Patent Application
20250090298
The present disclosure relates to cardiovascular implant devices, and more specifically to cardiovascular implant devices for minimizing disruption to and enhancing cardiovascular hemodynamics.
Various medical devices can be implanted in the cardiovascular system at sites where blood will flow through or around the implanted device. For example, prosthetic or artificial valve devices can be deployed to replace native valves that are diseased or malfunctioning. Edge-to-edge valve repair devices are also deployed to native valve sites to treat tricuspid regurgitation (TR) or mitral regurgitation (MR). Additionally, stents can be deployed into the cardiovascular system to hold open a stenosed vessel. These implantable devices can be placed in natural flow paths within the cardiovascular system.
In one example, a cardiovascular implant device includes an expandable annular frame and a flow conditioner. The expandable annular frame is formed of a plurality of struts and is configured to conform to an interior shape of a blood vessel or a chamber of a heart when expanded inside the blood vessel or the chamber of the heart. The flow conditioner is connected to the plurality of struts of the expandable annular frame. The flow conditioner is positioned to modify a hemodynamic characteristic of a flow of blood through or out of the expandable annular frame.
In another example, a prosthetic valve device includes an annular frame formed of a plurality of struts, a valvular body mounted within the annular frame, and a flow conditioner. The valvular body includes a plurality of leaflets that regulate a flow of blood through the annular frame. The flow conditioner is connected to the plurality of struts of the annular frame. The flow conditioner is positioned to modify a hemodynamic characteristic of the flow of blood through or out of the annular frame.
In another example, a prosthetic valve system includes a present device having a frame with a bi-directionally flared profile that is formed of a first plurality of struts, a prosthetic valve device configured to sit within the present device, a first flow conditioner, and a second flow conditioner. The prosthetic valve device includes an annular frame formed of a second plurality of struts and a valvular body mounted within the annular frame. The valvular body includes a plurality of leaflets that regulate a flow of blood through the annular frame. The first flow conditioner is connected to the first plurality of struts of the present device. The first flow conditioner is positioned to modify a first hemodynamic characteristic of the flow of blood through or out of the present device. The second flow conditioner is connected to the second plurality of struts of the prosthetic valve device. The second flow conditioner is positioned to modify a second hemodynamic characteristic of the flow of blood through or out of the prosthetic valve device.
In another example, a cardiovascular implant device includes a body and a flow conditioner connected to the body. The body is configured to attach to one or more leaflets of a natural 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 the one or more leaflets. The flow conditioner is positioned to modify a hemodynamic characteristic of a flow of blood around the cardiovascular implant device.
Heart H is a human heart that receives blood from and delivers blood to vasculature V. Heart H includes four chambers: right atrium RA, right ventricle RV, left atrium LA, and left ventricle LV.
The right side of heart H, including right atrium RA and right ventricle RV, receives deoxygenated blood from vasculature V and pumps the blood to the lungs. Blood flows into right atrium RA from superior vena cava SVC, inferior vena cava IVC, and coronary sinus CS.
A majority of the blood flows into right atrium RA from superior vena cava SVC and inferior vena cava IVC, which are offset from one another. Due to the offset of the major entry blood flows from superior vena cava SVC and inferior vena cava IVC, a natural flow vortex occurs in right atrium RA (a right-sided flow vortex). This allows a substantial portion of blood from right atrium RA to pass through right atrium RA and enter right ventricle RV by direct flow. The right-sided flow vortex in right atrium RA preserves kinetic energy and momentum of the major blood flows entering right atrium RA and allows a substantial portion of blood to naturally pass from right atrium RA to right ventricle RV without any contribution to flow needed from the pumping action of right atrium RA. With contraction, right atrium RA also pumps the residual portion of the entering blood not caught in the direct flow through tricuspid valve TV into right ventricle RV. The blood enters right ventricle RV and then flows through pulmonary valve PV into pulmonary artery PA. With preservation of direct inflow from right atrium RA, blood entering right ventricle RV also forms a natural flow vortex (a right-ventricular flow vortex) in right ventricle RV, which naturally re-directs blood entering right ventricle RV to pulmonary artery PA by direct flow without requiring right ventricle RV to perform substantial work of pumping blood. Residual blood that is not transported to pulmonary artery PA via pulmonary valve PV by direct flow is pumped by the contraction of right ventricle RV. The blood flows from pulmonary artery PA into smaller arteries that deliver the deoxygenated blood to the lungs via the pulmonary circulatory system. The lungs can then oxygenate the blood.
The left side of heart H, including left atrium LA and left ventricle LV, receives the oxygenated blood from the lungs and provides blood flow to the body. Blood flows into left atrium LA from pulmonary veins PVS. The offset of the right and left pulmonary veins PVS also leads to the formation of a natural flow vortex in left atrium LA (left-sided flow vortex), which helps maintain momentum and minimize work as the blood traverses left atrium LA to mitral valve MV. Direct flow, as described above, and the pumping action of left atrium LA propels the blood through mitral valve MV into left ventricle LV. As the blood enters left ventricle LV, a natural flow vortex (a left-ventricular flow vortex) forms in left ventricle LV, which redirects flow naturally towards the left ventricular outflow of aortic valve AV so that it can be efficiently pumped by left ventricle LV through aortic valve AV into aorta AT. The blood flows from aorta AT into arteries that deliver the oxygenated blood to the body via the systemic circulatory system.
Natural flow patterns of blood flow exist in heart H and help move blood through heart H and into the vasculature connected to heart H in a way that maximizes preservation of blood flow momentum and kinetic energy. The natural flow pattern for blood moving through arteries and veins is typically helical in nature (helical flow patterns). The natural flow pattern for blood moving through the chambers of heart H is typically vortical in nature (vortical flow patterns).
Blood flows enter the right atrium RA from superior vena cava SVC, inferior vena cava IVC, and coronary sinus CS. The superior vena cava opening and the inferior vena cava opening in right atrium RA are offset so that the blood flowing into right atrium RA from superior vena cava SVC and inferior vena cava IVC do not collide with each other. Due to its orientation and physical proximity, coronary sinus CS flow is entrained into inferior vena cava IVC flow. The blood flowing through superior vena cava SVC and inferior vena cava IVC has a helical flow pattern. A majority of the blood in right atrium RA enters right atrium RA through inferior vena cava IVC, and the blood flowing from inferior vena cava IVC into right atrium RA is pointed towards the top of right atrium RA. The helical flow pattern of the blood flowing into right atrium RA from inferior vena cava IVC helps to form a clockwise right-sided flow vortex in right atrium RA (when looking at the heart from the right side). The flow of blood entering right atrium RA from superior vena cava SVC will flow along the inter-atrial septum and towards tricuspid valve TV. The helical flow pattern of the blood flowing from superior vena cava SVC into right atrium RA helps the flow of blood naturally join with the clockwise right-sided flow vortex formed in right atrium RA by the flow of blood from inferior vena cava IVC, which is joined by coronary sinus CS flow. A small amount of blood flows into right atrium RA from coronary sinus CS. The flow flowing through coronary sinus CS will have a helical flow pattern. The helical flow pattern of the blood exiting coronary sinus CS will naturally join with inferior vena cava IVC flow and the right-sided flow vortex in right atrium RA. The right-sided flow vortex in right atrium RA is shown with velocity stream lines labeled RVF in
The right-sided flow vortex formed in right atrium RA helps the blood flow through right atrium RA, through tricuspid valve TV, into the right ventricle, through the pulmonary valve, and into the pulmonary artery. The right heart is an inefficient pump and can act more like a conduit. The right-sided flow vortex formed in the right heart helps to preserve kinetic energy and the momentum of blood flow as it moves from superior vena cava SVC and inferior vena cava IVC (the Vena Cavac) through the right heart and into the pulmonary artery, even with minimal to no pumping being provided by the right heart. This is especially important for maintaining right heart output, which must match left heart output, during periods of high output and heart rates during exercise. The right-sided flow vortex formed in right atrium RA helps to move the blood from right atrium RA through tricuspid valve TV and into the right ventricle with minimal loss of momentum and kinetic energy. The blood shoots from right atrium RA through the right ventricle, out the right ventricular outflow tract, through the pulmonary valve, and into the pulmonary artery. Approximately 50% of the blood will flow into the pulmonary artery without any pumping required by the right heart because of the right-sided flow vortices of right atrium RA and right ventricle RV and anatomical constraints of the right heart. Right heart contraction enhances the flow of residual blood through the right heart.
Blood flows into left atrium LA from pulmonary veins PVS. There are four pulmonary veins PVS that flow into left atrium LA. The blood flowing through pulmonary veins PVS has a helical flow pattern. The offset of helical flow of the blood flowing from pulmonary veins PVS into left atrium LA helps to form a counter-clockwise left-sided flow vortex (when looking at the heart from the right side) in left atrium LA. The left-sided flow vortex in left atrium LA directs flow towards mitral valve MV. The left-sided flow vortex in left atrium LA is shown with velocity stream lines labeled LVF in
Although not illustrated in
It is hypothesized that if the intra-cardiac blood flow patterns in heart H (including right-sided flow vortex in right atrium RA and left-sided flow vortex in left atrium LA) are disrupted, blood flow from superior vena cava SVC and inferior vena cava IVC (the Vena Cavac), through right atrium RA, through the right ventricle, and into the pulmonary artery, and blood flow from the pulmonary veins, through the left atrium LA, through the left ventricle, and into the aorta become less efficient and place increased mechanical workloads on the respective ventricles. This is especially important in already failing hearts, where the ability to increase the workload of the heart muscle is impaired. Disruptions in the intra-cardiac blood flow patterns in heart H (including right-sided flow vortex in right atrium RA and left-sided flow vortex in left atrium LA) can happen for a variety of reasons. For example, the anatomy of heart H can change as patients age. This can affect the offset between the opening of superior vena cava SVC and the opening of inferior vena cava IVC. The blood flow entering right atrium RA from superior vena cava SVC and the blood flow entering right atrium RA from inferior vena cava IVC can collide as the anatomy of heart H changes, which disrupts the natural formation of the right-sided flow vortex in right atrium RA. In another example, right atrium RA can be enlarged in patients with heart failure with or without atrial fibrillation. The enlargement of right atrium RA can also disrupt the right-sided flow vortex formed in right atrium RA. Similarly, left atrium LA can be enlarged in patients with heart failure with or without atrial fibrillation. The enlargement of left atrium LA can disrupt the left-sided flow vortex formed in left atrium LA. Additionally, patients with a patent foramen ovale (a natural inter-atrial septal shunt) or a secundum atrial septal defect due to failure of the patent foramen ovale to fully close may not have the expected intra-cardiac blood flow patterns (including right-sided flow vortex in right atrium RA and left-sided flow vortex in left atrium LA), including the expected flow vortexes created during atrial filling. Closure of a secundum atrial septal defect with altered right atrial non-single vortex flow patterns has been shown to revert to a dominant single vortical flow pattern after the atrial septal defect is occluded.
In another example, the introduction of implant devices, such as valves or stents, to the cardiovascular anatomy can also disrupt the natural flow patterns in the vessels or chambers of heart H in which or near where the device is implanted, such as the right-sided flow vortex in right atrium RA and the left-sided flow vortex in left atrium LA. This can be due to mismatches (however slight) between the artificial flow path through the implanted device and the natural flow path that has been replaced. For example, aortic vortical and/or helical flow can be disrupted after transcatheter aortic valve replacement (TAVR). Pre-TAVR, helical flow in the aorta can move the blood downstream through the aorta. Post-TAVR, vortical flows may have a more pronounced effect, which can result in less energy toward forward (downstream) movement in the aortic flow. Moreover, blood flowing through an implanted device will tend to hug to the walls of the device. If the device structure ends abruptly at a downstream end of the device, the flow of blood will immediately separate from the edge and become turbulent flow, which in turn causes flow reversal and thereby decreased hemodynamic efficiency.
When the right-sided flow vortex in right atrium RA changes, momentum and energy of the blood flow are lost and the right heart needs to pump harder to move the blood from right atrium RA into the right ventricle and the pulmonary artery. This is due to the right-sided flow vortex contributing less to the movement of blood through the right heart. Similarly, when the left-sided flow vortex in left atrium LA changes, the left heart needs to pump harder to move the blood from left atrium LA into the left ventricle and the aorta. This is due to the left-sided flow vortex contributing less to the movement of blood through the left heart. Further, as the intra-cardiac flow patterns in heart H (including right-sided flow vortex in right atrium RA and left-sided flow vortex in left atrium LA) change due to age or disease, areas of turbulence can be created in the flow patterns of heart H and there can be a loss of fluid dynamics leading to inefficiencies that could lead to diminished flow. This can increase the susceptibility of the right heart and/or the left heart to fail (the inability to pump enough blood to meet the body's oxygen demands), as heart H has to do more work to move the same amount of blood through heart H. More work is needed to recreate the lost momentum naturally preserved by the intra-cardiac flow patterns in heart H (including right-sided flow vortex in right atrium RA and left-sided flow vortex in left atrium LA), putting additional strain on heart H. Hemodynamic efficiency of valves in heart H also play a role in the work required by heart H. Small changes or inefficiencies in hemodynamics caused by diseased or malfunctioning valves, or the presence of artificial valve devices, when multiplied by tens of thousands of beats can result in significant unnecessary energy consumption by heart H.
Changes in intra-cardiac flow patterns change intra-cardiac energetics. Heart H is uniquely designed to maximize efficiency by preserving the kinetic energy and momentum of blood flow, thus minimizing the work needed to propagate the blood flow into the chambers, between the chambers, and out of the chambers. Anything that disrupts the intra-cardiac flow patterns in heart H (including right-sided flow vortex in right atrium RA and left-sided flow vortex in left atrium LA) can reduce the efficiency of the energetics of heart H due to a loss of potential energy, which makes it more difficult for heart H to do its job of propagating blood into, between, and out of the chambers. Anything that disrupts the intra-cardiac flow patterns through heart H (including right-sided flow vortex in right atrium RA and left-sided flow vortex in left atrium LA) can increase the amount of work heart H has to do, prolong transit times through heart H, and makes it more difficult for heart H to eject blood. This is especially problematic for people experiencing heart failure, as the heart failure can be exacerbated due to disruptions in the intra-cardiac flow patterns through heart H (including right-sided flow vortex in right atrium RA and left-sided flow vortex in left atrium LA).
As illustrated in
Cardiovascular implant device 100 is an implantable device for use in a cardiovascular system. Cardiovascular implant device 100 is configured to be implanted in blood vessels or chambers of heart H. In the illustrated example, cardiovascular implant device 100 is a “prestent” or docking station for supporting a valve device, such as a prosthetic valve device. Cardiovascular implant device 100 can be delivered into the cardiovascular system via a catheter (i.e., transcatheter delivery) or can be surgically placed using transcatheter or surgical procedures known in the art. As shown in
Frame 112 forms a main body of device 100. Frame 112 can be expandable. Frame 112 can have a wide variety of different shapes and sizes. As shown in
Frame 112 can be formed in a variety of ways, e.g., connecting individual wires together to form a mesh or lattice, braiding, cutting from a sheet and then rolling or otherwise forming into the shape of frame 112, molding, cutting from a cylindrical tube (e.g., cutting from a nitinol tube), other ways, or a combination of these. Frame 112 can be made from a highly flexible metal, metal alloy, or 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, but other metals and highly resilient or compliant non-metal materials can be used to make frame 112. All or a portion of frame 112 can be monolithically formed of any of these materials. These materials can allow frame 112 to be compressed to a small size, and then-when the compression force is released-frame 112 can self-expand back to its pre-compressed shape. Frame 112 can expand back to its pre-compressed shape due to the material properties frame 112 is made of and/or frame 112 can be expanded by inflation or expansion of a device positioned inside frame 112. For example, frame 112 can be compressed such that frame 112 can fit into a delivery catheter. Frame 112 can also be made of other materials and can be expandable and collapsible in different ways, e.g., mechanically-expandable, balloon-expandable, self-expandable, or a combination of these.
Frame 112 extends between inflow end 118 and outflow end 120 of cardiovascular implant device 100. Inflow end 118 can be an end of device 100 that is relatively upstream of outflow end 120 with respect to a flow of blood along flow axis 130, as represented by arrow A in
Frame 112 is formed of a plurality of struts 122. Struts 122 make up the lattice or mesh of frame 112 and define openings (or cells) 128 therein. Struts 122 can be integrally formed. In some examples, all or a portion of struts 122 are monolithically formed from the same material. Openings 128 extend through frame 112 from inner surface 125 to outer surface 127. Each of openings 128 is bounded on one or more sides by ones of struts 122. Openings 128 can have any suitable shape or size, which can in turn be based on an overall shape or size of frame 112. In the example shown in
Central flow path 129 is an open channel through a central portion of annular frame 112. Central flow path 129 is defined by inner surface 125 of frame 112. Central flow path 129 extends from inflow end 118 to outflow end 120 such that device 100 is open at each end. Accordingly, blood flowing through and out of device 100 follows central flow path 129. More specifically, flow axis 130 is a longitudinal axis through device 100 along which blood flows as it passes or is directed through device 100 (e.g., in the direction indicated by arrow A in
Cover 114 is a covering for one or more portions of frame 112. Cover 114 can be a fabric material, a polymer material, or other material. For example, cover 114 can be a material that promotes tissue ingrowth where device 100 contacts adjacent tissue walls of a vessel or chamber of heart H. Cover 114 can also form a seal to limit or prevent blood flow through portions of frame 112 that are covered by cover 114. Cover 114 can be attached to frame 112 by any suitable attachment means, such as by stitching, gluing, tying, etc. Cover 114 can be shaped and positioned in a variety of ways. In the example shown in
Valve seat 116 is a portion of device 100 for holding, supporting, or attaching to a valve device, such as a prosthetic valve device. In some examples, valve seat 116 can be a portion of frame 112. In some examples, valve seat 116 can be monolithically formed with frame 112. In other examples, valve seat 116 can be formed separately from frame 112 and attached. Valve seat 116 can take any form that provides a supporting surface for implanting or deploying a valve within device 100 after device 100 is implanted in the cardiovascular system. In the example shown in
Flow conditioners 110 are fins or fin-type flow conditioners. Each individual one of flow conditioners 110 can also be referred to as a flow conditioner feature. Flow conditioners 110 are elongated projections from frame 112. More specifically, flow conditioners 110 are connected to frame 112 at corresponding ones of struts 122. Flow conditioners 110 are attached by an attachment mechanism (as described in greater detail with reference to
In general, flow conditioners 110 can take a number of different forms (i.e., shapes, sizes, etc.). In some examples, flow conditioners 110 can be airfoils. Flow conditioners 110 can have a symmetrical or asymmetrical and regular or irregular shape and can have variable geometries. Physical dimensions (e.g., length, width, shape, cross-sectional shape, etc.) of flow conditioners 110 can be configured to prevent flow conditioners 110 from interfering (or contacting) other parts of device 100 or adjacent tissue walls. In other examples, components of device 100 (e.g., cover 114) can be designed to fit around flow conditioners 110 or to permit flow conditioners 110 to pass through. The physical dimension of flow conditioners 110 can further be configured to allow flow conditioners 110 to collapse and expand with expandable frame 112 (e.g., to fit within a delivery catheter). The physical dimensions of flow conditioners 110 can further be configured to prevent flow conditioners 110 from occluding a vessel of chamber of heart H in which device 100 is implanted. That is, a length and/or width of flow conditioners 110 can be relatively short enough so that flow conditioners 110 do not protrude from device 100 and extend fully across a vessel or chamber of heart H and block blood flow. The physical dimensions of flow conditioners 110 can further be configured to modify a hemodynamic characteristic (e.g., helicity, vorticity, velocity, turbulence, flow direction, etc.) of blood flowing through or out of device 100 in a particular manner.
One or more flow conditioners 110 can be positioned in any suitable arrangement with respect to frame 112 of device 100. In some examples, flow conditioners 110 can be arranged about a circumference of inner surface 125 of frame 112. In some examples, flow conditioners 110 can be located adjacent inflow end 118 (as shown in
Once device 100 is implanted in cardiovascular system (e.g., in inferior vena cava IVC as shown in
Cardiovascular implant device 100, including flow conditioners 110, can produce hemodynamic effects to minimize disruption to or enhance the natural flow patterns in heart H, such as the left-sided flow vortex in left atrium LA, the right-sided flow vortex in right atrium RA, and/or helical flow in coronary sinus CS. Flow conditioners 110 can modify hemodynamic characteristics of blood flowing through or out of device 100 such that (a) any disruptions to the natural flow patterns that would be caused by an implantable device are minimized; (b) reduced flow due to a pathophysiology or other cause is mitigated; and/or (c) baseline flow is enhanced. As a result, device 100 can maintain kinetic energy of the cardiovascular blood flow, which in turn reduces the cardiac work needed and improves cardiac efficiency. These hemodynamic effects can potentially improve patient outcomes after receiving cardiovascular implant device 100 because device 100 can be more effective and potentially safer. At the same time, flow conditioners 110 can be incorporated relatively easily into device 100 in many configurations, so different variations of device 100 can be optimized for use in many different scenarios (e.g., for many different patient conditions).
Flow conditioner 140 is one example of fin-type flow conditioners 110 as described above with reference to
Flow conditioner 140 is attached to frame 112 at attachment region 142, thereby forming joint 144 with a corresponding portion of frame 112. More specifically, joint 144 is formed between flow conditioner 140 and one of struts 122. Joint 144 can include any suitable attachment mechanism, such as a hinge, a flexible section of tissue or another material, a spring, etc. In some examples, joint 144 is a flexible joint that readily permits deflection of flow conditioner 140. In other examples, joint 144 is a rigid joint (e.g., if flow conditioner 140 is integrally formed with the corresponding strut 122).
Flow conditioner 140 can also be biased radially inwards from frame 112 by bias member 146, which can be a spring or other suitable feature for biasing flow conditioner 140. Bias member 146 is attached to one or more of struts 122. In some examples, joint 144 and bias member 146 are on a same one of struts 122. In other examples, joint 144 can be on a first one of struts 122 and bias member 146 can be attached to a second one of struts 122. In some such examples, the second one of struts 122 to which bias member 146 is attached can be adjacent to the first one of struts 122. In yet other examples, device 100 does not include bias member 146.
As illustrated in
The attachment angle 148 at joint 144 allows the initial positioning of flow conditioners 140 to be adjusted based on a desired hemodynamic effect. Moreover, the amount of disruption (or flow modification) caused by flow conditioner 140 on blood flowing through or out of device 100 can be calibrated at attachment angle 148 or by the incorporation of bias member 146. Specifically, the amount of deflection of flow conditioner 140 in response to increased blood flow (or increased velocity of blood flow) can be controlled by a tension of bias member 146. Bias member 146 can be adjusted to permit greater or lesser deflection of flow conditioner 140 based on a desired interaction between flow conditioner 140 and blood flowing through or out of device 100. Additionally, deflectable flow conditioners 140 can have increased compliance. These characteristics allow flow conditioner 140 to be flexibly implemented in a wide variety of implantable devices to cause different hemodynamic effects, and the positioning of flow conditioner 140 can be tuned for each implementation.
Flow conditioner 140′ includes a similar structure and function as described above with respect to flow conditioners 110 (
Flow conditioner 140′ can be monolithically formed with one or more of struts 122 of frame 112. More specifically, flow conditioner 140′ and a portion of frame 112 to which flow conditioner 140′ is connected (one or more struts 122) can be monolithically formed of a shape-memory alloy, such as nitinol. In other examples, flow conditioner 140′ can be connected to frame 112 by an electrically controllable mechanism, such as a motorized hinge. Flow conditioner 140′ has one or more extension regions 142′ along its length (e.g., from a root portion to a tip portion). Extension region 142′ is a region where flow conditioner 140′ extends from frame 112 at one (or more) of struts 122. In some examples, flow conditioner 140′ extends monolithically from frame 112 at extension region 142′.
Extension angle 148′ is formed between fin longitudinal axis 150 of flow conditioner 140′ and strut longitudinal axis 152 of a corresponding one of struts 122 from which flow conditioner 140′ extends. Extension angle 148′, as illustrated in
Electrical connectors 160 are electrical connections between flow conditioner 140′ and control system 170. As shown in
Control system 170 is a system of components for controlling (e.g., electromechanically actuating) flow conditioners 140′. Control system 170 can include wired or wireless connections between components. Moreover, all or some of components of control system 170 can be externally located outside the body. In one example, control system 170 can include receiver 178 and transmitter 179 in order to wirelessly communicate with mobile device 180 to receive and send signals for controlling flow conditioners 140′. In some examples, receiver 178 and transmitter 179 can be a transceiver. In other examples, control system 170 may not include receiver 178, transmitter 179, and mobile device 180, and instead controller 172 can directly implement predefined process instructions for controlling flow conditioners 140′. Alternatively, control system 170 may not include controller 172, and instead switch 176 can be manually activated to supply current from power source 174 to flow conditioners 140′.
Controller 172 is configured to implement process instructions for operational control of flow conditioners 140′. For instance, controller 172 can include one or more processors and computer-readable memory configured to implement functionality and/or process instructions for execution within control system 170. Examples of one or more processors can include, e.g., any one or more of a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or other equivalent discrete or integrated logic circuitry.
Computer-readable memory of controller 172 can be configured to store information used by controller 172 during operation of control system 170. Computer-readable memory, in some examples, is described as computer-readable storage media. In some examples, a 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 certain examples, a non-transitory storage medium can store data that can, over time, change (e.g., in RAM or cache). In some examples, the computer-readable memory is used to store program instructions for execution by the one or more processors. Computer-readable memory, in one example, is used by software or applications running on controller 172 to temporarily store information during program execution. Computer-readable memory can include volatile and non-volatile memories. Examples of volatile memories can include, e.g., random access memories (RAM), dynamic random access memories (DRAM), static random access memories (SRAM), and other forms of volatile memories. Examples of non-volatile storage elements can include, for example, magnetic hard discs, optical discs, flash memories, or forms of electrically programmable memories (EPROM) or electrically erasable and programmable (EEPROM) memories.
Examples of controller 172 can include any one or more of microcontrollers or other computers. Controller 172 can be configured to communicate with any one or more of the components of control system 170, including: switch 176, receiver 178, and transmitter 179. Although the example of
Power source 174 supplies current to flow conditioner 140′ via electrical connectors 160. In some examples, power source 174 can be a battery. Switch 176 is between power source 174 and flow conditioner 140′. Switch 176 can be activated (or turned on) such that current can flow from power source 174 to flow conditioner 140′. Switch 176 can also be deactivated (or turned off) such that current does not flow from power source 174 to flow conditioner 140′. Switch 176 can be activated or deactivated manually or by a control signal from controller 172. For example, switch 176 can be a metal-oxide semiconductor field-effect transistor (MOSFET) or any other electrical switch.
Controller 172 is connected to or includes receiver 178 and transmitter 179 (or a transceiver rather than separate transmitter and receiver) for sending and receiving wireless signals. For example, receiver 178 can receive a Bluetooth Low Energy (BLE) signal. In other examples, receiver 178 can receive a Wi-Fi signal. In yet 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.
Mobile device 180 is an access point for remotely controlling flow conditioners 140′. For example, mobile device 180 can be a cell phone, tablet, or other device capable of sending a wireless signal to receiver 178 to communicate with controller 172. Mobile device 180 can include a user interface (UI) for displaying control options for control system 170 to a user, such as a physician. Mobile device 180 can include a display and/or other UI elements (e.g., keyboard, buttons, monitor, graphical control elements presented at a touch-sensitive display, or other UI elements). In some examples, mobile device includes a graphical user interface (GUI) that includes graphical representations of control options for control system 170, such as graphical representations of a button for activating switch 176.
In operation of control system 170, switch 176 is activated so that current can flow from power source 174 to flow conditioner 140′ along electrical connectors 160. Switch 176 can be manually activated or can be activated based on a signal from controller 172. Controller 172 can send signals based on predefined instructions, such as configurations, stored thereon or can receive a signal from mobile device 180 via receiver 178. The supplied current causes flow conditioner 140′ to deflect to adjusted angle 149′. In some examples, flow conditioner 140′ that is formed of a shape-memory alloy reaches its transformation temperature and shifts to a preset shape that coincides with the transformation temperature. That is, as illustrated in
Control system 170 allows the positioning of flow conditioner 140′ to be actively controlled or adjusted once device 100 has been implanted in the cardiovascular system. That is, the amount of disruption (or flow modification) caused by flow conditioners 140′ on blood flowing through or out of device 100 can be actively calibrated by changing extension angle 148′ to adjusted angle 149′ in response to supplied current from power source 174. In this way, a user such as a physician or a patient can adjust the position of flow conditioner 140′ based on changed conditions without having to directly access flow conditioner 140′ (e.g., via a surgical procedure or other route). For example, in response to a worsening heart disease, the position of flow conditioner 140′ could be adjusted to have a more significant effect on hemodynamics. Further, control system 170 using mobile device 180 allows remote control and adjustment of the positioning of flow conditioner 140′, which may streamline a procedure for adjusting the positioning of flow conditioner 140′ or provide a user-friendly alternative option for adjusting the positioning of flow conditioner 140′. Forming flow conditioner 140′ and a corresponding portion of frame 112 of a shape-memory alloy also allows for active control of flow conditioner 140′ by a relatively minor modification to the structure of device 100.
Each of flow conditioners 185A, 185B, 185C, 185D, and 185E can one of fin-type flow conditioners 110 shown in
Flow conditioner 185A includes flow microfeature 186A, which is a leading edge notch. Flow conditioner 185B includes flow microfeature 186B, which is a boundary layer fence. Flow conditioner 185C includes flow microfeature 186C, which is a leading edge dogtooth. Flow conditioner 185D includes flow microfeature 186D, which is a group of vortex generators. Flow conditioner 185E includes flow microfeature 186E, which is a group of vortilons (shown in
Flow microfeatures 186A, 186B, 186C, 186D, and 186E interact with blood flowing through or out of device 100 as it reaches flow conditioners 185A, 185B, 185C, 185D, and 185E. Each of flow microfeatures 186A, 186B, 186C, 186D, and 186E can produce characteristic flow effects on the flow of blood through or out of device 100.
Flow conditioners 185A, 185B, 185C, 185D, and 185E including flow microfeatures 186A, 186B, 186C, 186D, and 186E provide a wider range of options and greater flexibility for designing cardiovascular implant devices to modify hemodynamic characteristics for producing desired hemodynamic effects on blood flowing through or out of the device. Incorporating flow microfeatures 186A, 186B, 186C, 186D, and 186E or combinations of flow microfeatures 186A, 186B, 186C, 186D, and 186E can result in finer or more granular control of hemodynamic effects.
Cardiovascular implant device 200 includes a similar structure and function to cardiovascular implant device 100 described above, except device 200 includes plate-type flow conditioners 210 instead of fin-type flow conditioners (e.g., flow conditioners 110).
Flow conditioners 210 are flow plates or plate-type flow conditioners. Each individual one of flow conditioners 210 can also be referred to as a flow conditioner feature. Flow conditioners 210 can be flattened or cylindrical projections from frame 212. More specifically, flow conditioners 210 are connected to frame 212 at corresponding ones of struts 222. In some examples, flow conditioners 210 are attached to multiple struts 222 along portions of frame 212. In some examples, flow conditioners 210 are connected circumferentially at several locations along inner surface 225 of frame 212. In some examples, flow conditioners 210 are continuously formed with inner surface 225 of frame 212. Flow conditioners 210 are attached by an attachment mechanism or monolithically formed with a portion of frame 212. Each plate-type flow conditioner 210 can be a single part rather than a plurality of individual fin-type flow conditioners.
In general, flow conditioners 210 can take a number of different forms (i.e., shapes, sizes, etc.). Physical dimensions (e.g., length, width, shape, cross-sectional shape, etc.) of flow conditioners 210 can be configured to prevent flow conditioners 210 from interfering (or contacting) other parts of device 200 or adjacent tissue walls. In other examples, components of device 200 (e.g., cover 214) can be designed to fit around flow conditioners 210 or to permit flow conditioners 210 to pass through. The physical dimension of flow conditioners 210 can further be configured to allow flow conditioners 210 to collapse and expand with expandable frame 212 (e.g., to fit within a delivery catheter). The physical dimensions of flow conditioners 210 can further be configured to prevent flow conditioners 210 from occluding a vessel of chamber of heart H in which device 200 is implanted. That is, a length and/or width of flow conditioners 210 can be relatively short enough so that flow conditioners 210 do not protrude from device 200 and extend fully across a vessel or chamber of heart H and block blood flow. The physical dimensions of flow conditioners 210 can further be configured to modify a hemodynamic characteristic (e.g., helicity, vorticity, velocity, turbulence, flow direction, etc.) of blood flowing through or out of device 200 in a particular manner.
One or more flow conditioners 210 can be positioned in any suitable arrangement with respect to frame 212 of device 200. In the example shown in
Each flow conditioner 210 includes walls 232 that define flow passages 234 therein. Flow passages 234 extend through a corresponding one of flow conditioners 210 such that blood flowing along flow axis 230 through central flow path 229 within device 200 can pass through the corresponding flow conditioner 210. That is, flow passages 234 extend from an upstream side to a downstream side of the corresponding flow conditioner 210. The form of each flow conditioner 210 can depend largely on the configuration of flow passages 234. Flow passages are bounded, at least partially, by walls 232. In some examples, flow passages 234 are closed channels that are surrounded by walls 232 (as shown in
Once device 200 is implanted in the cardiovascular system, circulating blood passes through device 200. As blood flows, into, through, and out of device 200 along flow axis 230, the blood flows through flow passages 234 of flow conditioners 210. Flow conditioners 210 interact with the blood flow to modify or affect a hemodynamic characteristic (e.g., helicity, vorticity, velocity, turbulence, flow direction, etc.) of the flow. Flow conditioners 210 can interact with blood flowing through or out of device 200 by adding flow resistance and/or changing the direction of the blood flow to prevent reversal of blood flow. For example, flow conditioners 210 may increase or decrease vorticity or helicity of the flow. In some examples, flow conditioners 210 may cause the flow to be smoother (decrease the turbulence). In other examples, flow conditioners 210 can increase turbulence in the flow. In some examples, flow conditioners 210 can change a flow direction of the flow. In some examples, flow conditioners 210 can align the flow with a natural vortical flow pattern of blood through a vessel or chamber of heart H, such as the left-sided flow vortex in left atrium LA or the right-sided flow vortex in right atrium RA. In other examples, flow conditioners 210 can align the flow with a natural helical flow pattern of blood though a vessel or chamber of heart H, such as helical flow in coronary sinus CS. Flow conditioners 210 that are located at inflow end 218 and/or outflow end 220 of device 200 can create helical flow patterns near an adjacent vessel or chamber wall to force blood to flow back towards the center of the vessel or chamber in a same helical direction, thereby producing forward movement of the blood. More generally, flow conditioners 210 adjacent to inflow end 218 can modify a hemodynamic characteristic of blood flowing through frame 212, and flow conditioners 210 adjacent to outflow end 220 can modify a hemodynamic characteristic of blood flowing out of frame 212.
Like device 100 described above, cardiovascular implant device 200, including flow conditioners 210, can produce hemodynamic effects to minimize disruption to or enhance the natural flow patterns in heart H, such as the left-sided flow vortex in left atrium LA, the right-sided flow vortex in right atrium RA, and/or helical flow in coronary sinus CS. Flow conditioners 210 can modify hemodynamic characteristics of blood flowing through or out of device 200 such that (a) any disruptions to the natural flow patterns that would be caused by an implantable device are minimized; (b) reduced flow due to a pathophysiology or other cause is mitigated; and/or (c) baseline flow is enhanced. As a result, device 200 can maintain kinetic energy of the cardiovascular blood flow, which in turn reduces the cardiac work needed and improves cardiac efficiency. These hemodynamic effects can potentially improve patient outcomes after receiving cardiovascular implant device 200 because device 200 can be more effective and potentially safer. At the same time, flow conditioners 210 can be incorporated relatively easily into device 200 in many configurations, so different variations of device 200 can be optimized for use in many different scenarios (e.g., for many different patient conditions).
Each of flow conditioners 285A, 285B, 285C, 285D, and 285E can be plate-type flow conditioners 210 shown in
Flow conditioners 285A, 285B, 285C, 285D, and 285E interact with blood flowing through or out of device 200 as it passes through the corresponding flow passages 288A, 288B, 288C, 288D, and 288E. Flow conditioners 285A, 285B, 285C, 285D, and 285E, each having different respective types or arrangements of walls 286A, 286B, 286C, 286D, and 286E and flow passages 288A, 288B, 288C, 288D, and 288E, can produce characteristic flow effects on the flow of blood through or out of device 200.
Flow conditioners 285A, 285B, 285C, 285D, and 285E including walls 286A, 286B, 286C, 286D, and 286E and flow passages 288A, 288B, 288C, 288D, and 288E provide a wider range of options and greater flexibility for designing cardiovascular implant devices to modify hemodynamic characteristics for producing desired hemodynamic effects on blood flowing through or out of the device. Incorporating flow conditioners 285A, 285B, 285C, 285D, and 285E including walls 286A, 286B, 286C, 286D, and 286E and flow passages 288A, 288B, 288C, 288D, and 288E or combinations of these can result in finer or more granular control of hemodynamic effects.
Cardiovascular implant device 300 includes a similar structure and function to cardiovascular implant device 100 described above, except device 300 is located at a valve site rather than a non-valve site. For example,
Fin-type flow conditioners 310 can generally include the same structure and function as fin-type flow conditioners 110 shown in
Once device 300 is implanted in cardiovascular system (e.g., in pulmonary artery PA as shown in
In addition to the benefits described above with respect to device 100, device 300, according to techniques of this disclosure, allows for modifying hemodynamic characteristics at or adjacent the site of a native heart valve that has been replaced. Despite being in a location where a native valve was previously (and, therefore, the location of a natural flow path regulator), an implantable device may still disrupt natural flow patterns due to factors such as the size of the device, the position of the device, any contact between the device and nearby tissue, or other factors. Flow conditioners 310 incorporated on device 300 can produce hemodynamic effects to minimize disruption to or enhance the natural flow patterns at or adjacent to a valve site.
Cardiovascular implant device 400 includes a similar structure and function to cardiovascular implant device 300 described above, except device 400 includes plate-type flow conditioners 410 instead of fin-type flow conditioners (e.g., flow conditioners 310). Further, plate-type flow conditioners 410 can generally include the same structure and function as plate-type flow conditioners 210 shown in
Once device 400 is implanted in the cardiovascular system, circulating blood passes through device 400. As blood flows, into, through, and out of device 400 along flow axis 430, the blood flows through flow passages 434 of flow conditioners 410. Flow conditioners 410 interact with the blood flow to modify or affect a hemodynamic characteristic (e.g., helicity, vorticity, velocity, turbulence, flow direction, etc.) of the flow. Flow conditioners 410 can interact with blood flowing through or out of device 400 by adding flow resistance and/or changing the direction of the blood flow to prevent reversal of blood flow. For example, flow conditioners 410 may increase or decrease vorticity or helicity of the flow. In some examples, flow conditioners 410 may cause the flow to be smoother (decrease the turbulence). In other examples, flow conditioners 410 can increase turbulence in the flow. In some examples, flow conditioners 410 can change a flow direction of the flow. In some examples, flow conditioners 410 can align the flow with a natural vortical flow pattern of blood through a vessel or chamber of heart H, such as the left-sided flow vortex in left atrium LA or the right-sided flow vortex in right atrium RA. In other examples, flow conditioners 410 can align the flow with a natural helical flow pattern of blood through a vessel or chamber of heart H, such as helical flow in coronary sinus CS. Flow conditioners 410 that are located at inflow end 418 and/or outflow end 420 of device 400 can create helical flow patterns near an adjacent vessel or chamber wall to force blood to flow back towards the center of the vessel or chamber in a same helical direction, thereby producing forward movement of the blood. More generally, flow conditioners 410 adjacent to inflow end 418 can modify a hemodynamic characteristic of blood flowing through frame 412, and flow conditioners 410 adjacent to outflow end 420 can modify a hemodynamic characteristic of blood flowing out of frame 412.
In addition to the benefits described above with respect to device 200, device 400, according to techniques of this disclosure, allows for modifying hemodynamic characteristics at or adjacent the site of a native heart valve that has been replaced. Despite being in a location where a native valve was previously (and, therefore, the location of a natural flow path regulator), an implantable device may still disrupt natural flow patterns due to factors such as the size of the device, the position of the device, any contact between the device and nearby tissue, or other factors. Flow conditioners 410 incorporated on device 400 can produce hemodynamic effects to minimize disruption to or enhance the natural flow patterns at or adjacent to a valve site.
As illustrated in
Cardiovascular implant device 500 is an implantable device for use in a cardiovascular system. Cardiovascular implant device 500 is configured to be implanted in blood vessels or chambers of heart H. In the illustrated example, cardiovascular implant device 500 is a valve device, such as a prosthetic valve device. In some examples, device 500 is deployed into a valve seat of a previously implanted prestent or docking station device (e.g., devices 100, 200, 300, and 400). Cardiovascular implant device 500 can be delivered into the cardiovascular system via a catheter (i.e., transcatheter delivery) or can be surgically placed using transcatheter or surgical procedures known in the art. In some examples, device 500 can be delivered and/or implanted using the same catheter or surgical procedure that is used for a prestent device (e.g., devices 100, 200, 300, and 400). In other examples, device 500 can be delivered and/or implanted by a separate catheter or in a separate surgical procedure. Device 500 can be located in any vessel or chamber of heart H at a site in heart H where there is not naturally a valve (a “non-valve” site) or at a site where there is a natural valve (e.g., aortic valve AV, mitral valve MV, pulmonary valve PV, etc.). For example,
Frame 512 forms a main body of device 500. Frame 512 can be expandable. Frame 512 can have a wide variety of different shapes and sizes. As shown in
Frame 512 can be formed in a variety of ways, e.g., connecting individual wires together to form a mesh or lattice, braiding, cutting from a sheet and then rolling or otherwise forming into the shape of frame 512, molding, cutting from a cylindrical tube (e.g., cutting from a nitinol tube), other ways, or a combination of these. Frame 512 can be made from a highly flexible metal, metal alloy, or 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, but other metals and highly resilient or compliant non-metal materials can be used to make frame 512. All or a portion of frame 512 can be monolithically formed of any of these materials. These materials can allow frame 512 to be compressed to a small size, and then-when the compression force is released-frame 512 can self-expand back to its pre-compressed shape. Frame 512 can be expanded back to its pre-compressed shape due to the material properties of the material frame 112 is made out of and/or frame 512 can be expanded by inflation or expansion of a device positioned inside the frame. For example, frame 512 can be compressed such that frame 512 can fit into a delivery catheter. Frame 512 can also be made of other materials and can be expandable and collapsible in different ways, e.g., mechanically-expandable, balloon-expandable, self-expandable, or a combination of these.
Frame 512 extends between inflow end 518 and outflow end 520 of cardiovascular implant device 500. Inflow end 518 can be an end of device 500 that is relatively upstream of outflow end 520 with respect to a flow of blood along flow axis 530, as represented by arrow A in
Frame 512 is formed of a plurality of struts 522. Struts 522 make up the lattice or mesh of frame 512 and define openings (or cells) 528 therein. Struts 522 can be integrally formed. In some examples, all or a portion of struts 522 are monolithically formed from the same material. Openings 528 extend through frame 512 from inner surface 525 to outer surface 527. Each of openings 528 is bounded on one or more sides by ones of struts 522. Openings 528 can have any suitable shape or size, which can in turn be based on an overall shape or size of frame 512. In the example shown in
Central flow path 529 is an open channel through a central portion of annular frame 512. Central flow path 529 is defined by inner surface 525 of frame 512. Central flow path 529 extends from inflow end 518 to outflow end 520 such that device 500 is open at each end. Accordingly, blood flowing through and out of device 500 follows central flow path 529. More specifically, flow axis 530 is a longitudinal axis through device 500 along which blood flows as it passes or is directed through device 500 (e.g., in the direction indicated by arrow A in
Cover 514 is a covering for one or more portions of frame 512. Cover 514 can be a fabric material, a polymer material, or other material. For example, cover 514 can be a material that promotes tissue ingrowth where device 500 contacts adjacent tissue walls of a vessel or chamber of heart H. Cover 514 can also form a seal to limit or prevent blood flow through portions of frame 512 that are covered by cover 514. Cover 514 can be attached to frame 512 by any suitable attachment means, such as by stitching, gluing, tying, etc. Cover 514 can be shaped and positioned in a variety of ways. In the example shown in
Valvular body 516 is mounted within annular frame 512. More specifically, valvular body 516 is connected to inner surface 525 of frame 512. Valvular body 516 includes one or more leaflets 531. In the example shown in
Fin-type flow conditioners 510 can generally include the same structure and function as fin-type flow conditioners 110 shown in
Once device 500 is implanted in cardiovascular system (e.g., in aorta AT at aortic valve AV as shown in
In addition to the benefits described above with respect to devices 100 and 300, incorporating flow conditioners 510 directly on a valve device (e.g., device 500) provides an alternative or additional option to incorporating flow conditioners on a prestent or docking station device (e.g., devices 100 and 300). Flow conditioners 510 incorporated on device 500 can produce hemodynamic effects to minimize disruption to or enhance the natural flow patterns in scenarios where a prosthetic valve is implanted without a prestent or docking station.
Cardiovascular implant device 600 includes a similar structure and function to cardiovascular implant device 500 described above, except device 600 includes plate-type flow conditioners 610 instead of fin-type flow conditioners (e.g., flow conditioners 510). Further, plate-type flow conditioners 610 can generally include the same structure and function as plate-type flow conditioners 210 shown in
Once device 600 is implanted in the cardiovascular system, circulating blood is delivered through device 600. As blood flows into, through, and out of device 600 along flow axis 630, the blood flows through flow passages 634 of flow conditioners 610. Flow conditioners 610 interact with the blood flow to modify or affect a hemodynamic characteristic (e.g., helicity, vorticity, velocity, turbulence, flow direction, etc.) of the flow. Flow conditioners 610 can interact with blood flowing through or out of device 600 by adding flow resistance and/or changing the direction of the blood flow to prevent reversal of blood flow. For example, flow conditioners 610 may increase or decrease vorticity or helicity of the flow. In some examples, flow conditioners 610 may cause the flow to be smoother (decrease the turbulence). In other examples, flow conditioners 610 can increase turbulence in the flow. In some examples, flow conditioners 610 can change a flow direction of the flow. In some examples, flow conditioners 610 can align the flow with a natural vortical flow pattern of blood through a vessel or chamber of heart H, such as the left-sided flow vortex in left atrium LA or the right-sided flow vortex in right atrium RA. In other examples, flow conditioners 610 can align the flow with a natural helical flow pattern of blood through a vessel or chamber of heart H, such as helical flow in coronary sinus CS. Flow conditioners 610 that are located at inflow end 618 and/or outflow end 620 of device 600 can create helical flow patterns near an adjacent vessel or chamber wall to force blood to flow back towards the center of the vessel or chamber in a same helical direction, thereby producing forward movement of the blood. More generally, flow conditioners 610 adjacent to inflow end 618 can modify a hemodynamic characteristic of blood flowing through frame 612, and flow conditioners 610 adjacent to outflow end 620 can modify a hemodynamic characteristic of blood flowing out of frame 612.
In addition to the benefits described above with respect to devices 200 and 400, incorporating flow conditioners 610 directly on a valve device (e.g., device 600) provides an alternative or additional option to incorporating flow conditioners on a prestent or docking station device (e.g., devices 200 and 400). Flow conditioners 610 incorporated on device 600 can produce hemodynamic effects to minimize disruption to or enhance the natural flow patterns in scenarios where a prosthetic valve is implanted without a prestent or docking station.
Cardiovascular implant device 700 is an implantable device for use in a cardiovascular system. Cardiovascular implant device 700 is configured to be implanted in blood vessels or chambers of heart H. In the illustrated example, cardiovascular implant device 700 is a stent device. 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 or surgical procedures known in the art. In some examples, device 700 can be delivered and/or implanted using the same catheter or surgical procedure that is used for an adjacent (or nearby) prestent device (e.g., devices 100, 200, 300, and 400) or a valve device (e.g., devices 500 and 600). In other examples, device 700 can be delivered and/or implanted by a separate catheter or in a separate surgical procedure. Device 700 can be located in any vessel or chamber of heart H. In some examples, device 700 is located at a site in heart H where there is not naturally a valve (a “non-valve” site). In other examples, device 700 is located near a site where there is a natural valve (e.g., near aortic valve AV, mitral valve MV, pulmonary valve PV, etc.). For example,
Frame 712 forms a main body of device 700. Frame 712 can be expandable. Frame 712 can have a wide variety of different shapes and sizes. As shown in
Frame 712 can be formed in a variety of ways, e.g., connecting individual wires together to form a mesh or lattice, braiding, cutting from a sheet and then rolling or otherwise forming into the shape of frame 712, molding, cutting from a cylindrical tube (e.g., cutting from a nitinol tube), other ways, or a combination of these. Frame 712 can be made from a highly flexible metal, metal alloy, or 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, but other metals and highly resilient or compliant non-metal materials can be used to make frame 712. All or a portion of frame 712 can be monolithically formed of any of these materials. These materials can allow frame 712 to be compressed to a small size, and then-when the compression force is released-frame 712 can self-expand back to its pre-compressed shape. Frame 712 can expand back to its pre-compressed shape due to the material properties of the material frame 712 is made out of and/or frame 712 can be expanded by inflation or expansion of a device positioned inside frame 712. For example, frame 712 can be compressed such that frame 712 can fit into a delivery catheter. Frame 712 can also be made of other materials and can be expandable and collapsible in different ways, e.g., mechanically-expandable, balloon-expandable, self-expandable, or a combination of these.
Frame 712 extends between inflow end 718 and outflow end 720 of cardiovascular implant device 700. Inflow end 718 can be an end of device 700 that is relatively upstream of outflow end 720 with respect to a flow of blood along flow axis 730, as represented by arrow A in
Frame 712 is formed of a plurality of struts 722. Struts 722 make up the lattice or mesh of frame 712 and define openings (or cells) 728 therein. Struts 722 can be integrally formed. In some examples, all or a portion of struts 722 are monolithically formed from the same material. Openings 728 extend through frame 712 from inner surface 725 to outer surface 727. Each of openings 728 is bounded on one or more sides by ones of struts 722. Openings 728 can have any suitable shape or size, which can in turn be based on an overall shape or size of frame 712. In the example shown in
Central flow path 729 is an open channel through a central portion of annular frame 712. Central flow path 729 is defined by inner surface 725 of frame 712. Central flow path 729 extends from inflow end 718 to outflow end 720 such that device 700 is open at each end. Accordingly, blood flowing through and out of device 700 follows central flow path 729. More specifically, flow axis 730 is a longitudinal axis through device 700 along which blood flows as it passes or is directed through device 700 (e.g., in the direction indicated by arrow A in
Although not shown in
Fin-type flow conditioners 710 can generally include the same structure and function as fin-type flow conditioners 110 shown in
Once device 700 is implanted in the cardiovascular system (e.g., in aorta AT as shown in
In addition to the benefits described above with respect to devices 100 and 300, incorporating flow conditioners 710 directly on a stent device (e.g., device 700) can produce hemodynamic effects to minimize disruption to or enhance the natural flow patterns at any sites where a stent may be implanted. To some extent, this may be a greater variety of locations throughout the cardiovascular system (e.g., any vessel or chamber of heart H), compared to valve devices or prestent/docking station devices which may have more limited applications.
Cardiovascular implant device 800 includes a similar structure and function to cardiovascular implant device 700 described above, except cardiovascular implant device 800 includes plate-type flow conditioner 810 instead of fin-type flow conditioners (e.g., flow conditioners 710). In the example shown in
Once device 800 is implanted in the cardiovascular system (e.g., in aorta AT as shown in
In addition to the benefits described above with respect to devices 200 and 400, incorporating flow conditioner 810 directly on a stent device (e.g., device 800) can produce hemodynamic effects to minimize disruption to or enhance the natural flow patterns at any sites where a stent may be implanted. To some extent, this may be a greater variety of locations throughout the cardiovascular system (e.g., any vessel or chamber of heart H), compared to valve devices or prestent/docking station devices which may have more limited applications.
Cardiovascular implant device 900 is an implantable device for use in a cardiovascular system. Cardiovascular implant device 900 is configured to be implanted in blood vessels or chambers of heart H. In the illustrated example, cardiovascular implant device 900 is an edge-to-edge valve repair device. Cardiovascular implant device 900 can be delivered into the cardiovascular system via a catheter (i.e., transcatheter delivery) or can be surgically placed using transcatheter or surgical procedures known in the art. In some examples, device 900 can be delivered and/or implanted using the same catheter or surgical procedure that is used for an adjacent (or nearby) stent device (e.g., devices 700 and 800). In other examples, device 900 can be delivered and/or implanted by a separate catheter or in a separate surgical procedure. Device 900 can be located in any vessel or chamber of heart H. In particular, device 900 is located near a site where there is a natural valve (e.g., near mitral valve MV, a tricuspid valve, an aortic valve, a pulmonary valve, etc.). For example,
Body 912 forms a main body of device 900. Body 912 can be formed in a variety of ways and can be made from a highly flexible metal, metal alloy, or 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, but other metals and highly resilient or compliant non-metal materials can be used to make body 912. All or a portion of body 912 can be monolithically formed of any of these materials. Body 912, including central spacer 922, paddles 924, and clasps 926, can have an expanded and a closed or collapsed configuration. For example, body 912 can be sized or collapsed to fit into a delivery catheter in a closed configuration. Body 912 can, in some examples, be expanded during an implantation procedure to attach device 900 to a natural valve of heart H.
Body 912 includes central spacer 922. Central spacer 922 forms a central portion of device 900. Central spacer 922 can be generally elongated, cylindrical, or tapered in shape. Central spacer 922 is configured to extend through an opening between leaflets of a natural valve of heart H and maintain a separation between sets of paddles 924 and clasps 926 that bridges the opening between the leaflets. Central longitudinal axis 928 extends longitudinally through central spacer 922.
Clasps 926 are elongated projections from body 912 that extend radially outward from central spacer 922 and central longitudinal axis 928. Clasps 926 include a respective first arm 927A and second arm 927B arranged in a U-shape or V-shape. First arms 927A of clasps 926 are configured to contact or press against a first side of the leaflets of the natural valve of heart H. In the example shown in
Paddles 924 are paddle shaped or elongated and relatively widened and flattened projections from body 912 that extend radially outward from central spacer 922 and central longitudinal axis 928. Paddles 924 are configured to contact or press against second arms 927B of clasps 926. In the example shown in
Body 912 extends between inflow end 918 and outflow end 920 of cardiovascular implant device 900. Inflow end 918 can be an end of device 900 that is relatively upstream of outflow end 920 with respect to a flow of blood parallel to central longitudinal axis 928, as represented by arrow A in
Although not shown in
Fin-type flow conditioners 910 can generally include the same structure and function as fin-type flow conditioners 110 shown in
Once device 900 is implanted in the cardiovascular system (e.g., attached to mitral valve MV as shown in
In addition to the benefits described above with respect to devices 100, 300, 500, and 700, incorporating flow conditioners 910 on an edge-to-edge valve repair device (e.g., device 900) can produce hemodynamic effects to minimize disruption to or enhance the natural flow patterns at natural valve sites prior to a valve replacement procedure. Device 900 including flow conditioners 910 can mitigate adverse changes on intraventricular flow dynamics that may be associated with increased left ventricular work.
Although depicted in
Step 2002 includes obtaining a first MRI of a heart. The first MRI (magnetic resonance imaging) can visualize the flow patterns of blood flow in the heart of the patient. Specifically, the first MRI can visualize the flow patterns of blood flow in the vessels and/or chambers (right atrium, left atrium, right ventricle, and left ventricle) of the heart of the patient.
The first MRI can be a 4D MRI that visualizes the flow patterns of blood flow in the heart of a patient. Additionally, the 4D MRI can measure volumes in the chambers of the heart, sizes of the chambers of the heart, geometries of the chambers of the heart, compliances of the chambers of the heart, and/or blood pressures in the chambers of the heart. The 4D MRI can also track movement of the chambers of the heart and movement of the tricuspid valve (also known as tricuspid annular plan systolic excursion (TAPSE)).
Step 2004 includes generating a simulation of the flow patterns in the heart. The simulation of the flow patterns in the heart can be generated based on the first MRI. This allows the simulation to be patient specific. The simulation will simulate the flow patterns in the heart of the patient, such as in the vessels and/or chambers of the heart. The simulation can also simulate the volumes, sizes, geometries, compliances, and blood pressures of the chambers of the heart based on data from the first MRI. The simulation can be generated using any suitable software program.
Step 2006 includes simulating blood flow in the heart when various cardiovascular implant devices including flow conditioners are implanted in the heart. The simulated blood flow in the heart is modulated by the cardiovascular implant devices including the flow conditioners to simulate the impact of the cardiovascular implant devices and the flow conditioners on the flow patterns in the heart. The blood flow in the heart can be simulated when the heart includes cardiovascular implant devices including various types of flow conditioners (e.g., fin type and/or plate type) having varying forms (e.g., varying shapes, sizes, presence of flow microfeatures, etc.), varying physical dimensions, varying arrangements or positions with respect to the cardiovascular implant device, varying attachment or extension angles, and/or other possible variations described herein.
Step 2008 includes selecting the cardiovascular implant device including a flow conditioner (or multiple flow conditioners) that complements the flow patterns in the heart. The cardiovascular implant device including the flow conditioner is selected to minimize or eliminate disruption of or enhance flow patterns in the heart. Specifically, step 2008 can include selecting a design of the cardiovascular implant device including the flow conditioner that complements the flow patterns in the heart. More specifically, a type of the flow conditioner can be selected to complement the flow patterns in the heart; a form and/or physical dimension of the flow conditioner can be selected to complement the flow pattern in the heart; and an arrangement or position and/or angle of the flow conditioner can be selected to complement the flow pattern in the heart.
The right atrium of the heart has a right-sided flow vortex as a natural flow pattern in the heart. The design of the cardiovascular implant device including the flow conditioner can be selected to complement the right-sided flow vortex in the right atrium of the heart. The left atrium of the heart has a left-sided flow vortex as a natural flow pattern in the heart. The design of the cardiovascular implant device including the flow conditioner can be selected to complement the left-sided flow vortex in the left atrium of the heart. The coronary sinus and other vessels of the heart may have a helical flow pattern. The design of the cardiovascular implant device including the flow conditioner can be selected to complement the helical flow pattern in the coronary sinus or other vessels of the heart.
In an alternate example, step 2008 can include selecting a design of a cardiovascular implant device including a flow conditioner that enhances the flow pattern in the right atrium of the heart and/or reestablishes the natural flow pattern in the right atrium of the heart. Specifically, if the patient has lost the right-sided flow vortex of blood flow in the right atrium of the heart due to age, disease, or anatomical defects, the design of the cardiovascular implant device including the flow conditioner can be selected to reestablish the right-sided flow vortex of blood flow in the right atrium of the heart.
Step 2010 includes implanting the cardiovascular implant device including the flow conditioner in the heart. The cardiovascular implant device including the flow conditioner can be implanted using any suitable method.
Step 2012 includes obtaining a second MRI of the heart. The second MRI (magnetic resonance imaging) can visualize the flow patterns of blood flow in the heart of the patient after the cardiovascular implant device including the flow conditioner has been implanted. Specifically, the second MRI can visualize the flow patterns of blood flow in the vessels and/or chambers (right atrium, left atrium, right ventricle, and left ventricle) of the heart of the patient after the cardiovascular implant device including the flow conditioner has been implanted.
The second MRI can be a 4D MRI that visualizes the flow patterns of blood flow in the heart of a patient after the cardiovascular implant device including the flow conditioner has been implanted. Additionally, the 4D MRI can measure volumes in the chambers of the heart, sizes of the chambers of the heart, geometries of the chambers of the heart, compliances of the chambers of the heart, and/or blood pressures in the chambers of the heart. The 4D MRI can also track movement of the chambers of the heart and movement of the tricuspid valve (also known as tricuspid annular plan systolic excursion (TAPSE)).
The second MRI is obtained to confirm that the cardiovascular implant device including the flow conditioner complements (e.g., has minimal to no disruption of or enhances) the flow patterns in the heart. Further, the second MRI can be obtained to determine whether the cardiovascular implant device including the flow conditioner has enhanced and/or reestablished the natural flow patterns in the heart. Specifically, the second MRI can be obtained to determine whether the cardiovascular implant device including the flow conditioner has reestablished a right-sided flow vortex in a right atrium of the heart.
The second MRI can also confirm the overall health of the heart after the cardiovascular implant device including the flow conditioner has been implanted. Specifically, the volumes in the chambers of the heart, sizes of the chambers of the heart, geometries of the chambers of the heart, compliances of the chambers of the heart, and/or blood pressures in the chambers of the heart from the second MRI can be compared to the same readings from the first MRI to confirm overall health of the heart. In one example, the volumes, sizes, geometries, and/or compliances of the chambers of the heart can be analyzed to determine if the left side of the heart has experienced remodeling (shrinkage) due to the reduced blood pressure on the left side of the heart after the cardiovascular implant device including the flow conditioner has been implanted. Further, the volumes, sizes, geometries, and/or compliances of the chambers of the heart can be analyzed to determine if the right side of the heart is being overloaded due to the increased blood pressure in the right side of the heart.
Step 2014 includes adjusting the cardiovascular implant device including the flow conditioner. The cardiovascular implant device including the flow conditioner can be adjusted if the second MRI shows that the implantation of the cardiovascular implant device including the flow conditioner has not had the desired effect on the flow patterns in or overall health of the heart. In one example, a type of the flow conditioner can be changed, such as from one or more fin type, plate type, or deflector type flow conditioners or a combination of types to one or more of a different type of flow conditioner or a different combination of types. In another example, a form, physical dimension, and/or arrangement or position of the flow conditioner can be adjusted. In another example, the angle of the flow conditioner can be adjusted. For example, the flow conditioner can be connected to the cardiovascular implant device by an adjustable bias member that can be adjusted such that the flow conditioner has a different angle, or the flow conditioner can be electromechanically actuated to a different angle.
Method 2000 as described herewith can be used to aid in the selection and implantation of any suitable cardiovascular implant device including a flow conditioner. In one example, method 2000 can be used to aid in the selection and implantation of cardiovascular implant device 100 (shown in
Any of the various systems, devices, apparatuses, etc. in this disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise sterilization of the associated system, device, apparatus, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.). That is, any of devices 100, 200, 300, 400, 500, 600, 700, 800, and 900 or components of devices 100, 200, 300, 400, 500, 600, 700, 800, and 900 can be sterilized before being delivered into the body.
The treatment techniques, methods, steps, etc. described or suggested herein or in references incorporated herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (e.g., with the body parts, tissue, etc. being simulated), etc.
The following are non-exclusive descriptions of possible examples of the present invention.
A cardiovascular implant device includes an expandable annular frame and a flow conditioner. The expandable annular frame is formed of a plurality of struts and is configured to conform to an interior shape of a blood vessel or a chamber of a heart when expanded inside the blood vessel or the chamber of the heart. The flow conditioner is connected to the plurality of struts of the expandable annular frame. The flow conditioner is positioned to modify a hemodynamic characteristic of a flow of blood through or out of the expandable annular frame.
The cardiovascular implant device of the preceding paragraph can optionally include, additionally and/or alternatively, any one or more of the following features, configurations, and/or additional components:
The flow conditioner can include one or more fins.
The one or more fins can be connected circumferentially about an interior of the expandable annular frame.
The one or more fins can be connected to ones of the plurality of struts that form a first row of openings in the expandable annular frame, the first row of openings being adjacent to an outflow end of the expandable annular frame.
The one or more fins can be angled radially inward from a circumference of the expandable annular frame.
The one or more fins can be connected adjacent to an inflow or outflow end of the expandable annular frame.
The one or more fins can be angled radially inward from the inflow or outflow end of the expandable annular frame.
The one or more fins can include a first fin connected to the expandable annular frame at an inflow end of the cardiovascular implant device to modify the hemodynamic characteristic of the flow of blood through the expandable annular frame and a second fin connected to the expandable annular frame at an outflow end of the cardiovascular implant device to modify the hemodynamic characteristic of the flow of blood out of the expandable annular frame.
Each fin of the one or more fins can be deflectable by the flow of blood through or out of the expandable annular frame.
Each fin of the one or more fins can be connected to the expandable annular frame by a spring.
The one or more fins can be airfoils, and the one or more fins can include flow microfeatures proximal to a leading edge of respective ones of the one or more fins.
The flow microfeatures can include at least one of a vortex generator, a leading edge notch, a leading edge dogtooth, a boundary layer fence, and a vortilon.
The flow conditioner and the expandable annular frame can form a monolithic structure.
The flow conditioner and a portion of the expandable annular frame to which the flow conditioner is connected can be formed of a shape-memory alloy.
The shape-memory alloy can be nitinol.
The flow conditioner can be electromechanically actuated.
An attachment angle of the flow conditioner as measured with respect to a longitudinal axis of a respective one of the plurality of struts to which the flow conditioner is connected can be controllable over a range of possible angles.
The flow conditioner can include one or more plates that span across a portion of the expandable annular frame such that the one or more plates intersect a flow axis through the expandable annular frame, the one or more plates each including a plurality of flow passages.
The one or more plates can include a first plate having a first plurality of flow passages and a second plate having a second plurality of flow passages, and the first plate can be connected at an inflow end of the cardiovascular implant device to modify the hemodynamic characteristic of the flow of blood through the expandable annular frame and the second plate can be connected to an outflow end of the cardiovascular implant device to modify the hemodynamic characteristic of the flow of blood out of the expandable annular frame.
The flow conditioner can be connected to the expandable annular frame at an inflow end of the cardiovascular implant device to modify the hemodynamic characteristic of the flow of blood through the expandable annular frame.
The flow conditioner can be connected to the expandable annular frame at an outflow end of the cardiovascular implant device to modify the hemodynamic characteristic of the flow of blood out of the expandable annular frame.
The flow conditioner can include a first flow conditioner feature connected to the expandable annular frame at an inflow end of the cardiovascular implant device and a second flow conditioner feature connected to the expandable annular frame at an outflow end of the cardiovascular implant device, and the first flow conditioner feature can be positioned to modify the hemodynamic characteristic of the flow of blood through the expandable annular frame and the second flow conditioner feature can be positioned to modify the hemodynamic characteristic of the flow of blood out of the expandable annular frame.
The flow conditioner can have a physical dimension that causes the flow conditioner to avoid interaction with an adjacent tissue wall.
The flow conditioner can include at least one of a fin and a plate, the plate including a plurality of flow passages.
The cardiovascular implant device can be sterilized.
The cardiovascular implant device can be a docking station configured to support an expandable transcatheter valve.
The cardiovascular implant device can be a stent.
The cardiovascular implant device can be configured to be implanted at a valve site.
The cardiovascular implant device can be configured to be implanted at a non-valve site.
A prosthetic valve device includes an annular frame formed of a plurality of struts, a valvular body mounted within the annular frame, and a flow conditioner. The valvular body includes a plurality of leaflets that regulate a flow of blood through the annular frame. The flow conditioner is connected to the plurality of struts of the annular frame. The flow conditioner is positioned to modify a hemodynamic characteristic of the flow of blood through or out of the annular frame.
The prosthetic valve device of the preceding paragraph can optionally include, additionally and/or alternatively, any one or more of the following features, configurations, and/or additional components:
The flow conditioner can include one or more fins.
The one or more fins can be connected circumferentially about an interior of the annular frame.
The one or more fins can be connected to ones of the plurality of struts that form a first row of openings in the annular frame, the first row of openings being adjacent to an outflow end of the annular frame.
The one or more fins can be angled radially inward from a circumference of the annular frame.
The one or more fins can be connected adjacent to an inflow or outflow end of the annular frame.
The one or more fins can be angled radially inward from the inflow or outflow end of the annular frame.
The one or more fins can include a first fin connected to the annular frame at an inflow end of the prosthetic valve device to modify the hemodynamic characteristic of the flow of blood through the annular frame and a second fin connected to the annular frame at an outflow end of the prosthetic valve device to modify the hemodynamic characteristic of the flow of blood out of the annular frame.
Each fin of the plurality of fins can be deflectable by the flow of blood through or out of the annular frame.
Each fin of the plurality of fins can be connected to the annular frame by a spring.
The one or more fins can be airfoils, and the one or more fins can include flow microfeatures proximal to a leading edge of respective ones of the one or more fins.
The flow microfeatures can include at least one of a vortex generator, a leading edge notch, a leading edge dogtooth, a boundary layer fence, and a vortilon.
The flow conditioner and the annular frame can form a monolithic structure.
The flow conditioner and a portion of the annular frame to which the flow conditioner is connected can be formed of a shape-memory alloy.
The shape-memory alloy can be nitinol.
The flow conditioner can be electromechanically actuated.
An attachment angle of the flow conditioner as measured with respect to a longitudinal axis of a respective one of the plurality of struts to which the flow conditioner is connected can be controllable over a range of possible angles.
The flow conditioner can include one or more plates that span across a portion of the annular frame such that the one or more plates intersect a flow axis through the annular frame, the one or more plates each including a plurality of flow passages.
The one or more plates can include a first plate having a first plurality of flow passages and a second plate having a second plurality of flow passages, and the first plate can be connected at an inflow end of the prosthetic valve device to modify the hemodynamic characteristic of the flow of blood through the annular frame and the second plate can be connected to an outflow end of the prosthetic valve device to modify the hemodynamic characteristic of the flow of blood out of the annular frame.
The flow conditioner can be connected to the annular frame at an inflow end of the prosthetic valve device to modify the hemodynamic characteristic of the flow of blood through the annular frame.
The flow conditioner can be connected to the annular frame at an outflow end of the prosthetic valve device to modify the hemodynamic characteristic of the flow of blood out of the annular frame.
The flow conditioner can include a first flow conditioner feature connected to the annular frame at an inflow end of the prosthetic valve device and a second flow conditioner feature connected to the annular frame at an outflow end of the prosthetic valve device, and the first flow conditioner feature can be positioned to modify the hemodynamic characteristic of the flow of blood through the annular frame and the second flow conditioner feature can be positioned to modify the hemodynamic characteristic of the flow of blood out of the annular frame.
The flow conditioner can have a physical dimension that causes the flow conditioner to avoid interaction with the valvular body and/or an adjacent tissue wall.
The flow conditioner can include at least one of a fin and a plate, the plate including a plurality of flow passages.
The prosthetic valve device can be sterilized.
The prosthetic valve device can be configured to be implanted at a valve site.
The prosthetic valve device can be configured to be implanted at a non-valve site.
A prosthetic valve system includes a prestent device having a frame with a bi-directionally flared profile that is formed of a first plurality of struts, a prosthetic valve device configured to sit within the prestent device, a first flow conditioner, and a second flow conditioner. The prosthetic valve device includes an annular frame formed of a second plurality of struts and a valvular body mounted within the annular frame. The valvular body includes a plurality of leaflets that regulate a flow of blood through the annular frame. The first flow conditioner is connected to the first plurality of struts of the prestent device. The first flow conditioner is positioned to modify a first hemodynamic characteristic of the flow of blood through or out of the prestent device. The second flow conditioner is connected to the second plurality of struts of the prosthetic valve device. The second flow conditioner is positioned to modify a second hemodynamic characteristic of the flow of blood through or out of the prosthetic valve device.
The prosthetic valve system of the preceding paragraph can optionally include, additionally and/or alternatively, any one or more of the following features, configurations, and/or additional components:
The first flow conditioner and the second flow conditioner can include one or more fins.
Individual fins of the one or more fins can be connected circumferentially about a respective interior of the frame of the prestent device and/or the annular frame of the prosthetic valve device.
The individual fins of the one or more fins can be angled radially inward from a respective circumference of the frame of the prestent device and/or the annular frame of the prosthetic valve device.
Individual fins of the one or more fins can be connected adjacent to a respective inflow or outflow end of the frame of the prestent device and/or the annular frame of the prosthetic valve device.
The one or more fins can include a first fin connected to the frame at an inflow end of the prestent device to modify the hemodynamic characteristic of the flow of blood through the prestent device, a second fin connected to the frame at an outflow end of the prestent device to modify the hemodynamic characteristic of the flow of blood out of the prestent device, a third fin connected to the annular frame at an inflow end of the prosthetic valve device to modify the hemodynamic characteristic of the flow of blood through the prosthetic valve device, and a fourth fin connected to the annular frame at an outflow end of the prosthetic valve device to modify the hemodynamic characteristic of the flow of blood out of the prosthetic valve device.
Each fin of the one or more fins of the first flow conditioner can be deflectable by the flow of blood through or out of the prestent device, and each fin of the one or more fins of the second flow conditioner can be deflectable by the flow of blood through or out of the prosthetic valve device.
An individual fin of the one or more fins can be connected to the frame of the prestent device or the annular frame of the prosthetic valve device by a spring.
The one or more fins can be airfoils, and the one or more fins can include flow microfeatures proximal to a leading edge of respective ones of the one or more fins.
The flow microfeatures can include at least one of a vortex generator, a leading edge notch, a leading edge dogtooth, a boundary layer fence, and a vortilon.
The first flow conditioner and the frame of the prestent device can form a first monolithic structure, and the second flow conditioner and the annular frame of the prosthetic valve device can form a second monolithic structure.
The first flow conditioner and a portion of the frame of the prestent device to which the first flow conditioner is connected and the second flow conditioner and a portion of the annular frame of the prosthetic valve device to which the second flow conditioner is connected can all be formed of a shape-memory alloy.
The shape-memory alloy can be nitinol.
The first flow conditioner and the second flow conditioner can be electromechanically actuated.
The first flow conditioner can include one or more plates that span across a portion of the frame of the prestent device such that the one or more plates of the first flow conditioner intersect a flow axis through the frame, the second flow conditioner can include one or more plates that span across a portion of the annular frame of the prosthetic valve device such that the one or more plates of the second flow conditioner intersect a flow axis through the annular frame, and each of the one or more plates of the first and second flow conditioners can include a respective plurality of flow passages.
The one or more plates of the first and second flow conditioners can include a first plate connected at an inflow end of the prestent device to modify the hemodynamic characteristic of the flow of blood through the prestent device, a second plate connected at an outflow end of the prestent device to modify the hemodynamic characteristic of the flow of blood out of the prestent device, a third plate connected at an inflow end of the prosthetic valve device to modify the hemodynamic characteristic of the flow of blood through the prosthetic valve device, and a fourth plate connected at an outflow end of the prosthetic valve device to modify the hemodynamic characteristic of the flow of blood out of the prosthetic valve device.
The first flow conditioner can be connected to the frame at an inflow end of the prestent device to modify the hemodynamic characteristic of the flow of blood through the prestent device, or the first flow conditioner can be connected to the frame at an outflow end of the prestent device to modify the hemodynamic characteristic of the flow of blood out of the prestent device.
The second flow conditioner can be connected to the annular frame at an inflow end of the prosthetic valve device to modify the hemodynamic characteristic of the flow of blood through the prosthetic valve device, or the second flow conditioner can be connected to the annular frame at an outflow end of the prosthetic valve device to modify the hemodynamic characteristic of the flow of blood out of the prosthetic valve device.
The first flow conditioner can include one or more fins and the second flow conditioner can include one or more plates that span across a portion of the annular frame of the prosthetic valve device such that the one or more plates of the second flow conditioner intersect a flow axis through the annular frame, or the first flow conditioner can include one or more plates that span across a portion of the frame of the prestent device such that the one or more plates of the first flow conditioner intersect a flow axis through the frame and the second flow conditioner can include one or more fins.
The first flow conditioner and the second flow conditioner can have respective physical dimensions that cause the first and second flow conditioners to avoid interaction with an adjacent tissue wall.
Each of the first flow conditioner and the second flow conditioner can include at least one of a fin and a plate, the plate including a plurality of flow passages.
The prestent device and the prosthetic valve device can be sterilized.
The prosthetic valve system can be configured to be implanted at a valve site.
The prosthetic valve system can be configured to be implanted at a non-valve site.
A cardiovascular implant device includes a body and a flow conditioner connected to the body. The body is configured to attach to one or more leaflets of a natural 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 the one or more leaflets. The flow conditioner is positioned to modify a hemodynamic characteristic of a flow of blood around the cardiovascular implant device.
The cardiovascular implant device of the preceding paragraph can optionally include, additionally and/or alternatively, any one or more of the following features, configurations, and/or additional components:
The flow conditioner can include one or more fins.
Each fin of the one or more fins can be deflectable by the flow of blood around the cardiovascular implant device.
Each fin of the one or more fins can be connected to the body by a spring.
The one or more fins can be airfoils, and the one or more fins can include flow microfeatures proximal to a leading edge of respective ones of the one or more fins.
The flow microfeatures include at least one of a vortex generator, a leading edge notch, a leading edge dogtooth, a boundary layer fence, and a vortilon.
The flow conditioner and the body can form a monolithic structure.
The flow conditioner and a portion of the body to which the flow conditioner is connected can be formed of a shape-memory alloy.
The shape-memory alloy can be nitinol.
The flow conditioner can be electromechanically actuated.
The flow conditioner can be connected to the body at an inflow end of the cardiovascular implant device.
The flow conditioner can be connected to the body at an outflow end of the cardiovascular implant device.
The flow conditioner can include a first flow conditioner feature connected to the body at an inflow end of the cardiovascular implant device and a second flow conditioner feature connected to the body at an outflow end of the cardiovascular implant device.
The flow conditioner can be connected to the body at the central spacer.
The flow conditioner can be connected to the body at the clasps.
The flow conditioner can have a physical dimension that causes the flow conditioner to avoid interaction with an adjacent tissue wall.
The cardiovascular implant device can be sterilized.
The cardiovascular implant device can be an edge-to-edge valve repair device.
While the invention has been described with reference to an exemplary example(s), it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope thereof. Therefore, it is intended that the invention not be limited to the particular example(s) disclosed, but that the invention will include all examples falling within the scope of the appended claims.
This application is a continuation of International Application No. PCT/US2023/024703, filed Jun. 7, 2023, which claims the benefit of U.S. Provisional Application No. 63/349,824, filed Jun. 7, 2022, the disclosures of which are hereby incorporated by reference in their entireties.
| Number | Date | Country | |
|---|---|---|---|
| 63349824 | Jun 2022 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2023/024703 | Jun 2023 | WO |
| Child | 18969649 | US |
