Systems and methods for treating heart failure by altering blood flow direction in odd veins

Abstract

Systems and methods for treating heart failure by altering the direction of blood flow in the odd veins are disclosed, as well as systems, devices and methods for controllably and selectively occluding, limiting and / or diverting flow within the vasculature of a patient. Systems, devices, and methods for altering the direction of blood flow in odd veins. A device may include an implant configured to redirect blood from a pulmonary artery to an odd vein, and an implant configured to be disposed in the odd vein of a patient to at least partially block blood flow from the odd vein into a superior vena cava.

Description

[0001] Incorporation by reference of any priority application

[0002] This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 63 / 331,496, filed on April 15, 2022. The entire contents of all of the above applications are hereby incorporated by reference. Any and all applications claiming foreign or domestic priority as indicated in the Application Data Sheet filed with this application are hereby incorporated by reference under 37 CFR 1.57. Technical Field

[0003] The present disclosure relates to systems, devices and methods for treating heart failure, and systems, devices and methods for controllably and selectively occluding, restricting and / or diverting flow within a patient's vasculature, including redirecting blood flow in the azygos vein. Background Art Technical Field

[0005] Heart failure, or congestive heart failure, occurs when the heart cannot pump blood effectively. Certain cardiovascular conditions, including narrowing of the heart arteries and high blood pressure, can gradually weaken and / or stiffen the heart muscle, reducing the heart's efficiency. As cardiac output decreases, blood pressure drops and blood circulation slows. Fluid can accumulate in the lungs, causing shortness of breath. Reduced blood flow and increased fluid further damage the heart and can eventually be life-threatening.

[0006] At the same time, as the heart begins to fail, the kidneys experience a drop in renal blood pressure. In response, renal sympathetic nerve activation releases hormones, including renin, angiotensin, and aldosterone, to increase water and sodium retention and increase extracellular fluid in an effort to raise blood pressure and drive blood back to the heart. The increased pressure and fluid increase the stress on the damaged heart, further accelerating the mechanisms of failure.

[0007] Heart failure can initially be treated with lifestyle changes to reduce the workload on the heart, but in many cases, medications and / or renal interventions (such as ablation) can be used to reduce blood pressure and fluid accumulation. As the disease progresses, surgical interventions may be required, such as coronary artery bypass grafting, stent placement, heart valve repair or replacement, implantation of a cardioverter defibrillator, use of a ventricular assist device, or heart transplantation. Summary of the invention

[0008] Certain aspects of the present application relate to methods, systems and devices for treating heart failure. Certain aspects of the present application relate to methods, systems and devices for diverting or changing the direction of blood flow in the azygos vein.

[0009] In some aspects, the technology described herein relates to a system for treating heart failure in a patient, the system comprising: an implant configured to be disposed in the azygos vein of the patient to at least partially block blood flow from the azygos vein to the superior vena cava. In some aspects, the implant further comprises a controllable valve. In some aspects, the implant comprises a shunt configured to be disposed between the pulmonary artery and the azygos vein.

[0010] In some aspects, the technology described herein relates to a system wherein an implant is configured to redirect blood in the azygos vein. In some aspects, the implant is configured to divert blood in the azygos vein to the hemiazygos vein, the accessory hemiazygos vein, the internal mammary vein, or the internal thoracic vein.

[0011] In some aspects, the technology described herein relates to a system in which an implant includes an expandable tubular body configured to extend between a pulmonary artery and an azygos vein. In some aspects, the implant includes an upstream end that substantially does not obstruct blood flow in the pulmonary artery. In some aspects, the implant includes an upstream end that is configured to expand radially against an inner wall of the pulmonary artery. In some aspects, the implant includes a downstream end that is configured to expand radially against an inner wall of the azygos vein. In some aspects, the downstream end of the implant is configured to direct blood into the azygos vein in the opposite direction of the forward direction of blood flow in the azygos vein.

[0012] In some aspects, the technology described herein relates to a system wherein an implant comprises a valve configured to regulate blood flow from the azygos vein to the superior vena cava. In some aspects, the implant comprises a porous portion configured to allow blood to flow from the azygos vein into the superior vena cava.

[0013] In some aspects, the technology described herein relates to a system wherein an implant includes a first implant configured to be positioned in the azygos vein to at least partially block blood flow from the azygos vein to the superior vena cava, and also includes a second implant configured to direct blood from the pulmonary artery to the azygos vein.

[0014] In some aspects, the technology described herein relates to a system that also includes a controller configured to regulate blood flow through the implant. In some aspects, the controller is configured to regulate blood flow through the implant based on one or more pressure readings.

[0015] In some aspects, the technology described herein relates to a method of treating heart failure in a patient, the method comprising restricting blood flow from the patient's azygos vein into the superior vena cava. In some aspects, blood flow from the azygos vein into the superior vena cava is restricted by an implant disposed in the azygos vein that at least partially obstructs blood flow in the azygos vein. In some aspects, the implant is implanted chronically.

[0016] In some aspects, the technology described herein relates to a method in which a shunt is disposed between the pulmonary artery and the azygos vein to restrict blood from flowing from the azygos vein into the superior vena cava. The shunt diverts blood from the pulmonary artery to the azygos vein. In some aspects, the shunt is configured to direct blood into the azygos vein against the direction of blood flow in the azygos vein. In some aspects, the shunt does not substantially extend into the pulmonary artery or into the azygos vein. In some aspects, the shunt has a length extending in the pulmonary artery and in the azygos vein.

[0017] In some aspects, the technology described herein relates to a method wherein a shunt has an upstream end within the pulmonary artery, the upstream end being upstream of a connection between the pulmonary artery and the azygos vein relative to a direction of blood flow within the pulmonary artery. In some aspects, the shunt has a downstream end within the azygos vein, the downstream end being upstream of a connection between the pulmonary artery and the azygos vein relative to a direction of blood flow within the azygos vein. In some aspects, the shunt is disposed between the right upper pulmonary artery and the azygos vein.

[0018] In some aspects, the technology described herein relates to a method for treating heart failure of a patient, the method comprising redirecting blood from the pulmonary artery to the azygos vein via a shunt implanted between the pulmonary artery and the azygos vein. In some aspects, the redirection of blood is sufficient to relieve pulmonary congestion of the patient and reduce left ventricular end-diastolic pressure (LVEDP). In some aspects, the redirection of blood is sufficient to reduce pulmonary artery pressure to relieve pulmonary hypertension, thereby reducing the workload of the patient's right ventricle. In some aspects, the redirection of blood is sufficient to simulate visceral vascular capacity and redistribute blood to the visceral compartment of the patient. In some aspects, the redirection of blood is sufficient to cause expansion and / or pressure increase of the intercostal veins of the patient. In some aspects, the redirection of blood causes blood to be redirected from the pulmonary artery to the azygos vein and redirected to the superior vena cava. In some aspects, the redirection of blood causes blood to be redirected from the pulmonary artery to the azygos vein and redirected to the hemiazygos vein. In some aspects, the redirection of blood causes blood to be redirected from the pulmonary artery to the azygos vein and redirected to the para-hemiazygos vein. In some aspects, the diversion of blood results in redirecting blood from the pulmonary artery into the azygos vein and into the internal mammary vein or the internal thoracic vein.

[0019] In some aspects, the technology described herein relates to a method wherein blood is diverted from the right pulmonary artery to the azygos vein. In some aspects, the technology described herein relates to a method further comprising restricting and / or blocking blood flow from the azygos vein to the superior vena cava.

[0020] In some aspects, the technology described herein relates to a method, wherein an implantable shunt includes a controllable valve. In some aspects, the technology described herein relates to a method, the method also includes controlling the amount of blood flowing through the shunt with a controller. In some aspects, the technology described herein relates to a method, the method also includes controlling the amount of blood flowing through the shunt based on feedback received from one or more pressure sensors disposed within the patient.

[0021] In some aspects, the technology described herein relates to a method in which a shunt is implanted between a pulmonary artery and an azygos vein by: delivering a first catheter within the pulmonary artery; delivering a second catheter within the azygos vein; aligning a first magnet carried by the first catheter with a second magnet carried by the second catheter to align the first catheter and the second catheter; delivering a guidewire between the pulmonary artery and the azygos vein while the first catheter and the second catheter are aligned; and delivering a shunt or a delivery device for a shunt between the pulmonary artery and the azygos vein using the guidewire.

[0022] In some aspects, the technology described herein relates to an implantable shunt configured to be implanted between a pulmonary artery and an azygos vein of a patient and configured to divert flow into the azygos vein to treat heart failure.

[0023] In some aspects, the technology described herein relates to an implantable flow control system, comprising: an implant, the implant comprising: an expandable body, the expandable body comprising a proximal end and a distal end and an inner cavity extending from the proximal end to the distal end, wherein the expandable body is configured to contract to a contracted configuration for delivery into a patient's body, and to expand from the contracted configuration to an expanded configuration for implantation in the patient's body; and a liquid restrictor, the liquid restrictor being disposed within the expandable body, the liquid restrictor comprising: a first partition, the first partition partially blocking a first portion of the inner cavity when the expandable body is in the expanded configuration; and a second partition, the second partition being movable relative to the first partition to selectively block and not block a second portion of the inner cavity when the expandable body is in the expanded configuration.

[0024] In some aspects, the technology described herein relates to a system wherein a first divider includes a first expandable wire frame and a first fabric portion extending across the first expandable wire frame, and a second divider includes a second expandable wire frame and a second fabric portion extending across the second expandable wire frame.

[0025] In some aspects, the second partition is configured to rotate relative to the first partition to selectively increase or decrease the size of the opening through the inner cavity. In some aspects, the technology described herein relates to a system wherein the first partition is fixed relative to the expandable body. In some aspects, the controller is configured to control the movement of the second partition relative to the first partition.

[0026] In some aspects, the technology described herein relates to a system wherein the implant comprises a shunt configured to be implanted between a first blood vessel and a second blood vessel of a patient. In some aspects, the implant is configured to expand within the blood vessel of the patient.

[0027] In some aspects, the technology described herein relates to a system for treating heart failure, the system comprising: an implantable shunt configured to divert blood flow in a patient from a first blood vessel to a second blood vessel, wherein the implantable shunt is implantable between the first blood vessel and the second blood vessel, and wherein the implantable shunt includes an adjustable flow opening; and a controller configured to control the adjustable flow opening to control the amount of blood flowing through the implantable shunt, wherein the controller is configured to receive readings from one or more pressure sensors located in the patient, and wherein the controller is programmed to control the adjustable flow opening based on the readings.

[0028] In some aspects, the first vessel is the right pulmonary artery and the second vessel is the azygos vein.In some aspects, the controller is configured to receive one or more of central venous pressure, right ventricular pressure, pulmonary artery pressure, aortic and left atrial pressures.

[0029] In some aspects, the technology described herein relates to an implantable shunt including one or more of the features described above. In some aspects, the technology described herein relates to a method including one or more of the features described above. In some aspects, the technology described herein relates to a system including one or more of the features described above.

[0030] Certain aspects of the present application relate to methods, systems and devices for creating a shunt between two blood vessels, such as between a pulmonary artery and an azygos vein, to selectively divert or control blood flow. In one aspect, a method for treating heart failure in a patient is provided. The method includes diverting blood from the pulmonary artery to the azygos vein via a shunt implanted between the pulmonary artery and the azygos vein.

[0031] The methods, systems and devices described above or as further described herein may also include one or more of the following features. The diversion of blood may be sufficient to relieve the patient's pulmonary congestion and reduce the left ventricular end-diastolic pressure (LVEDP). The diversion of blood may be sufficient to reduce pulmonary artery pressure to relieve pulmonary hypertension, thereby reducing the workload of the patient's right ventricle. The diversion of blood may be sufficient to simulate visceral vascular capacity and redistribute blood to the patient's visceral compartment. The diversion of blood may be sufficient to cause dilation and / or pressure increase in the patient's intercostal veins. The diversion of blood may cause blood to be redirected from the pulmonary artery to the azygos vein and redirected to the superior vena cava. The diversion of blood may cause blood to be redirected from the pulmonary artery to the azygos vein and redirected to the hemiazygos vein. The diversion of blood may cause blood to be redirected from the pulmonary artery to the azygos vein and redirected to the accessory hemiazygos vein. The diversion of blood may cause blood to be redirected from the pulmonary artery to the azygos vein and redirected to the internal mammary vein or the internal thoracic vein. Blood may be diverted from the right pulmonary artery to the azygos vein.

[0032] Methods, systems and devices described above or as further described herein may include limiting and / or blocking blood from flowing from the azygos vein into the superior vena cava. In embodiments in conjunction with a shunt, the shunt may include a controllable valve. Methods, systems and devices may also include controlling the amount of blood flowing through the shunt with a controller. The methods, systems and devices may also include controlling the amount of blood flowing through the shunt based on feedback received from one or more pressure sensors disposed in the patient. The shunt may be implanted between the pulmonary artery and the azygos vein in the following manner: delivering a first catheter in the pulmonary artery, delivering a second catheter in the azygos vein, aligning a first magnet carried by the first catheter with a second magnet carried by the second catheter to align the first catheter and the second catheter, while the first catheter and the second catheter are aligned, delivering a guidewire between the pulmonary artery and the azygos vein, and using the guidewire to deliver a shunt or a delivery device for a shunt between the pulmonary artery and the azygos vein.

[0033] In one aspect, an implantable shunt is provided, the implantable shunt being configured to be implanted between a patient's pulmonary artery and azygos vein, and being configured to divert flow into the azygos vein to treat heart failure. The implantable shunt can be configured to operate or be implanted according to any method described above or as further described herein.

[0034] In one aspect, an implantable flow control system is provided. The system may include an implant comprising an expandable body, the expandable body comprising a proximal end and a distal end and an inner cavity extending from the proximal end to the distal end, wherein the expandable body is configured to contract to a contracted configuration for delivery into a patient, and to expand from the contracted configuration to an expanded configuration for implantation into the patient. The system may also include a liquid restrictor disposed within the expandable body. The liquid restrictor may include a first partition and a second partition, the first partition partially blocking a first portion of the inner cavity when the expandable body is in an expanded configuration, and the second partition being movable relative to the first partition to selectively block and unblock a second portion of the inner cavity when the expandable body is in an expanded configuration.

[0035] The systems described above or as further described herein may also include one or more of the following features. The first separator may include a first expandable wire frame and a first fabric portion extending across the first expandable wire frame, and the second separator may include a second expandable wire frame and a second fabric portion extending across the second expandable wire frame. The second separator may be configured to rotate relative to the first separator to selectively increase or decrease the size of the opening through the inner cavity. The first separator can be fixed relative to the expandable body. The system may also include a controller configured to control the movement of the second separator relative to the first separator. The implant may also include a shunt configured to be implanted between the first blood vessel and the second blood vessel of the patient. The implant may be configured to expand within the patient's blood vessel.

[0036] In one aspect, a system for treating heart failure is provided. The system may include an implantable shunt configured to divert blood flow in a patient from a first blood vessel to a second blood vessel, wherein the implantable shunt is implantable between the first blood vessel and the second blood vessel, and wherein the implantable shunt includes an adjustable flow opening. The system may also include a controller configured to control the adjustable flow opening to control the amount of blood flowing through the implantable shunt, wherein the controller is configured to receive readings from one or more pressure sensors located in the patient, and wherein the controller is programmed to control the adjustable flow opening based on the readings.

[0037] The system described above or as further described herein may also include one or more of the following features. The first vessel may be the right pulmonary artery and the second vessel may be the azygos vein. The controller may be configured to receive one or more of central venous pressure, right ventricular pressure, pulmonary artery pressure, aortic and left atrial pressure. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Certain features of the present disclosure are described below with reference to the accompanying drawings. The embodiments shown are intended to illustrate rather than limit these embodiments. Various features of the different disclosed embodiments can be combined to form further embodiments, which are part of the present disclosure.

[0039] Figure 1A Cardiovascular features near the heart are shown.

[0040] Figure 1B The venous system in the chest is shown.

[0041] Figure 1C Relevant anatomy of the upper chest is shown.

[0042] Figure 2A Another view of relevant anatomy in the upper chest is shown.

[0043] Figure 2B Shows relative to Figure 2A Examples of implant locations for the views shown.

[0044] Figure 3A Pulmonary artery and azygos vein blood flow before intervention is shown.

[0045] Figure 3B Shown after shunt implantation Figure 3A Example of blood flow.

[0046] FIG. 4A to FIG. 4C Various views of one embodiment of a shunt implant are shown.

[0047] Figure 5A and Figure 5B An example of altered blood flow paths in the pulmonary artery and azygos vein following implantation of an embodiment of the device is shown.

[0048] Fig. 6A An embodiment of a sleeve implant and resulting blood flow is shown.

[0049] Figure 6B An embodiment of a valved implant and resulting blood flow is shown.

[0050] Figure 6C An embodiment of a porous implant and resulting blood flow is shown.

[0051] Figure 7 An example of an implementation for gaining access between the pulmonary artery and the azygos vein is shown.

[0052] Fig. 8A and 8B An embodiment of a controllable valve that may be used in an implant is shown.

[0053] Fig. 9An embodiment of a shunt implant having a controllable valve is shown.

[0054] Fig.10 An embodiment of a system having an adjustable shunt is shown. DETAILED DESCRIPTION

[0055] The various features and advantages of the present disclosure will now be described with reference to the accompanying drawings. The following description is merely illustrative in nature and is in no way intended to limit the present disclosure, its application or use. The present disclosure extends beyond the specifically disclosed embodiments and / or uses and their obvious modifications and equivalents. Therefore, the scope of the present disclosure should not be limited by any particular embodiment described below. The features of the illustrated embodiments may be modified, combined, removed and / or replaced, as will be apparent to those of ordinary skill in the art after considering the principles disclosed herein. In addition, the embodiments disclosed herein may include several novel features, none of which is individually responsible for its desired attributes or necessary for practicing the systems, devices and / or methods disclosed herein.

[0056] Like reference numbers are used to identify parts, components, features, and / or elements of the systems and devices described herein that may function identically or similarly in various embodiments. Differences between various embodiments are discussed herein.

[0057] Embodiments of the present application relate to controlling cardiac output to treat or prevent heart failure in patients. Certain embodiments relate to creating a vertical shunt (which may also be referred to as an implant, catheter, or arteriovenous (AV) fistula) between the right pulmonary artery and the azygos vein to divert blood from the right pulmonary artery.

[0058] Figure 1A The patient's anatomy is shown, including the heart 130, with the right atrium 132, right ventricle 134, pulmonary artery 140, pulmonary vein 122, left atrium 136, left ventricle 138, and aorta 146 including aortic arch 147. Also shown are the inferior and superior vena cava 144, 142, as well as the left and right internal jugular veins 112, 110, left and right subclavian veins 116, 114, and left and right brachiocephalic veins 120, 118. This central cardiovascular complex collects deoxygenated blood from the body, pumps it to the lungs and back for oxygenation, and then pumps oxygenated blood to the body.

[0059] Figure 1BThe venous anatomy in the patient's chest is shown, including the azygos vein 150 that drains into the superior vena cava 142, as well as the accessory hemiazygos vein 156, hemiazygos vein 158, lumbar vein 160, and other vessels that drain into the azygos vein 150. Also shown are the right brachiocephalic vein 118, right subclavian vein 114, axillary vein 154, and internal thoracic vein 152 that also drain into the superior vena cava 142.

[0060] Figure 1C , Figure 2A and Figure 2B The upper chest is shown, including the sternum 166, right bronchus 162, right pulmonary vein 164, and lymph nodes 168. Figure 2B As shown, the branch of the right pulmonary artery 140 extends adjacent to the azygos vein 150, which provides a possible location for the implantation of the shunt 200. In some embodiments, any branch of the pulmonary artery 140 may be suitable. For example, the location distal to the right pulmonary artery, including the permanent arterial trunk, the right superior trunk, the parietal artery, the anterior artery, the posterior recurrent artery, various intersegmental branches, the ascending artery and the interrenal artery may be suitable locations. Similarly, although the proximal arc of the azygos vein 150 extending on the pulmonary artery 140 is shown just before the junction with the superior vena cava 142, any location along the azygos vein 150 may be suitable. The implantation location may be selected based on the patient's specific anatomical structure, the distance between the branch of the pulmonary artery 140 and the azygos vein 150, the estimated blood flow through the corresponding blood vessels, the estimated pressure difference, the ease of surgical access, the avoidance of any interfering structures (such as the right bronchus 162, lymph nodes 168, nerves and other non-target vascular systems) and / or the preference of the implanting physician, etc.

[0061] In some embodiments, a device implanted at this location, such as a shunt 200, is adapted to redirect or divert a certain amount of blood from the right pulmonary artery 140 that exits the right ventricle 134 of the heart 130 to the azygos vein 150 that passes adjacent to the right pulmonary artery 140. Figure 2BIn the figure, for the sake of clarity, both the pulmonary artery 140 and the azygos vein 150 are shown, and a channel can be formed between the arterial system and the venous system to facilitate the creation of a visceral compartment in the thoracic blood vessels. When the right pulmonary artery 140 is connected to the azygos vein 150, the pressure difference between the arterial system and the venous system can cause blood to flow from the pulmonary artery 140 into the azygos vein 140, and further can produce backflow in the azygos vein 150. Implants such as shunts 200 can be delivered percutaneously to the patient in a contracted configuration and expanded to an expanded configuration after implantation. The blood diverted from the right pulmonary artery 140 to the azygos vein 150 can enlarge (expand) and pressurize the intercostal veins, thereby effectively increasing the intravascular volume and creating additional blood grooves in the intercostal veins. The redirection or diversion of blood can be fully adapted to the venous capacity system. The redirection or diversion of blood can cause an increase in venous capacity, thereby increasing cardiac output. At least some of the blood redirected into the azygos vein 150 may continue into the superior vena cava 142 and back into the right atrium 132, or it may flow through other vessels, such as the accessory hemiazygos vein 156, the hemiazygos vein 158, and the internal mammary vein (or internal thoracic vein 152), to the superior vena cava 142 or the inferior vena cava 144 and into the right atrium 132. The flow path created from the right pulmonary artery 140 through the azygos vein 150 and back into the right atrium 132 effectively creates an additional blood sink in the visceral compartments within the body.

[0062] In some embodiments, the amount of blood redirected to the azygos vein 150 can be controlled by selecting an appropriate diameter for an implant such as the shunt 200, thereby controlling the amount of increased venous capacity or the volume of the additional blood sink. In some embodiments, a control mechanism (e.g., a controllable fluid restrictor 1000 discussed below) can be incorporated into the shunt 200 to control the blood flow into the azygos vein 150. It is expected that the volume increase of blood flow from the azygos vein 150 to the superior vena cava 142 can reach a hemodynamically significant degree, in some examples at least about 0.5L or 1L or more.

[0063] like Figure 3A As shown, the azygos vein 150 generally flows in a positive or antegrade direction 300 into the superior vena cava 142. The pulmonary artery 140 flows in a positive or antegrade direction 302 toward the lungs. Figure 3BAs shown, creating a passage or fistula 200 between the pulmonary artery 140 and the azygos vein can cause the blood flow in the azygos vein to turn or redirect. The passage or fistula 200 can be provided by any implant described herein, or can be produced by other devices or technologies. In some embodiments, after creating the passage or fistula 200, the blood from the right ventricle 134 flows through the pulmonary artery 140 along the forward or anterograde direction 304A as usual. Then, the blood can be redirected along direction 304B, through the passage 200, and enter the azygos vein 150. At least some of the blood from the azygos vein 150 can be redirected to flow back to the chest cavity along the reverse or retrograde direction 304C in the azygos vein. In some embodiments, all blood is turned to the reverse or retrograde direction 304C. In some embodiments, some blood continues to enter the superior vena cava 142 along the forward or anterograde direction 300. In some embodiments, the connection between the azygos vein 150 and the superior vena cava 142 can be closed or controlled or regulated (e.g., by surgery or using a valve) to direct blood that has been diverted from the right pulmonary artery 140 to the accessory hemiazygos vein 156, the hemiazygos vein 158, the internal thoracic vein 152, or other vessels, including the intercostal veins, the internal mammary veins, and other vessels as described above.

[0064] The amount of blood diverted from the right pulmonary artery 140 into the azygos vein 150 reduces the amount of blood reaching the lungs, which can advantageously reduce pressure and relieve pulmonary congestion, and reduce left ventricular end-diastolic pressure (LVEDP). The diversion of blood can be sufficient to reduce pulmonary artery pressure to relieve pulmonary hypertension, thereby reducing the workload of the patient's right ventricle 134. Therapy can be customized by controlling one or both of the amount of blood diverted from the right pulmonary artery 140 and the amount of blood flowing from the azygos vein 150 to the superior vena cava 142.

[0065] A connection between the right pulmonary artery 140 (or a branch of the right pulmonary artery 140) may be created surgically or percutaneously by placing a device such as a shunt 200 between the right pulmonary artery 140 and the azygos vein 150. For example, Figure 4A shows a side view of the diverter 200, Figure 4B shows a stereogram, Figure 4CAnother stereogram is shown. The implant or shunt 200 may include an expandable body 210 having a lumen 213 between the two ends. In some embodiments, the first end of the shunt is disposed in the pulmonary artery, the second end of the shunt is disposed in the azygos vein, and the middle portion of the shunt is disposed at the connection between the pulmonary artery and the azygos vein. The expandable body 210 may be configured to contract for delivery into the patient and expand to engage with the inner wall of one or more blood vessels of the patient once implanted, shown as an expanded configuration. For example, a first or upstream portion of the shunt 200 may radially expand and engage with the length of the pulmonary artery 140 upstream of the connection between the pulmonary artery 140 and the azygos vein 150 relative to the direction of blood flow in the pulmonary artery. A second or downstream portion of the shunt 200 may radially expand and engage with the length of the azygos vein 150 upstream of the connection between the pulmonary artery 150 and the azygos vein 140 relative to the direction of blood flow in the azygos vein. Once implanted, blood flowing through the blood vessel in which the implant 200 is implanted may flow through the lumen 213.

[0066] As shown, the shunt 200 may include an inner body 225 that is located within the outer body 215. In some embodiments, an implant such as a shunt 200 may include an expandable body 210, wherein the outer body 215 of an expandable membrane or fabric layer at least partially covers the inner body 225 of a metal frame including one or more struts as discussed above. In some embodiments, the shunt 200 includes an inner body 225 made of an expandable tubular frame (e.g., nitinol) that may include struts. These struts may be covered with an outer body 215, such as a biocompatible material, such as a film or fabric of PTFE. In some embodiments, the expandable body 210 may include an expandable membrane or fabric inner body 225 that is surrounded or partially surrounded by a tubular outer body 215 of an expandable stent-like metal frame as described above.

[0067] In some embodiments, the shunt 200 has a length sufficient to connect the pulmonary artery 140 to the azygos vein 150. In some embodiments, each end of the shunt 200 can include a flare, barb, hook or other anchoring structure to facilitate securing the end in the corresponding blood vessel. In some embodiments, the shunt 200 can be tubular and have a length sufficient to radially expand against the length of the pulmonary artery 140 and extend along it to secure the upstream or inlet end of the shunt 200 and guide blood from the pulmonary artery 140 to the shunt 200. The length can also be sufficient to radially expand against the length of the azygos vein 150 and extend along it, for example, to secure the downstream or outlet end of the shunt 200 and guide blood into the azygos vein 150. In some embodiments, the downstream or outlet end of the shunt 200 is configured to guide blood upstream in the azygos vein 150 to the above-mentioned intrathoracic vessels and visceral cavity. In some embodiments, the downstream or outlet end of the shunt 200 is configured to guide blood flow downstream in the azygos vein 150 to the superior vena cava 142.

[0068] In some embodiments, the expandable body 210 can be configured as a double-walled stent, wherein the outer body 215 includes an outer wall and the inner body 225 includes an inner wall. Each of the outer body 215 and the inner body 225 can include a material layer. Each of the outer body 215 and the inner body 225 can include a frame including a plurality of struts. In some embodiments, one or more struts are sandwiched between the outer body 215 and the inner body 225. In some embodiments, a plurality of struts, such as struts of the outer body 215, struts of the inner body 225, or struts between the outer body 215 and the outer body 225, are made of a single wire. In some embodiments, a plurality of struts can be cut from one or more tubes.

[0069] Both the outer body 215 and the inner body 225 can be configured to contract and expand as described herein. In addition, the outer body 215 and the inner body 225 can be configured to contract and expand together. For example, in some embodiments, the outer body 215 and the inner body 225 are configured to be implanted together and expand together in the target blood vessel. In some embodiments, the outer body 215 and the inner body 225 are configured to be implanted separately or one by one. For example, the outer body 215 can be implanted and expanded first, and then the inner body 225 can be implanted and expanded within the outer body 215.

[0070] In some embodiments, one or both of the outer body 215 and the inner body 225 can have a porous portion, as discussed below. In some embodiments, the outer body 215 and the inner body 225 can have the same length and aligned proximal and distal ends, such as FIG. 4A to FIG. 4CAs shown, to produce a double-walled stent as discussed above. In some embodiments, the outer body 215 and the inner body 225 can have different lengths and / or can have non-aligned proximal and / or distal ends, thereby producing a portion of the stent 200 having one wall and a portion having two walls. In some embodiments, the outer body 215 and the inner body 225 can have portions. For example, the stent 200 can include an outer body 215 of material, and an inner body 225 having, for example, a first metal strut portion at one end and, for example, a second metal strut portion at the other end. In some embodiments, the implantable device can include multiple devices 200 as described below.

[0071] In some embodiments, such as FIG. 5A to FIG. 5B In the example shown in , the implant may be a short shunt 200 configured to provide a connection between two blood vessels (e.g., between the pulmonary artery 140 and the azygos vein 150). The shunt 200 may preferably be disposed between the pulmonary artery 140 and the azygos vein 150 without substantially extending into the lumen of either vessel. Figure 5A As shown in the side view of , shunt 200 can be implanted to create a flow path between the branch of pulmonary artery 140 and azygos vein 150. This position allows blood flow 304 to continue to flow as usual in the branch of pulmonary artery 140 along the forward or antegrade direction 304A to the lungs, and a portion of blood flow 304 is diverted through shunt 200 along direction 304B into azygos vein 150. Figure 5B As shown in the top view of , blood flow 304 exits the shunt 200 and enters the azygos vein 150 and may provide return flow in a reverse or retrograde direction 304C. This return flow may create a thoracic groove in chest vessels, such as the intercostal veins, the accessory hemiazygos vein 156, the hemiazygos vein 158, and other veins as discussed above. A portion of the diverted blood may also enter the superior vena cava 142. As further described below, in some embodiments, the shunt 200 may include a controllable valve. Also as further described below, in some embodiments, blood flow from the azygos vein 150 to the superior vena cava 142 may be individually restricted or occluded, such as by placing an additional flow-limiting implant in the azygos vein 150 downstream of the shunt 200.

[0072] In this and other embodiments, the diversion of blood in the azygos vein 150 can advantageously create a thoracic trough that can simulate splanchnic vascular capacity and redistribute blood to the splanchnic compartment, thereby reducing cardiac workload. Reducing pulmonary artery pressure can relieve pulmonary hypertension, thereby reducing the workload of the right ventricle. Diverting blood flow can also reduce pulmonary congestion in the patient and reduce left ventricular end-diastolic pressure (LVEDP).

[0073] FIG. 6A to FIG. 6CAdditional embodiments of implant devices are shown to redirect blood flow in the azygos vein 150. In some embodiments, one end of the implant 600 is located within the lumen of a branch of the pulmonary artery 140, and the other end of the implant 600 is located within the lumen of the azygos vein 150, such as Fig. 6A As shown. In this example, one or both ends of the implant 600 are guided into the corresponding blood vessels to further assist the desired blood flow. As shown, one end of the implant 600 in the azygos vein 150 is placed upstream of the implant position relative to the blood flow direction in the azygos vein 150 to generate backflow and redirect blood from the pulmonary artery 140 to the thoracic trough as described above. Similarly, one end of the implant 600 in the pulmonary artery 140 can be guided upstream to collect the blood flowing in the pulmonary artery 140. In some embodiments, the implant 600 can be a longer shunt, which can be the same as the shunt 200 discussed above in other aspects. In other embodiments, the upstream end of the implant 600 can extend into the pulmonary artery 140 without substantially blocking the pulmonary artery 140, to allow blood to flow into the implant 600 and continue to flow downstream through the pulmonary artery 140. The implant 600 can be non-porous or include one or more non-porous portions to guide, limit or prevent the blood flow between the azygos vein 150 and the superior vena cava 142.

[0074] In some embodiments, implant 700 may include one or more valves 702. For example, Figure 6B As shown, one end of the implant 700 is located within the pulmonary artery 140, and the other end of the implant 700 is located within the azygos vein 150 upstream of the new connection between the pulmonary artery 140 and the azygos vein 150. The implant 700 can be similar to the shunt 200 or the implant 600 in some aspects. A valve 702 can be included in the implant 700 to selectively direct blood from the pulmonary artery 140 to the azygos vein 150 and / or the superior vena cava 142. For example, the valve 702 can be disposed along the length of the implant 700 to selectively allow blood to enter the superior vena cava 142 from the pulmonary artery 140 in the azygos vein 150 in a forward direction. The valve 702 can be disposed on a portion of the implant 700 that is downstream of the connection between the pulmonary artery 140 and the azygos vein 150. In some embodiments, the valve 702 can be a pressure valve that is designed to open after a desired amount of blood has been diverted to the thoracic trough. For example, in some embodiments, valve 702 is a check valve designed to open at a predetermined pressure, such as a leaflet valve or a spring valve. In some embodiments, valve 702 may be a hole or iris designed to allow a predetermined volume of blood to enter superior vena cava 142 from pulmonary artery 140. Figure 6BAs shown, in some embodiments, after implantation of the device 700, the valve 702 can be located within the azygos vein 150. In some embodiments, the valve 702 can be located on a side of the implant 700 closer to the superior vena cava 142, such as Figure 6B As shown. In some embodiments, valve 702 can be a one-way valve to control the direction of blood flow. In some embodiments, valve 702 can be located in the azygos vein 150 closer to the thoracic groove, for example, at one end of the implant 700 located upstream of the connection between the pulmonary artery 140 and the azygos vein 150 in the azygos vein 150. In some embodiments, valve 702 can be located in the pulmonary artery 140 to control the amount of blood that is diverted from the pulmonary artery 140 and enters the azygos vein 150 through the implant 700. In some embodiments, valve 702 can be configured to be arranged in the implant 700 between the pulmonary artery 140 and the azygos vein 150 after implantation. In some embodiments, multiple valves 702 (e.g., two valves or three valves) can be arranged at any of the above positions along the implant 700.

[0075] In some embodiments, implant 800 may include a porous portion 804. For example, Figure 6C As shown, one end of implant 800 is located within pulmonary artery 140, and the other end of implant 800 is located within azygos vein 150. Implant 800 can be similar to shunt 200 or implants 600 and 700 in some aspects. A porous portion 804 can be included in at least a portion of implant 800 disposed within azygos vein 150 to selectively direct blood from pulmonary artery 140 to azygos vein 150 and / or superior vena cava 142. For example, porous portion 804 can be disposed along the length of implant 800 to allow blood to enter superior vena cava 142 from pulmonary artery 140. Figure 6C As shown, in some embodiments, after implanting the device 700, the porous portion 804 can be located within the azygos vein 150. In some embodiments, the porous portion 804 can be located on a side of the implant 800 closer to the superior vena cava 142, such as Figure 6C As shown. In some embodiments, the porous portion 804 can be located within the pulmonary artery 140 to control the amount of blood that is diverted from the pulmonary artery 140 through the implant 800 and enters the azygos vein 150. In some embodiments, the implant 800 can include one or more porous portions 804 and one or more valves 802. The valve 802 can be similar to the valve 702 in some or all aspects. In some embodiments, a single opening can be used in addition to or in place of the porous portion 804. In some embodiments, the opening or porous portion can be configured to allow a predetermined flow rate, pressure, and / or volume of blood to leave the implant in a specific direction.

[0076] In some embodiments, an implant, such as implant 800 or the like, can be implanted to position one end of implant 800 in pulmonary artery 140 as discussed above, and to position the other end of implant 800 within azygos vein 150, such that the other end is arranged to radially expand against azygos vein 150 at a location downstream of the connection between pulmonary artery 140 and azygos vein 150. For example, porous portion 804 can be located in azygos vein 150 closer to the thoracic notch, such as on a side of implant 800 located within azygos vein 150.

[0077] In some embodiments, blood can be redirected upstream in the azygos vein 150 by a valve (such as valves 702, 802) placed in the azygos vein 150 and / or a controllable valve as discussed below. In some embodiments, blood flow from the azygos vein 150 to the superior vena cava 142 is restricted to slow or block the outflow of blood. While blood continues to enter the thoracic groove from the left ventricle 138 as usual, the restricted outflow increases the blood volume in the visceral compartment. In some embodiments, blood flow from the azygos vein 150 to the superior vena cava 142 can be restricted or redirected upstream with an external ligature, occluder, or other implanted device. In some embodiments, the visceral compartment or thoracic groove can be created by restricting or preventing blood from flowing through another vein in the thoracic veins, for example, the accessory hemiazygos vein 156, the hemiazygos vein 158, the lumbar vein 160, and other blood vessels that flow into the azygos vein 150.

[0078] In some embodiments, the implant device can be installed via a percutaneous approach. Figure 7 As shown, in one example of a percutaneous method, a magnetic element can be used to orient two adjacent blood vessels. For example, in some embodiments, the magnetic element can be a magnet aligned in each blood vessel, such as a magnetic ring 930A and 930B. For example, a first catheter 910B can be delivered to the right pulmonary artery 140, and a second catheter 910A can be delivered to the azygos vein 150, each catheter with magnets 930A, 930B. In some embodiments, one or both of the catheters 910A, 910B can include hinges 916A, 916B, or can be hinged in other ways. In some embodiments, the hinges 916A, 916B are controlled by steering wires 912A, 912B. In some embodiments, one or both of the catheters 910A, 910B can include a preformed curved portion or portion presenting a preformed shape. For example, in some embodiments, a catheter such as catheter 910A can include a portion that assumes a preformed shape after being released from a delivery sheath, after a delivery stylet is removed, after reaching a particular temperature, and / or after receiving an electrical pulse. In some embodiments, one or both of catheters 910A, 910B can include one or more lumens.

[0079] In some embodiments, magnets 930A, 930B can be used to align catheters 910A, 910B, so that a guide wire (not shown) is delivered from one blood vessel to another. The guide wire can be used to enable the delivery device for delivering the implant to enter. In some embodiments, magnets 930A, 930B can be connected to control wires 914A, 914B. In some embodiments, control wires 914A, 914B can be used to switch the polarity of magnets 930A, 930B to selectively repel, which may be useful for removing catheters 930A, 930B after delivery. In some embodiments, magnets 930A, 930B can be electromagnets, and control wires 914A, 914B can be used to selectively activate and deactivate magnets 930A, 930B at different times during placement, delivery and / or removal of catheters 910A, 910B.

[0080] In some embodiments, the azygos vein 150 can be accessed via the superior vena cava 142. In some embodiments, the azygos vein 150 can be accessed via the inferior vena cava 144. In some embodiments, the Swan-Ganz approach can be used to access the pulmonary artery 140. For example, the pulmonary artery 140 can be accessed via the superior vena cava 142 or the inferior vena cava 144, through the right atrium 132 and the right ventricle 134. In some embodiments, as described above, the azygos vein 150 and the pulmonary artery 140 are accessed separately, and each end of the implant can be deployed and / or placed in each blood vessel separately via a tool (e.g., catheters 910A and 910B). In some embodiments, the pulmonary artery 140 and the azygos vein 150 are accessed from one blood vessel (e.g., using the Swan-Ganz approach through the pulmonary artery 140 to create an opening to the azygos vein 150, or vice versa), and the implant can be placed in the entered blood vessel via a tool.

[0081] As described above, in some embodiments, the implant includes a valve, such as valves 702 and 802. In some embodiments, the implant includes a controllable valve or fluid restrictor to form an adjustable shunt. In some embodiments, an adjustable shunt implant, such as Fig. 9 The implant 1100 shown in FIG. 1 may include FIG. 8A to FIG. 8BThe controllable fluid restrictor 1000 shown in . The adjustable shunt 1100 can be retractable so that it can be delivered percutaneously. In some embodiments, the controllable fluid restrictor 1000 includes one or more wire frames 1002. A valve or regulator, such as a controllable fluid restrictor 1000, can be located within an implant (e.g., an adjustable shunt 1100) such that the wire frame 1002 extends across a cross-section of the adjustable shunt 1100. The wire frame 1002 can be retracted along with the rest of the adjustable shunt 1100 for delivery. When expanded, the wire frame 1002 forms a pair of discs, each having a portion of the fabric extending across the cross-section of the shunt 1100, such as FIG. 8A to FIG. 8B shown.

[0082] One or more wire frames 1002 can be fixed or stationary relative to the rest of the shunt 1100, such as the fixed partition 1010, to prevent blood from flowing through a portion of the controllable fluid restrictor 1000. At least one wire frame, such as the rotating partition 1004, can be rotated relative to the fabric of the fixed partition 1010 to control the size of the opening 1006 through the shunt 1100. The rotating partition 1004 can also include a fabric portion to prevent blood from flowing through the controllable fluid restrictor 1000. In some embodiments, the rotating partition 1004 can be selectively rotated to open or close the controllable fluid restrictor 1000. Fig. 8A As shown, the fixed partition 1010 and the rotating partition 1004 can be oriented so that their respective fabric portions are arranged to block a large portion of the lumen or cross-section of the shunt 1100, thereby allowing blood to pass only through the small opening 1006. In some embodiments, the fixed partition 1010 and the rotating partition 1004 can be oriented so that their respective fabric portions are arranged to completely block the cross-section of the shunt 1100. Figure 8B As shown, the rotating partition 1004 can be rotated so that the fabric of the rotating partition 1004 is partially or completely aligned with the fabric of the fixed partition 1010, thereby selectively opening the controllable liquid restriction 1000 and enlarging the opening 1006 to allow more blood to pass through the controllable liquid restriction 1000. In some embodiments, the fabric of the fixed partition 1010 has approximately the same area as the fabric of the rotating partition 1004. In some embodiments, the fabric areas of the fixed partition 1010 and the rotating partition 1004 are equal. In some embodiments, the respective fabric areas of the fixed partition 1010 and the rotating partition 1004 can be arranged to block an area of ​​the cross-section of the diverter 1100 that is less than the entire cross-section, for example, 95%, 90%, 80%, 75%, 60%, 50%, 45%, 33%, 20%, 15%, 10%, 5%, or any other portion of the combined area.

[0083] The rotation of the rotating divider 1004 can be accomplished by a drive line, such as Fig. 9 , which may include a torque cable driven by a motor located in the control unit. In other aspects, the adjustable shunt 1100 may be similar to the shunt 200 and implants 600, 700 and 800, including an expandable body 1110 having an inner body 1125, an outer body 1115 and an inner cavity 1113. The adjustable shunt 1100 may also include additional valves and / or porous portions as discussed above.

[0084] In some embodiments, a feedback control implant may be provided, such as an adjustable shunt 1100 disposed between the right pulmonary artery 140 and the azygos vein 150. The feedback control implant may also be placed at other locations in the body, such as a shunt between two blood vessels or an implant within a blood vessel. The implant may include any type of valve or flow regulator to regulate the flow opening within the implant, and may incorporate a feedback control loop as described below. The implant as described above or as described elsewhere in this specification may be implanted for a long period of time.

[0085] Fig.10 A system including an adjustable shunt is shown according to one embodiment. The adjustable shunt 1220 can be controlled by a drive line 1216 connected to a motor disposed in a control unit 1210 located outside the patient's body or implanted therein. The control unit 1210 can be patient controlled and / or patient monitored, for example, wirelessly via an application on a smartphone 1232. The connection between the smartphone 1232 or other suitable device and the control unit 1210 can be wireless 1230, such as Fig.10As shown. In some embodiments, the connection is wired, such as when the control unit 1210 is located outside the patient's body. The control unit 1210 may include a battery 1212 or other power source and circuitry configured to receive wired or wireless signals, such as signal 1214, from a sensor. For example, pressure, flow, and / or electrical sensors may be disposed in various locations within or around the heart 130 or in other locations within the body. For example, one or more sensors may be used to measure right ventricular pressure 1214A, central venous pressure 1214B, pulmonary artery pressure 1214C, aortic pressure 1214D, and left atrial pressure 1214E. Based on these pressure readings and / or other signals 1214, the control unit 1210 may appropriately actuate the drive circuit 1216 to control the adjustable shunt 1220 so as to control the amount of blood flowing through the adjustable shunt 1220. The control logic including the above-described feedback loop may be optimized to treat patients with heart failure, such as by controlling the amount of blood diverted from the right pulmonary artery 140 to the azygos vein 150. This can reduce the amount of blood reaching the lungs, which can advantageously reduce pressure and relieve lung congestion, and lower left ventricular end-diastolic pressure (LVEDP).

[0086] In some embodiments, an adjustable shunt 1220 with a controllable valve 1100 is used to adjust the implant for a specific patient. For example, the rotating partition 1004 is rotated by the clinician via the drive wire 1216 to adjust the opening 1006 and then set a period of time. In this case, the system can provide the clinician with a signal 1214 collected by the sensor.

[0087] In some embodiments, the shunt or any implant described above may include other mechanisms for limiting and / or blocking blood flow through the shunt, such as those described in U.S. Provisional Application No. 63 / 336,924, filed on April 29, 2022, U.S. Provisional Application No. 63 / 494,635, filed on February 13, 2023, and U.S. Patent Application No. 18 / 300,076, filed on April 13, 2023, with attorney case number INQB.014A and entitled “SYSTEMS, DEVICES, AND METHODS FOR CONTROLLABLY AND SELECTIVELY OCCLUDING, RESTRICTING, AND DIVERTING FLOW WITHIN A PATIENT'S SVASCULATURE,” the entire contents of which are hereby incorporated by reference into this document.

[0088] In some embodiments, a method for treating heart failure includes diverting blood from the pulmonary artery 140 to the azygos vein 150. Implanted devices, such as shunt 200, adjustable shunt 1100 or 1200, and implants 600, 700, and 800, can be used to divert blood. In some embodiments, the diversion of blood is sufficient to reduce pulmonary congestion and reduce left ventricular end-diastolic pressure (LVEDP) of the patient, and / or reduce pulmonary artery pressure to relieve pulmonary hypertension, thereby reducing the workload of the patient's right ventricle. In some embodiments, the diversion of blood is sufficient to simulate splanchnic vascular capacity and redistribute blood to the patient's splanchnic compartments. In some embodiments, the diversion of blood is sufficient to cause dilation and / or increased pressure in the patient's intercostal veins.

[0089] Some of the features or advantages encompassed by one or more of the above embodiments or other aspects of the present application include, but are not limited to, one or more of the following:

[0090] Increase cardiac output by pressorizing or dilating veins, such as the intercostal veins;

[0091] · Accommodate the diverted blood in the venous volume system;

[0092] The diversion of blood is sufficient to reduce the tension and stretch on the left ventricular wall, which increases tissue levels of vasoconstrictors such as norepinephrine, angiotensin II, and certain cytokines that have deleterious effects on the heart and vascular system, leading to exacerbation of heart failure;

[0093] Devices and methods for placing a shunt between the right pulmonary artery and the azygos vein or creating a fistula between the right pulmonary artery and the azygos vein to redirect blood through one or more pathways back into the right atrium;

[0094] Reduces stress on the lungs and lowers LVDP by diverting blood away from the pulmonary arteries to reduce the amount of blood reaching the lungs;

[0095] A valve or regulator for controlling blood flow between two body locations, wherein the valve or regulator is controlled based on a feedback loop that takes into account pressures taken from various locations in the body;

[0096] A valve or regulator that is incorporated into a collapsible percutaneously delivered shunt;

[0097] A valve or regulator for controlling blood flow to treat or prevent heart failure;

[0098] Use of a linear disc that rotates relative to a stationary disc and is controlled by a drive circuit to regulate blood flow;

[0099] Mimics visceral vascular capacity and redistributes blood to the patient's visceral compartments;

[0100] diverted to the blood to counteract vasoconstrictors released by patients suffering from heart failure;

[0101] A catheter system that uses magnets to align two different catheters placed in two different vessels in different domains so that a shunt can be created between the two vessels using standard interventional techniques. Once the alignment of the vessels is complete and the wires have been passed through the vessels, the aligned magnets can be rotated in such a way that the same poles of the magnets face each other, thereby disconnecting from each other due to the repulsive force of the magnets.

[0102] In some embodiments, an implant or system can provide various features as described above in a single implant. In some embodiments, features are provided in multiple cooperating implants for modular installation.

[0103] Features, materials, characteristics or groups described in conjunction with a particular aspect, embodiment or example should be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith. All features disclosed in this specification (including any accompanying claims, abstract and drawings), or all steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features or steps are mutually exclusive. Protection is not limited to the details of any foregoing embodiments. The scope of protection extends to any novel feature or any novel combination of features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel step or any novel combination of steps of any method or process so disclosed.

[0104] Although certain embodiments have been described, these embodiments are presented only by way of example and are not intended to limit the scope of protection. In fact, the novel methods and systems described herein can be embodied in various other forms. In addition, various omissions, substitutions and changes can be made to the form of the methods and systems described herein. It will be appreciated by those skilled in the art that in some embodiments, the actual steps taken in the process shown or disclosed may be different from the steps shown in the figure. According to the embodiment, some of the steps above can be removed, and other steps can be added. For example, the actual steps or the order of steps taken in the disclosed process may be different from the steps or the order of steps shown in the figure. According to the embodiment, some of the steps above can be removed, and other steps can be added. In addition, the features and attributes of the specific embodiments disclosed above can be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure.

[0105] Although the present disclosure includes certain embodiments, examples, and applications, it will be understood by those skilled in the art that the present disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments or uses and obvious modifications and equivalents thereof, including embodiments that do not provide all of the features and advantages set forth herein. Therefore, the scope of the present disclosure is not intended to be limited by the described embodiments, and may be defined by the claims as presented herein or as presented in the future.

[0106] Unless otherwise specifically stated or otherwise understood in the context of use, conditional language such as "can", "may" or "could" is generally intended to convey that certain embodiments include and other embodiments do not include certain features, elements or steps. Therefore, such conditional language is generally not intended to imply that features, elements or steps are required for one or more embodiments in any way, or that one or more embodiments must include logic for determining whether these features, elements or steps are included in any particular embodiment or whether they will be performed in any particular embodiment with or without user input or prompts. The terms "include", "comprise", "have" and the like are synonymous and are used inclusively in an open-ended manner, and do not exclude additional elements, features, actions, operations, etc. In addition, the term "or" is used in its inclusive sense (rather than its exclusive sense) so that when, for example, it is used to connect a column of elements, the term "or" represents one, some or all elements in the column. Similarly, the term "and / or" for a list of two or more items covers all the following interpretations of the word: any one of the items in the list, all the items in the list, and any combination of the items in the list. Furthermore, the term "each" as used herein, in addition to its ordinary meaning, may also mean any subset of a group of elements to which the term "each" applies. In addition, the words "herein," "above," "below," and words of similar meaning, when used in this application, refer to this application as a whole and not to any particular portions of this application.

[0107] Unless specifically stated otherwise, linking language such as the phrase "at least one of X, Y, and Z" should be understood as generally used to convey that an item, term, etc., may be X, Y, or Z, depending on the context. Thus, such linking language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.

[0108] Language of degree used herein, such as the terms "approximately," "substantially," and "substantially" used herein, refers to a value, amount, or characteristic that is close to the value, amount, or characteristic that still performs the desired function or achieves the desired result. For example, the terms "approximately," "about," "substantially," and "substantially" may refer to an amount that is within less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the amount. As another example, in certain embodiments, the terms "substantially parallel" and "substantially parallel" refer to a value, amount, or characteristic that deviates from perfect parallelism by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degrees.

Claims

1. A system for treating heart failure in a patient, the system comprising: An implant is configured to be placed in the azygos vein of a patient to at least partially occlude blood flow from the azygos vein into the superior vena cava.

2. The system of claim 1, wherein the implant further comprises a controllable valve.

3. A system according to any of the preceding claims, wherein the implant comprises a shunt configured to be disposed between the pulmonary artery and the azygos vein.

4. A system according to any of the preceding claims, wherein the implant is configured to redirect blood in the azygos vein.

5. The system of claim 4, wherein the implant is configured to divert blood in the azygos vein to the hemiazygos vein, the accessory hemiazygos vein, or the internal mammary vein or the internal thoracic vein.

6. A system according to any of the preceding claims, wherein the implant comprises an expandable tubular body configured to extend between the pulmonary artery and the azygos vein.

7. The system of claim 6, wherein the implant includes an upstream end that does not substantially obstruct blood flow in the pulmonary artery.

8. The system of claim 6, wherein the implant comprises an upstream end configured to expand radially against an inner wall of the pulmonary artery.

9. The system of any one of claims 6 to 8, wherein the implant comprises a downstream end configured to expand radially against an inner wall of the azygos vein.

10. The system of any one of claims 6 to 9, wherein the downstream end of the implant is configured to direct blood into the azygos vein opposite to a forward direction of blood flow in the azygos vein.

11. The system of any one of claims 6 to 10, wherein the implant comprises a valve configured to regulate blood flow from the azygos vein into the superior vena cava.

12. The system of any one of claims 6 to 10, wherein the implant comprises a porous portion configured to allow blood to flow from the azygos vein into the superior vena cava.

13. A system according to any of the preceding claims, wherein the implant includes a first implant configured to be positioned in the azygos vein to at least partially block blood flow from the azygos vein to the superior vena cava, and the implant further includes a second implant configured to direct blood from the pulmonary artery to the azygos vein.

14. The system of any of the preceding claims, further comprising a controller configured to regulate blood flow through the implant.

15. The system of claim 14, wherein the controller is configured to regulate blood flow through the implant based on one or more pressure readings.

16. A method of treating heart failure in a patient, the method comprising restricting blood flow from the patient's azygos vein into the superior vena cava.

17. The method of claim 16, wherein the blood flow from the azygos vein into the superior vena cava is restricted by an implant disposed in the azygos vein, the implant at least partially occluding blood flow in the azygos vein.

18. The method of claim 16 or 17, wherein the implant is implanted chronically.

19. The method of any one of claims 16 to 18, wherein the blood flow from the azygos vein into the superior vena cava is restricted by positioning a shunt between the pulmonary artery and the azygos vein, the shunt diverting blood from the pulmonary artery to the azygos vein.

20. The method of claim 19, wherein the shunt is configured to direct blood into the azygos vein against the direction of blood flow within the azygos vein.

21. The method of claim 19 or 20, wherein the shunt does not extend substantially into the pulmonary artery or into the azygos vein.

22. The method of claim 19 or 20, wherein the shunt has a length extending within the pulmonary artery and within the azygos vein.

23. The method of claim 22, wherein the shunt has an upstream end within the pulmonary artery, the upstream end being upstream of a connection between the pulmonary artery and the azygos vein relative to a direction of blood flow within the pulmonary artery.

24. A method according to claim 22 or 23, wherein the shunt has a downstream end within the azygos vein, the downstream end being upstream of the connection between the pulmonary artery and the azygos vein relative to the direction of blood flow within the azygos vein.

25. The method of any one of claims 19 to 24, wherein the shunt is positioned between the right superior pulmonary artery and the azygos vein.

26. A method for treating heart failure in a patient, the method comprising diverting blood from the pulmonary artery to the azygos vein via a shunt implanted between the pulmonary artery and the azygos vein.

27. The method of claim 26, wherein the diversion of blood is sufficient to relieve pulmonary congestion and reduce left ventricular end-diastolic pressure (LVEDP) in the patient.

28. The method of any one of claims 26 to 27, wherein the diversion of blood is sufficient to reduce pulmonary artery pressure to relieve pulmonary hypertension, thereby reducing the workload of the patient's right ventricle.

29. The method of any one of claims 26 to 28, wherein the diversion of blood is sufficient to simulate splanchnic vascular volume and redistribute blood into splanchnic compartments of the patient.

30. The method of any one of claims 26 to 29, wherein the diversion of blood is sufficient to cause dilation and / or increased pressure in the patient's intercostal veins.

31. The method of any one of claims 26 to 30, wherein the diversion of blood results in redirection of blood from the pulmonary artery into the azygos vein and into the superior vena cava.

32. The method of any one of claims 26 to 31, wherein the diversion of blood results in redirection of blood from the pulmonary artery into the azygos vein and into the hemiazygos vein.

33. The method of any one of claims 26 to 32, wherein the diversion of blood results in redirection of blood from the pulmonary artery into the azygos vein and into the accessory hemiazygos vein.

34. The method of any one of claims 26 to 33, wherein the diversion of blood results in redirection of blood from the pulmonary artery into the azygos vein and into the internal mammary vein or the internal thoracic vein.

35. The method of any one of claims 26 to 34, wherein the blood is diverted from the right pulmonary artery to the azygos vein.

36. The method of any one of claims 26 to 35, further comprising restricting and / or blocking blood flow from the azygos vein into the superior vena cava.

37. A method according to any one of claims 26 to 36, wherein the flow diverter comprises a controllable valve.

38. The method of any one of claims 26 to 37, further comprising controlling the amount of blood flowing through the shunt with a controller.

39. The method of any one of claims 26 to 38, further comprising controlling the amount of blood flowing through the shunt based on feedback received from one or more pressure sensors disposed within the patient.

40. The method of any one of claims 26 to 39, wherein the shunt is implanted between the pulmonary artery and the azygos vein by: delivering a first catheter within the pulmonary artery; delivering a second catheter within the azygos vein; aligning a first magnet carried by the first catheter with a second magnet carried by the second catheter to align the first catheter with the second catheter; delivering a guidewire between the pulmonary artery and the azygos vein while the first catheter and the second catheter are aligned; as well as The shunt or a delivery device for the shunt is delivered between the pulmonary artery and the azygos vein using the guidewire.

41. An implantable shunt configured to be implanted between a patient's pulmonary artery and azygos vein and configured to divert flow into the azygos vein to treat heart failure.

42. An implantable shunt according to claim 41 configured to be operated or implanted according to the method of any one of claims 26 to 39.

43. An implantable flow control system, the implantable flow control system comprising: An implant, comprising: an expandable body comprising a proximal end and a distal end and a lumen extending from the proximal end to the distal end, wherein the expandable body is configured to collapse to a collapsed configuration for delivery into a patient and to expand from the collapsed configuration to an expanded configuration for implantation into the patient; and A liquid restrictor, the liquid restrictor being disposed within the expandable body, the liquid restrictor comprising: a first partition that partially blocks a first portion of the lumen when the expandable body is in the expanded configuration; and A second partition is movable relative to the first partition to selectively block and unblock a second portion of the lumen when the expandable body is in the expanded configuration.

44. The system of claim 43, wherein the first divider comprises a first expandable wire frame and a first fabric portion extending across the first expandable wire frame, and the second divider comprises a second expandable wire frame and a second fabric portion extending across the second expandable wire frame.

45. The system of claim 43 or 44, wherein the second divider is configured to rotate relative to the first divider to selectively increase or decrease the size of the opening through the lumen.

46. ​​The system of any one of claims 43 to 45, wherein the first partition is fixed relative to the expandable body.

47. The system of any one of claims 43 to 46, further comprising a controller configured to control movement of the second divider relative to the first divider.

48. The system of any one of claims 43 to 47, wherein the implant comprises a shunt configured to be implanted between a first blood vessel and a second blood vessel of the patient.

49. The system of any one of claims 43 to 47, wherein the implant is configured to expand within a blood vessel of the patient.

50. A system for treating heart failure, the system comprising: an implantable shunt configured to divert blood flow in a patient from a first blood vessel to a second blood vessel, wherein the implantable shunt is implantable between the first blood vessel and the second blood vessel, and wherein the implantable shunt includes an adjustable flow opening; and A controller configured to control the adjustable flow opening to control the amount of blood flowing through the implantable shunt, wherein the controller is configured to receive readings from one or more pressure sensors disposed within the patient, and wherein the controller is programmed to control the adjustable flow opening based on the readings.

51. The system of claim 50, wherein the first vessel is the right pulmonary artery and the second vessel is the azygos vein.

52. The system of claim 50 or 51, wherein the controller is configured to receive one or more of central venous pressure, right ventricular pressure, pulmonary artery pressure, aortic pressure, and left atrial pressure.

53. An implantable shunt comprising one or more of the features hereinbefore described.

54. A method comprising one or more of the features described above.

55. A system comprising one or more of the features described above.

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