Systems, devices and methods for controllably and selectively occluding, restricting and diverting flow within a patient's blood vessels - Patents.com

Abstract

Various systems, devices, components and methods are disclosed for controllably and selectively occluding, restricting and / or diverting flow within a patient's blood vessel. The flow restriction system may include an implant having a flow restrictor and an implantable controller having an actuator for actuating the flow restrictor. The flow restriction system may also include an external device for controlling operation of the implant via the implantable controller.

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. Patent Application No. 18 / 300076, filed April 13, 2023, U.S. Provisional Patent Application No. 63 / 336924, filed April 29, 2022, and U.S. Provisional Patent Application No. 63 / 484635, filed February 13, 2023. All of the above applications are incorporated herein by reference in their entireties. All applications in 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 35 U.S.C. § 1.57.

[0002] The present disclosure relates to systems, devices and methods for treating heart failure, including systems, devices and methods for controllably and selectively occluding, restricting and / or diverting flow within a patient's blood vessels.

[0003] A problem identified in heart failure is volume overload, where there is a build-up of excess pressure in the venous system that causes the heart to fail as a pump. Reducing the total amount of fluid in the body, such as by administering diuretics, is one way to reduce volume overload and improve cardiac function. Another way to improve cardiac function in heart failure is to shift the distribution of blood in the vascular system. Such a shift in blood distribution affects cardiac preload, which in turn effectively affects the pumping ability of the heart. Additionally, shifting venous blood volume away from the renal system and / or lymphatic trunks can promote diuresis, further reducing volume overload and improving cardiac function. Summary of the Invention [Means for solving the problem]

[0004] Current non-pharmacological therapies aimed at reducing volume overload and / or reducing preload lack permanent controllability and / or adjustability. Furthermore, current methods of improving and / or controlling diuresis include systemic administration of diuretics, which can significantly impact a patient's quality of life. A more controllable method of controlling diuresis is desired. To address these and other unmet needs, the present disclosure describes various aspects of permanent implantable flow restriction systems, devices and methods for controllably and selectively occluding, restricting and / or diverting flow within a patient's blood vessels. The permanent implantable flow restriction systems and devices described herein can be actuated by various means, such as magnetic, fluidic including pneumatic, mechanical, thermal (e.g., induction heating), and / or other energy sources. Furthermore, the permanent implantable flow restriction systems and devices described herein can be configured to produce partial and / or complete occlusion of a blood vessel from within and / or outside the vessel. Such an ability to homeostatically control vascular occlusion in a patient may, for example, allow for controlled diuresis without systemic drugs / medication.

[0005] Disclosed herein is a permanently implantable flow restriction system for controllably and selectively occluding, restricting and / or diverting flow within a patient's blood vessels to relieve renal congestion and / or reduce cardiac preload.

[0006] In the permanently implantable flow restriction system described above, or in other embodiments as described herein, one or more of the following features may be provided. In some embodiments, the system is adapted to controllably and selectively reduce central venous pressure and / or other venous pressure, which may include inferior vena cava pressure, renal vein pressure, and / or other venous pressures disclosed herein. In some embodiments, the system is adapted to promote renal circulation. In some embodiments, the system is adapted to promote or control diuresis. In some embodiments, the system is adapted to increase cardiac output. In some embodiments, the system is adapted to controllably and selectively occlude or divert flow from the superior vena cava. In some embodiments, the system is adapted to controllably and selectively occlude or divert flow from the inferior vena cava. In some embodiments, the system includes a magnetically actuated implantable device. In some embodiments, the system has a fluidically actuated implantable device. In some embodiments, the system has a thermally actuated implantable device. In some embodiments, the system includes a mechanically actuated implantable device. In some embodiments, the system includes an implantable device configured to be delivered extravenously to at least partially surround or be positioned adjacent to a patient's vein. In some embodiments, the system includes an implantable stent with a mechanical fastening mechanism. In some embodiments, the system further includes a control unit configured to control the occlusion, restriction, and / or diversion of flow in the patient's blood vessel. In some embodiments, the control unit is configured to receive measurements from one or more pressure sensors positioned in the patient, and the control unit is configured to control the occlusion, restriction, and / or diversion of flow in the patient's blood vessel based on the measurements. In some embodiments, the therapy provided by the system is digitally actuated. In some embodiments, the therapy provided by the system is scheduled based on a time of day and / or an amount of time per day.

[0007] Disclosed herein is a permanently implantable flow restriction system for controllably and selectively occluding, restricting and / or diverting vascular flow in a patient, the system including an implant. The implant can have an expandable body and a flow restrictor. The expandable body can have a proximal end, a distal end and a lumen extending from the proximal end to the distal end, the expandable body configured to fold into a collapsed configuration for delivery into the patient and expand from the collapsed configuration to an expanded configuration for implantation into the patient. The flow restrictor can be connected to the expandable body, the flow restrictor configured to adjustably occlude the lumen when the expandable body is in the expanded configuration.

[0008] In the permanently implantable flow restrictor system described above, or in other embodiments as described herein, one or more of the following features may be provided. In some embodiments, the expandable body has an expandable metal frame having a plurality of struts and defining a plurality of collapsible cells. In some embodiments, one or more of the struts of the expandable body are aligned obliquely relative to a longitudinal axis of the implant. In some embodiments, the expandable body is configured to fold laterally and / or by stretching. In some embodiments, the expandable body is configured to fold radially. In some embodiments, one or more of the struts of the expandable body merge into an end of the implant that is offset relative to a central longitudinal axis of the implant. In some embodiments, the flow restrictor has a magnet and the implant is magnetically actuated. In some embodiments, the flow restrictor is configured to move between a first non-occluding position and a second at least partially occluding position that at least partially blocks the lumen. In some embodiments, the flow restrictor has one or more struts connecting the magnet to the expandable body and material spanning the one or more struts. In some embodiments, the system further comprises a magnetic field source configured to actuate the implant. In some embodiments, the magnetic field source is configured to be implanted within an interstitial space and / or blood vessel adjacent to the implant. In some embodiments, the magnetic field source is configured to be disposed outside the patient's body. In some embodiments, the flow restrictor comprises a balloon and the implant is fluidically actuated. In some embodiments, the balloon is configured to expand from an unactuated state to an actuated state at least partially blocking the lumen. In some embodiments, the balloon is configured as a prolate or oblate spheroid. In some embodiments, the balloon is configured as an elongated partial circle secured to the interior of the expandable body and / or to an attachment portion of the expandable body. In some embodiments, the balloon is configured as a cylinder with a through opening secured to the interior of the expandable body and / or to an attachment portion of the expandable body.In some embodiments, the expandable body has an inner body and an outer body, and the balloon is disposed between the inner body and the outer body. In some embodiments, the inner body is configured to be more compliant than the outer body. In some embodiments, the inner body is configured to encase the balloon and hide it from flow through the lumen. In some embodiments, the inner body is configured to have a smooth inner surface. In some embodiments, the inner body is configured to deflect inwardly and at least partially occlude the lumen when the balloon is actuated. In some embodiments, the system further comprises a tube fluidly connected to the balloon and a fluid reservoir. In some embodiments, the fluid reservoir is configured to be implanted subcutaneously. In some embodiments, the tube is connected coaxially to the balloon. In some embodiments, the tube is connected off-center and / or tangentially to the balloon. In some embodiments, the expandable body further comprises a plurality of struts and / or membranes located downstream of the balloon relative to a direction of flow through the implant and disposed within the flow path of the lumen, the plurality of struts and / or membranes configured to filter and / or capture thrombus. In some embodiments, the flow restrictor further comprises a shaft configured to cover the balloon when the balloon is in an unactuated state. In some embodiments, the shaft is configured to hide the balloon from flow through the lumen when the balloon is in an unactuated state. In some embodiments, the flow restrictor comprises a material, balloon and / or wire configured to change shape when heated, and the implant is thermally actuated. In some embodiments, the flow restrictor comprises a material, balloon and / or wire configured to change shape when moved, and the implant is mechanically actuated. In some embodiments, the flow restrictor comprises a shape memory material configured to at least partially occlude the lumen when mechanically actuated.

[0009] Disclosed herein is a permanently implantable flow restriction system including an implantable control unit having a housing and an actuator disposed within the housing, an implant having an expandable body having a proximal end, a distal end and a longitudinally extending lumen and a flow restrictor configured to adjustably occlude the lumen when the expandable body is in an expanded configuration, a tube configured to connect the proximal end of the implant's expandable body to the housing of the implantable control unit, and a shaft disposed for movement within the tube and configured to connect the actuator of the implantable control unit to the flow restrictor of the implant, such that actuation of the actuator of the implantable control unit causes the shaft to move within the tube to cause the flow restrictor of the implant to adjustably occlude the lumen.

[0010] In the permanently implantable flow restriction system described above, or in other embodiments as described herein, one or more of the following features may be provided. In some embodiments, the expandable body of the implant further comprises a filter portion disposed adjacent the proximal end and configured to capture thrombi, the filter portion having a plurality of struts extending radially outward and distally from a connection between the proximal end of the expandable body and the tube, and a radial support portion connected to the filter portion and disposed distally of the filter portion and configured to fluidly seal against an inner wall of the patient's blood vessel, the radial support portion extending in a chevron pattern around the expandable body. In some embodiments, the flow restrictor is connected to the radial support portion and extends distally from the radial support portion. In some embodiments, the flow restrictor is integrally formed with the expandable body. In some embodiments, the flow restrictor has a plurality of petals, each formed by a pair of struts extending distally from near and meeting at a distal apex of the chevron ring of the radial support portion, and a material spanning each of the plurality of petals. In some embodiments, the flow restrictor has three or more petals. In some embodiments, the material further spans the radial support. In some embodiments, the distal end of each petal of the flow restrictor connects to a distal end of the shaft via a suture or wire, and proximal sliding of the shaft within the tube causes the suture or wire to pull the distal end of each petal of the flow restrictor toward each other to at least partially occlude the lumen. In some embodiments, the distal end of the tube is fluidly sealed to the shaft by a collapsible and extendable flexible coupling. In some embodiments, the implant is configured to be implanted within the patient's inferior vena cava below the patient's renal veins, and the distal end of the flow restrictor is positioned to receive blood flow through the implant. In some embodiments, the system further comprises one or more pressure sensors configured to measure a vascular pressure of the patient and to output at least one signal responsive to the measured pressure. In some embodiments, the one or more pressure sensors comprises a pressure sensor configured to measure a renal pressure of the patient.In some embodiments, the pressure sensor configured to measure the patient's renal pressure is disposed proximal to the flow restrictor. In some embodiments, the pressure sensor configured to measure the patient's renal pressure is disposed adjacent to the proximal end of the expandable body or the distal end of the tube. In some embodiments, the one or more pressure sensors include a pressure sensor configured to measure the patient's inferior vena cava pressure. In some embodiments, the pressure sensor configured to measure the patient's inferior vena cava pressure is disposed proximal or distal to the flow restrictor. In some embodiments, the pressure sensor configured to measure the patient's inferior vena cava pressure is disposed adjacent to the distal end of the expandable body. In some embodiments, the implantable control unit further comprises a processor, the processor operably connected to the one or more pressure sensors and configured to receive and process at least one signal to measure the pressure of the patient's blood vessel. In some embodiments, the implantable control unit further comprises a communication module operably connected to the processor and configured to wirelessly communicate with an external device. In some embodiments, the communication module transmits the measured pressure of the patient's blood vessel to the external device. In some embodiments, the processor is operatively connected to an actuator of the implantable control unit, and based on the measured pressure, the patient or user can digitally actuate the actuator via an external device, thereby causing the flow restrictor of the implant to adjustably occlude the lumen. In some embodiments, the expandable body further comprises one or more anchors configured to secure the implant within the patient's blood vessel. In some embodiments, the implantable control unit is configured to be powered by a battery disposed within the housing. In some embodiments, the battery of the implantable control unit is configured to be charged by inductive charging. In some embodiments, the implantable control unit is configured to be powered by induction.

[0011] Disclosed herein is an implant for controllably and selectively occluding, restricting, and / or diverting vascular flow in a patient. The implant can be configured to be implanted within the patient's inferior vena cava. The implant can have an expandable body having a proximal end, a distal end, and a longitudinally extending lumen, and a flow restrictor extending from the expandable body, the flow restrictor configured to adjustably occlude the lumen when the expandable body is in an expanded configuration. When implanted, the flow restrictor can be configured to be located upstream of the expandable body with respect to blood flow.

[0012] In the implants described above, or in other embodiments as described herein, one or more of the following features may be provided. In some embodiments, the expandable body of the implant further comprises a filter portion disposed adjacent the proximal and / or distal end and configured to capture thrombi. In some embodiments, the flow restrictor comprises a plurality of petals configured to fold radially inward to adjustably occlude the lumen, an outer surface of the plurality of petals configured to occlude blood flow when folded radially inward. In some embodiments, each of the plurality of petals is formed by a pair of struts extending from the expandable body and meeting at a distal apex. In some embodiments, the flow restrictor carries an occluding material, and an area between the plurality of petals is free of occluding material. In some embodiments, the occluding material further spans at least a portion of the expandable body. In some embodiments, the flow restrictor has a non-circular opening when at least partially occluding the lumen. In some embodiments, the flow restrictor has a star-shaped opening when at least partially occluding the lumen.

[0013] Disclosed herein is a method for controllably and selectively occluding, restricting, and / or bypassing blood flow through a blood vessel of a patient, which may include measuring renal pressure from an implant, detecting an increase in renal pressure, transmitting an indication of the increased renal pressure to an external device, and receiving a command from the external device to activate the implant, where activating the implant causes the implant to at least partially occlude blood through a blood vessel of the patient's vascular system.

[0014] Disclosed herein is a permanently implantable flow restriction system that may include an implant configured for implantation within a patient's inferior vena cava to adjustably occlude the inferior vena cava, the implant having a pressure sensor, and an implantable control unit, the implantable control unit having an actuator, the actuator causing the implant to adjustably occlude the inferior vena cava upon actuation of the actuator, a processor operatively connected to the pressure sensor and configured to receive and process signals from the pressure sensor to measure pressure in the inferior vena cava, and a communications module operatively connected to the processor and configured to wirelessly communicate with an external device, the processor further configured to receive commands from the external device to actuate the actuator, causing the implant to adjustably occlude the inferior vena cava.

[0015] In the permanently implantable flow restriction system described above, or in other embodiments as described herein, one or more of the following features may be provided. In some embodiments, the pressure sensor is further configured to measure the patient's renal pressure. In some embodiments, the system does not include an auxiliary device or a pump. In some embodiments, the implantable control unit further comprises a housing, and the actuator is disposed within the housing. In some embodiments, the implant is configured to be implanted within the inferior vena cava upstream of the patient's renal veins.

[0016] Disclosed herein is a permanently implantable flow restriction system. The system can include an implant configured to be implanted within a patient's inferior vena cava to adjustably occlude the inferior vena cava, and an implantable control unit removably connected to the implant, the implantable control unit having an actuator, the actuator causing the implant to adjustably occlude the inferior vena cava upon actuation of the actuator, a processor configured to receive commands to actuate the actuator, and a communications module operably connected to the processor and configured to wirelessly communicate with an external device. In some aspects, the implantable control unit further includes a housing, the actuator disposed within the housing. In some aspects, the implant is configured to be implanted within the patient's inferior vena cava upstream of the renal veins.

[0017] Disclosed herein is a permanently implantable flow restriction system that can include an implant configured for implantation within a patient's inferior vena cava upstream of the patient's renal veins to adjustably occlude the inferior vena cava, and an implantable control unit operatively connected to the implant via a tube, the control unit having an actuator, actuation of the actuator causing the implant to adjustably occlude the inferior vena cava, a processor configured to receive commands to actuate the actuator, and a communications module operatively connected to the processor and configured to wirelessly communicate with an external device.

[0018] Disclosed herein is a method of implanting a permanently implantable flow restriction system in a patient, the method including: accessing the patient's subclavian vein, implanting an implant within the patient's inferior vena cava below the patient's renal veins, the implant configured to at least partially occlude the inferior vena cava upon activation, testing activation of the implant, forming a subclavian subcutaneous pocket for an implantable controller, the implantable controller configured to activate the implant to at least partially occlude the inferior vena cava, operably connecting the implant to the implantable controller, and implanting the implantable controller within the subclavian subcutaneous pocket.

[0019] In the above method, or in other embodiments as described herein, one or more of the following features may be provided. In some embodiments, the method further comprises identifying a renal vein of the patient. In some embodiments, the method further comprises testing the functionality of the system once the implantable controller is operably connected to the implant. In some embodiments, testing the functionality of the system comprises digitally operating the system via an external device.

[0020] Disclosed herein is a method for controllably and selectively occluding, restricting, and / or diverting vascular flow in a patient, which may include measuring inferior vena cava pressure from an implant implanted in the patient's inferior vena cava upstream of the patient's renal veins, detecting an increase in inferior vena cava pressure, transmitting an indication of the increased inferior vena cava pressure to an external device, and receiving an instruction from the external device to actuate the implant, where actuating the implant causes the implant to at least partially occlude blood flow through the inferior vena cava.

[0021] In the above methods, or in other embodiments as described herein, one or more of the following features may be provided. In some embodiments, actuating the implant to at least partially occlude blood flow through the inferior vena cava promotes renal circulation. In some embodiments, actuating the implant to at least partially occlude blood flow through the inferior vena cava promotes diuresis. In some embodiments, actuating the implant to at least partially occlude blood flow through the inferior vena cava reduces renal vein pressure. In some embodiments, the method further comprises measuring renal vein pressure from the implant when blood flow through the inferior vena cava is at least partially occluded by the implant. In some embodiments, the implant is permanently implanted.

[0022] Disclosed herein is a method for controllably and selectively occluding, restricting, and / or diverting vascular flow in a patient. The method can include measuring inferior vena cava pressure from an implant implanted in the patient's inferior vena cava upstream of the patient's renal veins, detecting when the inferior vena cava pressure reaches a threshold value, transmitting an indication to an external device that the inferior vena cava pressure has reached a threshold value, and receiving an indication from the external device to actuate the implant, whereby actuating the implant causes the implant to at least partially occlude blood flow through the inferior vena cava. In some embodiments, the implant is permanently implanted.

[0023] Disclosed herein is a flow restriction system. The flow restriction system may be a permanently implantable flow restriction system. The flow restriction system may include an implant configured to be implanted in a patient's inferior vena cava upstream of the patient's renal veins and to adjustably occlude the inferior vena cava, and an implantable control unit operably connected to the implant via a tube, the implantable control unit having an actuator, where actuation of the actuator causes the implant to adjustably occlude the inferior vena cava, a processor configured to receive commands to actuate the actuator, and a communication module operably connected to the processor and configured to wirelessly communicate with an external device.

[0024] In the above system, or in other aspects as described herein, one or more of the following features may be provided. In some aspects, the implant has an expandable body having a proximal end, a distal end, and a longitudinally extending lumen, and a flow restrictor configured to hinge relative to the expandable body to at least partially restrict flow through the lumen. In some aspects, the flow restrictor has a plurality of struts and a material spanning the plurality of struts, the material configured to block blood flow. In some aspects, the flow restrictor is disposed adjacent a distal end of the expandable body such that, when implanted within the inferior vena cava, the flow restrictor is upstream of the expandable body with respect to blood flow. In some aspects, the implant further comprises a filter portion disposed adjacent a proximal end of the expandable body, the filter portion configured to capture thrombus. In some aspects, the implant has a pressure sensor operably connected to a processor of the implantable control unit. In some aspects, the implantable control unit is configured to wirelessly transmit pressure measurements from the pressure sensor to an external device. In some aspects, the system further comprises an external device. In some embodiments, the external device comprises a handheld device or a mobile device. In some embodiments, actuation of the actuator to cause the implant to adjustably occlude the inferior vena cava is controlled via the external device. In some embodiments, said actuation via the external device is controlled by a patient or user. In some embodiments, the flow restrictor has a non-circular opening when at least partially restricting flow through the lumen. In some embodiments, the system does not include an auxiliary device or a pump. In some embodiments, the implantable control unit is configured to be removably connectable to the implant. In some embodiments, the implant is configured to be mechanically actuated by wires.

[0025] Disclosed herein is a flow restriction system. The flow restriction system may be a permanently implantable flow restriction system. The flow restriction system may include an implantable control unit having a housing and an actuator disposed within the housing, an implant including an expandable body having a proximal end, a distal end, and a longitudinally extending lumen, and a flow restrictor configured to adjustably occlude the lumen when the expandable body is in an expanded configuration, a tube configured to connect the proximal end of the implant's expandable body to the housing of the implantable control unit, and a shaft movably disposed within the tube and configured to connect the actuator of the implantable control unit to the flow restrictor of the implant, such that actuation of the actuator of the implantable control unit causes the shaft to move within the tube to cause the flow restrictor of the implant to adjustably occlude the lumen.

[0026] In the above system, or in other embodiments as described herein, one or more of the following features may be provided. In some embodiments, the expandable body of the implant further comprises a filter portion disposed adjacent the proximal end and configured to capture thrombi, the filter portion including a plurality of struts extending radially outward and distally from a connection between the proximal end of the expandable body and the tube, and a radial support portion connected to the filter portion and disposed distally of the filter portion, the radial support portion configured to fluidly seal against an inner wall of the patient's blood vessel. In some embodiments, the flow restrictor is connected to the radial support portion and extends distally from the radial support portion. In some embodiments, the flow restrictor is integrally formed with the expandable body. In some embodiments, the flow restrictor has a plurality of petals each formed by a pair of struts extending distally from the radial support portion and joining at a distal apex, and material spanning each of the plurality of petals. In some embodiments, the flow restrictor has three or more petals. In some embodiments, the material further spans at least a portion of the radial support portion. In some embodiments, the distal end of each petal of the flow restrictor connects to the distal end of the shaft via a suture or wire, and the suture or wire pulls the distal ends of the petals of the flow restrictor toward each other to at least partially occlude the lumen upon proximal sliding or rotation of the shaft within the tube. In some embodiments, the distal end of the tube is fluidly sealed to the shaft by a collapsible and extendable flexible coupling. In some embodiments, the implant is configured to be implanted within the patient's inferior vena cava below the patient's renal vein, and the distal end of the flow restrictor is positioned to initially receive blood flow through the implant. In some embodiments, the system further comprises one or more pressure sensors configured to measure a pressure in the patient's blood vessel and output at least one signal responsive to the measured pressure. In some embodiments, the one or more pressure sensors comprise a pressure sensor configured to measure the patient's renal pressure. In some embodiments, the pressure sensor configured to measure the patient's renal pressure is positioned proximal to the flow restrictor.In some embodiments, the pressure sensor configured to measure the patient's renal pressure is disposed adjacent to the proximal end of the expandable body or the distal end of the tube. In some embodiments, the one or more pressure sensors include a pressure sensor configured to measure the patient's inferior vena cava pressure. In some embodiments, the pressure sensor configured to measure the patient's inferior vena cava pressure is disposed proximal or distal to the flow restrictor. In some embodiments, the pressure sensor configured to measure the patient's inferior vena cava pressure is disposed adjacent to the distal end of the expandable body. In some embodiments, the implantable control unit further comprises a processor, the processor operably connected to the one or more pressure sensors and configured to receive and process at least one signal to measure the pressure of the patient's blood vessel. In some embodiments, the implantable control unit further comprises a communication module operably connected to the processor and configured to wirelessly communicate with an external device. In some embodiments, the communication module transmits the measured pressure of the patient's blood vessel to the external device. In some embodiments, the processor is operatively connected to an actuator of the implantable control unit, and based on the measured pressure, the actuator can be digitally actuated by a patient or user via an external device, thereby causing a flow restrictor of the implant to adjustably occlude the lumen. In some embodiments, the system further comprises an external device. In some embodiments, the expandable body further comprises one or more anchors configured to secure the implant within a blood vessel of the patient. In some embodiments, the implantable control unit is configured to be powered by a battery disposed within the housing. In some embodiments, the battery is configured to be charged by inductive charging. In some embodiments, the implantable control unit is configured to be powered by induction.

[0027] Disclosed herein is an implantable flow restriction system that may include an implant having an expandable body having a metal frame having a proximal end, a distal end, and a longitudinally extending lumen, a flow restrictor having a plurality of petals, each formed by a plurality of struts, and material spanning each of the plurality of petals, the flow restrictor configured to hinge relative to the expandable body to at least partially restrict flow through the lumen, and an implantable control unit having an actuator configured to operatively connect to the flow restrictor of the implant, a processor configured to receive commands to actuate the actuator, and a communications module operatively connected to the processor and configured to wirelessly communicate with an external device, where actuation of the actuator causes the flow restrictor to at least partially restrict flow through the lumen.

[0028] In the above system, or in other embodiments as described herein, one or more of the following features may be provided. In some embodiments, the system further comprises a tube configured to connect a proximal end of the expandable body of the implant to the implantable control unit, and a shaft arranged to move within the tube and configured to connect an actuator of the implantable control unit to a flow restrictor of the implant, the shaft being moved within the tube to cause the flow restrictor of the implant to at least partially restrict flow through the lumen upon actuation of the actuator of the implantable control unit. In some embodiments, the implant further comprises a filter portion arranged adjacent the proximal end of the expandable body, the filter portion being configured to capture thrombus. In some embodiments, the plurality of struts forming each of the plurality of petals extend distally from the expandable body and comprise a pair of struts joined at a distal apex. In some embodiments, the implant comprises a pressure sensor operably connectable to a processor of the implantable control unit. In some embodiments, the implantable control unit is configured to wirelessly transmit pressure measurements from the pressure sensor to an external device. In some embodiments, the system further comprises an external device. In some embodiments, the external device comprises a handheld device or a mobile device. In some embodiments, actuation of the actuator to cause the flow restrictor to at least partially restrict flow through the lumen is controlled via an external device. In some embodiments, the implant is configured to be implanted within the patient's inferior vena cava upstream of the patient's renal vein and to adjustably occlude blood flow in the inferior vena cava when the flow restrictor at least partially restricts flow through the lumen of the implant. In some embodiments, when implanted within the patient, the flow restrictor of the implant is configured to be located upstream of the expandable body with respect to flow through the lumen. In some embodiments, an outer surface of the plurality of petals is configured to occlude blood flow when hinged relative to the expandable body.

[0029] Disclosed herein is an implantable flow restriction system that may include an implant having an expandable body having a proximal end, a distal end, and a longitudinally extending lumen, and a flow restrictor configured to be secured within a vessel of a patient's vasculature, and an implantable control unit having an actuator configured to operably connect to the flow restrictor of the implant, a processor configured to receive commands to actuate the actuator, and a communications module operably connected to the processor and configured to wirelessly communicate with an external device, where actuation of the actuator causes the flow restrictor to retract a wall of the vessel to at least partially restrict flow through the lumen.

[0030] In the above system, or in other embodiments as described herein, one or more of the following features may be provided. In some embodiments, the system further comprises a tube configured to connect a proximal end of the expandable body of the implant to an implantable control unit, and a shaft arranged to move within the tube and configured to connect an actuator of the implantable control unit to a flow restrictor of the implant, such that actuation of the actuator of the implantable control unit causes the shaft to move within the tube such that the flow restrictor of the implant retracts a wall of the vessel to at least partially restrict flow through the lumen. In some embodiments, the flow restrictor has a plurality of petals, each formed by a plurality of struts and configured to hinge relative to the expandable body. In some embodiments, the plurality of struts forming each of the plurality of petals extend distally from the expandable body and have a pair of struts joining at a distal apex. In some embodiments, the flow restrictor further comprises material spanning each of the plurality of petals. In some embodiments, the flow restrictor is configured to at least partially bite into the vessel wall. In some embodiments, the flow restrictor further comprises one or more anchors configured to secure the flow restrictor to the vessel wall. In some embodiments, the implant comprises a pressure sensor operably connectable to a processor of the implantable control unit. In some embodiments, the implantable control unit is configured to wirelessly transmit pressure measurements from the pressure sensor to an external device. In some embodiments, the system further comprises an external device. In some embodiments, the external device comprises a handheld device or a mobile device. In some embodiments, actuation of the actuator to cause the flow restrictor to retract the walls of the blood vessel to at least partially restrict flow through the lumen is controlled via the external device. In some embodiments, the implant is implanted within the patient's inferior vena cava upstream of the patient's renal vein and configured to adjustably occlude blood flow in the inferior vena cava when the flow restrictor retracts the walls of the inferior vena cava to at least partially restrict flow through the lumen of the implant.In some embodiments, when implanted in a patient, the flow restrictor of the implant is configured to be located upstream of the expandable body with respect to flow through the lumen, hi some embodiments, the system does not include an auxiliary device or pump.

[0031] Disclosed herein is a method of implanting a permanently implantable flow restriction system in a patient, which may include implanting an implant in the patient's inferior vena cava below the patient's renal veins, the implant configured to at least partially occlude the inferior vena cava upon activation, subcutaneously implanting an implantable controller, and operably connecting the implant to the implantable controller, the implantable controller having an actuator configured to actuate the implant to at least partially occlude the inferior vena cava, and a processor configured to receive commands to actuate the actuator.

[0032] In the above method, or in other embodiments as described herein, one or more of the following features may be provided. In some embodiments, the implant is operably connected to the implantable controller prior to implanting the implantable controller. In some embodiments, the method further includes accessing the patient's subclavian vein. In some embodiments, the method further includes testing operation of the implant after implantation of the implant in the inferior vena cava and prior to operably connecting the implant to the implantable controller. In some embodiments, implanting the implantable controller includes subcutaneously implanting the implantable controller adjacent the patient's clavicle. In some embodiments, the implantable controller further includes a communications module operably connected to the processor and configured to wirelessly communicate with an external device. In some embodiments, the method further includes activating the implant to at least partially occlude the inferior vena cava. In some embodiments, activating the implant includes receiving a command from the external device. In some embodiments, the implant has an expandable body having a proximal end, a distal end, and a longitudinally extending lumen, and a flow restrictor configured to hinge relative to the expandable body to at least partially restrict flow through the lumen. In some embodiments, the flow restrictor is disposed adjacent a distal end of the expandable body, and implanting the implant within the inferior vena cava includes disposing the distal end to initially receive blood flow through the implant. In some embodiments, the implantable flow restriction system further includes a tube extending from the implant and configured to removably connect to the implantable controller, and a shaft disposed to travel within the tube and configured to removably connect an actuator of the implantable controller to the flow restrictor of the implant, and operably connecting the implant to the implantable controller includes connecting the tube to the implantable controller and connecting the shaft to the actuator of the implantable controller.In some aspects, the method includes implanting the tube and shaft such that the tube and shaft extend from the implant through the inferior vena cava, through the right atrium, through at least a portion of the superior vena cava, and through at least a portion of the patient's subclavian vein. In some aspects, the implant further includes a pressure sensor disposed downstream of the flow restrictor relative to a direction of blood flow in the inferior vena cava, the pressure sensor configured to measure pressure. In some aspects, the pressure sensor is disposed adjacent to the patient's renal vein when the implant is implanted in the inferior vena cava below the renal vein. In some aspects, the method further includes removing the implant and the implanted controller from the patient.

[0033] Disclosed herein is a method for controllably and selectively occluding, restricting, and / or diverting vascular flow in a patient, which may include measuring inferior vena cava pressure from an implant implanted in the patient's inferior vena cava upstream of the patient's renal veins, transmitting the inferior vena cava pressure from an implantable controller located in the patient to an external device, receiving by the implantable controller from the external device a command to actuate the implant, and actuating the implant, where actuating the implant causes the implant to at least partially occlude blood flow through the inferior vena cava.

[0034] In the above method, or in other embodiments as described herein, one or more of the following features may be provided. In some embodiments, actuating the implant to at least partially occlude blood flow through the inferior vena cava promotes renal circulation. In some embodiments, actuating the implant to at least partially occlude blood flow through the inferior vena cava promotes diuresis. In some embodiments, actuating the implant to at least partially occlude blood flow through the inferior vena cava reduces renal vein pressure. In some embodiments, actuating the implant to at least partially occlude blood flow through the inferior vena cava reduces cardiac preload. In some embodiments, the method further comprises measuring renal vein pressure from the implant when blood flow through the inferior vena cava is at least partially occluded by the implant. In some embodiments, the method further comprises detecting an increase in inferior vena cava pressure and transmitting an indication of the increased inferior vena cava pressure to an external device. In some embodiments, the method further comprises detecting that the inferior vena cava pressure has reached a threshold value and transmitting an indication of the inferior vena cava pressure has reached a threshold value to an external device. In some embodiments, the implant has a flow restrictor configured to at least partially occlude blood flow through the inferior vena cava when the implant is activated, and a pressure sensor disposed downstream of the flow restrictor with respect to a direction of blood flow in the inferior vena cava, the pressure sensor configured to measure said pressure. In some embodiments, activation of the implant is controlled via an external device. In some embodiments, activation of the implant is controlled by the patient via the external device. In some embodiments, a command to activate the implant is received wirelessly from the external device. In some embodiments, the method further includes receiving a command from the external device to deactivate the implant, where deactivating the implant causes the implant to not occlude blood flow through the inferior vena cava. In some embodiments, the method further includes deactivating the implant after a duration.In some embodiments, the method further includes deactivating the implant after the pressure measured from the implant reaches a threshold value. In some embodiments, the method further includes deactivating the implant a duration after the pressure measured from the implant reaches a threshold value. In some embodiments, the implantable controller has a communication module configured to wirelessly communicate with an external device, a processor operably connected to the communication module and configured to receive instructions to activate the implant, and an actuator operably connected to the processor and configured to activate the implant. In some embodiments, the actuating the implant includes hingedly moving the flow restrictor relative to the expandable body of the implant to at least partially occlude blood flow through the inferior vena cava. In some embodiments, the actuating the implant includes mechanically actuating the implant by a wire.

[0035] Disclosed herein is a method for controllably and selectively occluding, restricting, and / or diverting flow through a blood vessel of a patient, which may include activating a flow restrictor implanted within the blood vessel of the patient, where activating the flow restrictor causes the flow restrictor to retract a wall of the blood vessel to at least partially restrict flow through the blood vessel.

[0036] In the above method, or in other embodiments as described herein, one or more of the following features may be provided. In some embodiments, the flow restrictor is implanted in the patient's inferior vena cava upstream of the patient's renal vein, and actuating the flow restrictor causes the flow restrictor to retract the walls of the inferior vena cava to at least partially restrict flow through the inferior vena cava. In some embodiments, actuating the flow restrictor to cause the flow restrictor to retract the walls of the inferior vena cava to at least partially restrict flow through the inferior vena cava promotes renal circulation. In some embodiments, actuating the flow restrictor to cause the flow restrictor to retract the walls of the inferior vena cava to at least partially restrict flow through the inferior vena cava promotes diuresis. In some embodiments, actuating the flow restrictor to cause the flow restrictor to retract the walls of the inferior vena cava to at least partially restrict flow through the inferior vena cava reduces renal vein pressure. In some embodiments, actuating the flow restrictor to cause the flow restrictor to retract the walls of the inferior vena cava to at least partially restrict flow through the inferior vena cava reduces cardiac preload. In some embodiments, the method further comprises measuring the inferior venous pressure from an implant including a flow restrictor. In some embodiments, the method further comprises transmitting the inferior venous pressure from an implantable controller located within the patient to an external device. In some embodiments, the method further comprises receiving, by the implantable controller, a command from the external device to activate the flow restrictor. In some embodiments, the method further comprises measuring the renal vein pressure from an implant having a flow restrictor when flow through the inferior vena cava is at least partially restricted. In some embodiments, the method further comprises detecting an increase in the inferior vena cava pressure and transmitting an indication to the external device indicating that the inferior vena cava pressure has increased. In some embodiments, the method further comprises detecting that the inferior vena cava pressure has reached a threshold value and transmitting an indication to the external device indicating that the inferior vena cava pressure has reached a threshold value. In some embodiments, the operation of the flow restrictor is controlled via the external device.In some embodiments, the command to activate the flow restrictor is received wirelessly from an external device. In some embodiments, the method further includes receiving a command from the external device to stop operation of the flow restrictor, whereby the walls of the inferior vena cava do not obstruct flow through the inferior vena cava. In some embodiments, the method further includes stopping operation of the flow restrictor after a duration. In some embodiments, the method further includes stopping operation of the flow restrictor after a pressure measured from the implant reaches a threshold value. In some embodiments, the method further includes stopping operation of the implant after a duration after the pressure measured from the implant reaches a threshold value. In some embodiments, the implantable controller has a communication module configured to wirelessly communicate with the external device, a processor operably connected to the communication module, the processor configured to receive a command to activate the flow restrictor, and an actuator operably connected to the processor, the actuator configured to activate the flow restrictor. In some embodiments, activating the flow restrictor includes hingedly moving the flow restrictor relative to an expandable body of the implant having the flow restrictor. In some embodiments, actuating the flow restrictor comprises mechanically actuating the flow restrictor by a wire.

[0037] Disclosed herein is an implant configured to be implanted in a patient to controllably and selectively occlude, restrict, and / or divert blood flow in the patient's blood vessel. The implant can include an expandable body having a proximal end, a distal end, and a longitudinally extending lumen, a filter portion disposed adjacent the proximal end and configured to capture thrombi, and a flow restrictor extending from the distal end of the expandable body, the flow restrictor configured to adjustably occlude the lumen when the expandable body is in an expanded configuration, the flow restrictor configured to be disposed upstream of the expandable body with respect to blood flow when implanted.

[0038] In the implants described above, or in other embodiments as described herein, one or more of the following features may be provided. In some embodiments, the filter portion has a plurality of struts extending proximally and radially inward. In some embodiments, the expandable body of the implant further comprises a radial support portion connected to the filter portion and disposed distally of the filter portion, the radial support portion configured to fluidly seal against an inner wall of the patient's blood vessel. In some embodiments, the flow restrictor is connected to the radial support portion and extends distally from the radial support portion. In some embodiments, the flow restrictor is integrally formed with the expandable body. In some embodiments, the flow restrictor has a plurality of petals configured to fold radially inward to adjustably occlude the lumen, an outer surface of the plurality of petals configured to occlude blood flow when folded radially inward. In some embodiments, each of the plurality of petals is formed by a pair of struts extending from the expandable body and meeting at a distal apex. In some embodiments, the flow restrictor has three or more petals. In some embodiments, the flow restrictor carries an occlusive material, and the area between the plurality of petals is free of occlusive material. In some embodiments, the flow restrictor carries an occlusive material, and the occlusive material spans the area between the plurality of petals. In some embodiments, the occlusive material further spans at least a portion of the expandable body. In some embodiments, the flow restrictor has a non-circular opening when at least partially occluding the lumen. In some embodiments, the flow restrictor has a star-shaped opening when at least partially occluding the lumen. In some embodiments, the implant further comprises a pressure sensor. In some embodiments, the pressure sensor is disposed proximal to the flow restrictor. In some embodiments, the implant further comprises an anchor extending proximally from the radial support portion, the anchor configured to secure the implant within a blood vessel of the patient. In some embodiments, the implant is configured to be implanted within the patient's inferior vena cava.In some aspects, a system is provided that includes an implant as described herein and a delivery sheath configured to embed the implant, wherein the implant remains in a folded configuration upon extension from the delivery sheath while at least a portion of the radial support portion remains within the delivery sheath.

[0039] Disclosed herein is an implant configured to be implanted in a patient to occlude, restrict, and / or divert flow of a blood vessel of the patient, which may include an expandable body having a metal frame having a proximal end, a distal end, and a longitudinally extending lumen, and a flow restrictor having a plurality of petals each formed by a pair of struts extending distally from the expandable body and joining at a distal apex, and material spanning each of the plurality of petals, the flow restrictor configured to fold radially inward to at least partially restrict flow through the lumen.

[0040] In the implants described above, or in other embodiments as described herein, one or more of the following features may be provided. In some embodiments, the expandable body of the implant further comprises a filter portion disposed adjacent the proximal end and configured to capture thrombi. In some embodiments, the expandable body of the implant further comprises a radial support portion connected to the filter portion and disposed distal to the filter portion, the radial support portion configured to fluidly seal against an inner wall of the patient's blood vessel. In some embodiments, the flow restrictor is integrally formed with the expandable body. In some embodiments, an outer surface of the plurality of petals of the flow restrictor is configured to occlude blood flow when folded radially inward. In some embodiments, the flow restrictor has three or more petals. In some embodiments, the area between the plurality of petals is free of material. In some embodiments, the material further spans the area between the plurality of petals. In some embodiments, the material further spans at least a portion of the expandable body. In some embodiments, the flow restrictor has a non-circular opening when at least partially occluding the lumen. In some embodiments, the flow restrictor has a star-shaped opening when at least partially occluding the lumen. In some embodiments, the implant further comprises a pressure sensor. In some embodiments, the pressure sensor is disposed proximal to the flow restrictor. In some embodiments, the implant further comprises an anchor extending proximally from the radial support portion, the anchor configured to secure the implant within the patient's blood vessel. In some embodiments, the implant is configured to be implanted within the patient's inferior vena cava. In some embodiments, when implanted, the flow restrictor is configured to be located upstream of the expandable body with respect to blood flow. In some embodiments, a system is provided that includes an implant as described herein and a delivery sheath configured to implant the implant. In some embodiments, the system, the implant is configured to remain in a folded configuration upon extending from the delivery sheath while at least a portion of the radial support portion remains within the delivery sheath.

[0041] Disclosed herein is an implant configured to be implanted into a patient to occlude, restrict, and / or divert flow in a blood vessel of the patient. The implant can have an expandable body having a proximal end, a distal end, and a longitudinally extending lumen, and a flow restrictor configured to be secured within a blood vessel of the patient, such that actuation of the flow restrictor causes the flow restrictor to retract a wall of the blood vessel to at least partially restrict flow through the lumen.

[0042] In the implants described above, or in other embodiments as described herein, one or more of the following features may be provided. In some embodiments, the flow restrictor has a plurality of petals, each formed by a plurality of struts and configured to hinge relative to the expandable body. In some embodiments, the struts forming each of the plurality of petals extend distally from the expandable body and have a pair of struts joining at a distal apex. In some embodiments, the flow restrictor further comprises material spanning each of the plurality of petals. In some embodiments, the flow restrictor is configured to at least partially bite into the vessel wall. In some embodiments, the flow restrictor further comprises one or more anchors configured to secure the flow restrictor to the vessel wall. In some embodiments, the flow restrictor is integrally formed with the expandable body. In some embodiments, the implant comprises a pressure sensor configured to measure pressure. In some embodiments, the pressure sensor is disposed proximal to the flow restrictor. In some embodiments, the expandable body of the implant further comprises a filter portion disposed adjacent a proximal end of the expandable body, the filter portion configured to capture thrombus. In some aspects, the filter portion has a plurality of struts extending proximally and radially inward. In some aspects, the implant is configured to be implanted within the patient's inferior vena cava. In some aspects, when implanted, the flow restrictor is configured to be located upstream of the expandable body with respect to flow through the lumen of the implant.

[0043] For purposes of providing a summary of the disclosure, certain aspects, advantages and novel features of certain embodiments have been described herein. It is to be understood that not necessarily all such advantages are achieved by any particular embodiment of the technology disclosed herein. Thus, the embodiments disclosed herein may be implemented or performed to achieve or optimize one advantage or group of advantages taught herein without necessarily achieving other advantages that may be taught or suggested herein.

[0044] 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]

[0045] [Figure 1A] FIG. 1 illustrates a patient's anatomy, including a heart with a right atrium, a right ventricle, a left atrium, and a left ventricle, a superior vena cava connected to the right atrium, an inferior vena cava connected to the right atrium and connected to the patient's renal and hepatic veins, and other blood vessels and organs of the patient. [Figure 1B] FIG. 1 illustrates a patient's anatomy including connections between the ducts of the patient's lymphatic system, such as the thoracic duct and right lymphatic duct, and the patient's veins. [Figure 2A] FIG. 1 illustrates a magnetically actuated, permanently implantable flow restriction system implanted within a patient, according to some aspects of the present disclosure. [Figure 2B] FIG. 1 illustrates a magnetically actuated, permanently implantable flow restriction system implanted within a patient, according to some aspects of the present disclosure. [Figure 3A] 1A-1D are various views of an embodiment of a magnetically actuated permanently implantable flow restriction system according to some aspects of the present disclosure. [Figure 3B]1A-1D are various views of an embodiment of a magnetically actuated permanently implantable flow restriction system according to some aspects of the present disclosure. [Figure 3C] 1A-1D are various views of an embodiment of a magnetically actuated permanently implantable flow restriction system according to some aspects of the present disclosure. [Figure 3D] 1A-1D are various views of an embodiment of a magnetically actuated permanently implantable flow restriction system according to some aspects of the present disclosure. [Figure 4A] 11A-11D are various views of another embodiment of a magnetically actuated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 4B] 11A-11D are various views of another embodiment of a magnetically actuated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 4C] 11A-11D are various views of another embodiment of a magnetically actuated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 4D] 11A-11D are various views of another embodiment of a magnetically actuated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 5A] 11A-11D are various views of another embodiment of a magnetically actuated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 5B] 11A-11D are various views of another embodiment of a magnetically actuated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 5C] 11A-11D are various views of another embodiment of a magnetically actuated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 5D] 11A-11D are various views of another embodiment of a magnetically actuated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 5E] 11A-11D are various views of another embodiment of a magnetically actuated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 5F]11A-11D are various views of another embodiment of a magnetically actuated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 6A] 11A-11D are various views of another embodiment of a magnetically actuated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 6B] 11A-11D are various views of another embodiment of a magnetically actuated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 6C] 11A-11D are various views of another embodiment of a magnetically actuated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 6D] 11A-11D are various views of another embodiment of a magnetically actuated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 7A] FIG. 1 illustrates a fluid-actuated, permanently implantable flow restriction system implanted within a patient, according to some aspects of the present disclosure. [Figure 7B] FIG. 1 illustrates a fluid-actuated, permanently implantable flow restriction system implanted within a patient, according to some aspects of the present disclosure. [Figure 8A] 1A-1D are various views of an embodiment of a fluid-actuated permanently implantable flow restriction system according to some aspects of the present disclosure. [Figure 8B] 1A-1D are various views of an embodiment of a fluid-actuated permanently implantable flow restriction system according to some aspects of the present disclosure. [Figure 8C] 1A-1D are various views of an embodiment of a fluid-actuated permanently implantable flow restriction system according to some aspects of the present disclosure. [Figure 8D] 1A-1D are various views of an embodiment of a fluid-actuated permanently implantable flow restriction system according to some aspects of the present disclosure. [Figure 9A] 11A-11D are various views of another embodiment of a fluid-actuated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 9B]11A-11D are various views of another embodiment of a fluid-actuated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 9C] 11A-11D are various views of another embodiment of a fluid-actuated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 9D] 11A-11D are various views of another embodiment of a fluid-actuated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 10A] 1A-1D illustrate various embodiments of a fluid-actuated, permanently implantable flow restriction system according to some aspects of the present disclosure. [Figure 10B] 1A-1D illustrate various embodiments of a fluid-actuated, permanently implantable flow restriction system according to some aspects of the present disclosure. [Figure 10C] 1A-1D illustrate various embodiments of a fluid-actuated, permanently implantable flow restriction system according to some aspects of the present disclosure. [Figure 11A] 1A-1D illustrate various embodiments of a fluid-actuated, permanently implantable flow restriction system according to some aspects of the present disclosure. [Figure 11B] 1A-1D illustrate various embodiments of a fluid-actuated, permanently implantable flow restriction system according to some aspects of the present disclosure. [Figure 11C] 1A-1D illustrate various embodiments of a fluid-actuated, permanently implantable flow restriction system according to some aspects of the present disclosure. [Figure 12A] 1A-1D illustrate various embodiments of a fluid-actuated, permanently implantable flow restriction system according to some aspects of the present disclosure. [Figure 12B] 1A-1D illustrate various embodiments of a fluid-actuated, permanently implantable flow restriction system according to some aspects of the present disclosure. [Figure 12C] 1A-1D illustrate various embodiments of a fluid-actuated, permanently implantable flow restriction system according to some aspects of the present disclosure. [Figure 13A]FIG. 13 illustrates another embodiment of a fluid-actuated, permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 13B] FIG. 13 illustrates another embodiment of a fluid-actuated, permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 13C] FIG. 13 illustrates another embodiment of a fluid-actuated, permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 13D] FIG. 13 illustrates another embodiment of a fluid-actuated, permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 14A] 13A-13D show various views of an embodiment of a fluid-actuated, permanently implantable flow restriction system according to some aspects of the present disclosure. [Figure 14B] 13A-13D show various views of an embodiment of a fluid-actuated, permanently implantable flow restriction system according to some aspects of the present disclosure. [Figure 14C] 13A-13D show various views of an embodiment of a fluid-actuated, permanently implantable flow restriction system according to some aspects of the present disclosure. [Figure 14D] 13A-13D show various views of an embodiment of a fluid-actuated, permanently implantable flow restriction system according to some aspects of the present disclosure. [Figure 15A] 1A-1C illustrate another embodiment of a fluid-actuated, permanently implantable flow restriction system and a method of manufacturing the fluid-actuated, permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 15B] 1A-1C illustrate another embodiment of a fluid-actuated, permanently implantable flow restriction system and a method of manufacturing the fluid-actuated, permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 15C] 1A-1C illustrate another embodiment of a fluid-actuated, permanently implantable flow restriction system and a method of manufacturing the fluid-actuated, permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 16A] 1A-1C illustrate another embodiment of a fluid-actuated, permanently implantable flow restriction system and another method of manufacturing a fluid-actuated, permanently implantable flow restriction system according to some aspects of the present disclosure. [Figure 16B] 1A-1C illustrate another embodiment of a fluid-actuated, permanently implantable flow restriction system and another method of manufacturing a fluid-actuated, permanently implantable flow restriction system according to some aspects of the present disclosure. [Figure 16C] 1A-1C illustrate another embodiment of a fluid-actuated, permanently implantable flow restriction system and another method of manufacturing a fluid-actuated, permanently implantable flow restriction system according to some aspects of the present disclosure. [Figure 17A] 11A-11D are various views of another embodiment of a fluid-actuated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 17B] 11A-11D are various views of another embodiment of a fluid-actuated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 18A] 11A-11D are various views of a frame of another embodiment of a fluid-actuated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 18B] 11A-11D are various views of a frame of another embodiment of a fluid-actuated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 18C] 11A-11D are various views of a frame of another embodiment of a fluid-actuated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 19A] 11A-11D are various views of a frame of another embodiment of a fluid-actuated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 19B] 11A-11D are various views of a frame of another embodiment of a fluid-actuated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 19C]11A-11D are various views of a frame of another embodiment of a fluid-actuated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 20A] 11A-11C show various views of a frame of another embodiment of a fluid-actuated, permanently implantable flow restriction system in a collapsed configuration and an expanded configuration, in accordance with some aspects of the present disclosure. [Figure 20B] 11A-11C show various views of a frame of another embodiment of a fluid-actuated, permanently implantable flow restriction system in a collapsed configuration and an expanded configuration, in accordance with some aspects of the present disclosure. [Figure 20C] 11A-11C show various views of a frame of another embodiment of a fluid-actuated, permanently implantable flow restriction system in a collapsed configuration and an expanded configuration, in accordance with some aspects of the present disclosure. [Figure 20D] 11A-11C show various views of a frame of another embodiment of a fluid-actuated, permanently implantable flow restriction system in a collapsed configuration and an expanded configuration, in accordance with some aspects of the present disclosure. [Figure 21A] FIG. 13 illustrates another embodiment of a fluid-actuated, permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 21B] FIG. 13 illustrates another embodiment of a fluid-actuated, permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 21C] 1 illustrates an embodiment of a mechanically actuated, permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 22A] FIG. 1 illustrates a thermally activated permanently implantable flow restriction system implanted within a patient, according to some aspects of the present disclosure. [Figure 22B] FIG. 1 illustrates a thermally activated permanently implantable flow restriction system implanted within a patient, according to some aspects of the present disclosure. [Figure 23A] FIG. 1 illustrates an embodiment of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 23B]FIG. 1 illustrates an embodiment of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 24A] 1A-1D illustrate various embodiments of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 24B] 1A-1D illustrate various embodiments of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 25A] 1A-1D illustrate various embodiments of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 25B] 1A-1D illustrate various embodiments of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 26A] 1A-1D illustrate various embodiments of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 26B] 1A-1D illustrate various embodiments of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 27A] 11A-11D are various views of another embodiment of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 27B] 11A-11D are various views of another embodiment of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 27C] 11A-11D are various views of another embodiment of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 27D] 11A-11D are various views of another embodiment of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 28A] 11A-11D are various views of another embodiment of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 28B]11A-11D are various views of another embodiment of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 28C] 11A-11D are various views of another embodiment of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 28D] 11A-11D are various views of another embodiment of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 29A] 11A-11D are various views of another embodiment of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 29B] 11A-11D are various views of another embodiment of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 29C] 11A-11D are various views of another embodiment of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 29D] 11A-11D are various views of another embodiment of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 30A] 11A-11D are various views of another embodiment of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 30B] 11A-11D are various views of another embodiment of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 31A] 11A-11D are various views of another embodiment of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 31B] 11A-11D are various views of another embodiment of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 32A] 11A-11D are various views of another embodiment of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 32B]11A-11D are various views of another embodiment of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 32C] 11A-11D are various views of another embodiment of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Fig. 32D] 11A-11D are various views of another embodiment of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 33A] 11A-11D are various views of another embodiment of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 33B] 11A-11D are various views of another embodiment of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 33C] 11A-11D are various views of another embodiment of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Figure 33D] 11A-11D are various views of another embodiment of a thermally activated permanently implantable flow restriction system in accordance with some aspects of the present disclosure. [Diagram 34] FIG. 1 illustrates a patient's anatomy, including the inferior vena cava, which is connected to the patient's renal system via the renal veins, and to the patient's other veins, along with their location relative to the patient's spine. [Figure 35A] 1 illustrates a method of occluding the inferior vena cava of a patient, according to some aspects of the present disclosure. [Figure 35B] 1 illustrates a method of occluding the inferior vena cava of a patient, according to some aspects of the present disclosure. [Figure 36A] FIG. 1 illustrates another extravascular method of occluding the inferior vena cava of a patient, according to some aspects of the present disclosure. [Figure 36B] FIG. 1 illustrates another extravascular method of occluding the inferior vena cava of a patient, according to some aspects of the present disclosure. [Figure 37A] FIG. 1 illustrates another extravascular method of occluding the inferior vena cava of a patient, according to some aspects of the present disclosure. [Figure 37B]FIG. 1 illustrates another extravascular method of occluding the inferior vena cava of a patient, according to some aspects of the present disclosure. [Figure 37C] FIG. 1 illustrates another extravascular method of occluding the inferior vena cava of a patient, according to some aspects of the present disclosure. [Figure 38] FIG. 1 illustrates another extravascular method of occluding the inferior vena cava of a patient, according to some aspects of the present disclosure. [Figure 39] FIG. 1 illustrates another extravascular method of occluding the inferior vena cava of a patient, according to some aspects of the present disclosure. [Diagram 40] FIG. 1 illustrates another extravascular method of occluding the inferior vena cava of a patient, according to some aspects of the present disclosure. [Diagram 41] FIG. 1 illustrates a control system for a permanently implantable flow restriction system according to some aspects of the present disclosure. [Diagram 42] FIG. 1 illustrates a permanently implantable flow restriction system implanted within a patient, according to some aspects of the present disclosure. [Figure 43A] 1 illustrates an embodiment of an implant for a permanently implantable flow restriction system, according to some aspects of the present disclosure. [Figure 43B] 1 illustrates an embodiment of an implant for a permanently implantable flow restriction system, according to some aspects of the present disclosure. [Figure 43C] 1 illustrates an embodiment of an implant for a permanently implantable flow restriction system, according to some aspects of the present disclosure. [Fig. 43D] 1 illustrates an embodiment of an implant for a permanently implantable flow restriction system, according to some aspects of the present disclosure. [Figure 44A] 43A-43D are various end views of the implant according to some embodiments of the present disclosure. [Figure 44B] 43A-43D are various end views of the implant according to some embodiments of the present disclosure. [Figure 44C] 43A-43D are various end views of the implant according to some embodiments of the present disclosure. [Fig.44D] 43A-43D, according to some aspects of the present disclosure. FIG. [Diagram 45] 43A-43D are flattened patterns of the expandable body of the implant according to some embodiments of the present disclosure. [Figure 46A] 1A-1D are various views of components of a permanently implantable flow restriction system according to some aspects of the present disclosure. [Figure 46B] 1A-1D are various views of components of a permanently implantable flow restriction system according to some aspects of the present disclosure. [Figure 47A] 43A-43D illustrate the interaction of various components of a flow restriction system that actuates the implant of FIGS. 43A-43D, according to some embodiments of the present disclosure. [Figure 47B] 43A-43D illustrate the interaction of various components of a flow restriction system that actuates the implant of FIGS. 43A-43D, according to some embodiments of the present disclosure. [Figure 47C] 43A-43D illustrate the interaction of various components of a flow restriction system that actuates the implant of FIGS. 43A-43D, according to some embodiments of the present disclosure. [Figure 47D] 43A-43D illustrate the interaction of various components of a flow restriction system that actuates the implant of FIGS. 43A-43D, according to some embodiments of the present disclosure. [Figure 48A] 1A-1C illustrate various embodiments of a flow restriction system implant with sensors positioned at various locations relative to the flow restrictor portion of the implant, in accordance with some aspects of the present disclosure. [Figure 48B] 1A-1C illustrate various embodiments of a flow restriction system implant with sensors positioned at various locations relative to the flow restrictor portion of the implant, in accordance with some aspects of the present disclosure. [Figure 48C] 1A-1C illustrate various embodiments of a flow restriction system implant with sensors positioned at various locations relative to the flow restrictor portion of the implant, in accordance with some aspects of the present disclosure. [Figure 49] 1 illustrates an embodiment of an implantable flow restriction system implant, according to some aspects of the present disclosure. [Figure 50] 1 illustrates an embodiment of an implantable flow restriction system implant, according to some aspects of the present disclosure. [Figure 51A] 1 illustrates an embodiment of an implantable flow restriction system implant, according to some aspects of the present disclosure. [Figure 51B] 1 illustrates an embodiment of an implantable flow restriction system implant, according to some aspects of the present disclosure. [Figure 52] 1 illustrates an embodiment of an implantable flow restriction system implant, according to some aspects of the present disclosure. [Figure 53] 1 illustrates an embodiment of an implantable flow restriction system implant, according to some aspects of the present disclosure. [Figure 54] 1 illustrates an embodiment of an implantable flow restriction system implant, according to some aspects of the present disclosure. [Figure 55A] 1A-1C illustrate the interaction of various components of a flow restriction system to actuate an implant of the flow restriction system, according to some aspects of the present disclosure. [Figure 55B] 1A-1C illustrate the interaction of various components of a flow restriction system to actuate an implant of the flow restriction system, according to some aspects of the present disclosure. [Figure 55C] 1A-1C illustrate the interaction of various components of a flow restriction system to actuate an implant of the flow restriction system, according to some aspects of the present disclosure. [Figure 56A] 1 illustrates an embodiment of an implantable flow restriction system implant, according to some aspects of the present disclosure. [Figure 56B] 1 illustrates an embodiment of an implantable flow restriction system implant, according to some aspects of the present disclosure. [Figure 57A]1 illustrates an embodiment of an implantable flow restriction system implant, according to some aspects of the present disclosure. [Figure 57B] 1 illustrates an embodiment of an implantable flow restriction system implant, according to some aspects of the present disclosure. [Figure 58A] 1 illustrates an embodiment of an implantable flow restriction system implant, according to some aspects of the present disclosure. [Figure 58B] 1 illustrates an embodiment of an implantable flow restriction system implant, according to some aspects of the present disclosure. [Figure 58C] 1 illustrates an embodiment of an implantable flow restriction system implant, according to some aspects of the present disclosure. [Figure 59] 1 illustrates an embodiment of an implantable flow restriction system implant, according to some aspects of the present disclosure. [Figure 60] 1 illustrates an embodiment of an implantable flow restriction system implant, according to some aspects of the present disclosure. [Figure 61A] 1 illustrates an embodiment of an implantable flow restriction system implant, according to some aspects of the present disclosure. [Figure 61B] 1 illustrates an embodiment of an implantable flow restriction system implant, according to some aspects of the present disclosure. [Figure 61C] 1 illustrates an embodiment of an implantable flow restriction system implant, according to some aspects of the present disclosure. [Figure 62] 1A-1C illustrate embodiments of anchors for an implantable flow restriction system implant according to some aspects of the present disclosure. [Figure 63] 1 illustrates an embodiment of an implantable flow restriction system implant, according to some aspects of the present disclosure. [Fig. 64A] 1A-1D illustrate an embodiment of a shaft of an implantable flow restriction system according to some aspects of the present disclosure. [Fig. 64B]1A-1D illustrate an embodiment of a shaft of an implantable flow restriction system according to some aspects of the present disclosure. [Figure 65] 1 is a schematic diagram illustrating certain features of an implantable controller and an external device of an implantable flow restriction system according to some aspects of the present disclosure. [Figure 66A] 1A-1C illustrate embodiments of connectors between components of a flow restriction system according to some aspects of the present disclosure. [Figure 66B] 1A-1C illustrate embodiments of connectors between components of a flow restriction system according to some aspects of the present disclosure. [Figure 66C] 1A-1C illustrate embodiments of connectors between components of a flow restriction system according to some aspects of the present disclosure. [Figure 67A] 1A-1C illustrate embodiments of connectors between components of a flow restriction system according to some aspects of the present disclosure. [Figure 67B] 1A-1C illustrate embodiments of connectors between components of a flow restriction system according to some aspects of the present disclosure. [Fig.68A-BCD] 1A-1C illustrate embodiments of connectors between components of a flow restriction system according to some aspects of the present disclosure. [Fig. 69A-B] 1A-1D illustrate an embodiment of an implant assembly having an extender for implantation, according to some aspects of the present disclosure. [Figure 70A] 1A-1D illustrate embodiments of a device for testing the functionality of an implant during implantation of the implant, in accordance with some aspects of the present disclosure. [Figure 70B] 1A-1D illustrate embodiments of a device for testing the functionality of an implant during implantation of the implant, in accordance with some aspects of the present disclosure. [Figure 71A] 1A-1D illustrate embodiments of a device for testing the functionality of an implant during implantation of the implant, in accordance with some aspects of the present disclosure. [Figure 71B] 1A-1D illustrate embodiments of a device for testing the functionality of an implant during implantation of the implant, in accordance with some aspects of the present disclosure. [Figure 72] 1 illustrates a method of implanting an implantable flow restriction system according to some aspects of the present disclosure. [Figure 73A] 1A-1D illustrate the deployment of an implantable flow restriction system implant, according to some aspects of the present disclosure. [Figure 73B] 1A-1D illustrate the deployment of an implantable flow restriction system implant, according to some aspects of the present disclosure. [Figure 73C] 1A-1D illustrate the deployment of an implantable flow restriction system implant, according to some aspects of the present disclosure. [Fig. 73D] 1A-1D illustrate the deployment of an implantable flow restriction system implant, according to some aspects of the present disclosure. [Figure 74] FIG. 1 illustrates guidelines for treating patients using implantable flow restriction systems, according to some aspects of the disclosure. [Figure 75] 13A-13D illustrate a manual method of using an implantable flow restriction system according to some aspects of the present disclosure. [Figure 76] 1 illustrates a semi-automated method of using an implantable flow restriction system according to some aspects of the present disclosure. [Figure 77] 1 illustrates an automated method of using an implantable flow restriction system, according to some aspects of the present disclosure. [Fig. 78A-BC] 1 illustrates an embodiment of providing therapy using an implantable flow restriction system, in accordance with some aspects of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0046] Various features and advantages of the present disclosure will now 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, removed, 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 implement the systems, devices, and / or methods disclosed herein.

[0047] Parts, components, features and / or elements of the permanent implantable flow restriction systems and devices described herein that may function the same or similarly across the various embodiments are identified using the same reference numbers with a different letter following the reference number, and differences between the various embodiments are described herein.

[0048] The present disclosure describes various embodiments of permanently implantable flow restriction systems, devices, and methods that controllably and selectively occlude, restrict, and / or divert flow in a patient's blood vessels. Such systems, devices, and methods can be used to redirect flow and / or promote perfusion in a patient's blood vessels and / or one or more of the patient's organs. In some circumstances, it may be advantageous to controllably and selectively occlude, restrict, and / or divert flow in a patient's blood vessels to reduce renal congestion (or promote reduction of renal congestion), reduce hepatic congestion (or promote reduction of hepatic congestion), reduce cardiac preload, and / or reduce lymphatic / interstitial congestion. For example, a permanently implantable flow restriction system adapted to controllably and selectively occlude and / or restrict a patient's superior vena cava upstream of where it enters the patient's right atrium can be used to reduce cardiac preload. Such permanently implanted flow restriction systems may also be adapted to controllably and selectively reduce central venous pressure and / or pressure in other veins disclosed herein and / or increase cardiac output. As another example, a permanently implanted flow restriction system adapted to controllably and selectively occlude and / or restrict a patient's inferior vena cava may be used to reduce renal congestion upstream of where the patient's renal vein joins the inferior vena cava (e.g., below where the renal vein joins the inferior vena cava). Such permanently implanted systems may also be adapted to controllably and selectively promote renal circulation, promote and / or control diuresis, and / or reduce volume overload. Various embodiments of the permanently implanted flow restriction systems and devices described herein may be configured to be implanted within a patient for months, a year, or years. Additionally, various embodiments of the permanently implanted flow restriction systems and devices may be configured to controllably and selectively occlude, restrict, and / or divert flow within a patient's blood vessels without an auxiliary device or pump.

[0049] The permanently implantable flow restriction systems, devices, and methods described herein may be adapted for percutaneous delivery. As such, the systems and devices described herein may be configured to be delivered via a catheter or similar delivery device, may have a collapsed configuration for delivery into a patient, and may expand from the collapsed configuration to an expanded configuration for implantation into the patient. Additionally, the systems and devices described herein, or components thereof, may be adapted to be retrievable after placement (e.g., by including a hook or other feature for retrieval) for repositioning and / or removal from the body. In some embodiments, the systems and devices described herein may be configured to be delivered and implanted within a patient's blood vessels. For example, the permanently implantable flow restriction systems described herein may be percutaneously implanted within the patient's superior vena cava upstream of the patient's right atrium. Such implantable flow restriction systems may be controlled to selectively occlude, restrict, and / or divert flow within the patient's superior vena cava (e.g., to reduce cardiac preload). As another example, the permanently implantable flow restriction systems described herein can be percutaneously implanted in a patient's inferior vena cava upstream of where the patient's renal veins connect with the inferior vena cava. Such an implantable flow restriction system can be controlled to selectively occlude, restrict, and / or divert flow in the patient's inferior vena cava (e.g., to relieve renal congestion). In some embodiments, the systems and devices described herein can be configured to be delivered extravenously to at least partially surround a patient's blood vessel or to be positioned adjacent to a patient's blood vessel. For example, the permanently implantable flow restriction systems described herein can be percutaneously implanted outside a patient's inferior vena cava and at least partially surround a patient's superior vena cava or to be positioned adjacent to a patient's superior vena cava. Such an implantable flow restriction system can be controlled to selectively occlude, restrict, and / or divert flow in a patient's inferior vena cava (e.g., to relieve renal congestion).

[0050] The permanently implanted flow restriction systems, devices and methods described herein can be actuated in a variety of ways. Without limitation, the systems and devices of the present disclosure can be actuated magnetically, including electromagnetically, fluidically, including pneumatically, mechanically, thermally (e.g., inductive heating), and / or by other energy sources. Additionally, the systems and devices described herein can be actuated by direct connection (e.g., wires, fluid-communicating tubing) and / or advantageously remotely. For example, a magnetically actuated flow restriction device described herein implanted in a patient's superior vena cava can be actuated by a magnet on the patient's back. As another example, a fluid-actuated flow restriction device described herein implanted in or adjacent to a patient's inferior vena cava externally can be actuated by applying pressure to a subcutaneously implanted fluid reservoir fluidly connected to the flow restriction device. In another example, a thermally actuated flow restriction device described herein implanted in a patient's superior vena cava can be actuated by heat, via inductive heating, via a separate device implanted in the patient and / or external to the patient. Remote actuation can provide a safer and more comfortable patient experience, including in terms of infection risk, compared to other methods that may involve direct in / out-of-body connections.

[0051] The permanently implantable flow restriction systems and devices described herein can be configured to partially occlude and / or completely occlude a blood vessel of a subject. Additionally, the systems and devices described herein can be configured to not occlude or not substantially occlude a blood vessel of a subject until actuated. In other words, the systems and devices of the present disclosure can substantially occlude all flow through a blood vessel, occlude partial flow through a blood vessel, and / or control substantially all flow through a blood vessel unimpeded. For example, the flow restriction systems and / or devices can be configured to adjustably occlude blood flow in a blood vessel in a range of 0 to 100 percent. In some embodiments of the systems and devices described herein, the implantable flow restriction systems and / or devices can be configured to not substantially occlude flow through a blood vessel unless actuated to partially and / or completely close. In some cases, the systems and devices described herein can be configured to substantially occlude all and / or a portion of the flow through a blood vessel unless actuated to open. Additionally, in some embodiments, the systems and devices described herein can have a bias to partially close, but once implanted, can be fully opened by the flow of blood in a blood vessel of a subject. It should be understood that the permanently implantable flow restriction systems and devices of the present disclosure may be controllably configured to provide conditions ranging from and including substantially no flow obstruction to substantially complete obstruction to flow within a vessel. In some cases, such control may be binary (e.g., open or closed) or graduated (e.g., open, varying degrees of partial obstruction, or closed).

[0052] The permanently implantable flow restriction systems and devices described herein can be sized and configured for implantation within a patient's intended target vessel, such as the superior vena cava (SVC), inferior vena cava (IVC), etc. The flow restriction devices, also referred to herein as implants, occluders, and / or prostheses, can have an expanded (e.g., implanted) diameter ranging from about 5 mm to about 50 mm, about 10 mm to about 40 mm, about 15 mm to about 30 mm, or can have a diameter greater than about 50 mm or less than about 5 mm, depending on the application. In some embodiments, implants as described herein can be oversized relative to the intended vessel, and thus can exert an outward force on the vessel in which they are implanted (e.g., to enhance fixation within the vessel). The flow restriction devices can have an expanded (e.g., implanted) length ranging from about 0.5 cm to about 5 cm, about 0.75 cm to about 4 cm, about 1 cm to about 3 cm, or can have a length greater than about 5 cm or less than about 0.5 cm, depending on the application.

[0053] The permanently implantable flow restriction devices described herein configured to be implanted within a patient's blood vessel may generally include an expandable body (configured for percutaneous delivery as described herein) and a flow restrictor configured to controllably and selectively occlude, restrict, and / or divert flow within the patient's blood vessel. The expandable body may have a proximal end, a distal end, and a lumen extending from the proximal end to the distal end. The expandable body may generally have a frame (which may also be referred to as a stent) having an open cell structure and / or a closed cell structure. Additionally, the expandable body may include features to aid in maintaining fixation and / or placement within the body, such as free tips, barbs, and / or anchors that may extend in any direction relative to the implant. In some cases, such barbs and / or anchors may have partial hook, hook, and / or straight configurations. The expandable body may be made of a material configured to expand upon delivery, such as a shape memory material such as Nitinol. In some embodiments, the expandable body can be configured to fold / collaps radially. Alternatively, or in addition, the expandable body can be configured to fold / collaps laterally when pushed or pulled. In some variations, the expandable body can be constructed of a material with little or no shape memory, and a balloon can be used to expand the expandable body for implantation. The expandable body can include one or more layers of material, such as an inner material layer (e.g., within its lumen) and / or an outer material layer (e.g., outside its lumen). Such inner and / or outer material layers can be constructed of ePTFE·PTFE·PET fabric, polyurethane, and / or the like. Additionally, any of such layers can include anti-thrombogenic coatings, drug-eluting coatings, and the like. In some embodiments, it may be desirable to utilize materials and / or coatings that prevent pinching within the implant to facilitate subsequent retrieval and / or removal of the implant.Conversely, in some cases, it may be desirable to utilize materials and / or coatings that permit and / or promote wedging within the implant. An expandable body as described herein for one embodiment using a particular type of flow restrictor is not limited to being utilized with that particular flow restrictor, but may be used in other embodiments using other types of flow restrictors. In some embodiments, the flow restrictor may be integrally formed with the expandable body.

[0054] The flow restrictor of the implants described herein can be sized and / or oriented in a number of ways relative to the expandable body to which it is connected or formed. For example, the flow restrictor can be sized such that, upon full actuation, it completely or partially occludes the lumen of the expandable body to which it is connected or formed. With respect to orientation, the flow restrictor can be configured to span the entire length of the expandable body to which it is connected or formed, or to span a portion of the length of the expandable body. In the latter scenario, the flow restrictor can be oriented at the proximal end, the distal end, or any location therebetween (e.g., midway or near the middle) of the expandable body. In some cases, the flow restrictor can be disposed adjacent to the distal or proximal end of the expandable body, extend beyond the distal or proximal end of the expandable body, or the like.

[0055] The implants described herein, or portions thereof (e.g., the flow restrictor of the implant), can be configured to anchor within the vasculature of a patient's blood vessel. In some embodiments, actuation of a flow restrictor implanted within the vasculature of a patient's blood vessel causes the flow restrictor to retract the walls of the vessel to at least partially restrict flow through the vessel and / or the lumen of the implant that constitutes the flow restrictor. To retract the walls of the vessel, the flow restrictor or portions thereof can be attached or anchored to the walls of the vessel (e.g., the interior wall of the vessel). Such attachment / anchor can include a mechanical link. For example, the flow restrictor can include one or more anchors configured to attach / anchor at least a portion of the flow restrictor to at least a portion of the wall of the vessel (e.g., the interior wall of the vessel). As another example, the flow restrictor or portions thereof can be configured to at least partially dig into the walls of the vessel. In such examples, the flow restrictor or portions thereof can have a structure, material and / or coating that promotes digging. Further in this example, such a flow restrictor may include a structure having multiple struts, a structure having multiple struts with a mesh spanning the multiple struts, or a structure having multiple struts with a material (e.g., a porous or non-porous material) spanning the multiple struts.

[0056] Vascular access for delivery of a permanently implantable flow restriction device as described herein may include the internal jugular vein, subclavian vein, femoral vein, and / or others. From such access points, the flow restriction device may be advanced by a delivery device (e.g., a delivery catheter) within the patient's vasculature until a desired implantation location is reached, whereupon the flow restriction device may be delivered and expanded for permanent implantation. Guidewires, introducers, and the like may be utilized for delivery, as well as standard imaging modalities. Additionally, the flow restriction devices herein may include radiopaque features to aid in delivery and implantation. Additionally, the flow restriction device may include features for indexing the delivery device to aid in enabling accurate orientation of the flow restriction device within the patient. For example, the implant may index features of the delivery device that remain external to the patient (e.g., logos or other markings). A permanently implantable flow restriction system may include a flow restriction device, a power source for actuating the flow restriction device, and a delivery device.

[0057] The permanently implantable flow restriction systems and devices described herein may be configured for open-loop and / or closed-loop control. For example, the flow restriction systems and devices described herein may be activated manually, semi-automatically, and / or fully automatically. In some cases, the therapy provided by the flow restriction systems and devices described herein may be activated digitally by interaction with a smartphone, an external terminal / device, or the like. For example, if a patient desires to stimulate diuresis, the patient may activate such therapy by pressing a button or touch screen on a smartphone (e.g., the therapy may be activated digitally). In some embodiments, the flow restriction devices described herein may include and / or cooperate with sensors attached to or located remotely from the flow restriction device that may provide physiological parameters of interest useful in controlling the flow restriction device. Such physiological parameters of interest may include pressure, flow, and the like. As one example, the flow restriction device may have a MEMS pressure sensor attached to its proximal end, its distal end, or both, and the pressure sensor is configured to measure pressure at such a location relative to the flow restriction device (e.g., upstream, downstream, both upstream and downstream, etc.). As another example, the MEMS pressure sensor may be placed in a vessel and / or organ remote from the flow restriction device and output a measurement of pressure at such a location for control of the flow restriction device. The sensor may be utilized to enable fully automated real-time control of the flow restriction devices described herein. Additionally, absolute sensor data and / or differential sensor data may be utilized.

[0058] The use of the permanently implantable flow restriction systems and devices described herein can be standardized across patients or, preferably, customized for an individual patient, such as via a prescription provided by a healthcare provider. Treatment protocols can vary depending on the type of flow restriction device implanted, its type of operation, and / or where it is implanted. The flow restriction systems and devices described herein can be utilized continuously, hourly, multiple times per day, once per day, overnight, once every other day, once every few days, once per week, once per month, or any frequency as needed or prescribed. Additionally, the treatment provided by the flow restriction systems and devices described herein may be based on an amount of time per day, hours per day, days per week, specific days of the week, and the like. Additionally, administration of treatments can have durations of seconds, minutes, hours, days, and the like. For example, treatment with the flow restriction devices described herein may have a duration of 15 minutes, 30 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 5 hours, 12 hours, or any duration necessary or required for the intended use and desired results. Furthermore, treatment times may vary in duration or may be standardized. In some cases, treatment may be determined by an algorithm, such as an algorithm providing the duration and amount of flow restriction to be utilized. Such output from the algorithm may be performed manually, semi-automatically, or fully automatically. In some embodiments, treatment provided by the flow restriction systems and devices described herein may be based on venous pressure, such as inferior vena cava pressure, renal vein pressure, femoral vein pressure, and / or pressure of other veins disclosed herein. For example, treatment using the flow restriction devices described herein may be performed until a pressure threshold is met (e.g., treatment may be performed until the pressure of interest reaches or falls below the pressure threshold). Such a threshold may be, for example, about 8 mmHg for the inferior vena cava. In some embodiments, the therapy provided by the flow restriction systems and devices described herein can be based on a combination of duration and venous pressure.For example, treatment with the flow restriction devices described herein may be administered for a duration after a pressure threshold has been met (e.g., turned off after 4 hours once the inferior vena cava pressure falls below 8 mmHg).

[0059] One or more permanently implantable flow restriction devices described herein may be implanted in a patient. In some cases, it may be beneficial to implant only one flow restriction device in a patient, and in other cases, it may be beneficial to implant multiple flow restriction devices in a patient. When multiple flow restriction devices are implanted in a patient, the devices may work together as necessary to achieve a desired therapeutic outcome. Furthermore, flow restriction devices using the same or different operating modes may be implanted in the same patient.

[0060] The permanently implantable flow restriction systems, devices and methods disclosed herein have been described in particular ways that may provide certain advantages, but such description is not intended to be limiting. The permanently implantable flow restriction systems and devices may be implanted within various blood vessels and / or passageways of a patient, including blood vessels (e.g., veins, arteries) of a patient's vascular system, a patient's lymphatic system, a patient's reproductive system, etc.

[0061] Any and / or all of the embodiments and / or features of the permanent implantable flow restriction systems, devices and methods described and / or illustrated herein may be applied to the various systems, devices and methods described or illustrated in U.S. Provisional Application No. 63 / 331,496, filed April 15, 2022, entitled "SYSTEMS AND METHODS FOR TREATING HEART FAILURE BY DIRECTING BLOOD FLOW THROUGH SHUNT BETWEEN THE PULMONARY ARTERY AND THE AZYGOS VEIN," and U.S. Patent Application No. 18 / 300,293, filed April 13, 2023, entitled "SYSTEMS AND METHODS FOR TREATING HEART FAILURE BY REDIRECTING BLOOD FLOW IN THE AZYGOS VEIN," each of which is incorporated by reference in its entirety and vice versa. For example, any and / or all of the embodiments and / or features of the permanently implantable flow restriction systems, devices and methods described and / or illustrated herein, such as magnetically, fluidically, mechanically and / or thermally actuated flow restrictors, may be applied in pulmonary artery to azygos vein shunts as described in the above-referenced applications. As another example, any and / or all of the embodiments and / or features of the pulmonary artery to azygos vein shunts described and / or illustrated in U.S. Provisional Application No. 63 / 311,496, such as an adjustable shunt including a disk that is rotatable relative to a fixed frame to control the size of the opening through the shunt, may be applied to the permanently implantable flow restriction systems, devices and methods described and / or illustrated herein. Additionally, any and / or all of the embodiments and / or features of the permanently implantable flow restriction systems, devices and methods described and / or illustrated herein may be applied and / or used in atrial-septal shunts and / or pulmonary artery-superior vena cava shunts.

[0062] FIG. 1A illustrates a simplified representation of a patient's anatomy, including a heart having a right atrium, a right ventricle, a left atrium, and a left ventricle, a superior vena cava connected to the right atrium, an inferior vena cava connected to the right atrium and connected to the patient's renal and hepatic veins, and other blood vessels and organs of the patient.

[0063] FIG. 1B illustrates a simplified view of a patient's anatomy, including connections between the ducts of the patient's lymphatic system, such as the thoracic duct and the right lymphatic duct, and the patient's veins. As shown, the thoracic duct connects to the left subclavian vein near its confluence with the left internal jugular vein and drains into the left subclavian vein. Also shown is the right lymphatic duct connecting to the right subclavian vein and draining into the right subclavian vein.

[0064] FIG. 2A illustrates candidate locations for implantation and placement of a magnetically actuated permanently implantable flow restriction system 1. The magnetically actuated permanently implantable flow restriction system 1 may include a magnetically actuated implant 100, a magnetic field source 10 configured to actuate (e.g., open and close) the implant 100, and a delivery device (not shown). A number of implants 100 are illustrated implanted within a patient along with a number of candidate locations for the magnetic field source 10. In particular, FIG. 2A illustrates an implant 100 implanted within a patient's superior vena cava upstream of its connection to the right atrium, with associated location options for the magnetic field source 10 being external to the patient, such as proximal to the patient's back, and / or internal to the patient, such as the aortic arch or the interstitial space adjacent to the superior vena cava. The implant 100 positioned in this location may controllably and selectively occlude, restrict, and / or divert flow within the patient's superior vena cava and connected vessels and / or organs to reduce cardiac preload, reduce central venous pressure and / or other venous pressures disclosed herein, and / or increase cardiac output. Also shown is an implant 100 implanted in the patient's inferior vena cava upstream of its connection to the hepatic vein, and an implant 100 implanted in the patient's inferior vena cava upstream of its connection to the renal vein. Locations of the magnetic field source 10 for actuating the implant 100 located in the inferior vena cava can include the aorta, the interstitial space adjacent the inferior vena cava, as shown, and / or the magnetic field source 10 can be located external to the patient, such as proximal to the patient's back. The implant 100 located in the inferior vena cava upstream of the hepatic vein can controllably and selectively occlude, restrict, and / or divert flow within the patient's inferior vena cava and connected vessels and / or organs to reduce (or facilitate relief of) hepatic congestion. Additionally, the implant 100 positioned within the inferior vena cava upstream of the renal veins can controllably and selectively occlude, restrict, and / or divert flow within the patient's inferior vena cava and connected blood vessels and / or organs to relieve renal congestion (or promote relief of renal congestion), promote renal circulation, and / or control diuresis (e.g., increase diuresis).Although multiple implants 100 and multiple magnetic field sources 10 are shown, only one implant 100 may be implanted or multiple implants 100 may be implanted at the location shown and / or at other locations, each having a corresponding magnetic field source 10. In some embodiments in which multiple implants 100 are implanted, the magnetic field source 10 may be configured to actuate multiple implants 100.

[0065] 2B illustrates additional candidate locations for implantation and placement of the magnetically actuated permanently implantable flow restriction system 1. A number of implants 100 implanted within a patient are illustrated along with a number of candidate locations for the magnetic field source 10. In particular, FIG. 2B illustrates an implant 100 implanted within the patient's right subclavian vein upstream of where the right lymphatic duct joins the right subclavian vein, and an implant 100 implanted within the patient's right internal jugular vein upstream of where the right internal jugular vein joins the right subclavian vein. The implant 100 in such a position can controllably and selectively occlude, restrict, and / or divert flow within the implanted vein to reduce pressure in the right lymphatic duct, increase lymphatic drainage, and / or reduce interstitial pressure (which may improve cardiac and renal function, respectively), as well as reduce cardiac preload and / or increase cardiac output. Also shown is an implant 100 implanted in a patient's left internal jugular vein upstream of where it joins the left subclavian vein, and an implant 100 implanted in a patient's left subclavian vein upstream of where the thoracic duct joins and drains into the left subclavian vein. The implant 100 in such a position can controllably and selectively occlude, restrict, and / or divert flow in the implanted vein to reduce pressure in the thoracic duct, increase lymphatic drainage, and / or reduce interstitial pressure (which may improve cardiac and renal function, respectively), and reduce cardiac preload and / or increase cardiac output. The magnetic field source 10 for actuating the implant 100 shown in FIG. 2B can be located external to the patient, such as proximal to the patient's back, and / or in an artery or interstitial space adjacent to the implant 100. Although multiple implants 100 and multiple magnetic field sources 10 are shown, only one implant 100 may be implanted, or multiple implants 100 may be implanted at the locations shown and / or at other locations, each having a corresponding magnetic field source 10. In some embodiments in which multiple implants 100 are implanted, the magnetic field source 10 may be configured to actuate multiple implants 100.

[0066] The magnetic field source 10 for actuating the magnetically actuated implant 100 may be a permanent magnet, an electromagnet, or the like. The magnetic field source 10 may be worn and / or located in proximity to the patient when it is desired to actuate the implant 100. For example, the magnetic field source 10 may be located on a belt worn by the patient, may be located on the patient's clothing, and / or may be located or attached to furniture used by the patient (e.g., the patient's bed, the patient's chair, etc.). In some embodiments, the magnetic field source 10 may include a safety mechanism that may be actuated to expose and / or turn on the magnetic field source 10 so that its magnetic field actuates the implant 100. Actuation of the implant 100 by the magnetic field source 10 may be controlled and / or regulated by selecting a magnet of a particular strength and / or displacement and / or by selecting a particular voltage of the electromagnet. Thus, the magnetic actuation of the implant 100 may be adjusted and / or regulated during use such that the implant 100 creates substantially no obstruction to flow, several stages of partial obstruction to flow, and / or substantially complete obstruction to flow. In some embodiments, magnetic actuation can actuate the implant 100 (e.g., binary on / off) such that the implant 100 creates substantially no obstruction to flow or substantially complete obstruction to flow. In some cases, the binary on / off control of the implant 100 can include providing substantially no obstruction to flow (binary off) and partial obstruction to flow (binary on), or vice versa. In other words, even in a fully actuated "closed" state, the implant 100 can be configured to allow at least partial flow.

[0067] Figures 3A-3D show various views of an embodiment of a magnetically actuated implant 100a, with Figures 3A and 3B showing side and end views of the implant 100a in a non-occluded (e.g., open) state, and Figures 3C and 3D showing side and end views of the implant 100a in an occluded (e.g., at least partially closed) state.

[0068] The implant 100a may include an expandable body 110a having a proximal end 111a, a distal end 112a, and a lumen 113a extending from the proximal end 111a to the distal end 112a. As described above, the expandable body 110a may be configured to be folded for delivery into a patient and, once implanted, expand to engage an inner wall of a patient's blood vessel in an expanded configuration as shown. The expandable body 110a as shown in this embodiment or as may be used in other embodiments may have a plurality of struts defining a plurality of cells. The cells may form a symmetric or asymmetric pattern about a central longitudinal axis of the expandable body. In an asymmetric pattern as shown, the expandable body 110a may include a first row of cells at the proximal end 111a arranged circumferentially about the central longitudinal axis. The expandable body 110a may include a second row of cells distal to the first row of cells, for example at the distal end 112a, arranged circumferentially about a central longitudinal axis, but missing one or more cells such that only a partial circumference of cells is formed. Once implanted, blood flowing through a vessel in which the implant 100a is implanted may flow through the lumen 113a. The implant 100a may also have a flow restrictor 150a connected to the expandable body 110a. The flow restrictor 150a may be offset from the central longitudinal axis of the expandable body 110a. The flow restrictor 150a may include a magnet 180a, a number of struts 160a connecting the magnet 180a to the expandable body 110a, and material 170a spanning between the number of struts 160a and / or the magnet 180a and the expandable body 110a to occlude flow through the lumen 113a. When the implant 100a is in the expanded configuration, the plurality of struts 160a can extend distally from the second row of cells toward one side of the expandable body 110a. A magnet 180a can be disposed on one side of the expandable body 110a and aligned with a sidewall of the expandable body 110a.Material 170a may be disposed on the interior and / or exterior of expandable body 110a and may be continuous with material 130a of expandable body 110a, such as ePTFE·PTFE·PET fabric, polyurethane and / or other similar materials as described above, with or without a coated anti-thrombogenic or other functional coating, or material 170a may be separate from or discontinuous with material 130a.

[0069] In use, the magnetic field source 10 can activate the implant 100a by interacting with the magnet 180a. The magnet 180a can move from an unactivated state (e.g., at rest), where it is offset from the central longitudinal axis and may be aligned with a sidewall of the expandable body 110a, to an activated state toward the opposite side of the expandable body 110a. In the activated state, the magnet 180a can move toward or beyond the central longitudinal axis. In the activated state, the magnet 180a can extend the material 170a at least partially across the lumen to at least partially occlude or block the lumen. Depending on the desired unactivated state (e.g., at rest) of the implant 100a, the implant 100a can be oriented such that its distal end 112a receives blood flow from the vessel in which the implant 100a is implanted and its proximal end 111a drains blood flow, or can be implanted in the opposite orientation. For example, if it is desired that the implant 100a not occlude flow in an unactuated state, the implant can be oriented such that its proximal end 111a accepts flow and its distal end 112a expels flow. In such an orientation, when actuated by the magnetic field source 10, the magnet 180a of the flow restrictor 150a can be attracted to or repelled by the magnetic field source 10 (depending on how it is oriented relative to the magnetic field source 10) and hinged relative to the expandable body 110a by the multiple struts 160a to occlude the lumen 113a (as shown in FIGS. 3C-3D). As another example, if it is desired that the implant 100a occlude flow in an unactuated state, the implant can be oriented such that its distal end 112a accepts flow and its proximal end 111a expels flow. In such an orientation, blood flow can cause flow restrictor 150a to occlude lumen 113a until magnetic field source 10 activates flow restrictor 150a by attractive or repulsive forces, at which point flow restrictor 150a can hinge open to unocclude flow (as shown in Figures 3A-3B).

[0070] 3A-3D, implant 100a can be configured to partially occlude flow in lumen 113a even when flow restrictor 150a is in a closed position as shown in FIG 3D. Such a configuration can be advantageous when actuation of implant 100a is binary and it is desired not to completely occlude flow in lumen 113a upon actuation.

[0071] In some embodiments, the level of occlusion provided by the magnetically actuated implant 100a based on a predetermined strength of the magnetic field source 10 can be adjusted by the configuration of the implant, such as the number and / or thickness of the multiple struts 160a connecting the magnet 180a to the expandable body 110a. Although two struts 160a are used as shown in Figures 3A-3D, one, three, four, or any number of struts may be used to adjust the force required to actuate the flow restrictor 150a.

[0072] In addition to anti-thrombogenic coatings and the like, when using the implant 100a, the implant 100a may be periodically actuated to help prevent the development of thrombi and / or clogging between the flow restrictor 150a and the interior vessel wall, particularly when the distal end 112a is accepting flow. In situations where a patient having the implant 100a needs to undergo an MRI, the magnet 180a may be configured to be removable from the implant 100a, such as by a procedure using a catheter that removes the magnet 180a but leaves the implant 100a in place. In some embodiments, as described above, the implant 100a may be configured to be retrievable, such that the implant 100a may be removed from the patient prior to imaging where the magnet 180a may interfere or cause problems.

[0073] 4A-4D show various views of another embodiment of a magnetically actuated implant 100b, with FIGS. 4A and 4B showing side and end views of the implant 100b in a non-occluded (e.g., open) state and FIGS. 4C and 4D showing side and end views of the implant 100b in an occluded (e.g., at least partially closed) state. The implant 100b may be the same as or similar to the features described with respect to the implant 100a and / or may include any of those features. For example, the implant 100b may have an expandable body 110b and a flow restrictor 150b that are the same as or similar to the expandable body 110a and the flow restrictor 150a of the implant 100a. However, the expandable body 110b of the implant 100b, i.e., the extension body 110b that may be used in other embodiments, may have an extension portion 120b as shown in FIGS. 4A and 4C. The extension 120b can extend from the distal end 112b of the expandable body 110b to provide a landing surface for the flow restrictor 150b to abut when closed to occlude flow. The extension 120b can have one or more struts extending distally from the second row of cells of the expandable body 110b, and can have one or more cells that extend only partially circumferentially about the central longitudinal axis. Thus, the extension 120b can advantageously provide a surface to receive the end of the flow restrictor 150b, instead of the end potentially contacting the inner wall of the vessel in which the implant 100b is to be implanted. Also, the material 130b of the expandable body 110b can extend to the extension 120b in a continuous manner.

[0074] 5A-5F show various views of another embodiment of a magnetically actuated implant 100c, with 5A and 5B showing side and end views of implant 100b in a non-occluded (e.g., open) state, 5C and 5D showing side and end views of implant 100b in a partially occluded (e.g., partially occluded) state, and 5E and 5F showing side and end views of implant 100b in a fully occluded (e.g., fully occluded) state. Implant 100c may be the same as or similar to and / or include any of the features described with respect to implant 100a. For example, implant 100c may have an expandable body 110c and a flow restrictor 150c that are the same as or similar to expandable body 110a and flow restrictor 150a of implant 100a. However, flow restrictor 150c of implant 100c may be configured to cause complete or substantially complete occlusion of lumen 113c when fully closed, as shown in FIG. 5F.

[0075] 6A-6D show various views of another embodiment of a magnetically actuated implant 100d, with FIGS. 6A and 6B showing side and end views of implant 100b in a non-occluded (e.g., open) state and FIGS. 6C and 6D showing side and end views of implant 100d in a fully or substantially fully occluded (e.g., fully closed) state. Implant 100d may be the same as or similar to and / or include any of the features described with respect to implants 100a, 100b, and / or 100c. For example, as shown, implant 100d may have an expandable body 110d with an extension 120d the same as or similar to extension 120b of implant 100b, and a flow restrictor 150d the same as or similar to flow restrictor 150c of implant 100c.

[0076] FIG. 7A illustrates candidate locations for implantation and placement of a fluid-actuated, permanently implantable flow restriction system 2. The fluid-actuated, permanently implantable flow restriction system 2 may include a fluid-actuated implant 200 with a fluid reservoir 20 configured to actuate (e.g., open or close) the implant 200, a tube 270 configured to fluidly connect the implant 200 and the fluid reservoir 20, and a delivery device (not shown). A number of implants 200 are shown implanted within a patient along a number of potential routing options for the tube 270. In particular, FIG. 7A illustrates an implant 200 implanted within a patient's superior vena cava upstream of its connection to the right atrium. The implant 200 positioned in this location may controllably and selectively occlude, restrict, and / or divert flow within the patient's superior vena cava and connected vessels and / or organs to reduce cardiac preload, reduce central venous pressure and / or other venous pressures disclosed herein, and / or increase cardiac output. Also shown is an implant 200 implanted in the patient's inferior vena cava upstream of its connection to the hepatic vein, and an implant 200 implanted in the patient's inferior vena cava upstream of its connection to the renal vein. The implant 200 positioned in the inferior vena cava upstream of the hepatic vein can controllably and selectively occlude, restrict, and / or divert flow in the patient's inferior vena cava and connected vessels and / or organs to relieve (or promote relief of) hepatic congestion. Additionally, the implant 200 positioned in the inferior vena cava upstream of the renal vein can controllably and selectively occlude, restrict, and / or divert flow in the patient's inferior vena cava and connected vessels and / or organs to relieve (or promote relief of) renal congestion, promote renal circulation, and / or control diuresis (e.g., increase diuresis). Although multiple implants 200 are shown, only one implant 200 may be implanted, or multiple implants 200 may be implanted in the locations as shown and / or in other locations, each with a corresponding fluid reservoir 20. In some embodiments in which multiple implants 200 are implanted, the fluid reservoir 20 may be configured to actuate multiple implants 200 .

[0077] FIG. 7B illustrates other candidate locations for implantation and placement of a fluid-actuated permanently implantable flow restriction system 2. Multiple implants 200 are shown implanted within a patient along multiple potential paths of associated tubing 270. In particular, FIG. 7B illustrates an implant 200 implanted within a patient's right subclavian vein upstream of where the right lymphatic duct joins the right subclavian vein, and an implant 200 implanted within a patient's right internal jugular vein upstream of where the right internal jugular vein joins the right subclavian vein. Implants 200 placed in such locations can controllably and selectively occlude, restrict, and / or divert flow within the implanted vein to reduce pressure in the right lymphatic duct, increase lymphatic drainage, and / or reduce interstitial pressure (which can improve cardiac and renal function, respectively), as well as reduce cardiac preload and / or increase cardiac output. Also shown is an implant 200 implanted in a patient's left internal jugular vein upstream of where the left internal jugular vein joins the left subclavian vein, and an implant 200 implanted in a patient's left subclavian vein upstream of where the thoracic duct joins the left subclavian vein and drains into the left subclavian vein. Implants 200 positioned in such locations can controllably and selectively occlude, restrict, and / or divert flow in the implanted vein to reduce pressure in the thoracic duct, increase lymphatic drainage, and / or reduce interstitial pressure (which may improve cardiac and renal function, respectively), and reduce cardiac preload and / or increase cardiac output. Although multiple implants 200 are shown, only one implant 200 may be implanted, or multiple implants 200 may be implanted in locations as shown and / or other locations, each with a corresponding tube 270 and fluid reservoir 20. In some embodiments where multiple implants 200 are implanted, the fluid reservoir 20 may be configured to actuate the multiple implants 200.

[0078] The fluid reservoir 20 may be implanted subcutaneously, for example, located in or adjacent to the patient's thigh, pelvis, and / or clavicle, similar to how and where a pacemaker is implanted. External pressure may be applied to the fluid reservoir 20 (e.g., above the subcutaneous location where the fluid reservoir is implanted subcutaneously) to actuate the implant 200, which is fluidly connected to the reservoir 20 via a tube 270.

[0079] 8A-8D show various views of an embodiment of a fluid-actuated implant 200a, with FIGS. 8A and 8B showing perspective and end views of the implant 200a in an unactuated (e.g., non-occluding) state and FIGS. 8C and 8D showing perspective and end views of the implant 200a in an actuated (e.g., occluding) state. The implant 200a can include an expandable body 210a having a proximal end 211a, a distal end 212a, and a lumen 213a extending from the proximal end 211a to the distal end 212a. As described above, the expandable body 210a can be configured to be folded for delivery to a patient and to expand in the illustrated expanded configuration once implanted to mate with an inner wall of the patient's blood vessel. Once implanted, blood flowing through the vessel in which the implant 200a is implanted can flow through the lumen 213a. The implant 200a may also have a flow restrictor 250a connected to the expandable body 210a. The flow restrictor 250a may include a balloon 280a, a fluid reservoir 20a, and a tube 270a fluidly connecting the balloon 280a to the fluid reservoir 20a. As shown, in some embodiments, the balloon 280a may be configured as an elongated partial circle affixed to the interior of the expandable body 210a (and / or to an attachment portion of the expandable body as described herein), although other balloon shapes may be used. The implant 200a may be oriented within the patient's vasculature so that either its proximal end 211a or distal end 212a receives flow, depending on the location of the implant 200a and the location of the fluid reservoir 20a.

[0080] The balloon 280a can be made of polyurethane, polysiloxane, etc., and can have a hydrophilic and anti-thrombogenic coating. In some cases, the balloon 280a and / or the tube 270a can be made of an anti-thrombogenic hydrogel. Although not shown, as described above, the expandable body 210a can have ePTFE·PTFE·PET fabric, polyurethane, and / or similar materials disposed on the interior and / or exterior of the expandable body 210a, with or without being coated with an anti-thrombogenic or other functional coating.

[0081] The fluid reservoir 20a can be configured to maintain an expanded state (e.g., full state) at rest. For example, the fluid reservoir 20a can include woven nitinol spheres configured to maintain the fluid reservoir in an expanded state at rest. As described above, external pressure can be applied to collapse the fluid reservoir 20a, causing fluid within the fluid reservoir 20a to flow out of the fluid reservoir 20a, through the tube 270a, and into the balloon 280a, expanding / inflating the balloon 280a. The balloon 280a expansion / inflating can cause partial occlusion of the lumen 213a (as shown in FIG. 8D) and / or complete occlusion of the lumen 213a as described in other embodiments herein. Cessing the external pressure on the fluid reservoir 20a allows the fluid reservoir 20a to return to its expanded state, drawing a vacuum on the balloon 280a, causing the fluid reservoir 20a to both fill with fluid and cause the balloon 280a to return to its collapsed / uninflated state. The fluid used to actuate the flow restrictor 250a may include saline, other biologically safe and compatible fluids, or air or other gases.

[0082] 8A-8D, implant 200a can be configured to partially occlude flow through lumen 213a even when balloon 280a of flow restrictor 250a is fully expanded, as shown in FIG 8D. Such a configuration can be advantageous when actuation of implant 200a is binary and it is desired not to completely occlude flow through lumen 213a upon actuation.

[0083] In some embodiments, the level of occlusion provided by the fluid-actuated implant 200a is based on the level of external pressure applied to the fluid reservoir 20a. Alternatively, or in addition, the level of occlusion provided by the fluid-actuated implant 200a may be based on the configuration of the balloon 280a and whether or not it completely occludes the lumen 213a when fully expanded / inflated.

[0084] In some variations, the balloon 280a of the flow restrictor 250a may be fluidly connected to a port configured to extend from within the patient's body to the outside of the patient's body and allow the balloon 280a to be fluidly actuated outside the patient's body. Such a port may be directly connected to the tube 270a (in which case no fluid reservoir 20a is required) or may be connected to the fluid reservoir 20a.

[0085] 9A-9D show various views of another embodiment of a fluid-actuated implant 200b, with FIGS. 9A and 9B showing perspective and end views of the implant 200b in a non-occluded state, and FIGS. 9C and 9D showing perspective and end views of the implant 200b in an occluded state. The implant 200b may be the same as or similar to the features described with respect to the implant 200a and / or may include any of those features. For example, the implant 200b may have an expandable body 210b and a flow restrictor 250b that are the same as or similar to the expandable body 210a and the flow restrictor 250a of the implant 200a. However, the balloon 280b of the flow restrictor 250b may have a different shape. As shown, the balloon 280b of the implant 200b may have a cylindrical shape with a through opening whose outer longitudinal surface is secured to the interior of the expandable body 210b (and / or to the attachment portion of the expandable body as described herein). When actuated, balloon 280a can expand / inflate to substantially narrow lumen 213b, thereby occluding flow through lumen 213b.

[0086] 10A-12C show various embodiments of flow restrictor balloons for fluid-activated implants. FIGS. 10A-10C show an implant 200c with a flow restrictor 250c having multiple balloons 280c arranged longitudinally along the length of an expandable body 210c. FIG. 10A shows a perspective view of the implant 200c in an unactuated (e.g., non-occluding) state, FIG. 10B shows an end view of the implant 200c in an unactuated (e.g., non-occluding) state, and FIG. 10C shows an end view of the implant 200c in an actuated (e.g., occluding) state. FIGS. 11A-11C show an implant 200d with a flow restrictor 250d having multiple balloons 280d arranged transversely relative to the length of the expandable body 210d. FIG. 11A shows a perspective view of the implant 200d in an unactuated (e.g., non-occluding) state, FIG. 11B shows an end view of the implant 200d in an unactuated (e.g., non-occluding) state, and FIG. 11C shows an end view of the implant 200d in an actuated (e.g., occluding) state. 12A-12C show an implant 200e with a flow restrictor 250e having a balloon 280e arranged in a helical wrap along the length of an expandable body 210e. Figure 12A is a perspective view of the implant 200e in an unactuated (e.g., non-occluding) state, Figure 12B is an end view of the implant 200e in an unactuated (e.g., occluding) state, and Figure 12C is an end view of the implant 200e in an actuated (e.g., occluding) state.

[0087] 13A-13D show another embodiment of a fluid-activated implant 200f. FIG. 13A is a perspective view of the implant 200f, FIG. 13B is an end view of the implant 200f, FIG. 13C is a perspective view of the implant 200f in an unactuated state, and FIG. 13D is a perspective view of the implant 200f in an actuated state. The implant 200f may be the same as or similar to, and / or may include any of, the features described with respect to the implants 200a, 200b, 200c, 200d, and / or 200e. Unlike the previously described fluid-activated implants, the expandable body 210f of the implant 200f may include an outer body 215f and an inner body 225f. Each of the outer body 215f and the inner body 225f may include a frame having multiple struts and / or multiple cells, as described herein. Additionally, both the outer body 215f and the inner body 225f can be configured to fold and expand as described herein. Additionally, the outer body 215f and the inner body 225f can be configured to fold and expand together. In other words, the expandable body 210f can be configured as a double-walled stent with an outer body 215f having an outer wall and an inner body 225f having an inner wall. The outer body 215f can have an outer and / or inner layered material 230f as described herein. Similarly, the inner body 225f can have an outer and / or inner layered material 240f as described herein. As shown in FIGS. 13C-13D, the balloon 280f of the flow restrictor 250f can be disposed between the outer body 215f and the inner body 225f. The balloon 280f can have any shape and / or configuration described herein, including a prolate or oblate spheroid shape. Additionally, although not shown, the inner body 225f can be sealed to the outer body 215f along their respective distal and proximal ends, and such a seal can be completely circumferential except for where the tube 270f extends from the expandable body 210f.The outer body 215f can be stiffer than the more compliant inner body 225f, which can allow the inner body 225f to deflect inward (e.g., buckle inward) and occlude (e.g., at least partially and / or completely occlude) the lumen 213f upon actuation of the flow restrictor 250f and expansion / inflation of the balloon 2280f, as shown in FIG. 13D. The difference in stiffness and / or compliance between the outer body 215f and the inner body 225f can be provided by different strut configurations, different strut thicknesses, etc. Having an inner body 225f that can substantially encapsulate the balloon 280f and hide the balloon from flow through the lumen 213f can advantageously reduce the risk of thrombus formation. Additionally, the inner body 225f can provide a smooth surface in the lumen 213f (thus providing an implant 200f with smooth all blood contacting surfaces), which can also advantageously reduce the risk of thrombus formation.

[0088] 14A-14D show various views of an embodiment of a fluid-actuated implant 200f according to FIGS. 13A-13D. FIG. 14A shows a side view of the implant 200f, FIG. 14B shows a perspective view of the implant 200f, FIG. 14C shows a top view of the implant 200f, and FIG. 14D shows another perspective view of the implant 200f. As shown, the inner body 225f is disposed within the outer body 215f, and a balloon 280f (not visible) is disposed between the two. Visible in these views is a tube 270f that is fluidly connected to the balloon 280f. Additionally, as shown, the implant 200f includes a port connected to the tube 270f on the opposite side to which the tube 270f connects to the balloon 280f, which port is configured to fluidly actuate the balloon 280f instead of a fluid reservoir.

[0089] 15A-15C show another embodiment of a fluid-actuated implant 200g and a method of manufacturing the fluid-actuated implant 200g. The implant 200g may be the same as or similar to the features described with respect to the implants 200a-200f and / or may include any of the features. The implant 200g is shown without a layer or membrane of material covering the expandable body 210g, although a layer or membrane of material as described herein may optionally be present. The expandable body 210g as shown or that may be used in other embodiments may have a metal frame that may be laser cut or formed from one or more wires. FIG. 15A shows a side view of the expandable body 210g with an attachment portion 217g configured to connect the balloon 280g of the flow restrictor 250g to the expandable body 210g. As shown, the attachment portion 217g may have a tubular shape. Additionally, the attachment portion 217g may be disposed off-center and along the side of the expandable body 210g of the implant 200g. As shown, the multiple struts of the expandable body 210g may extend distally from the attachment portion 217g to form a tapered or angled opening at the proximal end 211g. As part of the manufacturing process, the balloon 280g and / or its associated tube 270g may be connected (e.g., by reflow) to at least the attachment portion 217g of the expandable body 210g, as shown in the side view of FIG. 15B. The balloon 280g and / or its associated tube 270g may be connected to the side of the attachment portion 217g or may pass through the attachment portion 270g. The balloon 280g may also be connected to the interior of the expandable body 210g. After being connected / bonded to the attachment portion 217g and / or the interior of the expandable body 210g, the balloon 280f of the flow restrictor 250f may be actuated to occlude the lumen of the expandable body 210g, as shown in the side view of FIG. 15C.As shown in some embodiments, when actuated, the balloon 280g of the flow restrictor 250g can expand at least partially within the expandable body 210g as well as at least partially outside or proximal to the opening of the expandable body 210g. In some cases, when actuated, the balloon 280g of the flow restrictor 250g can expand completely within the expandable body 210g. The balloon 280g can have any shape and / or configuration as described herein, including a prolate or oblate spheroid shape.

[0090] 16A-16C show another embodiment of a fluid-actuated implant 200h and another method of manufacturing the fluid-actuated implant 200h. The implant 200h may be the same as or similar to and / or include any of the features described with respect to the implants 200a-200f. The implant 200h is shown without a layer or membrane of material covering the expandable body 210h, although a layer or membrane of material as described herein may optionally be present. The expandable body 210h as shown or that may be used in other embodiments may have a metal frame that may be laser cut or formed from one or more wires. FIG. 16A shows a side view of the expandable body 210h with an attachment portion 217g configured to connect the balloon 280h of the flow restrictor 250h to the expandable body 210h. The attachment portion 217g may have a cylindrical shape with a longitudinal opening therethrough. Additionally, the attachment portion 217h may be disposed off-center along a side of the expandable body 210h of the implant 200h. As shown, the struts of the expandable body 210h may extend distally from the attachment portion 217h to form a tapered or angled opening at the proximal end 211h. The expandable body 210h may have a circumferential portion having at least one row of collapsible cells distal to the tapered or proximal opening. As part of the manufacturing process, the balloon 280h and / or its associated tube 270h may be connected (e.g., by reflow) to at least the attachment portion 217h of the expandable body 210h, as shown in the side view of FIG. 16B. The balloon 280h and / or its associated tube 270h may be connected to the side of the attachment portion 217h or may penetrate the attachment portion 270h. The balloon 280h may also be connected to the interior of the expandable body 210h. After being connected / anchored to the attachment portion 217h and / or the interior of the expandable body 210h, the balloon 280h of the flow restrictor 250h can be actuated to occlude the lumen of the expandable body 210h, as shown in the side view of FIG. 16C.As shown in some embodiments, when actuated, the balloon 280h of the flow restrictor 250h can expand at least partially within the expandable body 210h as well as at least partially outside or proximal to the opening of the expandable body 210h. In some cases, when actuated, the balloon 280h of the flow restrictor 250h can expand completely within the expandable body 210h. The balloon 280h can have any shape and / or configuration as described herein, including a prolate or oblate spheroid shape.

[0091] 17A and 17B show various views of another embodiment of a fluid-actuated implant 200i. The implant 200i may be the same or similar to and / or include any of the features described with respect to the implants 200a-200h. FIGS. 17A and 17B show side and end views of the implant 200i in an actuated configuration. The expandable body 210i as shown or as may be used in other embodiments may be symmetrical about its central longitudinal axis and may have multiple rows of collapsible cells. As shown, the flow restrictor 250i may include a balloon 280i with a tube 270i that is not coaxial with the balloon but is off-center / tangentially disposed with respect to the balloon 280i. Such an off-center / tangential configuration may advantageously prevent the balloon from being pushed out of the inner wall of the expandable body 210i upon expansion / inflation, which may occur with a coaxial configuration. Additionally, the off-center / tangential configuration may advantageously allow for the tube 270i to be connected to the inner wall of the expandable body 210i both proximal and distal to the balloon 280i (e.g., to better secure the balloon 280i). This configuration of the flow restrictor 250i may be used with any of the fluid-actuated implants described herein, including implants having an expandable body having an outer body and an inner body (e.g., as shown in Figures 13A-13D and 14A-14D). Additionally, the balloon 280i may have any shape and / or configuration as described herein, including a prolate or oblate spheroid shape.

[0092] 18A-18C show various views of an embodiment of an expandable body 210j of a fluid-actuated implant 200j. FIG. 18A shows a perspective view of the expandable body 210j, FIG. 18B shows an end view of the expandable body 210j, and FIG. 18C shows a side view of the expandable body 210j. The expandable body 210j as shown or as may be used in other embodiments has a four-cell structure with four collapsible cells at the distal end 212j that extend circumferentially around a central longitudinal axis. Also as shown, the expandable body 210j includes a mounting portion 217j similar or identical to the mounting portion 217g of the implant 200g, which may be offset relative to the central longitudinal axis of the expandable body. As shown, the struts at the proximal end 211j of the expandable body 210j may extend away from the attachment portion 217j and / or the end of the implant offset relative to the central longitudinal axis of the implant to advantageously facilitate folding and / or retrieval of the implant 200j. In other words, a configuration of the expandable body 210j in which the struts at the proximal end 211j of the expandable body 210j merge proximally at the attachment portion 217j and / or the end of the implant offset relative to the central longitudinal axis of the implant can facilitate folding of the implant 200j. The four-cell expandable body 210j can be used with any of the fluid-actuated implants described herein.

[0093] 19A-19C show various views of an embodiment of an expandable body 210k of a fluid-actuated implant 200k. FIG. 19A shows a perspective view of the expandable body 210k, FIG. 19B shows an end view of the expandable body 210k, and FIG. 19C shows a side view of the expandable body 210k. As shown, the expandable body 210k has six collapsible cells at a distal end 212j that extend circumferentially about a central longitudinal axis of the expandable body. Also shown, the expandable body 210k includes a mounting portion 217k similar or identical to the mounting portion 217g of the implant 200g, which may be offset relative to the central longitudinal axis of the expandable body. As shown, the struts at the proximal end 211k of the expandable body 210k may extend away from the attachment portion 217k and / or the end of the implant offset relative to the central longitudinal axis of the implant to advantageously facilitate folding and / or retrieval of the implant 200k. In other words, a configuration of the expandable body 210k in which the struts at the proximal end 211k of the expandable body 210k merge proximally at the attachment portion 217k and / or the end of the implant offset relative to the central longitudinal axis of the implant can facilitate folding of the implant 200k. The six-cell expandable body 210k can be used with any of the fluid-actuated implants described herein.

[0094] 20A-20D show various views of an embodiment of expandable body 210l of fluid-actuated implant 200l. FIG. 20A shows a side view of expandable body 210l in an expanded configuration, FIG. 20B shows a side view of expandable body 210l in a collapsed configuration, FIG. 20C shows a perspective view of expandable body 210l in an expanded configuration, and FIG. 20D shows a perspective view of expandable body 210l in a collapsed configuration. Also, as shown, expandable body 210l can include attachment portion 217l similar or the same as attachment portion 217g of implant 200g, which can be offset relative to a central longitudinal axis of the expandable body. The expandable body 210l as shown or may be used in other embodiments may have an angled or inclined proximal opening at its proximal end 211l, with a plurality of struts of the expandable body 210l extending distally away from the attachment portion such that the portion of the expandable body 210l opposite the side on which the attachment portion 217l is located (e.g., approximately 180 degrees from the location of the attachment portion 217l when viewed from the end) is more distal than the portion of the expandable body 210l that connects to the attachment portion 217l. The expandable body 210l may also have an angled or inclined distal opening at its distal end 212l, as shown, with the side of the expandable body 210l longitudinally aligned with the attachment portion 217l being located more proximally than the opposite side. In some cases, and as shown, the distal opening may have a similar (or the same) angle or inclination as the proximal opening. Additionally, the expandable body 210l can have longitudinally extending struts (e.g., extending parallel or substantially parallel to a central longitudinal axis of the expandable body 210l) and diagonal struts. The diagonal struts of the expandable body 210l, when expanded, can be aligned diagonally to the longitudinally extending struts and oriented in the same or generally the same direction (as best shown in the side view of FIG. 20A). The struts of the expandable body 210l can merge proximally at their proximal ends 211j at attachment portions 217l (e.g., at the end of the implant offset relative to the central longitudinal axis of the implant).With such a configuration, the expandable body 210l can be advantageously configured to fold / crimp by being pulled / pushed (e.g., by stretching relative to lateral folding / crimping relative to radial folding / crimping), thereby facilitating retrieval after deployment. For example, the expandable body 210l can be collapsed from its expanded shape by pulling on the attachment portion 217l or any tube connected to the implant 200l. As another example, the expandable body 210l can be collapsed from its expanded shape by applying a longitudinal force (e.g., pushing) toward the expandable body 210l above where the attachment portion 217l is located. The expandable body 210l can be used with any of the fluid-actuated implants described herein.

[0095] FIG. 21A illustrates a side view of another embodiment of a fluid-operated implant 200m. The implant 200m may be the same as or similar to and / or include any of the features described with respect to any of the fluid-operated implants described herein. As illustrated, the implant 200m may have a flow restrictor 250m including a balloon 280m and a tube 270m substantially concentrically aligned with the expandable body 210m such that the balloon 280m is substantially centrally located within the lumen 213m. The balloon 280m may have any shape and / or configuration as described herein, including a prolate or oblate spheroid. In some embodiments, a portion of the tube 270m may extend through the interior of the balloon 280m and may extend through some or all of the balloon 280m as illustrated (e.g., from a proximal end of the balloon 280m to a distal end of the balloon 280m). Further, in some cases, the portion of the tube 270m that extends through the interior of the balloon 280m may have a smaller diameter (e.g., overall diameter) than the diameter of the tube 270m that does not extend through the interior of the balloon 280m (e.g., the tube 270m proximal to the balloon 280m as shown). In some embodiments, the portion of the tube 270m that extends through the interior of the balloon 280m may have a smaller wall thickness than other portions of the tube 270m. When the balloon 280m is not actuated (e.g., when the balloon 280m is folded relative to the portion of the tube 270m extending therethrough), such a configuration of variable diameter and / or variable wall thickness tubes may advantageously provide a smooth transition between the tube 270m proximal to the balloon 280m and the balloon 280m with the inner tube 270m such that the flow restrictor 250m has a substantially uniform overall diameter (e.g., the outer diameter of the balloon 280m when folded is no greater than the outer diameter of the tube 270m proximal to the balloon 280m). A flow restrictor 250m having a substantially uniform overall diameter may advantageously reduce the risk of thrombus formation, particularly in a permanent implant 200m.

[0096] Unlike other embodiments described, the expandable body 210m shown or that may be used in other embodiments may include a plurality of struts 237m and / or a membrane 235m disposed at a distal end 212m of the implant 200m (e.g., distal to the flow restrictor 250m relative to the direction of flow through the implant 200m) and located within the flow path of the lumen 213m. The expandable body 210m when expanded may have a proximal portion that increases in radial dimension from proximal to distal, a central portion that may have a constant outer diameter dimension configured to mate with the inner wall of a blood vessel, and a distal portion that decreases in radial dimension from proximal to distal. The distal portion may have a membrane 235m. The tube 270m may terminate proximally of the distal portion, or the distal portion may be connected to the tube 270m. Such a plurality of struts 237m and / or membrane 235m can function as a filter to capture thrombus that may pass through or be generated by the implant 200m (e.g., to prevent pulmonary embolism). For example, about 4 to about 12 or more struts 237m can be disposed at the distal end of the implant 200m, the struts 237m configured to capture thrombus. Alternatively or additionally, a membrane 235m can be disposed at the distal end of the implant 200m within the flow passage of the lumen 213m, the membrane configured to capture thrombus. The membrane 235m can be configured to capture thrombus while allowing flow therethrough, and such membrane can have perforations throughout. The perforations throughout the membrane 235m can range in size from about 0.5 mm to about 7 mm, from about 1 mm to about 5 mm, or any size range above or below such ranges. As shown in some embodiments, the implant 200m can include a retrieval portion 219m configured to aid in retrieval of the implant 200m after implantation. For example, as shown, the retrieval portion 219m can be configured as a hook, although the retrieval portion 219m can be configured as a loop or other shape to aid in retrieval. The retrieval portion 219m can be disposed adjacent the distal end 212m of the implant 200m (as shown) or adjacent the proximal end 211m of the implant.In some cases, a tube 270m may be used to aid in retrieval and / or positioning of the implant 200m.

[0097] 21B illustrates a side view of another embodiment of a fluid-actuated implant 200n, with the left side view showing the flow restrictor 250n of the implant 200n in an unactuated state, the center side view showing the flow restrictor 250n in a partially actuated state, and the right side view showing the flow restrictor 250n in a substantially fully actuated state. The implant 200n may be the same as or similar to and / or include any of the features described with respect to any of the fluid-actuated implants described herein, such as the implant 200m. As illustrated, the implant 200n may be configured with a flow restrictor 250n, which may include a balloon 280n, a tube 270n, and a shaft 290n substantially concentrically aligned with the expandable body 210n such that the balloon 280n is substantially centrally located within the lumen 213n. The balloon 280m may have any shape and / or configuration as described herein, including a prolate or oblate spheroid shape. Unlike implant 200m, flow restrictor 250n of implant 200m may be configured to conceal balloon 280n when in an unactuated state (e.g., as shown in the left diagram of FIG. 21B). For example, shaft 290n may be configured to cover balloon 280n and / or tube 270n when balloon 280n is in an unactuated state. Additionally, shaft 290n may be configured to conceal balloon 280n and / or tube 270n from flow through the lumen when balloon 280n is in an unactuated state. Such a configuration may advantageously reduce the risk of thrombus formation, particularly in a permanent implant 200n.

[0098] In some embodiments, the flow restrictor 250n can be configured such that the balloon 280n folds internally within the shaft 290n when deactivated. In some cases, as shown in FIG. 21B, the flow restrictor 250n can be configured such that the shaft 290n can advance distally to cover the balloon 280n when the balloon 280n is in an unactuated state. In such a configuration, the shaft 290n can be biased, for example, by a spring force and / or such that the shaft 290n can be spring loaded, to advance over the balloon 280n when the balloon 280n is in an unactuated state. Additionally, in such a configuration, when the balloon 280n is actuated, the expansion of the balloon 280n can cause the shaft 290n to retract proximally. In other words, shaft 290n can advance distally over balloon 290n when the balloon is deflated, and when balloon 280n is inflated / expanded, the force generated by the inflation / expansion of the balloon can retract shaft 290n proximally, allowing balloon 280n to at least partially occlude lumen 213n (e.g., the biasing force of the shaft in the distal direction can be strong enough to suck in balloon 280n when balloon 280n is deflated / expanded, but weak enough to retract proximally to allow balloon 280n to inflate / expand upon actuation).

[0099] 21C illustrates a side view of an embodiment of a mechanically actuated implant 200o, with the left side view illustrating the flow restrictor 250o of the implant 200o in an unactuated state and the right side view illustrating the flow restrictor 250o in a substantially fully actuated state. The implant 200o may be the same as or similar to and / or include any of the features described with respect to any of the implants described herein, such as implants 200m and 200n. As illustrated, the implant 200o may be configured with a flow restrictor 250o, which may include an expandable occluder 280o and a shaft 290o substantially concentrically aligned with the expandable body 210o such that the expandable occluder 280o is substantially centrally located within the lumen 213o. The expandable occluder 280o, when in an actuated state, may have any shape and / or configuration as described and / or illustrated herein, including a prolate spheroid, an ellipsoid, an oblate spheroid, and / or a cylindrical shape as illustrated. Unlike implants 200m and 200n, expandable occluder 280o of flow restrictor 250n may be constructed of a shape memory material (e.g., Nitinol) that is movable between an unactuated state and an actuated state. For example, as shown in the left diagram of FIG. 21C, expandable occluder 280o may be retracted proximally relative to shaft 290o causing expandable occluder 280o to collapse within shaft 290o and substantially hide the occluder from flow through lumen 213o. Upon mechanical actuation, such as distal movement of expandable occluder 280o relative to shaft 290o, expandable occluder 280o may expand within lumen 213o to at least partially occlude lumen 213o. To vary the degree of occlusion of lumen 213o, expandable occluder 280o may be fully extended distally from within shaft 290o, partially extended distally from within shaft 290o, or unexpanded and hidden within shaft 290o. The nature of hiding the expandable body 280o within the shaft 290o may advantageously reduce the risk of thrombus formation, especially in a permanent implant 200o.The expandable body 280o can be configured with a mesh, knit, and / or any other configuration to create at least a partial obstruction to flow. Additionally, the flow restrictor 250o having the expandable body 280o and shaft 290o can be implemented in any of the implants described and / or illustrated herein.

[0100] 22A illustrates candidate locations for implantation and placement of a thermally activated permanently implantable flow restriction system 3. The thermally activated permanently implantable flow restriction system 3 may include a thermally activated implant 300, an energy source 30 configured to actuate (e.g., open and close) the implant 300, and a delivery device (not shown). A number of implants 300 are shown implanted within a patient along with a number of candidate locations for the energy source 30. In particular, FIG. 22A illustrates an implant 300 implanted within a patient's superior vena cava upstream of its connection to the right atrium, with associated location options for the energy source 30 being external to the patient, such as proximal to the patient's back, chest, and / or abdomen, and / or internal to the patient, such as in the interstitial space adjacent to the aortic arch or superior vena cava. An implant 300 placed in this location can controllably and selectively occlude, restrict, and / or divert flow within the patient's superior vena cava and connected vessels and / or organs to reduce cardiac preload, reduce central venous pressure and / or other venous pressures disclosed herein, and / or increase cardiac output. Also shown is an implant 300 implanted within the patient's inferior vena cava upstream of its connection to the hepatic vein, and an implant 300 implanted within the patient's inferior vena cava upstream of its connection to the renal vein. The location of the energy source 30 for actuating the implant 300 placed within the inferior vena cava can include the aorta, the interstitial space adjacent to the inferior vena cava as shown, and / or the energy source 30 can be located external to the patient, such as proximal to the patient's back, chest, and / or abdomen. An implant 300 placed within the inferior vena cava upstream of the hepatic vein can controllably and selectively occlude, restrict, and / or divert flow within the patient's inferior vena cava and connected vessels and / or organs to reduce (or facilitate reduction of) hepatic congestion. Additionally, the implant 300 positioned within the inferior vena cava upstream of the renal veins can controllably and selectively occlude, restrict, and / or divert flow within the patient's inferior vena cava and connected vessels and / or organs to relieve renal congestion (or promote relief of renal congestion), increase renal circulation, and / or control diuresis (e.g., increase diuresis).Although multiple implants 300 and energy sources 30 are shown, only one implant 300 may be implanted, or multiple implants 300 may be implanted at locations as shown and / or other locations, each having a corresponding energy source 30. In some embodiments in which multiple implants 300 are implanted, the energy source 30 may be configured to actuate multiple implants 300.

[0101] FIG. 22B illustrates additional potential locations for implantation and placement of a thermally activated permanently implantable flow restriction system 3. Multiple implants 300 and corresponding energy sources 30 are illustrated implanted within a patient. In particular, FIG. 22B illustrates an implant 300 implanted within the patient's right subclavian vein upstream of where the right lymphatic duct joins the right subclavian vein, and an implant 300 implanted within the patient's right internal jugular vein upstream of where the right internal jugular vein joins the right subclavian vein. The implants 300 in such locations can controllably and selectively occlude, restrict, and / or divert flow within the implanted veins to reduce pressure in the right lymphatic duct, increase lymphatic drainage, and / or reduce interstitial pressure (which may improve cardiac and renal function, respectively), as well as reduce cardiac preload and / or increase cardiac output. Also shown is an implant 300 implanted in a patient's left internal jugular vein upstream of where it joins the left subclavian vein, and an implant 300 implanted in a patient's left subclavian vein upstream of where the thoracic duct joins and drains into the left subclavian vein. The implant 300 in such a location can controllably and selectively occlude, restrict, and / or divert flow in the implanted vein to reduce pressure in the thoracic duct, increase lymphatic drainage, and / or reduce interstitial pressure (which may improve cardiac and renal function, respectively), and reduce cardiac preload and / or increase cardiac output. An energy source 30 for actuating the implant 300 shown in FIG. 22B can be located external to the patient, such as near the patient's back, chest, or neck, and / or within an artery or interstitial space adjacent to the implant 300. Although multiple implants 300 are shown, only one implant 300 may be implanted, or multiple implants 300 may be implanted in the locations shown and / or other locations, each with a corresponding energy source 30. In some embodiments in which multiple implants 300 are implanted, the energy source 30 may be configured to actuate multiple implants 300 .

[0102] The energy source 30 for actuating the thermally actuated implant 300 may include ultrasound, microwave, electromagnet, and / or any form of induction heating. For example, the thermally actuated implant 300 may generally include an induction coil, such as a copper coil, capable of generating an electric current through induction. Such a coil may be connected to a shape-changing material, such as a Nitinol wire, that may undergo a temperature change (e.g., heating) and a corresponding change in shape and / or stiffness due to the electric current from the connected coil. The energy source 30 may be worn and / or located in proximity to the patient when it is desired to actuate the implant 300. For example, the energy source 30 may be located on a belt worn by the patient, may be located on the patient's clothing, and / or may be located or attached to furniture used by the patient (e.g., the patient's bed, the patient's chair, etc.). The actuation of the implant 300 by the energy source 30 may be controlled and / or regulated by varying the power of the energy source 30. Thus, thermal actuation of the implant 300 can be adjusted and / or regulated during use such that the implant 300 provides substantially no obstruction to flow, several stages of partial obstruction to flow, and / or substantially complete obstruction to flow. In some embodiments, thermal actuation can be used to actuate the implant 300 (e.g., binary on / off) such that the implant 300 provides substantially no obstruction to flow or substantially complete obstruction to flow. In some cases, the binary on / off control of the implant 300 can include providing substantially no obstruction to flow (binary off) and partial obstruction to flow (binary on), or vice versa. In other words, even when fully actuated and in a "closed" state, the implant 300 can be configured to allow at least partial flow.

[0103] 23A-26B illustrate an embodiment of a thermally actuated implant 300a, with FIG. 23A illustrating a side cross-sectional view of the implant 300a in a non-occluded (e.g., open) state within a blood vessel, and FIG. 23B illustrating a side cross-sectional view of the implant 300a in an occluded (e.g., closed) state. The implant 300a may include an expandable body 310a having a proximal end 311a, a distal end 312a, and a lumen 313a extending from the proximal end 311a to the distal end 312a. As described above, the expandable body 310a may be configured to be collapsed for delivery to a patient and, once implanted, to expand to mate with an inner wall of the patient's blood vessel in the illustrated expanded configuration. Once implanted, blood flowing through the blood vessel in which the implant 300a is implanted may flow through the lumen 313a. The implant 300a may also have a flow restrictor 350a connected to the expandable body 310a. The flow restrictor 350a can include a material 380a, such as a graft material used in prosthetic valves, for occluding flow through the lumen 313a with a wire 370a embedded within the material 380a. The wire 370a can be made of a shape-changing material, such as Nitinol, as described above, that changes shape when heated. Although not shown, the expandable body 310a can include or be connected to an inductive coil, such as a copper coil. In some embodiments, the expandable body 310a is itself the inductive coil. Also, although not shown, the expandable body 310a can be made of a material, such as ePTFE·PTFE·PET fabric, polyurethane, or the like, that may or may not be coated with an anti-thrombogenic or other functional coating, disposed on the interior and / or exterior of the expandable body 310a, as described above.

[0104] In use, the energy source 30 can actuate the implant 300a by interacting with the induction coil of the implant 300a. Depending on the desired unactuated (e.g., resting) state of the implant 300a, the implant 300a can be oriented such that its distal end 312a receives blood flow from the vessel in which the implant 300a is implanted and its proximal end 311a drains blood flow, or can be implanted in the opposite orientation. For example, if it is desired that the implant 300a not occlude flow in its unactuated state, the implant can be oriented such that its proximal end 311a receives flow and its distal end 312a drains flow. In such an orientation, when actuated by the energy source 30, the induction coil of the implant 300a generates an electric current that flows through the connected wire 370a, causing the wire 370a to change shape and / or stiffness, thereby moving the material 380a closer together such that the lumen 313a is occluded (as shown in FIG. 23B). As another example, if it is desired for the implant 300a to occlude flow in the unactuated state, the implant can be oriented such that its distal end 312a accepts flow and its proximal end 311a expels flow. In such an orientation, blood flow can cause the flow restrictor 350a to occlude the lumen 313a until the energy source 30 activates the flow restrictor 350a, at which point the flow restrictor 150a can open to unocclude flow.

[0105] In some embodiments, the level of occlusion provided by the thermally activated implant 300a can be based on a given power level of the energy source 30 and can be adjusted by the configuration of the implant 300a, such as the thickness and / or shape of the wire 370a connected to the material 380a, and / or the shape and / or properties of the material 380a. Various embodiments of material 380a with connected / embedded wires 370a are shown in Figures 24A-26B. Figures 24A-24B show a tricuspid flow restrictor 350a having three sections of material 380a that come together as shown to occlude the lumen 313a. Figures 25A and 25B show a bicuspid flow restrictor 350a having two sections of material 380a that come together as shown to occlude the lumen 313a. 26A and 26B show a unicuspid flow restrictor 350a having one section of material 380a that can occlude lumen 313a as shown.

[0106] 27A-27D show another embodiment of a thermally actuated implant 300b. FIG. 27A shows a side view of implant 300b, FIG. 27B shows a corresponding end view of implant 300b in an unactuated (e.g., open) state, FIG. 27C shows a side view of implant 300b in an actuated (e.g., closed) state, and FIG. 27D shows a corresponding end view of implant 300b in an actuated (e.g., closed) state. Implant 300b may be the same as or similar to the features described with respect to implant 300a and / or may include any of those features. For example, implant 300b may have an induction coil, expandable body 310b, and flow restrictor 350b that are the same as or similar to induction coil, expandable body 310a, and flow restrictor 350a of implant 300a. However, flow restrictor 350b may have a different configuration. As shown, flow restrictor 350b of implant 300b may be funnel-shaped with funnel-forming material 380b and have wire 370b slidably embedded within the end of the funnel shape formed by material 380b. Upon actuation, wire 370b may tighten or otherwise change shape to substantially close the end of funnel-shaped flow restrictor 350b, similar to a purse string suture, thereby occluding flow in lumen 313b.

[0107] 28A-28D show another embodiment of a thermally actuated implant 300c. FIG. 28A shows a side view of implant 300c in an unactuated (e.g., open) state, FIG. 28B shows a corresponding end view of implant 300c in an unactuated (e.g., open) state, while FIG. 28C shows a side view of implant 300c in an actuated (e.g., closed) state, while FIG. 28D shows a corresponding end view of implant 300c in an actuated (e.g., closed) state. Implant 300c may be the same as or similar to the features described with respect to implants 300a and 300b and / or may include any of those features. For example, implant 300c may have an induction coil, expandable body 310a / 310b and flow restrictor 350a / 350b that are the same as or similar to the induction coil, expandable body 310a / 310b and flow restrictor 350a / 350b of implants 300a and 300b. However, flow restrictor 350c may have different configurations. As shown, flow restrictor 350c of implant 300c may be funnel-shaped with funnel-forming material 380c and have wire 370c slidably embedded within the end of the funnel shape formed by material 380c. Upon actuation, wire 380c may be caused to tighten or otherwise change shape by sliding a longitudinal end of the material along itself to substantially close the end of funnel-shaped flow restrictor 350c, thereby occluding flow in lumen 313c.

[0108] 29A-29D show another embodiment of a thermally actuated implant 300d. FIG. 29A shows a side view of implant 300d in an unactuated (e.g., open) state and FIG. 29B shows a corresponding end view of implant 300d in an unactuated (e.g., open) state, while FIG. 29C shows a side view of implant 300d in an actuated (e.g., closed) state and FIG. 29D shows a corresponding end view of implant 300d in an actuated (e.g., closed) state. Implant 300d may be the same as or similar to the features described with respect to implant 300a and / or may include any of those features. For example, implant 300d may have an induction coil, expandable body 310d, and flow restrictor 350d that are the same as or similar to induction coil, expandable body 310a, and flow restrictor 350a of implant 300a. However, flow restrictor 350d may have a different configuration. As shown, flow restrictor 350d of implant 300d can have a balloon 380d connected to and supported within lumen 313d of implant 300d by wire 370d. As shown, wire 370d can be connected to distal end 312d of expandable body 310d of implant 300d. When actuated, wire 370d can transfer heat to balloon 380d (e.g., wire 370d can extend into balloon 380d), causing balloon 380d to expand and thereby occlude flow in lumen 313d.

[0109] 30A and 30B show another embodiment of a thermally activated implant 300e. FIG. 30A shows a side view of the implant 300e in an unactivated (e.g., open) state, while FIG. 30B shows a side view of the implant 300e in an activated (e.g., closed) state. The implant 300e may be the same as or similar to and / or include any of the features described with respect to the implant 300d. However, the wire 370e of the flow restrictor 350e may be connected to the proximal end 311d of the expandable body 310e of the implant 300e.

[0110] 31A and 31B show another embodiment of a thermally actuated implant 300f. FIG. 31A shows a side view of the implant 300f in an unactuated (e.g., open) state, while FIG. 31B shows a side view of the implant 300f in an actuated (e.g., closed) state. The implant 300f may be the same as or similar to and / or include any of the features described with respect to implants 300d and 300e. However, the flow restrictor 350f may include multiple wires 370f connecting to both the proximal end 311f and the distal end 312f of the expandable body 310f of the implant 300f.

[0111] 32A-32D show another embodiment of a thermally actuated implant 300g. FIG. 32A shows a side view of implant 300g in an unactuated (e.g., open) state, FIG. 32B shows a corresponding end view of implant 300g in an unactuated (e.g., open) state, while FIG. 32C shows a side view of implant 300g in an actuated (e.g., closed) state, FIG. 32D shows a corresponding end view of implant 300g in an actuated (e.g., closed) state. Implant 300g may be the same as or similar to the features described with respect to implant 300a and / or may include any of those features. For example, implant 300g may have an induction coil, expandable body 310g, and flow restrictor 350g that are the same as or similar to induction coil, expandable body 310a, and flow restrictor 350a of implant 300a. However, flow restrictor 350g may have a different configuration. As shown, flow restrictor 350g of implant 300g can include multiple wires 370g with wire-spanning material 380g. Upon actuation, wires 370g can change shape to bring their free ends together and substantially occlude flow in lumen 313g with wire-spanning material 380g.

[0112] 33A-33D show another embodiment of a thermally actuated implant 300h. FIG. 33A shows a side view of implant 300h in an unactuated (e.g., open) state, and FIG. 33B shows a corresponding end view of implant 300h in an unactuated (e.g., open) state, while FIG. 33C shows a side view of implant 300h in an actuated (e.g., closed) state, and FIG. 33D shows a corresponding end view of implant 300h in an actuated (e.g., closed) state. Implant 300h may be the same as or similar to the features described with respect to implant 300a and / or may include any of those features. For example, implant 300h may have an induction coil, expandable body 310h, and flow restrictor 350h that are the same as or similar to induction coil, expandable body 310a, and flow restrictor 350a of implant 300a. However, expandable body 310h and flow restrictor 350h may have different configurations. As shown, the expandable body 310h can have an outer body 315h and an inner body 325h. The inner body 325h can be configured to slidably move within the outer body 315h. Additionally, an expandable membrane 380h (which can alternatively be a balloon) can connect one end of the outer body 315h to an opposite end of the inner body 325h to form a generally closed / sealed space below the membrane 380h. In the unactuated state shown in FIGS. 33A and 33B, the implant 300h can be configured such that the inner body 325h is biased to extend from the outer body 315h, folding the membrane 380h against the inner wall of the inner body 325h. Upon actuation, the closed / sealed space below the membrane 380h can be heated, causing the membrane 380h to expand and retract the inner body 325h inside the outer body 315h. In some embodiments, the inner body 325h can be configured to move like a screw within the outer body 315h. Additionally, in some embodiments, the implant 300h can be mechanically actuated, such as by a pull wire, instead of by heat.

[0113] Figure 34 shows the patient's anatomy, including the inferior vena cava and the patient's nearby spine. Additionally, various veins that connect to the inferior vena cava, such as the renal vein and various lumbar veins, are shown. The extravascular space in this region is not open, but is bounded by membranes and muscles; therefore, free space is limited. Additionally, the inferior vena cava is relatively compliant compared to other surrounding tissues and structures.

[0114] 35A-36A illustrate a method of occluding a patient's inferior vena cava using a fluid-actuated implant 400a. The implant 400a may be the same as or similar to and / or include any of the features described with respect to the fluid-actuated implants described herein, with the exception that the implant 400a may not include an expandable body. The implant 400a may include a flow restrictor 450a including a balloon 480a fluidly connected to a tube 470a for inflating / deflating the balloon (such as by a fluid reservoir as described herein). The tube 470a may also be used to advance and / or position the balloon 480a within the patient's body. As shown in FIG. 35A, the flow restrictor 450a may be advanced within the patient's vasculature to the inferior vena cava and into a lumbar vein (or other vein, as appropriate) connected to the inferior vena cava. As shown in FIG. 35B, upon actuation of the flow restrictor 450a, the balloon 480a may be inflated to cause at least a partial occlusion of the inferior vena cava.

[0115] 36A and 36B illustrate an extravascular method of occluding a patient's inferior vena cava using a fluid-actuated implant 400b. The implant 400b may be the same as or similar to the features described with respect to the implant 400a, and / or may include any of those features. As shown in FIG. 36A, the implant 400b may have an occluder 490b disposed in a lumbar vein (or other vein, if desired) connected to the inferior vena cava. The occluder 490b may be configured to completely occlude blood flow in the lumbar vein. As shown in FIG. 36B, the implant 400b may further include a flow restrictor 450b having a balloon 480b that can be advanced and positioned adjacent to the occluder 490b in the lumbar vein. In this position, the flow restrictor 450b may be actuated to expand the balloon 480b and rupture the lumbar vein, as shown in FIG. 36B. When held in this position, the balloon 480b of the flow restrictor can seal against the inferior vena cava in both the unactuated and actuated states, preventing blood loss from the inferior vena cava. Activating the flow restrictor 450b causes the balloon 480b to expand and compress the outer wall of the inferior vena cava, causing at least partial occlusion of the inferior vena cava by buckling the inferior vena cava inward in its position. In some embodiments, as shown in FIG. 36B, an occluder 490b can be provided on the implant 400b to help secure and maintain the implant 400b in the desired position.

[0116] 37A-37C illustrate another extravascular method of occluding a patient's inferior vena cava using a fluid-actuated implant 400c. The implant 400c may be the same as or similar to, and / or include any of, the features described with respect to implants 400a and 400b. As shown in FIG. 37A, an occluder 490c may be advanced and placed into a lumbar vein (or other vein, if desired) connected to the inferior vena cava on either side of an implant 400b also advanced and placed into the lumbar vein. In this position, the flow restrictor 450c may be actuated to expand the balloon 480c, as shown in FIG. 37B, to rupture the lumbar vein. The implant 400c may then be advanced to a desired location outside the inferior vena cava, as shown in FIG. 37C. Once the implant 400c is deployed and the flow restrictor 450c is activated, the balloon 480c inflates and compresses the outer wall of the inferior vena cava, causing the inferior vena cava to buckle inwardly in place, thereby causing at least partial occlusion of the inferior vena cava.

[0117] FIG. 38 illustrates another extravascular method of occluding a patient's inferior vena cava using a fluid-actuated implant 400d. The implant 400d may be the same as or similar to, and / or include any of, the features described with respect to implants 400a, 400b, and 400c. As shown in FIG. 38, the implant 400d is advanced through the inferior vena cava and out of the inferior vena cava. The balloon 480d of the flow restrictor 450d can seal against the inferior vena cava in both the unactuated and actuated states, preventing blood loss from the inferior vena cava. When the flow restrictor 450d is actuated, the balloon 480d expands and presses against the outer wall of the inferior vena cava, causing the inferior vena cava to buckle inwardly at that point, thereby causing at least partial occlusion of the inferior vena cava. As described above, the inferior vena cava is the most compliant structure in this space, and therefore presses preferentially as opposed to the adjacent aorta.

[0118] Figure 39 illustrates another extravascular method of occluding a patient's inferior vena cava using a fluid-actuated implant 400e. This method may be the same or similar to the extravascular method of occluding a patient's inferior vena cava described with respect to Figure 38, with the addition of placing an occluder 490e in the wall of the inferior vena cava to help seal the penetration through the wall of the inferior vena cava. When the flow restrictor 450e is actuated, the balloon 480e may expand and compress the outer wall of the inferior vena cava, causing the inferior vena cava to buckle inwardly in that position, thereby causing at least partial occlusion of the inferior vena cava.

[0119] 40 illustrates another extravascular method of occluding a patient's inferior vena cava. This method can include placing an occluder / disk 490f attached to a wire 470f and through the wall of the inferior vena cava. Pulling the wire 470f can pull the occluder / disk 490f, and thus the wall of the inferior vena cava, inward, causing at least partial occlusion of the inferior vena cava. Although not shown, a variation of this method can also include extending the wire 470f through the wall of the inferior vena cava at least twice so that pulling the wire compresses the inferior vena cava (e.g., similar to a purse string suture).

[0120] FIG. 41 illustrates a control unit (which may also be referred to herein as a "controller") that may be used with any of the implants, such as implants 100, 200, 300, 400, and 500 described herein. The control unit may be capable of patient control and / or patient monitoring, for example, wirelessly via an app on a smartphone as shown. As illustrated, the control unit may be configured to be implantable within a patient and may include a source of operation for the implant, a motherboard including a processor, memory, and in some embodiments a communication module, and a power source. The control unit may include circuitry configured to receive wireless or wired signals from pressure sensors (e.g., MEMS sensors) located at various locations in or around the heart or other locations within the body to measure, for example, pressure in the right ventricle, right atrial pressure, central venous pressure, aortic pressure, left atrial pressure, left ventricular pressure, aortic pressure, superior vena cava pressure, inferior vena cava pressure, hepatic vein pressure, renal vein pressure, femoral vein pressure, and / or pressure in any of the veins or portions thereof disclosed herein. Based on these measurements, the control unit can appropriately actuate the implant to control the adjustable occlusion of the implant in order to control the amount of blood flowing through the implant.

[0121] The control unit can provide closed-loop, fully autonomous, and / or real-time adjustability and control of the implant. The control unit can implement treatment protocols / algorithms prescribed by a physician, and / or the control logic can be optimized to treat a heart failure patient, for example, by reducing cardiac preload, reducing central venous pressure and / or other venous pressures disclosed herein, increasing cardiac output, reducing renal congestion (or promoting renal drainage), promoting renal circulation, and / or promoting or controlling diuresis (e.g., increasing diuresis). In some embodiments, the control unit can receive data from sensors connected to the implant as described herein for control of the operation of the implant.

[0122] 42 illustrates potential locations for implantation and placement of an implantable flow restriction system 5. The implantable flow restriction system 5 may be a mechanically actuated permanent implantable flow restriction system 5. Although certain embodiments of the implantable flow restriction system 5 may be described as permanent systems, components of the implantable flow restriction system may also be used in acute systems. Additionally, certain embodiments of the implant 500 of the implantable flow restriction system 5 have been described as being mechanically actuated. This may include electromechanically actuated implants. Other actuation methods are possible, such as fluid or gas driven systems.

[0123] The implantable flow restriction system 5 can include an implant 500 connected to a controller 50 (which may also be referred to herein as a "control unit") via, for example, a tube 570 and a shaft 590 (all of which may be implanted), and an external device 15 for operating the system 5. In some embodiments, the implantable flow restriction system 5 includes an implant 500, a controller 50, a tube 570, and a shaft 590. One implant 500 is shown in FIG. 42 implanted in a patient's inferior vena cava upstream of a connection to the renal vein (e.g., below the renal vein). The implant 500 positioned in the inferior vena cava upstream of the renal vein can controllably and selectively occlude, restrict, and / or divert flow within the patient's inferior vena cava and connected vessels and / or organs to reduce (or promote relief of) renal congestion, promote renal circulation, and / or control diuresis (e.g., promote diuresis). To this end, the implant 500 can have a flow restrictor portion 550 and / or a flow restrictor 560. Such flow restrictor portion 550 and / or flow restrictor 560 may be actuated by controller 50 via shaft 590 and tube 570, as further described herein.

[0124] The implant 500 can be implanted such that the flow restrictor portion 550 is upstream from other portions of the implant 500 (e.g., the flow restrictor portion 550 is the first portion of the implant 500 to receive blood flowing through the implant). In such a position, the shaft 590 and tube 570 can extend proximally from the implant 500, up the inferior vena cava, through the right atrium, into the superior vena cava (SVC), through the subclavian vein (left subclavian vein as shown), and out of the subclavian vein to connect with the controller 50, which can be implanted in a subclavian subcutaneous pocket (e.g., similar to the placement of a pacemaker). In some embodiments, the implant 500 can be implanted in other locations as shown and described with respect to the implants 100, 200, and 300. Additionally, in some embodiments, multiple implants 500 can be implanted in a patient, as shown and described with respect to the implants 100, 200, and 300. If multiple implants 500 are implanted within a patient, each may be connected to a single controller 50 via a separate tube 570 and shaft 590, or each may be connected to its own controller 50 via a separate tube 570 and shaft 590.

[0125] 43A-43D show various views of an embodiment of an implant 500a, which may be an implant 500 in an implantable flow restriction system 5. FIGS. 43A and 43C show a side view of the implant 500a in a non-occluding (e.g., open, unactuated) state, FIG. 43B shows an end view of the implant 500a in a non-occluding (e.g., open, unactuated) state, and FIG. 43D shows a side view of the implant 500a in a fully occluded (e.g., closed, actuated) state. FIGS. 43A-43D also show how the implant 500a can be connected to a tube 570a and a shaft 590a for manipulation thereof. The implant 500a can have an expandable body 510a having a proximal end 511a, a distal end 512a, and a lumen 513a for receiving blood flow therethrough. The implant 500a can be connected to a distal end 572a of a tube 570a and can include a filter portion 520a, a radial support portion 540a (which may also be referred to herein as a “sealing portion” or “sealing region”), and a flow restrictor portion 550a.

[0126] 43A-43D, filter portion 520a can be disposed adjacent proximal end 511a, radial support portion 540a can connect to and be disposed distal to filter portion 520a, and flow restrictor portion 550a can connect to and be disposed distal to radial support portion 540a. Filter portion 520a can be configured to capture thrombus that may pass through lumen 513a of implant 500a and can include a plurality of struts 527a extending distally and radially outward from a connection between tube 570a and implant 500a.

[0127] Radial support portion 540a can be configured to fluidly seal against the inner wall of the inferior vena cava and can include rings 545a that extend around the circumference of implant 500a in a chevron pattern. As shown, ring 545a can include a plurality of ring struts 542a, with adjacent pairs of ring struts 542a joined at a plurality of proximal apices 543a and a plurality of distal apices 544a. As further shown, each of the plurality of proximal apices 543a of ring 545a of radial support portion 540a can be connected to a strut 527a of filter portion 520a.

[0128] The flow restrictor portion 550a can include a plurality of petals 560a configured to restrict / occlude flow through the lumen 513a of the implant 500a upon actuation. As shown, each petal 560a can be formed by a pair of struts 562a extending distally from an adjacent pair of distal apices 544a of the ring 545a of the radial support portion 540a and joining at a distal apice 564a. Each of the plurality of petals 560a can also include struts 566a extending proximally from the respective distal apices 564a, which can aid in the ability of the petals to restrict flow during use. As further shown, the flow restrictor 550a can include a material 530a spanning each of the plurality of petals 560. The material 530a can include ePTFE·PTFE·PET fabric, polyurethane, and / or as described herein. The area between the petals 560 may be free of material 530a. In some embodiments, material 530a may span the area between the petals 560. Material 530a may also span the radial support portion 540a to aid in the ability of the implant 500a, in use, to fluidly seal against the inner wall of the inferior vena cava (or the inner wall of any other lumen / vessel in which the implant is placed) and restrict / block blood flow. In some embodiments, as shown, the implant 500a may include a number of anchors 525a configured to secure the implant 500a within the inferior vena cava (or any other lumen / vessel in which the implant is placed). Such anchors 525a may extend generally proximally from each of the proximal apices 543a of the ring 545a.

[0129] 43A-43D, each of the petals 560a can be connected to the shaft 590a by a connector. Various connectors have been described herein, such as, for example, sutures, wires, struts, etc. For example, each of the distal apices 564a of the petals 560a can be connected to a suture or wire 595a at one end thereof, and the other end of the suture or wire 595a can be connected to a distal end 592a of the shaft 590a that extends generally centrally through the lumen 513a of the implant 500a. Additionally, as shown, the distal end 592a of the shaft 590a can be substantially longitudinally aligned with the distal apices 564a of the petals 560a in the unactuated / open state of the implant 500a. In such relative position, the suture or wire 595a can extend substantially radially outward from the distal end 592a of the shaft 590a to connect to the distal apex 564a of the petal 560a. The shaft 590a can slidably move through the lumen of the tube 570a and extend from its distal end 572a as shown, and a collapsible and extensible coupling 580a can fluidly seal the lumen of the tube 570a to the shaft 590a. A proximal end 571a (not shown) of the tube 570a can be connected to the controller 50a, and the shaft 590a can extend from such proximal end 571a and be operably connected to an actuator of the controller 50a. To actuate the flow restrictor portion 550a of the implant 500a and at least partially occlude / restrict flow through the implant, the actuator of the controller 50a can be actuated to move the shaft 590a in a proximal direction relative to the tube 570a and the implant 500a, which causes the distal apices 564a of the plurality of petals 560a to move radially inward toward one another via their connections to the suture or wire 595a and to the distal end 592a of the shaft 590a. In other words, proximal movement of the shaft 590a can cause the petals 560a to come together and at least partially restrict flow through the lumen 513a of the implant 500a, as shown in FIG.For example, the petals 560a can fold radially inward (e.g., hinged relative to the expandable body) with the distal apex 564a of the petals 560a forming the most distal tip of the implant 500a. In use, blood flows toward and is occluded by the outer surface of the petals 560a. In some embodiments, the flow restrictor portion 550a (e.g., the petals 560a) can be configured to be attached or secured to the wall of a blood vessel in which the implant 500a is implanted, and when actuated, can retract the wall of the blood vessel to at least partially restrict flow through the blood vessel and / or lumen 513a. To this end, as described herein, the flow restrictor portion 550a (e.g., the petals 560a) can include one or more anchors and / or be configured to at least partially dig into the wall of the blood vessel.

[0130] The tube 570a may have a unitary or composite structure. For example, the tube 570a may include a tube section, a braided section, and / or a liner. The tube 570a may be constructed of, for example, PEBAX. The liner, if included, may be constructed of PTFE, HDPE, or a silicone blend and may facilitate sliding movement of the shaft 590a within the tube 570a (e.g., the liner may reduce friction within the tube 570a and the force required to slide the shaft 590a within the tube 570a). Connections between components of the system 5, such as the tube 570a, the implant 500a, the collapsible and extendable coupling 580a, and the shaft 590a, may be made by reflow (e.g., using PEBAX), heat shrink, etc.

[0131] 43B, implant 500a can be configured such that sutures or wires 595a are substantially aligned with struts 527a of filter portion 520a. Such substantial alignment can advantageously allow other interventional devices to pass through implant 500a, if desired. For example, such substantial alignment can allow a 28 French interventional device to pass through implant 500a.

[0132] Although the implant 500a in FIGS. 43A-43D is shown as having six petals 560a, six sutures or wires 595a connecting each of the six petals 560a to the shaft 590a, and a filter portion 520a having six struts 527a, the implant 500a can be configured to have a fewer or greater number of each of these.

[0133] 44A-44C show end views of the implant 500a of FIGS. 43A-43D in various states of actuation and restriction / occlusion of flow therethrough. FIG. 44A shows the implant 500a in an unactuated, non-restrictive / unoccluded state, FIG. 44B shows the implant 500a in a partially actuated, partially restrictive / occluded state, and FIG. 44C shows the implant 500a in a fully actuated, fully restrictive / occluded state. As shown throughout FIGS. 44A-44C, the lumen 513a of the implant 500a (e.g., the lumen or opening of the flow restrictor portion 550a) can change from a generally circular shape when unactuated (FIG. 44A), to a generally star-shaped / radial shape when at least partially actuated (FIG. 44B), to a substantially blocked lumen when fully actuated (FIG. 44C). In some embodiments, the lumen 513a of the implant 500a (e.g., the lumen or opening of the flow restrictor portion 550a) can have a generally circular shape when unactuated, a generally circular shape when partially actuated, and a substantially occluded lumen when fully actuated. When folded radially inward, an outer surface of each of the plurality of petals 560a can block blood flow with the material 530a. In some embodiments, as shown in FIG. 44D, the implant 500a can be configured such that its lumen 513a can remain at least partially open even when the flow restrictor portion 550a is fully actuated, such as by forming an elongated gap 514a between each or at least a portion of the petals 560a.

[0134] FIG. 45 shows a flat pattern of the expandable body 510a of the implant 500a of FIGS. 43A-43D, with the features previously described and identified.

[0135] FIGURES 46A and 46B show various views of the components of an implantable flow restriction system 5a, which may be implanted as shown above with respect to FIGURE 42. FIGURE 46A shows an implant 500a connected to a shaft 590a and a tube 570a. The implant 500a, shaft 590a and tube 570a may be referred to herein as an implant assembly 501a. FIGURE 46B shows the implant 500a connected to the shaft 590a and tube 570a, which are in turn connected to a controller 50a. In other words, FIGURE 46B shows the implant assembly 501a connected to the controller 50a.

[0136] 47A-47D illustrate the interaction of the various components of the implant assembly 501a to actuate the implant 500a of FIGS. 43A-43D, with material 530a of the implant 500a removed for clarity. As described with respect to FIGS. 43A-43D, each of the distal apices 564a of the petals 560a can be connected to a suture or wire 595a at one end thereof, and the other end of the suture or wire 595a can be connected to the distal end 592a of the shaft 590a. As an example, the suture or wire 595a can be connected to the distal apices 564a through an eyelet in the distal apices 564a, as shown. Further to this example, the suture or wire 595a may be connected to the distal end 592a of the shaft 590a via a crimp as shown, although other forms of connection (e.g., by set screws, press-fit fittings, adhesives, and / or threaded ends) are possible and considered within the scope of this disclosure. In some embodiments, the suture or wire 595a may extend from the distal end 592a of the shaft 590a, pass through an eyelet in the distal apex 564a of the petal 560a, and back to connect to the distal end 592a of the shaft 590a. In some embodiments, the suture or wire 595a may be integrally formed with the shaft 590a or may be a part of the shaft 590a. For example, in embodiments in which the shaft 590a has a braided construction with multiple individual wires 593 as described with respect to FIGS. 64A-64B, the suture or wire 595a may be one or more of such individual wires 593.

[0137] 47A-47D, with material 530a removed from view, foldable and extendable coupling 580a configured to fluidly seal tube 580a to shaft 590a is visible. In some embodiments, as shown, foldable and extendable coupling 580a can extend around shaft 590a such that no portion of shaft 590a is exposed except where shaft 590a is connected to suture or wire 595a. Alternatively, in some embodiments, foldable and extendable coupling 580a can extend around shaft 590a such that no portion of shaft 590a is exposed, which may include covering where shaft 590a is coupled to suture or wire 595a. As shown, the foldable and extendable coupling 580a can be connected at its proximal end to the distal end 572a of the tube 570a and can be connected at its distal end to the shaft 590a adjacent the distal end 592a of the shaft 590a, thereby allowing sliding and / or rotational movement of the shaft 590a within the coupling.

[0138] In some embodiments, as shown in FIGURES 47A and 47B, the implant 500a (e.g., flow restrictor portion 550a) can be actuated by longitudinal movement (e.g., proximal and distal movement) of the shaft 590a relative to the implant 500a. Such longitudinal movement can include sliding of the shaft 590a within the tube 570a. In the unactuated, non-restrictive / non-occluding state shown in FIGURE 47A, the shaft 590a is in its distal-most position relative to the implant 500a and the collapsible and extendable coupling 580a is in its extended state. In the extended state, the collapsible and extendable coupling 580a can have a generally straight shape as shown. As shaft 590a moves proximally within tube 570a as shown in FIG. 47B (e.g., as shaft 590a moves proximally relative to tube 570a and implant 500a), shaft 590a pulls petals 560a radially inward toward one another via suture or wire 595a, occluding / restricting flow through implant 500a. Such proximal movement of shaft 590a also causes collapsible and extensible coupling 580a to collapse into a collapsed state. Additionally, as shown in FIG. 47B, when shaft 590a is in a proximal-most position relative to implant 500a, suture or wire 595a may be oriented substantially longitudinally.

[0139] In some embodiments, as shown in FIG. 47C and FIG. 47D, the implant 500a (e.g., the flow restrictor portion 550a) can be actuated by rotating the shaft 590a relative to the implant 500a (e.g., clockwise or counterclockwise). Such rotation of the shaft 590a can cause the suture or wire 595a to wind or wrap about the shaft 590a to at least partially close the flow restrictor portion 550a. In other words, such rotation of the shaft 590a can cause the suture or wire 595a to wind or wrap around the shaft 590a to at least partially fold the plurality of petals 560a radially inward. To this end, the embedded controller 50a can be configured to rotate the shaft 590a. Additionally, in such embodiments, the tube 570a can be configured to rotate the shaft 590a therein. Moreover, in such embodiments, the collapsible and extendable coupling 580a can be configured for such rotational movement, with Figures 47C and 47D each showing the shaft 590a rotated such that the petals 560a of the implant 500a are pulled at least partially radially inward, and Figure 47D showing the shaft 590a rotated further than shown in Figure 47C.

[0140] 42, the implant 500a can be positioned in the inferior vena cava below the renal veins such that the distal apexes 564a of the petals 560a are oriented toward the incoming blood flow. In other words, the implant 500a can be implanted such that the flow restrictor portion 550a is upstream of other portions of the implant 500a (e.g., such that the flow restrictor portion 550a is the first portion of the implant 500a to receive blood flow through the implant). In such a position, the shaft 590a and tube 570a can extend proximally from the implant 500a, up the inferior vena cava, through the right atrium, into the superior vena cava (SVC), through the subclavian vein (left subclavian vein as shown), and out of the subclavian vein to connect to the controller 50a, which can be implanted in a subclavian subcutaneous pocket (e.g., similar to the placement of a pacemaker). Additionally, such positioning of the flow restrictor portion 550a with the petals 560a may provide the functional advantage of pushing any thrombus that may have formed or otherwise collected on the outer surface of the petals 560a when the implant 500a is actuated / closed toward the wall of the inferior vena cava upon opening of the petals 560a, rather than allowing thrombus to pass through the implant 500a upon opening of the petals 560a (as may occur if the petals 560a are not oriented toward the incoming blood flow). In this way, any thrombus is directed toward the area of ​​seal with the wall of the inferior vena cava around the implant 500a, and not through the implant 500a toward the heart.

[0141] In some embodiments, any of the flow restriction devices described herein (e.g., including at least implant 500a) may cooperate with and / or be used with a sensor located remote from the flow restriction device that may provide a physiological parameter of interest useful for control of the flow restriction device. Such physiological parameters of interest may include pressure, flow, heart rate, and / or the like. As an example, the flow restriction device may be used with a pressure sensor located in a vessel and / or organ remote from the flow restriction device to provide a measurement of pressure at such location for control of the flow restriction device. One example of an implantable sensor is a MEMS pressure sensor. The MEMS or other implantable pressure sensor may be a remote component of the flow restriction device or may be an independent sensor with a separate control system. In one example, the MEMS pressure sensor may be located in the pulmonary artery and measure the pressure of blood flowing through the pulmonary artery. The MEMS or other pressure sensor may include a separate electronic system configured to receive measurements (e.g., data indicative of pressure) from the MEMS pressure sensor. These measurements may be used by the patient, the patient's physician, or the like to determine when the patient should receive treatment via the flow restriction device. In one embodiment, the MEMS pressure sensor may include a capacitive sensor. In another embodiment, the MEMS pressure sensor may include a barometer and be powered by an external antenna (e.g., in the form of a radio frequency signal). For example, the external antenna may be included in an antenna device, and when a patient applies the antenna device to his or her body, a pressure measurement may be taken and transmitted to the electronics system. Additionally or alternatively, the MEMS pressure sensor may include an inductor that can be used to create a circuit that generates a frequency, such as, for example, an LC circuit or an LC tank circuit. This frequency may be used to determine the pressure.

[0142] In some embodiments, the MEMS pressure sensor described above can be coupled to a portion of the flow restriction device described herein. As an example, the flow restriction device can have the MEMS pressure sensor attached to its proximal end, its distal end, both its ends, its shaft, etc. In the example of implant 500a, the MEMS pressure sensor can be coupled to shaft 590a. The MEMS pressure sensor may be tied / coupled to the flow restriction device using suturing, reflow, and / or the like. In this example, the MEMS pressure sensor is configured to measure pressure at such a location (e.g., upstream, downstream, both upstream and downstream, etc.) relative to the flow restriction device. As described above, the MEMS pressure sensor can transmit pressure measurements to a separate electronics system. Additionally or alternatively, the MEMS pressure sensor can transmit measurements to a control system (e.g., controller 50a) of the flow restriction device.

[0143] 48A-C show implant 500a with sensor 600 positioned at various locations relative to flow restrictor portion 550a. Sensor 600 can be configured to measure pressure within the vessel at that location, such that the location of sensor 600 relative to flow restrictor portion 550a can identify which vessel pressure is being measured depending on the actuation state of flow restrictor portion 550a. Sensor 600 can be positioned adjacent to the proximal end of implant 500a and proximal to flow restrictor portion 550a (e.g., attached to tube 550a proximal to implant 500a) when actuated as shown in FIG. 48A, adjacent to the distal end of shaft 590a and proximal to flow restrictor portion 550a when actuated as shown in FIG. 48B, and / or positioned on an extension of shaft 590a and distal to flow restrictor portion 550a when actuated as shown in FIG. 48C. When the flow restrictor portion 550a of the implant 500a is not activated (e.g., when the implant is in a non-restrictive / non-occluded state), the sensor 600 positioned as shown in any of FIGS. 48A-8C will measure substantially the same pressure. For example, when the flow restrictor portion 550a of the implant 500a is not activated, the sensor 600 positioned as shown in any of FIGS. 48A-48C will measure substantially the same inferior vena cava pressure. However, when the flow restrictor portion 550a of the implant 500a is activated, the sensor 600 positioned as shown in FIGS. 48A and 48B will measure renal vein pressure (e.g., because it may be positioned in proximity to the renal vein), whereas the sensor 600 positioned as shown in FIG. 48C will measure femoral vein pressure. The implant 500a may include a sensor 600 at any of the locations shown in FIGS. 48A and 48B that measures renal vein pressure. In some embodiments, the implant 500a can include multiple sensors 600, one positioned as shown in Figures 48A and 8B to measure renal venous pressure and one positioned as shown in Figure 48C to measure femoral venous pressure.The sensor 600 of the implant 500a can be operatively connected to the controller 50a, for example, via a wire extending between the sensor 600 and the controller 50a through the tube 570a. In some embodiments, the shaft 590a or a portion thereof can operatively connect the sensor 600 to the controller 50a. Pressures and / or differentials thereof measured from signals generated by the sensor 600 (e.g., differentials between multiple sensors and / or differentials between pressures measured over time) can be utilized to control the implant 500a.

[0144] FIG. 49 illustrates another embodiment of an implant 500b that can be used in connection with an implantable flow restriction system 5. The implant 500b may be the same as or similar to and / or include any of the features described with respect to the implant 500a. For example, the implant 500b may have an expandable body 510b having a filter portion 520b, a radial support portion 540b, and a flow restrictor portion 550b that are the same as or similar to the expandable body 510a having a filter portion 520a, a radial support portion 540a, and a flow restrictor portion 550a of the implant 500a. FIG. 49 illustrates a side view of the expandable body 510a of the implant 500b without material covering the flow restrictor portion 550b. Unlike the implant 500a, the expandable body 510b of the implant 500b may include a plurality of distally extending struts 546 and / or a plurality of proximally extending struts 547. The distally extending struts 546 may extend distally generally longitudinally from the proximal apex 543b of the radial support portion 540b as shown. Additionally, the distally extending struts 546 may be configured to enhance sealing between the implant 500b and the wall of a vessel in which the implant 500b is implanted (e.g., the wall of the inferior vena cava). The proximally extending struts 547 may extend proximally generally longitudinally from the distal apex 544b of the radial support portion 540b as shown. Additionally, the proximally extending struts 547 may be configured to enhance sealing between the implant 500b and the wall of a vessel in which the implant 500b is implanted (e.g., the wall of the inferior vena cava). In some embodiments, the implant 500b includes only the distally extending struts 546. Implant 500a can include multiple distally extending struts and / or multiple proximally extending struts similar to or identical to multiple distally extending struts 546 and multiple proximally extending struts 547.

[0145] FIG. 50 illustrates another embodiment of an implant 500c that can be used in conjunction with an implantable flow restriction system 5. The implant 500c may be the same as or similar to and / or include any of the features described with respect to other implants described herein, such as implants 500a and 500b. For example, the implant 500c may have an expandable body 510c having a filter portion 520c, a radial support portion 540c, and a flow restrictor portion 550c, similar to the expandable body 510a having a filter portion 520a, a radial support portion 540a, and a flow restrictor portion 550a of the implant 500a. FIG. 49 illustrates a side view of the expandable body 510c of the implant 500c connected to a shaft 590c and a tube 570c with a collapsible and extendable coupling 580c, which may be the same as or similar to the shaft 590a, tube 570a, and collapsible and extendable coupling 580a described with respect to the implant 500a. Unlike implant 500a, flow restrictor portion 550c may be connected and disposed between filter portion 520c and radial support portion 540c as shown. In such a configuration, blood flowing through implanted implant 500c will first flow through radial support portion 540c, rather than through the flow restrictor portion as in implant 500a. Operation of flow restrictor portion 550c with petals 560c may be the same or similar to that described with respect to flow restrictor portion 550a of implant 500a (e.g., by sutures or wires 595c connected between shaft 570c and distal apex 564a of petals 560a). Additionally, implant 500c may be similarly disposed in the inferior vena cava below the renal veins such that distal apex 564c of petals 560c is directed toward the incoming blood flow.

[0146] 51A and 51B illustrate another embodiment of an implant 500d that can be used in conjunction with an implantable flow restriction system 5. The implant 500d can be the same as or similar to and / or include any of the features described with respect to other implants described herein, such as implants 500a, 500b, and 500c. For example, the implant 500d can have an expandable body 510d having a filter portion 520d, a radial support portion 540d, and a flow restrictor portion 550d, similar to the expandable body 510c having a filter portion 520c, a radial support portion 540c, and a flow restrictor portion 550c of the implant 500c. 51A and 51B show side views of the expandable body 510d of the implant 500d connected to a shaft 590d and a tube 570d, which may include a collapsible and extendable coupling (not shown) that may be the same or similar to the shaft 590a, the tube 570a, and the collapsible and extendable coupling 580a described with respect to the implant 500a. Material spanning the petals 560d of the flow restrictor portion 550d has been removed to show the features of the implant 500d. Similar to the implant 500c, the flow restrictor portion 550d may be connected and disposed between the filter portion 520d and the radial support portion 540d as shown. In such an arrangement, blood flowing through the implanted implant 500d will first flow through the radial support portion 540d before impinging on the flow restrictor portion 550d (similar to the implant 500c). Unlike implants 500a and 500c, implant 500d includes multiple struts 595d rather than sutures or wires 595a and 595c connecting apexes 564d of petals 560d to shaft 590d. Such struts 595d can be integrally formed with expandable body 510d. With multiple struts 595d, operation of flow restrictor portion 550d having petals 560d can be similar to that described with respect to flow restrictor portion 550a of implant 500a.As shown, the flow restrictor portion 550d may be oriented in an opposite direction to the flow restrictor portions 550a, 550b, and 550c such that the apex 564d is directed away from the incoming blood flow in use. With such orientation, actuation of the flow restrictor portion 550d may occur by distal movement (e.g., pushing) of the shaft 590d rather than proximal movement (e.g., pulling) of the shaft 590d. However, in some embodiments, the flow restrictor portion may be oriented in the same direction as the flow restrictor portions 550a, 550b, and 550c such that the apex 564d is directed toward the incoming blood flow in use. FIG. 51A illustrates an unactuated implant 500d (e.g., with the flow restrictor portion 550d in a non-restrictive / non-occluding state) and FIG. 51B illustrates a partially actuated implant 500d (e.g., with the flow restrictor portion 550d in a partially restrictive / occluding state).

[0147] 52 illustrates another embodiment of an implant 500e that can be used in conjunction with an implantable flow restriction system 5. The implant 500e may be the same as or similar to and / or include any of the features described with respect to other implants described herein, such as implants 500a, 500b, 500c, and 500d. Unlike the other implants described herein, the implant 500e may have an expandable body 510e with filter portions 520e and 520e' at proximal and distal ends, connected thereto, and with combined radial support portion 540e and flow restrictor portion 550e between such filter portions 520e, 520e'. 52 illustrates an expandable body 510e of implant 500e connected to a shaft 590e and a tube 570e, which may include a collapsible and extendable coupling (not shown) that may be the same as or similar to the shaft 590a, tube 570a, and collapsible and extendable coupling 580a described with respect to implant 500a. Material spanning petals 560e of flow restrictor portion 550e has been removed to show the features of implant 500e. The flow restrictor portion 550e can include petals 560e as shown, which can be oriented such that proximal movement of the shaft 590e causes the petals 560e to fold radially inward to occlude / restrict flow through the implant 500e (e.g., the petals 560e can be pulled inward to close by a suture or wire 595e connected between the ends of the petals and the distal end of the shaft 590e, as described herein in related embodiments). So configured, blood flowing through the implanted implant 500e flows first through the filter portion 520e', through the combined radial support portion 540e and flow restrictor portion 550e, and through the filter portion 520e. Additionally, the implant 500e can be similarly positioned in the inferior vena cava below the renal veins such that the ends of the petals 560e are directed toward the incoming blood flow.Also as shown, implant 500e can include an anchor 525e extending generally proximally and an anchor 525e' extending generally distally at a location where the combined radial support portion 540e and flow restrictor portion 550e intersect with filter portions 520e and 520e'.

[0148] 53 illustrates another embodiment of an implant 500f that can be used in conjunction with an implantable flow restriction system 5. The implant 500f may be the same as or similar to and / or include any of the features described with respect to other implants described herein, such as implants 500a, 500b, 500c, 500d, and 500e. Similar to implant 500e, implant 500f may have an expandable body 510f having filter portions 520f and 520f' at proximal and distal ends, with combined radial support portion 540f and flow restrictor portion 550f connected thereto and between such filter portions 520f, 520f'. FIG. 53 shows a side view of the expandable body 510f of the implant 500f connected to a shaft 590f and a tube 570f, which may include a collapsible and extendable coupling (not shown) that may be the same as or similar to the shaft 590a, tube 570a, and collapsible and extendable coupling 580a described with respect to the implant 500a. Additionally, FIG. 53 shows the implant 500f in an unactuated state (e.g., non-restrictive / non-occluding state). Material 530f is shown straddling petals 560f of the flow restrictor portion 550f, which may be the same as or similar to material 530a of the implant 500a. As shown, the flow restrictor portion 550f may be oriented in an opposite direction to the flow restrictor portions 550a, 550b, 550c, and 550e such that the apex 564f of the petals 560f is oriented away from the incoming blood flow in use. In such an orientation, actuation of flow restrictor portion 550f may occur by distal movement (e.g., pushing) of shaft 590f rather than proximal movement (e.g., pulling) of shaft 590f. However, in some embodiments, the flow restrictor portion may be oriented in the same manner as flow restrictor portions 550a, 550b, 550c, and 550e such that apex 564f is oriented toward the incoming blood flow in use.Also, as shown, implant 500f can include a generally proximally extending anchor 525f and a generally distally extending anchor 525f' at a location where combined radial support portion 540f and flow restrictor portion 550f intersect filter portions 520f and 520f'.

[0149] 54 illustrates another embodiment of an implant 500g that can be used in conjunction with an implantable flow restriction system 5. The implant 500g may be the same as or similar to and / or include any of the features described with respect to other implants described herein, such as implants 500a, 500b, 500c, 500d, 500e, and 500f. Like the implant 500f, the implant 500g may have an expandable body 510g with filter portions 520g, 520g' at proximal and distal ends and radial support portions 540g connected thereto and between such filter portions 520g, 520g'. Unlike the implants 500a-500f, the implant 500g may include a flow restrictor 560g that is not integrally formed with the expandable body 510g. The flow restrictor 560g of the implant 500g may be configured to be disposed within the lumen 513g of the implant 500g (e.g., substantially centrally disposed within the lumen 513g) and attached to a distal end or portion of the tube 570g. As shown, the flow restrictor 560g may have a balloon that can expand from a folded configuration to at least partially block flow through the lumen 513g. Actuation (e.g., inflation) of the balloon flow restrictor 560g may occur by distal movement of the shaft 590g relative to the implant 500g, which enters the balloon flow restrictor 560g and inflates the balloon (e.g., the shaft may assume a three-dimensional shape that at least partially fills the balloon flow restrictor 560g, inflating the balloon). The balloon flow restrictor 560g may deflate with retraction of the shaft 590g (e.g., proximal movement of the shaft 590g relative to the implant 500g).

[0150] In some embodiments, implant 500g can be used in conjunction with other implantable flow restriction systems described herein, such as implantable flow restriction system 2. In such embodiments, implant 500g can be similar to and / or include any of the features described with respect to implant 200m. For example, implant 500g can be fluidly actuated to at least partially restrict flow through lumen 513g (e.g., balloon flow restrictor 560g can be fluidly actuated).

[0151] 55A-55C show another embodiment of an implant 500h that can be used in conjunction with an implantable flow restriction system 5. The implant 500h may be the same as or similar to and / or include any of the features described with respect to other implants described herein, such as implants 500a, 500b, 500c, 500d, 500e, and 500f. Like the implant 500e, the implant 500h may have an expandable body 510h with filter portions 520h and 520h' at proximal and distal ends, and a combined radial support portion 540h and flow restrictor portion 550h connected thereto and between such filter portions 520h, 520h'. 55A-55C show side views of the expandable body 510h of implant 500h connected to shaft 590h and tube 570h, which may include shaft 590a, tube 570a, and collapsible and extendable coupling 580h, which may be the same or similar to shaft 590a, tube 570a, and collapsible and extendable coupling 580a described with respect to implant 500a. FIG. 55A shows implant 500h in an unactuated state (e.g., non-restrictive / non-occluding state), FIG. 55B shows implant 500h in a partially actuated state (e.g., partially restrictive / occluding state), and FIG. 55C shows implant 500h in a fully actuated state (e.g., restrictive / occluding state). Material spanning petals 560h of flow restrictor portion 550h has been removed to show features of implant 500h and the interaction between such features during actuation. Additionally, similar to implants 500a, 500b, 500c and 500e, apexes 564h of petals 560h can face distally (e.g., when in an unactuated state). Similar to actuation of flow restrictor portion 550a of implant 500a, FIGS. 55A-C illustrate that proximal movement of shaft 590h relative to tube 570h and implant 500h can actuate flow restrictor portion 550h to occlude / restrict flow through implant 500h.Specifically, proximal movement of shaft 590h can pull apices 564h of petals 560h of flow restrictor portion 550h radially inward via suture or wire 595h connected therebetween. Figures 55A-C also illustrate how collapsible and extendable coupling 580h can extend and collapse (e.g., in the same or similar manner as described with respect to collapsible and extendable coupling 580a of implant 500a) during actuation of implant 500h.

[0152] 56A and 56B show another embodiment of an implant 500i that can be used in conjunction with an implantable flow restriction system 5. FIG. 56A shows the implant 500i in an unactuated state, and FIG. 56B shows the implant in an actuated state. The implant 500i may be the same as or similar to, and / or include any features described with respect to, other implants described herein, such as implants 500a, 500b, 500c, 500d, 500e, 500f, and 500h. Similar to the implant 500e, the implant 500i may have an expandable body 510i with filter portions 520i and 520i' at proximal and distal ends, connected thereto, and radial support portions 540i between such filter portions 520i, 520'. Unlike the implants 500a-500f and 500h, the implant 500i may include a flow restrictor 560i that is not integrally formed with the expandable body 510i. The flow restrictor 560i of the implant 500i is disposed within the lumen 513i of the implant 500i and is configured to be attached to a distal end of the shaft 590i and can include a plurality of struts 562i extending radially outward from a connection to the distal end of the shaft 590i. Additionally, the flow restrictor 560i can include material 530i spanning between the plurality of struts 562i to form an umbrella-shaped flow restrictor 560i. A suture or wire 595i can connect the radially outer ends of the plurality of struts 562i to a fixed point adjacent the distal end of the tube 570i. To activate the flow restrictor 560i and at least partially occlude / restrict flow through the implant 500i, the shaft 590i can be moved proximally relative to the tube 570i and the expandable frame 510i, allowing the biasing force of the multiple struts 562i radially outward to expand the flow restrictor 560i (e.g., opening the umbrella-shaped flow restrictor 560i). To return the flow restrictor 560i to an unactivated state, the shaft 590i can be moved distally relative to the tube 570i and the expandable frame 510i, causing the multiple struts 562i to collapse radially inward (e.g., closing the umbrella-shaped flow restrictor 560i).Although not shown, implant 500i may also include a foldable and extendable coupling 580i similar to foldable and extendable coupling 580a of implant 500a that fluidly seals shaft 590i to tube 570i and enables longitudinal movement therebetween (e.g., distal and proximal movement).

[0153] In one variation, the flow restrictor 560i" may be fixed to a distal extension of the tube 570i, and the radially outer ends of the struts 562i may be connected via sutures or wires 595i to a distal end of a movable shaft 590i that is movably disposed within the tube 570i". In such a configuration, the flow restrictor 560i may be actuated by distal movement of such shaft 590i relative to the expandable body 510i and tube 570i, allowing the biasing force of the struts 562i radially outward to expand the flow restrictor 560' (e.g., opening the umbrella-shaped flow restrictor 560i). To return the flow restrictor 560i to a non-actuated state, the shaft 590i may be moved proximally relative to the tube 570i and expandable frame 510i, causing the struts 562i to fold radially inward (e.g., closing the umbrella-shaped flow restrictor 560i).

[0154] 57A and 57B show another embodiment of an implant 500j that can be used in conjunction with an implantable flow restriction system 5. FIG. 57A shows the implant 500j in an unactuated state (e.g., non-occluding / non-restricting state), and FIG. 57B shows the implant 500j in an actuated state (e.g., at least partially occluded / restricting state). The implant 500j may be the same as or similar to and / or include any features described with respect to other implants described herein, such as implants 500a, 500b, 500c, 500d, 500e, 500f, 500h, and 500i. Similar to the implant 500i, the implant 500j may have an expandable body 510j with filter portions 520j and 520j' at proximal and distal ends, and a radial support portion 540j connected thereto and between such filter portions 520j, 520j'. The implant 500j may include a flow restrictor 560j that may be integrally formed with or connected to the expandable body 510j. The flow restrictor 560j of the implant 500j may be configured to be disposed within the lumen 513j of the implant 500j and to have a proximal end attached to a proximal end of the expandable frame 510j. Additionally, as shown in FIG. 57A, the flow restrictor 560j may include a number of struts 562j that extend generally longitudinally and distally from a proximal end of the expandable frame 510j in an unactuated state (e.g., non-occluding / non-restricting state) of the implant 500j. The flow restrictor 560j may include material 530j spanning the multiple struts to form an umbrella-shaped flow restrictor 560j. Sutures or wires 595j can connect the distal ends of the multiple struts 562j to the distal end of a shaft 590j configured for slidable movement within tube 570j (the shaft 590j is hidden from view within tube 570j).To actuate the flow restrictor 560j and at least partially occlude / restrict flow through the implant 500j, the shaft 590j can be moved proximally relative to the tube 570j and the expandable frame 510j to pull the distal ends of the plurality of struts 562j via the sutures or wires 595j and bend the plurality of struts 562j radially outward. Such radially outward movement of the distal ends of the plurality of struts 562j can open the umbrella-shaped flow restrictor 560j, as shown in FIG. 57B, where the flow restrictor 560j with the material 530j can at least partially occlude / restrict flow through the implant 500j.

[0155] 58A-58C illustrate another embodiment of an implant 500k that can be used in conjunction with an implantable flow restriction system 5. FIG. 58A illustrates the implant 500k in an unactuated (e.g., non-occluding / non-restricting) state, FIG. 58B illustrates the implant 500k in a partially actuated state, and FIG. 58C illustrates the implant 500k in an actuated (e.g., at least partially occluding / restricting) state. The implant 500k may be the same as or similar to and / or include any of the features described with respect to other implants described herein, such as implants 500a, 500b, 500c, 500d, 500e, 500f, 500h, 500i, and 500j. Similar to the implant 500j, the implant 500k may have an expandable body 510k with filter portions 520k and 520k′ at proximal and distal ends, connected thereto, and with radial support portions 540k between such filter portions. Unlike some implants described herein, implant 500k may include a flow restrictor 560k that is not integrally formed with expandable body 510k. Flow restrictor 560k of implant 500k may be disposed within lumen 513k of implant 500k and configured to extend from and retract into tube 570k as shown. To this end, flow restrictor 560k may be attached to a distal end of shaft 590k (not visible as it is within tube 570k) and may have an expandable frame made of multiple struts 562k with material 530k spanning multiple struts 562k to form a generally umbrella-shaped flow restrictor 560k. To activate the flow restrictor 560k and at least partially block / restrict flow through the implant 500k, the shaft 590k can be moved distally relative to the tube 570k and the expandable frame 510k to allow the flow restrictor 560k to extend distally out of the tube 570k and expand (e.g., opening the umbrella-shaped flow restrictor 560k).To return the flow restrictor 560k to its inactivated state, the shaft 590k can be moved proximally relative to the tube 570k and the expandable frame 510k, causing the expandable frame having multiple struts 562k to collapse so as to retract into the tube 570k (e.g., closing the umbrella-shaped flow restrictor 560i).

[0156] FIG. 59 illustrates another embodiment of an implant 500l that can be used in conjunction with an implantable flow restriction system 5. FIG. 59 illustrates the implant 500l in an actuated state (e.g., at least partially occluded / restricted state). The implant 500l can be the same as the implant 500k, except that the flow restrictor 560l of the implant 500l can have an expandable coil configured to assume a three-dimensional shape when expanded as shown. The operation of the flow restrictor 560l is also the same as the operation of the flow restrictor 560k described herein. For example, to actuate the flow restrictor 560l to at least partially occlude / restrict flow through the implant 500l, the shaft 590l can be moved distally relative to the tube 570l and the expandable frame 510l such that the flow restrictor 560l extends distally from the tube 570l and expands (e.g., allowing the expandable coil to assume a three-dimensional shape). To return flow restrictor 560l to its unactuated state, shaft 590l can be moved proximally relative to tube 570l and expandable frame 510l, causing the expandable coil to collapse into tube 570l.

[0157] FIG. 60 illustrates an embodiment of a removable implant 500m that can be used in conjunction with an implantable flow restriction system 5. The illustrated implant 500m may be similar or the same as the implant 500c described with respect to FIG. 50, but may be configured to be detached from the tube 570m and shaft 590m. Any of the implants described herein may be configured to be detached. A removable implant allows for removal of such implant from the patient when needed. Additionally, a removable implant allows for removal of the tubes, shaft, and / or controller of the system from the patient when needed. To remove the implant 500m from the tube 570m, the connection between the implant 500m and the tube 570m can be severed as illustrated. In some embodiments, severing the connection between the implant 500m and the tube 570m can include pulling the tube 570m while maintaining the implant 500m in place, disengaging the implant 500m from the tube 570m. In some embodiments, severing the connection between the implant 500m and the tube 570m can include peeling or cutting an outer wrap or membrane attaching the implant 500m to the tube 570m. Such peeling or cutting can be done by another interventional device or via a drawstring housed within the tube 570m and accessible at a proximal end of the tube 570m. To remove the implant 500m from the shaft 590m, the connection between the suture or wire 595m and the implant 500m can be cut as shown. In some embodiments, severing the connection between the suture or wire 595m and the implant 500m can include cutting or heating the suture or wire 595m by another interventional device.In some embodiments, severing the connection between the suture or wire 595m and the implant 500m can include pushing the shaft 590m distally beyond the implant 500m to disconnect the suture or wire 595m from the implant 500m (e.g., the connection between the suture or wire 595m and the implant 500m can be configured to remain intact as long as the shaft 590m does not extend beyond the distal end of the implant 500m). In some embodiments, to remove the implant 500m from the tube 570m and the shaft 590m, the connection between the implant 500m and the shaft 590m is first severed, followed by severing the connection between the implant 500m and the tube 570m.

[0158] 61A-61C show another embodiment of an implant 500n. FIG. 61A shows a side view of the implant 500n in an unactuated state (e.g., non-occluding / non-restricting state), FIG. 61B shows a side view of the implant 500n in an actuated state (e.g., at least partially occluding / restricting state), and FIG. 61C shows an end view of the implant 500n in an unactuated state. The implant 500n may be the same as or similar to and / or include any features described with respect to other implants described herein. As shown, the implant 500n may have an expandable body 510n having a proximal end 511n, a distal end 512n, and a lumen 513n for receiving blood flow therethrough. The implant 500n may include a filter portion 520n, a radial support portion 540n, a flow restrictor portion 550n, a radial support portion 540n′, and a filter portion 520n′. Additionally, the implant 500n can include a material 530n that spans at least the flow restrictor portion 550o (as shown, the material 530n spans the flow restrictor portion 550n and the radial support portions 540n, 540n'). The flow restrictor portion 550n can be configured to occlude / restrict flow by tightening radially inward with a suture or wire 595n as shown in FIG. 61B. Such suture or wire 595n can wrap around the flow restrictor portion 550n and / or pass through eyelets in the multiple struts 562n that make up the flow restrictor portion 550n. Although not shown, the implant 500n can be connected to a tube 570n at its proximal end 511n. Such a tube 570n can be connected to the implant 500n at a location that is substantially centered in the lumen 513n (as shown for at least some of the other embodiments of the implant 500 described herein). In some embodiments, such tubes 570n can connect to the implant 500n at locations along the circumference of the implant 500n (eg, on the sides of the implant 500n).A suture or wire 595n can extend from around the flow restrictor portion 550n through the tube 570n and connect to an actuator of the controller 50 to actuate the implant 500n. In some embodiments, the suture or wire 595n can be connected to a shaft 590n extending through the tube 570n as described herein for other embodiments to actuate the implant 500n. In such embodiments, a collapsible and extendable coupling 580n similar to other collapsible and extendable couplings described herein can be used to fluidly seal the shaft 590n to the tube 570n.

[0159] FIG. 62 illustrates another embodiment of the implant 500o. FIG. 62 illustrates a perspective view of the implant 500o in an unactuated state (e.g., non-occluding / non-restricting state). The implant 500o may be the same as or similar to, and / or include any of, the features described with respect to the implant 500n and other implants described herein. As illustrated, the implant 500o may have an expandable body 510o having a proximal end 511o, a distal end 512o, and a lumen 513o receiving blood flow therethrough. The implant 500o may include a radial support portion 540o, a flow restrictor portion 550o, and a radial support portion 540o'. Unlike the implant 500n, the implant 500o may omit filter portions adjacent the proximal and distal ends. Although not illustrated, the implant 500o may include material 530o spanning at least the flow restrictor portion 550o. In some embodiments, the material 530o can span the flow restrictor portion 550o and the radial support portions 540o, 540o'. Similar to the flow restrictor portion 550n of the implant 500n, the flow restrictor portion 550o can be configured to occlude / restrict flow by tightening radially inward with a suture or wire 595o. Such suture or wire 595o can be wrapped around the flow restrictor portion 550o and / or passed through eyelets 596o in the struts 562o that make up the flow restrictor portion 550o. Although not shown, the implant 500o can be connected to a tube 570o at its proximal end 511o. Such a tube 570o can be connected to the implant 500o at a location along the circumference of the implant 500o (e.g., on a side of the implant 500o). A suture or wire 595o may extend from around the flow restrictor portion 550o through the tube 570o and connect to an actuator of the controller 50 to actuate the implant 500o.In some embodiments, a suture or wire 595o can be connected to the shaft 590o extending through the tube 570o as described herein for other embodiments for actuation of the implant 500o. In such embodiments, a collapsible and extendable coupling 580o similar to other collapsible and extendable couplings described herein can be used to fluidically seal the shaft 590o to the tube 570o. As shown in FIG. 62, the implant 500o can include anchors 525o and 525o' at the proximal and distal ends, respectively. The anchors 525o and 525o' can have a hook-like shape that facilitates anchoring the implant 500o within a vessel. In some embodiments, the implant 500o or features thereof can be used as or incorporated into a shunt (e.g., a pulmonary artery to azygos vein shunt as described in U.S. Provisional Application No. 63 / 331,496, which is incorporated herein by reference).

[0160] 63 illustrates an embodiment of an anchor 525p of an implant 500p of an implantable flow restriction system 5. The implant 500p may be the same as or similar to the implant 500a described herein, except for the configuration of the anchor 525p. As illustrated, the anchor 525p may have a circular configuration with a break in the circle, allowing the anchor 525p to pass over and receive at least a portion of the expandable frame 510p of the implant 500p within such circle. For example, although the anchor 525p is shown receiving a portion of the expandable frame 510p where the radial support portion 540p and the flow restrictor portion 550p meet, the anchor 525p may be positioned along and / or receive any portion of the implant 500p. Also, as shown in FIG. 63, at the breaks in the circular configuration of the anchor 525p, the anchor 525p can have multiple portions 527p extending generally outwardly from such circle and substantially coplanar with such circle. Such multiple portions 527p can extend generally parallel to one another as shown, or can extend at angles to one another. Such multiple portions 527p can facilitate fixation of the implant 500p in a vessel or shunt.

[0161] 64A and 64B show an embodiment of a shaft 590 of an implantable flow restriction system 5 described herein. The shaft described below can be used in connection with any of the implants described herein. FIG. 64A shows a side view of the shaft 590, and FIG. 64B shows a perspective cross-sectional view of the shaft 590. As shown, the shaft 590 (which may also be referred to herein as a "wire" or "cable") may have a braided construction with multiple individual wires 593. In some embodiments, multiple individual wires 593 may be twisted together to form a bundle, and the shaft 590 may be made of multiple such bundles twisted together. In some embodiments, the shaft 590 may be made of a single wire, rod, hypotube, or laser cut hypotube, depending on the application. For example, in the case of a flow restriction system where the shaft pulls a portion of the implant to actuate and activate its flow restrictor, the shaft may be configured to pull and may have the same or similar configuration as shown in FIG. 64A and 64B. As another example, for a flow restriction system in which the shaft pushes against a portion of the implant to activate its flow restrictor, the shaft can be configured to push. In another example, for a flow restriction system in which the shaft is activated by rotating, the shaft can be configured to rotate. In some embodiments, one or more wires 593 of the shaft 590 can be configured to transmit power and / or signals to and / or from one or more sensors 600 of the flow restriction system 5. The shaft 590 can be flexible and, in some embodiments, can have a lubricious coating or a lubricious surface to facilitate sliding movement within the tube 570, as described herein. Additionally, the shaft 590 can be made of a biocompatible material (e.g., stainless steel).

[0162] 65 shows a schematic diagram of certain features that may be incorporated into the implantable flow restriction system 5 as well as any other embodiment of the implantable flow restriction system described herein. As shown, the implantable controller 50 of the implantable flow restriction system 5 may include a processor 51, an actuator 52, a memory device 53, a power source 54, and / or a communication module 55. Also shown, the external device 15 used to operate the implantable flow restriction system 5 may include a processor 16, a user interface 17, a memory device 18, a power source 19, and a communication module 21. In some embodiments, the external device 15 may be a cell phone, a tablet, a handheld device, a mobile device, or the like.

[0163] Processors 51 and 16 may be configured, among other things, to process data, execute instructions to perform one or more functions, and / or control the operation of controller 50 and external device 15, respectively. For example, processor 51 may control the operation of actuator 52 and sensor 600 of implantable flow restriction system 5. As another example, processor 51 may process signals and / or data received and / or acquired from sensor 600 of implantable flow restriction system 5. Additionally, processor 51 may execute instructions to perform functions related to storing and / or transmitting such signals and / or data received and / or acquired from sensor 600 of implantable flow restriction system 5 (e.g., transmitting such signals and / or data to external device 15). Processor 51 may execute instructions to perform functions related to storing and / or transmitting any or all of such received data.

[0164] Storage devices 53 and 18 may include one or more memory devices for storing data, including, but not limited to, dynamic and / or static random access memory (RAM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), etc. Such stored data may be, for example, processed and / or unprocessed data obtained from implantable flow restriction system 5.

[0165] The communications modules 55 and 21 may facilitate communications (e.g., via wireless connections) between the implantable flow restriction system 5 (and / or its components, such as the controller 50) and the external device 15, as well as other separate devices, such as separate monitoring, computing, electronic, and / or mobile devices. For example, the communications module 55 may be configured to enable the implantable flow restriction system 5 to wirelessly communicate with the external device 15 and / or other devices, systems, and / or networks via any of a variety of communications protocols. The communications modules 55 and 21 may be configured to use any of a variety of wireless communications protocols, such as Wi-Fi (802.11x), Bluetooth, ZigBee, Z-wave, cellular, infrared, near field communication (NFC), RFID, satellite transmissions, proprietary protocols, combinations thereof, and the like. The communications module 55 may enable data and / or instructions to be transmitted and / or received between the implantable flow restriction system 5 and a separate computing device, such as the external device 15. The communications module 55 may be configured to transmit (e.g., wirelessly) the processed and / or unprocessed data (e.g., data from the sensor 600) and / or other information to one or more separate computing devices, which may include, among others, external device 15, a patient monitor, a mobile device (e.g., an iOS or Android enabled smartphone, tablet, laptop), desktop computer, server or other computing or processing device for display and / or further processing.Such separate computing devices may be configured to store and / or further process the received data and / or other information, display information indicative of the received data and / or information or information derived from the received data and / or information, and / or transmit information, including displays, alarms, alerts and notifications, to various other types of computing devices and / or systems that may be associated with a hospital, a caregiver (e.g., primary care physician), and / or a user (e.g., employer, school, friends, family) that have permission to access the patient's data. As another example, the communications module 55 of the controller 50 of the implantable flow restriction system 5 may be configured to wirelessly transmit the processed and / or unprocessed obtained data, information and / or other information (e.g., the operating status of the implant 500) to a mobile phone, which may include one or more hardware processors configured to execute an application that generates a graphical user interface that displays information representative of the processed or unprocessed data, information and / or other information obtained from the implantable flow restriction system 5. The communications modules 55 and 21 may be and / or include wireless transceivers.

[0166] The power sources 54 and 19 can provide power to each of the hardware components of the implantable flow restriction system 5 and the external device 15 described herein. For example, the power source 54 of the controller 50 can provide power to the sensor 600, the communication module 55, the processor 51, and the actuator 52. In some embodiments, the power source 54 can include a battery, an inductive receiver / rectifier, or both. The power source 19 can include a battery. In some embodiments, the external device 15 can also include an inductive transmitter for wirelessly transmitting power to an inductive receiver / rectifier (if included) of the implantable flow restriction system 5 (e.g., of the controller 50). Any such batteries can be rechargeable. For example, such batteries can be lithium batteries, lithium polymer batteries, lithium ion batteries, lithium ion polymer batteries, lead acid batteries, nickel cadmium batteries, or nickel metal hydride batteries. In some embodiments, such batteries can be non-rechargeable.

[0167] The actuator 52 of the controller 50 of the implantable flow restriction system 5 may be configured to move the shaft 590 within the tube 570 for actuation of the flow restrictor 560 and / or the flow restrictor portion 550 of the implant 500 (which may include any of the implants described herein). For example, the actuator 52 may be configured to slide the shaft 590 proximally and / or distally relative to the tube 570 and the implant 500. As another example, the actuator 52 may be configured to rotationally move the shaft 590 relative to the tube 570 and the implant 500. Additionally, the actuator 52 may be configured to cause the flow restrictor 560 and / or the flow restrictor portion 550 of the implant 500 to occlude / restrict flow through the implant 500 in a range of about 0% to about 100%.

[0168] The user interface 17 of the external device 15 may be configured to allow a patient or their healthcare provider to interact with the external device 15 to control the implantable flow restriction system 5. The user interface may include buttons, a touch screen, and / or a microphone for accepting physical touch and / or verbal input / commands.

[0169] 66A-66C illustrate an embodiment of a connector 700 between components of the flow restriction system 5. The connector 700 can be configured, for example, to removably connect the proximal end 592 of the shaft 590 to the actuator 51 of the controller 50. As shown in FIG. 66A, the connector 700 can include a first component 710 and a second component 720 configured to removably connect to one another via complementary features. Such first component 710 and second component 720 can be secured to the proximal end 592 of the shaft 590 and the actuator 51, respectively, or vice versa. The first component 710 can be configured cylindrically and have a circular recess 712 at one of its ends and a protrusion extending radially inward into the recess 712, visually indicated by a dot 714 located on the outer surface of the first component 710. The second component 720 can be cylindrically configured and have a circular, bar-like protrusion 722 extending from one of its ends sized to fit within the recess 712 of the first component 710. Additionally, the protrusion 720 can have a slot 724 configured to receive the protrusion extending radially inwardly within the recess 712 of the first component 710. As shown in FIGS. 66A and 66B , the slot 724 extends longitudinally from the end of the protrusion 722 and then rotates approximately 90 degrees or more to align the slot 724 with the point 714, and when the protrusion 722 is fully inserted into the recess 712, the first component 710 and the second component 720 can be rotated relative to each other in a first direction to secure the first component 710 and the second component 720 together (e.g., the first and second components can remain connected due to the interaction between the protrusion of the first component 710 and the slot 724 of the second component 720). FIG. 66C illustrates a method of removing the first component 710 from the second component 720, which may include pushing the first component 710 and the second component 720 together, rotating the first component 710 and the second component 720 relative to one another in a second direction opposite the first direction, and then separating the first component 710 and the second component 720 from one another.

[0170] 67A and 67B show a variation 700' of the connector 700. Similar to the connector 700, the connector 700' can be configured to removably connect the proximal end 592 of the shaft 590 to the actuator 51 of the controller 50. As shown in FIG. 67A, the connector 700' can include a first component 710' and a second component 720' configured to removably connect to one another via complementary features. The first component 710' can be configured cylindrically and have a circular recess 712 at one of its ends, similar to the first component 710. Instead of a protrusion and a dot 714 indicating the location of such protrusion, the first component 710' can include a slot 714' through the wall of the first component that extends longitudinally from the end of the first component 710' having the recess 712' and then rotates about 90 degrees or more. The second component 720' can be configured as a cylinder 722' sized to fit within the recess 712' of the first component 710' and can have a circular, bar-like protrusion 724' extending radially outward from its outer surface configured to fit within the slot 714'. To connect the first component 710' and the second component 720' to one another, the cylinder 722' can be fully inserted into the recess 712' with the protrusion 724' aligned with the slot 714', and the first component 710' and the second component 720' can be rotated in a first direction relative to one another (e.g., interaction between the slot 714' of the first component 710' and the protrusion 724' of the second component 720' can keep the first component and second component connected). To remove the first component 710' from the second component 720', the first component 710' and the second component 720' can be pressed together and rotated relative to one another in a second direction opposite the first direction, and then the first component 710 and the second component 720 can be separated from one another.

[0171] 68A-68D illustrate an embodiment of a connector 750 between components of an implantable flow restriction system 5. The connector 750 can be configured, for example, to removably connect and fluidly seal the proximal end 572 of the tube 570 to the controller 50 (e.g., to the housing of the controller 50). To this end, the connector 750 can extend from the controller 50 (e.g., from the housing of the controller 50). FIG. 68A illustrates the tube 570 separated from the connector 750 but in position for connection to the connector, FIG. 68B illustrates a side view of a portion of the connector 750, FIG. 68C illustrates an end view of the connector 750, and FIG. 68D illustrates a side cross-sectional view of the connector 750. The connector 750 can have a body 751 having a generally cylindrical shape with a lumen 753 extending therethrough. The connector 750 can include a first component 760 having a longitudinal through hole 762 configured to receive a proximal end 572 of a tube 570, and a second component 770 configured to receive the first component 760 (e.g., as shown in FIG. 68D). Both the first and second components 760, 770 can be received by the body 751. The proximal end of the second component 770 can include a plurality of radially inwardly extending arms 772 configured to bias the first component 760 distally away from the second component 770. Such arms 772 can also be configured to grab onto an outer surface of the tube 570 when the tube 570 is inserted into the connector 750. To connect and fluidly seal the tube 570 to the connector 750, the proximal end 572 of the tube 570 can be fully inserted into the connector 750 through the through hole 762 of the first part 760 until it cannot be inserted any further. A third component 780 configured as a circumferential ring within body 751 disposed proximally of first and second components 760, 770 can provide a fluid seal between tube 570 and connector 750. In this fully inserted position, arms 772 of second component 770 can grip the exterior surface of tube 570 to prevent removal from connector 750.To release the connection between the tube 570 and the connector 750, the first component 760 is pushed inside the connector 750 (e.g., pushed proximally into the connector 750) to radially expand the arms 772 at the proximal end of the first component 760 and detach the arms from the tube 570, while the tube 570 is pulled out of the connector 750 (e.g., moved distally relative to the connector 750).

[0172] 69A and 69B show an embodiment of an implant assembly 501 having an implant 500, a tube 570, and a shaft 590 with an extender 800 to aid in implantation of the implant assembly 501. The illustrated implant 500, tube 570, and shaft 590 correspond to the implant 500a, tube 570a, and shaft 590a described herein, but in some embodiments, they may be any of the implants described herein. The extender 800 may comprise a flexible tube attached to the tube 570 adjacent the proximal end 572 and extending proximally therefrom. For example, the extender 800 may be constructed of PEBAX reflowed onto the tube 570. In some embodiments, the extender 800 is a proximal extension of the tube 570. The extender 800 can advantageously provide a healthcare provider implanting the implant assembly 501 with a graspable component outside the body to aid in positioning and handling the implant assembly 501 as it is implanted in a patient. As shown in the close-up view of FIG. 69B, the extender can be cut at the cut line 803 and removed (e.g., by sliding proximally) from the implant assembly 501 when no longer needed. In some embodiments, the extender 800 is configured to peel away from the implant assembly 501 at the cut line 803. When the extender 800 is removed, the proximal end 572 of the tube 572 can be coincident with the cut line 803. Also shown in FIGS. 69A and 69B is a device 850 for testing the functionality of the implant 500, which may extend proximally through the extender 800 and will be described with respect to FIGS. 70A and 70B, 71A and 71B, and 72.

[0173] 70A and 70B show an embodiment of a device 850 for testing the function of an implant 500 during its implantation. As shown, the device 850 can be removably connected to a proximal end 591 of a shaft 590 for pulling and / or pushing the shaft 590 to actuate the flow restrictor 560 and / or the flow restrictor portion 550 of the implant 500. To this end, the device 850 can include one of the components of the connector 700 described herein, such as the first component 710 shown, for removably connecting to another component of the connector 700, such as the second component 720 shown attached to the proximal end 592 of the shaft 590. In some embodiments, the device 850 can include the second component 720 of the connector 700, and the shaft 590 can have the first component 710 attached to the second component. FIG. 70A shows the device 850 connected to the shaft 590, and FIG. 70B shows the device 850 disconnected from the shaft 590. To facilitate pulling and / or pushing the shaft 590 through the device 850, the device 850 can include a proximal extension 855. As shown in FIGS. 70A and 70B, the proximal extension 855 can comprise a suture. In a variation 850' of the device 850 as shown in FIGS. 71A and 71B, the proximal extension 855' can comprise a shaft. In some embodiments, the proximal extension 855, 855' can comprise a wire, rod, hypotube, or laser cut hypotube depending on the needs of the application (e.g., depending on the need to pull or push the shaft 590 to test the operation of the flow restrictor 560 and / or flow restrictor portion 550 of the implant 500). Alternatively or in addition to testing the functionality of the implant 500, the device 850, 850' can also be used to aid in the removal of the implant 500, if desired.For example, to remove the implant 500 from the patient, the implantable controller 50 can be disconnected from the shaft 590 and the tube 570, the device 850, 850' can be connected to the shaft 590, the sheath can be slid over the device 850, 850' and distally over the shaft 590, the sheath can be slid over the implant 500 causing the implant 500 to collapse within the sheath, and the sheath containing the implant 500, shaft 590 and tube 570 can then be retracted proximally and removed from the patient. The device 850, 850' can advantageously provide a working length to aid in removal of the implant assembly 501 outside the body.

[0174] 72 illustrates a method 900 of implanting an implantable flow restriction system 5. Method 900 may be applied to any of the embodiments of the implantable flow restriction system 5 and its components described herein. Additionally, method 900 may include other steps and / or omit steps. Method 900 may be performed under local or general anesthesia in a cardiac catheterization laboratory, and may be performed minimally invasively.

[0175] The method 900 may include a step 905 of accessing the patient's subclavian vein. An access point to the subclavian vein, which may be the right or left subclavian vein, may be created at or near the junction of the middle and medial thirds where the first rib joins the clavicle. The subclavian vein may be blindly punctured or may be punctured under image guidance. Once access to the subclavian vein is created, a guidewire may be advanced from the subclavian vein through the superior vena cava (SVC), through the right atrium, and into the vena cava (IVC). A delivery sheath with a dilator (also referred to herein as a "delivery catheter") may be positioned over the guidewire into the subclavian vein and into the inferior vena cava.

[0176] Method 900 may optionally include a step 910 of identifying the renal vein. Identifying the renal vein may be performed during implantation with a delivery sheath using fluoroscopy and intravascular staining, or may be performed prior to implantation using CT imaging. Once the renal vein has been identified, the distal end of the delivery sheath may be positioned within the inferior vena cava below the renal vein (e.g., within the inferior vena cava upstream of the connection to the renal vein) and the dilator may be removed from the delivery sheath.

[0177] The method 900 may include a step 915 of implanting the implant assembly 501. In other words, the step 915 may include implanting the implant 500 connected to the tube 570 and the shaft 590. To this end, the implant assembly 501 may be inserted into a delivery sheath and delivered into the inferior vena cava such that the implant 500 is located below the renal vein. To aid in the delivery and handling of the implant assembly 501, an extender 800 may be optionally attached to the implant assembly 501, as described with respect to Figures 69A and 69B. Repositioning of the implant 500 may be performed as necessary.

[0178] Once the implant 500 is deployed from the distal end of the delivery sheath, the method 900 may optionally include a step 920 of testing the functionality of the implant assembly 501. To this end, the implant 500 may be actuated and its functionality tested using a device 850 for testing the functionality of the implant 500 as described with respect to FIGS. 70A-B and 71A-B (e.g., the flow restrictor 560 and / or flow restrictor portion 550 of the implant 500 may be actuated via the device 850 to at least partially occlude flow through the implant 500). If the functionality test is successful, the delivery sheath may be proximally removed from the implant assembly 501, leaving the implant assembly 501 in place within the patient. If the functionality test is not successful, the implant 500 may be resheathed within the delivery sheath (e.g., by moving the delivery sheath distally over the implant 500 and / or by pulling the implant 500 proximally relative to the delivery sheath) and the implant assembly 501 may be removed from the patient.

[0179] If used, the method 900 can include a step 925 of removing the extender 800. This can be done by cutting the extender at the cut line 803 or peeling it away at the cut line 803, as described with respect to Figures 69A and 69B. The device 850 for testing the functionality of the implant 500 can also be removed.

[0180] The method 900 may include a step 930 of forming a subclavian subcutaneous pocket for the implantable controller 50 of the system 5 .

[0181] The method 900 may include a step 935 of connecting the implant assembly 501 to an implantable controller 50. To this end, the shaft 590 may be connected to the actuator 51 of the controller 50 as described with respect to Figures 66A-66C and 67A and 67B. Additionally, the tube 570 may be connected to the controller 50 as described with respect to Figures 68A-68D.

[0182] The method 900 may include a step 940 of testing the functionality of the implantable flow restriction system 5. To this end, the external device 15 may be used to test the operation of the implant 500.

[0183] Once it has been determined that the external device 15 can operate the system 5 normally, the method 900 may include the step of implanting the implantable controller 50. To this end, the implantable controller 50 may be inserted into the subcutaneous pocket formed in step 930. Sutures may be placed to complete the implantation procedure.

[0184] In some embodiments, vascular access can be via the femoral vein, the radial vein, or any of the veins shown in FIG. 42. Depending on the location of the vascular access, the implantable controller 50 can be implanted at a location other than that described in method 900. Additionally, depending on the location of the vascular access, the implant 500 can be configured as described with respect to implant 500a, or can have an inverse configuration (e.g., with the flow restrictor 560 inverted and configured to be operated by pushing shaft 590 rather than pulling shaft 590).

[0185] 73A-73D show the deployment of an implant 500 of an implantable flow restriction system 5 from a distal end 1002 of a delivery sheath 1000. The deployment of the implant 500 described with respect to FIGS. 73A-73D is applicable to any of the embodiments of the implants described herein.

[0186] As shown in FIG. 73A, distal movement of the implant 500 relative to the distal end 1002 of the delivery sheath 1000 can result in the implant 500 extending out of the distal end 1002 of the delivery sheath 1000. Such relative movement can occur by maintaining the position of the implant 500 and retracting the delivery sheath 1000 proximally, by maintaining the position of the delivery sheath and extending the implant 500 distally therefrom, or both. Advantageously, as shown in FIG. 73A, the configuration of the expandable frame 510 of the implant 500 allows the implant 500 to remain folded on itself while extending distally beyond the distal end 1002 of the delivery sheath 1000. Such a configuration can facilitate repositioning of the implant, if necessary. For example, the implant 500 can remain folded on itself while at least a portion of the radial support portion 540 remains within the delivery sheath 1000.

[0187] 73B and 73C illustrate the gradual radial expansion of the implant 500 as it continues to expand distally beyond the distal end 1002 of the delivery sheath 1000. As illustrated, partial radial expansion of the implant 500 can occur when a majority of the filter portion 520 extends distally beyond the distal end 1002 of the delivery sheath 1000. Advantageously, as shown in FIG. 73C, the anchors 525 can maintain a hidden position (e.g., extending at least partially radially inward) while the implant 500 is in a partially expanded state. Such a configuration of the implant 500 can aid in repositioning the implant 500 within the vessel as needed and / or retracting the implant 500 within the delivery sheath 1000 as needed.

[0188] 73D illustrates full deployment of implant 500 from the distal end 1002 of the delivery sheath. Once fully deployed, implant 500 can be in a fully expanded state as shown. In such a state, anchors 525 can assume a generally longitudinally oriented position that aids in anchoring implant 500 within the vessel. Advantageously, implant 500 can be configured to be retrieved and retracted into delivery sheath 1000 even after full deployment from the delivery sheath due to the configuration of filter portion 520 that can push proximal ends of implant 500 and anchors 525 radially inward upon proximal retraction.

[0189] FIG. 74 illustrates a guideline 1100 for treating a patient using an implantable flow restriction system 5 described herein. In some embodiments, the guideline 1100 can be applied to any of the flow restriction systems described herein. The guideline 1100 can include assessing the patient's inferior vena cava pressure. If the inferior vena cava pressure is determined to be normal, no treatment by the system 5 may be required, as shown. Normal inferior vena cava pressure may be a pressure between about 0 mmHg and about 8 mmHg. If the inferior vena cava pressure is determined to be high, the system 5 can be activated, as shown. High inferior vena cava pressure may be a pressure above about 8 mmHg. The inferior vena cava pressure can be measured by the system 5 via the sensor 600. Additionally, activation of the system can be via the external device 15 as described herein (e.g., digital wireless activation). If the inferior vena cava pressure remains high after activation of the system 5, the patient is advised to consult a medical professional / healthcare provider.

[0190] 75-77 illustrate various methods of using the implantable flow restriction system 5 described herein. The methods described with respect to FIGS. 75-77 may be adapted to any of the flow restriction systems described herein. Additionally, while the methods described with respect to FIGS. 75-77 are described as using a sensor 600 connected to the implant 500, the system 5 may include other sensors proximate to the implant 500 and / or remote from the implant 500 for pressure measurement and control of the system 5 (such as the sensors described with respect to FIG. 41 and elsewhere herein). Additionally, although the methods described with respect to FIGS. 75-77 are described as being performed by a patient having the system 5 implanted, any steps of such methods may be performed by the patient's medical professional / healthcare provider or an authorized user.

[0191] 75 illustrates a manual method 1200 (which may also be referred to as a "patient-directed method") of using an implantable flow restriction system 5. Additionally, method 1200 may include other steps and / or omit steps.

[0192] Manual method 1200 can include requesting 1205 a pressure measurement (e.g., a renal venous pressure measurement or a femoral venous pressure measurement). Such a request can be made by the patient using external device 15 or other separate electronic device as described herein (e.g., via wireless communication with system 5).

[0193] The manual method 1200 may include a step 1210 in which the system 5 measures a pressure based on the request from step 1205. Such a pressure measurement may be measured by a sensor 600 of the system 5. To this end, the processor 51 of the controller 50 may be operatively connected to the pressure sensor 600 and configured to receive and process a signal from the pressure sensor 600 to calculate a pressure (e.g., in a patient's blood vessel). For example, an implant 500 implanted in the inferior vena cava upstream of the renal vein, having a sensor 600 connected to the implant 500, may be used to measure inferior vena cava pressure, renal vein pressure, and / or femoral vein pressure (e.g., as described with respect to Figures 48A-48C). In other words, inferior vena cava pressure, renal vein pressure, and / or femoral vein pressure may be measured from the implant 500.

[0194] The manual method 1200 may include a step 1215 in which the system 5 detects an increase in pressure. For example, the system 5 may compare the pressure measured in step 1210 to previously measured pressures and / or pressure values ​​in memory (e.g., in storage device 53) to determine whether the pressure has increased and / or is high / high pressure. The determination of high pressure may be performed according to guidelines 1100.

[0195] The manual method 1200 may include a step 1220 in which, if an increased pressure is detected in step 1215, the system 5 notifies the patient of the increased pressure. To this end, the system 5 (e.g., the controller 50) may send an indication to the external device 15 indicating that the pressure has increased. Such pressures may include inferior vena cava pressure, renal vein pressure, and / or femoral vein pressure. Additionally, step 1220 may include notifying the patient via the external device 15 that the pressure has increased and / or is high / high pressure. This may include receiving a command from the external device 15 to activate the implant 500.

[0196] The manual method 1200 may include a step 1225 of actuating the system 5, such as by a patient. To this end, the patient may interact with the external device 15 (e.g., via the user interface 17) to cause actuation of the implant 500. Actuation of the implant 500 may include actuation of the flow restrictor 560 and / or the flow restrictor portion 550 as described herein, which may at least partially occlude the lumen 513 of the implant 500. Additionally, actuation of the implant 500 may at least partially occlude the flow of blood through a vessel of the patient's vascular system. For example, in the case of an implant 500 implanted in the inferior vena cava below the renal veins of a patient, actuation of the implant 500 may at least partially occlude the flow of blood through the inferior vena cava.

[0197] The manual method 1200 may include a step 1230 of deactivating the system 5. Deactivating the system 5 may include returning the implant 500 to a deactivated, non-occluding / non-restrictive state, as described herein. Such deactivation may occur manually, semi-automatically, or automatically. For example, the system 5 may remain activated until deactivated by interaction with the external device 15. As another example, the system 5 may present a notification to notify the patient that treatment is complete and to deactivate the system 5. Such a notification may be similar to the notification of increased pressure described in step 1220. In other examples, the system 5 may remain activated for a duration, and the system 5 may be deactivated after such duration has elapsed. In yet another example, the system 5 may remain activated as long as the pressure remains elevated / high, and periodic measurements of pressure may be included for such determination.

[0198] FIG. 76 illustrates a semi-automatic method 1300 (which may also be referred to as "patient-initiated automatic sensing") using an implantable flow restriction system 5. Additionally, method 1200 may include other steps and / or omit steps. Method 1300 may be similar to method 1200 in many respects. For example, method 1300 may include steps 1305, 1310, 1315, 1320, and 1325, which are the same as steps 1210, 1215, 1220, 1225, and 1230, respectively, of method 1200. Unlike manual method 1200, semi-automatic method 1300 may omit step 1205, which requests a pressure measurement. In semi-automatic method 1300, where there is no such request for a pressure measurement, system 5 may automatically measure pressure via system 5. Such automatic pressure measurements may occur based on a predetermined schedule or time interval, which may be the same or different depending on the time of day, the patient, or other factors of the patient. The method 1300 may be referred to as semi-automatic in that the system 5 must be activated in step 1320 .

[0199] 77 illustrates an automatic method 1400 (which may also be referred to as "closed loop" or "fully closed loop") using an implantable flow restriction system 5. Method 1400 may be similar in many respects to method 1300. For example, method 1400 may include steps 1405, 1410, 1415, and 1420 that are the same as steps 1305, 1310, 1320, and 1325, respectively, of method 1300. Unlike semi-automatic method 1300, automatic method 1400 may omit step 1320, in which the system is activated by the patient. In automatic method 1400, system 5 may be automatically activated to provide therapy without the need for activation by the patient.

[0200] 78A-78C illustrate an embodiment of providing therapy using an implantable flow restriction system 5 as described herein. The delivery of therapy using the system 5 described with respect to FIGS. 78A-78C can be applied to any of the methods described with respect to FIGS. 75-77. FIGS. 78A-78C illustrate an implant 500 of the system 5 in the inferior vena cava below the renal vein of a patient. As shown in FIG. 78A, the system 5 detects elevated or high / high pressure inferior vena cava, renal vein and / or femoral vein pressure. Concomitant with elevated or high / high pressure renal vein pressure, urine production may be reduced. Depending on the method of use, the system 5 can be activated manually, semi-automatically, or automatically. When activated, the implant 500 can at least partially occlude / restrict blood flow in the inferior vena cava as described herein and illustrated in FIG. 78B (where the implant 500 is shown in an occluded / restricted state). With such placement of the implant 500 in the inferior vena cava, activation of the system 5 can reduce renal pressure (e.g., reduce renal vein pressure). Such reduction in renal pressure can increase urine production (e.g., promote / increase diuresis) in the patient. Activation of the system 5 can also increase femoral pressure (e.g., femoral vein pressure). The system 5 can be deactivated as shown in FIG. 78C. When deactivated, the implant 500 is in a substantially non-occluding / non-restricting state and does not substantially block / restrict blood flow through the implant. In other words, in a deactivated state, the implant 500 can not substantially block / occlude / restrict blood flow in the inferior vena cava. Such deactivation can reduce femoral pressure while not substantially affecting renal pressure or urine production (e.g., renal pressure and urine production can normalize with deactivation of the system 5).

[0201] Any portion of the implants described herein (e.g., filter portion 520, radial support portion 540, and flow restrictor portion 550) may be omitted, overlapped, or connected to one another in a different order. Additionally, while flow restrictor portion 550 and / or flow restrictor 560 have been described as having a particular orientation with respect to the orientation of implant 500 and / or the flow of blood through implant 500, such flow restrictor portion 550 and / or flow restrictor 560 may be reversed or oriented other than as illustrated. Additionally, features of the implants described herein may be implemented in any of the implants described herein. Additionally, while some implants described herein are illustrated and described as having components for actuation (e.g., tube 570, shaft 590) that are substantially centrally located within an associated lumen, such implants may be adapted for such components to be located around or along the sides of the implant to create an implant having a lumen that is substantially free of such components.

[0202] Although the systems, devices and / or components thereof have been described as having particular orientations and / or positions when implanted within a patient, they are not intended to be limited to such orientations and / or positions. For example, while the systems, devices and / or components thereof have been described as extending from the superior vena cava or veins branching therefrom to the inferior vena cava, such systems, devices and / or components thereof may extend from the femoral vein to the inferior vena cava. For example, while system 5 has been described as having an implantable controller 50 implanted within a subclavian subcutaneous pocket with other portions of the system extending through the superior vena cava and into the inferior vena cava, the implantable controller 50 of system 5 may be adapted for implantation within a subcutaneous pocket in or near the patient's groin with other portions of the system extending through the femoral vein to the inferior vena cava. In such embodiments, venous access may be throu...

Claims

1. It is an implant, An expandable body having a metal frame with a proximal end, a distal end, and a longitudinally extending lumen, A flow limiter, Each of the multiple petal-like parts is formed by multiple supports, The material that spans each of the aforementioned multiple petal-like parts, The flow limiter is configured to move in a hinge manner relative to the expandable body until it at least partially restricts the flow through the lumen. The flow limiter and, The implant having, An embedded control unit, Actuator configured to be operably connected to the flow limiter of the implant Eta and, A processor configured to receive instructions to operate the actuator, A communication module configured to be operablely connected to the processor and to communicate wirelessly with an external device, The actuator operates to cause the flow limiter to restrict, at least partially, the flow through the lumen. The aforementioned embedded control unit, An embedded flow limiting system having

2. A tube configured to connect the proximal end of the expandable body of the implant to the implantable control unit, A shaft positioned to move within the tube and configured to connect the actuator of the implantable control unit to the flow limiter of the implant, It has, The system according to claim 1, wherein the operation of the actuator of the embedded control unit causes the shaft to move within the tube in order to cause the flow limiter of the implant to at least partially restrict the flow through the lumen.

3. The system according to claim 1 or 2, wherein the implant further comprises a filter portion positioned adjacent to the proximal end of the expandable body, the filter portion being configured to capture thrombi.

4. The system according to claim 1 or 2, wherein each of the plurality of supports forming the plurality of petal-like parts has a pair of supports that extend distally from the expandable body and are connected at the distal apex.

5. The system according to claim 1 or 2, wherein the implant has a pressure sensor that can be operably connected to the processor of the implantable control unit.

6. The system according to claim 5, wherein the embedded control unit is configured to wirelessly transmit pressure measurements from the pressure sensor to the external device.

7. The system according to claim 1 or 2, further comprising the aforementioned external device.

8. The system according to claim 1 or 2, wherein the external device includes a handheld device or a mobile device.

9. The system according to claim 1 or 2, wherein the operation of the actuator that causes the flow limiter to at least partially restrict the flow through the lumen is controlled by the external device.

10. The system according to claim 1 or 2, wherein the implant is embedded in the patient's inferior vena cava upstream of the patient's renal vein, and the flow limiter is configured to regulate occlusion of the blood flow in the inferior vena cava when the flow limiter restricts at least partially the flow through the lumen of the implant.

11. The system according to claim 1 or 2, wherein the flow limiter of the implant is configured to be located upstream of the expandable body with respect to the flow through the lumen when implanted in a patient.

12. The system according to claim 1 or 2, wherein the outer surfaces of the plurality of petal-shaped parts are configured to obstruct blood flow when moved in a hinge-like manner.

13. It is an implant, An expandable body having a proximal end, a distal end, and a longitudinally extending lumen, A flow limiter configured to be fixed inside the blood vessel of the patient, An implant having, An embedded control unit, An actuator configured to be operably connected to the flow limiter of the implant, A processor configured to receive instructions to operate the actuator, A communication module configured to be operablely connected to the processor and to communicate wirelessly with an external device, The actuator operates to cause the flow limiter to restrict, at least partially, the flow through the lumen. An embedded control unit, An embedded flow limiting system having the following features.

14. A tube configured to connect the proximal end of the expandable body of the implant to the implantable control unit, A shaft positioned to move within the tube and configured to connect the actuator of the implantable control unit to the flow limiter of the implant, It further possesses, The system according to claim 13, wherein the actuator of the implantable control unit causes the flow limiter of the implant to retract the wall of the blood vessel in order to at least partially restrict the flow through the lumen.

15. The system according to claim 13 or 14, wherein the flow limiter has a plurality of petal-shaped parts, each formed by a plurality of support columns and configured to move in a hinge manner relative to the expandable body.

16. The system according to claim 15, wherein each of the plurality of supports forming the plurality of petal-like parts has a pair of supports that extend distally from the expandable body and are connected at the distal apex.

17. The flow limiter further comprises a material that spans each of the plurality of petal-shaped parts, according to claim 15.

18. The system according to claim 13, wherein the flow limiter is configured to penetrate at least partially into the wall of the blood vessel.

19. The system according to claim 13, wherein the flow limiter further comprises one or more anchors configured to fix the flow limiter to the wall of the blood vessel.

20. The system according to claim 13, wherein the implant has a pressure sensor that can be operably connected to the processor of the implantable control unit.

21. The system according to claim 20, wherein the embedded control unit is configured to wirelessly transmit pressure measurements from the pressure sensor to the external device.

22. The system according to claim 13, further comprising the aforementioned external device.

23. The system according to claim 13, wherein the external device includes a handheld device or a mobile device.

24. The system according to claim 13, wherein the operation of the actuator that causes the flow limiter of the implant to retract the wall of the blood vessel in order to at least partially restrict the flow through the lumen is controlled by the external device.

25. The system according to claim 13, wherein the implant is embedded in the patient's inferior vena cava upstream of the patient's renal vein, and is configured to regulatively occlude the blood flow in the inferior vena cava when the flow limiter causes the wall of the inferior vena cava to retract in order to at least partially restrict the flow through the lumen of the implant.

26. The system according to claim 13, wherein the flow limiter of the implant is configured to be located upstream of the expandable body with respect to the flow through the lumen when implanted in the patient.

27. The system according to claim 13, wherein the system does not include an auxiliary device or a pump.

28. The system according to claim 13, wherein the implant further comprises a filter portion positioned adjacent to the proximal end of the expandable body and positioned to capture a thrombus.

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