating flow regulator 810 directly onto a stent device (e.g., device 800), hemodynamic effects can be generated that minimize disruption to or enhance the natural flow pattern at any site where a stent can be implanted. To some extent, this can be at a more diverse set of locations throughout the cardiovascular system (e.g., any blood vessel or chamber of heart H) compared to valve devices or pre-stent devices / docking station devices that may have more limited uses.

[0121] Device 900 (FIG. 20) FIG. 20 is a cross-sectional view of heart H showing an exemplary arrangement of cardiovascular implant device 900 including fin-type flow regulator 910. As shown in FIG. 20, cardiovascular implant device 900 includes fin-type flow regulator 910, body 912, inflow end 918, and outflow end 920. Body 912 includes central spacer 922, paddle 924, clasp 926 (including first arm 927A and second arm 927B), and central longitudinal axis 928. FIG. 20 also shows device 900, heart H, left atrium LA, left ventricle LV, mitral valve MV, and aorta AT.

[0122] The cardiovascular implant device 900 is an implantable device for use within the cardiovascular system. The cardiovascular implant device 900 is configured to be implanted within a blood vessel or chamber of the heart H. In the illustrated example, the cardiovascular implant device 900 is an edge-to-edge valve repair device. The cardiovascular implant device 900 can be delivered into the cardiovascular system via a catheter (i.e., transcatheter delivery), or surgically placed using transcatheter procedures known in the art or using surgical procedures. In some examples, the device 900 can be delivered and / or implanted using the same catheter or surgical procedure as that used with an adjacent (or nearby) stent device (e.g., devices 700, 800). In other examples, the device 900 can be delivered and / or implanted by a different catheter or by a different surgical procedure. The device 900 can be placed within any blood vessel or chamber of the heart H. In particular, the device 900 is placed in the vicinity of a location where a native valve is present (e.g., in the vicinity of the mitral valve MV, tricuspid valve, aortic valve, pulmonary valve, etc.). For example, FIG. 20 shows an exemplary placement of the device 900 attached to the mitral valve MV. Other examples can include the device 900 attached to other native valves such as the tricuspid valve, aortic valve, pulmonary valve, etc.

[0123] The body 912 forms the main body of the device 900. The body 912 can be formed in various manners and can be formed from a highly flexible metal, a metal alloy, or a polymer. Examples of metals and metal alloys that can be used include, but are not limited to, nitinol and other shape memory alloys, elgiloy, and stainless steel. However, when manufacturing the body 912, other metals, highly elastic non-metallic materials, or soft non-metallic materials can be used. All or part of the body 912 can be integrally formed from any of those materials. The body 912 including the central spacer 922, the paddle 924, and the clasp 926 can have an expanded configuration and an occlusive configuration, i.e., a collapsed configuration. For example, the body 912 can be sized or collapsed to fit within a delivery catheter in the occlusive configuration. The body 912 can be expanded during a implantation procedure for attaching the device 900 to a native valve of the heart H in some examples.

[0124] The body 912 includes the central spacer 922. The central spacer 922 forms the central portion of the device 900. The shape of the central spacer 922 can generally be an elongated shape, a cylindrical shape, or a tapered shape. The central spacer 922 is configured to extend through an opening between the valve leaflets of a native valve of the heart H and to maintain a separation between each pair of paddles 924 and clasps 926 that bridges the opening between the valve leaflets. The central longitudinal axis 928 extends longitudinally through the central spacer 922.

[0125] The clasp 926 is an elongated protrusion from the body 912 and extends radially outward from the central spacer 922 and the central longitudinal axis 928. The clasp 926 includes a respective first arm 927A and a second arm 927B arranged in a U-shape or a V-shape. The first arm 927A of the clasp 926 is configured to contact or press against the first side of the tip of the native valve of the heart H. In the example shown in FIG. 20, the first arm 927A is in contact with the side of the tip of the mitral valve MV facing the left atrium LA. The second arm 927B of the clasp 926 (shown by a dashed line on the back side of a part of the paddle 924 in FIG. 20) is configured to contact or press against the second side of the tip of the native valve of the heart H. In the example shown in FIG. 20, the second arm 927B is in contact with the side of the tip of the mitral valve MV facing the left ventricle LV. The paired first arm 927A and second arm 927B function together to grip the tip of the native valve of the heart H.

[0126] The paddle 924 is a relatively wide and flat protrusion having a paddle shape or an elongated shape, extending radially outward from the body 912, the central spacer 922, and the central longitudinal axis 928. The paddle 924 is configured to contact or press against the second arm 927B of the clasp 926. In the example shown in FIG. 20, the paddle 924 is disposed on the side of the mitral valve MV facing the left ventricle LV such that the paddle 924 is located inside the left ventricle LV. Each of the paddles 924 has a corresponding clasp 926 for fixing the device 900 to the valve leaflet and also for holding the valve leaflets together around the device 900. Thus, each pair consisting of a paddle 924 and a corresponding clasp 926 can have complementary shapes and / or sizes, whereby the pairs fit together to grip one or more valve leaflets. The paddle 924 and the clasp 926 can be driven independently or cooperatively so as to have different angles with respect to the central longitudinal axis 928. The angle of the paddle 924 with respect to the central longitudinal axis 928 can be adjusted based on the desired degree of contact (i.e., pressure) between the paddle 924 and the clasp 926 at the second arm 927B.

[0127] The body 912 extends between the inflow end 918 and the outflow end 920 of the cardiovascular implant device 900. The inflow end 918 can be the end of the device 900 such that when the device 900 is implanted within a blood vessel or chamber of the heart H, it is located upstream of the outflow end 920 with respect to the blood flow parallel to the central longitudinal axis 928 represented by arrow A in FIG. 20. Thus, the outflow end 920 is the end of the device 900 such that when the device 900 is implanted within a blood vessel or chamber of the heart H, it is located downstream of the inflow end 918 with respect to the blood flow parallel to the central longitudinal axis 928 represented by arrow A in FIG. 20. In the example shown in FIG. 20, the outflow end 920 is disposed inside the left ventricle LV and the inflow end 918 is disposed upstream within the left atrium LA, whereby the left atrium LA pumps blood through the mitral valve MV around the device 900 and into the left ventricle LV. Although the inflow end 918 is defined as being located upstream of the outflow end 920, it will be understood that other actual arrangements regarding the inflow end 918 or the outflow end 920 are possible depending on the location where the device 900 is implanted.

[0128] Although not shown in FIG. 20, the device 900 can also include a cover, which can generally include the same structure and function as the covers 114, 514 described above.

[0129] The fin-type flow regulator 910 can generally include the same structure and function as the fin-type flow regulator 110 shown in FIGS. 3A-4, the fin-type flow regulator 140 shown in FIGS. 5A-5B, the fin-type flow regulator 140' shown in FIGS. 6A-8, and the fin-type flow regulators 185A-185E shown in FIGS. 9A-9E. One or more flow regulators 910 can be arranged in any suitable arrangement with respect to the body 912 of the device 900. In some examples (e.g., as shown in FIG. 20), the flow regulator 910 can be connected to and arranged around the central spacer 922, the paddle 924, and / or the clasp 926. In some examples, the flow regulator 910 can be circumferentially connected around the central spacer 922 such that the flow regulator 910 extends radially outward with respect to the central longitudinal axis 928. In some examples, the flow regulator 910 can be arranged adjacent to the inlet end 918 and / or adjacent to the outlet end 920. The device 900 can include any number of flow regulators 910 at any of the one or more positions described above. The position of the flow regulator 910 can be configured such that the flow regulator 910 does not interfere with other parts of the device 900 or adjacent tissue walls. In other examples, the components of the device 900 can be designed to conform to or pass through the flow regulator 910. The position of the flow regulator 910 can be further configured such that the flow regulator 910 can be crushed or expanded together with the body 912 (e.g., for fitting inside a delivery catheter). The position of the flow regulator 910 can be further configured such that the flow regulator 910 does not occlude the blood vessels in the chambers of the heart H into which the device 900 is implanted internally. The position of the flow regulator 910 can be further configured to change the hemodynamic characteristics (e.g., helicity, vorticity, velocity, turbulence, flow direction, etc.) of the blood flowing around the device 900 in a specific manner.

[0130] After the device 900 is implanted into the cardiovascular system (e.g., attached to the mitral valve MV as shown in FIG. 20), the circulating blood passes around the device 900. As the blood flows around the device 900 parallel to the central longitudinal axis 928, the flow regulator 910 interacts with the blood flow to change or affect the hemodynamic characteristics of the flow (e.g., helicity, vorticity, velocity, turbulence, flow direction, etc.). The flow regulator 910 can interact with the blood flowing around the device 900 by adding flow resistance and / or changing the direction of the blood flow, thereby preventing the reversal of the blood flow. For example, the flow regulator 910 can increase or decrease the vorticity or helicity of the flow. In some examples, the flow regulator 910 may make the flow smoother (reduce turbulence). In other examples, the flow regulator 910 can increase the turbulence in the flow. In some examples, the flow regulator 910 can change the direction of the flow. In some examples, the flow regulator 910 can align the flow with the natural vortex pattern of the blood through the blood vessels or chambers of the heart H, such as the left-handed vortex flow in the left atrium LA or the right-handed vortex flow in the right atrium RA. In other examples, the flow regulator 910 can align the flow with the natural helical flow pattern of the blood through the blood vessels or chambers of the heart H, such as the helical flow in the coronary sinus CS. The flow regulator 910 disposed adjacent to the inlet end 918 and / or the outlet end 920 of the device 900 can reverse the blood flow toward the center of the blood vessel or chamber in the same helical direction by generating a helical flow pattern in the vicinity of the adjacent blood vessel wall or chamber wall, thereby generating forward movement of the blood. More generally, the flow regulator 910 adjacent to the inlet end 918 can change the hemodynamic characteristics of the blood flowing into the natural valve of the heart H, and the flow regulator 910 adjacent to the outlet end 920 can change the hemodynamic characteristics of the blood flowing out from the natural valve of the heart H.

[0131] In addition to the advantages described above with respect to devices 100, 300, 500, 700, by incorporating the flow regulator 910 onto an edge-to-edge valve repair device (e.g., device 900), prior to the valve repair procedure, hemodynamic effects can be generated at the native site that minimize disruption to or enhance the native flow pattern. The device 900 including the flow regulator 910 can mitigate adverse effects on intracardiac flow dynamics that may be associated with increasing the work of the left ventricle.

[0132] As a separate example, although illustrated in FIGS. 3A - 20, the cardiovascular implant devices according to the techniques of the present disclosure can include any combination of the above-described features with each other, unless explicitly limited otherwise. The valve devices (e.g., devices 500, 600) and / or stents (e.g., devices 100, 200, 300, 400, 700, 800) can be used alone or in combination to restrict, enhance, or adjust the flow to enhance or restore the normal vortex flow pattern and the normal helical flow pattern. Moreover, dedicated flow regulator devices (i.e., devices including the flow regulators described herein) can be used in patients who do not have severe valve regurgitation and can slow or prevent progressive atrial and ventricular chamber remodeling. In other words, in patients with moderate regurgitation who are not yet candidates for edge-to-edge valve repair or valve replacement, the flow regulator devices described herein can mitigate the impact of moderate regurgitation on cardiac remodeling. Any flow regulator device described herein can maintain the kinetic energy of the blood flow in the cardiovascular system, thereby reducing the necessary cardiac work and improving cardiac efficiency.

[0133] FIG. 21 is a flowchart showing a method 2000 for selecting a cardiovascular implant device including a flow regulator for implantation into the heart. Method 2000 includes steps 2002-2014. The cardiovascular implant device including a flow regulator is selected according to method 2000 to minimize or eliminate disturbances to the flow pattern of blood flow within the patient's heart or to enhance the flow pattern of blood flow within the patient's heart.

[0134] Step 2002 includes obtaining a first MRI of the heart. The first MRI (magnetic resonance imaging) can visualize the flow pattern of blood flow within the patient's heart. Specifically, the first MRI can visualize the flow pattern of blood flow within the patient's heart, within blood vessels and / or chambers (right atrium, left atrium, right ventricle, and left ventricle).

[0135] The first MRI can be a 4D MRI that visualizes the flow pattern of blood flow within the patient's heart. Additionally, the 4D MRI can measure the volume within the heart chambers, the size of the heart chambers, the geometry of the heart chambers, the distensibility of the heart chambers, and / or the blood pressure within the heart chambers. The 4D MRI can also track the movement of the heart chambers and the movement of the tricuspid valve (also known as tricuspid annular plane systolic excursion (TAPSE)).

[0136] Step 2004 includes generating a simulation of the flow pattern within the heart. The simulation of the flow pattern within the heart can be generated based on the first MRI. This enables the simulation to be performed for each patient. In this simulation, the flow pattern within the patient's heart, such as within the blood vessels and / or chambers of the heart, is simulated. In this simulation, it is also possible to simulate the volume, size, geometry, extensibility, and blood pressure of the heart chambers based on the data from the first MRI. This simulation can be generated using any suitable software program.

[0137] Step 2006 includes simulating the blood flow within the heart when various cardiovascular implant devices, including a flow regulator, are implanted within the heart. The simulated blood flow within the heart simulates the impact that the cardiovascular implant device, including the flow regulator, has on the flow pattern within the heart by being adjusted by the cardiovascular implant device. The blood flow within the heart can be simulated when the heart has various types of flow regulators (e.g., fin-type and / or plate-type) including various forms (e.g., various shapes, sizes, presence of flow micro-features, etc.), various physical dimensions, various arrangements or positions with respect to the cardiovascular implant device, various attachment angles or extension angles, and / or other possible variations described herein.

[0138] Step 2008 includes selecting a cardiovascular implant device that includes a flow regulator (or a plurality of flow regulators) to complement the flow pattern within the heart. The cardiovascular implant device that includes the flow regulator is selected to minimize or eliminate turbulence with respect to the flow pattern within the heart or to enhance the flow pattern within the heart. Specifically, step 2008 can include selecting a design of a cardiovascular implant device that includes a flow regulator to complement the flow pattern within the heart. More specifically, the type of the flow regulator can be selected to complement the flow pattern within the heart, the form and / or physical dimensions of the flow regulator can be selected to complement the flow pattern within the heart, and the placement or position and / or angle of the flow regulator can be selected to complement the flow pattern within the heart.

[0139] The right atrium of the heart has a right-handed swirling flow as a natural flow pattern within the heart. The design of the cardiovascular implant device that includes the flow regulator can be selected to complement the right-handed swirling flow within the right atrium of the heart. The left atrium of the heart has a left-handed swirling flow as a natural flow pattern within the heart. The design of the cardiovascular implant device that includes the flow regulator can be selected to complement the left-handed swirling flow within the left atrium of the heart. The coronary sinus and other blood vessels of the heart may have a helical flow pattern. The design of the cardiovascular implant device that includes the flow regulator can be selected to complement the helical flow pattern within the coronary sinus or within other blood vessels of the heart.

[0140] In an alternative example, step 2008 can include selecting a design of a cardiovascular implant device that includes a flow regulator to enhance the flow pattern in the right atrium of the heart and / or a design of a cardiovascular implant device that includes a flow regulator to re-establish the natural flow pattern in the right atrium of the heart. Specifically, if a patient has lost the vortex of the rightward flow of blood in the right atrium of the heart due to aging, disease, or an anatomical defect, the design of the cardiovascular implant device that includes a flow regulator can be selected to re-establish the vortex of the rightward flow of blood in the right atrium of the heart.

[0141] Step 2010 includes implanting a cardiovascular implant device that includes a flow regulator into the heart. The cardiovascular implant device that includes a flow regulator can be implanted using any suitable method.

[0142] Step 2012 includes obtaining a second MRI of the heart. The second MRI (magnetic resonance imaging) can visualize the flow pattern of blood in the patient's heart after the cardiovascular implant device that includes a flow regulator has been implanted. Specifically, the second MRI can visualize the flow pattern of blood in the blood vessels of the patient's heart and / or within the chambers (right atrium, left atrium, right ventricle, and left ventricle) after the cardiovascular implant device that includes a flow regulator has been implanted.

[0143] The second MRI can be a 4D MRI that visualizes the flow pattern of blood in the patient's heart after the cardiovascular implant device that includes a flow regulator has been implanted. Additionally, the 4D MRI can measure the volume within the chambers of the heart, the size of the chambers of the heart, the geometry of the chambers of the heart, the distensibility of the chambers of the heart, and / or the blood pressure within the chambers of the heart. The 4D MRI can also track the movement of the chambers of the heart and the movement of the tricuspid valve (also known as the tricuspid annular plane systolic excursion (TAPSE)).

[0144] A second MRI is acquired to confirm that a cardiovascular implant device including a flow regulator complements the flow pattern within the heart (e.g., the flow regulator minimizes or eliminates turbulence with respect to the flow pattern within the heart, or enhances the flow pattern within the heart). Further, the second MRI can be acquired to determine whether a cardiovascular implant device including a flow regulator enhances and / or re - establishes the natural flow pattern within the heart. Specifically, the second MRI can be acquired to determine whether a cardiovascular implant device including a flow regulator re - establishes a right - hand vortex flow within the right atrium of the heart.

[0145] The second MRI can also confirm the overall health of the heart after a cardiovascular implant device including a flow regulator has been implanted. Specifically, the overall health of the heart can be confirmed by comparing the volume within the chambers of the heart, the size of the chambers of the heart, the geometry of the chambers of the heart, the distensibility of the chambers of the heart, and / or the blood pressure within the chambers of the heart from the second MRI with the same measurements from the first MRI. In one example, by analyzing the volume, size, geometry, and / or distensibility of the chambers of the heart, it can be determined whether the left side of the heart has experienced remodeling (shrinking) due to a decrease in blood pressure on the left side of the heart after a cardiovascular implant device including a flow regulator has been implanted. Further, by analyzing the volume, size, geometry, and / or distensibility of the chambers of the heart, it can be determined whether the right side of the heart is overloaded due to an increase in blood pressure on the right side of the heart.

[0146] Step 2014 includes adjusting a cardiovascular implant device that includes a flow regulator. The cardiovascular implant device that includes a flow regulator can be adjusted if a second MRI indicates that the implantation of the cardiovascular implant device that includes a flow regulator is not producing a desired effect on the flow pattern within the heart or on the overall health of the heart. In one example, the type of flow regulator can be changed from, for example, one or more of a fin type, plate type, or deflector type of flow regulator, or a combination of those types, to one or more different types of flow regulators, or different combinations of those types. In another example, the shape, physical dimensions, and / or the placement or position of the flow regulator can be adjusted. In another example, the angle of the flow regulator can be adjusted. For example, the flow regulator can be connected to the cardiovascular implant device by an adjustable biasing member that can be adjusted so that the flow regulator has different angles, or the flow regulator can be electromechanically actuated to different angles.

[0147] The method 2000 described herein can be used to assist in the selection and implantation of any suitable cardiovascular implant device that includes a flow regulator. In one example, the method 2000 can be used to assist in the selection and implantation of a cardiovascular implant device 100 (shown in FIGS. 3A - 9E), a cardiovascular implant device 200 (shown in FIGS. 10A - 11E), a cardiovascular implant device 300 (shown in FIGS. 12 - 13), a cardiovascular implant device 400 (shown in FIG. 14), a cardiovascular implant device 500 (shown in FIGS. 15A - 16B), a cardiovascular implant device 600 (shown in FIGS. 17A - 17C), a cardiovascular implant device 700 (shown in FIG. 18), a cardiovascular implant device 800 (shown in FIG. 19), or a cardiovascular implant device 900 (shown in FIG. 20). The method 2000 can be used to select a design of the cardiovascular implant devices 100, 200, 300, 400, 500, 600, 700, 800, 900 that will complement the flow pattern within the heart (e.g., minimize or remove or enhance turbulence). In an alternative example, the method 2000 can be used with respect to any other design of cardiovascular implant device that includes a flow regulator.

[0148] Any of the various systems, devices, apparatuses in the present disclosure can be sterilized (e.g., by heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure safety for use in a patient, and the methods herein can include sterilizing the associated systems, devices, apparatuses, etc. (e.g., by heat, radiation, ethylene oxide, hydrogen peroxide, etc.). That is, any of the devices 100, 200, 300, 400, 500, 600, 700, 800, 900 or the components of the devices 100, 200, 300, 400, 500, 600, 700, 800, 900 can be sterilized prior to delivery into the body.

[0149] Treatment techniques, methods, steps, etc., as described or suggested in this specification, or as described or suggested in the documents incorporated herein by reference, can be implemented on a living animal, or on a non-living simulation such as a cadaver, a cadaver's heart, an anthropomorphic ghost, a simulator (e.g., where a body part, tissue, etc. is simulated), etc.

Example

[0150] Description of possible examples The following is a non-exclusive description of possible examples of the present invention.

[0151] The cardiovascular implant device includes an expandable annular frame and a flow regulator. The expandable annular frame is formed from a plurality of struts and is configured to conform to the internal shape of a blood vessel or chamber of the heart when expanded inside the blood vessel or chamber of the heart. The flow regulator is connected to the plurality of struts of the expandable annular frame. The flow regulator is arranged to change the hemodynamic characteristics of the blood flow flowing through or derived from the expandable annular frame.

[0152] The cardiovascular implant device of the preceding paragraph can optionally, additionally, and / or alternatively include any one or more of the following features, configurations, and / or additional components.

[0153] The flow regulator can include one or more fins.

[0154] One or more fins can be circumferentially connected around the inside of the expandable annular frame.

[0155] One or more fins can be connected to the plurality of struts that form a first row of openings in the expandable annular frame, and the first row of openings is adjacent to the outflow end of the expandable annular frame.

[0156] One or more fins can be inclined radially inwards from the periphery of the expandable annular frame.

[0157] One or more fins can be connected adjacent to the inlet or outlet end of the expandable annular frame.

[0158] One or more fins can be inclined radially inwards from the inlet or outlet end of the expandable annular frame.

[0159] One or more fins can include a first fin that is connected to the expandable annular frame at the inlet end of the cardiovascular implant device, thereby changing the hemodynamic characteristics of the blood flow passing through the expandable annular frame, and a second fin that is connected to the expandable annular frame at the outlet end of the cardiovascular implant device, thereby changing the hemodynamic characteristics of the blood flow flowing out from the expandable annular frame.

[0160] Each fin of one or more fins can be deflectable by the blood flow passing through or derived from the expandable annular frame.

[0161] Each fin of one or more fins can be connected to the expandable annular frame by a spring.

[0162] One or more fins can be airfoil-shaped, and one or more fins can include flow micro-features adjacent to the leading edge of the corresponding one or more fins.

[0163] The flow micro-features can include at least one of a vortex generator, a leading edge notch, a leading edge canine tooth, a boundary layer fence, and a volution.

[0164] The flow regulator and the expandable annular frame can form an integral structure.

[0165] The flow regulator and the portion of the expandable annular frame to which the flow regulator is connected can be formed of a shape memory alloy.

[0166] The shape memory alloy can be nitinol.

[0167] The flow regulator can be driven electro-mechanically.

[0168] The mounting angle of the flow regulator, measured with respect to the longitudinal axis of the corresponding strut of the plurality of struts to which the flow regulator is connected, can be controllable over a possible angular range.

[0169] The flow regulator can include one or more plates straddling a portion of the expandable annular frame, the one or more plates intersecting the flow axis through the expandable annular frame, and each of the one or more plates includes a plurality of flow paths.

[0170] The one or more plates can include a first plate having a first plurality of flow paths and a second plate having a second plurality of flow paths. The first plate can be connected at the inflow end of the cardiovascular implant device to change the hemodynamic characteristics of the blood flow through the expandable annular frame. The second plate can be connected to the outflow end of the cardiovascular implant device to change the hemodynamic characteristics of the blood flow flowing out from the expandable annular frame.

[0171] The flow regulator can be connected to the expandable annular frame at the inflow end of the cardiovascular implant device to change the hemodynamic characteristics of the blood flow through the expandable annular frame.

[0172] The flow regulator can be connected to an expandable annular frame at the outflow end of a cardiovascular implant device, thereby changing the hemodynamic characteristics of the blood flow flowing out from the expandable annular frame.

[0173] The flow regulator can include a first flow regulator feature connected to an expandable annular frame at the inflow end of a cardiovascular implant device and a second flow regulator feature connected to an expandable annular frame at the outflow end of the cardiovascular implant device. The first flow regulator feature can be arranged to change the hemodynamic characteristics of the blood flow flowing through the expandable annular frame, and the second flow regulator feature can be arranged to change the hemodynamic characteristics of the blood flow flowing out from the expandable annular frame.

[0174] The flow regulator can have physical dimensions that avoid the flow regulator interacting with adjacent tissue walls.

[0175] The flow regulator can include at least one of fins and plates, and the plates include a plurality of flow channels.

[0176] The cardiovascular implant device can be sterilized.

[0177] The cardiovascular implant device can be a docking station configured to support an expandable transcatheter valve.

[0178] The cardiovascular implant device can be a stent.

[0179] The cardiovascular implant device can be configured to be implanted at a valve site.

[0180] The cardiovascular implant device can be configured to be implanted at a non-valve site.

[0181] The artificial valve device includes an annular frame formed from a plurality of struts, a valve body attached inside the annular frame, and a flow regulator. The valve body includes a plurality of valve leaflets that control the blood flow passing through the annular frame. The flow regulator is connected to the plurality of struts of the annular frame. The flow regulator is arranged to change the hemodynamic characteristics of the blood flow flowing through or derived from the annular frame.

[0182] The artificial valve device of the preceding paragraph can optionally, additionally, and / or alternatively include any one or more of the following features, configurations, and / or additional components.

[0183] The flow regulator can include one or more fins.

[0184] One or more fins can be circumferentially connected around the inside of the annular frame.

[0185] One or more fins can be connected to the plurality of struts that form the first row of openings in the annular frame, and the first row of openings is adjacent to the outflow end of the annular frame.

[0186] One or more fins can be inclined radially inwards from the periphery of the annular frame.

[0187] One or more fins can be connected adjacent to the inflow end or the outflow end of the annular frame.

[0188] One or more fins can be inclined radially inwards from the inflow end or the outflow end of the annular frame.

[0189] One or more fins can include a first fin that is connected to the annular frame at the inflow end of the artificial valve device to change the hemodynamic characteristics of the blood flow passing through the annular frame, and a second fin that is connected to the annular frame at the outflow end of the artificial valve device to change the hemodynamic characteristics of the blood flow flowing out from the annular frame.

[0190] Each fin of the plurality of fins can be deflectable by the blood flow passing through or derived from the annular frame.

[0191] Each fin of the plurality of fins can be connected to the annular frame by a spring.

[0192] One or more fins can be airfoil-shaped, and one or more fins can include flow micro-features proximate to the leading edge of the corresponding one or more fins.

[0193] The flow micro-features can include at least one of a vortex generator, a leading edge notch, a leading edge canine tooth, a boundary layer fence, and a vortilon.

[0194] The flow regulator and the annular frame can form an integral structure.

[0195] The flow regulator and the portion of the annular frame to which the flow regulator is connected can be formed from a shape memory alloy.

[0196] The shape memory alloy can be nitinol.

[0197] The flow regulator can be driven electromechanically.

[0198] The mounting angle of the flow regulator, measured with respect to the longitudinal axis of the corresponding strut of the plurality of struts to which the flow regulator is connected, can be controllable over a possible angle range.

[0199] The flow regulator can include one or more plates spanning across a part of the annular frame, the one or more plates intersecting the flow axis through the annular frame, and each of the one or more plates includes a plurality of flow channels.

[0200] The one or more plates can include a first plate having a first plurality of flow channels and a second plate having a second plurality of flow channels. The first plate can be connected at the inlet end of the artificial valve device to change the hemodynamic characteristics of the blood flow through the annular frame. The second plate can be connected to the outlet end of the artificial valve device to change the hemodynamic characteristics of the blood flow flowing out from the annular frame.

[0201] The flow regulator can be connected to the annular frame at the inlet end of the artificial valve device to change the hemodynamic characteristics of the blood flow through the annular frame.

[0202] The flow regulator can be connected to the annular frame at the outlet end of the artificial valve device to change the hemodynamic characteristics of the blood flow flowing out from the annular frame.

[0203] The flow regulator can include a first flow regulator feature connected to the annular frame at the inlet end of the artificial valve device and a second flow regulator feature connected to the annular frame at the outlet end of the artificial valve device. The first flow regulator feature can be arranged to change the hemodynamic characteristics of the blood flow through the annular frame, and the second flow regulator feature can be arranged to change the hemodynamic characteristics of the blood flow flowing out from the annular frame.

[0204] The flow regulator can have physical dimensions that avoid the flow regulator interacting with the valve body and / or adjacent tissue walls.

[0205] The flow regulator can include at least one of fins and plates, and the plate includes a plurality of flow paths.

[0206] The artificial valve device can be sterilized.

[0207] The artificial valve device can be configured to be implanted at a valve site.

[0208] The artificial valve device can be configured to be implanted at a non-valve site.

[0209] The artificial valve system includes a prestent device having a frame with a bidirectional expanding diameter profile formed from a first plurality of struts, an artificial valve device configured to seat inside the prestent device, a first flow regulator, and a second flow regulator. The artificial valve device includes an annular frame formed from a second plurality of struts and a valve body attached inside the annular frame. The valve body includes a plurality of valve leaflets that control the blood flow passing through the annular frame. The first flow regulator is connected to the first plurality of struts of the prestent device. The first flow regulator is arranged to change a first hemodynamic characteristic of the blood flow flowing through or derived from the prestent device. The second flow regulator is connected to the second plurality of struts of the artificial valve device. The second flow regulator is arranged to change a second hemodynamic characteristic of the blood flow flowing through or derived from the artificial valve device.

[0210] The artificial valve system of the preceding paragraph can optionally, additionally, and / or alternatively include any one or more of the following features, configurations, and / or additional components.

[0211] The first flow regulator and the second flow regulator can include one or more fins.

[0212] Individual fins of one or more fins can be circumferentially connected around the corresponding interior of the frame of the prestent device and / or the annular frame of the artificial valve device.

[0213] Individual fins of one or more fins can be inclined radially inwards from the corresponding peripheries of the frame of the prestent device and / or the annular frame of the artificial valve device.

[0214] Individual fins of one or more fins can be connected adjacent to the corresponding inlet or outlet ends of the frame of the prestent device and / or the annular frame of the artificial valve device.

[0215] One or more fins can include a first fin that changes the hemodynamic characteristics of the blood flow passing through the prestent device by being connected to the frame at the inlet end of the prestent device, a second fin that changes the hemodynamic characteristics of the blood flow flowing out from the prestent device by being connected to the frame at the outlet end of the prestent device, a third fin that changes the hemodynamic characteristics of the blood flow passing through the artificial valve device by being connected to the annular frame at the inlet end of the artificial valve device, and a fourth fin that changes the hemodynamic characteristics of the blood flow flowing out from the artificial valve device by being connected to the annular frame at the outlet end of the artificial valve device.

[0216] Each fin of one or more fins of the first flow regulator can be deflectable by the blood flow passing through or flowing out from the prestent device, and each fin of one or more fins of the second flow regulator can be deflectable by the blood flow passing through or flowing out from the artificial valve device.

[0217] Individual fins of the one or more fins can be connected by springs to the frame of the prestent device or to the annular frame of the artificial valve device.

[0218] The one or more fins can be airfoil-shaped, and the one or more fins can each include flow micro-features proximate to the leading edge of the corresponding one or more fins.

[0219] The flow micro-features can include at least one of a vortex generator, a leading edge notch, a leading edge canine tooth, a boundary layer fence, and a vortilon.

[0220] The first flow regulator and the frame of the artificial valve device can form a first integral structure, and the second flow regulator and the annular frame of the artificial valve device can form a second integral structure.

[0221] The first flow regulator and the portion of the frame of the prestent device to which the first flow regulator is connected can be formed from a shape memory alloy, and the second flow regulator and the portion of the annular frame of the artificial valve device to which the second flow regulator is connected can be formed from a shape memory alloy.

[0222] The shape memory alloy can be nitinol.

[0223] The first flow regulator and the second flow regulator can be driven electro-mechanically.

[0224] The first flow regulator can include one or more plates spanning across a part of the frame of the prestent device, and one or more plates of the first flow regulator intersect with respect to the flow axis through the frame. The second flow regulator can include one or more plates spanning across a part of the annular frame of the artificial valve device, and one or more plates of the second flow regulator intersect with respect to the flow axis through the annular frame. Each of the one or more plates of the first flow regulator and the second flow regulator can include a corresponding plurality of flow paths.

[0225] One or more plates of the first flow regulator and the second flow regulator can include a first plate connected at the inflow end of the prestent device to change the hemodynamic characteristics of the blood flow passing through the prestent device, a second plate connected at the outflow end of the prestent device to change the hemodynamic characteristics of the blood flow flowing out from the prestent device, a third plate connected at the inflow end of the artificial valve device to change the hemodynamic characteristics of the blood flow passing through the artificial valve device, and a fourth plate connected at the outflow end of the artificial valve device to change the hemodynamic characteristics of the blood flow flowing out from the artificial valve device.

[0226] The first flow regulator can be connected to the frame at the inflow end of the prestent device to change the hemodynamic characteristics of the blood flow passing through the prestent device, or the first flow regulator can be connected to the frame at the outflow end of the prestent device to change the hemodynamic characteristics of the blood flow flowing out from the prestent device.

[0227] The second flow regulator can change the hemodynamic characteristics of the blood flow passing through the artificial valve device by connecting to the annular frame at the inflow end of the artificial valve device, or the second flow regulator can change the hemodynamic characteristics of the blood flow flowing out from the artificial valve device by connecting to the annular frame at the outflow end of the artificial valve device.

[0228] The first flow regulator can include one or more fins, and the second flow regulator can include one or more plates spanning across a part of the annular frame of the artificial valve device, where the one or more plates of the second flow regulator intersect with the flow axis through the annular frame, or the first flow regulator can include one or more plates spanning across a part of the frame of the stent device, where the one or more plates of the first flow regulator intersect with the flow axis through the frame, and the second flow regulator can include one or more fins.

[0229] The first flow regulator and the second flow regulator can have corresponding physical dimensions such that the first flow regulator and the second flow regulator avoid interacting with the adjacent tissue wall.

[0230] Each of the first flow regulator and the second flow regulator can include at least one of a fin and a plate, and the plate includes a plurality of flow channels.

[0231] The stent device and the artificial valve device can be sterilized.

[0232] The artificial valve system can be configured to be implanted at the valve site.

[0233] The artificial valve system can also be configured to be implanted at a non-valve site.

[0234] The cardiovascular implant device includes a main body and a flow regulator connected to the main body. The main body is configured to be attached to one or more valve leaflets of a natural heart valve. The main body includes a central spacer and clasps extending radially outward from the central spacer. Each of the clasps includes a first arm and a second arm for gripping one or more valve leaflets. The flow regulator is arranged to change the hemodynamic characteristics of the blood flow passing through the periphery of the cardiovascular implant device.

[0235] The cardiovascular implant device of the preceding paragraph can optionally, additionally, and / or alternatively include any one or more of the following features, configurations, and / or additional components.

[0236] The flow regulator can include one or more fins.

[0237] Each of the one or more fins can be deflected by the blood flow passing through the periphery of the cardiovascular implant device.

[0238] Each of the one or more fins can be connected to the main body by a spring.

[0239] The one or more fins can be airfoil-shaped, and the one or more fins can each include flow micro-features proximate to the leading edge of the corresponding one or more fins.

[0240] The flow micro-features can include at least one of a vortex generator, a leading edge notch, a leading edge canine tooth, a boundary layer fence, and a vortilon.

[0241] The flow regulator and the main body can form a one-piece structure.

[0242] The flow regulator and the portion of the main body to which the flow regulator is connected can be formed from a shape memory alloy.

[0243] The shape memory alloy can be nitinol.

[0244] The flow regulator can be driven electro-mechanically.

[0245] The flow regulator can be connected to the main body at the inlet end of the cardiovascular implant device.

[0246] The flow regulator can be connected to the main body at the outlet end of the cardiovascular implant device.

[0247] The flow regulator can include a first flow regulator feature connected to the main body at the inlet end of the cardiovascular implant device and a second flow regulator feature connected to the main body at the outlet end of the cardiovascular implant device.

[0248] The flow regulator can be connected to the main body at the central spacer.

[0249] The flow regulator can be connected to the main body at the clasp.

[0250] The flow regulator can have physical dimensions that avoid the flow regulator interacting with adjacent tissue walls.

[0251] The cardiovascular implant device can be sterilized.

[0252] The cardiovascular implant device can be an edge-to-edge valve repair device.

[0253] Although the present invention has been described with reference to exemplary embodiments, those skilled in the art will understand that various modifications can be made without departing from the scope of the present invention, and that constituent members can be replaced by equivalents. In addition, many modifications can be made to adapt a particular situation or material to the teachings of the present invention without departing from the essential scope of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed, and it is intended that the present invention include all examples falling within the scope of the appended claims.

Claims

1. A cardiovascular implant device, An expandable annular frame formed from a plurality of struts, configured to conform to the internal shape of the blood vessel or chamber of the heart when expanded within the blood vessel or chamber of the heart; and A flow regulator connected to the plurality of struts of the expandable annular frame, disposed to alter the hemodynamic characteristics of blood flow passing through or exiting from the expandable annular frame, the cardiovascular implant device comprising.

2. The cardiovascular implant device of claim 1, wherein the flow regulator includes one or more fins.

3. The cardiovascular implant device of claim 2, wherein the one or more fins are circumferentially connected around the inside of the expandable annular frame.

4. The cardiovascular implant device of claim 3, wherein the one or more fins are inclined radially inwards from the periphery of the expandable annular frame.

5. The cardiovascular implant device of claim 2, wherein the one or more fins are connected adjacent to the inflow or outflow end of the expandable annular frame.

6. The cardiovascular implant device of claim 2, comprising a first fin connected to the expandable annular frame at the inflow end of the cardiovascular implant device to alter the hemodynamic characteristics of blood flow passing through the expandable annular frame, and a second fin connected to the expandable annular frame at the outflow end of the cardiovascular implant device to alter the hemodynamic characteristics of blood flow exiting from the expandable annular frame.

7. The cardiovascular implant device according to claim 2, wherein each fin of the one or more fins is deflectable by the blood flow derived through or from the expandable annular frame.

8. The cardiovascular implant device according to claim 2, wherein the one or more fins are airfoil-shaped, and each of the one or more fins includes flow micro-features proximate to the leading edge of the corresponding one or more fins.

9. The cardiovascular implant device according to claim 1, wherein the flow regulator and the expandable annular frame form an integral structure.

10. The cardiovascular implant device according to claim 9, wherein the flow regulator and the portion of the expandable annular frame to which the flow regulator is connected are formed of a shape memory alloy.

11. The cardiovascular implant device according to claim 10, wherein the shape memory alloy is nitinol.

12. The cardiovascular implant device according to claim 10, wherein the flow regulator is driven electro-mechanically.

13. The cardiovascular implant device according to claim 1, wherein the flow regulator includes one or more plates spanning across a portion of the expandable annular frame, the one or more plates intersecting the flow axis through the expandable annular frame, and each of the one or more plates includes a plurality of flow channels.

14. The one or more plates include a first plate having a first plurality of flow channels and a second plate having a second plurality of flow channels, the first plate being connected at the inlet end of the cardiovascular implant device to change the hemodynamic characteristics of the blood flow through the expandable annular frame, and the second plate being connected to the outlet end of the cardiovascular implant device to change the hemodynamic characteristics of the blood flow flowing out from the expandable annular frame. The cardiovascular implant device according to claim 13.

15. The flow regulator is connected to the expandable annular frame at the inlet end of the cardiovascular implant device to change the hemodynamic characteristics of the blood flow through the expandable annular frame. The cardiovascular implant device according to claim 1.

16. The flow regulator is connected to the expandable annular frame at the outlet end of the cardiovascular implant device to change the hemodynamic characteristics of the blood flow flowing out from the expandable annular frame. The cardiovascular implant device according to claim 1.

17. The flow regulator includes a first flow regulator feature connected to the expandable annular frame at the inlet end of the cardiovascular implant device and a second flow regulator feature connected to the expandable annular frame at the outlet end of the cardiovascular implant device. The first flow regulator feature is arranged to change the hemodynamic characteristics of the blood flow through the expandable annular frame, and the second flow regulator feature is arranged to change the hemodynamic characteristics of the blood flow flowing out from the expandable annular frame. The cardiovascular implant device according to claim 1.

18. The flow regulator has physical dimensions such that the flow regulator avoids interacting with adjacent tissue walls. The cardiovascular implant device according to claim 1.

19. The cardiovascular implant device according to claim 1, wherein the flow regulator includes at least one of fins and plates, and the plate includes a plurality of flow paths.

20. The cardiovascular implant device according to claim 1, wherein the cardiovascular implant device is sterilized.

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