Dynamic venous occlusion device

Abstract

A system for regulating blood flow through a blood vessel of the heart, the system comprising a valve, the valve comprising an outer frame and configured to be at least partially disposed within the blood vessel.

Description

[Background technology]

[0001] (Related Applications) This application claims priority to U.S. Provisional Application No. 63 / 378,794, filed October 7, 2022, and entitled "DYNAMIC VENOUS OCCLUSION DEVICES," the disclosure of which is hereby incorporated by reference in its entirety.

[0002] The present invention relates generally to the field of medical devices and procedures.

[0003] Redistribution of blood from the splanchnic venous circulation to the inferior vena cava (IVC) can contribute to increases in central venous pressure (CVP), pulmonary artery pressure, and / or pulmonary capillary wedge pressure (PCWP), particularly during periods of elevated sympathetic nervous system tone (e.g., exercise) in patients with heart failure. Summary of the Invention

[0004] Described herein are one or more methods and / or devices for facilitating management of blood flow through and / or into one or more blood vessels and / or ventricles of the heart.

[0005] For purposes of summarizing the present disclosure, certain aspects, advantages, and novel features will be described. It will be understood that not all such advantages may necessarily be achieved by any particular example. Thus, the disclosed embodiments may be implemented in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other advantages that may be taught or suggested herein.

[0006] The methods and structures disclosed herein for treating patients also encompass similar methods and structures performed on or placed on a simulated patient, which are useful, for example, for training, demonstration, treatment and / or device development, and the like. The simulated patient can be physical, virtual, or a combination of physical and virtual. The simulation can include simulation of all or part of a patient, for example, the whole body, a body part (e.g., the chest), a system (e.g., the cardiovascular system), an organ (e.g., the heart), or any combination thereof. The physical elements may be natural, including human or animal cadavers or parts thereof, synthetic, or any combination of natural and synthetic. The virtual elements may be entirely in silico or may be overlaid on one or more of the physical components. The virtual elements may be presented on any combination of screens, headsets, holographic, projection, loudspeakers, headphones, pressure transducers, temperature transducers, or presented using any combination of suitable technologies.

[0007] Various embodiments are shown in the accompanying drawings for illustrative purposes and should not be construed as limiting the scope of the present invention in any way. In addition, various features of different disclosed embodiments can be combined to form additional embodiments that are part of the present disclosure. Throughout the drawings, reference numbers may be reused to indicate correspondence between referenced elements. However, it should be understood that the use of similar reference numbers in relation to multiple drawings does not necessarily imply similarity between the respective embodiments associated therewith. Furthermore, it should be understood that features in each drawing are not necessarily drawn to scale, and that the illustrated sizes are presented for the purpose of illustrating aspects of the invention. In general, some of the illustrated features may be relatively smaller than illustrated in some embodiments or configurations. [Brief explanation of the drawings]

[0008] [Figure 1]FIG. 1 provides a schematic diagram of parts of the renal circulation. [Figure 2] Figure 2 provides another schematic diagram of the splanchnic circulation, showing blood flow from the aorta to the inferior vena cava (IVC). [Figure 3] Figure 3 shows the portion of the splanchnic venous circulation that acts as a blood reservoir between the aorta and the IVC. [Figure 4] FIG. 4 illustrates an exemplary system for regulating blood flow through one or more blood vessels, which may include the IVC and / or SVC of the heart. [Figure 5] FIG. 5 illustrates an exemplary occlusion valve configured to dynamically occlude one or more blood vessels of the heart, according to one or more embodiments. [Figure 6A] 6A-6C provide overhead views of an exemplary occlusion valve configured to dynamically occlude one or more blood vessels of the heart, according to one or more embodiments. [Figure 6B] 6A-6C provide overhead views of an exemplary occlusion valve configured to dynamically occlude one or more blood vessels of the heart, according to one or more embodiments. [Figure 6C] 6A-6C provide overhead views of an exemplary occlusion valve configured to dynamically occlude one or more blood vessels of the heart, according to one or more embodiments. [Figure 7A] 7A-7C provide overhead views of an exemplary occlusion valve configured to dynamically occlude one or more blood vessels of the heart, according to one or more embodiments. [Figure 7B] 7A-7C provide overhead views of an exemplary occlusion valve configured to dynamically occlude one or more blood vessels of the heart, according to one or more embodiments. [Figure 7C] 7A-7C provide overhead views of an exemplary occlusion valve configured to dynamically occlude one or more blood vessels of the heart, according to one or more embodiments. [Figure 8A] 8A and 8B illustrate another exemplary occlusion valve configured to dynamically occlude one or more blood vessels of the heart, according to one or more embodiments. [Figure 8B]8A and 8B illustrate another exemplary occlusion valve configured to dynamically occlude one or more blood vessels of the heart, according to one or more embodiments. [Figure 9A] 9A-9C illustrate another exemplary occlusion valve configured to dynamically occlude one or more blood vessels of the heart, according to one or more embodiments. [Figure 9B] 9A-9C illustrate another exemplary occlusion valve configured to dynamically occlude one or more blood vessels of the heart, according to one or more embodiments. [Figure 9C] 9A-9C illustrate another exemplary occlusion valve configured to dynamically occlude one or more blood vessels of the heart, according to one or more embodiments. [Figure 10] FIG. 10 illustrates an exemplary system including one or more valves according to one or more embodiments described herein. [Figure 11] FIG. 11 illustrates an exemplary frame of an occlusion valve, as described in any of the examples herein. [Figure 12] FIG. 12 provides an overhead view of a valve with multiple leaflets 1205, according to one or more embodiments described herein. [Figure 13] FIG. 13 provides an overhead view of a multi-leaflet valve according to one or more embodiments described herein. [Figure 14] FIG. 14 provides a side view of a valve with multiple leaflets extending from a frame, according to one or more embodiments described herein. [Figure 15A] 15A-15C illustrate an example valve and / or one or more components of a valve, according to one or more embodiments described herein. [Figure 15B] 15A-15C illustrate an example valve and / or one or more components of a valve, according to one or more embodiments described herein. [Figure 15C] 15A-15C illustrate an example valve and / or one or more components of a valve, according to one or more embodiments described herein. [Figure 16A]16A and 16B illustrate an exemplary occlusion valve, which may comprise various components of the valves described herein, according to one or more embodiments. [Figure 16B] 16A and 16B illustrate an exemplary occlusion valve, which may comprise various components of the valves described herein, according to one or more embodiments. [Figure 17A] 17A-17D illustrate an exemplary valve configured to dynamically occlude one or more blood vessels of the heart, according to one or more embodiments herein. [Figure 17B] 17A-17D illustrate an exemplary valve configured to dynamically occlude one or more blood vessels of the heart, according to one or more embodiments herein. [Figure 17C] 17A-17D illustrate an exemplary valve configured to dynamically occlude one or more blood vessels of the heart, according to one or more embodiments herein. [Figure 17D] 17A-17D illustrate an exemplary valve configured to dynamically occlude one or more blood vessels of the heart, according to one or more embodiments herein. [Figure 18A] 18A and 18B illustrate an exemplary valve configured to dynamically occlude one or more blood vessels of the heart, in accordance with one or more embodiments herein. [Figure 18B] 18A and 18B illustrate an exemplary valve configured to dynamically occlude one or more blood vessels of the heart, in accordance with one or more embodiments herein. [Figure 19] FIG. 19 illustrates an exemplary circuit configured to control and / or power one or more valves, as described in the examples herein. [Figure 20] FIG. 20 illustrates another circuit for controlling one or more valves described herein, according to one or more embodiments. [Figure 21A] 21A and 21B illustrate an exemplary dynamic occlusion valve configured for at least partial placement within one or more blood vessels of the heart, in accordance with one or more embodiments herein. [Figure 21B]21A and 21B illustrate an exemplary dynamic occlusion valve configured for at least partial placement within one or more blood vessels of the heart, in accordance with one or more embodiments herein. [Figure 22A] 22A and 22B illustrate another exemplary valve configured to dynamically occlude one or more blood vessels of the heart, according to one or more embodiments. [Figure 22B] 22A and 22B illustrate another exemplary valve configured to dynamically occlude one or more blood vessels of the heart, according to one or more embodiments. [Figure 23A] 23A-23C illustrate another exemplary valve configured to dynamically occlude one or more blood vessels of the heart, in accordance with one or more embodiments herein. [Figure 23B] 23A-23C illustrate another exemplary valve configured to dynamically occlude one or more blood vessels of the heart, in accordance with one or more embodiments herein. [Figure 23C] 23A-23C illustrate another exemplary valve configured to dynamically occlude one or more blood vessels of the heart, in accordance with one or more embodiments herein. [Figure 24A] 24A and 24B illustrate another exemplary valve configured to dynamically occlude one or more blood vessels of the heart, according to one or more embodiments. [Figure 24B] 24A and 24B illustrate another exemplary valve configured to dynamically occlude one or more blood vessels of the heart, according to one or more embodiments. [Figure 25A] 25A and 25B illustrate an exemplary ratchet mechanism configured to allow dynamic adjustment of one or more components of the various valves described herein. [Figure 25B] 25A and 25B illustrate an exemplary ratchet mechanism configured to allow dynamic adjustment of one or more components of the various valves described herein. DETAILED DESCRIPTION OF THE INVENTION

[0009] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0010] Although certain preferred embodiments and examples are disclosed below, the inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, as well as modifications and equivalents thereof. Accordingly, the scope of claims that may arise from this specification is not limited by any of the specific embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable order and are not necessarily limited to any particular disclosed order. Various operations may be described sequentially as multiple separate operations, in a manner that may be useful for understanding a particular embodiment, but the order of description should not be construed as implying that these operations are order-dependent. Additionally, structures, systems, and / or devices described herein may be embodied as integrated or separate components. For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not all such aspects or advantages are necessarily achieved by any particular embodiment. Thus, for example, various embodiments may be implemented in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages that may also be taught or suggested herein.

[0011] The following includes a general description of human cardiac anatomy that is relevant to certain inventive features and embodiments disclosed herein and is included to provide context for certain aspects of the present disclosure.

[0012] FIG. 1 provides a schematic diagram of portions of the renal circulation 100 and / or splanchnic circulation. The term "splanchnic circulation" refers to blood flow from the celiac, superior mesenteric, and inferior mesenteric arteries of origin to the abdominal digestive tract. The renal circulation 100 and / or splanchnic circulation receives approximately 25% of cardiac output and retains a similar proportion of total blood volume under normal conditions. The renal circulation 100 and / or splanchnic circulation may act as a site of cardiac output regulation and / or as a blood reservoir. Multiple regulatory pathways are involved in the distribution of blood in the splanchnic circulation.

[0013] Total blood flow to the splanchnic organs is controlled by resistance vessels in the mesenteric and hepatic arterial systems. Venous outflow from the splanchnic organs converges to form the portal vein 3, which provides approximately 75% of the total blood supply to the liver 5. Portal blood tends to contain high concentrations of substrates provided by intestinal absorption, as well as bacteria and endotoxins.

[0014] The renal veins 12 drain blood from the right kidney 14 and left kidney 16 and connect to the inferior vena cava 10 (IVC). The superior mesenteric vein 6 lies transverse to the superior mesenteric artery and is a major venous tributary of the abdominal cavity, responsible for draining most of the abdominal organs. The inferior mesenteric vein 8 drains blood from the large intestine. The splenic vein 12 is a vessel that drains blood from the spleen, the fundus of the stomach, and part of the pancreas.

[0015] The portal vein 3 receives blood from the stomach, intestines, pancreas, and spleen 7 and carries it through the porta hepatis to the liver 5. The porta hepatis serves as the entrance for the portal vein 3 and the proper hepatic artery, and is the outlet for the bile duct.

[0016] After blood is processed by the liver 5, it pools in the central veins of the lobule core. Blood from these central veins eventually converges into the right and left hepatic veins 9, exits the superior surface of the liver 5, and drains into the IVC 10 for distribution to the rest of the body.

[0017] The splanchnic venous circulation is highly adaptive and may act as a blood reservoir that may be recruited to support the need for increased blood volume during periods of increased sympathetic nervous system tone, such as exertion, to support increased cardiac output and vasodilation of peripheral vasculature supporting active muscles. However, patients with heart failure may have multiple comorbidities that prevent them from using this additional blood volume. Such comorbidities may include chronotropic insufficiency, an inability to increase stroke volume, and / or peripheral microvascular dysfunction. This can lead to venous congestion and / or a sudden increase in pulmonary capillary wedge pressure (PCWP).

[0018] 2 provides another schematic diagram of the splanchnic circulation 200, showing blood flow from the aorta 8 to the IVC 10. Blood travels from the aorta 8 to the abdominal digestive tract, including the stomach 11, liver 5, spleen 7, pancreas 13, small intestine 15, and large intestine 17. The splanchnic circulation 200 includes three major branches of the abdominal aorta 9, including the celiac artery 19, superior mesenteric artery 21 (SMA), and inferior mesenteric artery 23 (IMA). The hepatic portal circulation (e.g., hepatic artery 18 and / or portal vein 3) delivers the majority of blood flow to the liver 5.

[0019] The celiac trunk 19 is the first major division of the abdominal aorta 8, approximately 1.25 cm long, and branches horizontally at T12. It has three main divisions: the left gastric artery, the common hepatic artery 18, and the splenic artery, which provide the primary blood supply to the stomach 11, upper duodenum, spleen 7, and pancreas 13.

[0020] The SMA 21 arises from the abdominal aorta 8 anteriorly, usually at L1, 1 cm inferior to the celiac trunk 19. The five major divisions of the SMA 21 are the inferior pancreaticoduodenal artery, the iliac artery, the ileocolic artery, the right colic artery, and the middle colic artery. The SMA 21 supplies the lower duodenum, jejunum, ileum, cecum, appendix, ascending colon, and two-thirds of the transverse colon. It is the largest splanchnic arterial vessel, delivering more than 10% of cardiac output and therefore has a significant impact on embolic mesenteric ischemia.

[0021] The IMA 23 branches off the abdominal aorta 8 anteriorly at L3, midway between the renal arteries and the iliac bifurcation. The major branches of the IMA 23 are the left colic artery, the sigmoid bifurcation, and the superior rectal artery. It forms a watershed with the middle colic artery and supplies the remaining one-third of the transverse colon, the descending colon, and the upper rectum.

[0022] Blood flows to the liver 5 via the portal vein 3 and into the sinusoids 25 of the liver 5. The hepatic vein 9 carries blood from the liver 5 to the IVC 10.

[0023] 3 shows a portion of the splanchnic venous circulation 300, which acts as a blood reservoir 30 between the aorta 8 and the IVC 10. The portal vein 30 carries blood between the visceral organs 27 (e.g., stomach, spleen, etc.) and the hepatic sinusoids 25, which also receive blood from the hepatic artery 18. The visceral organs 27 receive blood from the aorta 8 via various splanchnic arteries 29 (e.g., SMA, IMA, etc.). The amount of blood contained in the portal vein 30 at any given time may be variable.

[0024] For some patients (particularly those suffering from heart failure), fluid redistribution and / or stress blood volume from the splanchnic venous reservoir 30 to the IVC 10 may contribute to an increase in central venous pressure (CVP), pulmonary artery pressure, and / or PCWP, which may be particularly problematic during periods of increased sympathetic nervous system tone, such as exertion, and / or may lead to pulmonary congestion that may impact the patient's quality of life and / or result in acute decompensation.

[0025] The splanchnic venous circulation 300, particularly the portal vein 3, may advantageously provide a blood reserve to support the need for increased blood volume during periods of elevated sympathetic nervous system tone. Because blood flow from the splanchnic venous circulation 300 is directed through the hepatic vein 9 and into the IVC 10, devices placed within the hepatic vein 9 and / or IVC 10 to restrict blood flow may allow the reservoir 30 to expand with the increased blood volume.

[0026] Embodiments described herein may advantageously relate to devices and / or methods that can restrict, stagnate, and / or impede blood flow from the hepatic vein 9 to the IVC 10 to increase the pressure gradient between the IVC 10 and the hepatic and / or splanchnic venous circulation 300. In some embodiments, one or more flow-regulating implants may be configured for at least partial placement within the hepatic vein 9 and / or IVC 10 and / or at one or more junctions between the hepatic vein 9 and the IVC 10. As a result, blood flowing from the splanchnic venous reservoir 30 into the hepatic vein 9 may be slowed to increase the volume of blood in the splanchnic venous reservoir 30.

[0027] Some approaches to reducing blood volume redistribution may involve placing a fixed orifice flow controller in or near the IVC 10. Restricting flow from the hepatic vein 9 can be beneficial to prevent blood volume redistribution, but excessive restriction can result in hepatic congestion. It may be advantageous to adjust the response and increase the restriction only during blood volume redistribution.

[0028] Several examples presented herein relate to methods and / or devices for increasing restriction of blood flow from the hepatic vein 9 and / or IVC 10 into the right atrium as left atrial blood pressure increases. Various devices may be implanted using a transcatheter transvenous approach, for example, entering through the femoral vein. The delivery system may then be progressively unsheathed, and other components of the device may be sequentially implanted under fluoroscopic and acoustic guidance, as needed.

[0029] Individuals with chronic kidney disease (CKD) and heart failure suffer from decreased renal function when right atrial pressure is elevated. Maintaining relatively low pressure in the right atrium allows the kidneys to filter blood more effectively. In certain conditions, a sudden increase in blood volume can lead to an increase in blood pressure in the left atrium. Furthermore, patients may accumulate blood volume in the venous system, which, at some point, can increase blood pressure in the right atrium and, therefore, the IVC as a result of the volumetric state. This may be more likely in CKD patients with impaired diuresis due to nephron loss. Furthermore, this increased pressure on the venous side of the kidney may increase the likelihood of blood volume accumulation.

[0030] Controlling the return of blood can reduce the buildup of right heart pressure, and some embodiments described herein can help maintain relatively low right heart pressure during a blood volume surge.

[0031] The superior vena cava (SVC) returns approximately 30% of the blood volume to the right atrium. Controlling the amount of blood return through the SVC can help relieve right heart pressure.

[0032] The solutions presented herein relate to implantable dynamic valve systems that can be used to control pressure in the veins returning to the heart, particularly the SVC. Some exemplary dynamic valve systems may include, among other components, valves that can open, close, and latch or hold in place without constant power applied.

[0033] Acute heart failure is a common condition that can occur in patients with long-standing heart failure. Such patients may have a sudden, rapid onset of heart failure symptoms that cannot be treated using conventional therapies. The patient's symptoms may be rooted in volume overload. An increase in blood volume in the circulatory system requires the heart to work harder to push blood through the body. Long-term cardiac stress due to volume overload can exhaust the heart and ultimately result in, among other things, poor systolic function, shortness of breath (e.g., the patient feels like they are "drowning" due to increased intrapulmonary pressure), and / or signs of overall reduced blood volume circulation.

[0034] Diuretics can provide a relatively minimally invasive solution to hypovolemia, but they may not always be effective. During an episode of acute heart failure, patients may be admitted to the emergency room, where more potent forms of intravenous (IV) diuretics can be administered. If IV diuretics do not result in hypovolemia, reliable and effective treatments may not be available. The cardiovascular community has found that while diuretics function as intended (e.g., by allowing the kidneys to withdraw more water from the circulatory system), the kidneys are often unable to withdraw water from the blood due to low blood volume circulation, as only a partial volume of blood passes through the kidneys. Furthermore, patients suffering from compensated heart failure may have insufficient forward pressure for renal perfusion.

[0035] To increase the volume of blood passing through the kidney, a pressure gradient is required across the kidney. Two options exist to achieve this: increase forward pressure (i.e., increase cardiac output) or decrease central venous pressure. Elevated central venous pressure has been determined to be the primary contributor to lack of blood flow through the kidney and reduced diuretic effectiveness.

[0036] Some embodiments presented herein provide devices and / or methods for reducing central venous pressure and / or load on the right side of the heart (and subsequently the left side of the heart) by reducing the total blood volume in the central venous system via SVC or IVC occlusion therapy. In SVC occlusion therapy, the SVC auricle (where the SVC meets the right atrium) is temporarily occluded to restrict the amount of blood entering the right atrium / central venous system, which in turn reduces central venous pressure. In IVC occlusion therapy, a point in the IVC below the renal veins is temporarily occluded, again restricting the amount of blood entering the central venous system, thereby reducing central venous pressure. The reduction in central venous pressure creates an increased pressure gradient across the kidney, increasing renal perfusion and / or the effectiveness of diuretic therapy, while simultaneously decompressing the heart and helping to restore normal cardiac function.

[0037] Some embodiments presented herein relate to a prosthetic valve system for reducing blood flow through a blood vessel (e.g., the SVC and / or the IVC). In some embodiments, a prosthetic valve for placement within a blood vessel may include multiple valve leaflets configured to selectively open and close to reduce and / or not completely prevent blood flow through the prosthetic valve. The leaflets of some valves may have one or more positions between a fully closed state and a fully open state. In some embodiments, the system may include one or more sensors and / or a controller. A sensor coupled to the prosthetic valve may be configured to monitor pressure within a cardiac chamber (e.g., the right atrium). In some embodiments, the controller may be configured to provide power to the prosthetic valve and / or selectively control the leaflets of the valve in response to pressure readings from the one or more sensors. The controller may be configured to move the leaflets between a plurality of predetermined configurations. In some embodiments, the controller may be configured to individually control the leaflets.

[0038] In some examples, the prosthetic valve may include a latching mechanism to hold and / or lock the valve leaflets in place after being moved by the controller. The latching mechanism may be reversible to allow the controller to overcome the latching mechanism. In some examples, the controller may be configured to turn off power to the prosthetic valve when the leaflets are not being actively moved.

[0039] Some examples presented herein relate to venous occlusion therapy using a fully implantable and / or electronically controlled flow restrictor for the treatment of acute heart failure. In some examples, the therapy may involve occlusion of the SVC.

[0040] Some methods of SVC occlusion therapy may involve occluding the SVC using one or more balloons. In some cases, an open access point may be required for the device to hook up to a balloon pump and / or pressure monitor. Additionally, some devices may not be implantable, which may require hospital readmission. Some methods of IVC occlusion therapy may involve an IVC occlusion catheter. However, these methods may require periodic hospital readmission and / or may result in poor long-term decongestant results.

[0041] Some embodiments presented herein may advantageously eliminate excessive hospital readmissions and / or provide long-term decongestant therapy, improving both quality of life and overall survival and / or at a lower cost to the healthcare system.

[0042] Examples of fully implantable and / or flow-restricting devices are presented herein for vascular occlusion therapy. In some embodiments, the devices may be delivered to the SVC via a subclavian and / or transfemoral approach. Additionally or alternatively, one or more devices may be delivered to the IVC (e.g., below the renal veins) via a transfemoral approach. However, exemplary devices may be delivered to any anatomical location clinically determined to provide effective placement.

[0043] In some embodiments, one or more devices may be implanted and / or configured in a normally open position. For example, flow restriction may occur when the device receives a signal (e.g., electrical current) from a separate and / or remote electronic controller. Such devices may provide relatively safe operation. For example, in the event of device malfunction or failure, the device may not obstruct the blood flow path.

[0044] Some exemplary devices may involve the use of timing and / or activation signals controlled via an implantable microcontroller. For example, an Arduino Uno may be used. A small and / or inductive wireless rechargeable battery may be implanted to power the microcontroller and flow restriction device. Additionally or alternatively, power from a proxy device may be used to allow for greater physical distance between the patient and a charging station. In some examples, the implantable battery may be omitted and replaced with an inductive and / or magnetic resonance receiver coil to power the implant only when activated via an external power source. The implantable and / or rechargeable battery may be implanted and / or charged via magnetic resonance from an internal and / or external source. This may allow for greater safety for the patient during potential failure modes, since the power source (external to the patient's body) can be easily mechanically removed and forced off to shut down the device, rather than the software controlling the device.

[0045] In some embodiments, an implantable pressure sensor may be incorporated into one or more implants and / or a controller. The pressure sensor may be configured to transmit data transmissions via any suitable method, including an end-to-end encrypted cloud service and / or encrypted low-power Bluetooth technology. In some embodiments, data may be reviewed manually at the implanted device without a cloud and / or wireless connection.

[0046] Patients with heart failure with preserved ejection fraction (HFpEF) exhibit exercise intolerance and a significant inverse relationship between pulmonary capillary wedge pressure (PCWP) and peak oxygen uptake (VO2) during exercise. Something as simple as passive leg raising results in a significant increase in PCWP. Conversely, studies of patients with heart failure with reduced ejection fraction (HFrEF) have failed to identify any correlation between cardiac filling pressure and peak VO2. Furthermore, when examining the volume overload profiles of HFpEF and HFrEF patients, HFpEF patients retain excess volume in the interstitial space, while HFrEF patients retain excess volume in the vasculature. Considering these findings, it has been confirmed that not all congestion is the same. A possible complementary mechanism to conventional congestion, secondary to sodium and fluid retention, is at work in HFpEF patients. This possible mechanism is venous reservoir mobilization, resulting in rapid fluid shifts and subsequent hemodynamic changes. Patients with HFpEF and / or HFrEF may benefit from therapies that maintain renal venous decongestion.

[0047] Expanding on the venous occlusion therapy described above, some exemplary systems presented herein relate to flow restrictors placed within major splanchnic veins (e.g., hepatic veins) and / or used to regulate blood flow from splanchnic reservoirs. Flow restrictors may be used in conjunction with hemodynamic monitors to actively or passively adjust flow in response to cardiac filling pressure. For example, if a patient with HFpEF performs passive leg raising and PCWP subsequently increases, the flow restrictor may limit and / or reduce blood movement from the splanchnic reservoir, reducing cardiac filling pressure and PCWP. Furthermore, flow restrictors may be placed laparoscopically as rings wrapped around the outside of the vein.

[0048] Some heart valve replacements (both surgical and transcatheter) involve the use of passive leaflet movement, which can operate in two distinct functions: fully open to allow blood flow or fully closed to slow blood flow.

[0049] The exemplary systems described herein can advantageously provide electronic actuators that can control the timing and duration of the valve leaflets. Such systems can allow for fine tuning of valve function to improve performance and efficiency.

[0050] FIG. 4 illustrates an exemplary system for regulating blood flow through one or more blood vessels, which may include the IVC and / or SVC 22 of a heart 1. In some embodiments, the system includes one or more valves 402 and / or prosthetic valve systems configured to be at least partially delivered and / or secured within the IVC 10, the SVC 22, and / or other blood vessels. The valves 402 may include any implant (e.g., a stent) configured to be positioned within a blood vessel and / or to at least partially occlude blood flow through a blood vessel. While the valves 402 are shown positioned within the SVC 22, the one or more valves 402 may additionally or alternatively be delivered to other anatomical locations. The valves 402 may include one or more components, which may include a frame 404 and / or one or more valve leaflets positioned within a lumen formed by the frame 404. The valve system may further include one or more controllers 406, a battery 408, and / or a blood pressure monitoring sensor 412. In some embodiments, one or more components may be combined. For example, battery 408 and controller 406 may have a unitary structure. In some examples, some components of the system may be located outside the patient's body. For example, valve 402 and / or sensor(s) may be located within the patient's body and / or within the heart, and / or controller 406 and / or battery 408 may be located outside the patient's body. Although valve 402 is shown within SVC 22, one or more valves 402 may be located within the IVC (e.g., at or near one or more hepatic veins) and / or below the kidney.

[0051] In some embodiments, valve 402 may be at least partially dynamic and / or adjustable. For example, one or more leaflets of valve 402 may be configured to adjust and / or lock into place at different positions. In some embodiments, dynamic valve 402 may not completely close SVC 22, and / or the leaflets of valve 402 may be adjusted via controller 406 in response to pressure changes detected by sensor 412, resulting in a reduced flow of blood into right atrium 5.

[0052] The reduction in blood flow and / or blood pressure may be achieved in any suitable manner. In some embodiments, the valve 402 may include one or more valve leaflets configured to adjust to and / or between one or more (e.g., two or three) different and / or predetermined positions. The valve leaflets may be moved and / or adjusted between multiple positions in response to blood flow and / or pressure changes detected by the sensor 412. For example, when blood pressure exceeds a threshold level, the valve 402 may adjust (e.g., the leaflets of the valve 402 may adjust) to increase the amount of blood flow obstruction of the valve 402. The valve 402 may continue to adjust further in response to the blood pressure level remaining at the elevated level and / or increasing above second and / or additional threshold levels.

[0053] In some embodiments, the valve 402 may include three or more leaflets. The leaflets may be individually and / or jointly actuated and / or activated in response to an increase in blood flow. The amount of adjustment may depend on the amount of blood flow reduction required.

[0054] Actively maintaining the position of one or more leaflets after adjustment by the controller 406, without a feature that allows the controller 406 to shut down after adjustment, can require significant power from the battery 408. Leaflet adjustments may need to be maintained for up to 12 hours at a time, which can place an excessive strain on the controller 406 and / or battery 408.

[0055] To improve the effectiveness and / or efficiency of the controller 406 and / or battery 408, one or more leaflets of the valve 402 may be held and / or locked in place using one or more latching mechanisms and / or latching means. The latching mechanism and / or latching means may include any latch, peg, knob, notch, protrusion, arm, finger, cavity, disk, and / or similar mechanism configured to prevent and / or resist movement and / or adjustment of one or more leaflets beyond a given position. In some embodiments, the one or more latching mechanisms may be at least partially reversible and / or configured to retract in response to increased force from the leaflets.

[0056] In some examples, one or more leaflets may be moved to a desired position (e.g., causing a first amount of blood flow reduction), and / or an actuatable (e.g., rotatable) portion of the valve may be actuated to latch one or more leaflets in a desired position. In another example, one or more hard-stop latches (e.g., cavities and / or protrusions) may be positioned along the valve 402 (e.g., along the inner and / or outer surface of the frame 404) to receive one or more leaflets in a predetermined position. One or more leaflets may be configured to engage a reversible locking mechanism (e.g., a detent and / or other latching mechanism) configured to hold the leaflet in place while allowing the leaflet to be repositioned by overcoming the reversible locking mechanism. Once the leaflet(s) are in position, power to the leaflet(s) can be turned off to preserve battery life.

[0057] The system may be controlled within a closed-loop circuit. For example, a closed-loop feedback system may be used to control the valve 402. The system may initially be in a sensing mode in which pressure sensor(s) 412 below and / or above the valve 402 (e.g., located in the right atrium 5, SVC 22, and / or IVC) are used to monitor the pressure and / or gradient across the valve 402 and / or send pressure data to the controller 406. The controller 406 may then calculate the optimal filling pressure and / or the required current to open, close, and / or partially close the valve 402. The system may be configured to switch to a wake-up mode upon completion of the sensing mode. In the wake-up mode, the controller 406 may be configured to adjust the valve 402 to a previously calculated value to achieve the optimal filling pressure. The system may be configured to switch back to the sensing mode and begin the closed-loop cycle again. Additionally, the controller 406 may have its power supplied via wireless induction or an implantable battery 408. The controller 406 may also have peripheral devices external to the patient that are used to send and / or receive data to the controller 406. The transmitted data may be used to monitor the system and / or its critical care sensors 412. This data may then be uploaded to the patient's healthcare provider to enable long-term data acquisition and / or device management.

[0058] In some embodiments, the sensor 412 may be coupled to the valve 402 and / or the controller 406 via one or more actuation wires 407. Although two actuation wires 407 are shown in FIG. 4 , the system may include any number of actuation wires 407. The actuation wires 407 may be configured to conduct electrical signals (e.g., electrical current) from the sensor 412 to the controller 406 and / or the valve 402, and / or from the controller 406 to the valve 402 and / or the sensor 412. In some embodiments, the controller 406 may be configured to send one or more signals to the valve 402 based on and / or in response to signals received at the controller 406 and / or from the sensor 412.

[0059] The controller 406 and / or other devices may be configured to send one or more control signals to the valve 402 to cause and / or control movement of the valve 402. For example, the control signals may move one or more actuation wires 407, which may cause corresponding movement of one or more leaflets and / or other components of the valve 402. In some examples, the sending of the one or more control signals may be based at least in part on one or more blood flow signals received (e.g., by the controller 406) from a sensor 412. For example, the sensor 412 may be configured to send blood flow signals related to blood flow and / or pressure within the heart 1 via the actuation wires 407 to the controller 406 and / or other devices. The actuation wires 407 may be configured to receive and / or send control and / or blood flow signals to and / or from the controller 406, the valve 402, and / or the sensor 412.

[0060] FIG. 5 illustrates an exemplary occlusion valve 502 configured to dynamically occlude one or more blood vessels of the heart, according to one or more embodiments. The valve 502 is shown in a closed configuration. The valve 502 may include one or more leaflets 505 configured to extend at least partially across a lumen of the valve 502. For example, the valve 502 and / or a frame 504 of the valve 502 may have a generally cylindrical shape extending around a generally cylindrical lumen. The lumen may be configured to allow blood flow through the valve 502. The one or more leaflets 505 may be configured to selectively open and / or close the lumen of the valve 502. The valve 502 is shown in FIG. 5 in a fully closed configuration, with the one or more leaflets 505 extending completely across the lumen of the valve 502. However, the one or more leaflets 505 may be configured to dynamically adjust to a predetermined position to at least partially open the lumen and / or to create an opening through the leaflets 505. The valve may include a skirt 509 configured to extend at least partially along the frame 504 of the valve 502. The frame 504 may comprise a wire stent including a network of struts forming one or more cells. In some embodiments, the skirt 509 may be configured to extend across one or more cells and / or struts formed by the frame 504. The skirt 509 may be at least partially constructed of tissue, fabric, woven fabric, and / or any suitable material and / or may have a generally flexible structure.

[0061] The frame 504 of the valve 502 may form one or more flanges 511. For example, the valve 502 may include a flange 511 at a distal end of the valve 502. The valve 502 may additionally or alternatively include a flange 511 at a proximal end of the valve 502. The flange 511 may include a flared and / or protruding portion of the frame 504 configured to increase the diameter of the valve 502 at the distal and / or proximal ends of the valve 502. For example, the flange 511 may be configured to extend at least partially into the right atrium and / or other ventricles and / or blood vessels of the heart. In some embodiments, the skirt 509 may be configured to extend at least partially along the flange 511.

[0062] 5, the valve 502 includes three leaflets. However, the exemplary valve 502 may include other numbers of leaflets 505 (e.g., two or four). One or more leaflets 505 may extend in series around the circumference of the valve 502 and / or frame 504. For example, each of the leaflets 505 may extend from a different portion of the circumference of the valve 502 and / or frame 504. In some embodiments, one or more leaflets 505 may at least partially overlap and / or contact one another in the fully closed and / or partially closed configurations of the valve 502.

[0063] In some examples, the position of the valve leaflets 505 may be dynamically adjusted using various components of the adjustment system and / or various components of the valve 502. For example, a controller may send electrical signals and / or pulses from a battery to the valve leaflets 505 via one or more actuation wires 507. The actuation wires 507 may be constructed of any suitable material(s), including nitinol and / or other shape memory alloys. In some examples, the actuation wires 507 may be at least partially conductive and / or comprise one or more conductive wires configured to conduct electrical signals and / or pulses from one or more controllers and / or batteries to the actuation wires 507. The actuation wires 507 may comprise any wires, cords, arms, elongated members, and / or similar devices configured to conduct electrical signals and / or support one or more valve leaflets 505.

[0064] The actuation wires 507 may be shaped into a desired configuration. For example, one or more actuation wires 507 may be configured to loop through one or more portions of the skirt 509 and / or frame 504. In some embodiments, the actuation wires 507 may be configured to extend along and / or under one or more leaflets 505 of the valve 502 to support the leaflets 505. The actuation wires 507 may be shaped into a loop 513 (e.g., a horseshoe loop) and / or a similar shape along the underside of one or more leaflets 505.

[0065] In some embodiments, the multiple actuation wires 507 may be configured to support the leaflets 505 of the valve 502. For example, a first actuation wire 507a may pass through the skirt 509 at or near the first leaflet 505a and / or may form a first loop 513a underneath the first leaflet 505a. The first actuation wire 507a may exit through the skirt 509 at or near the first leaflet 505a. The first actuation wire 507a may be joined to a second actuation wire 507b via a first coupler 515a. The second actuation wire 507b may pass through the skirt 509 at or near the second leaflet 505b and / or may form a second loop 513b underneath the second leaflet 505b. The second actuation wire 507b may exit through the skirt 509 at or near the second leaflet 505b. The second actuation wire 507b may be joined to a third actuation wire 507c via a second coupler 515b. The third actuation wire 507c may pass through the skirt 509 at or near the third leaflet 505c and / or may form a third loop 513c below the third leaflet 505c. The third actuation wire 507c may exit through the skirt 509 at or near the third leaflet 505c.

[0066] Alternatively, a single actuation wire 507 may be configured to support each of the leaflets 505 of the valve 502. For example, couplers 515 may not be used, and instead, a single actuation wire 507 may extend in and out of the skirt 509 and along each of the leaflets 505, as shown in FIG.

[0067] One or more actuation wires 507 may be configured to form scaffolding that closes the valve leaflet(s) 505 when an electric current is applied to the actuation wire 507 and / or other conductive wires coupled to the actuation wire 507. For example, the actuation wire 507 may be configured to extend upward and / or toward the flange 511 in response to an electric current, thus closing the lumen of the valve 502. To open the valve 502, pressure built up from an obstruction of blood flow through the vessel may overcome the resistance of the valve leaflets 505 and / or actuation wire 507, causing the leaflets 505 and / or actuation wire 507 to retract and / or form an opening through the valve 502. Additionally or alternatively, one or more devices and / or mechanisms may be configured to force the valve leaflets 505 open. For example, a resilient (e.g., superelastic) wire (e.g., constructed at least in part from nitinol and / or other shape memory alloy) may act as a spring to force the valve leaflets 505 open.

[0068] In some embodiments, the valve 502 may be configured for delivery and / or use in the SVC and / or IVC of the heart. For example, the valve 502 may be positioned below one or more renal veins. The valve 502 may be configured to provide intermittent occlusion of one or more blood vessels, including the SVC and / or IVC.

[0069] The one or more actuation wires 507 may be configured to be powered via one or more actuators and / or controllers. The one or more actuation wires 507 may be attached to one or more valve leaflets 505 and / or may be coupled and / or secured to the frame 504 of the valve 502. In some embodiments, the one or more actuation wires 507 and / or actuators may be disposed within silicone tubing. The one or more actuators and / or controllers may be secured and / or coupled to one or more mounts on the frame 504.

[0070] In some embodiments, one or more leaflets 505 may be configured to move independently. For example, individual actuation wires 507 may be separately attached to separate leaflets 505 and / or configured to move in response to different signals and / or pulses from an actuator and / or controller. Additionally or alternatively, a single actuation wire 507 may be configured to differently and / or independently control different leaflets 505. In some embodiments, one or more leaflets 505 may be configured to move together (e.g., in a synchronized manner) and / or approximately simultaneously.

[0071] Valve 502 may be configured to selectively regulate blood flow through one or more blood vessels in which valve 502 may be disposed. In some embodiments, valve 502 may be configured to be implanted entirely within a blood vessel and / or may not be tethered to a catheter and / or other delivery device.

[0072] In some embodiments, the valve 502 may be biased toward an open state. For example, the leaflets 505 and / or actuation wires 507 may be biased to extend generally parallel to the frame 504. In response to signals and / or pulses from one or more actuators and / or a controller, the leaflets 505 and / or actuation wires 507 may be configured to extend generally perpendicular to the frame 504 and / or to a closed configuration as shown in FIG. 5. The one or more actuation wires 507 may be configured to form paddles that extend at least partially along one or more of the leaflets 505.

[0073] One or more actuating wires 507 may be configured to respond to changes in temperature. For example, one or more actuating wires 507 may be configured to extend to a closed configuration in response to the temperature of the valve 502 exceeding a threshold temperature value. The actuating wires 507 may be configured to be configured to maintain a closed and / or relaxed position in response to a temperature at or slightly above normal body temperature. In some embodiments, one or more actuating wires 507 may be heated with an electric current to increase the temperature of the actuating wires 507 and / or extend the one or more actuating wires 507 to a closed configuration.

[0074] In some embodiments, one or more actuation wires 507 may be configured to be wirelessly controlled and / or powered via a cloud server at a location external to the patient's body and / or remote from the patient's body. A wireless charger may be used to wirelessly power one or more actuators and / or controllers within the patient's body. Electrical current may be continuously supplied to one or more actuation wires 507 to maintain the valve leaflets 505 closed.

[0075] The valve 502 may include various features and / or mechanisms configured to reopen the valve 502 after the leaflets 505 have moved to an at least partially closed configuration. In one example, the valve 502 may include mechanical pull wires (e.g., fingers) configured to contract and / or pull the leaflets 505 back to an open state. In another example, one or more springs (e.g., constructed at least in part from nitinol and / or other shape memory alloys) may be configured to collapse when heated to pull the leaflets 505 back.

[0076] In some embodiments, the valve 502 may include one or more latching mechanisms configured to hold the valve leaflets 505 in one or more at least partially closed configurations to reduce the amount of power used by the valve 502. In one embodiment, the valve 502 may include one or more pin and / or rotation mechanisms configured to lock the valve leaflets 505 in a particular position. In another embodiment, one or more magnetic elements may be configured to mate with corresponding magnetic elements attached to the valve leaflets 505 and / or may be positioned at different positions along the valve 502 to hold the valve leaflets 505 in a particular position. The valve 502 may include multiple types of latching mechanisms, including active and / or passive latching mechanisms. The valve 502 may include one or more latching mechanisms configured to quickly release the valve leaflets 505 in response to a signal. For example, in an emergency situation, the one or more latching mechanisms may be configured to retract and / or release the valve leaflets 505.

[0077] The valve 502 may include one or more arms 506 configured to secure and / or position the valve 502 at a target location. The one or more arms 506 may have a generally curved configuration and / or may be configured to extend at least partially over a flange 511 of the valve 502.

[0078] 6A-6C provide overhead views of an exemplary occlusion valve 602 configured to dynamically occlude one or more blood vessels of the heart, according to one or more embodiments. The valve 602 may include one or more leaflets 605, one or more actuation wires 607, a frame 604, and / or a skirt 609. In FIG. 6A, the valve 602 is shown in an open configuration, in which the one or more leaflets 605 extend generally parallel to the cylindrical sides of the frame 604 and / or generally away from the lumen 610 of the valve 602. In FIG. 6B, the valve 602 is shown in a first, partially closed configuration, in which the one or more leaflets 605 extend at least partially into the lumen 610, at an angle to the cylindrical sides of the frame 604, and / or toward each other. In FIG. 6C, the valve 602 is shown in a second, partially closed configuration, in which one or more leaflets 605 are at a greater angle with the cylindrical side of the frame 604 and / or closer toward each other and extend further into the lumen 610.

[0079] Movement of the valve leaflets 605 from an open configuration to a partially closed and / or closed configuration may be caused at least in part by one or more actuation wires 607. The one or more actuation wires 607 may be configured to extend at least partially along the one or more valve leaflets 605. In some embodiments, the one or more actuation wires 607 may be attached, secured, and / or coupled to the one or more valve leaflets 605. For example, the one or more valve leaflets 605 may include flaps 616 and / or folds configured to at least partially encapsulate the actuation wires 607 and / or secure the actuation wires 607 to the valve leaflets 605.

[0080] The valve 602 may include a flange 611 at the distal and / or proximal end of the valve 602. The flange 611 may have a larger diameter relative to the rest of the valve 602.

[0081] In some embodiments, the valve 602 may include one or more arms 606 that may be configured to facilitate fixation of the valve 602 to a vessel and / or ventricle of the heart. The one or more arms 606 may have a generally curved configuration. For example, the one or more arms 606 may be configured to extend along the outer surface of the valve 602 from a distal end of the valve 602 toward a proximal end of the valve 602.

[0082] The one or more actuation wires 607 may be disposed along any suitable surface of the one or more leaflets 605 and / or may be configured to extend at least partially along and / or through the frame 604 and / or skirt 609. For example, as shown in FIGS. 6A-6C , the one or more actuation wires 607 may be configured to extend along the upper side of the leaflets 605 and / or may be configured to pull the leaflets 605 upward toward the distal end of the valve 602. Additionally or alternatively, the one or more actuation wires 607 may be configured to extend along the underside of the one or more leaflets 605 and / or may be configured to push the one or more leaflets 605 upward toward the distal end of the valve 602.

[0083] The leaflets 605 of the valve 602 may be held in a first partially closed configuration and / or a second partially closed configuration through the use of one or more latching mechanisms. For example, the frame 604 and / or skirt 609 may include one or more pegs, notches, protrusions, depressions, disks, springs, and / or similar mechanisms configured to grip, hold, and / or receive one or more leaflets 605 in a desired position.

[0084] One or more actuation wires 607 may be configured to form scaffolding that closes the valve leaflet(s) 605 when an electric current is applied to the actuation wire 607 and / or other conductive wires coupled to the actuation wire 607. For example, the actuation wire 607 may be configured to extend upward and / or toward the flange 611 in response to an electric current, thus closing the lumen of the valve 602. To open the valve 602, pressure built up from an obstruction of blood flow through the blood vessel may overcome the resistance of the valve leaflets 605 and / or actuation wire 607, causing the leaflets 605 and / or actuation wire 607 to retract and / or form an opening through the valve 602. Additionally or alternatively, one or more devices and / or mechanisms may be configured to force the valve leaflets 605 open. For example, a resilient (e.g., superelastic) wire (e.g., constructed at least in part from nitinol and / or other shape memory alloy) may act as a spring to force the valve leaflets 605 open.

[0085] In some embodiments, the valve 602 may be configured for delivery and / or use in the SVC and / or IVC of the heart. For example, the valve 602 may be positioned below one or more renal veins. The valve 602 may be configured to provide intermittent occlusion of one or more blood vessels, including the SVC and / or IVC.

[0086] The one or more actuation wires 607 may be configured to be powered via one or more actuators and / or controllers. The one or more actuation wires 607 may be attached to one or more valve leaflets 605 and / or may be coupled and / or secured to the frame 604 of the valve 602. In some embodiments, the one or more actuation wires 607 and / or actuators may be disposed within silicone tubing. The one or more actuators and / or controllers may be secured and / or coupled to one or more mounts on the frame 604.

[0087] In some embodiments, one or more leaflets 605 may be configured to move independently. For example, individual actuation wires 607 may be separately attached to separate leaflets 605 and / or configured to move in response to different signals and / or pulses from an actuator and / or controller. Additionally or alternatively, a single actuation wire 607 may be configured to control different leaflets 605 differently and / or independently. In some embodiments, one or more leaflets 605 may be configured to move together and / or approximately simultaneously.

[0088] Valve 602 may be configured to selectively regulate blood flow through one or more blood vessels in which valve 602 may be disposed. In some embodiments, valve 602 may be configured to be implanted entirely within a blood vessel and / or may not be tethered to a catheter and / or other delivery device.

[0089] In some embodiments, the valve 602 may be biased toward an open state. For example, the leaflets 605 and / or actuation wires 607 may be biased to extend generally parallel to the frame 604. In response to signals and / or pulses from one or more actuators and / or a controller, the leaflets 605 and / or actuation wires 607 may be configured to extend generally perpendicular to the frame 604 and / or to a closed configuration as shown in FIG. 6. The one or more actuation wires 607 may be configured to form paddles that extend at least partially along one or more of the leaflets 605.

[0090] One or more actuating wires 607 may be configured to respond to changes in temperature. For example, one or more actuating wires 607 may be configured to extend to a closed configuration in response to the temperature of the valve 602 exceeding a threshold temperature value. The actuating wires 607 may be configured to be configured to maintain a closed and / or relaxed position in response to a temperature at or slightly above normal body temperature. In some embodiments, one or more actuating wires 607 may be heated with an electric current to increase the temperature of the actuating wires 607 and / or extend the one or more actuating wires 607 to a closed configuration.

[0091] In some embodiments, one or more actuation wires 607 may be configured to be wirelessly controlled and / or powered via a cloud server at a location external to the patient's body and / or remote from the patient's body. A wireless charger may be used to wirelessly power one or more actuators and / or controllers within the patient's body. Electrical current may be continuously supplied to one or more actuation wires 607 to maintain the valve leaflets 605 closed.

[0092] The valve 602 may include various features and / or mechanisms configured to reopen the valve 602 after the leaflets 605 have moved to an at least partially closed configuration. In one example, the valve 602 may include mechanical pull wires (e.g., fingers) configured to contract and / or pull the leaflets 605 back to an open state. In another example, one or more springs (e.g., composed at least in part of nitinol and / or other shape memory alloys) may be configured to collapse when heated to pull the leaflets 605 back.

[0093] In some embodiments, the valve 602 may include one or more latching mechanisms configured to hold the valve leaflets 605 in one or more at least partially closed configurations to reduce the amount of power used by the valve 602. The latching mechanisms may be configured to hold the valve leaflets 605 in various predetermined positions, including each of the positions shown in FIGS. 6A-6C. In one embodiment, the valve 602 may include one or more pin and / or rotating mechanisms configured to lock the valve leaflets 605 in a particular position. In another embodiment, one or more magnetic elements may be configured to mate with corresponding magnetic elements attached to the valve leaflets 605 and / or may be positioned at different positions along the valve 602 to hold the valve leaflets 605 in a particular position. The valve 602 may include multiple types of latching mechanisms, including active and / or passive latching mechanisms. The valve 602 may include one or more latching mechanisms configured to quickly release the valve leaflets 605 in response to a signal. For example, in an emergency situation, the one or more latching mechanisms may be configured to retract and / or release the valve leaflets 605.

[0094] 7A-7C provide overhead views of an exemplary occlusion valve 702 configured to dynamically occlude one or more blood vessels of the heart, according to one or more embodiments. The valve 702 may include one or more leaflets 705, one or more actuation wires 707, a frame 704, and / or a skirt 709. In FIG. 7A, the valve 702 is shown in an open configuration, in which the one or more leaflets 705 extend generally parallel to the cylindrical sides of the frame 704 and / or generally away from the lumen 710 of the valve 702. In FIG. 7B, the valve 702 is shown in a first, partially closed configuration, in which the one or more leaflets 705 extend at least partially into the lumen 710, at an angle to the cylindrical sides of the frame 704, and / or toward each other. In FIG. 7C, valve 702 is shown in a fully closed configuration, with one or more leaflets 705 extending completely across and / or completely covering lumen 710.

[0095] One or more actuation wires 707 may be configured to form scaffolding that closes the valve leaflet(s) 705 when an electric current is applied to the actuation wire 707 and / or other conductive wires coupled to the actuation wire 707. For example, the actuation wire 707 may be configured to extend upward and / or toward the flange 711 in response to an electric current, thus closing the lumen of the valve 702. To open the valve 702, pressure built up from an obstruction of blood flow through the blood vessel may overcome the resistance of the valve leaflets 705 and / or actuation wire 707, causing the leaflets 705 and / or actuation wire 707 to retract and / or form an opening through the valve 702. Additionally or alternatively, one or more devices and / or mechanisms may be configured to force the valve leaflets 705 open. For example, a resilient (e.g., superelastic) wire (e.g., constructed at least in part from nitinol and / or other shape memory alloy) may act as a spring to force the valve leaflets 705 open.

[0096] In some embodiments, the valve 702 may be configured for delivery and / or use in the SVC and / or IVC of the heart. For example, the valve 702 may be positioned below one or more renal veins. The valve 702 may be configured to provide intermittent occlusion of one or more blood vessels, including the SVC and / or IVC. The valve 702 may include one or more fixation arms 706 configured to facilitate fixation of the valve 702 in the SVC, IVC, and / or other locations.

[0097] The one or more actuation wires 707 may be configured to be powered via one or more actuators and / or controllers. The one or more actuation wires 707 may be attached to one or more valve leaflets 705 and / or may be coupled and / or secured to the frame 704 of the valve 702. In some embodiments, the one or more actuation wires 707 and / or actuators may be disposed within silicone tubing. The one or more actuators and / or controllers may be secured and / or coupled to one or more mounts on the frame 704.

[0098] In some embodiments, one or more leaflets 705 may be configured to move independently. For example, individual actuation wires 707 may be separately attached to separate leaflets 705 and / or configured to move in response to different signals and / or pulses from an actuator and / or controller. Additionally or alternatively, a single actuation wire 707 may be configured to control different leaflets 705 differently and / or independently. In some embodiments, one or more leaflets 705 may be configured to move together and / or approximately simultaneously.

[0099] Valve 702 may be configured to selectively regulate blood flow through one or more blood vessels in which valve 702 may be disposed. In some embodiments, valve 702 may be configured to be implanted entirely within a blood vessel and / or may not be tethered to a catheter and / or other delivery device.

[0100] In some embodiments, the valve 702 may be biased toward an open state. For example, the leaflets 705 and / or actuation wires 707 may be biased to extend generally parallel to the frame 704. In response to signals and / or pulses from one or more actuators and / or a controller, the leaflets 705 and / or actuation wires 707 may be configured to extend generally perpendicular to the frame 704 and / or to a closed configuration as shown in FIG. 7. The one or more actuation wires 707 may be configured to form paddles that extend at least partially along one or more of the leaflets 705.

[0101] One or more actuation wires 707 may be configured to respond to changes in temperature. For example, one or more actuation wires 707 may be configured to extend to a closed configuration in response to the temperature of the valve 702 exceeding a threshold temperature value. The actuation wires 707 may be configured to be configured to maintain a closed and / or relaxed position in response to a temperature at or slightly above normal body temperature. In some embodiments, one or more actuation wires 707 may be heated with an electric current to increase the temperature of the actuation wires 707 and / or extend the one or more actuation wires 707 to a closed configuration.

[0102] In some embodiments, one or more actuation wires 707 may be configured to be wirelessly controlled and / or powered via a cloud server located external to and / or remote from the patient's body. A wireless charger may be used to wirelessly provide power to one or more actuators and / or controllers within the patient's body. Electrical current may be continuously supplied to one or more actuation wires 707 to maintain the valve leaflets 705 closed.

[0103] Valve 702 may include various features and / or mechanisms configured to reopen valve 702 after leaflets 705 have moved to an at least partially closed configuration. In one example, valve 702 may include mechanical pull wires (e.g., fingers) configured to contract and / or pull leaflets 705 back to an open state. In another example, one or more springs (e.g., constructed at least in part from nitinol and / or other shape memory alloys) may be configured to collapse when heated to pull leaflets 705 back.

[0104] In some embodiments, the valve 702 may include one or more latching mechanisms configured to hold the valve leaflets 705 in one or more at least partially closed configurations to reduce the amount of power used by the valve 702. In one embodiment, the valve 702 may include one or more pin and / or rotation mechanisms configured to lock the valve leaflets 705 in a particular position. In another embodiment, one or more magnetic elements may be configured to mate with corresponding magnetic elements attached to the valve leaflets 705 and / or may be positioned at different positions along the valve 702 to hold the valve leaflets 705 in a particular position. The valve 702 may include multiple types of latching mechanisms, including active and / or passive latching mechanisms. The valve 702 may include one or more latching mechanisms configured to quickly release the valve leaflets 705 in response to a signal. For example, in an emergency situation, the one or more latching mechanisms may be configured to retract and / or release the valve leaflets 705.

[0105] 8A and 8B show another exemplary occlusion valve 802 configured to dynamically occlude one or more blood vessels of the heart, according to one or more embodiments. FIG. 8A provides an overhead view of the valve 802, and FIG. 8B provides a bottom view of the valve 802. The valve 802 may comprise one or more leaflets 805, a frame 804, and / or a skirt 809. The valve 802 may further comprise one or more actuation members 808 (e.g., support arms), which may include wires, arms, elongated members, fingers, coils, and / or similar devices configured to support the one or more leaflets 805.

[0106] The one or more actuation members 808 may have a generally rigid and / or stiff structure and / or may be configured to effectively support one or more valve leaflets 805. In some embodiments, the one or more actuation members 808 may include one or more actuation wires and / or may be configured to couple to one or more actuation wires.

[0107] In some embodiments, valve 802 may include one or more arms 806 that may be configured to facilitate fixation of valve 802 to a vessel and / or ventricle of the heart. One or more arms 806 may have a generally curved configuration. For example, one or more arms 806 may be configured to extend along an outer surface of valve 802 from a distal end of valve 802 toward a proximal end of valve 802.

[0108] The one or more actuating members 808 may be disposed along any suitable surface of the one or more leaflets 805 and / or may be configured to extend at least partially along and / or through the frame 804 and / or skirt 809. For example, the one or more actuating members 808 may be configured to extend along an upper side of the leaflets 805 and / or may be configured to pull the leaflets 805 upward toward the distal end of the valve 802. Additionally or alternatively, the one or more actuating members 808 may be configured to extend along an underside of the one or more leaflets 805 and / or may be configured to push the one or more leaflets 805 upward toward the distal end of the valve 802.

[0109] The leaflets 805 of the valve 802 may be held in a first partially closed configuration and / or a second partially closed configuration through the use of one or more latching mechanisms. For example, the frame 804 and / or skirt 809 may include one or more pegs, notches, protrusions, depressions, disks, springs, and / or similar mechanisms configured to grip, hold, and / or receive one or more leaflets 805 in a desired position.

[0110] One or more actuation wires 807 may be configured to form scaffolding that closes the valve leaflet(s) 805 when an electric current is applied to the actuation wire 807 and / or other conductive wires coupled to the actuation wire 807. For example, the actuation wire 807 may be configured to extend upward and / or toward the flange 811 in response to an electric current, thus closing the lumen of the valve 802. To open the valve 802, pressure built up from an obstruction of blood flow through the vessel may overcome the resistance of the valve leaflets 805 and / or actuation wire 807, causing the leaflets 805 and / or actuation wire 807 to retract and / or form an opening through the valve 802. Additionally or alternatively, one or more devices and / or mechanisms may be configured to force the valve leaflets 805 open. For example, a resilient (e.g., superelastic) wire (e.g., composed at least in part of nitinol and / or other shape memory alloy) may act as a spring to force the valve leaflets 805 open.

[0111] In some embodiments, valve 802 may be configured for delivery and / or use in the SVC and / or IVC of the heart. For example, valve 802 may be positioned below one or more renal veins. Valve 802 may be configured to provide intermittent occlusion of one or more blood vessels, including the SVC and / or IVC.

[0112] The one or more actuation wires 807 may be configured to be powered via one or more actuators and / or controllers. The one or more actuation wires 807 may be attached to one or more valve leaflets 805 and / or may be coupled and / or secured to the frame 804 of the valve 802. In some embodiments, the one or more actuation wires 807 and / or actuators may be disposed within silicone tubing. The one or more actuators and / or controllers may be secured and / or coupled to one or more mounts on the frame 804.

[0113] In some embodiments, one or more leaflets 805 may be configured to move independently. For example, individual actuation wires 807 may be separately attached to separate leaflets 805 and / or configured to move in response to different signals and / or pulses from an actuator and / or controller. Additionally or alternatively, a single actuation wire 807 may be configured to control different leaflets 805 differently and / or independently. In some embodiments, one or more leaflets 805 may be configured to move together and / or approximately simultaneously.

[0114] Valve 802 may be configured to selectively regulate blood flow through one or more blood vessels in which valve 802 may be disposed. In some embodiments, valve 802 may be configured to be implanted entirely within a blood vessel and / or may not be tethered to a catheter and / or other delivery device.

[0115] In some embodiments, the valve 802 may be biased toward an open state. For example, the leaflets 805 and / or actuation wires 807 may be biased to extend generally parallel to the frame 804. In response to signals and / or pulses from one or more actuators and / or a controller, the leaflets 805 and / or actuation wires 807 may be configured to extend generally perpendicular to the frame 804 and / or to a closed configuration as shown in FIG. 8 . The one or more actuation wires 807 may be configured to form paddles that extend at least partially along one or more of the leaflets 805.

[0116] One or more actuating wires 807 may be configured to respond to changes in temperature. For example, one or more actuating wires 807 may be configured to extend to a closed configuration in response to the temperature of valve 802 exceeding a threshold temperature value. The actuating wires 807 may be configured to be configured to maintain a closed and / or relaxed position in response to a temperature at or slightly above normal body temperature. In some embodiments, one or more actuating wires 807 may be heated with an electrical current to increase the temperature of the actuating wires 807 and / or extend the one or more actuating wires 807 to a closed configuration.

[0117] In some embodiments, one or more actuation wires 807 may be configured to be wirelessly controlled and / or powered via a cloud server located external to and / or remote from the patient's body. A wireless charger may be used to wirelessly provide power to one or more actuators and / or controllers within the patient's body. Electrical current may be continuously supplied to one or more actuation wires 807 to maintain the valve leaflets 805 closed.

[0118] Valve 802 may include various features and / or mechanisms configured to reopen valve 802 after leaflets 805 have moved to an at least partially closed configuration. In one example, valve 802 may include mechanical pull wires (e.g., fingers) configured to contract and / or pull leaflets 805 back to an open state. In another example, one or more springs (e.g., constructed at least in part from nitinol and / or other shape memory alloys) may be configured to collapse when heated to pull leaflets 805 back.

[0119] In some embodiments, the valve 802 may include one or more latching mechanisms configured to hold the valve leaflets 805 in one or more at least partially closed configurations to reduce the amount of power used by the valve 802. In one embodiment, the valve 802 may include one or more pin and / or rotation mechanisms configured to lock the valve leaflets 805 in a particular position. In another embodiment, one or more magnetic elements may be configured to mate with corresponding magnetic elements attached to the valve leaflets 805 and / or may be positioned at different positions along the valve 802 to hold the valve leaflets 805 in a particular position. The valve 802 may include multiple types of latching mechanisms, including active and / or passive latching mechanisms. The valve 802 may include one or more latching mechanisms configured to quickly release the valve leaflets 805 in response to a signal. For example, in an emergency situation, the one or more latching mechanisms may be configured to retract and / or release the valve leaflets 805.

[0120] 9A-9C illustrate another exemplary occlusion valve 902 configured to dynamically occlude one or more blood vessels of the heart, according to one or more embodiments. Figure 9A provides a side view of the valve 902 in at least a partially open configuration. Figure 9B provides a perspective view of the valve 902 in a closed configuration. Figure 9C provides a perspective view of the valve 902 in at least a partially open configuration.

[0121] Valve 902 may include one or more leaflets and / or cap 903 configured to extend at least partially across a lumen of valve 902. For example, valve 902 and / or frame 904 of valve 902 may have a generally cylindrical shape extending around a generally cylindrical lumen. The lumen may be configured to allow blood flow through valve 902. Cap 903 may be configured to selectively open and / or close the lumen of valve 902.

[0122] The valve may include a skirt 909 configured to extend at least partially along a frame 904 of the valve 902. The frame 904 may comprise a wire stent including a network of struts forming one or more cells. In some embodiments, the skirt 909 may be configured to extend across one or more cells and / or struts formed by the frame 904. The skirt 909 may be at least partially constructed from tissue, fabric, woven fabric, and / or any suitable material and / or may have a generally flexible structure. The valve 902 may include one or more arms 906 configured to extend laterally and / or longitudinally from the valve 902 (e.g., from the cap 903) and / or configured to facilitate fixation of the valve 902 at one or more target locations.

[0123] In some embodiments, cap 903 may include a generally circular and / or disc-like distal portion 921 and / or base portion 922. Distal portion 921 may extend from base portion 922. Base portion 922 may have any suitable form and / or may include one or more attachment mechanisms (e.g., notches, pegs, cavities, arms, fingers, and / or similar mechanisms) configured to attach to coil 923 (e.g., springs) and / or similar devices (e.g., wires, arms, fingers, elongated arms, and / or similar mechanisms) configured to dynamically control the position of cap 903 relative to frame 904 and / or skirt 909. Coil 923 may be any biasing means and / or means for biasing cap 903 into one or more positions relative to frame 904 and / or skirt 909. The coil 923 may be coupled to and / or otherwise controlled by an actuator 924 configured to deliver current and / or pulses to the coil 923 to cause movement and / or adjustment of the coil 923 and / or cap 903.

[0124] In some examples, the position of the coil 923 and / or cap 903 may be dynamically adjusted using various components of the adjustment system and / or various components of the valve 902. For example, a controller may send electrical signals and / or pulses from a battery to the coil 923 and / or cap 903 via one or more actuation wires. The actuation wires and / or coil 923 may be constructed of any suitable material(s), including nitinol and / or other shape memory alloys. In some examples, the actuation wires and / or coil 923 may be at least partially conductive and / or include one or more conductive wires configured to conduct electrical signals and / or pulses from one or more controllers and / or batteries to the coil 923 and / or cap 903. The actuation wires and / or coil 923 may comprise any wire, cord, arm, elongated member, and / or similar device configured to conduct and / or adjust electrical signals and / or currents in response to such signals and / or currents.

[0125] The coil 923 may be shape-set into a desired configuration. For example, the coil 923 may be configured to form one or more loops and / or coils. The coil 923 may be shape-set into a desired configuration, which may be a generally compressed configuration and / or a generally expanded configuration. For example, the coil 923 may be shape-set into a generally expanded configuration in which the loops of the coil 923 are generally elongated and / or form relatively large gaps between each other. In response to heating and / or applying an electric current to the coil 923, the coil 923 may be configured to compress and / or the loops of the coil 923 may be configured to move closer together. The coil 923 may be configured to form a scaffold that closes the cap 903 when an electric current is applied to the coil 923 and / or a conductive wire coupled to the coil 923. To open valve 902, pressure built up from an obstruction of blood flow through a blood vessel may overcome the resistance of coil 923 and / or cap 903, causing coil 923 and / or cap 903 to retract and / or form an opening through valve 902. Additionally or alternatively, one or more devices and / or mechanisms may be configured to force open coil 923 and / or cap 903. For example, current may be applied and / or removed from coil 923 to relax and / or push cap 903 away from coil 923 and / or skirt 909.

[0126] In some embodiments, the valve 902 may be configured for delivery and / or use in the SVC and / or IVC of the heart. For example, the valve 902 may be positioned below one or more renal veins. The valve 902 may be configured to provide intermittent occlusion of one or more blood vessels, including the SVC and / or IVC.

[0127] The one or more coils 923 and / or cap 903 may be configured to be powered via one or more actuators and / or controllers. The one or more coils 923 and / or cap 903 may be coupled and / or secured to the frame 904 of the valve 902. In some embodiments, the one or more coils 923 and / or actuators 924 may be disposed within silicone tubing. The one or more actuators 924 and / or controller may be secured and / or coupled to one or more mounts of the frame 904.

[0128] Valve 902 may be configured to selectively regulate blood flow through one or more blood vessels in which valve 902 may be placed. In some embodiments, valve 902 may be configured to be implanted entirely within a blood vessel and / or may not be tethered to a catheter and / or other delivery device.

[0129] One or more coils 923 may be configured to respond to changes in temperature. For example, one or more coils 923 may be configured to extend to a closed configuration in response to the temperature of the valve 902 exceeding a threshold temperature value. The coils 923 may be geometry configured in response to a predetermined threshold temperature. The coils 923 may be configured to maintain an open and / or closed position in response to a temperature at or slightly above normal body temperature. In some embodiments, one or more coils 923 may be heated with an electric current to increase the temperature of the coils 923 and / or extend the one or more coils 923 to a closed and / or open configuration.

[0130] In some embodiments, one or more coils 923 may be configured to be wirelessly controlled and / or powered via a cloud server located external to and / or remote from the patient's body. A wireless charger may be used to wirelessly power one or more actuators and / or controllers within the patient's body. Current may be continuously supplied to one or more coils 923 to maintain the cap 903 in an open and / or closed state.

[0131] Valve 902 may include various features and / or mechanisms configured to reopen valve 902 after cap 903 has moved to an at least partially closed configuration. In one example, valve 902 may include a mechanical pull wire (e.g., a finger) configured to retract and / or pull cap 903 back to an open state. In another example, one or more springs (e.g., constructed at least in part from nitinol and / or other shape memory alloys) may be configured to extend when heated to push cap 903 away from frame 904 and / or skirt 909.

[0132] In some embodiments, the valve 902 may include one or more latching mechanisms configured to hold the coil 923 and / or cap 903 in one or more at least partially closed configurations to reduce the amount of power used by the valve 902. In one embodiment, the valve 902 may include one or more pin and / or rotating mechanisms configured to lock the coil 923 and / or cap 903 in a particular position. In another embodiment, one or more magnetic elements may be configured to mate with corresponding magnetic elements attached to the coil 923 and / or cap 903 and / or may be positioned at different positions along the valve 902 to hold the coil 923 and / or cap 903 in a particular position. The valve 902 may include multiple types of latching mechanisms, including active and / or passive latching mechanisms. The valve 902 may include one or more latching mechanisms configured to quickly release the coil 923 and / or cap 903 in response to a signal. For example, in an emergency situation, the one or more latching mechanisms may be configured to retract and / or release the coil 923 and / or cap 903.

[0133] In some embodiments, valve 902 may include a ring 917 at a distal end of valve 902. Ring 917 may have a generally rigid structure and / or may be configured to attach and / or couple to actuator 924.

[0134] 10 illustrates an exemplary system including one or more valves 1002 according to one or more embodiments described herein. In some embodiments, the various valves 1002 described herein may be secured via one or more anchors 1011, which may include a first anchor 1011a and / or a second anchor 1011b. The one or more anchors 1011 may comprise a stent and / or a wire frame. In some embodiments, the valve 1002 and / or the one or more anchors 1011 may be self-expandable and / or balloon-expandable.

[0135] In some examples, the first anchor 1011a may be positioned in the brachiocephalic vein 39 and / or other blood vessels above the right atrium 5 (e.g., the SVC 22). The second anchor 1011b may be positioned at least partially in the IVC 10 and / or other blood vessels below the right atrium 5. The first anchor 1011a may extend in a first direction (e.g., distal to the valve 1002) and / or the second anchor 1011b may extend in a second direction (e.g., proximally from the valve 1002).

[0136] The valve 1002 may have any suitable configuration and / or may comprise any of the valves 1002 described herein. In some embodiments, the valve 1002 may have a barbed configuration. The valve 1002 may comprise a single frame or multiple frames.

[0137] 11 illustrates an exemplary frame 1104 of an occlusion valve 1102, as described in any of the examples herein. The frame 1104 may be a passive flow restriction device and / or may be comprised of a balloon-expandable and / or self-expandable wireform and / or stent. In some examples, the frame 1104 may be constructed in a shape that reduces flow through the frame 1104. For example, the frame 1104 may be generally curved and / or have an hourglass shape.

[0138] In some embodiments, the frame 1104 may include one or more barbs 1127 at the distal end 1130 and / or the proximal end 1132 of the frame 1104. For example, the frame 1104 may include a flange 1111 at the distal end 1130, and / or the one or more barbs 1127 may be configured to improve securement of the flange 1111 and / or the frame 1104. The one or more barbs 1127 may include any suitable securement means and / or means for securement, which may include spikes, arms, fingers, protrusions, needles, pincers, and / or similar devices.

[0139] The frame 1104 may be configured to operate passively and / or may incorporate one or more active elements that can enable variable adjustment of the amount of flow restriction of the frame 1104 and / or other components of the exemplary valve (e.g., the leaflets and / or cap). Exemplary active elements may include nitinol actuation wires and / or other suitable devices. In some examples, the frame 1104 may be incorporated into one or more ratchet mechanisms to dynamically adjust one or more actuation features (e.g., actuation wires) of the valve and / or frame 1104. The ratchet mechanisms may be configured to dynamically adjust the amount of flow restriction to a fixed measurement and / or hold a given position and / or measurement without constant active actuation.

[0140] The frame 1104 and / or various valves described herein may be suitable for dynamically adjusting the amount of flow restriction despite having a uniform and / or constant surface area and / or size. For example, a physician may advantageously utilize a single valve size and / or configuration for multiple patients and / or to induce multiple flow effects. Furthermore, patients may not require extensive hemodynamic testing prior to a procedure to determine which size implant to use.

[0141] The valve 1102 may include one or more leaflets 1105 configured to extend at least partially across the lumen of the frame 1104. The valve 1102 may include any number of leaflets 1105 (e.g., two or three leaflets 1105).

[0142] 12 provides an overhead view of a valve 1202 including multiple leaflets 1205, according to one or more embodiments described herein. The valve 1202 illustrated in FIG. 12 includes two leaflets 1205 in a closed configuration (e.g., extending completely or nearly completely into the lumen of the valve 1202). However, the exemplary valve 1202 may include other numbers of leaflets 1205 (e.g., one, three, or four). The valve 1202 includes a first leaflet 1205a and a second leaflet 1205b. The first leaflet 1205a and the second leaflet 1205b may at least partially overlap in one or more partially and / or completely closed configurations.

[0143] One or more leaflets 1205 may be dynamically adjustable and / or configured to controllably and / or passively move between one or more positions, including a partially closed position, a fully open position, and / or a fully closed position. The valve 1202 may include one or more latching mechanisms configured to hold the leaflets 1205 in one or more positions.

[0144] In some embodiments, the leaflets 1205 may have a generally curved configuration. For example, one or more leaflets 1205 may have a generally oval and / or partial circular shape.

[0145] 13 provides an overhead view of a valve 1302 including multiple leaflets 1305, according to one or more embodiments described herein. The valve 1302 shown in FIG. 13 includes three leaflets 1305 in a closed configuration (e.g., extending completely or nearly completely into the lumen of the valve 1302). However, the exemplary valve 1302 may include other numbers of leaflets 1305 (e.g., one, two, or four). The valve 1302 includes a first leaflet 1305a, a second leaflet 1305b, and / or a third leaflet 1305c. The first leaflet 1305a, the second leaflet 1305b, and / or the third leaflet 1305c may at least partially overlap in one or more partially and / or completely closed configurations.

[0146] One or more leaflets 1305 may be dynamically adjustable and / or configured to controllably and / or passively move between one or more positions, including a partially closed position, a fully open position, and / or a fully closed position. The valve 1302 may include one or more latching mechanisms configured to hold the leaflets 1305 in one or more positions.

[0147] In some embodiments, the leaflets 1305 may have a generally curved configuration. For example, one or more leaflets 1305 may have a generally oval and / or partial circular shape.

[0148] 14 provides a side view of a valve 1402 including multiple leaflets 1405 extending from a frame 1404, according to one or more embodiments described herein. The valve 1402 shown in FIG. 14 includes two leaflets 1405 in a closed configuration (e.g., extending completely or nearly completely into the lumen of the valve 1402; however, the illustrative valve 1402 may include other numbers of leaflets 1405 (e.g., one, three, or four)). The valve 1402 includes a first leaflet 1405a and a second leaflet 1405b. The first leaflet 1405a and the second leaflet 1405b may at least partially overlap in one or more partially and / or completely closed configurations.

[0149] One or more of the leaflets 1405 may be dynamically adjustable and / or configured to controllably and / or passively move between one or more positions, including a partially closed position, a fully open position, and / or a fully closed position. The valve 1402 may include one or more latching mechanisms configured to hold the leaflets 1405 in one or more positions.

[0150] In some embodiments, the leaflets 1405 may have a generally curved configuration. For example, one or more leaflets 1405 may have a generally oval and / or partial circular shape.

[0151] 15A-15C illustrate an exemplary valve 1502 and / or one or more components of the valve 1502, according to one or more embodiments described herein. FIG. 15A provides an overhead view of the leaflets 1505 of the valve 1502 and / or support arms 1507 extending at least partially along the leaflets 1505. FIG. 15B provides a side view of the leaflets 1505 in an expanded and / or rigid configuration in which the support arms 1507 hold the leaflets 1505 away from the frame 1504 of the valve 1502 and / or extend the leaflets 1505 at least partially into the lumen of the valve 1502. FIG. 15C provides a side view of the leaflets 1505 in a folded and / or flexible configuration in which the support arms 1507 allow the leaflets 1505 to drape along the frame 1504 and / or not occlude the lumen of the valve 1502. The support arm 1507 may be foldable and / or configured to fold (e.g., break, bend, and / or sag) and / or stiffen in response to blood pressure signals and / or changes.

[0152] The support arms 1507 may be any support means and / or means for supporting the valve leaflets 1505 and may include actuation wires and / or other actuation members, elongated arms, fingers, and / or similar devices. In some embodiments, the support arms 1507 may be configured to adjust and / or transform between rigid and / or flexible configurations. For example, the support arms 1507 may have properties similar to a tape means, in which the support arms 1507 have a generally curved lateral configuration. The support arms 1507 may be configured to assume a generally rigid configuration (e.g., in response to an electrical current provided to the support arms 1507). In some embodiments, the support arms 1507 may be configured to respond to an increase in pressure and / or to collapse and / or "crack" in response to an increase in pressure. For example, an increase in pressure may cause the support arm 1507 and / or a portion of the support arm 1507 to bend, which may affect the structural integrity of the support arm 1507 and / or release tension holding the support arm 1507 in a straight and / or elongated configuration. In some examples, the support arm 1507 may operate passively and / or may be configured to adjust between a rigid and flexible configuration in response to changes in blood flow and / or may not require an external stimulus (e.g., an electrical current).

[0153] Valve 1502 may include additional leaflets 1505 and / or support arms 1507, which are not shown in Figures 15A-15C. For example, valve 1502 may include two or three leaflets 1505 and / or two or three support arms 1507.

[0154] 16A and 16B illustrate an exemplary occlusion valve 1602, which may include various components of the valve 1602 described herein, according to one or more embodiments. The valve 1602 may include a frame 1604 and / or one or more leaflets, caps, biasing members, and / or actuation members, as described in other embodiments herein. In some embodiments, the valve 1602 may include an occlusion element 1607, which may include any occlusion means and / or means for occluding the lumen of the valve 1602 and may comprise one or more balloons, diaphragms, leaflets, and / or similar devices. The occlusion element 1607 may be configured to expand and / or inflate passively and / or in response to an external stimulus (e.g., an electrical current). FIG. 16A illustrates the valve 1602 in an open and / or unexpanded configuration, in which the occlusion element 1607 does not extend and / or minimally extends across the lumen of the valve 1602. FIG. 16B shows the valve 1602 in a closed and / or expanded configuration, with the occlusion element 1607 extending at least partially across the lumen of the valve 1602.

[0155] Occlusion element 1607 may be coupled to and / or secured to frame 1604 and / or configured to expand away from frame 1604 in response to changes in blood flow and / or external stimuli. In some examples, occlusion element 1607 may be configured to responsively retract and / or open the lumen in response to blood flow when an increased volume of blood presses against occlusion element 1607 in its expanded configuration. In some examples, occlusion element 1607 may be coupled to an inner surface of frame 1604 and / or extend from an inner surface of frame 1604 and / or may be configured to extend across and / or at least partially occlude the lumen of frame 1604 as occlusion element 1607 expands.

[0156] 17A-17D illustrate another exemplary valve 1702 configured to dynamically occlude one or more blood vessels of the heart, according to one or more embodiments. The valve 1702 may include a frame 1704 and / or one or more leaflets and / or occlusion elements as described in other embodiments herein. In some embodiments, the valve 1702 may include a cap 1703 having a circular and / or disc shape. FIG. 17A provides a side view of the cap 1703 in an open state, in which a major (e.g., circular) axis of the cap 1703 extends generally parallel to the wall of the frame 1704. The cap 1703 may be configured to default to the open state and / or may present minimal occlusion of the lumen 1710 while in the open state. FIG. 17B provides a side view of the cap 1703 in a partially closed state, in which a major axis of the cap 1703 extends at an angle relative to the wall of the frame 1704. Figure 17C provides a side view of cap 1703 in a generally closed state, with the major axis of cap 1703 extending generally perpendicular to the wall of stent 1704. Figure 17D provides a top view of valve 1702 in a closed state. Although cap 1703 is shown as having a smaller diameter than frame 1704 in Figure 17D, cap 1703 may have a diameter approximately equal to frame 1704 and / or may be configured to more completely close lumen 1710 of valve 1702. Cap 1703 may be at least partially and / or completely disposed within lumen 1710 of valve 1702.

[0157] In some examples, the valve 1702 may include an actuating element 1707 (e.g., a wire) configured to extend at least partially through the cap 1703. The actuating element 1707 may extend through the length of the cap 1703. The actuating element 1707 may be configured to extend through an opening 1719 at or near the midpoint of the cap 1703. The opening 1719 may be located in a central portion of the cap 1703. In some examples, the actuating element 1707 may have shape memory properties and / or may be at least partially composed of nitinol and / or other shape memory alloys. The actuating element 1707 may be configured to bend in response to an electrical current and / or other stimulus from a controller and / or a battery. Bending of the actuating element 1707 may be configured to rotate the cap 1703 from an open state to a partially closed state and / or a fully closed state. In some examples, the cap 1703 may have multiple partially closed states. The valve 1702 may include one or more latching mechanisms configured to hold the cap 1703 in one or more partially closed, open, and / or fully closed positions.

[0158] 18A and 18B illustrate an exemplary valve 1802 configured to dynamically occlude one or more blood vessels of the heart, in accordance with one or more embodiments herein. The valve 1802 may include a coil 1823 (e.g., a biasing element) and / or an occlusion element 1803 (e.g., a diaphragm) configured to dynamically close a lumen of the valve 1802. FIG. 18A provides a side view of the coil 1823 and / or the occlusion element 1803 in at least a partially closed state. FIG. 18B provides a side view of the coil 1823 and / or the occlusion element 1803 in an open state. The coil 1823 and / or the occlusion element 1803 may be configured to default to the extended and / or open state shown in FIG. 18B and / or may be compressed to the configuration shown in FIG. 18A in response to a signal and / or current in and / or through the coil 1823.

[0159] The coil 1823 and / or the occlusion element 1803 (e.g., a cover) may extend at least partially through the frame 1804 of the valve 1802. The coil 1823 and / or the occlusion element 1803 may extend at least partially through and / or along a lumen formed by the frame 1804 of the valve 1802.

[0160] Coil 1823 may comprise an actuating element configured to extend at least partially through occlusion element 1803. In some examples, occlusion element 1803 may be configured to at least partially surround at least a portion of coil 1823. Coil 1823 may be responsive to an electrical current and / or other stimulus provided to coil 1823 via a controller and / or a battery. In some examples, occlusion element 1803 may have shape memory properties and / or be at least partially constructed from nitinol and / or other shape memory alloys.

[0161] In some embodiments, the coil 1823 and / or the occlusion element 1803 may be biased toward an open (e.g., extended) configuration shown in FIG. 18B , where the loops of the coil 1823 may expand and / or the occlusion element 1803 may be stretched to a relatively high length. The occlusion element 1803 may have a generally flexible and / or elastic structure and / or may be at least partially composed of a fabric, a polymer, and / or similar material. In response to an electric current, the coil 1823 may be configured to compress, which may compress and / or expand the occlusion element 1803 laterally, as shown in FIG. 18A . The lateral expansion of the occlusion element 1803 can cause occlusion of the lumen of the valve 1802. In the expanded configuration shown in FIG. 18A , the occlusion element 1803 may assume a circular and / or disc shape at or near a central section of the occlusion element 1803.

[0162] FIG. 19 illustrates an exemplary circuit 1900 configured to control and / or power one or more valves 1902 described in the examples herein. The circuit 1900 may be an implantable wireless circuit configured to control various valves described herein. The circuit 1900 may include a microcontroller 1952. The microcontroller 1952 may utilize a native Bluetooth Low Energy (BLE) and / or WIFI chipset. The circuit 1900 may further include an integrated circuit 1954 that utilizes a voltage regulator and / or transistor to regulate power delivery as indicated by an output signal from the microcontroller 1952. The circuit 1900 may include multiple power sources, which may include a low-energy power source 1956 provided by a wireless induction coil 1957 (e.g., a transceiver) to power the microcontroller 1952, and / or a high-energy power source 1958 comprised of a wireless rechargeable battery that can power the valve 1902. Additionally, the BLE and / or WIFI capabilities of the microcontroller 1952 can enable wireless communication from the microcontroller 1952 to a central device 1960 (e.g., a computer, a mobile device, a cloud server, etc.). Further encryption of the wireless communication may be established via Advanced Encryption Standard (AES) and / or end-to-end encryption protocols.

[0163] The circuit 1900 may utilize a closed-loop feedback system to control the valve 1902. The circuit 1900 may start in a sense mode, in which pressure sensors below and / or above the valve 1902 (e.g., located in the right atrium and / or vena cava) may be used to monitor the pressure and / or gradient across the valve 1902 and / or transmit data back to the controller 1952. The controller can then calculate the optimal fill pressure and / or the required current to open, close, and / or partially close the valve 1902. The circuit 1900 can switch to an actuation mode, in which the controller 1952 can adjust the valve 1902 to a previously calculated value to achieve the optimal fill pressure. The circuit 1900 can then switch back to the sense mode and begin the closed-loop cycle again. Additionally, the controller 1952 may have its power supplied via wireless induction or an implantable battery. The controller 1952 may also have a central device 1960 outside the patient that is used to transmit data to and / or from the controller 1952 and / or may be used to monitor the device and its critical care sensors. This data can then be uploaded to the patient's healthcare provider to enable long-term data acquisition and device management.

[0164] 20 illustrates another circuit 2000 for controlling one or more valves described herein, according to one or more embodiments. The circuit 2000 may include a controller 2052 (e.g., a microcontroller), an integrated circuit 2054, a power source 2056, and / or an actuator 2062 configured to dynamically control one or more valves. The circuit 2000 may further include a pull-down resistor 2059 coupled to the integrated circuit 2054.

[0165] 21A and 21B illustrate an exemplary dynamic occlusion valve 2102 configured for at least partial placement within one or more blood vessels of a heart, in accordance with one or more embodiments herein. Figure 21A provides a side view of the valve 2102 in an open state, and Figure 21B provides a side view of the valve 2102 in a closed state.

[0166] The valve 2102 may comprise an outer frame 2104 and / or an inner frame 2106. The outer frame 2104 and / or the inner frame 2106 may comprise a network of struts that form one or more cells through the outer frame 2104 and / or the inner frame 2106. In some embodiments, the inner frame 2106 may have a generally solid structure and / or may comprise a cover configured to cover one or more cells of the inner frame 2106.

[0167] The outer frame 2104 and / or the inner frame 2106 may be at least partially constructed from nitinol and / or other shape memory alloys. In some embodiments, the outer frame 2104 and / or the inner frame may have a generally elastic and / or superelastic structure. The outer frame 2104 and / or the inner frame may have shape memory properties and / or may be configured to naturally assume a given shape. In some embodiments, the inner frame 2106 may be configured to naturally assume the expanded configuration shown in FIG. 21A and / or may be configured to naturally contract and / or decrease in diameter in response to changes in temperature and / or blood flow. The inner frame 2106 may be configured to contract to form a generally narrow waist 2124 at or near a central section of the inner frame 2106. The inner frame may assume an hourglass shape in response to a signal and / or current at the valve 2102.

[0168] The valve 2102 may include a network of struts 2116, which may include thin metal wire and / or similar material. The struts 2116 may be coupled to the inner frame 2106 and / or extend between the arms and / or spines of the inner frame 2106. The struts 2116 may have a generally curved and / or coiled configuration and / or may be configured to compress (e.g., bend) and / or expand (e.g., straighten) in response to pressure and / or electrical current at and / or through the valve 2102 (e.g., through the struts 2116). In some examples, the struts 2116 may be configured to cause bending of the inner frame 2106 and / or the inner frame 2106 may be configured to cause compression of the struts 2116. The inner frame 2106 may comprise generally straight arms in a default configuration.

[0169] 22A and 22B show another exemplary valve 2202 configured to dynamically occlude one or more blood vessels of the heart, according to one or more embodiments. FIG. 22A illustrates the valve 2202 in an open configuration, and FIG. 22B illustrates the valve 2202 in a closed configuration. The valve 2202 may comprise a frame 2204 configured in a generally cylindrical and / or tubular configuration. In some embodiments, the valve 2202 may further comprise an actuation wire 2207 and / or coil around the frame 2204 and / or may be configured to at least partially surround the frame 2204. The actuation wire 2207 may be at least partially constructed from nitinol and / or other shape memory alloy and / or may be looped around at least a mid-section of the tubular frame 2204. When an electric current is applied to the actuation wire 2207, the actuation wire 2207 may be configured to compress and / or contract in length and / or diameter, reducing the diameter of at least a mid-section of the coil and / or frame 2204. This reduction in the inner diameter of the frame 2204 may result in a reduction in flow through the valve 2202. The frame 2204 may assume an hourglass shape in response to the electric current in the wire 2207.

[0170] 23A-23C show another exemplary valve 2302 configured to dynamically occlude one or more blood vessels of the heart, according to one or more embodiments. FIG. 23A provides a perspective view of the valve 2302 in an open state. FIG. 23B provides a side view of the valve 2302 in an open state. FIG. 23C provides a side view of the valve 2302 in a closed state, in which one or more actuating members 2307 press an occlusion sheet 2330 (e.g., one or more leaflets) against the lumen of the valve 2302. The one or more actuating members 2307 may be configured to extend inward in response to an electrical current and / or a signal in an actuation wire 2308 coupled to the actuating member 2307.

[0171] In some examples, the actuation member 2307 may include a composite cantilever beam configured to extend longitudinally along the frame 2304 of the valve 2302. The actuation member 2307 may include an actuation wire 2308 (e.g., constructed from nitinol) that extends along the elongated column of the actuation member 2307 and / or the valve 2302. The actuation wire 2308 may be embedded in a sheet 2330, which may comprise a substrate (e.g., tissue and / or synthetic leaflets), and cause deflection of the sheet 2330.

[0172] In some embodiments, the actuation member 2307 may include one or more inward and / or outward bends 2317 that allow for increased closure force on the sheet 2330 and / or allow for the sheet 2330 to be forced into the closed configuration shown in FIG. 23C using occlusion flow. The bends 2317 may form an inward bulge in the actuation member 2307.

[0173] 24A and 24B illustrate another exemplary valve 2402 configured to dynamically occlude one or more blood vessels of the heart, according to one or more embodiments. FIG. 24A provides a first cross-section of the valve 2402, showing the inner frame 2406 of the valve 2402. FIG. 24B provides a second cross-section of the valve 2402, showing channels 2412 constructed within the outer frame 2404 of the valve 2402. The outer frame 2404 and / or inner frame 2406 may be constructed similarly to a Tesla valve, where flow through the valve 2402 may be slowed due to various channels 2412 in the valve 2402.

[0174] Flow through the valve 2402 may be selectively and / or dynamically directed either through a generally open inner frame 2406 of the valve 2402 or through a passage 2412 in the outer frame 2404. For example, one or more caps, leaflets, check valves, and / or other occlusion elements may be configured to selectively close a passage through the inner frame 2406 of the valve 2402. In such cases, flow may be forced through the passage 2412 in the outer frame 2404, thus restricting flow through the vessel. The passage 2412 may have a three-dimensional form and / or any suitable structure. In some embodiments, the valve 2402 may comprise multiple passages 2412 with various paths having upward and / or downward curves to slow and / or impede flow through the valve 2402.

[0175] Valve 2402 may include one or more stoppers configured to selectively block blood flow through paths other than curved path 2412. For example, one or more stoppers may be configured to prevent blood flow between outer frame 2404 and inner frame 2406, forcing blood flow through inner frame 2406 and / or through curved path 2412. In some embodiments, a signal and / or current in valve 2402 may be configured to activate the stoppers in valve 2402.

[0176] 25A and 25B show an exemplary ratchet mechanism 2501 configured to allow dynamic adjustment of one or more components of the various valves described herein. The ratchet mechanism 2501 may be configured to vary the flow restriction in fixed increments without requiring constant actuation of one or more biasing mechanisms, thereby reducing overall energy consumption and power requirements.

[0177] In some embodiments, the frame of the valve may incorporate one or more ratchet mechanisms 2501 to dynamically adjust one or more actuation features (e.g., actuation wires) of the valve and / or frame. The ratchet mechanism 2501 may be configured to dynamically adjust the amount of flow restriction to a fixed measurement and / or hold a given position and / or measurement without constant active actuation.

[0178] Various exemplary medical implants and / or delivery methods are described herein. Some of the examples described herein may be used in combination and / or independently.

[0179] Further description of the embodiment Below is provided a list of examples, each of which may include aspects of any of the other examples disclosed herein. Furthermore, aspects of any of the examples described above may be implemented in any of the numbered examples provided below.

[0180] Depending on the embodiment, certain acts, events, or functions of any of the processes or algorithms described herein may be performed in a different order, added, combined, or omitted entirely. Thus, in a particular embodiment, not all described acts or events may be required to practice a process.

[0181] Example 1: A system for regulating blood flow through a blood vessel of the heart, the system comprising a valve, the valve comprising an outer frame and configured to be at least partially disposed within the blood vessel.

[0182] Example 2: The system of any example herein, particularly example 1, further comprising a controller disposed outside the heart, the controller configured to send a signal to the valve.

[0183] Example 3: The system of any example herein, particularly example 2, further comprising a battery configured to power the controller or the valve.

[0184] Example 4: The system of any example herein, particularly example 2, further comprising a sensor configured to be positioned within the heart, the sensor configured to transmit a signal related to blood flow to the controller.

[0185] Example 5: The system of any example herein, particularly example 4, wherein the controller is configured to send a signal to the valve based on a signal received from the sensor.

[0186] Example 6: The system of any example herein, particularly example 1, wherein the valve comprises two or more leaflets.

[0187] Example 7: The system of any example herein, particularly example 6, wherein the two or more leaflets at least partially overlap.

[0188] Example 8: The system of any example herein, particularly example 6, further comprising one or more actuation wires configured to control movement of the two or more leaflets.

[0189] Example 9: The system of any example herein, particularly example 8, wherein the one or more actuation wires are configured to receive signals from a controller located outside the heart.

[0190] Example 10: The system of any example herein, particularly example 8, wherein the one or more actuation wires are configured to cause independent movement of each of the two or more valve leaflets.

[0191] Example 11: The system of any example herein, particularly example 8, wherein the one or more actuation wires are configured to cause simultaneous movement of each of the two or more valve leaflets.

[0192] Example 12: The system of any example herein, particularly example 8, wherein the one or more actuation wires are configured to form a loop below or above the two or more leaflets.

[0193] Example 13: The system of any example herein, particularly Example 12, wherein the loop is configured to push or pull the two or more leaflets from a default open position to one or more at least partially closed positions.

[0194] Example 14: The system of any of the examples herein, particularly example 8, wherein the one or more actuation wires are configured to move the two or more leaflets between a plurality of predetermined positions.

[0195] Example 15: A system described in any example herein, particularly example 8, wherein the one or more actuation wires are configured to control one or more support arms coupled to the two or more valve leaflets.

[0196] Example 16: The system of any of the examples herein, particularly example 15, wherein the one or more support arms extend along the underside of the two or more leaflets.

[0197] Example 17: The system of any example herein, particularly example 1, wherein the valve comprises a cap configured to at least partially occlude the lumen of the outer frame.

[0198] Example 18: The system of any example herein, particularly example 17, wherein the cap comprises a disk-shaped distal portion.

[0199] Example 19: The system of any example herein, particularly example 17, further comprising one or more actuation wires configured to control the amount of separation between the outer frame and the cap.

[0200] Example 20: A system described in any example herein, particularly example 19, wherein the one or more actuation wires are configured to hold the cap in a position away from the outer frame by default, and the one or more actuation wires are configured to pull the cap towards the outer frame in response to current passing through the one or more actuation wires.

[0201] Example 21: The system of any example herein, particularly example 19, wherein the one or more actuation wires are coupled to an actuator.

[0202] Example 22: The system of any example herein, particularly example 19, wherein the one or more actuation wires form a coil spring.

[0203] Example 23: The system of any example herein, particularly example 17, wherein the cap is positioned at the inlet portion of the valve.

[0204] Example 24: The system of any example herein, particularly Example 1, further comprising a first anchor tethered to and extending proximally from the valve.

[0205] Example 25: The system of any example herein, particularly example 24, further comprising a second anchor tethered to the valve and extending proximally from the valve.

[0206] Example 26: A system described in any example herein, particularly example 1, wherein the outer frame comprises one or more barbed arms configured to secure the valve within the blood vessel.

[0207] Example 27: A system described in any example herein, particularly Example 1, further comprising one or more leaflets extending across the lumen of the outer frame and a foldable support arm extending along each of the one or more leaflets.

[0208] Example 28: A system described in any example herein, particularly Example 27, wherein the foldable support arm is configured to have a flexible default form and is configured to stiffen in response to an electric current.

[0209] Example 29: A system described in any example herein, particularly Example 1, further comprising a balloon coupled to the inner surface of the outer frame, the balloon configured to have a deflated default configuration and configured to be inflated with a gas or fluid to at least partially occlude the inner lumen of the outer frame.

[0210] Example 30: The system of any example herein, particularly example 1, further comprising a cap disposed within the lumen of the valve, and an actuation wire coupled to the cap.

[0211] Example 31: A system described in any example herein, particularly example 30, wherein the cap is configured to provide minimal obstruction of the lumen in a default configuration of the cap and the actuation wire.

[0212] Example 32: A system described in any example herein, particularly example 31, wherein the actuation wire is configured to cause rotation of the cap to increase occlusion of the lumen.

[0213] Example 33: A delivery system as described in any example herein, especially example 30, wherein the cap has a disk shape.

[0214] Example 34: The system of any example herein, especially example 30, wherein the cap comprises an opening in a central portion of the cap.

[0215] Example 35: The system of any example herein, particularly example 30, wherein the actuation wire extends through the length of the cap.

[0216] Example 36: A system as described in any example herein, particularly Example 1, further comprising an actuation wire extending at least partially through the lumen of the valve, and a cover at least partially enclosing the actuation wire.

[0217] Example 37: A system as described in any example herein, particularly example 36, wherein the actuation wire has a coiled configuration.

[0218] Example 38: A system described in any example herein, particularly Example 37, wherein the actuation wire is configured to have an extended default configuration and the actuation wire is configured to compress in response to an electric current.

[0219] Example 39: A system described in any example herein, particularly example 38, wherein the cover is configured to expand laterally in response to compression of the actuation wire to increase occlusion of the lumen.

[0220] Example 40: A system described in any example herein, particularly Example 1, wherein the valve further comprises an inner frame including a network of struts extending between the arms of the inner frame, and the arms of the inner frame have a generally straight default configuration.

[0221] Example 41: A system described in any example herein, particularly example 40, wherein the arms of the inner frame are configured to compress into an hourglass shape in response to an electric current at the valve.

[0222] Example 42: The system of any example herein, particularly example 1, further comprising one or more actuation wires at least partially coiled around the outer frame.

[0223] Example 43: A system described in any example herein, particularly example 42, wherein the one or more actuating wires are configured to compress the central section of the outer frame in response to an electric current passing through the one or more actuating wires.

[0224] Example 44: A system described in any example herein, particularly Example 1, further comprising one or more arms extending longitudinally along the outer frame and one or more actuation wires extending along the one or more arms.

[0225] Example 45: A system described in any example herein, particularly example 44, wherein each of the one or more arms includes an inner bulge.

[0226] Example 46: A system described in any example herein, particularly example 44, wherein the one or more actuation wires are configured to extend the one or more arms inward in response to an electric current passing through the one or more actuation wires.

[0227] Example 47: The system of any example herein, particularly example 1, wherein the valve further comprises an inner frame that forms one or more curved pathways.

[0228] Example 48: A system described in any example herein, particularly example 47, wherein the one or more curved paths form a Tesla valve.

[0229] Example 49: A system described in any example herein, particularly example 47, wherein the valve comprises one or more stoppers configured to block blood flow between the outer frame and the inner frame in response to an electric current at the valve, forcing blood flow through the inner frame.

[0230] Example 50: The system of any example herein, particularly example 1, further comprising a ratchet mechanism configured to control closure of the valve between multiple positions.

[0231] Example 51: A system described in any example herein, particularly Example 1, wherein the valve comprises two or more valve leaflets and one or more latches configured to hold the two or more valve leaflets in place.

[0232] Example 52: A system described in any example herein, particularly example 51, wherein the one or more ratchets extend from the outer frame.

[0233] Depending on the embodiment, certain acts, events, or functions of any of the processes or algorithms described herein may be performed in a different order, added, combined, or omitted entirely. Thus, in a particular embodiment, not all described acts or events may be required to practice a process.

[0234] In particular, conditional language used herein, such as "can," "could," "might," "may," "e.g.," and the like, is intended to have its ordinary meaning unless specifically stated otherwise or understood otherwise within the context of use, and is generally intended to convey that certain embodiments include certain features, elements, and / or steps, while other embodiments do not. Thus, such conditional language is generally not intended to imply that features, elements, and / or steps are required in any way by one or more embodiments, or that one or more embodiments necessarily include logic for determining whether those features, elements, and / or steps are included or performed in any particular embodiment, with or without authorial input or prompting. Terms such as "comprising," "including," "having," and the like are synonymous and used in their ordinary sense, and are used in an inclusive, non-limiting manner and do not exclude additional elements, functions, acts, operations, etc. Additionally, the term "or" is used in its inclusive sense (and not its exclusive sense), for example, when used to connect a list of elements, so that the term "or" refers to one, some, or all of the elements in the list. Connective language such as the phrase "at least one of X, Y, and Z" is understood in context to be used generally to convey that an item, term, element, etc. may be either X, Y, or Z, unless specifically stated otherwise. Thus, such connective language is not generally intended to imply that a particular embodiment requires that at least one of X, at least one of Y, and at least one of Z are each present.

[0235] In the foregoing description of the embodiments, it should be understood that various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in understanding one or more of the various inventive aspects. However, this method of disclosure should not be interpreted as reflecting an intention that any claim requires more features than are expressly recited in that claim. Moreover, any component, feature, or step illustrated and / or described in a particular embodiment herein may be applied to or used in conjunction with any other embodiment. Moreover, no component, feature, step, or group of components, features, or steps is necessary or essential to each embodiment. Accordingly, it is intended that the scope of the invention(s) herein, as disclosed and claimed below, should not be limited by the specific embodiments described above, but should be determined solely by a fair reading of the following claims.

[0236] It should be understood that certain sequential terms (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply physical characteristics or order. Thus, as used herein, sequential terms (e.g., "first," "second," "third," etc.) used to modify elements such as structures, components, operations, etc., do not necessarily indicate a priority or order of the element relative to any other elements, but rather may generally distinguish an element from another element having a similar or identical name (other than the use of sequential terms). Additionally, as used herein, the indefinite articles ("a" and "an") may indicate "one or more" rather than "one." Furthermore, an action performed "based on" a condition or event may also be performed based on one or more other conditions or events not expressly recited.

[0237] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by those skilled in the art to which the illustrative examples belong. Furthermore, terms such as those defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and are not to be interpreted in an idealized or overly formal sense unless expressly defined herein.

[0238] Although certain preferred embodiments and examples are disclosed below, the inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, as well as modifications and equivalents thereof. Accordingly, the scope of claims that may arise from this specification is not limited by any of the specific embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable order and are not necessarily limited to any particular disclosed order. Various operations may be described sequentially as multiple separate operations, in a manner that may be useful for understanding a particular embodiment, but the order of description should not be construed as implying that these operations are order-dependent. Additionally, structures, systems, and / or devices described herein may be embodied as integrated or separate components. For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not all such aspects or advantages are necessarily achieved by any particular embodiment. Thus, for example, various embodiments may be implemented in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages that may also be taught or suggested herein.

[0239] Spatially relative terms such as "outside," "inside," "upper," "lower," "below," "upper," "vertical," "horizontal," and similar terms may be used herein for ease of description to describe the relationship between one element or component and another element or component, as illustrated in the drawings. It is understood that spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the drawings. For example, if a device shown in the drawings is turned upside down, a device positioned "below" or "directly below" another device may be positioned "above" another device. Thus, the exemplary term "below" may include both a lower position and an upper position. Devices may also be oriented in other directions, and thus spatially relative terms may have different interpretations depending on the orientation.

[0240] Unless expressly stated otherwise, comparative and / or quantitative terms such as "less," "more," "greater than," and the like are intended to encompass equivalent concepts. For example, "less" may mean "less than" as well as "less than or equal to," in the strictest mathematical sense.

[0241] The delivery systems described herein may be used to position catheter tips and / or catheters in various regions of the human heart. For example, the catheter tip and / or catheter may be configured to pass from the right atrium to the coronary sinus. However, the description may refer to or generally apply to positioning a catheter tip and / or catheter from a first body chamber or lumen to a second body chamber or lumen, where it is understood that the catheter tip and / or catheter may be curved when positioned from the first body chamber or lumen to the second body chamber or lumen. A body chamber or lumen may refer to any one of a number of fluid channels, blood vessels, and / or organ chambers (e.g., a cardiac ventricle). Furthermore, references herein to "catheter," "tube," "sheath," "steerable sheath," and / or "steerable catheter" may generally refer to or apply to any type of elongated tubular delivery device including a lumen configured to slidably receive an instrument, such as for positioning within the atrium or coronary sinus, including, for example, a delivery catheter and / or cannula. It will be appreciated that other types of medical implant devices and / or procedures can be delivered to the coronary sinus using the delivery systems described herein, including, for example, ablation procedures, drug delivery and / or coronary sinus lead placement.

Claims

1. 1. A system for regulating blood flow through a blood vessel of the heart, the system comprising a valve, the valve comprising an outer frame and configured to be at least partially disposed within the blood vessel.

2. The system of claim 1 , further comprising a controller disposed outside the heart, the controller configured to send a signal to the valve.

3. The system of claim 1 , wherein the valve comprises two or more leaflets.

4. The system of claim 3 , further comprising one or more actuation wires configured to control movement of the two or more valve leaflets.

5. The system of claim 1 , wherein the valve comprises a cap configured to at least partially occlude a lumen of the outer frame.

6. The system of claim 1 , further comprising a first anchor tethered to the valve and extending proximally from the valve.

7. one or more leaflets extending across the lumen of the outer frame; The system of claim 1 , further comprising a foldable support arm extending along each of the one or more leaflets.

8. 10. The system of claim 1, further comprising a balloon coupled to an inner surface of the outer frame, the balloon configured to have a deflated default configuration and configured to be inflated with a gas or fluid to at least partially occlude the lumen of the outer frame.

9. a cap disposed within the valve lumen; The system of claim 1 , further comprising: an actuation wire coupled to the cap.

10. 10. The system of claim 1, wherein the valve further comprises an inner frame including a network of struts extending between arms of the inner frame, the arms of the inner frame having a generally straight default configuration.

11. one or more arms extending longitudinally along the outer frame; The system of claim 1 , further comprising one or more actuation wires extending along the one or more arms.

12. The system of claim 1 , wherein the valve further comprises an inner frame that defines one or more curved pathways.

13. The system of claim 1 , further comprising a ratchet mechanism configured to control closure of the valve between a plurality of positions.

14. The system of claim 1 , wherein the valve comprises two or more leaflets and one or more latches configured to hold the two or more leaflets in place.

15. 1. A method for regulating blood flow through a blood vessel of the heart, said method comprising: delivering a valve at least partially within a vessel of the heart, the valve comprising an outer frame; transmitting one or more control signals to the valve to control movement of the valve.

16. 16. The method of claim 15, further comprising receiving a blood flow signal from a sensor disposed within the heart, and wherein transmitting the one or more control signals is based at least in part on the blood flow signal.

17. The method of claim 15 , wherein the valve comprises two or more leaflets.

18. 16. The method of claim 15, wherein the valve comprises one or more actuation wires configured to receive the one or more control signals.

19. The method of claim 15 , wherein the valve comprises a cap configured to at least partially occlude an inner lumen of the outer frame.

20. The method of claim 15, further comprising delivering a first anchor tethered to and extending proximally from the valve. 1.

Images