Systems and methods for treating heart failure by redirecting blood flow in the azygos vein - Patents.com

Abstract

Systems and methods for treating heart failure by redirecting blood flow in the azygos vein, and systems, devices and methods for controllably and selectively occluding, restricting and / or diverting flow in a patient's vascular system. Systems, devices and methods for redirecting blood flow in the azygos vein. The devices may include an implant configured to divert blood from the pulmonary artery into the azygos vein, and an implant configured to be positioned in the patient's azygos vein to at least partially occlude blood flow from the azygos vein into the superior vena cava.

Description

[Technical field]

[0001] Incorporation by reference of all priority applications This application claims the benefit of priority under 35 U.S.C. §119(e) to U.S. Provisional Application No. 63 / 331,496, filed April 15, 2022. All of the above applications are incorporated herein by reference in their entireties. All applications for which a foreign or domestic priority claim is identified in an Application Data Sheet filed with this application are incorporated herein by reference pursuant to 37 C.F.R. §1.57.

[0002] The present disclosure relates to systems, devices and methods for controllably and selectively occluding, restricting and / or diverting flow within a patient's vascular system, including systems, devices and methods for treating heart failure, as well as systems, devices and methods for redirecting blood flow in the azygos vein. [Background technology]

[0003] Heart failure, or congestive heart failure, can occur when the heart can no longer pump blood efficiently. Certain cardiovascular diseases, including narrowing of the heart's arteries and high blood pressure, can gradually weaken and / or stiffen the heart muscle, reducing the heart's efficiency. Decreased cardiac output leads to lower blood pressure and poorer blood circulation. Fluid can accumulate in the lungs, causing shortness of breath. Reduced blood flow and increased fluid can further deteriorate the heart, eventually becoming life-threatening.

[0004] At the same time, as the heart begins to fail, the kidneys experience a drop in renal blood pressure. In response, renal sympathetic nerves become activated and release hormones, including renin, angiotensin, and aldosterone, which increase blood pressure and return blood to the heart, increasing water and sodium retention as well as increasing extracellular fluid. The increased blood pressure and fluid buildup exacerbates the stress on the failing heart, further accelerating failure mechanisms.

[0005] Heart failure is initially treated with lifestyle changes to reduce strain on the heart, but often involves drug therapy and / or renal interventions (such as ablation) to reduce blood pressure and fluid buildup. As the condition progresses, surgical interventions such as coronary artery bypass, stent placement, heart valve repair or replacement, implantation of a cardioverter-defibrillator, use of a ventricular assist device, or heart transplant may be required. Summary of the Invention [Means for solving the problem]

[0006] Certain aspects of the present application are directed to methods, systems and devices for treating heart failure.Certain aspects of the present application are directed to methods, systems and devices for diverting or redirecting blood flow to the azygos vein.

[0007] In some embodiments, the technology described herein relates to a system for treating heart failure in a patient, the system including an implant configured to be placed in the patient's azygos vein to at least partially occlude blood flow from the azygos vein to the superior vena cava. In some embodiments, the implant further includes a controllable valve. In some embodiments, the implant includes a shunt configured to be placed between the pulmonary artery and the azygos vein.

[0008] In some aspects, the technology described herein relates to a system in which an implant is configured to redirect blood in an azygos vein, hi some aspects, the implant is configured to divert blood in the azygos vein to a hemiazygos vein, an accessory hemiazygos vein, or an internal thoracic vein.

[0009] In some embodiments, 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 embodiments, the implant includes an upstream end that does not substantially impede blood flow in the pulmonary artery. In some embodiments, the implant includes an upstream end configured to radially expand against an inner wall of the pulmonary artery. In some embodiments, the implant includes a downstream end configured to radially expand against an inner wall of the azygos vein. In some embodiments, the downstream end of the implant is configured to direct blood into the azygos vein in a direction opposite to the antegrade direction of blood flow in the azygos vein.

[0010] In some embodiments, the technology described herein relates to a system in which an implant includes a valve configured to regulate blood flow from the azygos vein into the superior vena cava, hi some embodiments, the implant includes a porous portion configured to permit blood flow from the azygos vein into the superior vena cava.

[0011] In some embodiments, the technology described herein relates to a system, wherein the implant includes a first implant configured to be positioned within the azygos vein to at least partially occlude blood flow from the azygos vein into the superior vena cava, and further includes a second implant configured to direct blood from the pulmonary artery into the azygos vein.

[0012] In some embodiments, the technology described herein relates to a system further including a controller configured to regulate blood flow through the implant, hi some embodiments, the controller is configured to regulate blood flow through the implant based on one or more pressure measurements.

[0013] In some embodiments, the technology described herein relates to a method of treating heart failure in a patient, comprising restricting blood flow from the azygos vein into the superior vena cava of the patient. In some embodiments, blood is restricted from flowing from the azygos vein into the superior vena cava by an implant placed in the azygos vein that at least partially occludes blood flow in the azygos vein. In some embodiments, the implant is permanently implanted.

[0014] In some aspects, the technology described herein relates to a method in which blood is restricted from flowing from the azygos vein into the superior vena cava by placing a shunt between the pulmonary artery and the azygos vein that diverts blood from the pulmonary artery into 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 extend substantially into the pulmonary artery or the azygos vein. In some aspects, the shunt has a length that extends into the pulmonary artery and into the azygos vein.

[0015] In some embodiments, the technology described herein relates to methods in which the shunt has an upstream end in the pulmonary artery that is upstream of the connection between the pulmonary artery and the azygos vein with respect to the direction of blood flow in the pulmonary artery, hi some embodiments, the shunt has a downstream end in the azygos vein that is upstream of the connection between the pulmonary artery and the azygos vein with respect to the direction of blood flow in the azygos vein. In some embodiments, the shunt is placed between the right upper pulmonary artery and the azygos vein.

[0016] In some embodiments, the technology described herein relates to a method of treating heart failure in a patient, comprising diverting blood from the pulmonary artery to the azygos vein using a shunt implanted between the pulmonary artery and the azygos vein. In some embodiments, diverting blood is sufficient to decongest the patient's lungs and reduce left ventricular end diastolic pressure (LVEDP). In some embodiments, diverting blood is sufficient to reduce pulmonary artery pressure to alleviate pulmonary hypertension and thereby reduce the workload of the patient's right ventricle. In some embodiments, diverting blood is sufficient to simulate splanchnic vascular volume and redistribute blood to the patient's splanchnic compartment. In some embodiments, diverting blood is sufficient to cause distension and / or increased pressure in the patient's intercostal veins. In some embodiments, diverting blood causes blood to be diverted from the pulmonary artery into the azygos vein and superior vena cava. In some embodiments, diverting blood causes blood to be diverted from the pulmonary artery into the azygos vein and the hemiazygos vein. In some embodiments, the diverting of blood involves redirecting blood from the pulmonary artery into the azygos vein and into the accessory hemiazygos vein. In some embodiments, the diverting of blood involves redirecting blood from the pulmonary artery into the azygos vein and into the internal mammary vein.

[0017] In some embodiments, the techniques described herein relate to methods, in which blood is diverted from the right pulmonary artery into the azygos vein, hi some embodiments, the techniques described herein relate to methods, further comprising restricting and / or occluding blood from flowing from the azygos vein into the superior vena cava.

[0018] In some embodiments, the technology described herein relates to a method, wherein an implantable shunt includes a controllable valve. In some embodiments, the technology described herein relates to a method, further comprising controlling with a controller an amount of blood flowing through the shunt. In some embodiments, the technology described herein relates to a method, further comprising controlling an amount of blood flowing through the shunt based on feedback received from one or more pressure sensors disposed within the patient.

[0019] In some aspects, the technology described herein relates to a method in which a shunt is implanted between the pulmonary artery and the azygos vein by delivering a first catheter into the pulmonary artery, delivering a second catheter into 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 and second catheters, delivering a guidewire between the pulmonary artery and the azygos vein while the first and second catheters are aligned, and using the guidewire to deliver the shunt or a delivery device for the shunt between the pulmonary artery and the azygos vein.

[0020] In some aspects, the technology described herein relates to 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 for the treatment of heart failure.

[0021] In some embodiments, the technology described herein relates to an implantable flow control system having an implant with an expandable body having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, the expandable body configured to be folded into a folded configuration for delivery into a patient and to expand from the folded configuration to an expanded configuration for implantation within the patient, and a fluid restrictor disposed within the expandable body, the fluid restrictor having a first partition that partially occludes a first portion of the lumen when the expandable body is in the expanded configuration and a second partition that is movable relative to the first partition to selectively occlude and unocclude a second portion of the lumen when the expandable body is in the expanded configuration.

[0022] In some embodiments, the technology described herein relates to a system in which a first partition includes a first expandable wire frame and a first fabric portion extending across the first expandable wire frame, and a second partition includes a second expandable wire frame and a second fabric portion extending across the second expandable wire frame.

[0023] In some embodiments, the second partition is configured to rotate relative to the first partition to selectively increase or decrease the size of the opening through the lumen. In some embodiments, the technology described herein relates to a system in which the first partition is fixed relative to the expandable body. In some embodiments, the controller is configured to control the movement of the second partition relative to the first partition.

[0024] In some embodiments, the technology described herein relates to a system having a shunt configured to be implanted between a first blood vessel and a second blood vessel of a patient, in which the implant is configured to be expanded within the patient's blood vessel.

[0025] In some embodiments, the technology described herein relates to a system for treating heart failure including an implantable shunt configured to divert blood flow in a patient from a first blood vessel to a second blood vessel, the implantable shunt being implantable between the first blood vessel and the second blood vessel and having an adjustable flow opening; and a controller configured to control the adjustable flow opening to control an amount of blood flowing through the implantable shunt, the controller being configured to receive measurements from one or more pressure sensors disposed within the patient and programmed to control the adjustable flow opening based on the measurements.

[0026] In some embodiments, the first blood vessel is a right pulmonary artery and the second blood vessel is an azygos vein. In some embodiments, the controller is configured to receive one or more of a central venous pressure, a right ventricular pressure, a pulmonary artery pressure, an aortic pressure, and a left atrial pressure.

[0027] In some embodiments, the technology described herein relates to an implantable shunt having one or more of the features of the preceding description. In some embodiments, the technology described herein relates to a method having one or more of the features of the preceding description. In some embodiments, the technology described herein relates to a system having one or more of the features of the preceding description.

[0028] Certain aspects of the present application are directed to methods, systems and devices for forming a shunt between two blood vessels, such as between the pulmonary artery and the azygos vein, to selectively divert or control blood flow. In one aspect, a method of 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.

[0029] The methods, systems and devices described above or further herein below may further include one or more of the following features: The diversion of blood may be sufficient to decongest the patient's lungs and reduce left ventricular end diastolic pressure (LVEDP). The diversion of blood may be sufficient to reduce pulmonary artery pressure to alleviate pulmonary hypertension and, as a result, reduce the work of the patient's right ventricle. The diversion of blood may be sufficient to mimic splanchnic vascular volume and redistribute blood within the patient's splanchnic compartment. The diversion of blood may be sufficient to cause distension and / or increased pressure within the patient's intercostal veins. The diversion of blood may cause blood to be diverted from the pulmonary artery into the azygos vein and superior vena cava. The diversion of blood may cause blood to be diverted from the pulmonary artery into the azygos vein and the hemiazygos vein. The diversion of blood may cause blood to be diverted from the pulmonary artery into the azygos vein and the accessory hemiazygos vein. Blood diversion can result in redirection of blood from the pulmonary artery into the azygos vein and into the internal mammary vein. Blood can be diverted from the right pulmonary artery into the azygos vein.

[0030] The methods, systems, and devices described above or further herein below may include restricting and / or occluding blood from flowing from the azygos vein into the superior vena cava. In embodiments incorporating a shunt, the shunt may have a controllable valve. The methods, systems, and devices may further include controlling with a controller the amount of blood flowing through the shunt. The methods, systems, and devices may further include controlling the amount of blood flowing through the shunt based on feedback received from one or more pressure sensors located within the patient.

[0031] A shunt may be implanted between the pulmonary artery and the azygos vein by delivering a first catheter into the pulmonary artery, delivering a second catheter into 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 and second catheters, delivering a guidewire between the pulmonary artery and the azygos vein while the first and second catheters are aligned, and using the guidewire to deliver the shunt or a delivery device for the shunt between the pulmonary artery and the azygos vein.

[0032] In one aspect, an implantable shunt is provided that is configured to be implanted between a patient's pulmonary artery and azygos vein and configured to divert flow into the azygos vein for the treatment of heart failure. The implantable shunt may be configured to operate or be implanted according to any of the methods described above or further herein below.

[0033] In one aspect, an implantable flow control system is provided. The system may include an implant having an expandable body having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, the expandable body being configured to be folded into a collapsed configuration for delivery into a patient and to expand from the collapsed configuration to an expanded configuration for implantation within the patient. The system may further include a fluid restriction disposed within the expandable body. The fluid restriction may include a first partition that partially occludes a first portion of the lumen when the expandable body is in the expanded configuration, and a second partition that is movable relative to the first partition to selectively occlude and unocclude a second portion of the lumen when the expandable body is in the expanded configuration.

[0034] The system described above or further herein below may further include one or more of the following features: The first partition may have a first expandable wire frame and a first fabric portion extending across the first expandable wire frame, and the second partition may have a second expandable wire frame and a second fabric portion extending across the second expandable wire frame. The second partition may be configured to rotate relative to the first partition to selectively increase or decrease the size of the opening through the lumen. The first partition may be fixed relative to the expandable body. The system may further include a controller configured to control the movement of the second partition relative to the first partition. The implant may further include a shunt configured to be implanted between a first blood vessel and a second blood vessel of the patient. The implant may be configured to be expanded within the blood vessel of the patient.

[0035] 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, the implantable shunt being implantable between the first blood vessel and the second blood vessel and having an adjustable flow opening. The system may further include a controller configured to control the adjustable flow opening to control an amount of blood flowing through the implantable shunt, the controller configured to receive measurements from one or more pressure sensors disposed in the patient and programmed to control the adjustable flow opening based on the measurements.

[0036] The systems described above or further herein below may further include one or more of the following features: The first blood vessel may be a right pulmonary artery and the second blood vessel may be an azygos vein. The controller may be configured to receive one or more of a central venous pressure, a right ventricular pressure, a pulmonary artery pressure, an aortic pressure, and a left atrial pressure.

[0037] Certain features of the present disclosure are described below with reference to the drawings. The illustrated embodiments are intended to illustrate, but not to limit, the embodiments. Various features of the various disclosed embodiments can be combined to form further embodiments that are part of the present disclosure. [Brief description of the drawings]

[0038] [Figure 1A] FIG. 1 shows characteristic parts of cardiac blood vessels near the heart. [Figure 1B] FIG. 1 illustrates the venous system of the thorax. [Figure 1C] FIG. 1 illustrates relevant anatomical structures in the upper thorax. [Figure 2A] FIG. 2 is another view showing relevant anatomical structures in the upper thorax. [Figure 2B] FIG. 2B is a diagram showing an example of an embedding position for the diagram shown in FIG. 2A. [Figure 3A] FIG. 1 shows blood flow in the pulmonary artery and azygos vein before intervention. [Figure 3B] FIG. 3B shows an example of the blood flow in FIG. 3A after shunt implantation. [Figure 4A] FIG. 1 illustrates various views of one embodiment of a shunt implant. [Figure 4B] FIG. 1 illustrates various views of one embodiment of a shunt implant. [Figure 4C] FIG. 1 illustrates various views of one embodiment of a shunt implant. [Figure 5A] FIG. 13 shows an example of altered blood flow pathways in the pulmonary artery and azygos vein after implantation of an embodiment of the device. [Figure 5B] FIG. 13 shows an example of altered blood flow pathways in the pulmonary artery and azygos vein after implantation of an embodiment of the device. [Figure 6A] FIG. 1 illustrates one embodiment of a sleeve implant and the resulting blood flow. [Figure 6B] FIG. 1 illustrates one embodiment of a valved implant and the resulting blood flow. [Figure 6C] FIG. 1 illustrates an embodiment of a porous implant and the resulting blood flow. [Figure 7] FIG. 1 illustrates an example of an embodiment for accessing between the pulmonary artery and the azygos vein. [Figure 8A] FIG. 1 illustrates one embodiment of a controllable valve that may be used in the implant. [Figure 8B] FIG. 1 illustrates one embodiment of a controllable valve that may be used in the implant. [Figure 9] FIG. 1 illustrates one embodiment of a shunt implant with a controllable valve. [Figure 10] FIG. 1 illustrates one embodiment of a system with an adjustable shunt. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0039] Various features and advantages of the present disclosure will be described with reference to the accompanying drawings. The following description is merely exemplary in nature and is in no way intended to limit the present disclosure, its application or uses. The present disclosure extends beyond the specifically disclosed embodiments and / or uses, as well as obvious variations and equivalents thereof. Thus, it is intended that the scope of the present disclosure should not be limited by the specific embodiments described below. Features of the illustrated embodiments can be modified, combined, eliminated, and / or substituted as would be apparent to one skilled in the art upon consideration of the principles disclosed herein. Furthermore, the embodiments disclosed herein may include several novel features, no single one of which is responsible for its desirable properties or essential to implementing the systems, devices, and / or methods disclosed herein.

[0040] Parts, components, features and / or elements of the systems and devices described herein that may function the same or similarly across the various embodiments are identified using like reference numerals. Differences between the various embodiments are described herein.

[0041] FIELD OF THE DISCLOSURE Embodiments of the present application relate to controlling cardiac output to treat or prevent heart failure in a patient. Certain embodiments are directed to creating a shunt (which may also be referred to as an implant, conduit, or arteriovenous fistula) between the right pulmonary artery and the azygos vein to divert blood from the right pulmonary artery.

[0042] 1A shows a patient's anatomy, including a heart 130 having a right atrium 132, a right ventricle 134, a pulmonary artery 140, a pulmonary vein 122, a left atrium 136, a left ventricle 138, and an aorta 146 including an aortic arch 147. Also shown are the inferior vena cava 144 and the superior vena cava 142 with the left and right internal jugular veins 112 and 110, the left and right subclavian veins 116 and 114, and the left and right brachiocephalic veins 120 and 118. This central cardiovascular complex collects deoxygenated blood from the body, pumps it to the lungs for oxygenation and returns it to the heart, which then pumps oxygenated blood into the body.

[0043] 1B shows the venous anatomy of a patient's chest, including the azygos vein 150 draining into the superior vena cava 142, along with the accessory hemiazygos vein 156, the hemiazygos vein 158, the lumbar vein 160, and other vessels that drain into the azygos vein 150. Also shown are the right brachiocephalic vein 118, the right subclavian vein 114, the axillary vein 154, and the internal mammary vein 152, which drain into the superior vena cava 142.

[0044] 1C, 2A, and 2B show the upper thorax, including the sternum 166, right bronchus 162, right pulmonary vein 164, and lymph nodes 168. As shown in FIG. 2B, a branch of the right pulmonary artery 140 extends adjacent to the azygos vein 150, providing a possible site for implantation of the shunt 200. In some embodiments, any branch of the pulmonary artery 140 may be suitable. For example, locations distal to the right pulmonary artery may be suitable, including the truncus arteriosus, right superior truncus, apical pulmonary artery, anterior aorta, posterior recurrent artery, various intersegmental branches, ascending aorta, and interlobar arteries. Similarly, although the proximal arching portion of the azygos vein 150 extending above the pulmonary artery 140, just before its junction with the superior vena cava 142, is shown, any location along the azygos vein 150 may be suitable. The implantation location may be selected based on the patient's particular anatomy, the distance between the branches of the pulmonary artery 140 and the azygos vein 150, the estimated blood flow through each vessel, the estimated pressure differential, ease of surgical access, avoidance of any intervening tissue (such as the right bronchus 162, lymph nodes 168, nerves and other non-target vasculature), and / or the preference of the implanting physician, among other factors.

[0045] A device such as the shunt 200 implanted in this location in some embodiments is adapted to redirect or divert blood volume from the right pulmonary artery 140 exiting the right ventricle 134 of the heart 130 into the azygos vein 150, which passes adjacent to the right pulmonary artery 140. In some embodiments, the shunt 200, shown in both the pulmonary artery 140 and the azygos vein 150 in FIG. 2B for clarity, may form a passageway between the arterial and venous systems to help form a visceral compartment within the thoracic vasculature. When the right pulmonary artery 140 is connected to the azygos vein 150, pressure differences between the arterial and venous systems may allow blood to flow from the pulmonary artery 140 into the azygos vein 140, which may also cause backflow into the azygos vein 150. An implant such as the shunt 200 may be delivered percutaneously into a patient in a collapsed configuration and expanded to an expanded configuration upon implantation. Blood diverted from the right pulmonary artery 140 into the azygos vein 150 can make the intercostal veins larger (distended) and pressurized, effectively increasing the intervascular volume and creating an extra reservoir of blood in the intercostal veins. Blood redirection or diversion can be well accommodated in the venous capacitance system. Blood redirection or diversion can increase venous volume and increase cardiac output. At least a portion of the blood diverted into the azygos vein 150 can then flow into the superior vena cava 142 and back to the right atrium 132, or can flow through other vessels, such as the accessory hemiazygos vein 156, the hemiazygos vein 158, and the 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 from the right pulmonary artery 140 through the azygos vein 150 and back to the right atrium 132 effectively creates an extra reservoir of blood in the visceral compartments of the body.

[0046] In some embodiments, the amount of blood diverted into the azygos vein 150, and therefore the increase in venous capacity or excess blood reservoir volume, can be controlled by selecting an appropriate diameter of an implant such as the shunt 200. In some embodiments, a control mechanism (e.g., a controllable fluid restrictor 1000, described below) can be incorporated into the shunt 200 to control the flow of blood into the azygos vein 150. The increase in volume due to blood flow from the azygos vein 150 to the superior vena cava 142 can be hemodynamically significant, and in some instances is expected to be at least about 0.5 L, or 1 L or more.

[0047] As shown in FIG. 3A, the azygos vein 150 normally flows into the superior vena cava 142 in a forward or antegrade direction 300. The pulmonary artery 140 flows into the lungs in a forward or antegrade direction 302. As shown in FIG. 3B, a passageway or fistula 200 may be formed between the pulmonary artery 140 and the azygos vein to divert or redirect blood flow into the azygos vein. The passageway or fistula 200 may be formed by any implant as described herein or may be created by other devices or techniques. In some embodiments, after the passageway or fistula 200 is formed, blood from the right ventricle 134 flows normally through the pulmonary artery 140 along a forward or antegrade direction 304A. The blood may then be redirected through the passageway 200 along a direction 304B into the azygos vein 150. At least a portion of the blood may be redirected from the azygos vein 150 to flow in a backward or retrograde direction 304C within the azygos vein and back toward the thoracic cavity. In some embodiments, all of the blood is diverted in the backward or retrograde direction 304C. In some embodiments, some blood continues in a forward or antegrade direction 300 and flows into the superior vena cava 142. In some embodiments, the connection between the azygos vein 150 and the superior vena cava 142 may be closed or otherwise controlled or regulated (e.g., surgically or with a valve) to direct blood diverted from the right pulmonary artery 140 to the accessory hemizygos vein 156, the hemizygos vein 158, the internal thoracic vein 152, or other vessels including intercostal veins, internal thoracic veins, etc., as described above.

[0048] 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 pulmonary stress, relieve pulmonary congestion, and reduce left ventricular end-diastolic pressure (LVEDP). The diversion of blood may be sufficient to reduce pulmonary artery pressure and alleviate pulmonary hypertension, thereby reducing the workload of the patient's right ventricle 134. Therapy can be regulated 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 into the superior vena cava 142.

[0049] The connection between the right pulmonary artery 140 (or a branch of the right pulmonary artery 140) can be formed 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, FIG. 4A shows a side view of the shunt 200, FIG. 4B shows a perspective view of the shunt 200, and FIG. 4C shows another perspective view of the shunt 200. The implant or shunt 200 can include an expandable body 210 having a lumen 213 between two ends. In some embodiments, a first end of the shunt is disposed in the pulmonary artery, a second end of the shunt is disposed in the azygos vein, and an intermediate portion of the shunt is disposed at the junction between the pulmonary artery and the azygos vein. The expandable body 210 can be configured to be folded for delivery to a patient and expanded to engage the interior walls of one or more blood vessels of the patient upon implantation, as shown in the expanded configuration. For example, a first or upstream portion of the shunt 200 can expand radially along the length of the pulmonary artery 140 to engage the pulmonary artery 140, with respect to the direction of blood flow in the pulmonary artery, upstream of the connection between the pulmonary artery 140 and the azygos vein 150. A second or downstream portion of the shunt 200 can expand radially along the length of the azygos vein 150 to engage the azygos vein 150, with respect to the direction of blood flow in the azygos vein, upstream of the connection between the pulmonary artery 150 and the azygos vein 140. When implanted, blood flowing through the blood vessel in which the implant 200 is implanted can flow through the lumen 213.

[0050] As shown, the shunt 200 may include an inner body 225 located within an outer body 215. In some embodiments, an implant such as the shunt 200 may include an expandable body 210 with an outer body 215 made of an expandable membrane or fabric layer at least partially covering an inner body 225 made of a metal frame with one or more struts as described above. In some embodiments, the shunt 200 has an inner body 225 made of an expandable tubular frame (e.g., Nitinol) that may have struts. The struts may be covered by an outer body 215, such as a membrane or fabric made of a biocompatible material, such as PTFE. In some embodiments, the expandable body 210 may include an expandable membrane or fabric inner body 225 surrounded or partially surrounded by a tubular outer body 215 made of an expandable stent-like metal frame as described above.

[0051] In some embodiments, the shunt 200 has a length sufficient to connect the pulmonary artery 140 to the azygos vein 150. In some embodiments, both ends of the shunt 200 may include flares, barbs, hooks, or other anchoring structures that help secure the ends within their respective blood vessels. In some embodiments, the shunt 200 may be tubular and have a length sufficient to expand radially against and extend along the length of the pulmonary artery 140 to secure an upstream or inlet end of the shunt 200 and direct blood from the pulmonary artery 140 into the shunt 200. The length may also be sufficient to expand radially against and extend along the length of the azygos vein 150 to secure a downstream or outlet end of the shunt 200 and direct blood into the azygos vein 150, for example. In some embodiments, the downstream or outlet end of the shunt 200 is configured to direct blood upstream into the azygos vein 150 toward the thoracic vessels and visceral cavities described above. In some embodiments, the downstream or outlet end of the shunt 200 is configured to direct blood downstream into the azygos vein 150 and toward the superior vena cava 142.

[0052] In some embodiments, the expandable body 210 may be configured as a double-walled stent, with the outer body 215 having an outer wall and the inner body 225 having an inner wall.

[0053] Each of the outer body 215 and the inner body 225 may include a layer of material. Each of the outer body 215 and the inner body 225 may include a frame having 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, the plurality of struts, e.g., the struts of the outer body 215, the struts of the inner body 225, or the struts between the outer body 215 and the outer body 225, are made from a single wire. In some embodiments, the plurality of struts may be cut from one or more tubes.

[0054] Both the outer body 215 and the inner body 225 may be configured to fold and expand as described herein. Additionally, the outer body 215 and the inner body 225 may be configured to fold 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 vessel. In some embodiments, the outer body 215 and the inner body 225 are configured to be implanted separately or sequentially. For example, the outer body 215 is first implanted and expanded, and then the inner body 225 is embedded and expanded within the outer body 215.

[0055] In some embodiments, one or both of the outer body 215 and the inner body 225 may have a porous portion, as described below. In some embodiments, the outer body 215 and the inner body 225 may have the same length and the proximal and distal ends may be aligned, as shown in Figures 4A-4C, to form a double-walled stent, as described above. In some embodiments, the outer body 215 and the inner body 225 may have different lengths and / or the proximal and / or distal ends may be aligned, thereby forming one-walled and two-walled portions of the stent 200. In some embodiments, the outer body 215 and the inner body 225 may have multiple sections. For example, the stent 200 may include an outer body 215 of a material and an inner body 225 having a first metal strut portion, e.g., at one end, and a second metal strut portion, e.g., at the other end. In some embodiments, the implant device may include multiple devices 200, as described below.

[0056] In some embodiments, such as the example shown in FIGS. 5A-5B, the implant may be a short shunt 200 configured to form a connection between two blood vessels (e.g., between the pulmonary artery 140 and the azygos vein 150). The shunt 200 may be preferably positioned between the pulmonary artery 140 and the azygos vein 150 without extending substantially into the lumen of either blood vessel. As shown in the side view of FIG. 5A, the shunt 200 may be implanted to form a flow path between a branch of the pulmonary artery 140 and the azygos vein 150. With this location, blood flow 304 will normally proceed along a forward or antegrade direction 304A in the branch of the pulmonary artery 140 toward the lungs, while a portion of the blood flow 304 that is diverted through the shunt 200 along direction 304B will flow into the azygos vein 150. As shown in the top view of FIG. 5B, blood flow 304 may flow back out of the shunt 200 into the azygos vein 150 along a backward or retrograde direction 304C. Such backflow may form a thoracic reservoir in thoracic vessels, such as the intercostal veins, accessory hemizygos vein 156, hemizygos vein 158, and other vessels as described above. A portion of the diverted blood may flow into the superior vena cava 142. As described further below, in some embodiments, the shunt 200 may include a controllable valve. Also, as described further 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-restricting implant in the azygos vein 150 downstream of the shunt 200.

[0057] The diversion of blood in the azygos vein 150 in this and other embodiments may advantageously mimic splanchnic vascular volume and create a thoracic reservoir that can redistribute blood within the splanchnic compartment, thereby reducing the workload of the heart. Lowering pulmonary artery pressure may alleviate pulmonary hypertension, thereby reducing right ventricular workload. Diversion of blood flow may also decongest the patient's lungs and reduce left ventricular end diastolic pressure (LVEDP).

[0058] 6A-6C show additional embodiments of implantation devices for redirecting blood flow in the azygos vein 150. In some embodiments, as shown in FIG. 6A, 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. In this example, one or both ends of the implant 600 are oriented within the respective vessels to further aid in the desired resulting blood flow. As shown, the end of the implant 600 in the azygos vein 150 is positioned upstream of the location of the implant relative to the direction of blood flow in the azygos vein 150 to create a reverse flow and redirect blood from the pulmonary artery 140 into the thoracic reservoir as described above. Similarly, the end of the implant 600 in the pulmonary artery 140 may be directed upstream to collect blood flowing in the pulmonary artery 140. In some embodiments, the implant 600 may be a longer shunt or may be otherwise identical to the shunt 200 described above. In other embodiments, the upstream end of the implant 600 may extend into the pulmonary artery 140 without substantially obstructing the pulmonary artery 140, allowing blood to flow into the implant 600 and downstream through the pulmonary artery 140. The implant 600 may be non-porous or may include one or more non-porous portions to direct, restrict or impede blood flow between the azygos vein 150 and the superior vena cava 142.

[0059] In some embodiments, the implant 700 may include one or more valves 702. For example, as shown in FIG. 6B, 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 a new connection between the pulmonary artery 140 and the azygos vein 150. The implant 700 may be similar in some respects to the shunt 200 or the implant 600. The valves 702 may be included in the implant 700 to selectively direct blood from the pulmonary artery 140 into the azygos vein 150 and / or the superior vena cava 142. For example, the valves 702 may be positioned along the length of the implant 700 to selectively allow blood from the pulmonary artery 140 to flow in a forward direction within the azygos vein 150 into the superior vena cava 142. The valves 702 may be positioned in a portion of the implant 700 downstream from the connection between the pulmonary artery 140 and the azygos vein 150. In some embodiments, the valve 702 may be a pressure valve configured to open after a desired amount of blood has been diverted to the thoracic reservoir. For example, in some embodiments, the valve 702 is a check valve, such as a leaflet valve or a pop valve, configured to open under a predetermined pressure. In some embodiments, the valve 702 may be an opening or restriction configured to allow a predetermined amount of blood from the pulmonary artery 140 to the superior vena cava 142. As shown in FIG. 6B, in some embodiments, the valve 702 may be positioned within the azygos vein 150 after implantation of the device 700. In some embodiments, the valve 702 may be positioned closer to the superior vena cava 142 of the implant 700, as shown in FIG. 6B. In some embodiments, the valve 702 may be a one-way valve to control the direction of blood flow. In some embodiments, the valve 702 may be positioned closer to the thoracic reservoir within the azygos vein 150, for example, at the end of the implant 700 located within the azygos vein 150 upstream of the connection between the pulmonary artery 140 and the azygos vein 150. In some embodiments, a valve 702 may be placed in the pulmonary artery 140 to control the amount of blood that is diverted from the pulmonary artery 140 through the implant 700 and into the azygos vein 150 .In some embodiments, the valve 702 may be configured to be positioned within 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) may be positioned along the implant 700 in any of the locations described above.

[0060] In some embodiments, the implant 800 may include a porous portion 804. For example, as shown in FIG. 6C, one end of the implant 800 is located in the pulmonary artery 140 and the other end of the implant 800 is located in the azygos vein 150. The implant 800 may be similar in some respects to the shunt 200 or the implants 600 and 700. The porous portion 804 may be included in at least a portion of the implant 800 disposed in the azygos vein 150 to selectively direct blood from the pulmonary artery 140 to the azygos vein 150 and / or the superior vena cava 142. For example, the porous portion 804 may be disposed along the length of the implant 800 to allow blood from the pulmonary artery 140 to flow into the superior vena cava 142. As shown in FIG. 6C, in some embodiments, the porous portion 804 may be disposed in the azygos vein 150 after implantation of the device 700. In some embodiments, the porous portion 804 may be disposed on a side of the implant 800 closer to the superior vena cava 142, as shown in FIG. 6C. In some embodiments, a porous portion 804 may be placed in the pulmonary artery 140 to control the amount of blood that is diverted from the pulmonary artery 140 through the implant 800 and into the azygos vein 150. In some embodiments, the implant 800 may include one or more porous portions 804 and one or more valves 802. The valves 802 may be similar in some respects to the valves 702. In some embodiments, a single opening may be used in addition to or in place of the porous portion 804. In some embodiments, the opening or porous portion may be configured to allow a predetermined flow rate, a predetermined pressure, and / or a predetermined amount of blood to exit the implant in a particular direction.

[0061] In some embodiments, an implant, such as implant 800 or the like, may be implanted such that one end of implant 800 is positioned within pulmonary artery 140 as described above, and the other end of implant 800 is positioned within azygos vein 150 such that the other end of implant 800 is positioned to extend radially relative to azygos vein 150 at a location downstream from the connection between the pulmonary artery 140 and azygos vein 150. For example, porous portion 804 may be positioned closer to the thoracic reservoir within azygos vein 150, such as on the side of implant 800 that is positioned within azygos vein 150.

[0062] In some embodiments, blood may be diverted upstream within the azygos vein 150 by valves, such as valves 702, 802 and / or controllable valves, as described below, located within the azygos vein 150. In some embodiments, blood flow from the azygos vein 150 to the superior vena cava 142 is restricted to slow or prevent blood from flowing out. Blood continues to enter the thoracic reservoir from the left ventricle 138 as normal, so the restricted outflow increases the blood volume in the splanchnic compartment. In some embodiments, blood flow from the azygos vein 150 to the superior vena cava 142 may be restricted or diverted upstream with an external ligature, occluder, or other implanted device. In some embodiments, the splanchnic compartment or thoracic reservoir may be formed by restricting or preventing blood from flowing through other vessels of the thoracic vein, such as the accessory hemizygos vein 156, the hemizygos vein 158, the lumbar vein 160, and other vessels that flow into the azygos vein 150.

[0063] In some embodiments, the implantation device may be placed via a percutaneous approach. As shown in FIG. 7, in one example of a percutaneous approach, a magnetic element may be used to align two adjacent blood vessels. For example, in some embodiments, the magnetic element may be a magnet, e.g., magnetic rings 930A and 930B, aligned in each blood vessel. For example, a first catheter 910B may be delivered into the right pulmonary artery 140 and a second catheter 910A may be delivered into the azygos vein 150, each catheter carrying a magnet 930A, 930B. In some embodiments, one or both of the catheters 910A, 910B may include or otherwise be articulated by articulating portions 916A, 916B. In some embodiments, the articulating portions 916A, 916B are steered by steering wires 912A, 912B. In some embodiments, one or both of the catheters 910A, 910B may include a portion that assumes a preformed curvature or a preformed shape. For example, in some embodiments, a catheter such as catheter 910A may include as a portion that assumes a preformed shape after being released from a delivery sheath, after removing a delivery stylet, after reaching a certain temperature, and / or after receiving an electrical pulse. In some embodiments, one or both of catheters 910A, 910B may have one or more lumens.

[0064] In some embodiments, the magnets 930A, 930B may be used to align the catheters 910A, 910B to facilitate delivery of a guidewire (not shown) from one vessel to the other. The guidewire may be used to allow access for a delivery device used to deliver the implant. In some embodiments, the magnets 930A, 930B may be connected to the steering wires 914A, 914B. In some embodiments, the steering wires 914A, 914B may be used to switch the polarity of the magnets 930A, 930B to selectively repel each other, which may be useful for removing the catheters 930A, 930B after delivery. In some embodiments, the magnets 930A, 930B may be electromagnets, and the steering wires 914A, 914B may be used to selectively activate and deactivate the magnets 930A, 930B at various times during placement, delivery, and / or removal of the catheters 910A, 910B.

[0065] In some embodiments, the azygos vein 150 may be accessed via the superior vena cava 142. In some embodiments, the azygos vein 150 may be accessed via the inferior vena cava 144. In some embodiments, a Swan-Ganz technique may be used to access the pulmonary artery 140. For example, the pulmonary artery 140 may be accessed via the superior vena cava 142 or the inferior vena cava 144, through the right atrium 132 and right ventricle 134, and into the pulmonary artery 140. In some embodiments, the azygos vein 150 and the pulmonary artery 140 may be accessed separately as described above, and each end of the implant may be positioned and / or placed separately via tools (e.g., catheters 910A and 910B) in each vessel. In some embodiments, the pulmonary artery 140 and the azygos vein 150 may be accessed from one vessel (e.g., a Swan-Ganz technique through the pulmonary artery 140 may be used to create an opening to the azygos vein 150, or vice versa), and the implant may be placed via tools in the accessed vessel.

[0066] As discussed 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 restriction to form an adjustable shunt. In some embodiments, an adjustable shunt implant, such as the implant 1110 shown in FIG. 9, may include a controllable fluid restriction 1000, as shown in FIGS. 8A-8B. The adjustable shunt 1100 may be collapsible so that it may be delivered percutaneously. In some embodiments, the controllable fluid restriction 1000 includes one or more wire frames 1002. A valve or regulator, such as the controllable fluid restriction 1000, may be positioned within the implant, such as the adjustable shunt 1100, such that the wire frame 1002 extends across a cross section of the adjustable shunt 1100. The wire frame 1002 may be collapsible with the remainder of the adjustable shunt 1100 for delivery. When expanded, the wire frame 1002 forms a pair of disks, each having fabric that extends across a portion of the cross-section of the shunt 1100, as shown in Figures 8A-8B.

[0067] One or more wireform frames 1002 may be attached or fixed to the remainder of the shunt 1100, e.g., the fixed partition 1010, to prevent blood flow through a portion of the controllable fluid restriction 1000. At least one wireform frame, e.g., the rotating partition 1004, may be rotated relative to the fabric of the fixed partition 1010 to adjust the size of the opening 1006 through the shunt 1100. The rotating partition 1004 may also include a fabric portion that prevents blood flow through the controllable fluid restriction 1000. In some embodiments, the rotating partition 1004 may be selectively rotated to open or close the controllable fluid restrictor 1000. As shown in FIG. 8A, the fixed partition 1010 and the rotating partition 1004 may be oriented to position their respective fabric portions to occlude a majority of the lumen or cross-section of the shunt 1100, thereby allowing blood to pass through only the small opening 1006. In some embodiments, the fixed partition 1010 and the rotating partition 1004 may be oriented to position their respective fabric portions to completely occlude a cross section of the shunt 1100. As shown in FIG. 8B, the rotating partition 1004 can be rotated to partially or fully align the fabric of the rotating partition 1004 with the fabric of the fixed partition 1010, thereby selectively opening the controllable fluid restriction 1000 and enlarging the opening 1006 to allow more blood to pass through the controllable fluid 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 fabric areas of each of the fixed partition 1010 and rotating partition 1004 may be arranged to occlude less than the entire cross-section of the shunt 1100, for example, a combined area of ​​95%, 90%, 80%, 75%, 60%, 50%, 45%, 33%, 20%, 15%, 10%, 5% or other percentages.

[0068] Rotation of the rotating partition 1004 may be effected by a drive line, such as cable 1170 shown in Figure 9, which may include a torque cable driven by a motor located in the control unit. In other respects, the adjustable shunt 1100 may be similar to the shunt 200 and implants 600, 700 and 800 and includes an expandable body 1110 having an inner body 1125, an outer body 1115 and a lumen 1113. The adjustable shunt 1100 may also include additional valves and / or porous portions, as described above.

[0069] In some embodiments, a feedback-controlled implant may be provided, such as an adjustable shunt 1100 that is placed between the right pulmonary artery 140 and the azygos vein 150. Feedback-controlled implants may also be placed at other locations in the body, such as shunts between two blood vessels or implants within a blood vessel. The implant may have any type of valve or regulator to adjust the flow openings in the implant and may incorporate a feedback control loop as described below. Implants such as those described above or elsewhere herein may be permanently implanted.

[0070] A system with an adjustable shunt according to one embodiment is shown in FIG. 10. The adjustable shunt 1220 may be controlled by a drive line 1216 connected to a motor located in a control unit 1210, either external to the patient or implanted. The control unit 1210 may be controlled and / or monitored by the patient, for example, wirelessly via an app on a smartphone 1232. The connection between the smartphone 1232 or other suitable device and the control unit 1210 may be wireless 1230, as shown in FIG. 10. In some embodiments, for example, when the control unit 1210 is located external to the patient, the connection is wired. The control unit 1210 may include a battery 1212 or other power source and circuitry configured to receive wired or wireless signals from sensors, for example signal 1214. For example, pressure sensors, flow sensors and / or electrical sensors may be located at various locations in or around the heart 130 or other locations within the body. For example, one or more sensors may be used to measure pressure in the right ventricle 1214A, central venous pressure 1214B, pulmonary artery pressure 1214C, aortic pressure 1214D, and left atrial pressure 1214E. Based on these pressure measurements and / or other signals 1214, the control unit 1210 may appropriately actuate the drive line 1216 to control the adjustable shunt 1220 to control the amount of blood flowing through the adjustable shunt 1220. The control logic, including the feedback loop described above, may be optimized to treat heart failure patients, for example, by controlling the amount of blood diverted from the right pulmonary artery 140 into the azygos vein 150. This may reduce the amount of blood reaching the lungs, which may advantageously reduce pulmonary stress, eliminate pulmonary congestion, and reduce left ventricular end-diastolic pressure (LVEDP).

[0071] In some embodiments, an adjustable shunt 1220 with a controllable valve 1100 is used to tailor the implant for a particular patient. For example, the rotating partition 1004 is rotated by the clinician to adjust the opening 1006 via the drive line 1216 and then set for a period of time. In such a case, the system may provide the signal 1214 collected by the sensor to the clinician.

[0072] In some embodiments, the shunt or any of the above implants may have other mechanisms for restricting and / or occluding blood flowing through the shunt, as described in U.S. Provisional Application No. 63 / 336,924, filed April 29, 2022, U.S. Provisional Application No. 63 / 494,635, filed February 13, 2023, and U.S. Patent Application No. 18 / 300,076, filed April 13, 2023 (Attorney Docket No. INQB.014A), entitled "SYSTEMS, DEVICES, AND METHODS FOR CONTROLLABLY AND SELECTIVELY OCCLUDING, RESTRICTING, AND DIVERTING FLOW WITHIN A PATIENT'S VASCULATURE," the entireties of which are incorporated herein by reference.

[0073] In some embodiments, a method for treating heart failure includes diverting blood from the pulmonary artery 140 to the azygos vein 150. An implant device, such as the shunt 200, adjustable shunt 1100 or 1200, and implant 600, 700, 800, may be used to divert the blood. In some embodiments, the diversion of blood is sufficient to decongest the patient's lungs and reduce left ventricular end diastolic pressure (LVEDP) and / or reduce pulmonary artery pressure to alleviate pulmonary hypertension and, as a result, reduce the right ventricular work of the patient. In some embodiments, the diversion of blood is sufficient to mimic splanchnic vascular volume and redistribute blood within the patient's splanchnic compartment. In some embodiments, the diversion of blood is sufficient to cause distension and / or increased pressure in the patient's intercostal veins.

[0074] Some of the features or advantages that may be included in 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: Increasing cardiac output by pressurizing or distending veins, such as the intercostal veins. -Containment of diverted blood in the venous volume system. The diversion of blood is sufficient to increase tissue concentrations of vasoconstrictor substances such as norepinephrine, angiotensin II, and certain cytokines that have deleterious effects on the heart and vasculature, thereby decreasing tension in the left ventricular wall and stretching the wall, which in turn worsens heart failure. Devices and methods for placing a shunt 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. Reduces pressure on the lungs and diverts blood from the pulmonary artery, decreasing the amount of blood reaching the lungs and thus lowering LVDP. A valve or regulator used to control the flow of blood between two parts of the body, where the valve or regulator is controlled based on a feedback loop that takes into account the pressure obtained from various parts of the body. A valve or regulator as incorporated into a collapsible percutaneously delivered shunt. · Valves or regulators that control blood flow to treat or prevent heart failure. Use of a wire-type disk that rotates relative to a stationary disk and is controlled by a drive line to regulate blood flow. - To mimic splanchnic vascular volume and redistribute blood within the patient's splanchnic compartment. -Diversion of blood to counteract the effects of vasoconstrictor substances released by the patient as a result of heart failure. A catheter system that uses magnets to align two different catheters placed in two different blood vessels in different regions so that a shunt can be created between the two vessels using standard interventional techniques. Once the vessels are aligned and a guidewire is threaded through them, the alignment magnets are rotated so that like poles of the magnets face each other, allowing them to be separated from each other by the repulsive force of the magnets.

[0075] In some embodiments, an implant or system can provide various features as described above on a single implant, hi some embodiments, various features are provided on multiple cooperating implants for modular attachment.

[0076] It should be understood that features, materials, properties or groups described in connection with a particular aspect, embodiment or example are applicable to any other aspect, embodiment or example described herein, except where incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations in which at least some of such features or steps are mutually exclusive. Protection is not limited to the details of any of the foregoing embodiments. Protection extends to any novel or any novel combination of features disclosed in this specification (including any accompanying claims, abstract and drawings), or any novel or any novel combination of steps of a method or process so disclosed.

[0077] Although specific embodiments have been described, these embodiments are presented by way of example only and are not intended to limit the scope of protection. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms. Furthermore, various omissions, substitutions, and changes in the form of the methods and systems described herein may be made. Those skilled in the art will appreciate that in some embodiments, the actual steps taken in the illustrated or disclosed processes may differ from those shown in the figures. In some embodiments, some of the steps described above may be omitted and others may be added. For example, the actual steps or order of steps taken in the disclosed processes may differ from those shown in the figures. Depending on the embodiment, some of the steps described above may be omitted and others may be added. Furthermore, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which are within the scope of the present disclosure.

[0078] 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, including embodiments that do not provide all of the features and advantages described herein, as well as obvious modifications and equivalents thereof. Thus, the scope of the present disclosure is not intended to be limited by the described embodiments, but may be defined by the claims presented herein or presented in the future.

[0079] Conditional language, such as "can, could," "might or may," and the like, is generally intended to convey that a particular embodiment includes certain features, elements, or steps and other embodiments do not, unless otherwise indicated or understood otherwise within the context of use. Thus, such conditional language is generally not intended to imply that the features, elements, or steps are somehow required for one or more embodiments, or that one or more embodiments necessarily include logic that determines, with or without user input or prompting, whether those features, elements, or steps should be included or performed in any particular embodiment. The terms "comprising," "having," and the like are synonymous and are used inclusively, open-ended, and do not exclude additional elements, features, acts, operations, and the like. Additionally, the term "or" is used in its inclusive sense (not exclusive), e.g., when used to join a list of elements, the term "or" means one, some, or all of the elements in the list. Similarly, the term "and / or" referring to a list of two or more items encompasses all interpretations of the word: any one of the items in the list, all of the items in the list, and any combination of the items in the list. Furthermore, as used herein, the term "each" may refer to any subset of the set of elements to which the term "each" applies, in addition to having its ordinary meaning. Additionally, the words "herein," "above," "below," and words of similar import, when used in this application, refer to this application as a whole and not to any particular portions of this application.

[0080] Conjunctive language such as the phrase "at least one of X, Y, and Z," unless otherwise noted, is understood with context as being commonly used to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language is generally not intended to imply that a particular embodiment requires the presence of at least one X, at least one Y, and at least one Z.

[0081] As used herein, words of degree, such as the terms "approximately," "about," "generally," and "substantially," refer to a value, amount, or characteristic that is close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms "approximately," "about," "generally," and "substantially" may refer to amounts that are less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the stated amount. As another example, in certain embodiments, the terms "generally parallel" and "substantially parallel" refer to a value, amount, or characteristic that deviates from exactly parallel by no more than 15°, 10°, 5°, 3°, 1°, or 0.1°.

Claims

1. A system for treating heart failure in patients, A system having an implant configured to be positioned within the azygos vein of a patient to at least partially occlude blood flow from the azygos vein to the superior vena cava.

2. The system according to claim 1, further comprising a controllable valve in the implant.

3. The system according to claim 1, wherein the implant has a shunt configured to be positioned between the pulmonary artery and the azygos vein.

4. The system according to claim 1, wherein the implant is configured to change the direction of blood flow within the azygos vein.

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

6. The system according to claim 1, wherein the implant has an expandable tubular body configured to extend between the pulmonary artery and the azygos vein.

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

8. The system according to claim 6, wherein the implant has an upstream end configured to expand radially with respect to the inner wall of the pulmonary artery.

9. The system according to claim 6, wherein the implant has a downstream end configured to expand radially with respect to the inner wall of the azygos vein.

10. The system according to claim 9, wherein the downstream end of the implant is configured to guide blood into the azygos vein in a direction opposite to the forward direction of blood flow in the azygos vein.

11. The system according to claim 6, wherein the implant has a valve configured to regulate blood flow from the azygos vein into the superior vena cava.

12. The system according to claim 6, wherein the implant has a porous portion configured to allow blood flow from the azygos vein into the superior vena cava.

13. The system according to claim 1, wherein the implant comprises a first implant configured to be positioned within the azygos vein to at least partially occlude blood flow from the azygos vein into the superior vena cava, and a second implant configured to guide blood from the pulmonary artery into the azygos vein.

14. The system according to any one of claims 1 to 13, further comprising a controller configured to regulate blood flow through the implant.

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

16. An implantable shunt configured to be implanted between a patient's pulmonary artery and azygos vein, and configured to divert blood flow into the azygos vein for the treatment of heart failure.

17. The implantable shunt according to claim 16, configured to operate in such a way as to divert blood from the pulmonary artery to the azygos vein.

18. An embeddable flow control system, An expandable body having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, the expandable body being configured to be folded into a foldable shape for delivery into a patient and to expand from the foldable shape into an expanded shape for implantation into the patient, A fluid throttle disposed within the expandable body, When the expandable body is in the expanded shape, a first partition partially closes the first portion of the lumen, When the expandable body is in the expanded shape, a second partition is movable relative to the first partition in order to selectively close and release the second portion of the lumen, A fluid throttle having, A system having implants.

19. The system according to claim 18, wherein the first partition comprises a first expandable wire frame and a first fabric portion extending across the first expandable wire frame, and the second partition comprises a second expandable wire frame and a second fabric portion extending across the second expandable wire frame.

20. The system according to claim 18, wherein the second partition is configured to rotate relative to the first partition in order to selectively increase or decrease the size of the opening through the lumen.

21. The system according to claim 18, wherein the first partition is fixed to the expandable body.

22. The system according to claim 18, further comprising a controller configured to control the movement of the second partition relative to the first partition.

23. The system according to any one of claims 18 to 22, wherein the implant has a shunt configured to be embedded between the patient's first blood vessel and second blood vessel.

24. The system according to any one of claims 18 to 22, wherein the implant is configured to expand within the patient's blood vessels.

25. It is a system for treating heart failure, An implantable shunt configured to divert blood flow within a patient from a first vessel to a second vessel, the implantable shunt being implantable between the first vessel and the second vessel and having a flow-regulating opening, A controller configured to control the amount of blood flowing through the implantable shunt, the controller being configured to receive measurements from one or more pressure sensors placed in the patient, and programmed to control the flow-adjustable opening based on the measurements, A system that has

26. The system according to claim 25, wherein the first blood vessel is the right pulmonary artery and the second blood vessel is the azygos vein.

27. The system according to claim 25 or 26, wherein the controller is configured to receive one or more of the following: central venous pressure, right ventricular pressure, pulmonary artery pressure, aortic pressure, and left atrial pressure.

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