Systems and methods for increasing lymphatic flow by occluding blood flow

Abstract

A system and method for increasing lymphatic flow of a patient by occluding blood flow from the left subclavian vein and the left internal jugular vein to the innominate vein while allowing lymph fluid to flow from the left thoracic duct to the innominate vein. The system can include occluders with expandable cages positioned in the left subclavian vein and the left internal jugular vein to selectively control the flow of blood to the left innominate vein. The occluders can expand and collapse based on pressure measurements received from an implanted pressure sensor in the left innominate vein.

Description

INQB.035WO PCT SYSTEMS AND METHODS FOR INCREASING LYMPHATIC FLOW BY OCCLUDING BLOOD FLOW INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

[0001] This application claims the benefit of priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 63 / 665882, filed June 28, 2024. This application is hereby incorporated by reference herein in its entirety. BACKGROUND Field of the Invention

[0002] Embodiments of this application are directed to systems, methods and devices for increasing lymphatic flow by occluding blood flow. Description of the Related Art

[0003] Heart failure, or acute decompensated heart failure (ADHF), can occur when excess fluid builds up in tissues and organs. Venous pressure increases and drainage of fluid out of the tissues is slowed or stopped. The lymphatic system, for example the thoracic duct, is responsible for removing excess fluid from the tissue or organs. A lack of drainage from the thoracic duct can have significant implications for immune function, fluid balance, and nutrient absorption. For example, this can lead to lymphedema, immune system compromise, nutritional deficiencies, increased risk of infections, chylous ascites, and malabsorption syndrome.

[0004] Decreased thoracic duct flow can be initially treated by lifestyle changes to replace deficient nutrients and prevent constriction of lymphatic flow. Current therapies target vascular congestion, but even with diuretic therapy, residual congestion can linger and lead to poor outcomes. As cases progress in severity, surgical intervention (such as lymphovenous anastomosis) may be used to reduce restore flow of lymph fluid back to the venous system.SUMMARY

[0005] In patients with ADHF, flow of lymph fluid is slowed or stopped from the thoracic duct due to venous pressure in the venous system. At least partially occluding blood flow in the venous system, for example using an expandable occluder, can help reduce venous pressure and increase lymph flow. For example, expandable occluders can be positioned in the left internal jugular vein and the left subclavian vein. At least partially or fully occluding blood flow in the left internal jugular vein and the left subclavian vein, for a period of time, may allow at least some of the lymph fluid to flow through from the thoracic duct into the left innominate vein. This may increase lymph fluid flow into the venous system, and thereby reduce fluid buildup in the tissues. Advantageously, the systems described herein can impart a positive long-term clinical effect. In some examples, these systems can continually modulate based on in-vivo pressure measurements. The systems can modulate flow from two adjacent vessels to minimize or obviate the need for occlusion of upstream vessels. Also, this device may be retrieved long-term if desired.

[0006] Certain aspects of the present application are directed to methods, systems and devices for increasing lymphatic flow. The systems described herein can include a first expandable occluder configured to be positioned within a vessel such as the left internal jugular vein. The first expandable occluder can at least partially occlude fluid flow through the left internal jugular vein into a left innominate vein. For example, the expandable occluder may slow or stop blood flow through the vessel. The systems described herein can include a second expandable occluder configured to be positioned within a vessel such as the left subclavian vein. The second occluder can to at least partially occlude fluid flow through the left subclavian vein into a left innominate vein. Occluding flow from either or both of the left internal jugular vein and the left subclavian vein can reduce pressure in the left innominate vein. The systems described herein can include an implantable control unit configured to regulate expansion of the first expandable occluder and the second expandable occluder to decrease pressure in the left innominate vein. The systems described herein can include a chronic pressure sensor configured to be positioned in a vessel such as the left innominate vein.

[0007] In some examples, the implantable control unit is configured to receive pressure measurements from the chronic pressure sensor and control the first expandable occluder and the second expandable occluder based on the pressure measurements. The systemcan include a drive motor connectable to the first expandable occluder and the second expandable occluder, the drive motor configured to expand and collapse the first expandable occluder and the second expandable occluder. In some implementations, the drive motor can be positioned in at least one of the left innominate vein or a right innominate vein. In other implementations, the drive motor is positioned in a subcutaneous pocket outside of the vasculature.

[0008] The systems described herein can include a first expandable occluder configured to be positioned within a left internal jugular vein. The first expandable occluder can at least partially occlude fluid flow through the left internal jugular vein into a left innominate vein. The systems described herein can include a second expandable occluder configured to be positioned within a left subclavian vein to at least partially occlude fluid flow through the left subclavian vein into a left innominate vein. The systems described herein can include an implantable control unit configured to regulate expansion of the first expandable occluder and the second expandable occluder to decrease pressure in the left innominate vein. The systems described herein can include at least one drive line connectable to the first expandable occluder and the second expandable occluder. The systems described herein can include a drive motor connectable to the at least one drive line. The drive motor can be configured to advance and retract the at least one drive line to expand and collapse the first expandable occluder and the second expandable occluder.

[0009] In some examples, the system can include a chronic pressure sensor configured to be positioned in a vessel such as the left innominate vein. The implantable control unit is configured to receive pressure measurements from the chronic pressure sensor and control the first expandable occluder and the second expandable occluder based on the pressure measurements. The drive motor can be positioned in at least one of the left innominate vein or a right innominate vein. The chronic pressure sensor can be positioned on the at least one drive line. In some implementations, the at least one drive line can expand the first expandable occluder and the second expandable occluder independently. In other implementations, the at least one drive line is configured to expand the first expandable occluder and the second expandable occluder simultaneously. The at least one drive line can extend into a right innominate vein. The drive motor can be positioned in a subcutaneous pocket outside of the vasculature.

[0010] The systems described herein can include a first expandable occluder configured to be positioned within a left internal jugular vein to at least partially occlude fluid flow through the left internal jugular vein into a left innominate vein. The systems described herein can include a second expandable occluder configured to be positioned within a left subclavian vein to at least partially occlude fluid flow through the left subclavian vein into a left innominate vein. The systems described herein can include an implantable control unit configured to regulate expansion of the first expandable occluder and the second expandable occluder to decrease pressure in the left innominate vein. Each of the first expandable occluder and the second expandable occluder includes a distal cap, a proximal cap, an expandable cage extending between the distal cap and the proximal cap, and an elastic sheath carried by the expandable cage.

[0011] In some implementations, the system can include a chronic pressure sensor configured to be positioned in the left innominate vein. The implantable control unit can be configured to receive pressure measurements from the chronic pressure sensor and control the first expandable occluder and the second expandable occluder based on the pressure measurements. The system can include a drive motor connectable to the first expandable occluder and the second expandable occluder, the drive motor configured to expand and collapse the first expandable occluder and the second expandable occluder. The drive motor can be configured to be positioned in at least one of the left innominate vein or a right innominate vein. The drive motor can be configured to move the proximal cap toward the distal cap to expand the expandable cage of the first expandable occluder and the second expandable occluder. The drive motor can be positioned in a subcutaneous pocket outside of the vasculature.

[0012] The methods described herein can include positioning a first expandable occluder within a left internal jugular vein to at least partially occlude fluid flow through the left internal jugular vein into a left innominate vein. The methods described herein can include positioning a second expandable occluder in a left subclavian vein to at least partially occlude fluid flow through the left subclavian vein into the left innominate vein. The methods described herein can include positioning a chronic pressure sensor in the left innominate vein. The methods described herein can include expanding the first expandable occluder and the secondexpandable occluder based on feedback received from the chronic pressure sensor to at least partially occlude blood fluid into the left innominate vein.

[0013] In some examples, the method can include expanding the first expandable occluder and the second expandable occluder based on feedback from a second chronic pressure sensor positioned in a left thoracic duct. The method can include expanding the first expandable occluder and the second expandable occluder when pressure in the left innominate vein exceeds an upper threshold pressure value. The upper threshold pressure value can be between 16 and 21 mmHg. The method can include collapsing the first expandable occluder and the second expandable occluder when pressure in the left innominate vein falls below a lower threshold pressure value. The lower threshold pressure value can be between 11 and 16 mmHg. The method can include expanding the first expandable occluder and the second expandable occluder simultaneously. The method can include expanding the first expandable occluder and the second expandable occluder independently. The method can include expanding the first expandable occluder while the second expandable occluder is collapsed. The method can include expanding the second expandable occluder while the first expandable occluder is collapsed.

[0014] In some implementations, expanding the first expandable occluder can include moving, by a drive motor, a first end of the first expandable occluder closer to a second end of the second end of the first expandable occluder. The method can include moving, by a drive motor, a first end of the second expandable occluder closer to a second end of the second expandable occluder. The method can include expanding the first expandable occluder and the second expandable occluder based on input from a user device. The method can include expanding the first expandable occluder and the second expandable occluder based on a time interval. The method can include partially expanding the first expandable occluder and partially expanding the second expandable occluder. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Certain features of this disclosure are described below with reference to the drawings. The illustrated implementations are intended to illustrate, but not to limit, the implementations. Various features of the different disclosed implementations can be combined to form further implementations, which are part of this disclosure.

[0016] FIG.1A illustrates the left portion of the venous system and the left thoracic duct.

[0017] FIG.1B illustrates the venous system and the lymphatic system.

[0018] FIG.2A-2D illustrate an example of a system for increasing lymphatic flow by occluding blood flow with occluders in the venous system.

[0019] FIG.3A-3B illustrate another example of a system for increasing lymphatic flow by occluding blood flow with occluders in the venous system.

[0020] FIG. 4A shows a perspective view of an example of an occluder system with the occluder expanded.

[0021] FIG.4B shows a perspective view of the example of the expanded occluder of FIG.4A.

[0022] FIG.4C shows a side view of the example of the expanded occluder of FIG. 4A.

[0023] FIG.4D shows a perspective view of the example of the collapsed occluder of FIG.4A.

[0024] FIG.4E shows a cross-sectional front view of the example of the collapsed occluder of FIG.4A.

[0025] FIG.4F shows a cross-sectional front view of the example of the expanded occluder of FIG.4A.

[0026] FIG. 4G shows a cross-sectional view of the example of the expanded occluder of FIG.4A.

[0027] FIG. 5A illustrates an example of a collapsed occluder and a drive line detached from a drive motor.

[0028] FIG. 5B illustrates an example of an expanded occluder and drive line detached from the drive motor of FIG.5A. DETAILED DESCRIPTION

[0029] Various features and advantages of this disclosure will now be described with reference to the accompanying figures. The following description is merely illustrative in nature and is in no way intended to limit the disclosure, its application, or uses. Thisdisclosure extends beyond the specifically disclosed implementations and / or uses and obvious modifications and equivalents thereof. Thus, it is intended that the scope of this disclosure should not be limited by any particular implementations described below. The features of the illustrated implementations can be modified, combined, removed, and / or substituted as will be apparent to those of ordinary skill in the art upon consideration of the principles disclosed herein. Furthermore, implementations disclosed herein can include several novel features, no single one of which is solely responsible for its desirable attributes or which is essential to practicing the systems, devices, and / or methods disclosed herein.

[0030] Parts, components, features, and / or elements of the systems and devices described herein that can function the same or similarly across various implementations are identified using similar reference numerals. Differences between the various implementations are discussed herein. Implementations of the present application relate to at least partially occluding blood flow to increase lymphatic flow in patients. Certain embodiments are directed to selectively expanding one or more occluders, for example in the left internal jugular vein and / or the left subclavian vein, to reduce flow and / or pressure in the left innominate vein. This can cause the flow of lymph fluid from the left thoracic duct to the left innominate vein to increase. The system can include one or more occluders with expandable cages positioned in the left subclavian vein and / or the left internal jugular vein to selectively control the flow of blood to the left innominate vein. The one or more occluders can expand and collapse based on pressure measurements received from an implanted pressure sensor in the left innominate vein.

[0031] FIG. 1A illustrates a patient’s anatomy including the left internal jugular vein 112, the left subclavian vein 116, the left thoracic duct 102, and the left innominate vein 120. The veins collect deoxygenated blood from the body and pump it to the lungs for oxygenation. The left innominate vein 120, also known as the left brachiocephalic vein, receives blood from the left internal jugular vein 112 and left subclavian vein 116. The left innominate vein 120 plays a crucial role in venous return from the upper body. The left thoracic duct 102 drains extracellular fluid from most tissues in the body of the patient and carries it to the left internal jugular vein 112, the left subclavian vein 116, and / or the left innominate vein 120. The lymph fluid is mixed with blood and circulates throughout the body.

[0032] FIG. 1B illustrates a patient’s anatomy including the left internal jugular vein 112, the left subclavian vein 116, the left thoracic duct 102, the left innominate vein 120, the right internal jugular vein 110, the right subclavian vein 114, the right innominate vein 118, and the superior vena cava 142.

[0033] FIG. 2A illustrates an example of an occluder system 200 for increasing lymphatic flow by occluding blood flow with one or more occluders 204, 206 collapsed in the left portion of the venous system. Although certain examples are described herein with respect to the thoracic duct 102 and placement within veins connected thereto, similar systems may be used for the right lymphatic duct and placement within the veins connected thereto, for example the right subclavian vein 114 and the right internal jugular vein 110.

[0034] FIG. 2B illustrates the example of an occluder system 200 for increasing lymphatic flow by occluding blood flow of FIG. 2A with occluders 204, 206 collapsed in the venous system. FIG. 2C illustrates the example of an occluder system 200 for increasing lymphatic flow by occluding blood flow of FIG. 2A with occluders 204, 206 expanded in the left portion of the venous system. FIG. 2D illustrates the example of an occluder system 200 for increasing lymphatic flow by occluding blood flow of FIG. 2A with occluders 204, 206 expanded in the venous system.

[0035] As shown in FIG. 2A, the occluder system 200 can include a first occluder 204, for example in the left internal jugular vein 112. The occluder system 200 can include a second occluder 206, for example in the left subclavian vein 116. The occluders 204, 206 can be implanted in a collapsed state such that they do not significantly affect blood flow until they are activated and / or expanded. Although certain examples are described herein with two occluders 204, 206, in certain variations, the system may only include a single occluder having the properties of occlude 204 or 206. The system may also include additional occluders for example within the same veins (e.g., left subclavian vein 116, left internal jugular vein) or other veins (e.g., left innominate vein 120).

[0036] The occluder system 200 can include a pressure sensor 208. The pressure sensor 208 can be a chronic pressure sensor. For example, the pressure sensor 208 can be chronically implanted in the left innominate vein 120. In some embodiments, the pressure sensor 208 can be implanted at a junction between the left internal jugular vein 112 and the left subclavian vein 116. The pressure sensor 208 can be implanted directly in front of theostium of the thoracic duct 102. The pressure sensor 208 can be implanted between the superior vena cava and a location of the occluders 204, 206. The pressure sensor 208 can be implanted between the superior vena cava and the left subclavian vein 116. The pressure sensor 208 can be implanted in the bloodstream proximal to the occluders 204, 206. The pressure sensor 208 can measure central venous pressure. The pressure sensor 208 can measure a pressure parameter related to central venous pressure. The pressure sensor 208 can measure pressure directly in front of the ostium of the thoracic duct 102. The pressure differential between the thoracic duct 102 and the area in front of the ostium of the thoracic duct 102 can drive or control the emptying of the thoracic duct into the venous system. The occluders 204, 206 can be connected to the pressure sensor 208, for example by one or more drive lines 210, 212. In some embodiments, the first occluder 204 can be connected to the pressure sensor 208 by a first drive line 210, or first portion of a drive line. In some embodiments, the second occluder 206 can be connected to the pressure sensor 208 by a second drive line 212, or second portion of a drive line. The occluder system 200 can expand and collapse the one or more occluders 204, 206 based on feedback from the pressure sensor 208. In some implementations, the occluder system 200 can expand and collapse the one or more occluders 204, 206 based on a time interval, for example a predetermined time interval. As described further below, the occluder system 200 may include sensor(s) in addition or in alternative to the pressure sensor 208.

[0037] The drive motor 214 can advance and retract the one or more drive lines 210, 212. Advancing and retracting the one or more drive lines 210, 212 can expand and collapse the one or more occluder 204, 206, for example by moving ends of the occluders 204, 206 closer or further away from each other. In some implementations, advancing the one or more drive lines 210, 212 can advance a proximal end of the one or more occluders 204, 206 toward the distal end of the one or more occluders 204, 206 to expand the occluder. In some implementations, advancing the one or more drive lines 210, 212 can advance a distal end of the one or more occluders 204, 206 away from the proximal end of the one or more occluders 204, 206 to collapse the occluder. In some implementations, retracting the one or more drive lines 210, 212 can retract a proximal end of the one or more occluders 204, 206 away from the distal end of the one or more occluders 204, 206 to collapse the occluder. In some implementations, retracting the one or more drive lines 210, 212 can retract a distal end of theone or more occluders 204, 206 toward the proximal end of the one or more occluders 204, 206 to expand the occluder. In other embodiments, the occluders 204, 206 may take on other constructions, for example a balloon or a valve.

[0038] In some implementations, the drive lines 210, 212 can be advanced and retracted independently to expand and collapse the occluders 204, 206 independently. The drive motor 214 can expand the first occluder 204 while the second occluder 206 is collapsed. The drive motor 214 can expand the second occluder 206 while the first occluder 204 is collapsed. Advantageously, independently activating the occluders 204, 206 can prevent blocking upstream flow from any individual branch for too long. The drive lines 210, 212 can be advanced and retracted simultaneously to expand and collapse the occluders 204, 206 simultaneously. The drive lines 210, 212 can be advanced and retracted partially to expand and collapse the occluders 204, 206 partially.

[0039] In some implementations, the occlusion of blood is sufficient to reduce pressure in the left innominate vein 120 and / or to increase lymph fluid flow from the left thoracic duct 102 to relieve fluid buildup in the tissues of the patient. In particular, occluding blood flow from at least one of the left internal jugular vein 112 and the left subclavian vein 116 can have an acute effect on fluid buildup.

[0040] In some embodiments, depressurizing the left innominate vein 120 can increase the flow of lymph fluid by reducing the resistance to lymphatic drainage in the left thoracic duct 102. When the left innominate vein 120 is under increased pressure, such as in cases of venous congestion or obstruction, it can impede the drainage of lymphatic fluid into the bloodstream via the left thoracic duct 102. In some implementations, blocking flow from both the left subclavian vein 116 and left internal jugular vein 112 can be more effective at depressurizing the left innominate vein 120 than blocking just one of these veins individually. The left innominate vein forms from the confluence of the left subclavian vein 116 and left internal jugular vein 112. By simultaneously blocking both of these veins, venous pressure within the left innominate vein 120 can be significantly reduced.

[0041] In some embodiments, partially blocking both the left subclavian vein 116 and left internal jugular vein 112 can be effective at significantly increasing lymphatic fluid flow while allowing some blood flow into the left innominate vein 120. Advantageously, this can create additional lymphatic flow without completely blocking blood flow. For example, atleast one of the expandable occluders 204, 206 can be expanded to occlude at least 50% of blood flow from the left subclavian vein 116 and / or the left internal jugular vein 112. In some implementations, at least one of the expandable occluders 204, 206 can be expanded to occlude at least 25% and / or less than or equal to 75% of blood flow from the left subclavian vein 116 and / or the left internal jugular vein 112. In some implementations, at least one of the expandable occluders 204, 206 can be expanded to occlude at least 10% and / or less than or equal to 90% of blood flow from the left subclavian vein 116 and / or the left internal jugular vein 112. In some implementations, at least one of the expandable occluders 204, 206 can be expanded to occlude at least 5% and / or less than or equal to 100% of blood flow from the left subclavian vein 116 and / or the left internal jugular vein 112. In some embodiments, the level of expansion (and thus level of occlusion) may vary based on measurements received from the pressure sensor 208.

[0042] As shown in FIGS. 2B and 2D, the occluder system 200 can include a control unit 250. The control unit 250 can be an implantable control unit. The control unit 250 can regulate expansion of the one or more occluder 204, 206 to decrease pressure in the left innominate vein 120. The control unit 250 can be in wireless communication 232 with an external device 230. The control unit 250 can be connected to a drive motor 214. The pressure sensor 208 can be connected to the drive motor 214 by a proximal portion 211 of the first drive line 210 and / or the second drive line 212. The portion 211 of the one or more drive lines 210, 212 can extend through the left innominate vein 120, the superior vena cava 142, the right innominate vein 118, and the right subclavian vein 114 to the drive motor 214. In some embodiments, the drive motor 214 can be implanted subcutaneously outside the right subclavian vein 114. The drive motor 214 can be implanted in a subcutaneous pocket, for example with the control unit 250. The one or more drive lines 210, 212 can connect the occluders 204, 206 in the veins to the drive motor 214 in the subcutaneous pocket. The drive motor 214 and / or the control unit 250 can be implanted subcutaneously in a pocket outside the vasculature. In some implementations, the drive motor 214 and / or the control unit 250 can be implanted subcutaneously in a pocket outside at least one of the right subclavian vein, the right axillary vein, or the right brachial vein.

[0043] The control unit 250 can be subcutaneously implanted in the chest, for example near the collar bone. In some embodiments, the control unit 250 can be implantedsubcutaneously outside the right subclavian vein 114. The location of the various elements may change depending on the location of distal portion of the occluder system 200 and the control unit 250.

[0044] The control unit 250 may be in wired connection with the occluders 204, 206 via a controller connection wire. The controller connection wire can be integrated with the portion 211 of the one or more drive lines 210, 212. The controller connection wire can be connected to the drive motor 214 and / or a lead of the occluder system 200. The drive motor 214 can mechanically expand and / or collapse the occluders 204, 206. In other configurations, the control unit 250 can control the occluder system 200 wirelessly, for example by wirelessly controlling the drive motor 214.

[0045] The control unit 250 can be a Controller Area Network (CAN) bus. The control unit 250 can be implantable. For example, the control unit 250 can be implanted near the collar bone. The control unit 250 can regulate expansion of the occluders 204, 206 of the occluder system 200. The control unit 250 can include batteries and / or a wireless charging coil. The control unit 250 can charge wirelessly while implanted in the body through inductive charging. The control unit 250 can house the battery for the drive motor 214, the pressure sensor 208, and other electronics.

[0046] The control unit 250 can receive feedback or measurements, from one or more sensors. The sensors can be implantable. As a non-limiting example, the one or more sensors can include the pressure sensor 208, additional pressure sensors, flow, patency, electrocardiograms, and / or accelerometers. For example, the control unit 250 can include an electrocardiogram and / or an accelerometer. In some implementations, additional pressure sensors can be positioned in the left subclavian vein 116, the left internal jugular vein 112, the left thoracic duct 102, the superior vena cava 142, and / or at a second position in the left innominate vein 120.

[0047] In some embodiments, any of the sensors can be positioned in the vasculature independent of the occluder system 200. The pressure sensor 208 can measure innominate vein pressure. In some implementations, additional pressure sensors can measure left internal jugular vein pressure, central venous pressure, left subclavian vein pressure, thoracic duct pressure, superior vena cava pressure, and / or pressure in another vessel. Thesensors can communicate wirelessly with the control unit 250 or through the controller connection wire.

[0048] The control unit 250 can control the occluders 204, 206 at least in part based on feedback from the one or more sensors, for example pressure measurements from the pressure sensor 208. In some embodiments, the control unit 250 can automatically control the occluders 204, 206 based on feedback from the sensors. In other embodiments, the control unit 250 can control the occluder 204, 206 based on user activation.

[0049] In some configurations, the control unit 250 controls the occluder 204, 206 based at least in part on activity measurements from the accelerometer or electrical activity measurements from the electrocardiogram. The electrocardiogram and accelerometer can allow the control unit 250 to more accurately measure pressure, for example by taking into account a patient’s standing or supine position, level of exercise, or other factors that affect pressure in the vessels. For example, the control unit 250 can increase or decrease the thresholds described below based on the factors determined by the electrocardiogram and / or the accelerometer.

[0050] In some implementations, the control unit 250 can cause at least one of the occluders 204, 206 to expand or collapse at least in part based on a measured or derived pressure measurement. For example, the control unit 250 can cause at least one of the occluders 204, 206 to expand or collapse depending on whether the pressure measurement is above or below a threshold. For example, the control unit 250 can determine central venous pressure based on the pressure measurements collected from the one or more sensors. The control unit 250 can cause the at least one of the occluders 204, 206 to expand when left innominate vein pressure exceeds an upper threshold. The occluders 204, 206 may initially partially expand in response to measured pressure above a threshold. The occluders 204, 206 may fully expand in response to measured pressure above a threshold. Once the occluders 204, 206 are fully occluded, pressure may decrease to zero or negative pressure as distal contractility may still be pulling blood away from the coronary sinus ostium. The upper threshold can be 15 mmHg. In some embodiments, the upper threshold can be a value of at least 10 mmHg, for example between 10 mmHg and 20 mmHg. In some embodiments, the upper threshold can be at least about 6 mmHg, for example between 6 mmHg and 30 mmHg. In some embodiments, the upperthreshold can be determined based on the volume status, venous compliance, and / or other physiological parameters of the patient.

[0051] In some implementations, the control unit 250 can cause at least one of the occluders 204, 206 to expand or collapse based on the difference in pressure between the left thoracic duct 102 and the left innominate vein 120. In some embodiments, when the pressure in the left innominate vein is greater than or equal to the pressure in the left thoracic duct 102, the control unit 250 can cause at least one of the occluders 204, 206 to expand. In some embodiments, the pressure in the left thoracic duct 102 can be measured using an additional pressure sensor. In some embodiments, when the pressure in the left innominate vein is greater than or equal to 16 mmHg, the control unit 250 can cause at least one of the occluders 204, 206 to expand. In some embodiments, when the pressure in the left innominate vein is greater than or equal to a value between 11 mmHg and 21 mmHg, the control unit 250 can cause at least one of the occluders 204, 206 to expand.

[0052] In some embodiments, when the pressure in the left innominate vein is less than the pressure in the left thoracic duct 102, the control unit 250 can cause at least one of the occluders 204, 206 to collapse. In some embodiments, the pressure in the left thoracic duct 102 can be measured using an additional pressure sensor. In some embodiments, when the pressure in the left innominate vein is less than 16 mmHg, the control unit 250 can cause at least one of the occluders 204, 206 to collapse. In some embodiments, when the pressure in the left innominate vein is less than a value between 11 mmHg and 21 mmHg, the control unit 250 can cause at least one of the occluders 204, 206 to collapse.

[0053] The control unit 250 can include a wireless transceiver for communication with external devices 230. The control unit 250 can engage in wireless communication 232 with an external device 230, for example a computer, smart phone, other smart device, or database. In some embodiments, the control unit 250 can control the occluder system 200 based on user input from an external device. For example, the at least one of the occluders 204, 206 may be activated remotely, via a Bluetooth connection, via a smartphone app. In some implementations, a user can activate at least one of the occluders 204, 206 based on symptoms of the patient. For example, a user can activate at least one of the occluders 204, 206 based on swelling and / or pain in the arms, legs, fingers, toes, head, or neck of a patient. In some implementations, a user can activate at least one of the occluders 204, 206 based on swollenlymph nodes of a patient. The control unit 250 can send pressure data, performance data, battery health, and other data to external devices 230, for example to a patient or physician’s devices. The control unit 250 can upload the data to a database or cloud in a constant manner. The system can use a neural network to optimize an algorithm for expanding and collapsing the occluders 204, 206.

[0054] The occluder system 200 and control unit 250 can be chronically implanted. In some embodiments, the control unit 250 can be external to the patient, for example during a procedure. The occluder system 200 can be temporarily inserted in a patient with the control unit 250 external to the patient in order to temporarily occlude blood flow.

[0055] FIG. 3A illustrates an example of an occluder system 300 for increasing lymphatic flow by occluding blood flow with occluders 304, 306 collapsed in the left portion of the venous system. FIG.3B illustrates the example of an occluder system 300 for increasing lymphatic flow by occluding blood flow of FIG. 3A with occluders 304, 306 expanded in the left portion of the venous system. The occluder system 300 can include any of the features of the occluder system 200 of FIGS. 2A-D. The occluder system 300 can include a drive line portion 313 distal to an occluder 306. The drive motor can be positioned in the left subclavian vein 116 or in a vessel upstream of the subclavian vein 116. The drive motor can be implanted subcutaneously in a pocket outside of the left subclavian vein 116 or a vessel upstream of the subclavian vein 116. The drive motor can expand and collapse one or both occluders 304, 306 using the drive line that extends through the occluder 306.

[0056] The first occluder 304 can be connected to the pressure sensor 308 by the drive line 310. The second occluder 306 can be connected to the pressure sensor 308 by the drive line 312. The occluders 304, 306 can be connected to a drive motor by a portion 313 of the one or more drive lines 310, 312. The portion 313 of the one or more drive lines 310, 312 can extend through the left subclavian vein 116 and toward the drive motor. The controller connection wire can be integrated with the portion 313 of the one or more drive lines 310, 312. In some implementations, the drive motor and / or the control unit can be implanted subcutaneously in a pocket outside the vasculature. In some implementations, the drive motor and / or the control unit can be implanted subcutaneously in a pocket outside at least one of the left subclavian vein, the left axillary vein, or the left brachial vein. In some implementations,the drive line 310 can extend through the second occluder 306 and / or the pressure sensor 308 and connect to the first occluder 304.

[0057] FIG.4A shows a perspective view of an example of an occluder system 600 with the occluder 602 expanded. FIG. 4B shows a perspective view of the example of the expanded occluder 602 of FIG.4A. FIG.4C shows a side view of the example of the expanded occluder 602 of FIG. 4A. FIG. 4D shows a perspective view of the example of the collapsed occluder 602 of FIG. 4A. FIG. 4E shows a cross-sectional front view of the example of the collapsed occluder 602 of FIG.4A. FIG.4F shows a cross-sectional front view of the example of the expanded occluder 602 of FIG.4A. FIG.4G shows a cross-sectional view of the example of the expanded occluder 602 of FIG. 4A with the drive line 604 and shaft 1028 removed for clarity. The occluder 602 described below can be used with any of the systems and methods described above.

[0058] The occluder 602 can include an expandable cage 1020 attached to a proximal cap 1026 and a distal cap 1024. An elastic sheath 1022 can cover the expandable cage 1020. A shaft 1028 can extend through the expandable cage 1020. An inner distal cap 1030 can be inside the distal cap 1024 and a drive line connector 1032 can be inside the proximal cap 1026.

[0059] As shown in FIG.4A, the occluder system 600 can include an occluder 602 at a distal portion of the occluder system 600. The occluder 602 can be positioned in a vessel, for example chronically implanted. The occluder 602 can expand (FIGS.4B-4C) and collapse (FIG. 4D) to selectively occlude blood flow through the vessel. The occluder 602 can include an expandable cage 1020 and / or an elastic sheath 1022. For example, the elastic sheath 1022 can cover and inner and / or outer surface of the expandable cage 1020. In some implementations, the elastic sheath 1022 can encapsulate the expandable cage 1020.

[0060] The expandable cage 1020 can extend between a proximal cap 1026 and a distal cap 1024. The expandable cage 1020 can be a wire form or a braid, for example made of nitinol. The expandable cage 1020 can be interlocking wires forming a diamond-like pattern.

[0061] The elastic sheath 1022 can be a smooth expandable material. The elastic sheath 1022 can minimize creasing, folding, and potential areas for thrombosis initiation. The occluder 602 can be covered in a thrombus reducing pharmaceutical, for example heparin. Insome embodiments, the occluder 602 can partially expand or collapse based on pressure measurements or user input.

[0062] As shown in FIG.4B-4C, the occluder system 600 can include a shaft 1028 extending through the occluder 602. The shaft may be a tubular body or may include a sealed distal end. The shaft 1028 can extend through the drive line 604 from a drive motor 606 toward a distal end of the occluder 602. The shaft 1028 can extend proximally past the proximal cap 1026. The shaft 1028 can extend distally past the distal cap 1024 when the distal cap 1024 is moved toward the proximal cap 1026, for example when the occluder 602 is expanded. The shaft 1028 can align with a distal edge of the distal cap 1024 when the distal cap 1024 is moved away from the proximal cap 1026, for example when the occluder 602 is collapsed. The distal end of the shaft 1028 can be coupled with an anchoring element.

[0063] The proximal cap 1026 can move along the shaft 1028 of the occluder 602 toward the distal cap 1024 to expand the expandable cage 1020. The proximal cap 1026 can move along the shaft 1028 of the occluder 602 away from the distal cap 1024 to collapse the expandable cage 1020. In other configurations, the distal cap 1024 may move relative to the proximal cap 1026.

[0064] The proximal cap 1026 can be coupled, for example welded, to the drive line connector 1032. The drive line connector 1032 can be coupled, for example welded, to the drive line 604. In some embodiments, the drive line 604 can be coupled directly to the proximal cap 1026. In some embodiments, the proximal cap 1024 can move toward and away from the distal cap 1026 to expand and collapse the expandable cage 1020. When collapsed, the expandable cage 1020 can be positioned radially inward from the proximal cap 1026 and the distal cap 1024. When expanded, the expandable cage can expand radially outward relative to the proximal cap 1026 and the distal cap 1024. The expandable cage 1020 can be generally straight or tubular when collapsed and curve radially outward when expanded.

[0065] As seen in FIG.4F, the ends of the wires that make up the expandable cage 1020 can align in circular arrangements radially outside the shaft 1028. Each of the proximal cap 1026 and the distal cap 1024 can include an outer ring and an inner ring positioned within the outer ring. As seen in FIG. 4G, the ends of the wires that make up the expandable cage 1020 can be positioned radially between the inner ring and the respective outer ring.

[0066] As shown in FIG.4G, the drive line connector 1032 and the inner distal cap 1030 can be inside the proximal cap 1026 and the distal cap 1024. The drive line connector 1032 and the inner distal cap 1030 can house sensors.

[0067] The elastic sheath 1022 can be attached to a distal portion of the shaft 1028 and / or the proximal and distal caps 1026, 1024. The elastic sheath 1022 can stretch as the expandable cage 1020 expands and contract when the expandable cage 1020 collapses.

[0068] The occluder 602 can connect to a drive motor 606 by the drive line 604. The drive motor 606 can be an in-line motor or a linear actuator motor. The drive motor 606 can cause the drive line 604 to expand and collapse the occluder 602. In some implementations, the drive motor 606 can be positioned in the superior vena cava. The drive line 604 can be positioned in the azygos vein and / or the superior vena cava.

[0069] The drive motor 606 can have an actuation length, or a length that it can push and pull the drive line 604 to expand and collapse the occluder 602. The drive motor 606 can have an actuation length of approximately 10 mm to fully open or close the occluder. In some embodiments, the drive motor 606 can have an actuation length of approximately 5-15 mm to fully open or close the occluder. In some embodiments, the drive motor 606 can have an actuation length of approximately 1-20 mm to fully open or close the occluder. The actuation length can be a moveable length of the drive line 604.

[0070] The drive motor 606 can be controlled by the controller 250. The drive motor 606 can be directly connected to the controller 250, as a lead can be connected to the controller connection wire. In some embodiments, the occluder system 600 can be leadless. The drive motor 606 can connect directly to the controller 250, either by a wire or wirelessly. The drive motor 606 can be hermetically sealed to protect the motor from liquid and biological material.

[0071] The system described herein can be used to divert blood from the arterial system to the venous system. This can include diverting blood from the pulmonary artery to the azygos vein. The diversion of blood from an artery to a vein may be passive. The diversion of blood may be augmented through the use of an occluder positioned in the vein. The occluder may be positioned between an end of the shunt and an ostium from the vein to another vessel where blood flows antegrade toward the ostium. In some implementations, the artery and thevein may be non-parallel or generally extending in different directions relative to a superior- inferior direction.

[0072] FIG.5A illustrates an example of a collapsed occluder 602 and a drive line 604 detached from a drive motor 606. FIG.5B illustrates an example of an expanded occluder 602 and a drive line 604 detached from a drive motor 606.

[0073] The collapsed occluder 602 can have a length of approximately 2 cm. In some embodiments, the collapsed occluder 602 can have a length of approximately 1-3 cm. In some embodiments, the collapsed occluder 602 can have a length of approximately 0.5-5 cm. The collapsed occluder 602 can have a width of approximately .25 cm. In some embodiments, the collapsed occluder 602 can have a width of approximately 0.1-0.5 cm. In some embodiments, the collapsed occluder 602 can have a width of approximately 0.01-1 cm.

[0074] The expanded occluder 602 can have a length of approximately 1.75 cm. In some embodiments, the expanded occluder 602 can have a length of approximately 1-3 cm. In some embodiments, the expanded occluder 602 can have a length of approximately 0.5-5 cm. The expanded occluder 602 can have a width of approximately 1 cm. In some embodiments, the expanded occluder 602 can have a width of approximately 0.5-2 cm. In some embodiments, the expanded occluder 602 can have a width of approximately 0.1-2.5 cm. In some embodiments, the expanded occluder 602 can have a width that corresponds to a diameter of the left subclavian vein or left internal jugular vein, for example between 1 cm and 2 cm, or between 5 mm and 35 mm, or between 1 mm and 5 cm.

[0075] The drive motor 606 can attach to a proximal end of the drive line 604. The proximal cap 1026 of the occluder 602 can be movable by the drive line 604. The drive motor 606 can have a length of approximately 1.75 cm. In some embodiments, the drive motor 606 can have a length of approximately 1-2 cm. In some embodiments, the drive motor 606 can have a length of approximately .5-4 cm. The drive motor 606 can have a width of approximately .25 cm. In some embodiments, the drive motor 606 can have a width of approximately .1-.5 cm. In some embodiments, the drive motor 606 can have a width of approximately .01-1 cm. Additional Considerations and Terminology

[0076] Although certain methods have been described herein in connection with the azygos vein and the pulmonary artery, the systems described herein can also be used in other locations to redirect flow from an artery to a vein. Moreover, although the systems have been described herein as including an occluder system and a shunt, either of these components can be used independently. In an example, the occluder system can be effective in treating chronic refractory angina without a shunt. Chronic refractory angina can be caused by insufficient blood flow to the heart muscle. The occluder can be placed in the coronary sinus to occlude blood flow leaving the myocardium. This can cause an increase in blood pressure in the heart. The occluder can be adjusted in real-time. The occluder system can intervene and relieve potential angina symptoms before they occur or during occurrence.

[0077] Features, materials, characteristics, or groups described in conjunction with a particular aspect, embodiment, or example are to be understood to be applicable to any other aspect, embodiment or example described herein unless 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 where at least some of such features or steps are mutually exclusive. The protection is not restricted to the details of any foregoing embodiments. The protection extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

[0078] While certain embodiments have been described, these embodiments have been 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 processes illustrated or disclosed may differ from those shown in the figures. Depending on the embodiment, certain of the steps described above may be removed, 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 figure. Depending on the embodiment, certain of the steps described above may be removed, others may be added. Furthermore, the features and attributes of the specific embodiments disclosed above may becombined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure.

[0079] 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 which do not provide all of the features and advantages set forth herein. Accordingly, the scope of the present disclosure is not intended to be limited by the described embodiments, and may be defined by claims as presented herein or as presented in the future.

[0080] Conditional language, such as “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements, or steps. Thus, such conditional language is not generally intended to imply that features, elements, or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements, or steps are included or are to be performed in any particular embodiment. The terms “comprising,” “including,” “having,” and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Likewise the term “and / or” in reference to a list of two or more items, covers all of the following 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. Further, the term “each,” as used herein, in addition to having its ordinary meaning, can mean any subset of a set of elements to which the term “each” is applied. 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.

[0081] Conjunctive language such as the phrase “at least one of X, Y, and Z,” unless specifically stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language isnot 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.

[0082] Language of degree used herein, such as the terms “approximately,” “about,” “generally,” and “substantially” as used herein represent a value, amount, or characteristic 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 an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within 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 departs from exactly parallel by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degree.

Claims

WHAT IS CLAIMED IS:

1. A system for increasing lymphatic flow of a patient, the system comprising: a first expandable occluder configured to be positioned within a left internal jugular vein to at least partially occlude fluid flow through the left internal jugular vein into a left innominate vein; a second expandable occluder configured to be positioned within a left subclavian vein to at least partially occlude fluid flow through the left subclavian vein into a left innominate vein; an implantable control unit configured to regulate expansion of the first expandable occluder and the second expandable occluder to decrease pressure in the left innominate vein; and a chronic pressure sensor configured to be positioned in the left innominate vein.

2. The system of claim 1, wherein the implantable control unit is configured to receive pressure measurements from the chronic pressure sensor and control the first expandable occluder and the second expandable occluder based on the pressure measurements.

3. The system of any one of the preceding claims, further comprising a drive motor connectable to the first expandable occluder and the second expandable occluder, the drive motor configured to expand and collapse the first expandable occluder and the second expandable occluder.

4. The system of claim 3, wherein the drive motor is configured to be positioned in at least one of the left innominate vein or a right innominate vein.

5. The system of claim 3, wherein the drive motor is in a subcutaneous pocket.

6. A system for increasing lymphatic flow of a patient, the system comprising: a first expandable occluder configured to be positioned within a left internal jugular vein to at least partially occlude fluid flow through the left internal jugular vein into a left innominate vein; a second expandable occluder configured to be positioned within a left subclavian vein to at least partially occlude fluid flow through the left subclavian vein into a left innominate vein; andan implantable control unit configured to regulate expansion of the first expandable occluder and the second expandable occluder to decrease pressure in the left innominate vein; at least one drive line connectable to the first expandable occluder and the second expandable occluder; and a drive motor connectable to the at least one drive line, the drive motor configured to advance and retract the at least one drive line to expand and collapse the first expandable occluder and the second expandable occluder.

7. The system of claim 6, further comprising a chronic pressure sensor configured to be positioned in the left innominate vein.

8. The system of claim 7, wherein the implantable control unit is configured to receive pressure measurements from the chronic pressure sensor and control the first expandable occluder and the second expandable occluder based on the pressure measurements.

9. The system of claim 6, wherein the drive motor is configured to be positioned in at least one of the left innominate vein or a right innominate vein.

10. The system of claim 7, wherein the chronic pressure sensor is positioned on the at least one drive line.

11. The system of any one of claims 6-10, wherein the at least one drive line is configured to expand the first expandable occluder and the second expandable occluder independently.

12. The system of any one of claims 6-10, wherein the at least one drive line is configured to expand the first expandable occluder and the second expandable occluder simultaneously.

13. The system of any one of claims 6-10, wherein the at least one drive line extends into a right innominate vein.

14. The system of any one of claims 6-10, wherein the drive motor is in a subcutaneous pocket.

15. A system for increasing lymphatic flow of a patient, the system comprising: a first expandable occluder configured to be positioned within a left internal jugular vein to at least partially occlude fluid flow through the left internal jugular vein into a left innominate vein;a second expandable occluder configured to be positioned within a left subclavian vein to at least partially occlude fluid flow through the left subclavian vein into a left innominate vein; and an implantable control unit configured to regulate expansion of the first expandable occluder and the second expandable occluder to decrease pressure in the left innominate vein, wherein each of the first expandable occluder and the second expandable occluder comprises a distal cap; a proximal cap; an expandable cage extending between the distal cap and the proximal cap; and an elastic sheath carried by the expandable cage.

16. The system of claim 15, further comprising a chronic pressure sensor configured to be positioned in the left innominate vein.

17. The system of claim 16, wherein the implantable control unit is configured to receive pressure measurements from the chronic pressure sensor and control the first expandable occluder and the second expandable occluder based on the pressure measurements.

18. The system of any one of claims 15-17, further comprising a drive motor connectable to the first expandable occluder and the second expandable occluder, the drive motor configured to expand and collapse the first expandable occluder and the second expandable occluder.

19. The system of claim 18, wherein the drive motor is configured to be positioned in at least one of the left innominate vein or a right innominate vein.

20. The system of claim 18, wherein the drive motor is configured to move the proximal cap toward the distal cap to expand the expandable cage of the first expandable occluder and the second expandable occluder.

21. The system of claim 18, wherein the drive motor is in a subcutaneous pocket.

22. A method for increasing lymphatic flow of a patient, the method comprising: positioning a first expandable occluder within a left internal jugular vein to at least partially occlude fluid flow through the left internal jugular vein into a left innominate vein;positioning a second expandable occluder in a left subclavian vein to at least partially occlude fluid flow through the left subclavian vein into the left innominate vein; positioning a chronic pressure sensor in the left innominate vein; and expanding the first expandable occluder and the second expandable occluder based on feedback received from the chronic pressure sensor to at least partially occlude blood fluid into the left innominate vein.

23. The method of claim 22, further comprising expanding the first expandable occluder and the second expandable occluder based on feedback from a second chronic pressure sensor positioned in a left thoracic duct.

24. The method of claim 22, wherein expanding the first expandable occluder and the second expandable occluder based on the feedback received from the chronic pressure sensor comprises expanding the first expandable occluder and the second expandable occluder when pressure in the left innominate vein exceeds a threshold pressure value.

25. The method of claim 24, wherein the threshold pressure value is between 16 and 21 mmHg.

26. The method of claim 22, further comprising collapsing the first expandable occluder and the second expandable occluder when pressure in the left innominate vein falls below a threshold pressure value.

27. The method of claim 26, wherein the threshold pressure value is between 11 and 16 mmHg.

28. The method of claim 22, wherein expanding the first expandable occluder and the second expandable occluder comprises expanding the first expandable occluder and the second expandable occluder simultaneously.

29. The method of claim 22, wherein expanding the first expandable occluder and the second expandable occluder comprises expanding the first expandable occluder and the second expandable occluder independently.

30. The method of claim 29, further comprising expanding the first expandable occluder while the second expandable occluder is collapsed.

31. The method of claim 29, further comprising expanding the second expandable occluder while the first expandable occluder is collapsed.

32. The method of claim 22, wherein expanding the first expandable occluder and the second expandable occluder comprises moving, by a drive motor, a first end of the first expandable occluder closer to a second end of the first expandable occluder, and moving, by the drive motor, a first end of the second expandable occluder closer to a second end of the second expandable occluder.

33. The method of any one of claims 22-32, further comprising expanding the first expandable occluder and the second expandable occluder based on input from a user device.

34. The method of any one of claims 22-32, further comprising expanding the first expandable occluder and the second expandable occluder based on a time interval.

35. The method of claim 22, wherein expanding the first expandable occluder and the second expandable occluder comprises partially expanding the first expandable occluder and partially expanding the second expandable occluder.

Images