Systems, devices, and methods for controllably and selectively blocking, limiting, and diverting flow within vasculature of patient

Abstract

Various systems, devices, components, and methods for controllably and selectively occluding, limiting, and / or diverting flow within a patient's vasculature are disclosed. 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 limiting system may also include an external device for controlling operation of the implant via the implantable controller.

Description

Incorporation by reference of any priority application

[0001] This application claims the benefit of priority under 35 U.S.C. §119(e) to U.S. Patent Application No. 18 / 300,076, filed on April 13, 2023, U.S. Provisional Patent Application No. 63 / 336,924, filed on April 29, 2022, and U.S. Provisional Patent Application No. 63 / 484,635, filed on February 13, 2023. The entire contents of all of the above applications are hereby incorporated by reference. Any and all applications claiming foreign or domestic priority identified in the Application Data Sheet filed with this application are hereby incorporated by reference under 37 CFR 1.57. Technical Field

[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 vasculature. Background Art

[0003] One well-established problem in heart failure is volume overload, where too much pressure builds up in the venous system, which can cause the heart to not function properly as a pump. Reducing the total volume of fluid in the body (such as by administering diuretics) is one way to reduce volume overload and improve heart function. In heart failure, another way to improve heart function is to shift the distribution of blood in the vascular system. This shift in blood distribution can affect the preload of the heart and therefore the heart's ability to pump effectively. In addition, shifting venous blood volume from the renal system and / or lymphatic vessels can enhance diuresis, thereby further reducing volume overload and improving heart function. Summary of the invention

[0004] Current non-pharmacological therapies intended to alleviate volume overload and / or alleviate preload lack long-term controllability and / or adjustability. In addition, current methods for improving and / or controlling diuresis include systemic administration of diuretics, which can significantly affect the patient's quality of life. A more controllable method for controlling diuresis is needed. In order to address these and other unmet needs, the present disclosure describes various embodiments of long-term implantable flow limiting systems, devices and methods for controllably and selectively blocking, limiting and / or steering the flow in the patient's vascular system. Long-term implantable flow limiting systems and devices described herein can be actuated in a variety of ways, including magnetic actuation, fluid actuation (including pneumatic actuation), mechanical actuation, via heat (e.g., induction heating) actuation and / or via another energy source actuation. In addition, long-term implantable flow limiting systems and devices described herein can be configured to provide partial and / or complete obstruction to the blood vessel from within and / or outside the blood vessel. The ability of this long-term control to the obstruction of the patient's blood vessel can allow, for example, to control diuresis without the use of systemic drugs / pharmaceuticals.

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

[0006] In the above-mentioned long-term implantable flow limiting system or in other embodiments as described herein, one or more of the following features may also be provided. In some embodiments, the system is suitable for controllably and selectively reducing central venous pressure and / or other venous pressures, which may include inferior vena cava pressure, renal vein pressure, and / or the pressure of other veins disclosed herein. In some embodiments, the system is suitable for enhancing renal circulation. In some embodiments, the system is suitable for enhancing or controlling diuresis. In some embodiments, the system is suitable for increasing cardiac output. In some embodiments, the system is suitable for controllably and selectively blocking or diverting flow from the superior vena cava. In some embodiments, the system is suitable for controllably and selectively blocking or diverting flow from the inferior vena cava. In some embodiments, the system includes a magnetically actuated implantable device. In some embodiments, the system includes a fluid-actuated implantable device. In some embodiments, the system includes 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 the patient's vein or be positioned adjacent to the patient's vein. In some embodiments, the system includes a mechanical tightening mechanism on the implantable stent. In some embodiments, the system also includes a control unit configured to control the flow within the vascular system of the patient to be blocked, restricted and / or diverted. In some embodiments, the control unit is configured to receive readings from one or more pressure sensors located in the patient, and the control unit is configured to control the flow within the vascular system of the patient to be blocked, restricted and / or diverted based on the readings. In some embodiments, the treatment delivered by the system is digitally actuated. In some embodiments, the treatment delivered by the system is scheduled based on the time of day and / or the amount of time per day.

[0007] Disclosed herein is a long-term implantable flow limiting system for controllably and selectively blocking, limiting and / or diverting flow within a patient's vascular system, the system comprising an implant. The implant may include an expandable body and a flow restrictor. The expandable body may include a proximal end and a distal end and an inner cavity extending from the proximal end to the distal end, wherein the expandable body is configured to contract to a contracted state for delivery into a patient's body, and to expand from the contracted state to an expanded state for implantation into the patient's body. The flow restrictor may be connected to the expandable body, the flow restrictor being configured to adjustably block the inner cavity when the expandable body is in the expanded state.

[0008] In the above-mentioned long-term implantable flow limiting system or in other embodiments as described herein, one or more of the following features may also be provided. In some embodiments, the expandable body includes an expandable metal frame, which includes a plurality of pillars and defines a plurality of contractible units. In some embodiments, one or more of the plurality of pillars of the expandable body are diagonally aligned relative to the longitudinal axis of the implant. In some embodiments, the expandable body is configured to contract laterally and / or via elongation. In some embodiments, the expandable body is configured to contract radially. In some embodiments, one or more of the plurality of pillars of the expandable body are aggregated at one end of the implant offset relative to the central longitudinal axis of the implant. In some embodiments, the flow limiter includes a magnet and the implant is magnetically actuated. In some embodiments, the flow limiter is configured to move between a first non-blocking position and a second at least partially blocking position that at least partially blocks the inner cavity. In some embodiments, the flow limiter includes connecting a magnet to one or more pillars of the expandable body and a material spanning the one or more pillars. In some embodiments, the system also includes a magnetic field source configured to actuate the implant. In some embodiments, the magnetic field source is configured to be implanted in the interstitial space and / or blood vessel adjacent to the implant. In some embodiments, the magnetic field source is configured to be located outside the patient's body. In some embodiments, the flow restrictor includes a balloon, and the implant is fluid-actuated. In some embodiments, the balloon is configured to expand from a non-actuated state to an actuated state that at least partially blocks the inner cavity. In some embodiments, the balloon is configured as an oblate or oblate spheroid. In some embodiments, the balloon is configured as an elongated partial circle that adheres to the interior of the expandable body and / or the mounting portion of the expandable body. In some embodiments, the balloon is configured as a cylinder with a through opening that adheres to the interior of the expandable body and / or the mounting portion of the expandable body. In some embodiments, the expandable body includes 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 encapsulate the balloon and hide the balloon from contact with the flow flowing through the inner cavity. 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 block the inner cavity when the balloon is actuated. In some embodiments, the system also includes a tube and a fluid reservoir fluidly connected to the balloon. In some embodiments, the fluid reservoir is configured to be implanted subcutaneously. In some embodiments, the tube is coaxially connected to the balloon. In some embodiments, the tube is eccentrically and / or tangentially connected to the balloon.In some embodiments, the expandable body further comprises a plurality of struts and / or membranes, which are located downstream of the balloon and within the flow path of the lumen relative to the direction of the flow in the implant, and the plurality of struts and / or membranes are configured to filter and / or capture thrombi. In some embodiments, the flow restrictor further comprises an axis, which is configured to cover the balloon when the balloon is in its non-actuated state. In some embodiments, the axis is configured to hide the balloon from contact with the flow through the lumen when the balloon is in its non-actuated state. In some embodiments, the flow restrictor comprises a material, a balloon, and / or a wire configured to change shape when heated, and the implant is thermally actuated. In some embodiments, the flow restrictor comprises a material, a balloon, and / or a wire configured to change shape when moving, and the implant is mechanically actuated. In some embodiments, the flow restrictor comprises a shape memory material, which is configured to at least partially block the lumen when mechanically actuated.

[0009] A long-term implantable flow limiting system is disclosed herein. The system may include: an implantable control unit, the implantable control unit including a housing and an actuator disposed in the housing; an implant, the implant including an expandable body and a flow restrictor, the expandable body having a proximal end and a distal end and an inner cavity extending longitudinally therethrough, the flow restrictor being configured to adjustably block the inner cavity when the expandable body is in an expanded state; a tube, the tube connecting the proximal end of the expandable body of the implant to the housing of the control unit; and an axis, the axis being movably disposed in the tube, the axis being configured to connect the actuator of the implantable control unit to the flow restrictor of the implant; wherein actuation of the actuator of the implantable control unit causes the axis to slide in the tube so that the flow restrictor of the implant adjustably blocks the inner cavity.

[0010] In the above-mentioned long-term implantable flow limiting system or in other embodiments as described herein, one or more of the following features may also be provided. In some embodiments, the expandable body of the implant also includes: a filter portion, which is arranged adjacent to the proximal end, the filter portion is configured to capture thrombi, the filter portion includes a plurality of pillars, and the plurality of pillars extend radially outward and distally from the connection between the proximal end of the expandable body and the tube; and a radial support portion, which is connected to the filter portion and arranged distally of the filter portion, the radial support portion is configured to form a fluid seal on the inner wall of the patient's vascular system, and the radial support portion includes a ring extending along the circumference of the expandable body in a V-shaped pattern. 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 formed integrally with the expandable body. In some embodiments, the flow restrictor comprises: a plurality of flaps, each flap being formed by a pair of struts extending distally from adjacent distal vertices of the ring of the V-shaped pattern of the radial support portion and joined at the distal vertices; and a material spanning each flap of the plurality of flaps. In some embodiments, the flow restrictor comprises three or more flaps. In some embodiments, the material also spans the radial support portion. In some embodiments, the distal end of each flap of the flap of the flow restrictor is connected to the distal end of the shaft via a suture or a thread, and the proximal sliding of the shaft in the tube causes the suture or thread to pull the distal ends of each flap of the flap of the flow restrictor toward each other to at least partially block the lumen. In some embodiments, the distal end of the tube forms a fluid seal with the shaft through a retractable and extensible flexible coupling. In some embodiments, the implant is configured to be implanted in the inferior vena cava of the patient below the patient's renal vein, and the distal end of the flow restrictor is positioned to receive blood flow therethrough. In some embodiments, the system further comprises one or more pressure sensors configured to measure the pressure of the patient's vascular system and output at least one signal in response 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 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 comprise 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, wherein the processor is effectively connected to one or more pressure sensors and is configured to receive and process at least one signal to determine the pressure of the patient's vascular system. In some embodiments, the implantable control unit further comprises a communication module, which is effectively connected to the processor and is configured to communicate wirelessly with an external device. In some embodiments, the communication module transmits the determined pressure of the patient's vascular system to the external device. In some embodiments, the processor is effectively connected to an actuator of the implantable control unit, and based on the determined pressure, the patient or user can digitally actuate the actuator via an external device so that the flow restrictor of the implant can adjustably block the inner cavity. In some embodiments, the expandable body further comprises one or more anchors, which are configured to anchor the implant in the patient's vascular system. In some embodiments, the implantable control unit is configured to be powered by a battery disposed in 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 blocking, restricting and / or diverting flow in a patient's vascular system. The implant can be configured to be implanted in the inferior vena cava of the patient. The implant can include: an expandable body having a proximal end and a distal end and an inner cavity extending longitudinally therethrough; and a flow restrictor extending from the expandable body, the flow restrictor being configured to adjustably block the inner cavity when the expandable body is in an expanded state. When implanted, the flow restrictor can be configured to be located upstream of the expandable body relative to blood flow.

[0012] In the above-mentioned implant or in other embodiments as described herein, one or more of the following features may also be provided. In some embodiments, the expandable body of the implant also includes a filtering portion, which is arranged adjacent to the proximal end and / or the distal end and is configured to capture thrombi. In some embodiments, the flow restrictor includes a plurality of flaps, which are configured to fold radially inward to adjustably block the inner cavity, wherein when folded radially inward, the outer surface of the plurality of flaps is configured to block blood flow. In some embodiments, each flap in the plurality of flaps is formed by a pair of struts extending from the expandable body and joined at the distal apex. In some embodiments, the flow restrictor is provided with blocking material, and the region between the plurality of flaps does not have the blocking material. In some embodiments, the blocking material also spans at least a portion of the expandable body. In some embodiments, when the inner cavity is at least partially blocked, the flow restrictor has a non-circular opening. In some embodiments, when the inner cavity is at least partially blocked, the flow restrictor has a star-shaped opening.

[0013] A method of controllably and selectively blocking, restricting and / or diverting flow in a patient's vasculature is disclosed herein. The method may include: measuring renal pressure from an implant; detecting an increase in the renal pressure; transmitting an indication that the renal pressure has increased to an external device; receiving an instruction from the external device to activate the implant; wherein activating the implant causes the implant to at least partially block blood flow through a vessel in the patient's vasculature.

[0014] A long-term implantable flow restriction system is disclosed herein. The system may include: an implant configured to be implanted in the inferior vena cava of a patient and to adjustably block the inferior vena cava, the implant including a pressure sensor; and an implantable control unit, the implantable control unit including: an actuator, wherein actuation of the actuator causes the implant to adjustably block the inferior vena cava; a processor, the processor is effectively connected to the pressure sensor and configured to receive and process a signal from the pressure sensor to determine the pressure of the inferior vena cava; and a communication module, the communication module is effectively connected to the processor and configured to communicate wirelessly with an external device, wherein the processor is also configured to receive an instruction from the external device to actuate the actuator and cause the implant to adjustably block the inferior vena cava.

[0015] In the above-mentioned long-term implantable flow limiting system or in other embodiments as described herein, one or more of the following features may also be provided. In some embodiments, the pressure sensor is also 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 also includes a housing, and the actuator is disposed in the housing. In some embodiments, the implant is configured to be implanted in the inferior vena cava upstream of the patient's renal vein.

[0016] A long-term implantable flow limiting system is disclosed herein. The system may include: an implant configured to be implanted in the inferior vena cava of a patient and to adjustably block the inferior vena cava; and an implantable control unit removably connected to the implant, the implantable control unit including: an actuator, wherein actuation of the actuator causes the implant to adjustably block the inferior vena cava; a processor configured to receive instructions to actuate the actuator; and a communication module operatively connected to the processor and configured to communicate wirelessly with an external device. In some embodiments, the implantable control unit further includes a housing, and the actuator is disposed within the housing. In some embodiments, the implant is configured to be implanted in the inferior vena cava upstream of the patient's renal vein.

[0017] A long-term implantable flow restriction system is disclosed herein. The system may include: an implant configured to be implanted in the inferior vena cava of a patient upstream of a renal vein of the patient and to adjustably block the inferior vena cava; an implantable control unit effectively connected to the implant via a tube, the implantable control unit including: an actuator, wherein actuation of the actuator causes the implant to adjustably block the inferior vena cava; a processor configured to receive an instruction to actuate the actuator; and a communication module effectively connected to the processor and configured to communicate wirelessly with an external device.

[0018] A method for implanting a long-term implantable flow limiting system in a patient is disclosed herein. The method may include: accessing the patient's subclavian vein; implanting an implant in the patient's inferior vena cava below the patient's renal vein, the implant being configured to at least partially occlude the inferior vena cava when actuated; testing actuation of the implant; creating a subclavian subcutaneous pocket for an implantable controller, the implantable controller being configured to actuate the implant to at least partially occlude the inferior vena cava; operatively connecting the implant to the implantable controller; and implanting the implantable controller in the subclavian subcutaneous pocket.

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

[0020] A method of controllably and selectively blocking, restricting and / or diverting flow in a patient's vasculature is disclosed herein. The method may include: measuring inferior vena cava pressure from an implant implanted in the patient's inferior vena cava upstream of the patient's renal vein; detecting an increase in the inferior vena cava pressure; transmitting an indication that the inferior vena cava pressure has increased to an external device; and receiving an instruction to activate the implant from the external device; wherein activating the implant causes the implant to at least partially block 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 also be provided. In some embodiments, activating the implant to at least partially block blood flow through the inferior vena cava enhances renal circulation. In some embodiments, activating the implant to at least partially block blood flow through the inferior vena cava enhances diuresis. In some embodiments, activating the implant to at least partially block blood flow through the inferior vena cava reduces renal venous pressure. In some embodiments, the method further comprises measuring renal venous pressure from the implant when blood flow through the inferior vena cava is at least partially blocked by the implant. In some embodiments, the implant is implanted for a long time.

[0022] Disclosed herein is a method of controllably and selectively blocking, restricting and / or diverting flow through a patient's vasculature. The method may include: measuring inferior vena cava pressure from an implant implanted in the inferior vena cava of the patient upstream of the patient's renal vein; detecting that the inferior vena cava pressure has reached a threshold; transmitting an indication that the inferior vena cava pressure has reached the threshold to an external device; and receiving an instruction to activate the implant from the external device; wherein activating the implant causes the implant to at least partially block blood flow through the inferior vena cava. In some embodiments, the implant is implanted chronically.

[0023] A flow limiting system is disclosed herein. The flow limiting system may be a long-term implantable flow limiting system. The flow limiting system may include: an implant configured to be implanted in the inferior vena cava of the patient upstream of the patient's renal vein and to adjustably block the inferior vena cava; and an implantable control unit effectively connected to the implant via a tube, the implantable control unit including: an actuator, wherein actuation of the actuator causes the implant to adjustably block the inferior vena cava; a processor configured to receive an instruction to actuate the actuator; and a communication module effectively connected to the processor and configured to communicate wirelessly with an external device.

[0024] In the above system or in other embodiments as described herein, one or more of the following features may also be provided. In some embodiments, the implant includes: an expandable body having a proximal end and a distal end and an inner cavity extending longitudinally therethrough; and a flow restrictor configured to be hinged relative to the expandable body to at least partially restrict the flow through the inner cavity. In some embodiments, the flow restrictor includes a support and a material spanning the support, the material being configured to block blood flow. In some embodiments, the flow restrictor is positioned adjacent to the distal end of the expandable body so that when implanted in the inferior vena cava, the flow restrictor is upstream of the expandable body relative to the blood flow. In some embodiments, the implant also includes a filter portion, the filter portion being arranged adjacent to the proximal end of the expandable body, the filter portion being configured to capture thrombi. In some embodiments, the implant includes a pressure sensor operatively connected to a processor of an implantable control unit. In some embodiments, the implantable control unit is configured to wirelessly transmit pressure readings from the pressure sensor to an external device. In some embodiments, the system also includes an external device. In some embodiments, the external device comprises a handheld device or a mobile device. In some embodiments, the actuation of the actuator is controlled via the external device so that the implant can adjustably block the inferior vena cava. In some embodiments, this actuation via the external device is controlled by the patient or user. In some embodiments, when at least partially limiting the flow through the inner cavity, the flow restrictor has a non-circular opening. In some embodiments, the system does not include an auxiliary device or a pump. In some embodiments, an implantable control unit is configured to be removably connected to the implant. In some embodiments, the implant is configured to be mechanically actuated by a silk thread.

[0025] A flow limiting system is disclosed herein. The flow limiting system may be a long-term implantable flow limiting system. The flow limiting system may include: an implantable control unit, the implantable control unit including a shell and an actuator disposed in the shell; an implant, the implant including an expandable body and a flow restrictor, the expandable body having a proximal end and a distal end and an inner cavity extending longitudinally therethrough, the flow restrictor being configured to adjustably block the inner cavity when the expandable body is in an expanded state; a tube, the tube being configured to connect the proximal end of the expandable body of the implant to the shell of the implantable control unit; and an axis, the axis being movably disposed in the tube, the axis being configured to connect the actuator of the implantable control unit to the flow restrictor of the implant; wherein actuation of the actuator of the implantable control unit causes the axis to move in the tube so that the flow restrictor of the implant adjustably blocks the inner cavity.

[0026] In the above system or in other embodiments as described herein, one or more of the following features may also be provided. In some embodiments, the expandable body of the implant further includes: a filter portion, the filter portion is arranged adjacent to the proximal end, the filter portion is configured to capture thrombi, the filter portion includes a plurality of pillars, the plurality of pillars extending radially outward and distally from the connection between the proximal end of the expandable body and the tube; and a radial support portion, the radial support portion is connected to the filter portion and arranged distally of the filter portion, the radial support portion is configured to form a fluid seal on the inner wall of the patient's vascular system. 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 formed integrally with the expandable body. In some embodiments, the flow restrictor includes: a plurality of flaps, each flap being formed by a pair of pillars extending distally from the radial support portion and joined at the distal apex; and a material spanning each flap in the plurality of flaps. In some embodiments, the flow restrictor includes three or more flaps. In some embodiments, the material also spans at least a portion of the radial support portion. In some embodiments, the distal end of each flap of the flap of the flow restrictor is connected to the distal end of the shaft via a suture or a thread, and the shaft slides or rotates proximally in the tube so that the suture or thread pulls the distal ends of each flap of the flap of the flow restrictor toward each other to at least partially block the lumen. In some embodiments, the distal end of the tube forms a fluid seal with the shaft through a retractable and extensible flexible coupling. In some embodiments, the implant is configured to be implanted in the inferior vena cava of the patient below the renal vein of the patient, and the distal end of the flow restrictor is positioned to first receive blood flow through it. In some embodiments, the system also includes one or more pressure sensors, which are configured to measure the pressure of the patient's vascular system and output at least one signal in response to the measured pressure. In some embodiments, one or more pressure sensors include 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 arranged on the proximal side of the flow restrictor. In some embodiments, the pressure sensor configured to measure the patient's renal pressure is arranged 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 pressure of the patient's inferior vena cava. In some embodiments, the pressure sensor configured to measure the pressure of the patient's inferior vena cava is disposed proximal or distal to the flow restrictor. In some embodiments, the pressure sensor configured to measure the pressure of the patient's inferior vena cava is disposed adjacent to the distal end of the expandable body.In some embodiments, the implantable control unit further comprises a processor, wherein the processor is effectively connected to one or more pressure sensors and is configured to receive and process at least one signal to determine the pressure of the patient's vascular system. In some embodiments, the implantable control unit further comprises a communication module, which is effectively connected to the processor and is configured to communicate wirelessly with an external device. In some embodiments, the communication module transmits the determined pressure of the patient's vascular system to the external device. In some embodiments, the processor is effectively connected to an actuator of the implantable control unit, and based on the determined pressure, the patient or user can digitally actuate the actuator via an external device so that the flow restrictor of the implant can adjustably block the inner cavity. In some embodiments, the system further comprises an external device. In some embodiments, the expandable body further comprises one or more anchors, which are configured to anchor the implant in the patient's vascular system. In some embodiments, the implantable control unit is configured to be powered by a battery disposed in 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] The present invention discloses an implantable flow limiting system. The system may include: an implant, the implant including: an expandable body, the expandable body including a metal frame having a proximal end and a distal end and an inner cavity extending longitudinally therethrough; and a flow restrictor, the flow restrictor including: a plurality of flaps, each flap formed by a strut; and a material spanning each flap in the plurality of flaps; wherein the flow restrictor is configured to be hinged relative to the expandable body to at least partially restrict the flow through the inner cavity; and an implantable control unit, the implantable control unit including: an actuator, the actuator is configured to be effectively connected to the flow restrictor of the implant; a processor, the processor is configured to receive an instruction to actuate the actuator; and a communication module, the communication module is effectively connected to the processor and is configured to communicate wirelessly with an external device; wherein actuation of the actuator causes the flow restrictor to at least partially restrict the flow through the inner cavity.

[0028] In the above system or in other embodiments as described herein, one or more of the following features may also be provided. In some embodiments, the system further comprises: a tube configured to connect the proximal end of the expandable body of the implant to the implantable control unit; and an axis movably disposed within the tube, the axis configured to connect the actuator of the implantable control unit to the flow restrictor of the implant; wherein actuation of the actuator of the implantable control unit moves the axis within the tube so that the flow restrictor of the implant at least partially restricts flow through the lumen. In some embodiments, the implant further comprises a filter portion disposed adjacent to the proximal end of the expandable body, the filter portion being configured to capture thrombi. In some embodiments, the struts forming each of the plurality of flaps comprise a pair of struts extending distally from the expandable body and joined at the distal apex. In some embodiments, the implant comprises a pressure sensor operatively connected to a processor of the implantable control unit. In some embodiments, the implantable control unit is configured to wirelessly transmit pressure readings from the pressure sensor to an external device. In some embodiments, the system further comprises an external device. In some embodiments, the external device includes a handheld device or a mobile device. In some embodiments, actuation of the actuator is controlled via the external device so that the flow restrictor at least partially restricts the flow through the inner cavity. In some embodiments, the implant is configured to be implanted in the inferior vena cava of the patient upstream of the patient's renal vein, and when the flow restrictor at least partially restricts the flow through the inner cavity of the implant, the blood flow in the inferior vena cava can be adjusted to be blocked. In some embodiments, when implanted in the patient, the flow restrictor of the implant is configured to be located upstream of the expandable body relative to the flow through the inner cavity. In some embodiments, when hinged relative to the expandable body, the outer surface of the multiple valves is configured to block blood flow.

[0029] The present invention discloses an implantable flow restriction system. The system may include: an implant, the implant including: an expandable body having a proximal end and a distal end and an inner cavity extending longitudinally therethrough; and a flow restrictor configured to be fixed within a blood vessel of a patient's vascular system; and an implantable control unit, the implantable control unit including: an actuator configured to be effectively connected to the flow restrictor of the implant; a processor configured to receive an instruction to actuate the actuator; and a communication module effectively connected to the processor and configured to communicate wirelessly with an external device; wherein actuation of the actuator causes the flow restrictor to pull the wall of the blood vessel inwardly to at least partially restrict flow through the inner cavity.

[0030] In the above system or in other embodiments as described herein, one or more of the following features may also be provided. In some embodiments, the system further comprises: a tube configured to connect the proximal end of the expandable body of the implant to the implantable control unit; and an axis movably disposed within the tube, the axis configured to connect the actuator of the implantable control unit to the flow restrictor of the implant; wherein actuation of the actuator of the implantable control unit moves the axis within the tube so that the flow restrictor of the implant pulls the wall of the blood vessel inwardly to at least partially restrict the flow through the lumen. In some embodiments, the flow restrictor comprises a plurality of flaps, each flap being formed by a strut and configured to be hinged relative to the expandable body. In some embodiments, the struts forming each flap in the plurality of flaps comprise a pair of struts extending distally from the expandable body and joined at the distal apex. In some embodiments, the flow restrictor further comprises material spanning each flap in the plurality of flaps. In some embodiments, the flow restrictor is configured to at least partially grow inwardly into the vessel wall. In some embodiments, the flow restrictor further comprises one or more anchors configured to fix the flow restrictor to the vessel wall. In some embodiments, the implant comprises a pressure sensor operatively connected to a processor of an implantable control unit. In some embodiments, the implantable control unit is configured to wirelessly transmit pressure readings 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, the actuation of the actuator is controlled via an external device so that the flow restrictor pulls the wall of the vessel inwardly to at least partially restrict the flow through the lumen. In some embodiments, the implant is configured to be implanted in the inferior vena cava of the patient upstream of the patient's renal vein, and when the flow restrictor pulls the wall of the inferior vena cava inwardly to at least partially restrict the flow through the lumen of the implant, the blood flow in the inferior vena cava can be adjusted to be blocked. In some embodiments, when implanted in the patient, the flow restrictor of the implant is configured to be located upstream of the expandable body relative to the flow through the lumen. In some embodiments, the system does not include an auxiliary device or a pump.

[0031] A method for implanting a long-term implantable flow limiting system in a patient is disclosed herein. The method may include: implanting an implant in the inferior vena cava of the patient below the renal vein of the patient, the implant being configured to at least partially block the inferior vena cava when actuated; subcutaneously implanting an implantable controller; and effectively connecting the implant to the implantable controller, the implantable controller comprising an actuator and a processor, the actuator being configured to actuate the implant to at least partially block the inferior vena cava, the processor being configured to receive instructions to actuate the actuator.

[0032] In the above method or in other embodiments as described herein, one or more of the following features may also be provided. In some embodiments, before implanting the implantable controller, the implant is effectively connected to the implantable controller. In some embodiments, the method also includes entering the patient's subclavian vein. In some embodiments, the method also includes testing the actuation of the implant after the implant is implanted in the inferior vena cava and before the implant is effectively connected to the implantable controller. In some embodiments, implanting the implantable controller includes subcutaneously implanting the implantable controller at a position adjacent to the patient's clavicle. In some embodiments, the implantable controller also includes a communication module that is effectively connected to the processor and is configured to communicate wirelessly with an external device. In some embodiments, the method also includes actuating the implant to at least partially block the inferior vena cava. In some embodiments, actuating the implant includes receiving instructions from an external device. In some embodiments, the implant includes: an expandable body having a proximal end and a distal end and an inner cavity extending longitudinally therethrough; and a flow restrictor configured to be hinged relative to the expandable body to at least partially limit the flow through the inner cavity. In some embodiments, the flow restrictor is positioned adjacent to the distal end of the expandable body, and wherein implanting the implant in the inferior vena cava includes positioning the distal end to first receive blood flow therethrough. In some embodiments, the implantable flow restrictor system further includes: a tube extending from the implant, the tube being configured to releasably connect to an implantable controller; and a shaft movably disposed within the tube, the shaft being configured to releasably connect an actuator of the implantable controller to the flow restrictor of the implant; wherein effectively 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 embodiments, the method further includes implanting the tube and the shaft so that they extend from the implant through the inferior vena cava, the right atrium, at least a portion of the superior vena cava, and at least a portion of the subclavian vein of the patient. In some embodiments, the implant further includes a pressure sensor disposed downstream of the flow restrictor relative to the direction of blood flow in the inferior vena cava, the pressure sensor being configured to measure pressure. In some embodiments, the pressure sensor is positioned adjacent to a renal vein of the patient when the implant is implanted in the inferior vena cava below the renal vein. In some embodiments, the method further comprises removing the implant and the implantable controller from the patient.

[0033] A method of controllably and selectively blocking, restricting and / or diverting flow of a patient's vasculature is disclosed herein. The method may include: measuring inferior vena cava pressure from an implant implanted in the inferior vena cava of the patient upstream of the patient's renal vein; transmitting the inferior vena cava pressure from an implantable controller located in the patient to an external device; receiving, by the implantable controller, an instruction to activate the implant from the external device; and activating the implant; wherein activating the implant causes the implant to at least partially block 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 also be provided. In some embodiments, activating the implant to at least partially block blood flow through the inferior vena cava enhances renal circulation. In some embodiments, activating the implant to at least partially block blood flow through the inferior vena cava enhances diuresis. In some embodiments, activating the implant to at least partially block blood flow through the inferior vena cava reduces renal vein pressure. In some embodiments, activating the implant to at least partially block blood flow through the inferior vena cava reduces cardiac preload. In some embodiments, the method further includes measuring renal vein pressure from the implant when blood flow through the inferior vena cava is at least partially blocked by the implant. In some embodiments, the method further includes: detecting an increase in inferior vena cava pressure; and transmitting an indication that the inferior vena cava pressure has increased to an external device. In some embodiments, the method further includes: detecting that the inferior vena cava pressure has reached a threshold; and transmitting an indication that the inferior vena cava pressure has reached the threshold to an external device. In some embodiments, the implant includes: a flow restrictor configured to at least partially block blood flow through the inferior vena cava when the implant is activated; and a pressure sensor disposed downstream of the flow restrictor relative to the direction of blood flow in the inferior vena cava, the pressure sensor being configured to measure the 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 an external device. In some embodiments, an instruction to activate the implant is received wirelessly from an external device. In some embodiments, the method further includes receiving an instruction to deactivate the implant from the external device, wherein deactivating the implant causes the implant to not block 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 a pressure measured from the implant reaches a threshold. In some embodiments, the method further includes deactivating the implant after a duration after the pressure measured from the implant reaches a threshold. In some embodiments, the implantable controller includes: a communication module configured to communicate wirelessly with an external device; a processor operatively connected to the communication module, the processor configured to receive instructions to activate the implant; and an actuator operatively connected to the processor, the actuator configured to activate the implant. In some embodiments, activating the implant includes articulating the flow restrictor relative to the expandable body of the implant to at least partially block blood flow through the inferior vena cava. In some embodiments, activating the implant includes mechanically activating the implant via a wire.

[0035] A method of controllably and selectively occluding, restricting, and / or diverting flow through a patient's vasculature is disclosed herein. The method may include: activating a flow restrictor implanted in a vessel of the patient's vasculature, wherein activating the flow restrictor causes the flow restrictor to pull inwardly a wall of the vessel to at least partially restrict flow through the vessel.

[0036] In the above method or in other embodiments as described herein, one or more of the following features may also be provided. In some embodiments, a flow restrictor is implanted in the inferior vena cava of the patient upstream of the patient's renal vein, and wherein the flow restrictor is activated so that the flow restrictor pulls the wall of the inferior vena cava inwardly to at least partially limit the flow through the inferior vena cava. In some embodiments, the flow restrictor is activated so that the flow restrictor pulls the wall of the inferior vena cava inwardly to at least partially limit the flow through the inferior vena cava to enhance renal circulation. In some embodiments, the flow restrictor is activated so that the flow restrictor pulls the wall of the inferior vena cava inwardly to at least partially limit the flow through the inferior vena cava to enhance diuresis. In some embodiments, the flow restrictor is activated so that the flow restrictor pulls the wall of the inferior vena cava inwardly to at least partially limit the flow through the inferior vena cava to reduce renal vein pressure. In some embodiments, the flow restrictor is activated so that the flow restrictor pulls the wall of the inferior vena cava inwardly to at least partially limit the flow through the inferior vena cava to reduce cardiac preload. In some embodiments, the method also includes measuring the inferior vena cava pressure from an implant including a flow restrictor. In some embodiments, the method further comprises transmitting the inferior vena cava pressure from an implantable controller located in the patient to an external device. In some embodiments, the method further comprises receiving, by the implantable controller, an instruction to activate the flow restrictor from an external device. In some embodiments, the method further comprises measuring the renal venous pressure from an implant comprising a flow restrictor when the 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 that the inferior vena cava pressure has increased to an external device. In some embodiments, the method further comprises: detecting that the inferior vena cava pressure has reached a threshold; and transmitting an indication that the inferior vena cava pressure has reached the threshold to an external device. In some embodiments, activation of the flow restrictor is controlled via an external device. In some embodiments, an instruction to activate the flow restrictor is received wirelessly from an external device. In some embodiments, the method further comprises receiving an instruction to deactivate the flow restrictor from an external device, wherein deactivating the flow restrictor causes the wall of the inferior vena cava to not block the flow through the inferior vena cava. In some embodiments, the method further comprises deactivating the flow restrictor after a duration. In some embodiments, the method further comprises deactivating the flow restrictor after the pressure measured from the implant reaches a threshold. In some embodiments, the method further comprises deactivating the implant after a duration after the pressure measured from the implant reaches a threshold value. In some embodiments, the implantable controller comprises: a communication module configured to communicate wirelessly with an external device; a processor operatively connected to the communication module, the processor configured to receive an instruction to activate the flow restrictor; and an actuator operatively connected to the processor, the actuator configured to activate the flow restrictor. In some embodiments, activating the flow restrictor comprises articulating the flow restrictor relative to an expandable body of the implant comprising the flow restrictor.In some embodiments, activating the flow restrictor includes mechanically activating the flow restrictor via a wire.

[0037] Disclosed herein is an implant configured to be implanted in a patient for controllably and selectively blocking, restricting and / or diverting flow in the patient's vascular system. The implant may include: an expandable body and a filter portion, the expandable body having a proximal end and a distal end and an inner cavity extending longitudinally therethrough, the filter portion being disposed adjacent to the proximal end, the filter portion being configured to capture thrombi; and a flow restrictor extending from the distal end of the expandable body, the flow restrictor being configured to adjustably block the inner cavity when the expandable body is in an expanded state; wherein when implanted, the flow restrictor is configured to be located upstream of the expandable body relative to blood flow.

[0038] In the above-mentioned implant or in other embodiments as described herein, one or more of the following features may also be provided. In some embodiments, the filtering portion includes a plurality of pillars extending proximally and radially inward. In some embodiments, the expandable body of the implant also includes a radial support portion, which is connected to the filtering portion and is disposed distally of the filtering portion, and the radial support portion is configured to form a fluid seal on the inner wall of the patient's vascular system. 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 formed integrally with the expandable body. In some embodiments, the flow restrictor includes a plurality of flaps, which are configured to fold radially inwardly to adjustably block the inner cavity, wherein when folded radially inwardly, the outer surface of the plurality of flaps is configured to block blood flow. In some embodiments, each flap in the plurality of flaps is formed by a pair of pillars extending from the expandable body and engaging at the distal apex. In some embodiments, the flow restrictor includes three or more flaps. In some embodiments, the flow restrictor is provided with a blocking material, and the region between the plurality of flaps does not have the blocking material. In some embodiments, the flow restrictor is provided with a blocking material, and wherein the blocking material spans a plurality of flaps and an area between the plurality of flaps. In some embodiments, the blocking material also spans at least a portion of the expandable body. In some embodiments, the flow restrictor has a non-circular opening when the lumen is at least partially blocked. In some embodiments, the flow restrictor has a star-shaped opening when the lumen is at least partially blocked. 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 being configured to anchor the implant within the patient's vascular system. In some embodiments, the implant is configured to be implanted in the inferior vena cava of the patient. In some embodiments, a system is provided, comprising an implant as described herein and a delivery sheath configured to implant the implant. In some embodiments, in the above-mentioned system, the implant is configured to remain in a contracted state when at least a portion of the radial support portion remains within the delivery sheath when extended outside the delivery sheath.

[0039] Disclosed herein is an implant configured to be implanted in a patient for blocking, limiting and / or diverting flow in the patient's vascular system. The implant may include: an expandable body including a metal frame having a proximal end and a distal end and an inner cavity extending longitudinally therethrough; and a flow restrictor including: a plurality of flaps, each flap being formed by a pair of struts extending distally from the expandable body and joined at a distal apex; and a material spanning each of the plurality of flaps; wherein the flow restrictor is configured to fold radially inwardly to at least partially restrict flow through the inner cavity.

[0040] In the above-mentioned implant or in other embodiments as described herein, one or more of the following features may also be provided. In some embodiments, the expandable body of the implant further includes a filter portion, which is arranged adjacent to the proximal end, and the filter portion is configured to capture thrombi. In some embodiments, the expandable body of the implant further includes a radial support portion, which is connected to the filter portion and arranged distally of the filter portion, and the radial support portion is configured to form a fluid seal on the inner wall of the patient's vascular system. In some embodiments, the flow restrictor is formed integrally with the expandable body. In some embodiments, when folded radially inward, the outer surface of the multiple flaps of the flow restrictor is configured to block blood flow. In some embodiments, the flow restrictor includes three or more flaps. In some embodiments, the area between the multiple flaps does not have material. In some embodiments, the material also spans the area between the multiple flaps. In some embodiments, the material also spans at least a portion of the expandable body. In some embodiments, when the lumen is at least partially blocked, the flow restrictor has a non-circular opening. In some embodiments, when the lumen is at least partially blocked, the flow restrictor has a star-shaped opening. 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 being configured to anchor the implant within the patient's vascular system. In some embodiments, the implant is configured to be implanted in the inferior vena cava of the patient. In some embodiments, when implanted, the flow restrictor is configured to be located upstream of the expandable body relative to the blood flow. In some embodiments, a system is provided, comprising an implant as described herein and a delivery sheath configured to implant the implant. In some embodiments, in the above system, the implant is configured to remain in a contracted state when at least a portion of the radial support portion remains within the delivery sheath when extended outside the delivery sheath.

[0041] Disclosed herein is an implant configured to be implanted in a patient for blocking, restricting and / or diverting flow in the patient's vascular system. The implant may include: an expandable body having a proximal end and a distal end and an inner cavity extending longitudinally therethrough; and a flow restrictor configured to be fixed within a vessel of the patient's vascular system; wherein activation of the flow restrictor causes the flow restrictor to pull the wall of the vessel inwardly to at least partially restrict flow through the inner cavity.

[0042] In the above-mentioned implant or in other embodiments as described herein, one or more of the following features may also be provided. In some embodiments, the flow restrictor includes a plurality of flaps, each flap being formed by a support and being configured to be hinged relative to the expandable body. In some embodiments, the support forming each flap in the plurality of flaps includes a pair of supports extending distally from the expandable body and engaging at the distal apex. In some embodiments, the flow restrictor also includes material spanning each flap in the plurality of flaps. In some embodiments, the flow restrictor is configured to at least partially grow inwardly into the vessel wall. In some embodiments, the flow restrictor also includes one or more anchors, which are configured to fix the flow restrictor to the vessel wall. In some embodiments, the flow restrictor is formed integrally with the expandable body. In some embodiments, the implant includes 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 also includes a filtering portion, which is disposed adjacent to the proximal end of the expandable body, and the filtering portion is configured to capture thrombi. In some embodiments, the filter portion includes a plurality of struts extending proximally and radially inwardly. In some embodiments, the implant is configured to be implanted in the inferior vena cava of the patient. In some embodiments, when implanted, the flow restrictor is configured to be located upstream of the expandable body relative to the flow through the lumen of the implant.

[0043] To summarize the present disclosure, certain aspects, advantages, and novel features of several implementations have been described herein. It should be understood that not all of these advantages are necessarily achieved according to any particular implementation of the technology disclosed herein. Therefore, the embodiments disclosed herein may be implemented or performed in a manner that achieves or optimizes one advantage or a group of advantages taught herein without having to achieve other advantages taught or suggested herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] Certain features of the present disclosure are described below with reference to the accompanying drawings. The embodiments shown are intended to illustrate rather than limit these embodiments. Various features of the different disclosed embodiments can be combined to form further embodiments, which are part of the present disclosure.

[0045] Figure 1A The patient's anatomy is shown, including a heart having a right atrium, right ventricle, left atrium and left ventricle, a superior vena cava connected to the right atrium, an inferior vena cava connected to the right atrium and to the patient's renal veins, and other blood vessels and organs of the patient.

[0046] Figure 1B The patient's anatomy is shown, including connections between ducts of the patient's lymphatic system, such as the thoracic duct and the right lymphatic duct, and the patient's veins.

[0047] FIG. 2A to FIG. 2B A magnetically actuated, long-term implantable current limiting system implanted in a patient is shown in accordance with aspects of the present disclosure.

[0048] FIG. 3A to FIG. 3D Various views of an embodiment of a magnetically actuated, chronically implantable current limiting system according to aspects of the present disclosure are shown.

[0049] 4A to 4D Various views of another embodiment of a magnetically actuated, chronically implantable current limiting system according to aspects of the present disclosure are shown.

[0050] FIG. 5A to FIG. 5F Various views of another embodiment of a magnetically actuated, chronically implantable current limiting system according to aspects of the present disclosure are shown.

[0051] FIG. 6A to FIG. 6D Various views of another embodiment of a magnetically actuated, chronically implantable current limiting system according to aspects of the present disclosure are shown.

[0052] FIG. 7A to FIG. 7B A fluid-actuated, long-term implantable flow restriction system implanted in a patient is shown according to aspects of the present disclosure.

[0053] FIG. 8A to FIG. 8D Various views of an embodiment of a fluid-actuated, chronically implantable flow restricting system according to aspects of the present disclosure are shown.

[0054] 9A to 9D Various views of another embodiment of a fluid-actuated, chronically implantable flow restricting system according to aspects of the present disclosure are shown.

[0055] FIG. 10A to FIG. 12C Various embodiments of fluid-actuated, chronically implantable flow restricting systems according to aspects of the present disclosure are shown.

[0056] FIG. 13A to FIG. 13D Another embodiment of a fluid-actuated, chronically implantable flow-restricting system according to aspects of the present disclosure is shown.

[0057] FIG. 14A to FIG. 14DShown according to FIG. 13A to FIG. 13C and various views of embodiments of a fluid-actuated, chronically implantable flow restricting system according to aspects of the present disclosure.

[0058] FIG. 15A to FIG. 15C Another embodiment of a fluid-actuated, long-term implantable flow restrictor system and a method of making the fluid-actuated, long-term implantable flow restrictor system according to aspects of the present disclosure is shown.

[0059] FIG. 16A to FIG. 16C Another embodiment of a fluid-actuated, long-term implantable flow restrictor system and another method of making the fluid-actuated, long-term implantable flow restrictor system according to aspects of the present disclosure are shown.

[0060] FIG. 17A to FIG. 17B Various views of another embodiment of a fluid-actuated, chronically implantable flow restricting system according to aspects of the present disclosure are shown.

[0061] 18A to 18C Various views of a frame of another embodiment of a fluid-actuated, chronically implantable flow restricting system according to aspects of the present disclosure are shown.

[0062] FIG. 19A to FIG. 19C Various views of a frame of another embodiment of a fluid-actuated, chronically implantable flow restricting system according to aspects of the present disclosure are shown.

[0063] FIG. 20A to FIG. 20D Various views of a frame of another embodiment of a fluid-actuated, chronically implantable flow restrictor system in a collapsed state and an expanded state according to aspects of the present disclosure are shown.

[0064] Fig.21A Another embodiment of a fluid-actuated, chronically implantable flow restricting system according to aspects of the present disclosure is shown.

[0065] Fig.21B Another embodiment of a fluid-actuated, chronically implantable flow restricting system according to aspects of the present disclosure is shown.

[0066] Fig. 21C An embodiment of a mechanically actuated, chronically implantable flow limiting system according to aspects of the present disclosure is shown.

[0067] FIG. 22A to FIG. 22B A thermally activated, chronically implantable flow limiting system implanted in a patient is shown in accordance with aspects of the present disclosure.

[0068] FIG. 23A to FIG. 23B An embodiment of a thermally activated, chronically implantable current limiting system according to aspects of the present disclosure is shown.

[0069] FIG. 24A to FIG. 26BVarious embodiments of thermally activated, chronically implantable current limiting systems according to aspects of the present disclosure are shown.

[0070] FIG. 27A to FIG. 27D Various views of another embodiment of a thermally actuated, chronically implantable current limiting system according to aspects of the present disclosure are shown.

[0071] FIG. 28A to FIG. 28D Various views of another embodiment of a thermally actuated, chronically implantable current limiting system according to aspects of the present disclosure are shown.

[0072] FIG. 29A to FIG. 29D Various views of another embodiment of a thermally actuated, chronically implantable current limiting system according to aspects of the present disclosure are shown.

[0073] FIG. 30A to FIG. 30B Various views of another embodiment of a thermally actuated, chronically implantable current limiting system according to aspects of the present disclosure are shown.

[0074] FIG. 31A to FIG. 31B Various views of another embodiment of a thermally actuated, chronically implantable current limiting system according to aspects of the present disclosure are shown.

[0075] FIG. 32A to FIG. 32D Various views of another embodiment of a thermally actuated, chronically implantable current limiting system according to aspects of the present disclosure are shown.

[0076] FIG. 33A to FIG. 33D Various views of another embodiment of a thermally actuated, chronically implantable current limiting system according to aspects of the present disclosure are shown.

[0077] Fig.34 The patient's anatomy is shown, including the inferior vena cava connected to the patient's renal system via the renal veins and to the patient's other veins, and their locations relative to the patient's spine.

[0078] FIG. 35A to FIG. 35B A method of occluding the inferior vena cava of a patient according to aspects of the present disclosure is shown.

[0079] FIG. 36A to FIG. 36B Another extravascular method of occluding a patient's inferior vena cava is shown in accordance with aspects of the present disclosure.

[0080] FIG. 37A to FIG. 37C Another extravascular method of occluding a patient's inferior vena cava is shown in accordance with aspects of the present disclosure.

[0081] Fig.38 Another extravascular method of occluding a patient's inferior vena cava is shown in accordance with aspects of the present disclosure.

[0082] Fig.39 Another extravascular method of occluding a patient's inferior vena cava is shown in accordance with aspects of the present disclosure.

[0083] Fig.40 Another extravascular method of occluding a patient's inferior vena cava is shown in accordance with aspects of the present disclosure.

[0084] Fig.41 A control system for a chronically implantable current limiting system according to aspects of the present disclosure is shown.

[0085] Fig.42 A long-term implantable flow limiting system according to aspects of the present disclosure is shown implanted in a patient.

[0086] FIG. 43A to FIG. 43D An embodiment of an implant of a chronically implantable flow limiting system according to aspects of the present disclosure is shown.

[0087] FIG. 44A to FIG. 44C According to some aspects of the present disclosure FIG. 43A to FIG. 43D Various end views of the implant.

[0088] Fig.44D According to some aspects of the present disclosure FIG. 43A to FIG. 43D An end view of another embodiment of an implant.

[0089] Fig.45 According to some aspects of the present disclosure FIG. 43A to FIG. 43D A plan view of the expandable body of an implant.

[0090] FIG. 46A to FIG. 46B Various views of components of a chronically implantable flow limiting system according to aspects of the present disclosure are shown.

[0091] FIG. 47A to FIG. 47D shows an actuation according to some aspects of the present disclosure FIG. 43A to FIG. 43D The interaction of the various components of the implant's flow-limiting system.

[0092] FIG. 48A to FIG. 48C Various embodiments of implants of flow restricting systems according to aspects of the present disclosure are shown with sensors in various locations relative to a flow restrictor portion of the implant.

[0093] Fig.49 An embodiment of an implant of an implantable flow restriction system according to aspects of the present disclosure is shown.

[0094] Fig.50 An embodiment of an implant of an implantable flow restriction system according to aspects of the present disclosure is shown.

[0095] FIG. 51A to FIG. 51BAn embodiment of an implant of an implantable flow restriction system according to aspects of the present disclosure is shown.

[0096] Fig.52 An embodiment of an implant of an implantable flow restriction system according to aspects of the present disclosure is shown.

[0097] Fig.53 An embodiment of an implant of an implantable flow restriction system according to aspects of the present disclosure is shown.

[0098] Fig.54 An embodiment of an implant of an implantable flow restriction system according to aspects of the present disclosure is shown.

[0099] FIG. 55A to FIG. 55C The interaction of various components of an embodiment of a flow limiting system for actuating an implant thereof according to aspects of the present disclosure is shown.

[0100] FIG. 56A to FIG. 56B An embodiment of an implant of an implantable flow restriction system according to aspects of the present disclosure is shown.

[0101] FIG. 57A to FIG. 57B An embodiment of an implant of an implantable flow restriction system according to aspects of the present disclosure is shown.

[0102] FIG. 58A to FIG. 58C An embodiment of an implant of an implantable flow restriction system according to aspects of the present disclosure is shown.

[0103] Fig.59 An embodiment of an implant of an implantable flow restriction system according to aspects of the present disclosure is shown.

[0104] Fig.60 An embodiment of an implantable flow restricting system having a releasable implant according to aspects of the present disclosure is shown.

[0105] Figures 61A to 61C An embodiment of an implant of an implantable flow restriction system according to aspects of the present disclosure is shown.

[0106] Fig.62 An embodiment of an anchor for an implant of an implantable flow restricting system according to aspects of the present disclosure is shown.

[0107] Fig.63 An embodiment of an implant of an implantable flow restriction system according to aspects of the present disclosure is shown.

[0108] FIG. 64A to FIG. 64B An embodiment of a shaft of an implantable flow restriction system according to aspects of the present disclosure is shown.

[0109] Fig.65A schematic diagram showing certain features of an implantable controller and external devices of an implantable current limiting system according to aspects of the present disclosure.

[0110] Figures 66A to 66C Embodiments of connectors between components of a current limiting system according to aspects of the present disclosure are shown.

[0111] FIG. 67A to FIG. 67B Embodiments of connectors between components of a current limiting system according to aspects of the present disclosure are shown.

[0112] FIG. 68A to FIG. 68D Embodiments of connectors between components of a current limiting system according to aspects of the present disclosure are shown.

[0113] FIG. 69A to FIG. 69B An embodiment of an implant assembly having an extender for implantation according to aspects of the present disclosure is shown.

[0114] FIG. 70A to FIG. 70B An embodiment of an apparatus for testing the functionality of an implant during implantation of the implant according to some aspects of the present disclosure is shown.

[0115] FIG. 71A to FIG. 71B An embodiment of an apparatus for testing the functionality of an implant during implantation of the implant according to some aspects of the present disclosure is shown.

[0116] Fig.72 A method of implanting an implantable current limiting system according to some aspects of the present disclosure is shown.

[0117] FIG. 73A to FIG. 73D Deployment of an implant of an implantable flow restricting system according to aspects of the present disclosure is shown.

[0118] Fig.74 Guidelines for treating a patient using an implantable flow restrictor system according to aspects of the present disclosure are shown.

[0119] Fig.75 A manual method of using an implantable flow restriction system according to some aspects of the present disclosure is shown.

[0120] Fig.76 A semi-automated method of using an implantable current limiting system according to some aspects of the present disclosure is shown.

[0121] Fig.77 An automated method of using an implantable current limiting system according to some aspects of the present disclosure is shown.

[0122] Figures 78A to 78C Embodiments of delivering therapy using an implantable flow restriction system according to aspects of the present disclosure are shown. DETAILED DESCRIPTION

[0123] The various features and advantages of the present disclosure will now be described with reference to the accompanying drawings. The following description is merely illustrative in nature and is in no way intended to limit the present disclosure, its application or use. The present disclosure extends beyond the specifically disclosed embodiments and / or uses and their obvious modifications and equivalents. Therefore, the scope of the present disclosure should not be limited by any particular embodiment described below. The features of the illustrated embodiments may be modified, combined, removed and / or replaced, as will be apparent to those of ordinary skill in the art after considering the principles disclosed herein. In addition, the embodiments disclosed herein may include several novel features, none of which is individually responsible for its desired properties or necessary for practicing the systems, devices and / or methods disclosed herein.

[0124] The same reference numerals are used with different letters added after the reference numerals to identify parts, components, features and / or elements of the chronically implantable current limiting systems and devices described herein that may function the same or similarly in various embodiments. The differences between various embodiments are discussed herein.

[0125] The present disclosure describes various embodiments of long-term implantable flow limiting systems, devices and methods for controllably and selectively blocking, limiting and / or redirecting flow in a patient's vascular system. These systems, devices and methods can be used to redirect flow and / or enhance perfusion in one or more organs in the patient's vascular system and / or the patient's organs. In some cases, controllably and selectively blocking, limiting and / or redirecting flow in the patient's vascular system to reduce renal congestion (or promote renal decongestion), reduce hepatic congestion (or promote hepatic decongestion), reduce cardiac preload and / or reduce lymphatic / interstitial congestion can be advantageous. For example, a long-term implantable flow limiting system can be used to reduce cardiac preload, and the long-term implantable flow limiting system is suitable for controllably and selectively blocking and / or limiting the superior vena cava upstream of the position where the superior vena cava of the patient enters the right atrium of the patient. The long-term implantable flow limiting system can also be suitable for controllably and selectively reducing central venous pressure and / or the pressure of other veins disclosed herein and / or improving cardiac output. As another example, a long-term implantable flow limiting system can be used to reduce renal congestion, and the long-term implantable flow limiting system is suitable for controllably and selectively blocking and / or limiting the inferior vena cava of the patient upstream of the position where the renal vein is connected to the inferior vena cava (for example, below the position where the renal vein is connected to the inferior vena cava). The long-term implant system can also be suitable for controllably and selectively enhancing renal circulation, enhancing and / or controlling diuresis and / or alleviating volume overload. Various embodiments of the long-term implantable flow limiting system and device described herein can be configured to be implanted in the patient for several months, one year or several years. In addition, various embodiments of the long-term implantable flow limiting system and device can be configured to controllably and selectively block, limit the flow in the patient's vascular system and / or divert the flow in the patient's vascular system without auxiliary equipment or pumps.

[0126] Long-term implantable flow limiting systems, devices and methods described herein can be suitable for percutaneous delivery. In this way, the system and device described herein can be configured to be delivered via a catheter or similar delivery device, and can have a contracted state to be delivered into the patient's body, and can be expanded from the contracted state to an expanded state to be implanted in the patient's body. In addition, the system and device described herein or its components can be suitable for being retractable after deployment, such as to be repositioned and / or to be removed from the body (for example, by including a hook or other feature for retraction). In some embodiments, the system and device described herein can be configured to be delivered and implanted in the patient's vascular system. For example, a long-term implantable flow limiting system as described herein can be percutaneously implanted in the patient's superior vena cava upstream of the patient's right atrium. The implantable flow limiting system can be controlled to selectively block, limit and / or turn to the flow in the patient's superior vena cava (for example, to reduce the heart preload). As another example, a long-term implantable flow limiting system as described herein can be percutaneously implanted in the patient's inferior vena cava upstream of the position where the patient's renal vein is connected to the inferior vena cava. The implantable flow limiting system can be controlled to selectively block, limit and / or redirect flow in the inferior vena cava of the patient (e.g., to reduce renal congestion). In some embodiments, the systems and devices described herein can be configured to be delivered extravenously to at least partially surround the patient's vascular system or be positioned adjacent to the patient's vascular system. For example, a long-term implantable flow limiting system as described herein can be percutaneously implanted outside the inferior vena cava of the patient, and at least partially surround the patient's superior vena cava or be positioned adjacent to the patient's superior vena cava. The implantable flow limiting system can be controlled to selectively block, limit and / or redirect flow in the inferior vena cava of the patient (e.g., to reduce renal congestion).

[0127] The long-term implantable flow limiting systems, devices and methods described herein can be actuated in a variety of ways. Without limitation, the systems and devices disclosed herein can be magnetically actuated (including electromagnetic actuation), fluidically actuated (including pneumatic actuation), mechanically actuated, actuated via heat (e.g., induction heating) and / or actuated via another energy source. In addition, the systems and devices described herein can be actuated remotely by direct connection (e.g., silk thread, fluid-connected tube) and / or advantageously. For example, a magnetically actuated flow limiting device implanted in the superior vena cava of a patient as described herein can be actuated by a magnet on the patient's back. As another example, a fluid-actuated flow limiting device implanted in or outside the inferior vena cava of a patient as described herein and adjacent to the inferior vena cava of the patient can be actuated by pressing a subcutaneously implanted fluid reservoir connected to the flow limiting device fluid. In another example, a thermally actuated flow limiting device implanted in the superior vena cava of a patient as described herein can be actuated by heat generated by induction heating of a separate device implanted in the patient's body and / or a separate device outside the patient's body. Remote actuation may provide a safer and more comfortable patient experience, including with respect to infection risk, compared to other methods that may include direct connection into / out of the body.

[0128] The long-term implantable flow limiting systems and devices described herein can be configured to partially block and / or completely block the target blood vessel. In addition, the systems and devices described herein can be configured to not block or substantially not block the target blood vessel before actuation. In other words, the systems and devices disclosed herein can be controlled to substantially block all flows through the blood vessel, block partial flows through the blood vessel, and / or allow substantially all flows to pass through the blood vessel unimpeded. For example, the flow limiting system and / or device can be configured to adjustably block the blood flow in the blood vessel within the range of 0% to 100%. In some embodiments of the systems and devices described herein, the implantable flow limiting system and / or device can be configured to substantially not block the flow through the blood vessel unless actuated to partially and / or completely close. In some cases, the systems and devices described herein can be configured to substantially block all and / or partial flows through the blood vessel unless actuated to open. In addition, in some embodiments, the systems and devices described herein can have a partially closed bias, but once implanted, they can be fully opened due to the flow of blood in the target blood vessel. It should be understood that the long-term implantable flow limiting system and device of the present disclosure can be configured to be controllable so as to be adjusted between substantially no blockage of blood flow in the blood vessel to substantially complete blockage of blood flow in the blood vessel (including both cases). In some cases, the control can be binary (e.g., open or closed) or graded (e.g., open, partially closed to varying degrees, or closed).

[0129] The long-term implantable flow limiting system and device described herein can be sized and configured to be implanted in the patient's target blood vessel, such as the superior vena cava (SVC), the inferior vena cava (IVC), etc. The flow limiting device, which may also be referred to herein as an implant, an occluder and / or a prosthesis, can have an expansion (e.g., implantation) diameter in the range of about 5mm to about 50mm, about 10mm to about 40mm, about 15mm to about 30mm, or it can have a diameter greater than about 50mm or less than about 5mm, depending on the application. In some embodiments, the implant as described herein can be too large for the target blood vessel size, and therefore an outward force is applied on the blood vessel in which the implant is implanted (e.g., to improve anchoring in the blood vessel). The flow limiting device can have an expansion (e.g., implantation) length in the range of about 0.5cm to about 5cm, about 0.75cm to about 4cm, about 1cm to about 3cm, or it can have a length greater than about 5cm or less than about 0.5cm, depending on the application.

[0130] The long-term implantable flow limiting device described herein, which is configured to be implanted in a patient's blood vessel, can generally include an expandable body (configured for percutaneous delivery as described herein) and a flow restrictor, which is configured to controllably and selectively block, limit and / or divert the flow in the patient's vascular system. The expandable body can have a proximal end, a distal end and an inner cavity extending from the proximal end to the distal end. The expandable body can generally include a frame (which can also be referred to as a stent) having an open cell and / or a closed cell structure. In addition, the expandable body can include a feature that helps anchor and / or maintain its placement in the body, such as a free vertex, a barb and / or an anchor, which can extend in any direction relative to the implant. In some cases, these barbs and / or anchors can include partial hooks, hooks and / or straight states. The expandable body can be made of a material configured to expand after delivery, and can thus include a shape memory material, such as nitinol. In some embodiments, the expandable body can be configured to radially contract / curl. Alternatively or additionally, the expandable body can be configured to contract / curl laterally when pushed or pulled. In some variations, the expandable body can include a material that has no or almost no shape memory, and the balloon can be used to expand the expandable body for implantation. The expandable body can include one or more material layers, such as an inner material layer (e.g., in its lumen) and / or an outer material layer (e.g., outside its lumen). These inner and / or outer material layers can include ePTFE, PTFE, PET cloth, polyurethane and / or similar materials. In addition, any of these layers can include an anti-thrombotic coating, a drug eluting coating, etc. In some embodiments, it is desirable to use materials and / or coatings to prevent ingrowth in the implant to help the implant be retracted and / or removed in the future. On the contrary, in some cases, it is desirable to use materials and / or coatings to allow and / or promote ingrowth in the implant. As described herein, the expandable body of an embodiment of a flow restrictor with a specific type is not limited to use only with the specific flow restrictor, and can be used in other embodiments with other types of flow restrictors. In some embodiments, the flow restrictor can be integrally formed with the expandable body.

[0131] The flow limiter of the implant as described herein can be sized and / or oriented in a variety of ways relative to the expandable body to which it is connected or formed with it. For example, the flow limiter can be sized to completely or partially block the inner cavity of the expandable body to which it is connected or formed with it when fully actuated. Regarding orientation, the flow limiter can be configured to span the entire length of the expandable body to which it is connected or formed with it, or to be configured to span a portion of the length of the expandable body. In the latter case, the flow limiter can be oriented at the proximal end, the distal end, or anywhere therebetween (e.g., in the middle or near the middle) of the expandable body. In some cases, the flow limiter can be positioned adjacent to the distal end or proximal end of the expandable body, extend beyond the distal end or proximal end of the expandable body, etc.

[0132] Implants described herein or parts thereof (e.g., flow restrictors of implants) can be configured to be fixed within a blood vessel of a patient's vascular system. In some embodiments, activation of a flow restrictor in a blood vessel of a patient's vascular system causes the flow restrictor to pull the wall of the blood vessel inwardly to at least partially limit the flow through the blood vessel and / or the lumen of the implant including the flow restrictor. In order to pull the wall of the blood vessel inwardly, the flow restrictor or parts thereof can be attached or fixed to the wall of the blood vessel (e.g., the inner wall of the blood vessel). The connection / fixation can include mechanical connection. For example, the flow restrictor can include one or more anchors, and the one or more anchors are configured to attach / fix at least a portion of the flow restrictor to at least a portion of the wall of the blood vessel (e.g., the inner wall of the blood vessel). As another example, the flow restrictor or a portion thereof can be configured to at least partially grow inwardly into the wall of the blood vessel. In this example, the flow restrictor or a portion thereof can have a structure, material, and / or coating that promotes inward growth. Further to this example, the flow restrictor may include a structure having struts, a structure having struts and a mesh spanning the struts, or a structure having struts and a material (eg, porous or non-porous material) spanning the struts.

[0133] The vascular access for delivering the long-term implantable flow limiting device as described herein may include the internal jugular vein, the subclavian vein, the femoral vein, etc. From these entry points, the flow limiting device can be advanced in the patient's vascular system by a delivery device (e.g., a delivery catheter) until the desired implantation position is reached, after which the flow limiting device can be delivered and expanded for long-term implantation. Guidewires, introducers, etc. and standard imaging methods can be used for delivery. In addition, the flow limiting device herein may include a radiopaque feature to help delivery and implantation. In addition, the flow limiting device may include a feature for matching its delivery device to help achieve precise orientation of the flow limiting device in the patient's body. For example, an implant may match a feature (e.g., a marker or other mark) of its delivery device that is retained outside the patient. A long-term implantable flow limiting system may include a flow limiting device, a source for actuating the flow limiting device, and a delivery device.

[0134] Long-term implantable flow limiting system and device described herein can be configured for open-loop and / or closed-loop control.For example, flow limiting system and device described herein can be manually, semi-automatically and / or fully automatically actuated.In some cases, the treatment provided by flow limiting system and device described herein can be digitally actuated, such as by interacting with smart phones, external terminals / devices, etc.For example, if patients expect to enhance diuresis, they can activate the treatment (for example, treatment that can be digitally actuated) via pressing the button or touch screen of their smart phones.In some embodiments, flow limiting device described herein can include a sensor attached to the flow limiting device or located away from the flow limiting device and / or work with them, and these sensors can provide physiological parameters of interest useful for controlling the flow limiting device.These physiological parameters of interest can include pressure, flow rate, etc.As an example, the flow limiting device can have a MEMS pressure sensor attached to both of its proximal end, its distal end or its end, and the pressure sensor is configured to measure the pressure at this position relative to the flow limiting device (for example, upstream, downstream, upstream and downstream, etc.). As another example, a MEMS pressure sensor can be located in a blood vessel and / or organ away from a flow limiting device and provide a measurement of the pressure at these locations to control the flow limiting device. The sensor can be used to allow fully automatic, real-time control of the flow limiting device described herein. In addition, the absolute value of the sensor data and / or the differential of the sensor data can be utilized.

[0135] The utilization of long-term implantable current limiting system and equipment described herein can be standardized between patients, or preferably customized for individual patients, such as customized via a prescription provided by a care provider. The treatment plan can change according to the type of the current limiting device implanted, its actuation type and / or the position of its implantation. The current limiting system and equipment described herein can be used continuously, hourly, multiple times a day, once a day, overnight, once every other day, once every few days, once a week, once a month, or with any frequency required or specified. In addition, the treatment provided by the current limiting system and equipment described herein can be based on the amount of time per day, the time of the day, the number of days per week, the specific days of the week, etc. In addition, the example of treatment can have a duration of seconds, minutes, hours, days, etc. For example, the treatment using the current limiting device described herein can have a duration of 15 minutes, 30 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 5 hours, 12 hours, or any duration required or required for the expected use and desired results. In addition, the treatment time can be different in terms of duration, or they can be standardized. In some cases, treatment can be determined via an algorithm that provides the duration and amount of flow restriction to be utilized. The output from the algorithm can be implemented manually, semi-automatically, or fully automatically. In some embodiments, the treatment provided by the flow restriction system and device described herein can be based on venous pressure, such as the pressure of the inferior vena cava, the renal vein pressure, the femoral vein pressure, and / or the pressure of other veins disclosed herein. For example, treatment using the flow restriction device described herein can be applied until a pressure threshold is met (e.g., treatment can be applied until the target pressure reaches or is below a pressure threshold). For the inferior vena cava, the threshold can be, for example, about 8mmHg. In some embodiments, treatment provided by the flow restriction system and device described herein can be based on a combination of duration and venous pressure. For example, treatment using the flow restriction device described herein can be applied for a period of time after the pressure threshold is met (e.g., once the inferior vena cava pressure is below 8mmHg, treatment is stopped after 4 hours).

[0136] One or more long-term implantable flow limiting devices as described herein can be implanted in a patient. In some cases, it may be beneficial to implant only one flow limiting device in a patient, or it may be beneficial to implant multiple flow limiting devices in a patient. If multiple flow limiting devices are implanted in a patient, these devices can work together as needed to achieve the desired treatment results. In addition, flow limiting devices actuated in the same or different forms can be implanted in the same patient.

[0137] Although the long-term implantable flow limiting system, device and method disclosed herein are described in a specific manner that can provide certain advantages, this description is not intended to be limiting. The long-term implantable flow limiting system and device can be implanted in various blood vessels and / or passages of a patient, including blood vessels (e.g., veins, arteries) of the patient's vascular system, the patient's lymphatic system, the patient's reproductive system, etc.

[0138] Any and / or all embodiments and / or features of the long-term implantable current limiting systems, devices, and methods described and / or illustrated herein may be applied to the various systems, devices, and methods described and / or illustrated in U.S. provisional patent application No. US63 / 331,496, filed on April 15, 2022, entitled “SYSTEMS AND METHODS FOR TREATING HEART FAILURE BY DIRECTING BLOOD FLOW THROUGH A SHUNT BETWEEN THE PULMONARY ARTERY AND THE AZYGOS VEIN,” and U.S. patent application No. 18 / 300,293, filed on April 13, 2023, entitled “SYSTEMS AND METHODS FOR TREATING HEART FAILURE BY REDIRECTING BLOOD FLOW IN THE AZYGOS VEIN,” or vice versa, the entire contents of which are hereby incorporated by reference in their entirety. For example, any and / or all embodiments and / or features of the long-term implantable flow limiting systems, devices and methods described and / or shown herein, such as magnetically actuated, fluidically actuated, mechanically actuated and / or thermally actuated flow restrictors, can be applied to azygos vein shunts in the pulmonary artery, as described in the above-referenced applications. As another example, any and / or all embodiments and / or features of a shunt between the pulmonary artery and the azygos vein as described and / or shown in U.S. Provisional Patent Application No. US63 / 311,496, such as an adjustable shunt including a rotatable disk that can be rotated relative to a fixed frame to control the size of the opening through the shunt, can be applied to the long-term implantable flow limiting systems, devices and methods described and / or shown herein. In addition, any and / or all embodiments and / or features of the long-term implantable flow limiting systems, devices and methods described and / or shown herein can be applied to and / or used for atrial septal shunts and / or pulmonary artery to superior vena cava shunts.

[0139] Figure 1AA simplified representation of a patient's anatomy is shown, including a heart having a right atrium, right ventricle, left atrium, and left ventricle, a superior vena cava connected to the right atrium, an inferior vena cava connected to the right atrium and to the patient's renal veins and hepatic veins, and other blood vessels and organs of the patient.

[0140] Figure 1B The simplified representation of the patient's anatomical structure is shown, which includes the connection between the duct (such as the thoracic duct and the right lymphatic duct) of the patient's lymphatic system and the patient's vein. As shown in the figure, the thoracic duct connects and injects the left subclavian vein, near its junction with the left internal jugular vein. Also as shown in the figure, the right lymphatic duct connects and drains in the right subclavian vein.

[0141] Figure 2A Potential locations for implantation and placement of a magnetically actuated, long-term implantable current limiting system 1 are shown. The magnetically actuated, long-term implantable current limiting system 1 may include a magnetically actuated implant 100, a magnetic field source 10 configured to actuate (e.g., turn on / off) the implant 100, and a delivery device (not shown). Multiple implants 100 implanted in a patient's body and multiple potential locations for the magnetic field source 10 are shown. Specifically, Figure 2AAn implant 100 implanted in the SVC upstream of the connection between the SVC and the right atrium of the patient is shown, and the position of the supporting magnetic field source 10 thereof is selected outside the patient's body, such as on the proximal side of the patient's back, and / or in the patient's body, such as in the aortic arch or in the interstitial space adjacent to the SVC. The implant 100 placed in this position can controllably and selectively block, limit and / or divert the flow in the SVC and the connected vascular system and / or organs of the patient, such as to reduce the cardiac preload, reduce the pressure of the central venous pressure and / or other veins disclosed herein, and / or improve cardiac output. An implant 100 implanted in the IVC upstream of the connection between the IVC and the hepatic vein of the patient is also shown, as well as an implant 100 implanted in the IVC upstream of the connection between the IVC and the renal vein of the patient. The position of the magnetic field source 10 for actuating the implant 100 placed in the IVC can include the aorta as shown, the interstitial space adjacent to the IVC, and / or the magnetic field source 10 can be located outside the patient's body, such as on the proximal side of the patient's back. The implant 100 placed in the IVC upstream of the hepatic vein can controllably and selectively block, limit and / or divert the flow in the patient's IVC and connected vasculature and / or organs, such as to reduce liver congestion (or promote liver decongestion). In addition, the implant 100 placed in the IVC upstream of the renal vein can controllably and selectively block, limit and / or divert the flow in the patient's IVC and connected vasculature and / or organs, such as to reduce renal congestion (or promote renal decongestion), enhance 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 can be implanted, or multiple implants 100 can be implanted at the shown position and / or other positions, each implant having a corresponding magnetic field source 10. In some embodiments where multiple implants 100 are implanted, the magnetic field source 10 can be configured to actuate more than one implant 100.

[0142] Figure 2B Additional potential locations for implantation and placement of a magnetically actuated, long-term implantable current limiting system 1 are shown. Multiple implants 100 implanted in a patient's body and multiple potential locations for a magnetic field source 10 are shown. Specifically, Figure 2BAn implant 100 is shown implanted in the right subclavian vein of a patient upstream of the location where the right lymphatic duct connects to the right subclavian vein, and an implant 100 is implanted in the right internal jugular vein of a patient upstream of the location where the right internal jugular vein connects to the right subclavian vein. The implants 100 at these locations can controllably and selectively block, restrict and / or divert the flow in the veins in which they are implanted to reduce pressure at the right lymphatic duct, increase lymphatic drainage and / or relieve interstitial pressure (which can improve cardiac and renal function, respectively), and relieve cardiac preload and / or increase cardiac output. An implant 100 is also shown implanted in the left internal jugular vein upstream of the location where the left internal jugular vein of a patient connects to the left subclavian vein, and an implant 100 is implanted in the left subclavian vein upstream of the location where the thoracic duct of a patient connects and injects into the left subclavian vein. Implants 100 at these locations can controllably and selectively occlude, restrict, and / or divert flow within the veins in which they are implanted to reduce pressure at the thoracic duct, increase lymphatic drainage, and / or relieve interstitial pressure (which can each improve cardiac and renal function), and reduce cardiac preload and / or increase cardiac output. Figure 2B The magnetic field source 10 of the illustrated implant 100 may be located outside the patient's body, such as on the proximal side of 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 illustrated location and / or other locations, each with a corresponding magnetic field source 10. In some embodiments where multiple implants 100 are implanted, the magnetic field source 10 may be configured to actuate more than one implant 100.

[0143] The magnetic field source 10 for actuating the magnetically actuated implant 100 can be a permanent magnet, an electromagnet, etc. When it is desired to actuate the implant 100, the magnetic field source 10 can be worn and / or placed on the patient's proximal side. For example, the magnetic field source 10 can be placed in a belt worn by the patient, placed in the patient's clothes, and / or placed or installed in furniture used by the patient (e.g., the patient's bed, the patient's chair, etc.). In some embodiments, the magnetic field source 10 can include a safety mechanism that can be actuated to expose and / or open the magnetic field source 10 and allow its magnetic field to actuate the implant 100. By selecting a magnet of a specific strength and / or displacement, and / or by selecting a specific voltage for the electromagnet, the actuation of the implant 100 by the magnetic field source 10 can be controlled and / or adjusted. Therefore, the magnetic actuation of the implant 100 can be adjusted and / or adjusted during use so that the implant 100 provides substantially no obstruction of convection, partial obstruction of various levels of convection, and / or substantially complete obstruction of convection. In some embodiments, magnetic actuation can actuate implant 100 so that implant 100 provides substantially no obstruction of convection or substantially complete obstruction of convection (e.g., binary on / off). In some cases, binary on / off control of implant 100 can include providing substantially no obstruction of convection (binary off) and partial obstruction of convection (binary on), or vice versa. In other words, even when fully actuated and "closed", implant 100 can also be configured to still allow at least partial flow through it.

[0144] FIG. 3A to FIG. 3D Various views of an embodiment of a magnetically actuated implant 100a are shown, wherein Figure 3A and Figure 3B A side view and an end view, respectively, of the implant 100a are shown in a non-blocked (eg, open) state, and Figure 3C and Figure 3DThe side view and end view of the implant 100a in the blocking (e.g., at least partially closed) state are shown respectively. The implant 100a may include an expandable body 110a, which has a proximal end 111a, a distal end 112a and an inner cavity 113a extending from the proximal end 111a to the distal end 112a. As described above, the expandable body 110a can be configured to contract to be delivered into the patient's body, and once implanted, it is expanded to engage with the inner wall of the patient's blood vessel, shown as an expanded state. As shown in this embodiment or can be used in other embodiments, the expandable body 110a may include a plurality of pillars defining a plurality of units. These units can form a symmetrical or asymmetrical pattern around the central longitudinal axis of the expandable body. In the asymmetrical pattern as shown in the figure, the expandable body 110a may include a first row of units arranged circumferentially around the central longitudinal axis at the proximal end 111a. The expandable body 110a may include a second row of units distal to the first row of units, for example at the distal end 112a, wherein the second row of units is circumferentially arranged around the central longitudinal axis, but may lack one or more units so as to form only a partial circumferential unit. Once implanted, blood flowing through the blood vessel in which the implant 100a is implanted can flow through the inner cavity 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 pillar 160a connecting the magnet 180a to the expandable body 110a, and a material 170a spanning between the pillar 160a and / or the magnet 180a and the expandable body 110a so as to block the flow through the inner cavity 113a. When the implant 100a is in an expanded state, the struts 160a can extend distally from the second row of cells and toward one side of the expandable body 110a. The magnet 180a can be positioned to one side of the expandable body 110a and can be aligned with the side wall of the expandable body 110a. The material 170a can be continuous with the material 130a of the expandable body 110a, as described above, which can be ePTFE, PTFE, PET cloth, polyurethane and / or similar materials, which are placed inside and / or outside the expandable body 110a, coated with an anti-thrombotic or other functional coating or uncoated, or the material 170a can be separate or discontinuous from the material 130a.

[0145] In use, the magnetic field source 10 can actuate the implant 100a by interacting with the magnet 180a. The magnet 180a can move from a non-actuated (e.g., static state) offset from the central longitudinal axis and aligned with the side wall of the expandable body 110a to an actuated state toward the opposite side of the expandable body 110a. In the actuated state, the magnet 180a can move toward the central longitudinal axis or move through the central longitudinal axis. In the actuated state, the magnet 180a can cause the material 170a to at least partially extend across the lumen to at least partially block or obstruct the lumen. Depending on the desired non-actuated (e.g., static) state of the implant 100a, the implant 100a can be oriented so that its distal end 112a receives blood flow from the blood vessel in which the implant 100a is implanted and its proximal end 111a discharges blood flow, or it can be implanted in the opposite orientation. For example, if it is desired that the implant 100a not block flow in its non-actuated state, the implant can be oriented such that its proximal end 111a receives flow and its distal end 112a discharges flow. In this orientation, when actuated by the magnetic field source 10, the magnet 180a of the flow restrictor 150a can be attracted or repelled by the magnetic field source 10 (depending on the orientation relative to the magnetic field source 10) and articulates relative to the expandable body 110a via the struts 160a to block the lumen 113a (e.g., FIG. 3C to FIG. 3D As another example, if it is desired that the implant 100a block flow in its non-actuated state, the implant can be oriented so that its distal end 112a receives flow and its proximal end 111a discharges flow. In this orientation, blood flow can cause the flow restrictor 150a to block the lumen 113a until the magnetic field source 10 actuates the flow restrictor 150a by attraction or repulsion, after which the flow restrictor 150a can be hinged open to unblock flow (e.g., FIG. 3A to FIG. 3B shown).

[0146] Continue to refer FIG. 3A to FIG. 3D , implant 100a may be configured to partially block flow in lumen 113a even when flow restrictor 150a is in a closed position, such as Figure 3D This configuration may be advantageous when actuation of the implant 100a is binary and it is desirable not to completely block flow through the lumen 113a upon actuation.

[0147] In some embodiments, the level of occlusion provided by the magnetically actuated implant 100a based on a given strength of the magnetic field source 10 can be adjusted by the design of the implant, such as by adjusting the number and / or thickness of the struts 160a connecting the magnets 180a to the expandable body 110a. FIG. 3A to FIG. 3D As shown, two struts 160a are used, however, one strut, three struts, four struts, or any number of struts may be used to adjust the force required to actuate the restrictor 150a.

[0148] In addition to the anti-thrombotic coating, etc., the implant 100a can be periodically actuated to help prevent thrombosis and / or blockage between the flow restrictor 150a and the inner vessel wall while the implant 100a is in use, particularly if the distal end 112a is receiving flow. In the event that a patient with the implant 100a needs to undergo an MRI, the magnet 180a can be configured to be removable from the implant 100a, such as via a catheter-based process that removes the magnet 180a but leaves the implant 100a. In some embodiments and as described above, the implant 100a can be configured to be retractable so that the implant 100a can be removed from the patient prior to any imaging in which the magnet 180a may interfere with or cause problems.

[0149] 4A to 4D Various views of another embodiment of a magnetically actuated implant 100b are shown, wherein Figure 4A and Figure 4B 1 and 2 show a side view and an end view, respectively, of the implant 100b in a non-blocked (eg, open) state, and Figure 4C and Figure 4D A side view and an end view of implant 100b are shown, respectively, in an obstructed (e.g., at least partially closed) state. Implant 100b can be the same as or similar to any of the features described with respect to implant 100a and / or incorporate any of these features. For example, implant 100b can have an expandable body 110b and a flow restrictor 150b that are the same as or similar to the expandable body 110a and flow restrictor 150a of implant 100a. However, implant 100b or expandable bodies 110b that can be used in other embodiments can have features such as Figure 4A and Figure 4C . The extension 120b can extend from the distal end 112b of the expandable body 110b so that it can provide a landing area for the flow restrictor 150b to touch when closed to block flow. The extension 120b may include one or more struts extending distally from the second row of units of the expandable body 110b, and may include one or more units that extend circumferentially only partially around the central longitudinal axis. Therefore, the extension 120b can advantageously provide a surface for receiving the end of the flow restrictor 150b, rather than allowing the end to potentially touch the inner wall of the blood vessel in which the implant 100b is implanted. As also shown in the figure, the material 130b of the expandable body 110b can extend to the extension 120b in a continuous manner.

[0150] FIG. 5A to FIG. 5F Various views of another embodiment of a magnetically actuated implant 100c are shown, wherein Figure 5A and Figure 5B1 and 2 show a side view and an end view, respectively, of an implant 100b in a non-blocked (eg, open) state. Figure 5C and Figure 5D A side view and an end view, respectively, of the implant 100b are shown in a partially blocked (eg, partially closed) state, and Figure 5E and Fig. 5F A side view and an end view of implant 100b are shown, respectively, in a fully blocked (e.g., fully closed) state. Implant 100c can be the same as or similar to any of the features described with respect to implant 100a and / or incorporate any of these features. For example, implant 100c can have an expandable body 110c and a flow restrictor 150c that are the same as or similar to the expandable body 110a and flow restrictor 150a of implant 100a. However, the flow restrictor 150c of implant 100c can be configured to provide complete or substantially complete blockage of lumen 113c when fully closed, such as Fig. 5F shown.

[0151] FIG. 6A to FIG. 6D Various views of another embodiment of a magnetically actuated implant 100d are shown, wherein Fig. 6A and Figure 6B 1 and 2 show a side view and an end view, respectively, of the implant 100b in a non-blocked (eg, open) state, and Figure 6C and Fig.6D The side view and the end view of the implant 100d in the state of complete or substantially complete blocking (for example, fully closed) are shown respectively.Implant 100d can be identical or similar to any feature in the feature described in implant 100a, 100b and / or 100c and / or be incorporated into any feature in these feature.For example and as shown in the figure, implant 100d can have expandable main body 110d, it has the extension 120d identical or similar to the extension 120b of implant 100b, and the restrictor 150d identical or similar to the restrictor 150c of implant 100c.

[0152] Fig. 7A Potential locations for implantation and placement of a fluid-actuated, long-term implantable flow-limiting system 2 are shown. The fluid-actuated, long-term implantable flow-limiting system 2 may include a fluid-actuated implant 200 and a delivery device (not shown) having a fluid reservoir 20 configured to actuate (e.g., open / close) the implant 200 and a tube 270 configured to fluidically connect the implant 200 and the fluid reservoir 20. Multiple implants 200 implanted in a patient's body and multiple potential route options for the tube 270 are shown. Specifically, Fig. 7AAn implant 200 is shown implanted in the SVC of a patient upstream of its connection with the right atrium. An implant 200 placed in this location can controllably and selectively block, restrict, and / or divert flow within the patient's SVC and connected vasculature and / or organs, such as to reduce cardiac preload, relieve central venous pressure and / or pressure of other veins disclosed herein, and / or increase cardiac output. An implant 200 is also shown implanted in the IVC of a patient upstream of its connection with the hepatic veins, and an implant 200 implanted in the IVC of a patient upstream of its connection with the renal veins. An implant 200 placed in the IVC upstream of the hepatic veins can controllably and selectively block, restrict, and / or divert flow within the patient's IVC and connected vasculature and / or organs, such as to reduce hepatic congestion (or promote hepatic decongestion). In addition, an implant 200 placed in the IVC upstream of the renal vein can controllably and selectively block, limit and / or divert flow within the patient's IVC and connected vasculature and / or organs, such as to reduce renal congestion (or promote renal decongestion), enhance renal circulation and / or control diuresis (e.g., increase diuresis). Although multiple implants 200 are shown, only one implant 200 can be implanted, or multiple implants 200 can be implanted at the shown position and / or at other positions, each implant having a corresponding fluid reservoir 20. In some embodiments where multiple implants 200 are implanted, the fluid reservoir 20 can be configured to actuate more than one implant 200.

[0153] Figure 7B Additional potential locations for implantation and placement of a fluid-actuated, long-term implantable flow-restricting system 2 are shown. Multiple potential routes for multiple implants 200 and associated tubes 270 implanted in a patient are shown. Specifically, Figure 7BAn implant 200 implanted in the right subclavian vein of a patient's right lymphatic duct upstream of the location where the right subclavian vein is connected is shown, as well as an implant 200 implanted in the right internal jugular vein of a patient upstream of the location where the right internal jugular vein is connected to the right subclavian vein. The implants 200 at these locations can controllably and selectively block, restrict and / or divert the flow in the veins in which they are implanted to reduce pressure at the right lymphatic duct, increase lymphatic drainage and / or relieve interstitial pressure (which can improve cardiac and renal function, respectively), and relieve cardiac preload and / or increase cardiac output. An implant 200 implanted in the left internal jugular vein upstream of the location where the left internal jugular vein of a patient is connected to the left subclavian vein is also shown, as well as an implant 200 implanted in the left subclavian vein upstream of the location where the thoracic duct of a patient is connected and injected into the left subclavian vein. The implants 200 at these locations can controllably and selectively block, restrict and / or divert flow within the veins in which they are implanted to reduce pressure at the thoracic duct, increase lymphatic drainage and / or relieve interstitial pressure (which can each improve cardiac and renal function), and reduce cardiac preload and / or increase cardiac output. Although multiple implants 200 are shown, only one implant 200 can be implanted, or multiple implants 200 can be implanted at the locations shown and / or at other locations, each implant having a corresponding tube 270 and a fluid reservoir 20. In some embodiments where multiple implants 200 are implanted, the fluid reservoir 20 can be configured to actuate more than one implant 200.

[0154] The fluid reservoir 20 can be implanted subcutaneously and located within or adjacent to the patient's thigh, pelvis, and / or clavicle, for example, similar to the implantation manner and location of a pacemaker. External pressure can be applied to the fluid reservoir 20 (e.g., such as above the subcutaneous location of the subcutaneous implant fluid reservoir) to actuate the implant 200 that is fluidically connected to the reservoir 20 via the tube 270.

[0155] FIG. 8A to FIG. 8D Various views of an embodiment of a fluid-actuated implant 200a are shown, wherein Fig. 8A and Figure 8B A perspective view and an end view, respectively, of the implant 200a in a non-actuated (eg, non-blocking) state are shown, and Figure 8C and Fig.8DThe stereogram and end view of the implant 200a in the actuation (e.g., blocking) state are shown respectively. The implant 200a may include an expandable body 210a, which has a proximal end 211a, a distal end 212a and an inner chamber 213a extending from the proximal end 211a to the distal end 212a. As described above, the expandable body 210a may be configured to contract to be delivered into the patient's body, and once implanted, it is expanded to engage with the inner wall of the patient's blood vessel, shown as an expanded state. Once implanted, the blood flowing through the blood vessel implanted by the implant 200a can flow through the inner chamber 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 that fluidly connects the balloon 280a to the fluid reservoir 20a. As shown, in some embodiments, balloon 280a can be configured as an elongated partial circle adhered to the interior of expandable body 210a (and / or adhered to a mounting portion of the expandable body as described herein), however other balloon shapes can also be utilized. Implant 200a can be oriented within a patient's blood vessel with its proximal end 211a or its distal end 212a receiving flow, the orientation being determined by the location of implant 200a and the location of fluid reservoir 20a.

[0156] The balloon 280a can be made of polyurethane, polysiloxane, etc., and can have a hydrophilic and anti-thrombotic coating. In some cases, the balloon 280a and / or the tube 270a can be made of an anti-thrombotic hydrogel. Although not shown, as described above, the expandable body 210a can have ePTFE, PTFE, PET cloth, polyurethane and / or similar materials, which are placed inside and / or outside the expandable body 210a, coated with an anti-thrombotic or other functional coating or uncoated.

[0157] The fluid reservoir 20a can be configured to maintain an expanded (e.g., full) state when at rest. For example, the fluid reservoir 20a can include a braided nitinol ball that is configured to maintain the fluid reservoir in an expanded state when at rest. As described above, external pressure can be applied to cause the fluid reservoir 20a to collapse, thereby causing the fluid in the fluid reservoir 20a to flow out of the fluid reservoir 20a, through the tube 270a, and into the balloon 280a, thereby expanding / inflating the balloon 280a. The expansion / inflation of the balloon 280a can provide a partial occlusion of the lumen 213a (e.g., Fig.8D213a, as described in other embodiments herein. After the external pressure on the fluid reservoir 20a is stopped, the fluid reservoir 20a can return to its expanded state, thereby evacuating the balloon 280a and filling the fluid reservoir 20a with fluid while returning the balloon 280a to its contracted / unexpanded state. The fluid used to actuate the flow restrictor 250a can include saline, other biosafe and compatible fluids, or air or other gases.

[0158] Continue to refer FIG. 8A to FIG. 8D , implant 200a can be configured to partially block flow in lumen 213a even when balloon 280a of flow restrictor 250a is fully expanded, such as Fig.8D This configuration may be advantageous when actuation of implant 200a is binary and it is desirable not to completely block flow through lumen 213a upon actuation.

[0159] 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 additionally, the level of occlusion provided by the fluid-actuated implant 200a can be based on the design of the balloon 280a and whether it completely occludes the lumen 213a when fully expanded / inflated.

[0160] In some variations, the balloon 280a of the flow restrictor 250a can be fluidly connected to a port that is configured to extend from inside the patient's body to outside the patient's body and allow for fluid activation of the balloon 280a outside the patient's body. The port can be directly connected to the tube 270a (in which case the fluid reservoir 20a may not be required), or it can be connected to the fluid reservoir 20a.

[0161] 9A to 9D Various views of another embodiment of a fluid-actuated implant 200b are shown, wherein Fig. 9A and Fig. 9B A perspective view and an end view of the implant 200b are shown, respectively, in a non-blocking state, and Fig. 9C and Fig.9DThe stereogram and the end view of the implant 200b in the obstructed state are shown respectively.Implant 200b can be identical or similar to any feature in the feature described in implant 200a and / or be incorporated into any feature in these feature.For example, implant 200b can have an expandable main body 210a and a flow restrictor 250a identical or similar to the expandable main body 210b and the flow restrictor 250b of implant 200a.However, the sacculus 280b of flow restrictor 250b can have different shapes.As shown in the figure, the sacculus 280b of implant 200b can have a cylindrical shape with a through opening, and its outer longitudinal surface adheres to the inside of expandable main body 210b (and / or adheres to the mounting portion of expandable main body as described herein).When actuated, sacculus 280a can expand / expand to effectively narrow the inner chamber 213b, and therefore block the flow of the inner chamber 213b.

[0162] FIG. 10A to FIG. 12C Various embodiments of balloons for flow restrictors of fluid-actuated implants are shown. FIG. 10A to FIG. 10C An implant 200c is shown having a flow restrictor 250c comprising a plurality of balloons 280c arranged longitudinally along the length of an expandable body 210c. Fig. 10A shows a perspective view of implant 200c in a non-actuated (eg, non-blocking) state, Fig. 10B An end view of the implant 200c is shown in a non-actuated state, and Fig. 10C An end view of implant 200c is shown in an actuated (eg, occluded) state. FIG. 11A to FIG. 11C An implant 200d is shown having a flow restrictor 250d comprising a plurality of balloons 280d arranged transversely to the length of the expandable body 210d. Fig.11A shows a perspective view of an implant 200d in a non-actuated (eg, non-blocking) state, Fig. 11B shows an end view of the implant 200d in a non-actuated state, and Fig. 11C An end view of implant 200d is shown in an actuated (eg, occluded) state. FIG. 12A to FIG. 12C An implant 200e is shown having a flow restrictor 250e that includes a balloon 280e arranged such that it is coiled along the length of an expandable body 210e. Fig. 12A A perspective view of an implant 200e in a non-actuated (eg, non-blocking) state is shown, Fig. 12B An end view of the implant 200e is shown in a non-actuated state, and Fig. 12C An end view of implant 200e is shown in an actuated (eg, occluded) state.

[0163] FIG. 13A to FIG. 13DAnother embodiment of a fluid-actuated implant 200f is shown. Fig.13A A perspective view of implant 200f is shown, Fig. 13B An end view of implant 200f is shown, Fig. 13C shows a perspective view of the implant 200f in a non-actuated state, and Fig.13D A stereogram of an implant 200f in an actuated state is shown. Implant 200f can be identical or similar to any of the features described in implant 200a, 200b, 200c, 200d and / or 200e and / or be incorporated into any of these features. Different from the fluid-actuated implant discussed so far, the expandable body 210f of implant 200f can include an outer body 215f and an inner body 225f. Each of the outer body 215f and the inner body 225f can include a framework, which includes a plurality of pillars and / or a plurality of units as described herein. In addition, both the outer body 215f and the inner body 225f can be configured to contract and expand as described herein. In addition, the outer body 215f and the inner body 225f can be configured to contract and expand together. In other words, the expandable body 210f can be constructed as a double-walled stent, wherein the outer body 215f includes an outer wall, and the inner body 225f includes 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. FIG. 13C to FIG. 13D As shown, 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 include any shape and / or state as described herein, including an oblate spheroid or an oblate spheroid shape. In addition, although not shown, the inner body 225f can be sealed to the outer body 215f along their respective distal and proximal ends. The seal can be completely circumferential except for the location where the tube 270f extends from the expandable body 210f. The outer body 215f can be more rigid than the more compliant inner body 225f, which can allow the inner body 225f to deflect inwardly (e.g., bend inwardly) and block (e.g., at least partially block and / or completely block) the lumen 213f when the flow restrictor 250f is actuated and the balloon 2280f is expanded / inflated, as shown. Fig.13DAs shown. The difference in rigidity and / or flexibility between the outer body 215f and the inner body 225f can be achieved via different strut designs, different strut thicknesses, etc. Having an inner body 225f that can effectively encapsulate the balloon 280f and hide the balloon from contact with the flow flowing through the inner cavity 213f can advantageously reduce the risk of thrombosis. In addition, the inner body 225f can provide a smooth surface for the inner cavity 213f (which can therefore produce an implant 200f in which all blood contact surfaces are smooth), which can also advantageously reduce the risk of thrombosis.

[0164] FIG. 14A to FIG. 14D Shown according to FIG. 13A to FIG. 13D Various views of an embodiment of a fluid-actuated implant 200f. Fig.14A , Fig. 14B , Fig. 14C and Fig.14D Shown respectively the side view, stereogram, top view and another stereogram of implant 200f.As shown in the figure, interior body 225f is positioned in outer body 215f, and sacculus 280f (invisible) is arranged therebetween.Fluid is connected to the pipe 270f of sacculus 280f visible in these views.Further as shown in the figure, implant 200f comprises the port that is connected to pipe 270f, and this port is connected to the position of sacculus 280f relative with pipe 270f, and this port is configured to fluidly activate sacculus 280f rather than fluid reservoir.

[0165] FIG. 15A to FIG. 15C Another embodiment of fluid-actuated implant 200g is shown, and the method for manufacturing fluid-actuated implant 200g.Implant 200g can be identical or similar to any feature in the feature described in about implant 200a to 200f and / or be incorporated into any feature in these feature.Although implant 200g is shown as not having a material layer or film covering expandable main body 210g, this material layer or film as described herein can optionally exist.As shown in the figure or can be used for other embodiments expandable main body 210g can include metal frame, this metal frame can be laser cut or can be formed by one or more silk threads. Fig.15AA side view of an expandable body 210g is shown, wherein a mounting portion 217g is configured to connect a balloon 280g of a flow restrictor 250g to the expandable body 210g. As shown, the mounting portion 217g can have a tubular shape. In addition, the mounting portion 217g can be off-center and positioned along the side of the expandable body 210g of the implant 200g. As shown, the struts of the expandable body 210g can extend distally from the mounting 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 can be connected (e.g., reflow soldered) to at least the mounting portion 217g of the expandable body 210g, such as Fig. 15B 217g, or it may pass through the mounting portion 270g. The balloon 280g may also be connected to the interior of the expandable body 210g. After being connected / adhered to the mounting portion 217g and / or the interior of the expandable body 210g, the balloon 280f of the flow restrictor 250f may be actuated to block the lumen of the expandable body 210g, as shown in FIG. Fig. 15C . In some embodiments and as shown, when actuated, the balloon 280g of the flow restrictor 250g can expand at least partially within the expandable body 210g and 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 include any shape and / or state as described herein, including a prolate spheroid or an oblate spheroid shape.

[0166] FIG. 16A to FIG. 16C Another embodiment of fluid-actuated implant 200h is shown, and another method of manufacturing fluid-actuated implant 200h.Implant 200h can be identical or similar to any feature in the feature described about implant 200a to 200f and / or be incorporated into any feature in these feature.Although implant 200h is shown as not having a material layer or film covering expandable main body 210h, this material layer or film as described herein can be optionally present.The expandable main body 210h as shown in the figure or can be used for other embodiments can include a metal frame, which can be laser cut or can be formed by one or more silk threads. Fig.16AA side view of an expandable body 210h is shown, wherein a mounting portion 217g is configured to connect a balloon 280h of a flow restrictor 250h to the expandable body 210h. The mounting portion 217g can have a cylindrical shape with a longitudinal through-opening. Additionally, the mounting portion 217h can be off-center and positioned along the side of the expandable body 210h of the implant 200h. As shown, the struts of the expandable body 210h can extend distally from the mounting portion 217h to form a tapered or angled opening at a proximal end 211h. Distal to the tapered or proximal opening, the expandable body 210h can have a circumferential portion including at least one row of contractible cells. As part of the manufacturing process, the balloon 280h and / or its associated tube 270h can be connected (e.g., reflow soldered) to at least the mounting portion 217h of the expandable body 210h, such as Fig. 16B 210h. The balloon 280h and / or its associated tube 270h can be connected to one side of the mounting portion 217h, or it can pass through the mounting portion 270h. The balloon 280h can also be connected to the interior of the expandable body 210h. After being connected / adhered to the interior of the mounting portion 217h and / or the expandable body 210h, the balloon 280h of the flow restrictor 250h can be actuated to block the lumen of the expandable body 210h, as shown in FIG. Fig. 16C . In some embodiments and as shown, when actuated, the balloon 280h of the flow restrictor 250h can expand at least partially within the expandable body 210h and 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 include any shape and / or state as described herein, including a prolate spheroid or an oblate spheroid shape.

[0167] FIG. 17A to FIG. 17B Various views of another embodiment of a fluid-actuated implant 200i are shown.Implant 200i can be the same as or similar to and / or incorporate any of the features described with respect to implants 200a-200h. Fig.17A and Fig. 17BA side view and an end view of the implant 200i in an actuated configuration are shown, respectively. The expandable body 210i as shown or applicable to other embodiments can be symmetrical about its central longitudinal axis and can include multiple rows of contractible units. As shown, the flow restrictor 250i can include a balloon 280i, wherein the tube 270i is positioned eccentrically / tangentially to the balloon 280i rather than coaxially with the balloon. The eccentric / tangential configuration can advantageously prevent the balloon from falling off the inner wall of the expandable body 210i during expansion / inflation, which is a phenomenon that may occur in the case of a coaxial configuration. In addition, the eccentric / tangential configuration can advantageously allow the tube 270i to be connected to the inner wall of the expandable body 210i at both the proximal and distal sides of the balloon 280i (e.g., to better secure the balloon 280i). This configuration of the flow restrictor 250i can be used with any fluid-actuated implant described herein, including with an implant having an expandable body that includes an outer body and an inner body (e.g., such as FIG. 13A to FIG. 13D as well as FIG. 14A to FIG. 14D ). In addition, balloon 280i can include any shape and / or state as described and / or shown herein, including a prolate spheroid or an oblate spheroid shape.

[0168] 18A to 18C Various views of an embodiment of an expandable body 210j of a fluid-actuated implant 200j are shown. Fig.18A , Fig.18B and Fig.18C The stereogram, end view and side view of expandable body 210j are shown respectively.As shown in the figure, expandable body 210j or this expandable body that can be used for other embodiments comprises 4 unit configurations, which are included in 4 shrinkable units extending circumferentially around the central longitudinal axis at the distal end 212j.As also shown in the figure, expandable body 210j comprises a mounting portion 217j similar or identical to the mounting portion 217g of implant 200g, which can be offset relative to the central longitudinal axis of expandable body.As shown in the figure, the pillar at the proximal end 211j of expandable body 210j can extend away from the end of the mounting portion 217j and / or implant offset relative to the central longitudinal axis of the implant, to advantageously promote the contraction and / or retraction of implant 200j. In other words, the design of the expandable body 210j can promote the collapse of the implant 200j, in which the struts at the proximal end 211j of the expandable body 210j converge in the proximal direction at the mounting portion 217j and / or at an end of the implant that is offset relative to the central longitudinal axis of the implant. The 4-unit expandable body 210j can be used with any of the fluid-actuated implants described herein.

[0169] FIG. 19A to FIG. 19CVarious views of an embodiment of an expandable body 210k of a fluid-actuated implant 200k are shown. Fig.19A , Fig.19B and Fig.19C The stereogram, end view and side view of expandable body 210k are shown respectively. As shown in the figure, expandable body 210k includes 6 unit configurations, which include 6 shrinkable units extending circumferentially around the central longitudinal axis of expandable body at distal end 212j. As also shown in the figure, expandable body 210k includes a mounting portion 217k similar or identical to the mounting portion 217g of implant 200g, which can be offset relative to the central longitudinal axis of expandable body. As shown in the figure, the pillar at the proximal end 211k of expandable body 210k can extend away from the mounting portion 217k and / or the end of the implant offset relative to the central longitudinal axis of the implant, so as to facilitate the contraction and / or retraction of implant 200k. In other words, the design of expandable body 210k can promote the contraction of implant 200k, in which the pillar at the proximal end 211k of expandable body 210k is aggregated in the proximal direction at the mounting portion 217k and / or at the end of the implant offset relative to the central longitudinal axis of the implant. The 6-cell expandable body 210k may be used with any of the fluid-actuated implants described herein.

[0170] FIG. 20A to FIG. 20D Various views of an embodiment of an expandable body 2101 of a fluid-actuated implant 2001 are shown. Fig. 20A shows a side view of the expandable body 2101 in an expanded state, Fig. 20B shows a side view of the expandable body 2101 in a collapsed state, Fig. 20C A main body view of the expandable body 2101 in an expanded state is shown, and Fig.20DA stereogram of an expandable body 2101 in a contracted state is shown. Also as shown, the expandable body 2101 may include a mounting portion 2171 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. The expandable body 2101 as shown or as may be used in other embodiments may have an angled or inclined proximal opening at its proximal end 2111, wherein the pillars of the expandable body 2101 extend distally away from the mounting portion 2171, so that the portion of the expandable body 2101 opposite to the side where the mounting portion 2171 of the body is located (e.g., when viewed from the end, about 180 degrees from the position of the mounting portion 2171) is farther than the portion of the expandable body 2101 connected to the mounting portion 2171. As shown, the expandable body 210l may similarly have an angled or inclined distal end opening at its distal end 212l, wherein the side of the expandable body 210l that is longitudinally aligned with the mounting portion 217l is positioned closer than the opposite side. In some cases and as shown, the distal opening may have an angle or inclination similar to (or the same as) the proximal opening. In addition, the expandable body 210l may include longitudinally extending struts (e.g., extending parallel to or substantially parallel to the central longitudinal axis of the expandable body 210l) and diagonal struts. The diagonal struts of the expandable body 210l may be diagonally aligned relative to the longitudinally extending struts when expanded and oriented in the same or substantially the same direction (best shown in Fig. 20A ). The struts of the expandable body 210l can be gathered at the mounting portion 217l (e.g., at one end of the implant offset relative to the central longitudinal axis of the implant) at its proximal end 211j in the proximal end direction. By this arrangement, the expandable body 210l is advantageously configured to shrink / curl by being pulled / pushed (e.g., lateral contraction / curling rather than radial contraction / curling via elongation), which can allow for easier retraction after deployment. For example, the expandable body 210l can be contracted from its expanded state by pulling on the mounting portion 217l or any tube connected to the implant 200l. As another example, the expandable body 210l can be contracted from its expanded state by applying a longitudinal force (e.g., pushing) toward the expandable body 210l above the position where the mounting portion 217l is located. The expandable body 210l can be used with any fluid-actuated implant described herein.

[0171] Fig.21AThe side view of another embodiment of fluid-actuated implant 200m is shown.Implant 200m can be identical or similar to any feature part in the feature part described in any fluid-actuated implant in fluid-actuated implant as described herein and / or be incorporated into any feature part in these feature parts.As shown in the figure, implant 200m can be configured to have flow restrictor 250m, and this flow restrictor comprises sacculus 280m and pipe 270m, and this pipe is substantially coaxially aligned with expandable body 210m, so that sacculus 280m is substantially centered in inner chamber 213m.Sacculus 280m can comprise any shape and / or state as described and / or shown in this article, comprise prolate spheroid or oblate spheroid shape.In some embodiments, a part of pipe 270m can extend through the inside of sacculus 280m, partially or completely through sacculus 280m (for example, from the proximal end of sacculus 280m to the distal end of sacculus 280m) as shown in the figure. In addition, in some cases, the diameter of the portion of the tube 270m extending through the interior of the balloon 280m (e.g., the total diameter) can be smaller than the diameter of the tube 270m that does not extend through the interior of the balloon 280m (e.g., the tube 270m on the proximal side of the balloon 280m as shown). In some embodiments, the portion of the tube 270m extending through the interior of the balloon 280m can 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 contracted against the portion of the tube 270m extending through its interior), the configuration of the variable diameter and / or variable wall thickness tube can advantageously produce a smooth transition between the tube 270m located on the proximal side of the balloon 280m and the balloon 280m with the internal tube 270m, so that the flow restrictor 250m has a substantially uniform total diameter (e.g., when contracted, the outer diameter of the balloon 280m is no greater than the outer diameter of the tube 270m on the proximal side of the balloon 280m). A flow restrictor 250m having a substantially uniform overall diameter may advantageously reduce the risk of thrombosis, particularly in long-term implants 200m.

[0172] Different from other embodiments described, the expandable body 210m as shown or can be used for other embodiments can include a pillar 237m and / or a membrane 235m disposed at the distal end 212m of the implant 200m (e.g., at the distal end of the flow restrictor 250m relative to the direction of flow through the implant 200m) and located in the flow path of the lumen 213m. When expanded, the expandable body 210m can include a proximal portion with an increased radial dimension in the proximal to distal direction, a central portion that can have a constant outer dimension and is configured to engage the inner wall of the blood vessel, and a distal portion with a reduced radial dimension in the proximal to distal direction. The distal portion can include a membrane 235m. The tube 270m can terminate at the proximal side of the distal portion, or the distal portion can be connected to the tube 270m. These pillars 237m and / or membranes 235m can be used as filters to capture thrombi that may pass through the implant 200m or be generated therefrom (e.g., to prevent pulmonary embolism). For example, about 4 to about 12 or more pillars 237m can be arranged at the distal end of implant 200m, and pillar 237m is configured to capture thrombus.Alternatively or additionally, film 235m can be arranged at the distal end of implant 200m in the flow path of inner chamber 213m, and this film is configured to capture thrombus.Film 235m can be configured to allow flow through it, but still capture thrombus, and therefore can have the perforation running through.The size range of the perforation running through film 235m can be about 0.5mm to about 7mm, about 1mm to about 5mm, or any size above or below these scopes.In some embodiments and as shown in the figure, implant 200m can include the retracting part 219m that is configured to help retract implant 200m after implantation.For example and as shown in the figure, retracting part 219m can be configured as hook, although retracting part 219m can be configured as ring or other shapes to help retract. The retrieval portion 219m can be positioned adjacent to the distal end 212m of the implant 200m (as shown), or it can be positioned adjacent to the proximal end 211m of the implant. In some cases, the tube 270m can be used to assist in the retrieval and / or positioning of the implant 200m.

[0173] Fig. 21BThe side view of another embodiment of fluid-actuated implant 200n is shown, wherein the side view on the left side shows the restrictor 250n of the implant 200n in non-actuated state, the middle side view shows the restrictor 250n in the partially actuated state, and the side view on the right side shows the restrictor 250n in the substantially fully actuated state.Implant 200n can be identical or similar to any feature portion in the feature portion described in any fluid-actuated implant (such as implant 200m) in the fluid-actuated implant described herein and / or be incorporated into any feature portion in these feature portions.As shown in the figure, implant 200n can be configured to have restrictor 250n, and this restrictor can include sacculus 280n, pipe 270n and shaft 290n, and this shaft is substantially coaxially aligned with expandable body 210n, so that sacculus 280n is substantially centered in inner chamber 213n. The balloon 280m may include any shape and / or state as described and / or shown herein, including a prolate spheroid or an oblate spheroid shape. Unlike the implant 200m, the restrictor 250n of the implant 200m may be configured to conceal the balloon 280n when it is in its non-actuated state (e.g., as shown in Fig. 21B Left side). For example, shaft 290n can be configured to cover balloon and / or tube 270n when balloon 280n is in its non-actuated state. In addition, shaft 290n can be configured to hide balloon 280n and / or tube 270n from contact with flow through the lumen when balloon 280n is in its non-actuated state. This configuration can advantageously reduce the risk of thrombosis, particularly in long-term implants 200n.

[0174] In some embodiments, the flow restrictor 250n can be configured such that the balloon 280n collapses inwardly within the shaft 290n when not actuated. Fig. 21B As shown, the flow restrictor 250n can be configured so that the shaft 290n can be advanced in the distal direction to cover the balloon 280n when the balloon 280n is in its non-actuated state. In this configuration, when the balloon 280n is in its non-actuated state, the shaft 290n can be advanced forward to cover the balloon 280n, for example, by a spring force bias, and / or the shaft 290n can be spring-loaded. In addition, in this configuration, when the balloon 280n is actuated, the expansion of the balloon 280n can cause the shaft 290n to retract in the proximal direction. In other words, when the balloon is deflated / contracted, the shaft 290n can advance in the distal direction over the balloon 290n; when the balloon 280n is inflated / expanded, the force generated by the balloon inflation / expansion can retract the shaft 290n in the proximal direction and allow the balloon 280n to at least partially block the inner cavity 213n (for example, the biasing force of the shaft in the distal direction may be strong enough to wrap around the balloon 280n when the balloon is deflated / contracted, but weak enough to retract in the proximal direction to allow the balloon 280n to inflate / expand upon actuation).

[0175] Fig. 21C The side view of the embodiment of the mechanically actuated implant 200o is shown, wherein the side view on the left side shows the flow restrictor 250o of the implant 200o in a non-actuated state, and the side view on the right side shows the flow restrictor 250o in a substantially fully actuated state.Implant 200o can be identical or similar to any feature portion in the feature portion described in any implant (such as implant 200m and 200n) of the implant described herein and / or be incorporated into any feature portion in these feature portions.As shown in the figure, implant 200o can be configured to have flow restrictor 250o, and this flow restrictor comprises expandable obstruction device 280o and shaft 290o, and this shaft is substantially coaxially aligned with expandable body 210o, so that expandable flow restrictor 280o is substantially centered in inner chamber 213o. The expandable occluder 280o may include any shape and / or state as described and / or shown herein, including a prolate spheroid, an oblate spheroid, a sphere, and / or a cylinder as shown in its actuated state. Unlike implants 200m and 200n, the expandable occluder 280o of the flow restrictor 250n may include a shape memory material (e.g., nitinol) that can move between a non-actuated state and an actuated state. For example and as Fig. 21C As shown in the left side of the figure, the expandable blocker 280o can be retracted relative to the shaft 290o in the direction of the proximal end so that the expandable blocker 280o shrinks within the shaft 290o, thereby effectively hiding it from contact with the flow flowing through the inner cavity 213o. When mechanically actuated, such as when the expandable blocker 280o moves distally relative to the shaft 290o, the expandable blocker can expand within the inner cavity 213o to at least partially block the inner cavity 213o. In order to change the degree of blockage of the inner cavity 213o, the expandable blocker 280o can be fully extended from the shaft 290o to the distal end, partially extended from the shaft 290o to the distal end, or not extended and hidden in the shaft 290o. The ability to hide the expandable body 280o in the shaft 290o can advantageously reduce the risk of thrombosis, particularly in long-term implants 200o. The expandable body 280o can be constructed as a mesh, a braid and / or any other state to provide at least partial blockage of convection. Furthermore, the flow restrictor 250o including the expandable body 280o and the shaft 290o can be implemented in any of the implants described and / or illustrated herein.

[0176] Fig.22APotential locations for implantation and placement of a thermally actuated, long-term implantable current limiting system 3 are shown. The thermally actuated, long-term implantable current limiting system 3 may include a thermally actuated implant 300, an energy source 30 configured to actuate (e.g., open / close) the implant 300, and a delivery device (not shown). Multiple implants 300 implanted in a patient's body and multiple potential locations for the energy source 30 are shown. Specifically, Fig.22A The implant 300 implanted in the SVC upstream of the connection between the SVC and the right atrium of the patient is shown, and the position of the supporting energy source 30 is selected outside the patient's body, such as on the proximal side of the patient's back, chest and / or abdomen, and / or in the patient's body, such as in the aortic arch or the interstitial space adjacent to the SVC. The implant 300 placed in this position can controllably and selectively block, limit and / or divert the flow in the SVC and the connected vascular system and / or organs of the patient, such as to reduce the cardiac preload, reduce the pressure of the central venous pressure and / or other veins disclosed herein, and / or improve cardiac output. The implant 300 implanted in the IVC upstream of the connection between the IVC and the hepatic vein of the patient is also shown, and the implant 300 implanted in the IVC upstream of the connection between the IVC and the renal vein of the patient. The position of the energy source 30 for actuating the implant 300 placed in the IVC can include the aorta as shown, the interstitial space adjacent to the IVC, and / or the energy source 30 can be located outside the patient's body, such as on the proximal side of the patient's back, chest and / or abdomen. The implant 300 placed in the IVC upstream of the hepatic vein can controllably and selectively block, limit and / or divert the flow in the patient's IVC and the connected vasculature and / or organs, such as to reduce liver congestion (or promote liver decongestion). In addition, the implant 300 placed in the IVC upstream of the renal vein can controllably and selectively block, limit and / or divert the flow in the patient's IVC and the connected vasculature and / or organs, such as to reduce renal congestion (or promote renal decongestion), enhance renal circulation and / or control diuresis (e.g., increase diuresis). Although multiple implants 300 and energy sources 30 are shown, only one implant 300 can be implanted, or multiple implants 300 can be implanted in the shown position and / or other positions, each implant having a corresponding energy source 30. In some embodiments where multiple implants 300 are implanted, the energy source 30 can be configured to actuate more than one implant 300.

[0177] Fig. 22B Additional potential locations for implantation and placement of a thermally activated long-term implantable current limiting system 3 are shown. Multiple implants 300 and corresponding energy sources 30 are shown implanted in a patient's body. Specifically, Fig. 22BAn implant 300 is shown implanted in the right subclavian vein of a patient upstream of the location where the right lymphatic duct connects to the right subclavian vein, and an implant 300 is implanted in the right internal jugular vein of a patient upstream of the location where the right internal jugular vein connects to the right subclavian vein. The implants 300 at these locations can controllably and selectively block, restrict and / or divert the flow in the veins in which they are implanted to reduce pressure at the right lymphatic duct, increase lymphatic drainage and / or relieve interstitial pressure (which can improve cardiac and renal function, respectively), and relieve cardiac preload and / or increase cardiac output. An implant 300 is also shown implanted in the left internal jugular vein upstream of the location where the left internal jugular vein connects to the left subclavian vein, and an implant 300 is implanted in the left subclavian vein upstream of the location where the thoracic duct of a patient connects and injects into the left subclavian vein. Implants 300 at these locations can controllably and selectively occlude, restrict, and / or divert flow within the veins in which they are implanted to reduce pressure at the thoracic duct, increase lymphatic drainage, and / or relieve interstitial pressure (which can each improve cardiac and renal function), and reduce cardiac preload and / or increase cardiac output. Fig. 22B The energy source 30 of the illustrated implant 300 may be located external to the patient, such as proximal to the patient's back, chest, or neck, and / or in 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 at the illustrated location and / or at other locations, each with a corresponding energy source 30. In some embodiments where multiple implants 300 are implanted, the energy source 30 may be configured to actuate more than one implant 300.

[0178] The energy source 30 for actuating the thermally actuated implant 300 can include ultrasound, microwave, electromagnet and / or any form of induction heating.For example, the thermally actuated implant 300 can generally include an induction coil, such as a copper coil, which can generate electric current via induction.The coil can be connected to a shape-changing material, such as a nitinol wire, which can experience temperature changes (e.g., heating) due to the corresponding changes in the electric current and shape and / or rigidity of the coil connected.When it is desired to actuate the implant 300, the energy source 30 can be worn and / or placed on the patient's proximal side.For example, the energy source 30 can be placed in a waistband worn by the patient, placed in the patient's clothes, and / or placed or installed in the furniture (e.g., the patient's bed, the patient's chair, etc.) used by the patient.By changing the power of the energy source 30, the actuation of the energy source 30 to the implant 300 can be controlled and / or regulated. Therefore, the thermal actuation of implant 300 can be regulated and / or adjusted during use so that implant 300 provides substantially non-blocking of convection, partial blocking of each level of convection and / or substantially complete blocking of convection. In some embodiments, thermal actuation can actuate implant 300 so that implant 300 provides substantially non-blocking of convection or substantially complete blocking of convection (for example, binary on / off). In some cases, the binary on / off control of implant 300 can include providing substantially non-blocking (binary off) of convection and partial blocking (binary on) of convection, or vice versa. In other words, even when fully actuated and " closed ", implant 300 also can be configured to still allow at least part of the flow to pass through it.

[0179] FIG. 23A to FIG. 26B An embodiment of a thermally activated implant 300a is shown, Fig.23A A side cross-sectional view of implant 300a is shown in a non-occluded (eg, open) state within a blood vessel, and Fig. 23BA side cross-sectional view of an implant 300a in a blocked (e.g., closed) state is shown. The implant 300a may include an expandable body 310a having a proximal end 311a, a distal end 312a, and an inner cavity 313a extending from the proximal end 311a to the distal end 312a. As described above, the expandable body 310a may be configured to contract to be delivered into the patient's body, and once implanted, expand to engage with the inner wall of the patient's blood vessel, shown as an expanded state. Once implanted, blood flowing through the blood vessel into which the implant 300a is implanted may flow through the inner cavity 313a. The implant 300a may also have a flow restrictor 350a connected to the expandable body 310a. The flow restrictor 350a may include a material 380a, such as a transplant material for an artificial valve, for blocking the flow through the inner cavity 313a using a thread 370a embedded in the material 380a. The wire 370a may include a shape-changing material as described above, such as nitinol, which may change shape when heated. Although not shown, the expandable body 310a may include an induction coil, such as a copper coil, or be connected to an induction coil. In some embodiments, the expandable body 310a itself is the induction coil. Also not shown, the expandable body 310a may have a material, such as ePTFE, PTFE, PET cloth, polyurethane and / or similar materials, placed inside and / or outside the expandable body 310a, coated with an anti-thrombotic or other functional coating or uncoated, as described above.

[0180] 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 non-actuated (e.g., static) state of the implant 300a, the implant 300a can be oriented so that its distal end 312a receives blood flow from the blood vessel in which the implant 300a is implanted and its proximal end 311a discharges blood flow, or it can be implanted in the opposite orientation. For example, if it is desired that the implant 300a does not block flow in its non-actuated state, the implant can be oriented so that its proximal end 311a receives flow and its distal end 312a discharges flow. In this orientation, when actuated by the energy source 30, the induction coil of the implant 300a can generate an electric current that travels through the connected wire 370a and causes the wire 370a to undergo a shape and / or stiffness change, which can cause the material 380a to move and move closer together so that the lumen 313a is blocked (e.g., Fig. 23B As another example, if it is desired that the implant 300a block flow in its non-actuated state, the implant can be oriented so that its distal end 312a receives flow and its proximal end 311a discharges flow. In this orientation, blood flow can cause the flow restrictor 350a to block the lumen 313a until the energy source 30 actuates the flow restrictor 350a, after which the flow restrictor 150a can open to unblock flow.

[0181] In some embodiments, the level of blockage provided by the thermally actuated implant 300a can be based on a given power level of the energy source 30 and can be adjusted by the design of the implant 300a, such as by the thickness and / or shape of the wire 370a connected to the material 380a, and / or by the shape and / or properties of the material 380a. Figures 24A to 26B Various embodiments of material 380a having attached / embedded threads 370a are shown. Figures 24A to 24B A tricuspid valve-shaped flow restrictor 350a is shown, which includes three sections of material 380a that can be brought together as shown to block the lumen 313a. Figures 25A to 25B A mitral valve-shaped restrictor 350a is shown, which includes two sections of material 380a that can be brought together as shown to block the lumen 313a. FIG. 26A to FIG. 26B A unicuspid flow restrictor 350a is shown that includes a length of material 380a that can block lumen 313a as shown.

[0182] FIG. 27A to FIG. 27D Another embodiment of a thermally activated implant 300b is shown. Fig.27A and Fig.27B 3 and 4 show a side view and an end view of the implant 300b in a non-actuated (eg, open) state, respectively. Fig.27C and Fig.27D The side view and the end view of the implant 300b in actuation (for example, closure) state are shown respectively.Implant 300b can be identical or similar to any feature in the feature described in implant 300a and / or be incorporated into any feature in these feature.For example, implant 300b can have an induction coil, expandable main body 310a and current limiter 350a identical or similar to the induction coil, expandable main body 310b and current limiter 350b of implant 300a.But current limiter 350b can have different configurations.As shown in the figure, the current limiter 350b of implant 300b can have a funnel-shaped shape, wherein material 380b forms a funnel, and silk thread 370b slides and embeds in the end of this funnel-shaped shape formed by material 380b. Upon actuation, the wire 370b may coil upon itself or otherwise change shape to effectively close the end of the funnel-shaped flow restrictor 350b similar to a purse-string suture, thereby blocking flow within the lumen 313b.

[0183] FIG. 28A to FIG. 28D Another embodiment of a thermally activated implant 300c is shown. Fig.28A and Fig.28B 300c are shown in a side view and an end view, respectively, of an implant 300c in a non-actuated (eg, open) state, and Fig.28C and Fig.28DThe side view and the end view of the implant 300c in actuation (for example, closure) state are shown respectively.Implant 300c can be identical or similar to any feature in the feature described in implant 300a and 300b and / or be incorporated into any feature in these feature.For example, implant 300c can have an induction coil, expandable main body 310c and a current limiter 350c identical or similar to the induction coil, expandable main body 310a / 310b and the current limiter 350a / 350b of implant 300a and 300b.However, current limiter 350c can have different configurations.As shown in the figure, the current limiter 350c of implant 300c can have a funnel-shaped shape, wherein material 380c forms a funnel, and silk thread 370c is slidably embedded in the end of this funnel-shaped shape formed by material 380c. When actuated, the wire 380c may coil upon itself or otherwise change shape to effectively close the ends of the funnel-shaped flow restrictor 350c by sliding the longitudinal ends of the material along itself, thereby blocking flow from the lumen 313c.

[0184] FIG. 29A to FIG. 29D Another embodiment of a thermally activated implant 300d is shown. Fig.29A and Fig.29B 300d are shown in a side view and an end view, respectively, of an implant 300d in a non-actuated (eg, open) state, and Fig.29C and Fig.29D The side view and the end view of the implant 300d in actuation (for example, closure) state are shown respectively.Implant 300d can be identical or similar to any feature in the feature described in implant 300a and / or be incorporated into any feature in these feature.For example, implant 300d can have an induction coil, expandable main body 310a and current limiter 350a identical or similar to the induction coil, expandable main body 310d and current limiter 350d of implant 300a.However, current limiter 350d can have different configurations.As shown in the figure, the current limiter 350d of implant 300d can include the inner chamber 313d connected to implant 300d by silk thread 370d and supported in the saccule 380d therein.As shown in the figure, silk thread 370d can be connected to the distal end 312d of the expandable main body 310d of implant 300d. When actuated, the wire 370d can transfer heat to the balloon 380d (eg, the wire 370d can extend within the balloon 380d), thereby causing the balloon 380d to expand and thereby occlude flow within the lumen 313d.

[0185] FIG. 30A to FIG. 30B Another embodiment of a thermally activated implant 300e is shown. Fig. 30A A side view of the implant 300e is shown in a non-actuated (eg, open) state, and Fig. 30BA side view of implant 300e in an actuated (e.g., closed) state is shown. Implant 300e may be identical or similar to any of the features described with respect to implant 300d and / or incorporate any of these features. However, the wire 370e of flow restrictor 350e may be connected to the proximal end 311d of the expandable body 310e of implant 300e.

[0186] FIG. 31A to FIG. 31B Another embodiment of a thermally activated implant 300f is shown. Fig.31A A side view of the implant 300f is shown in a non-actuated (eg, open) state, and Fig.31B A side view of an implant 300f in an actuated (e.g., closed) state is shown. The implant 300f can be identical or similar to any of the features described in the features of implants 300d and 300e and / or incorporated into any of these features. However, the flow restrictor 350f can include multiple wires 370f connected to the proximal end 311f and distal end 312f of the expandable body 310f of the implant 300f.

[0187] FIG. 32A to FIG. 32D Another embodiment of a thermally activated implant 300g is shown. Fig.32A and Fig.32B 300g are shown in a side view and an end view, respectively, of an implant in a non-actuated (eg, open) state, and Fig.32C and Fig.32D The side view and the end view of the implant 300g in actuation (for example, closure) state are shown respectively.Implant 300g can be identical or similar to any feature in the feature described in implant 300a and / or be incorporated into any feature in these feature.For example, implant 300g can have an induction coil, expandable main body 310a and current limiter 350a identical or similar to the induction coil, expandable main body 310g and current limiter 350g of implant 300a.However, current limiter 350g can have different configurations.As shown in the figure, the current limiter 350g of implant 300g can include silk thread 370g, and material 380g spans between these silk threads.When actuating, silk thread 370g can change shape, thereby making their free ends gather together and effectively block the flow of inner chamber 313g via the material 380g that spans silk thread 370g.

[0188] FIG. 33A to FIG. 33D Another embodiment of a thermally activated implant 300h is shown. Fig.33A and Fig.33B 300h are shown in a side view and an end view, respectively, of an implant in a non-actuated (eg, open) state, and Fig.33C and Fig.33DThe side view and end view of the implant 300h in the actuation (e.g., closure) state are shown respectively.Implant 300h can be identical or similar to any feature in the feature described in implant 300a and / or be incorporated into any feature in these feature.For example, implant 300h can have an induction coil, expandable main body 310a and current limiter 350a identical or similar to the induction coil, expandable main body 310h and current limiter 350h of implant 300a.However, expandable main body 310h and current limiter 350h can have different configurations.As shown in the figure, expandable main body 310h can include outer main body 315h and inner main body 325h.Inner main body 325h can be configured to move slidably in outer main body 315h.In addition, expandable membrane 380h (it can alternatively be a balloon) can connect one end of outer main body 315h to the opposite end of inner main body 325h, and form a substantially closed / sealed space under membrane 380h. In such FIG. 33A to FIG. 33B In the non-actuated state shown, implant 300h can be configured so that interior body 325h can be biased to extend out outer body 315h, so that film 380h is contracted against the inner wall of interior body 325h. When actuated, the closed / sealed space under film 380h can be heated, so that film 380h is expanded and interior body 325h is pulled inwardly into outer body 315h. In some embodiments, interior body 325h can be configured to move in outer body 315h in a screw-like manner. Additionally, in some embodiments, implant 300h can be mechanically actuated, such as by pulling thread, rather than by heating.

[0189] Fig.34 The patient's anatomical structure is shown, including the IVC and its relative positional relationship to the patient's spine. Various veins connected to the IVC, such as the renal veins and various lumbar veins, are also shown. The extravascular space in this area is not open, and is sandwiched between membranes and muscles. Therefore, there is limited free space, or even no free space. In addition, the IVC is more compliant than other surrounding tissues and / or structures.

[0190] FIG. 35A to FIG. 36A A method of occluding a patient's IVC using a fluid-actuated implant 400a is shown. Implant 400a may be the same or similar to and / or incorporate any of the features described with respect to the fluid-actuated implants described herein, but implant 400a may not include an expandable body. Implant 400a may include a flow restrictor 450a comprising a balloon 480a fluidly connected to a tube 470a for expanding / defleasing the balloon (such as via a fluid reservoir as described herein or otherwise). Tube 470a may also be used to advance and / or position balloon 480a within the patient's body. As Fig.35AAs shown, flow restrictor 450a can be advanced through the patient's vasculature to the IVC and into a lumbar vein (or other vein, if desired) connected to the IVC. Fig.35B As shown, upon actuation of the flow restrictor 450a, the balloon 480a can expand and provide at least partial occlusion of the IVC.

[0191] FIG. 36A to FIG. 36B An extravascular method of occluding a patient's IVC using a fluid-actuated implant 400b is shown. Implant 400b may be the same as or similar to any of the features described with respect to implant 400a and / or incorporate any of these features. Fig.36A As shown, implant 400b may include an occluder 490b that is placed in a lumbar vein (or other vein if desired) connected to the IVC. Occluder 490b may be configured to completely block blood flow in the lumbar vein. Fig.36B As shown, the implant 400b may also include a flow restrictor 450b, which includes 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 can be actuated to expand the balloon 480b and rupture the lumbar vein, such as Fig.36B Maintaining this position, the restrictor balloon 480b can seal against the IVC in both its non-actuated and actuated states, preventing blood from escaping from the IVC. Upon actuation of the restrictor 450b, the balloon 480b can expand and provide at least partial occlusion of the IVC by pressing against the outer wall of the IVC and causing the IVC to flex inwardly at this location. In some embodiments and as Fig.36B As shown, an occluder 490b can be coupled to the implant 400b to help anchor the implant 400b and maintain it in a desired position.

[0192] FIG. 37A to FIG. 37C Another extravascular method of occluding a patient's IVC using a fluid-actuated implant 400c is shown. Implant 400c may be the same as or similar to any of the features described with respect to implants 400a and 400b and / or incorporate any of these features. Fig.37A As shown, occluder 490c can be advanced and placed in the lumbar vein (or other vein if desired) connected to the IVC, located on both sides of implant 400b that has also been advanced and placed in the lumbar vein. In this position, flow restrictor 450c can be actuated to expand balloon 480c and rupture the lumbar vein, such as Fig.37B Implant 400c can then be advanced to a desired location outside the IVC, such as Fig.37COnce implant 400c is positioned and upon actuation of flow restrictor 450c, balloon 480c can expand and provide at least partial occlusion of the IVC by pressing against the outer wall of the IVC and causing the IVC to flex inwardly at that location.

[0193] Fig.38 Another extravascular method of occluding a patient's IVC using a fluid-actuated implant 400d is shown. Implant 400d may be the same as or similar to any of the features described with respect to implants 400a, 400b, and 400c and / or incorporate any of these features. Fig.38 As shown, implant 400d has been advanced through the IVC and led out of the IVC. The balloon 480d of the flow restrictor 450d can be sealed against the IVC in both its non-actuated and actuated states to prevent blood from escaping from the IVC. When the flow restrictor 450d is actuated, the balloon 480d can expand and provide at least partial occlusion of the IVC by pressing against the outer wall of the IVC and causing the IVC to bend inwardly at this location. As described above, the IVC is the most compliant structure in the space and therefore is preferentially squeezed compared to the adjacent aorta.

[0194] Fig.39 Another extravascular method of occluding a patient's IVC using a fluid-actuated implant 400e is shown. Fig.38 The extravascular method of occluding the patient's IVC is the same or similar as described above, with the addition of an occluder 490e placed at the wall of the IVC to help seal the penetration through the wall of the IVC. Upon actuation of the restrictor 450e, the balloon 480e can expand and provide at least partial occlusion of the IVC by pressing against the outer wall of the IVC and causing the IVC to flex inwardly at that location.

[0195] Fig.40 Another extravascular method of blocking a patient's IVC is shown. The method may include placing an occluder / disc 490f attached to a wire 470f through the wall of the IVC. When the wire 470f is pulled, the occluder / disc 490f and thus the wall of the IVC can be pulled inward, thereby providing at least a partial blockage of the IVC. Although not shown, a variation of the method may include extending the wire 470f through the wall of the IVC at least twice so that the pulling of the wire can cause compression of the IVC (e.g., similar to a purse-string suture).

[0196] Fig.41A control unit (which may also be referred to herein as a "controller") is shown, which can be used with any implant described herein, such as implants 100, 200, 300, 400, and 500. The control unit can be patient-controlled and / or patient-monitored, for example, wirelessly controlled and monitored by an application on a smart phone as shown. As shown, the control unit can be configured to be implantable in the patient's body, and can include an implant actuation source, a mainboard including a processor, a memory, and a communication module and a power supply in some embodiments. The control unit can include a circuit configured to receive wireless or wired signals from a pressure sensor (e.g., a MEMS sensor) located in various positions in or around the heart or at other positions in the body, for example, to measure the pressure in the right ventricle, right atrial pressure, central venous pressure, aortic pressure, left atrial pressure, left ventricular pressure, aortic pressure, SVC pressure, IVC pressure, hepatic vein pressure, renal vein pressure, femoral vein pressure, and / or the pressure of any one of the veins disclosed herein or parts thereof. Based on these readings, the control unit can appropriately actuate the implant to control the adjustable obstruction of the implant, so as to control the amount of blood flowing through the implant. The control unit can provide closed-loop, fully autonomous and / or real-time regulation and control of the implant. The control unit can implement the treatment regimen / algorithm specified by the physician, and / or the control logic can be optimized to treat heart failure patients, such as by alleviating cardiac preload, alleviating central venous pressure and / or the pressure of other veins disclosed herein, increasing cardiac output, reducing renal congestion (or promoting renal decongestion), enhancing renal circulation, and / or enhancing or controlling diuresis (e.g., increasing diuresis). In some embodiments, the control unit can receive data from a sensor connected to an implant as described herein, so as to control the actuation of the implant.

[0197] Fig.42 Potential locations for implantation and placement of implantable flow limiting system 5 are shown. Implantable flow limiting system 5 can be a mechanically actuated, long-term implantable flow limiting system 5. Although certain embodiments of implantable flow limiting system 5 can be described as long-term systems, components of implantable flow limiting system can be used in acute systems. In addition, certain embodiments of implant 500 of implantable flow system 5 are described as being mechanically actuated. This can include electromechanically actuated implants. Other actuation methods are also possible, such as fluid or gas driven systems.

[0198] The implantable flow-limiting system 5 may include, for example, an implant 500 connected to a controller 50 (which may also be referred to herein as a "control unit") via 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-limiting system 5 includes the implant 500, the controller 50, the tube 570, and the shaft 590. Fig.42 5 shows an implant 500 implanted in the IVC upstream of the connection between the patient's IVC and the renal vein (e.g., below the renal vein). The implant 500 placed in the IVC upstream of the renal vein can controllably and selectively block, limit and / or divert the flow in the patient's IVC and the connected vascular system and / or organs, such as to reduce renal congestion (or promote renal decongestion), enhance renal circulation and / or control diuresis (e.g., increase diuresis). To this end, the implant 500 can have a restrictor portion 550 and / or a restrictor 560. The restrictor portion 550 and / or the restrictor 560 can be actuated by the controller 50 via the shaft 590 and the tube 570, as further described herein.

[0199] Implant 500 can be implanted so that the restrictor portion 550 is upstream of the other portions of implant 500 (e.g., the restrictor portion 550 is the first portion of implant 500 to receive blood flow therethrough). In this positioning, shaft 590 and tube 570 can extend proximally from implant 500 upward to the IVC, through the right atrium, into the superior vena cava (SVC), through the subclavian vein (the left subclavian vein as shown), and out of the subclavian vein to connect with the controller 50 that can be implanted in a subclavian subcutaneous pocket (e.g., similar to the placement of a pacemaker). In some embodiments, implant 500 can be implanted in other positionings, such as those shown and described with respect to implants 100, 200, and 300. In addition, in some embodiments, more than one implant 500 can be implanted in a patient, such as those shown and described with respect to implants 100, 200, and 300. Where multiple implants 500 are implanted in a patient, each implant may be connected to a single controller 50 via a separate tube 570 and shaft 590 , or each implant may be connected to their own controller 50 via a separate tube 570 and shaft 590 .

[0200] Figures 43A to 43D Various views of an embodiment of an implant 500a are shown, which may be an implant 500 that may be implantable in a flow restricting system 5 . Fig.43A and Fig.43C as well as Fig.43B 5 and 6 show a side view and an end view, respectively, of the implant 500a in a non-blocking (eg, open, non-actuated) state, and Fig.43D A side view of implant 500a is shown in a fully occluded (eg, closed, actuated) state. FIG. 43A to FIG. 43DAlso shown is how implant 500a can be connected to tube 570a and shaft 590a for its operation. Implant 500a can include expandable body 510a, which has proximal end 511a, distal end 512a and inner cavity 513a for receiving blood flow therethrough. Implant 500a can be connected to the distal end 572a of tube 570a and can include filtering portion 520a, radial support portion 540a (which may also be referred to as "sealing portion" or "sealing zone" in this article) and restrictor portion 550a.

[0201] like FIG. 43A to FIG. 43D As shown, the filter portion 520a can be positioned adjacent to the proximal end 511a, the radial support portion 540a can be connected to the filter portion 520a and located distally thereof, and the restrictor portion 550a can be connected to the radial support portion 540a and located distally thereof. The filter portion 520a can be configured to capture thrombi that can pass through the lumen 513a of the implant 500a and can include a plurality of struts 527a extending distally and radially outwardly from the connection between the tube 570a and the implant 500a.

[0202] The radial support portion 540a can be configured to fit the inner wall of the IVC to form a fluid seal, and can include a ring 545a extending along the circumference of the implant 500a with a V-shaped pattern. As shown, the ring 545a can include a plurality of ring pillars 542a, wherein the ring pillars 542a of adjacent pairs are connected at a plurality of proximal vertices 543a and a plurality of distal vertices 544a. Further as shown, each proximal vertex in a plurality of proximal vertices 543a of the ring 545a of the radial support portion 540a can be connected to the pillar 527a of the filtering portion 520a.

[0203] The flow restrictor portion 550a may include a plurality of flaps 560a, which are configured to limit / block the flow of the inner chamber 513a of the implant 500a when actuated. As shown, each flap 560a may be formed by a pair of pillars 562a, which extend distally from the adjacent pair of distal apex 544a of the ring 545a of the radial support portion 540a and are connected at the distal apex 564a. Each flap in the plurality of flaps 560a may also include a pillar 566a extending proximally from their respective distal apex 564a, which may contribute to the ability of the flap to limit flow when in use. As further shown, the flow restrictor 550a may include a material 530a for each flap across the plurality of flaps 560. The material 530a may include ePTFE, PTFE, PET cloth, polyurethane and / or similar materials as described herein. The region between the plurality of flaps 560 may not have the material 530a. In some embodiments, material 530a can span the area between multiple flaps 560. Material 530a can also span radial support portion 540a to help implant 500a fit the inner wall of IVC (or the inner wall of any other inner chamber / blood vessel it is placed) to form a fluid seal and limit / block the ability of blood flow when in use. In some embodiments and as shown in the figure, implant 500a can include multiple anchors 525a, which are configured to anchor implant 500a in IVC (or any other inner chamber / blood vessel it is placed). These anchors 525a can extend in a generally proximal direction from each proximal vertex in a plurality of proximal vertices 543a of ring 545a.

[0204] Continue to refer FIG. 43A to FIG. 43D, each flap 560a can be connected to the shaft 590a by a connector. Various connectors are described herein, such as sutures, silk threads, pillars or other. For example, each distal vertex in the distal vertex 564a of the flap 560a can be connected to the suture or silk thread 595a at one end of the suture or silk thread 595a, and the other end of the suture or silk thread 595a can be connected to the distal end 592a of the shaft 590a that extends through the inner chamber 513a of the implant 500a roughly in the middle. As shown further, in the unactuated / open state of the implant 500a, the distal end 592a of the shaft 590a can be substantially longitudinally aligned with the distal vertex 564a of the flap 560a. Utilizing this relative positioning, suture or silk thread 595a can extend from the distal end 592a of the shaft 590a in a substantially radially outward direction to be connected to the distal vertex 564a of the flap 560a. As shown in the figure, shaft 590a can slidably move through the inner chamber of pipe 570a and extend from its distal end 572a, and retractable and extensible coupling 580a can form fluid seal with the inner chamber of pipe 570a and shaft 590a.The proximal end 571a (not shown) of pipe 570a can be connected with controller 50a, and shaft 590a can extend from this proximal end 571a and be effectively connected with the actuator of controller 50a.In order to operate the restrictor part 550a of implant 500a and at least partially block / restrict the flow through it, the actuator of controller 50a can be actuated so that shaft 590a moves proximally relative to pipe 570a and implant 500a, so that the distal apex 564a of multiple flaps 560a is connected via the distal apex 564a with suture or silk thread 595a and the distal end 592a of shaft 590a and moves radially inwardly toward each other. In other words, proximal movement of shaft 590a can cause petals 560a to come together and at least partially restrict flow through lumen 513a of implant 500a, such as Fig.43D As shown. For example, the flap 560a can be folded radially inward (e.g., hinged relative to the expandable body), wherein the distal vertex 564a of the flap 560a forms the distal-most tip of the implant 500a. In use, blood flows to the outer surface of the flap 560a and is blocked by it. In some embodiments, the restrictor portion 550a (e.g., the flap 560a) can be configured to attach or fix to the wall of the blood vessel in which the implant 500a is implanted, and when actuated can pull the wall of the blood vessel inward to at least partially limit the flow through the blood vessel and / or the inner cavity 513a. To this end, and as described herein, the restrictor portion 550a (e.g., the flap 560a) can include one or more anchors and / or be configured to grow at least partially inward into the wall of the blood vessel.

[0205] Tube 570a can include an integral or composite structure. For example, tube 570a can include a tube portion, a braided portion and / or a liner. Tube 570a can include, for example, PEBAX. The liner (if included) can include PTFE, HDPE or a silicone blend and can facilitate the sliding movement of shaft 590a within tube 570a (for example, the liner can reduce friction within tube 570a and the force required to slide shaft 590a within tube 570a). Connections between components of system 5, such as tube 570a, implant 500a, retractable and extendable connector 580a and shaft 590a, can be achieved via reflow soldering (for example, using PEBAX), heat shrinking, etc.

[0206] refer to Fig.43B The end view of the implant 500a shown, the implant 500a can be configured to make suture or silk thread 595a and the pillar 527a of filtering part 520a basically align. If necessary, this basic alignment can advantageously allow other interventional devices to pass implant 500a. For example, this basic alignment can allow the interventional device of 28French to pass implant 500a.

[0207] and FIG. 43A to FIG. 43D While the implant 500a is shown having six petals 560a, six sutures or wires 595a connecting each of the six petals 560a to the shaft 590a, and a filtering portion 520a having six struts 527a, the implant 500a can be configured to have less than or greater than these respective numbers.

[0208] FIG. 44A to FIG. 44C Shows FIG. 43A to FIG. 43D End view of implant 500a in various states of actuation and restriction / blockage of flow therethrough. Fig.44A The implant 500a is shown in its unactuated, non-restrictive / non-blocking state. Fig.44B The implant 500a is shown in a partially actuated, partially restricted / blocked state, and Fig.44C The implant 500a is shown in a fully actuated, fully restricted / blocked state. FIG. 44A to FIG. 44C As shown, the lumen 513a of the implant 500a (eg, the lumen or opening of the restrictor portion 550a) can be substantially circular in shape when not actuated ( Fig.44A ) changes to a generally star / star-shaped 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 restrictor portion 550a) can have a generally circular shape when unactuated, a generally circular shape when partially actuated, and a substantially blocked lumen when fully actuated. When folded radially inward, the outer surface of each of the plurality of petals 560a can block blood flow via the material 530a. In some embodiments, such as Fig.44D As shown, implant 500a can be configured such that even when restrictor portion 550a is fully actuated, lumen 513a thereof can remain at least partially open, such as by forming elongated gaps 514a between each or at least some of the petals 560a.

[0209] Fig.45 Shows FIG. 43A to FIG. 43D 00a, with the various aspects discussed previously identified.

[0210] FIG. 46A to FIG. 46B Various views of components of an implantable flow limiting system 5a are shown, which can be as described above with respect to Fig.42 Implanted as shown. Fig.46A Implant 500a is shown connected to shaft 590a and tube 570a. Implant 500a, shaft 590a, and tube 570a may be referred to herein as implant assembly 501a. Fig.46B An implant 500a is shown connected to a shaft 590a and a tube 570a, which in turn are connected to a controller 50a. In other words, Fig.46B Implant component 501a is shown connected to controller 50a.

[0211] FIG. 47A to FIG. 47D Shows the actuation FIG. 43A to FIG. 43D 501a of the implant 500a, wherein material 530a of the implant 500a is removed for clarity. FIG. 43A to FIG. 43DAs described, each distal vertex in the distal vertex 564a of the flap 560a can be connected to the suture or thread 595a at one end of the suture or thread 595a, and the other end of the suture or thread 595a can be connected to the distal end 592a of the shaft 590a. As an example, as shown in the figure, the suture or thread 595a can be connected to the distal vertex 564a via the eyelet at the distal vertex 564a. Further for this example, as shown in the figure, the suture or thread 595a can be connected to the distal end 592a of the shaft 590a via crimping, although other forms of connection are possible and are considered to be within the scope of the present disclosure (e.g., via a fixing screw, a press-fit component, an adhesive and / or a threaded end). In some embodiments, the suture or thread 595a can extend from the distal end 592a of the shaft 590a, pass through the eyelet at the distal vertex 564a of the flap 560a, and fold back and connect to the distal end 592a of the shaft 590a. In some embodiments, the suture or thread 595a can be integrally formed or part of the shaft 590a. For example, the shaft 590a has a FIG. 64A to FIG. 64B In the described embodiments of the braided structure comprising a plurality of individual threads 593 , the suture or thread 595a may be one or more of the individual threads 593 .

[0212] Continue to refer FIG. 47A to FIG. 47D , when material 530a is removed from view, it can be seen that the shrinkable and extensible coupling 580a configured to form a fluid-tight seal between pipe 580a and shaft 590a.In some embodiments and as shown in the figure, shrinkable and extensible coupling 580a can extend around shaft 590a so that any part of shaft 590a is not exposed except that shaft 590a is connected to the position of suture or silk thread 595a.Alternatively, in some embodiments, shrinkable and extensible coupling 580a can extend around shaft 590a so that any part of shaft 590a is not exposed, which can include covering the position where shaft 590a is connected to suture or silk thread 595a.As shown in the figure, shrinkable and extensible coupling 580a can be connected to the distal end 572a of pipe 570a at its proximal end, and it can be connected to the shaft 590a adjacent to its distal end 592a at its distal end, which can allow shaft 590a to slide and / or rotate and move therein.

[0213] In some embodiments and as FIG. 47A to FIG. 47B As shown, the implant 500a (e.g., the 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. The longitudinal movement can include the shaft 590a sliding within the tube 570a. Fig.47AIn the non-actuated, non-restricted / non-blocking state shown, the shaft 590a is in its most distal position relative to the implant 500a, and the retractable and extendable coupling 580a is in its extended state. In its extended state, the retractable and extendable coupling 580a can have a generally straight configuration as shown. Fig.47B As shown, when the shaft 590a moves proximally within the tube 570a (e.g., when the shaft 590a moves proximally relative to the tube 570a and the implant 500a), the shaft 590a pulls the petals 560a radially inward toward each other via the sutures or threads 595a to block / restrict flow through the implant 500a. This proximal movement of the shaft 590a also causes the retractable and extendable coupling 580a to retract into its retracted state. In addition, and as shown Fig.47B As shown, when shaft 590a is in its most proximal position relative to implant 500a, suture or thread 595a can be oriented substantially longitudinally.

[0214] In some embodiments and as FIG. 47C to FIG. 47D As shown, implant 500a (for example, flow restrictor part 550a) can be actuated by rotating shaft 590a relative to implant 500a (for example, clockwise or counterclockwise). This rotation of shaft 590a can make suture or silk thread 595a coil around shaft 590a or twist and at least partially close flow restrictor part 550a. In other words, this rotation of shaft 590a can make suture or silk thread 595a coil around shaft 590a or twist and make flap 560a at least partially radially inward fold. For this reason, implantable controller 50a can be configured to rotate shaft 590a. In addition, in these embodiments, pipe 570a can be configured to be used for the rotational movement of shaft 590a therein. In addition, in these embodiments, retractable and extendable coupling 580a can be configured to be used for this rotational movement. FIG. 47C to FIG. 47D Each shows a petal portion 560a of an implant 500a being at least partially pulled radially inwardly as a result of rotation of the shaft 590a, Fig.47D Shows that the ratio Fig.47C Axis 590a is shown in a more rotated state.

[0215] Return to reference Fig.42, implant 500a can be located in the IVC below the renal veins so that the distal apex 564a of the valve portion 560a faces the direction of incoming blood flow. In other words, implant 500a can be implanted so that the restrictor portion 550a is upstream of the other portions of implant 500a (e.g., restrictor portion 550a is the first portion of implant 500a to receive blood flow therethrough). In this positioning, shaft 590a and tube 570a can extend proximally upward from implant 500a to the IVC, through the right atrium, into the superior vena cava (SVC), through the subclavian vein (the left subclavian vein as shown), and out of the subclavian vein to connect with controller 50a, which can be implanted in a subclavian subcutaneous bag (e.g., similar to the placement of a pacemaker). In addition, this positioning of the restrictor portion 550a including the flap 560a can provide a functional benefit, namely, when the implant 500a is actuated / closed toward the wall of the IVC, any thrombus that may form or otherwise accumulate at the outer surface of the flap 560a is pushed when the flap 560a is open, rather than allowing the thrombus to pass through the implant 500a when the flap 560a is open (such as, if the flap 560a is not facing the direction of blood flow, this may occur.) In this way, any thrombus is directed toward the sealing area around the implant 500a with the wall of the IVC, rather than passing through the implant 500a and toward the heart.

[0216] In some embodiments, any flow limiting device described herein (e.g., including at least implant 500a) can work with and / or be used in combination with sensors located away from the flow limiting device, which can provide physiological parameters of interest that can be used to control the flow limiting device. These physiological parameters of interest can include pressure, flow rate, heart rate, and / or other parameters. As an example, the flow limiting device can be used with a pressure sensor located in a blood vessel and / or organ away from the flow limiting device, and provide a measurement of the pressure at these locations to control the flow limiting device. An example of an implantable sensor is a MEMS pressure sensor. MEMS or other implantable pressure sensors can be remote components of the flow limiting device, or can be independent sensors with a separate control system. In one example, a MEMS pressure sensor can be located in a pulmonary artery and can measure the pressure of blood flowing through the pulmonary artery. MEMS or other pressure sensors can include a separate electronic system configured to receive readings (e.g., data indicating pressure) from a MEMS pressure sensor. These readings can be used by the patient, the patient's doctor, etc. to determine when the patient should be treated by the flow limiting device. In one example, the MEMS pressure sensor can include a capacitive sensor. In another example, the MEMS pressure sensor may include a barometer and may be powered by an external antenna (e.g., in the form of a radio frequency signal). For example, the external antenna may be contained within an antenna device, and when the patient holds the antenna device against his or her body, a pressure reading may be taken and transmitted to an electronic system. Additionally or alternatively, the MEMS pressure sensor may include an inductor that may be used to create a circuit that generates a frequency, such as an LC circuit or an LC resonant circuit. The frequency may then be used to determine the pressure.

[0217] In some embodiments, the above-mentioned MEMS pressure sensor can be connected to a part of the current limiting device described herein. As an example, the current limiting device can have a MEMS pressure sensor attached to its proximal end, its distal end, its two ends, its axis and / or similar positions. In the example of implant 500a, the MEMS pressure sensor can be connected to the axis 590a. The MEMS pressure sensor can be connected to / connected to the current limiting device using sutures, reflow soldering and / or similar methods. In this example, the MEMS pressure sensor will be configured to measure the pressure at this position (e.g., upstream, downstream, upstream and downstream, etc.) relative to the current limiting device. As described above, the MEMS pressure sensor can transmit the pressure reading to a separate electronic system. Additionally or alternatively, the MEMS pressure sensor can transmit the reading to the control system (e.g., controller 50a) of the current limiting device.

[0218] FIG. 48A to FIG. 48CAn implant 500a is shown having sensors 600 located at different positions relative to a restrictor portion 550a. The sensors 600 can be configured to measure pressure within the vasculature at their location, and thus the placement of the sensors 600 relative to the restrictor portion 550a can determine which vessel pressure is being measured depending on the activation state of the restrictor portion 550a. The sensors 600 can be positioned as follows if they are to be actuated: Fig.48A As shown, the proximal end of the implant 500a is located near the proximal end (e.g., such as a tube 570a attached to the proximal side of the implant 500a) and proximal to the restrictor portion 550a, which is to be actuated as shown in FIG. Fig.48B As shown, the restrictor portion 550a is located near the distal end of the shaft 590a and proximal to the restrictor portion 550a, and / or in the event that it is to be actuated. Fig.48C 590a and distal to the restrictor portion 550a. When the restrictor portion 550a of the implant 500a is not actuated (eg, the implant is in a non-restrictive / non-blocking state), as shown FIG. 48A to FIG. 48C The sensors 600 positioned in any of the positions shown in FIG. 5 will measure substantially the same pressure. For example, when the restrictor portion 550a of the implant 500a is not actuated, as shown in FIG. FIG. 48A to FIG. 48C The sensor 600 positioned in either of the positions shown will measure substantially the same IVC pressure. However, when the restrictor portion 550a of the implant 500a is actuated, as shown in FIG. FIG. 48A to FIG. 48B The sensor 600 positioned as shown will measure renal vein pressure (e.g., because it can be located near the renal vein), while Fig.48C The sensor 600 positioned as shown will measure the femoral vein pressure. The implant 500a may be included in FIG. 48A to FIG. 48B In some embodiments, the implant 500a may include more than one sensor 600, one of which may be located in one of the locations shown. FIG. 48A to FIG. 48B The position shown is used to measure renal vein pressure, while one case is located as shown Fig.48C The position shown in the figure is to measure the femoral vein pressure. One or more sensors 600 of implant 500a can be effectively connected with controller 50a, for example, via one or more silk threads, which extend between one or more sensors 600 and controller 50a by pipe 570a. In some embodiments, shaft 590a or a part thereof can effectively connect one or more sensors 600 with controller 50a. The pressure determined from the signal generated by sensor 600 and / or its difference (for example, the difference between multiple sensors, and / or the difference between the pressure determined by time) can be used to control implant 500a.

[0219] Fig.49 Another embodiment of an implant 500b that can be used in conjunction with an implantable flow limiting system 5 is shown. Implant 500b can be the same or similar to any of the features described with respect to implant 500a and / or incorporate any of these features. For example, implant 500b can have an expandable body 510b having a filter portion 520a, a radial support portion 540a, and a flow restrictor portion 550b that are the same or similar to the expandable body 510a of implant 500a having a filter portion 520a, a radial support portion 540a, and a flow restrictor portion 550a. Fig.49 The side view of the expandable main body 510a of implant 500b is shown, wherein there is no material to cover the restrictor portion 550b.Different from implant 500a, the expandable main body 510b of implant 500b can include a pillar 546 extending distally and / or a pillar 547 extending proximally.The pillar 546 extending distally can extend distally in a roughly longitudinal direction from the proximal apex 543b of radial support portion 540b as shown in the figure.In addition, the pillar 546 extending distally can be configured to strengthen the sealing of the wall (for example, the wall of IVC) of the blood vessel that implant 500b is implanted with implant 500b.The pillar 547 extending proximally can extend proximally in a roughly longitudinal direction from the distal apex 544b of radial support portion 540b as shown in the figure. In addition, the proximally extending struts 547 can be configured to enhance the seal of the implant 500b with the wall of the blood vessel in which the implant 500b is implanted (e.g., the wall of the IVC). In some embodiments, the implant 500b only includes the distally extending struts 546. The implant 500a can include distally extending struts and / or proximally extending struts similar or identical to the distally extending struts 546 and the proximally extending struts 547.

[0220] Fig.50 Another embodiment of an implant 500c that can be used in combination with an implantable flow limiting system 5 is shown. Implant 500c can be the same or similar to any of the features described in other implants described herein (such as implants 500a and 500b) and / or incorporated into any of these features. For example, implant 500c can have an expandable body 510c that has a filter portion 520a, a radial support portion 540a, and a flow restrictor portion 550a that is the same or similar to the expandable body 510a of implant 500a. 520c, radial support portion 540c, and flow restrictor portion 550c. Fig.49Show the side view of the expandable main body 510c of implant 500c, this expandable main body utilizes contractible and extensible coupling piece 580c to be connected to axle 590c and pipe 570c, this axle, pipe and contractible and extensible coupling piece can be identical or similar with about the described axle 590a of implant 500a, pipe 570a and contractible and extensible coupling piece 580a.Different from implant 500a, restrictor part 550c can be connected to filter part 520c and radial support section 540c as shown in the figure and be positioned between them.In this arrangement, the blood of the implant 500c that flows through implantation will first flow through radial support section 540c, rather than the restrictor part as in the implant 500a. Actuation of the restrictor portion 550c including the flap 560c can be the same or similar to the actuation described with respect to the restrictor portion 550a of the implant 500a (e.g., via a suture or thread 595c connected between the shaft 570c and the distal apex 564a of the flap 560a). In addition, the implant 500c can be similarly positioned within the IVC beneath the renal vein such that the distal apex 564c of the flap 560c faces the direction of incoming blood flow.

[0221] FIG. 51A to FIG. 51B Another embodiment of an implant 500d that can be used in combination with an implantable flow limiting system 5 is shown. Implant 500d can be identical or similar to any of the features described in other implants described herein (such as implants 500a, 500b, and 500c) and / or incorporated into any of these features. For example, implant 500d can have an expandable body 510d having a filter portion 520c, a radial support portion 540c, and a flow restrictor portion 550d identical or similar to the expandable body 510c of implant 500c having a filter portion 520c, a radial support portion 540d, and a flow restrictor portion 550d. FIG. 51A to FIG. 51BThe side view of the expandable main body 510d of implant 500d is shown, this expandable main body is connected to axle 590d and pipe 570d, and can be incorporated into expandable and extensible coupling piece (not shown), this axle, pipe and contractible and extensible coupling piece can be identical or similar with axle 590a, pipe 570a and contractible and extensible coupling piece 580a described about implant 500a.The material of spanning flap 560d of restrictor part 550d has been removed, to illustrate the characteristic part of implant 500d.Similar to implant 500c, restrictor part 550d can be connected to filter part 520d and radial support part 540d as shown in the figure and be positioned between them.In this arrangement, the blood of the implant 500d that flows through implantation will first flow through radial support part 540d before encountering restrictor part 550d (similar to implant 500c). Different from implants 500a and 500c, implant 500d includes a pillar 595d that connects the vertex 564d of flap 560d to shaft 590d instead of sutures or silk threads 595a and 595c. These pillars 595d can be formed integrally with expandable body 510d. Utilizing pillar 595d, the actuation of the restrictor portion 550d including flap 560d can be similar to the actuation described in the restrictor portion 550a about implant 500a. As shown in the figure, restrictor portion 550d can be oriented in the direction opposite to restrictor portion 550a, 550b and 550c, so that when in use, vertex 564d is towards the direction of blood flow away from entering. Utilizing this orientation, the actuation of restrictor portion 550d can occur via the distal movement (e.g., pushing) of shaft 590d instead of the proximal movement (e.g., pulling) of shaft 590d. However, in some embodiments, the restrictor portion may be oriented in the same manner as restrictor portions 550a, 550b, and 550c, such that, in use, apex 564d faces in the direction of incoming blood flow. Fig.51A The implant 500d is shown unactuated (eg, the restrictor portion 550d is in a non-restrictive / non-blocking state), and Fig.51B The implant 500d is shown partially actuated (eg, the restrictor portion 550d is in a partially restricting / blocking state).

[0222] Fig.52Another embodiment of an implant 500e that can be used in combination with an implantable flow limiting system 5 is shown. Implant 500e can be identical or similar to any of the features described in other implants described herein (such as implants 500a, 500b, 500c, and 500d) and / or incorporated into any of these features. Unlike other implants described herein, implant 500e can have an expandable body 510e having filter portions 520e and 520e' at its proximal and distal ends, wherein a combined radial support portion 540e and a flow restrictor portion 550e are connected to the expandable body and between these filter portions 520e, 520e'. Fig.52 The side view of the expandable main body 510e of implant 500e is shown, and this expandable main body is connected to shaft 590e and pipe 570e, and can be incorporated into expandable and extensible coupling piece (not shown), and this shaft, pipe and contractible and extensible coupling piece can be identical or similar with shaft 590a, pipe 570a and contractible and extensible coupling piece 580a described about implant 500a.The material of spanning flap 560e of flow restrictor part 550e has been removed, to illustrate the characteristic part of implant 500e.Flow restrictor part 550e can comprise flap 560e as shown in the figure, and these flaps can be oriented so that the proximal movement of shaft 590e makes flap 560e contract radially inwardly to block / restrict the flow by implant 500e (for example, can be via the suture or silk thread 595e connected between the end of these flaps and the distal end of shaft 590e to pull flap 560e inwardly to close, as described in the relevant embodiment herein). Arranged in this way, blood flowing through the implanted implant 500e will first flow through the filter portion 520e', then flow through the combined radial support portion 540e and the restrictor portion 550e, and then flow through the filter portion 520e. In addition, the implant 500e can be similarly located in the IVC below the renal vein so that the end of the valve portion 560e faces the direction of the incoming blood flow. As also shown in the figure, the implant 500e can include an anchor 525e extending generally proximally and an anchor 525e' extending generally distally, and the combined radial support portion 540e and the restrictor portion 550e meet the filter portion 520e and 520e' at these locations.

[0223] Fig.53Another embodiment of an implant 500f that can be used in combination with an implantable flow limiting system 5 is shown. Implant 500f can be identical or similar to any of the features described in other implants described herein (such as implants 500a, 500b, 500c, 500d and 500e) and / or be incorporated into any of these features. Similar to implant 500e, implant 500f can have an expandable body 510f, which has filtering portions 520f and 520f' at its proximal end and distal end, wherein a combined radial support portion 540f and a flow restrictor portion 550f are connected to the expandable body and between these filtering portions 520f, 520f'. Fig.53 A side view of an expandable body 510f of implant 500f is shown, which is connected to a shaft 590f and a tube 570f and may incorporate an expandable and extendable coupling (not shown), which shaft, tube, and retractable and extendable coupling may be the same or similar to the shaft 590a, tube 570a, and retractable and extendable coupling 580a described with respect to implant 500a. In addition, Fig.53 The implant 500f in an unactuated state (e.g., non-restricted / non-blocked state) is shown.Material 530f is shown as a flap 560f across a restrictor portion 550f, which can be identical or similar to the material 530a of implant 500a.As shown, restrictor portion 550f can be oriented in a direction opposite to restrictor portion 550a, 550b, 550c and 550e, so that when in use, the vertex 564f of flap 560f is toward the direction of the blood flow away from entering.Utilizing this orientation, the actuation of restrictor portion 550f can occur via the distal movement (e.g., pushing) of shaft 590f rather than the proximal movement (e.g., pulling) of shaft 590f.However, in some embodiments, restrictor portion can be oriented identically with restrictor portion 550a, 550b, 550c and 550e, so that when in use, vertex 564f is toward the direction of the blood flow entering. As also shown, implant 500f can include a generally proximally extending anchor 525f and a generally distally extending anchor 525f' where a combined radial support portion 540f and restrictor portion 550f meet filtering portions 520f and 520f'.

[0224] Fig.54Another embodiment of the implant 500g that can be used in combination with the implantable flow limiting system 5 is shown. Implant 500g can be identical or similar to any feature in the feature described in other implants described herein (such as implant 500a, 500b, 500c, 500d, 500e and 500f) and / or be incorporated into any feature in these feature. Similar to implant 500f, implant 500g can have an expandable body 510g, which has filtering portions 520g and 520g' at its proximal end and distal end, wherein radial support portion 540g is connected to the expandable body and between these filtering portions 520g, 520g'. Different from implants 500a-500f, implant 500g can include a flow restrictor 560g that is not formed integrally with expandable body 510g. The flow restrictor 560g of implant 500g can be arranged in the lumen 513g of implant 500G (for example, substantially centered in lumen 513g) and is configured to be attached to the distal end or distal portion of pipe 570g. As shown, flow restrictor 560g can include a balloon, which can expand from a contracted state to at least partially block the flow through lumen 513g. The actuation (for example, expansion) of balloon flow restrictor 560g can occur via the distal movement of shaft 590g relative to implant 500g, wherein shaft 590g enters balloon flow restrictor 560g and expands it (for example, shaft can present a three-dimensional shape to at least partially fill balloon flow restrictor 560g, thereby expanding it). When shaft 590g is retracted (for example, shaft 590g moves relative to the proximal side of implant 500g), balloon flow restrictor 560g can shrink.

[0225] In some embodiments, implant 500g can be used in combination with other implantable flow limiting systems described herein, such as implantable flow limiting system 2. In these embodiments, implant 500g can be similar to and / or incorporated into any of the features described with respect to implant 200m. For example, implant 500g can be fluidically actuated (e.g., balloon flow restrictor 560g can be fluidically actuated) to at least partially restrict flow through lumen 513g.

[0226] FIG. 55A to FIG. 55CAnother embodiment of an implant 500h that can be used in combination with an implantable flow limiting system 5 is shown. Implant 500h can be identical or similar to any of the features described in other implants described herein (such as implants 500a, 500b, 500c, 500d, 500e, and 500f) and / or incorporated into any of these features. Similar to implant 500e, implant 500h can have an expandable body 510h having filter portions 520h and 520h' at its proximal and distal ends, wherein a combined radial support portion 540h and a flow restrictor portion 550h are connected to the expandable body and between these filter portions 520h, 520h'. FIG. 55A to FIG. 55C A side view of an expandable body 510h of implant 500h is shown, which is connected to an axis 590h and a tube 570h and may incorporate an expandable and extendable connector 580h, which axis, tube, and contractible and extendable connector may be the same or similar to the axis 590a, tube 570a, and contractible and extendable connector 580a described with respect to implant 500a. Fig.55A The implant 500h is shown in an unactuated state (eg, a non-restrictive / non-blocking state). Fig.55B The implant 500h is shown in a partially actuated state (eg, a partially restricted / blocked state), and Fig.55C Implant 500h is shown in a fully actuated state (e.g., a restricted / blocked state). Material across the petal portion 560h of the restrictor portion 550h has been removed to illustrate features of the implant 500h and the interaction between these features during actuation. In addition, and similar to implants 500a, 500b, 500c, and 500e, the apex 564h of the petal portion 560h can point in a distal direction (e.g., when in an unactuated state). Similar to the actuation of the restrictor portion 550a of implant 500a, FIG. 55A to FIG. 55C It is shown that the proximal movement of the shaft 590h relative to the tube 570h and the implant 500h can actuate the restrictor portion 550h to block / restrict flow through the implant 500h. Specifically, the proximal movement of the shaft 590h can pull the apex 564h of the petal 560h of the restrictor portion 550h radially inward via the suture or wire 595h connected therebetween. FIG. 55A to FIG. 55C Also shown is how the retractable and extensible coupling 580h extends and retracts during actuation of the implant 500h (eg, the same or similar as described with respect to the retractable and extensible coupling 580a of the implant 500a).

[0227] FIG. 56A to FIG. 56B Another embodiment of an implant 500i that may be used in conjunction with the implantable flow limiting system 5 is shown. Fig.56AThe implant 500i is shown in an unactuated state, and Fig.56B The implant in actuated state is shown.Implant 500i can be identical or similar to any feature in the feature described in other implants described herein (such as implant 500a, 500b, 500c, 500d, 500e, 500f and 500h) and / or be incorporated into any feature in these feature.Similar to implant 500e, implant 500i can have expandable main body 510i, which has filter parts 520i and 520i' at its proximal end and distal end, wherein radial support part 540i is connected to this expandable main body and between these filter parts 520i, 520'.Different from implant 500a-500f and 500h, implant 500i can include a restrictor 560i that is not formed integrally with expandable main body 510i. The flow restrictor 560i of implant 500i can be arranged in the inner chamber 513i of implant 500i and be configured to be attached to the distal end of shaft 590i, and include the pillar 562i that radially extends outward to the distal end of shaft 590i from this connection.In addition, flow restrictor 560i can include the material 530i that spans between pillars 562i, to form umbrella-shaped flow restrictor 560i.Suture or silk thread 595i can connect the radially outward end of pillar 562i to the fixed point adjacent to the distal end of pipe 570i.In order to actuate flow restrictor 560i and at least partially block / restrict the flow through implant 500i, shaft 590i can move proximally relative to pipe 570i and expandable framework 510i, thereby allow the biasing force of the pillar 562i directed radially outward to expand flow restrictor 560i (for example, open umbrella-shaped flow restrictor 560i). To return the flow restrictor 560i to its unactuated state, the shaft 590i can be moved distally relative to the tube 570i and the expandable frame 510i, thereby causing the struts 562i to contract radially inward (e.g., closing the umbrella-shaped flow restrictor 560i). Although not shown, the implant 500i can also include a retractable and extendable coupling 580i similar to the retractable and extendable coupling 580a of the implant 500a, so as to form a fluid seal between the shaft 590i and the tube 570i and allow longitudinal movement (e.g., distal and proximal movement) therebetween.

[0228] In one variation, the flow restrictor 560i" can be secured to a distal extension of the tube 570i, and the radially outward ends of the struts 562i can be connected via sutures or threads 595i to the distal end of a movable shaft 590i movably disposed within the tube 570i". In this arrangement, the flow restrictor 560i can be actuated by distal movement of the shaft 590i relative to the expandable body 510i and the tube 570i, thereby allowing the biasing force of the radially outwardly oriented struts 562i to expand the flow restrictor 560' (e.g., opening the umbrella-shaped flow restrictor 560i). In order to restore the flow restrictor 560i to its unactuated state, the shaft 590i can be moved proximally relative to the tube 570i and the expandable frame 510i, thereby causing the struts 562i to contract radially inward (e.g., closing the umbrella-shaped flow restrictor 560i).

[0229] FIG. 57A to FIG. 57B Another embodiment of an implant 500j that may be used in conjunction with the implantable flow limiting system 5 is shown. Fig.57A The implant 500j is shown in an unactuated state (eg, a non-blocking / non-restrictive state), and Fig.57B An implant 500j in an actuated state (e.g., at least partially blocked / restricted state) is shown. Implant 500j can be identical or similar to any of the features described in other implants described herein (such as implants 500a, 500b, 500c, 500d, 500e, 500f, 500h, and 500i) and / or be incorporated into any of the features in these features. Similar to implant 500i, implant 500j can have an expandable body 510j, which has filtering portions 520j and 520j' at its proximal end and distal end, wherein radial support portion 540j is connected to the expandable body and between these filtering portions 520j, 520j'. Implant 500j may include a flow restrictor 560j, which may be integrally formed with or connected to the expandable body 510j. The flow restrictor 560j of the implant 500j can be disposed within the lumen 513j of the implant 500j and configured to be attached at its proximal end to the proximal end of the expandable frame 510j. Fig.57AShown, flow restrictor 560j can include pillars 562j, and these pillars are roughly longitudinally and extend distally from the proximal end of the expandable framework 510j in the non-actuated state (for example, non-blocking / unrestricted state) of implant 500j. Flow restrictor 560j can include the material 530j that spans between pillars 562j, to form umbrella-shaped flow restrictor 560j. Suture or silk thread 595j can connect the distal end of pillar 562j to the distal end of shaft 590j, and the shaft is configured to move slidably in pipe 570j (shaft 590j is hidden in pipe 570j and is not visible). In order to actuate flow restrictor 560j and at least partially block / restrict the flow through implant 500j, shaft 590j can move proximally relative to pipe 570j and expandable framework 510j, thereby via suture or silk thread 595j traction pillar 562j distal end and make them bend radially outward. This radial outward movement of the distal end of strut 562j can be as follows Fig.57B Shown is an open umbrella-shaped flow restrictor 560j, which together with material 530j can at least partially block / restrict flow through implant 500j.

[0230] FIG. 58A to FIG. 58C Another embodiment of an implant 500k that may be used in conjunction with the implantable flow limiting system 5 is shown. Fig.58A The implant 500k is shown in an unactuated state (eg, a non-blocking / non-restrictive state). Fig.58B The implant 500k is shown in a partially actuated state, and Fig.58CThe implant 500k in the actuated state (e.g., at least partially blocked / restricted state) is shown. The implant 500k can be identical or similar to any of the feature portions described in the feature portions of other implants described herein (such as implants 500a, 500b, 500c, 500d, 500e, 500f, 500h, 500i and 500j) and / or be incorporated into any of the feature portions in these feature portions. Similar to implant 500j, implant 500k can have an expandable body 510k, which has filtering portions 520k and 520k' at its proximal end and distal end, wherein radial support portion 540k is connected to the expandable body and between these filtering portions. Different from some implants in the implant described herein, implant 500k can include a restrictor 560k that is not formed integrally with expandable body 510k. The flow restrictor 560k of implant 500k can be arranged in the inner chamber 513k of implant 500k and be configured to extend out pipe 570k and retract in this pipe as shown in the figure.For this reason, flow restrictor 560k can be attached to the distal end of shaft 590k (due to it being invisible inside pipe 570k) and include the expandable framework made of pillar 562k, and this expandable framework has the material 530k that spans these pillars 562k to form roughly umbrella-shaped flow restrictor 560k.In order to actuate flow restrictor 560k and at least partially block / restrict the flow by implant 500k, shaft 590k can move distally relative to pipe 570k and expandable framework 510k, thereby allow flow restrictor 560k to extend out pipe 570k and expand (for example, open umbrella-shaped flow restrictor 560k) distally. To return the flow restrictor 560k to its unactuated state, the shaft 590k can be moved proximally relative to the tube 570k and the expandable frame 510k, thereby causing the expandable frame having struts 562k to collapse (eg, closing the umbrella-shaped flow restrictor 560i) as it is retracted into the tube 570k.

[0231] Fig.59 Another embodiment of an implant 5001 that may be used in conjunction with the implantable flow restricting system 5 is shown. Fig.59Implant 5001 is shown in an actuated state (e.g., at least partially blocked / restricted state). Implant 5001 can be the same as implant 500k, but the flow restrictor 5601 of implant 5001 can include an expandable coil configured to achieve a three-dimensional shape as shown after expansion. The actuation of the flow restrictor 5601 is also the same as the actuation of the flow restrictor 560k described herein. For example, in order to actuate the flow restrictor 5601 and at least partially block / restrict flow through the implant 5001, the shaft 5901 can be moved distally relative to the tube 5701 and the expandable frame 5101, thereby allowing the flow restrictor 5601 to extend distally out of the tube 5701 and expand (e.g., allowing the expandable coil to assume a three-dimensional shape). To return the flow restrictor 5601 to its unactuated state, the shaft 5901 can be moved proximally relative to the tube 5701 and the expandable frame 5101, thereby causing the expandable coil to collapse as it is retracted into the tube 5701.

[0232] Fig.60 An embodiment of a releasable implant 500m that can be used in conjunction with an implantable flow limiting system 5 is shown. The implant 500m shown can be used in conjunction with Fig.50Described implant 500c is similar or identical, yet it can be suitable for discharging from pipe 570m and axle 590m.Any implant in implant as herein described can be suitable for being releasable.If necessary, releasable implant can allow to remove this implant from patient.In addition, if necessary, releasable implant can allow to remove pipe, axle and / or controller of system from patient.In order to discharge implant 500m from pipe 570m, can cut off the connection between implant 500m and pipe 570m as shown in the figure.In some embodiments, cutting off the connection between implant 500m and pipe 570m can comprise traction pipe 570m, simultaneously implant 500m is maintained in position, thereby implant 500m is disengaged from pipe 570m.In some embodiments, cutting off the connection between implant 500m and pipe 570m can comprise peeling off or cutting the outer wrapping or film that implant 500m is attached to pipe 570m. This peeling off or cutting can be carried out by another interventional device or via the drawstring that can be contained in pipe 570m and accessible at the proximal end of pipe 570m.In order to discharge implant 500m from axle 590m, can cut off the connection between suture or silk 595m and implant 500m as shown in the figure.In some embodiments, cutting off the connection between suture or silk 595m and implant 500m can comprise cutting or heating suture or silk 595m via another interventional device.In some embodiments, cutting off the connection between suture or silk 595m and implant 500m can comprise axle 590m is pushed far side through implant 500m so that suture or silk 595m is disconnected with implant 500m (for example, the connection between suture or silk 595m and implant 500m can be configured to keep complete as long as axle 590m does not extend through the distal end of implant 500m). In some embodiments, to release 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 the connection between the implant 500m and the tube 570m.

[0233] Figures 61A to 61C Another embodiment of an implant 500n is shown. Fig.61A A side view of the implant 500n is shown in an unactuated state (eg, a non-blocking / non-restrictive state). Fig.61B A side view of the implant 500n is shown in an actuated state (eg, at least partially blocked / restricted state), and Fig.61CAn end view of an implant 500n in an unactuated state is shown. The implant 500n may be the same or similar to any of the features described with respect to other implants described herein and / or incorporate any of these features. As shown, the implant 500n may include an expandable body 510n having a proximal end 511n, a distal end 512n and an inner cavity 513n for receiving blood flow therethrough. The implant 500n may include a filtering portion 520n, a radial support portion 540n, a restrictor portion 550n, a radial support portion 540n' and a filtering portion 520n'. In addition, the implant 500n may include a material 530n that spans at least the restrictor portion 550o (as shown, the material 530n spans the restrictor portion 550n and the radial support portions 540n, 540n'). The restrictor portion 550n may be configured to be inserted through a suture or silk thread 595n such as Fig.61B 500n.As shown in Figure 5, the suture or silk thread 595n can be wound around the restrictor part 550n and / or pass through the eyelet of the pillar 562n constituting the restrictor part 550n.Although not shown, implant 500n can be connected to pipe 570n at its proximal end 511n.This pipe 570n can be connected to implant 500n (as shown in at least some embodiments in other embodiments of implant 500 as described herein) at the location of the center of lumen 513n substantially.In some embodiments, this pipe 570n can be connected to implant 500n at the location (for example, at a side of implant 500n) along the circumference of implant 500n.Suture or silk thread 595n can extend from around the restrictor part 550n and pass through pipe 570n to be connected to the actuator of controller 50, so as to actuate implant 500n. In some embodiments, suture or thread 595n can be connected to shaft 590n extending through tube 570n, such as described herein for other embodiments for actuating implant 500n. In these embodiments, a retractable and extendable coupling 580n similar to other retractable and extendable couplings described herein can be used to form a fluid seal between shaft 590n and tube 570n.

[0234] Fig.62 Another embodiment of 500° is shown. Fig.62The stereogram of the implant 500o in the non-actuated state (e.g., non-blocked / non-restricted state) is shown. The implant 500o can be identical or similar to any feature in the feature described in the implant 500n and other implants described herein and / or be incorporated into any feature in these feature. As shown, the implant 500o can include an expandable body 510o, which has a proximal end 511o, a distal end 512o and an inner chamber 513o for receiving blood flow therethrough. The implant 500o can include a radial support portion 540o, a flow restrictor portion 550o and a radial support portion 540o'. Different from the implant 500n, the implant 500o can omit the filtering portion adjacent to its proximal end and distal end. Although not shown, the implant 500o can include a material 530o that at least spans the flow restrictor portion 550o. In some embodiments, material 530o can span restrictor portion 550o and radial support portion 540o, 540o '.Similar to the restrictor portion 550n of implant 500n, restrictor portion 550o can be configured to block / restrict flow by tightening radially inwardly via suture or silk thread 595o.This suture or silk thread 595o can be wound around restrictor portion 550o and / or pass the eyelet 596o of the pillar 562o constituting restrictor portion 550o.Although not shown, implant 500o can be connected to pipe 570o at its proximal end 511o.This pipe 570o can be connected to implant 500o at the location (for example, at a side of implant 500o) along the circumference of implant 500o. A suture or thread 595o can extend from around the restrictor portion 550o and through the tube 570o to connect to an actuator of the controller 50 to actuate the implant 500o. In some embodiments, the suture or thread 595o can be connected to a shaft 590o that extends through the tube 570o, such as described herein for other embodiments for actuating the implant 500o. In these embodiments, a retractable and extendable coupling 580o similar to other retractable and extendable couplings described herein can be used to form a fluid seal between the shaft 590o and the tube 570o. Fig.62 As shown, implant 500o may include anchors 525o and 525o' at its proximal and distal ends, respectively. Anchors 525o and 525o' may have a hook-like configuration to facilitate anchoring implant 500o in a blood vessel. In some embodiments, implant 500o or its features may be used as or incorporated into a shunt (e.g., a pulmonary artery to azygos shunt, as described in U.S. Provisional Patent Application No. US63 / 331,496, incorporated herein by reference).

[0235] Fig.63An embodiment of an anchor 525p of an implant 500p of an implantable flow limiting system 5 is shown. Except for the construction of the anchor 525p, the implant 500p can be the same or similar to the implant 500a described herein. As shown, the anchor 525p can have a circular construction with a notch in the circle to allow the anchor 525p to pass over and receive at least a portion of the expandable frame 510p of the implant 500p within the circle. For example, the anchor 525p is shown as receiving a portion of the expandable frame 510p, where the radial support portion 540p and the flow limiter portion 550p meet, however the anchor 525p can be positioned along and / or receive any portion of the implant 500p. Also as shown in the drawings, Fig.63 As shown, at the notch of the circular state of the anchor 525p, the anchor 525p can have a portion 527p extending generally outward from the circle and substantially in the same plane as the circle. These portions 527p can extend generally parallel to each other as shown, or they can extend at an angle to each other. These portions 527p can facilitate anchoring the implant 500p in a blood vessel or shunt.

[0236] FIG. 64A to FIG. 64B An embodiment of a shaft 590 of an implantable flow restricting system 5 described herein is shown. The shafts described below may be used in conjunction with any of the implants described herein. Fig.64A and Fig.64B A side view and a three-dimensional cross-sectional view of shaft 590 are shown respectively. As shown, shaft 590 (which may also be referred to as a "wire" or "cable" in this article) can have a braided structure including multiple individual wires 593. In some embodiments, multiple individual wires 593 can be twisted together to form a bundle, and shaft 590 can be made of multiple such bundles twisted together. In some embodiments, shaft 590 can be made of a single wire, a rod, a hypotube, or a laser-cut hypotube, depending on the application. For example, for a flow limiting system that is actuated by pulling a portion of an implant through a shaft to actuate its flow limiter, the shaft can be configured for tensioning and can have a FIG. 64A to FIG. 64B 570. As another example, for a current limiting system actuated by pushing a portion of an implant through an axis to actuate its current limiter, the axis can be configured to be used for extrusion. In another example, for a current limiting system actuated by rotation of an axis, the axis can be configured to be used for rotation. In some embodiments, one or more wires 593 in the axis 590 can be configured to transmit power and / or signals to one or more sensors 600 of the current limiting system 5 and / or transmit power and / or signals from them. The axis 590 can be flexible and has a lubricating coating or a lubricating surface in some embodiments to facilitate sliding movement in the tube 570 as described herein. In addition, the axis 590 can be made of a biocompatible material (e.g., stainless steel).

[0237] Fig.65 A schematic diagram of certain features that may be incorporated into the implantable current limiting system 5 and any other embodiments of the implantable current limiting system described herein is shown. As shown, the implantable controller 50 of the implantable current limiting system 5 may include a processor 51, an actuator 52, a storage device 53, a power supply 54, and / or a communication module 55. As also shown, the external device 15 for operating the implantable current limiting system 5 may include a processor 16, a user interface 17, a storage device 18, a power supply 19, and a communication module 21. In some embodiments, the external device 15 may be a mobile phone, a tablet computer, a handheld device, a mobile device, or other.

[0238] The processors 51 and 16 may be configured to process data, execute instructions to perform one or more functions, and / or control the operation of the controller 50 and the external device 15, respectively, etc. For example, the processor 51 may control the operation of the actuator 52 and the sensor 600 of the long-term implantable current limiting system 5. As another example, the processor 51 may process signals and / or data received and / or obtained from the sensor 600 of the implantable current limiting system 5. In addition, the processor 51 may execute instructions to perform functions related to storing and / or transmitting the signals and / or data received and / or obtained from the sensor 600 of the implantable current limiting system 5 (e.g., such as transmitting the signals and / or data to the external device 15). The processor 51 may execute instructions to perform functions related to storing and / or transmitting any or all of the received data.

[0239] The storage devices 53 and 18 may include one or more memory devices that store 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. For example, the stored data may be processed and / or unprocessed data obtained from the implantable current limiting system 5.

[0240] The communication modules 55 and 21 can facilitate communication (e.g., via wireless connection) between the implantable current limiting system 5 (and / or its components, such as the controller 50) and the external device 15 and other separate devices (such as separate monitoring, computing, electrical and / or mobile devices). For example, the communication module 55 can be configured to allow the implantable current limiting system 5 to communicate wirelessly with the external device 15 and / or other devices, systems and / or networks via any of a variety of communication protocols. The communication modules 55 and 21 can be configured to use any of a variety of wireless communication protocols, such as Wi-Fi (802.11x), Cellular phone, infrared, near field communication (NFC), RFID, satellite transmission, proprietary protocols, combinations thereof, etc. The communication module 55 can allow data and / or instructions to be transmitted to and / or received from the implantable current limiting system 5 and a separate computing device (such as an external device 15). The communication module 55 can be configured to transmit (e.g., wirelessly) processed and / or unprocessed data (e.g., data from one or more sensors 600) and / or other information to one or more separate computing devices, which can include external devices 15, patient monitors, mobile devices (e.g., smart phones, tablets, laptops that support iOS or Android), desktop computers, servers or other computing or processing devices, etc., for display and / or further processing. These separate computing devices can be configured to store and / or further process the received data and / or other information, to display information indicative of the received data and / or information or derived from the received data and / or information, and / or to transmit information (including displays, alarms, warnings, and notifications) to various other types of computing devices and / or systems that may be associated with a hospital, care provider (e.g., primary care provider), and / or user (e.g., employer, school, friend, family) that has permission to access the patient's data. As another example, the communication module 55 of the controller 50 of the implantable current limiting system 5 can be configured to wirelessly transmit processed and / or unprocessed acquired data, information, and / or other information (e.g., the actuation state of the implant 500) to a mobile phone, which can include one or more hardware processors configured to execute an application that generates a graphical user interface that displays processed or unprocessed data, information, and / or other information obtained from the implantable current limiting system 5. The communication modules 55 and 21 can be and / or include wireless transceivers.

[0241] Power supplies 54 and 19 can provide power to the hardware components of the implantable current limiting system 5 and the external device 15 described herein, respectively. For example, the power supply 54 of the controller 50 can provide power to one or more sensors 600, the communication module 55, the processor 51, and the actuator 52. In some embodiments, the power supply 54 may include a battery, an inductive receiver / rectifier, or both. The power supply 19 may include a battery. In some embodiments, the external device 15 may also include an inductive transmitter to wirelessly transmit power to the inductive receiver / rectifier (if included) of the implantable current limiting system 5 (e.g., the controller 50). Any of these batteries can be rechargeable. For example, these batteries can be lithium, lithium polymer, lithium ion, lithium ion polymer, lead acid, nickel cadmium, or nickel metal hydride batteries. In some embodiments, these batteries may be non-rechargeable.

[0242] The actuator 52 of the controller 50 of the implantable flow limiting system 5 can be configured to move the shaft 590 within the tube 570 so as to actuate 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 can 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 can be configured to rotate the shaft 590 relative to the tube 570 and the implant 500. In addition, the actuator 52 can be configured to block / restrict the flow through the implant 500 by causing the flow restrictor 560 and / or the flow restrictor portion 550 of the implant 500 to be within a range of about 0% to about 100% (including both ends).

[0243] User interface 17 of external device 15 may be configured to allow the patient or their care provider to interact with external device 15 to control implantable current limiting system 5. The user interface may include buttons, a touch screen, and / or a microphone to accept physical touch and / or verbal input / commands.

[0244] Figures 66A to 66C 5 shows an embodiment of a connector 700 between components of the flow limiting system 5. The connector 700 can be configured, for example, to releasably connect the proximal end 592 of the shaft 590 to the actuator 51 of the controller 50. Fig.66A As shown, the connector 700 may include a first component 710 and a second component 720 configured to be releasably connected to each other via complementary features. The first component 710 and the second component 720 may be fixed to the proximal end 592 of the shaft 590 and the actuator 51, respectively, or vice versa. The first component 710 is configured as a cylinder and may have a circular groove 712 at one of its ends and a protrusion extending radially inward into the groove 712, the protrusion being visually marked by a point 714 located on the outer surface of the first component 710. The second component 720 may be configured as a cylinder and may have a circular rod-shaped protrusion 722 extending from one of its ends and sized to fit within the groove 712 of the first component 710. In addition, the protrusion 720 may have a narrow slot 724 configured to receive the protrusion extending radially inward into the groove 712 of the first component 710. As shown in FIG. FIG. 66A to FIG. 66B As shown, the narrow groove 724 can extend from the end of the protrusion 722 in the longitudinal direction and then turn more than about 90 degrees, so that after the narrow groove 724 is aligned with the point 714 and the protrusion 722 is fully inserted into the groove 712, the first component 710 and the second component 720 can be rotated relative to each other in the first direction to fix the first component 710 and the second component 720 together (for example, the first component and the second component can be maintained connected via the interaction between the protrusion of the first component 710 and the narrow groove 724 of the second component 720). Fig.66C It shows how to release the first component 710 from the second component 720, which may include pressing the first component 710 and the second component 720 together, rotating the first component 710 and the second component 720 relative to each other in a second direction opposite the first direction, and then separating the first component 710 and the second component 720 from each other.

[0245] FIG. 67A to FIG. 67B A variation 700' of the connector 700 is shown. Similar to the connector 700, the connector 700' can be configured to releasably connect the proximal end 592 of the shaft 590 to the actuator 51 of the controller 50. Fig.67A As shown, the connector 700' may include a first component 710' and a second component 720' configured to be releasably connected to each other via complementary features. The first component 710' may be configured as a cylinder and may have a circular groove 712 at one end thereof similar to the end of the first component 710. Instead of a protrusion and a point 714 marking the position of the protrusion, the first component 710' may include a narrow groove 714' through the wall of the first component, the narrow groove extending longitudinally from the end of the first component 710' having the groove 712' and then turning more than about 90 degrees. The second component 720' may be configured as a cylinder 722' sized to fit within the groove 712' of the first component 710' and may have a circular rod-like protrusion 724' extending radially outward from its outer surface and configured to fit within the narrow groove 714'. To connect the first component 710' and the second component 720' to each other, the cylinder 722' can be fully inserted into the groove 712', wherein the protrusion 724' is aligned with the slot 714', and the first component 710' and the second component 720' can be rotated relative to each other in a first direction (e.g., the first component and the second component can remain connected via the interaction between the slot 714' of the first component 710' and the protrusion 724' of the second component 720'). To release 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 each other in a second direction opposite to the first direction, and then the first component 710 and the second component 720 can be separated from each other.

[0246] FIG. 68A to FIG. 68D An embodiment of a connector 750 is shown between components of the implantable flow limiting system 5. The connector 750 can be configured, for example, to releasably connect and fluid-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 Tube 570 is shown separated from connector 750 but in position for connection to the connector, Fig.68B A side view of a portion of connector 750 is shown, Fig.68C An end view of connector 750 is shown, and Fig.68D 750 is shown in a cross-sectional side view. 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 member 760 having a longitudinal through hole 762 configured to receive the proximal end 572 of the tube 570 and a second member 760 configured to receive the first member 760 (e.g., as shown in FIG. Fig.68D ) of the connector 750. Both the first component 760 and the second component 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, which are configured to bias the first component 760 in a direction away from the second component 770. These arms 772 can also be configured to grasp the outer surface of the tube 570 when the tube 570 is inserted into the connector 750. In order to connect the tube 570 to the connector 750 and fluid-tight, the proximal end 572 of the tube 570 can be fully inserted into the connector 750 via the through hole 762 of the first component 760 until it can no longer be inserted further. The fluid seal can be formed between the tube 570 and the connector 750 via a third component 780, which is configured as a circumferential ring within the body 751 located proximal to the first component 760 and the second component 770. In this fully inserted position, the arms 772 of the second component 770 can grasp the outer surface of the tube 570 and prevent it from being released from the connector 750. In order to release the connection between the tube 570 and the connector 750, the first component 760 can be pressed inwardly into the connector 750 (e.g., pressed proximally into the connector 750) so that the proximal end of the first component 760 radially expands the arms 772 and releases them from the tube 570 while the tube 570 is pulled out of the connector 750 (e.g., moved distally relative to the connector 750).

[0247] FIG. 69A to FIG. 69BAn embodiment of an implant assembly 501 is shown that includes an implant 500, a tube 570, and a shaft 590 having an extender 800 to assist in implanting the implant assembly 501. The implant 500, tube 570, and shaft 590 shown correspond to the implant 500a, tube 570a, and shaft 590a described herein, although in some embodiments, they can be any of the implants described herein. The extender 800 can include a flexible tube that is attached to the tube 570 at a location adjacent to its proximal end 572 and extends proximally therefrom. For example, the extender 800 can include PEBAX reflow soldered onto the tube 570. In some embodiments, the extender 800 is a proximal continuation of the tube 570. The extender 800 can advantageously provide a care provider implanting the implant assembly 501 with a component that can be grasped in vitro to assist in positioning and manipulating the implant assembly during implantation of the implant assembly 501 into a patient. As Fig.69B As shown in the enlarged view of , when no longer needed, the extender can be cut at the cutting line 803 and taken out (e.g., by sliding proximally) from the implant assembly 501. In some embodiments, the extender 800 is configured to be peeled off from the implant assembly 501 at the cutting line 803. Once the extender 800 is removed, the proximal end 572 of the tube 572 can overlap with the cutting line 803. FIG. 69A to FIG. 69B Also shown is a device 850 for testing the functionality of the implant 500, which can be extended proximally through the extender 800 and referenced to FIG. 70A to FIG. 70B , FIG. 71A to FIG. 71B as well as Fig.72 Give a description.

[0248] FIG. 70A to FIG. 70B An embodiment of a device 850 for testing the functionality of an implant 500 during implantation is shown. As shown, the device 850 can be releasably connected to the proximal end 591 of the shaft 590 so as to pull and / or push the shaft 590 to actuate the restrictor 560 and / or 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, to releasably connect with another of the components 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 thereto. Fig.70A Device 850 is shown connected to shaft 590, and Fig.70B The device 850 is shown separated from the shaft 590. To facilitate pulling and / or pushing the shaft 590 through the device 850, the device 850 may include a proximal extension 855. FIG. 70A to FIG. 70BAs shown, the proximal extension 855 may include a suture. In one variation 850' of the device 850, such as FIG. 71A to FIG. 71B As shown, the proximal extension 855' may include a shaft. In some embodiments, the proximal extension 855, 855' may include a wire, a rod, a hypotube, or a 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 actuation of the restrictor 560 and / or the restrictor portion 550 of the implant 500). Alternatively or additionally, in order to test the function of the implant 500, if necessary, the device 850, 850' may also be used to help remove the implant 500. For example, in order to remove implant 500 from the patient, implantable controller 50 can be disconnected from shaft 590 and pipe 570, equipment 850, 850' can be connected to shaft 590, sheath can slide on equipment 850, 850' and slide on shaft 590 and pipe 570 in the body distally, sheath can slide on implant 500 and shrink it in sheath, then sheath with implant 500, shaft 590 and pipe 570 can be retracted proximally from the patient's body, and finally taken out from the patient's body. Equipment 850, 850' can advantageously provide working length, to help implant assembly 501 be removed from the body.

[0249] Fig.72 A method 900 for implanting an implantable flow limiting system 5 is shown. The method 900 can be applied to any of the embodiments of the implantable flow limiting system 5 and its components described herein. In addition, the method 900 can include other steps and / or omit steps. The method 900 can be performed in a cardiac catheterization laboratory under local or general anesthesia and can be performed in a minimally invasive manner.

[0250] Method 900 may include step 905 of entering the patient's subclavian vein. The entry point of the subclavian vein (which may be the right subclavian vein or the left subclavian vein) may be at or near the junction of the middle third and the inner third (i.e., the location where the first rib and the clavicle are joined). The subclavian vein may be punctured blindly or under image guidance. Once the subclavian vein is entered, a guide wire may be advanced through the subclavian vein, through the superior vena cava (SVC), through the right atrium, and into the inferior vena cava (IVC). A delivery sheath with a dilator (which may also be referred to herein as a "delivery catheter") may be placed in the subclavian vein over the guide wire and into the IVC.

[0251] The method 900 can optionally include a step of identifying the renal vein 910. Identification of the renal vein can be performed during implantation via fluoroscopy and intravascular dye through the delivery sheath, or can be performed prior to implantation by CT imaging. With the renal vein identified, the distal end of the delivery sheath can be placed in the IVC below the renal vein (e.g., in the IVC upstream of its connection with the renal vein), and the dilator can be removed from the delivery sheath.

[0252] Method 900 may include step 915 of implanting implant assembly 501. In other words, step 915 may include implanting implant 500 connected to tube 570 and shaft 590. To this end, implant assembly 501 may be inserted into a delivery sheath and delivered into the IVC, wherein implant 500 is positioned below the renal vein. To aid in the delivery and manipulation of implant assembly 501, extender 800 may optionally be attached to implant assembly 501, as described with respect to FIG. 69A to FIG. 69B If necessary, repositioning of implant 500 may be performed.

[0253] Once the implant 500 has been deployed out of 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, as described with respect to FIG. 70A to FIG. 70B as well as FIG. 71A to FIG. 71B The equipment 850 for testing the function of implant 500 shown in the figure can be used to actuate implant 500 and test its function (for example, the restrictor 560 and / or restrictor part 550 of implant 500 can be actuated via equipment 850 to at least partially block the stream passing through implant 500). If the functional test is successful, then the delivery sheath can be removed from implant assembly 501 proximal sides, thereby implant assembly 501 is left in the appropriate position in the patient's body. If the functional test is unsuccessful, then implant 500 can be re-enclosed in the delivery sheath (for example, by the delivery sheath on the implant 500 distally moving and / or with respect to the delivery sheath to the proximal traction implant 500) and implant assembly 501 is removed from the patient.

[0254] In use, method 900 may include a step 925 of removing extender 800. This may be done by cutting the extender at cut line 803 or peeling the extender at cut line 803, as described with respect to FIG. 69A to FIG. 69B The device 850 for testing the functionality of the implant 500 may also be removed.

[0255] Method 900 may include step 930 of creating a subclavian subcutaneous pocket for implantable controller 50 of system 5 .

[0256] Method 900 may include step 935 of connecting implant assembly 501 to implantable controller 50. To this end, shaft 590 may be connected to actuator 51 of controller 50, as described with respect to Figures 66A to 66C as well as FIG. 67A to FIG. 67B In addition, the tube 570 can be connected to the controller 50, as described with respect to FIG. 68A to FIG. 68D described.

[0257] The method 900 may include a step 940 of testing the functionality of the implantable current limiting system 5. To this end, the external device 15 may be used to test the operation of the implant 500.

[0258] In the event that it is confirmed that the external device 15 can successfully operate the system 5, 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 made in step 930. Closure may be performed, and the implantation process is concluded.

[0259] In some embodiments, the femoral vein, radial vein, or Fig.42 The implant 500 may be implanted in a location other than the location described in method 900, depending on the location of the vascular access. Additionally, implant 500 may be configured as described with respect to implant 500a, or it may have an opposite configuration (e.g., wherein flow restrictor 560 is flipped and configured to operate by pushing on shaft 590 rather than pulling on shaft 590), depending on the location of the vascular access.

[0260] FIG. 73A to FIG. 73D The implant 500 of the implantable flow restricting system 5 is shown deployed out of the distal end 1002 of the delivery sheath 1000. FIG. 73A to FIG. 73D The described deployment of implant 500 may be applied to any of the embodiments of implants described herein.

[0261] like Fig.73A As shown, distal movement of the implant 500 relative to the distal end 1002 of the delivery sheath 1000 can cause the implant 500 to extend beyond the distal end 1002 of the delivery sheath 1000. This 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. Fig.73A As shown, due to the configuration of the expandable frame 510 of the implant 500, the implant 500 can remain contracted when extending distally past the distal end 1002 of the delivery sheath 1000. This configuration can facilitate repositioning of the implant if necessary. For example, the implant 500 can remain contracted when at least a portion of the radial support portion 540 remains inside the delivery sheath 1000.

[0262] FIG. 73B to FIG. 73C The implant 500 is shown to be progressively radially expanded as the implant 500 continues to extend distally past the distal end 1002 of the delivery sheath 1000. As shown, partial radial expansion of the implant 500 may occur once a majority of the filter portion 520 has extended distally past the distal end 1002 of the delivery sheath 1000. Advantageously and as Fig.73C As shown, anchor 525 can maintain a collapsed position (e.g., at least partially extending radially inward) when implant 500 is in a partially expanded state. This configuration of implant 500 can help implant 500 reposition within a blood vessel when needed and / or retract implant 500 within delivery sheath 1000 when needed.

[0263] Fig.73D The implant 500 is shown fully deployed out of the distal end 1002 of the delivery sheath. After fully deployed, the implant 500 can reach its fully expanded state as shown. In this state, the anchor 525 can assume its generally longitudinal orientation to help anchor the implant 500 in the blood vessel. Advantageously, due to the configuration of the filtering portion 520 that can cause the proximal end of the implant 500 and the anchor 525 to be radially inwardly gathered when retracted proximally, the implant 500 can be configured to be retracted and retracted into it even after being fully deployed from the delivery sheath 1000.

[0264] Fig.74 A guide 1100 for treating a patient using an implantable flow limiting system 5 described herein is shown. In some embodiments, the guide 1100 can be applied to any of the flow limiting systems described herein. The guide 1100 can include assessing the patient's IVC pressure. If the IVC pressure is determined to be normal, the system 5 may not require any action, as shown. Normal IVC pressure may be a pressure between about 0 mmHg and about 8 mmHg. If the IVC pressure is determined to be high, the system 5 may be activated, as shown. High IVC pressure may be a pressure greater than about 8 mmHg. The IVC pressure may be measured by the system 5 via a sensor 600. In addition, the activation of the system may occur via an external device 15 as described herein (e.g., digital, wireless activation). If the IVC pressure is still high after the system 5 is activated, the patient may be advised to consult their medical professional / care provider.

[0265] Figure 75 to Figure 77 Various methods of using the implantable flow limiting system 5 described herein are shown. Figure 75 to Figure 77 The method described can be applied to any of the current limiting systems described herein. Figure 75 to Figure 77The method described is described using sensor 600 connected to implant 500, but system 5 may include other sensors proximate to implant 500 and / or remote from implant 500 for pressure determination and control of system 5 (e.g., such as sensors related to Fig.41 and sensors described elsewhere herein). In addition, although Figure 75 to Figure 77 The methods described have been described as being performed by a patient having system 5 implanted, but any of the steps of the methods may be performed by the patient's medical professional / care provider or an authorized user.

[0266] Fig.75 A manual method 1200 (which may also be referred to as a "patient-driven method") of using the implantable flow limiting system 5 is shown. Additionally, the method 1200 may include other steps and / or omit steps.

[0267] Manual method 1200 may include a step 1205 of requesting a pressure measurement (eg, a renal vein pressure measurement or a femoral vein pressure measurement). The request may be made by the patient using external device 15 or other separate electronic device as described herein (eg, via wireless communication with system 5).

[0268] Manual method 1200 may include step 1210 of system 5 measuring pressure based on the request from step 1205. The pressure measurement may be measured via one or more sensors 600 of system 5. To this end, processor 51 of controller 50 may be operatively connected to pressure sensor 600 and configured to receive and process signals from pressure sensor 600 to determine pressure (e.g., pressure of the patient's vasculature). For example, implant 500 implanted in the IVC upstream of the renal vein with sensor 600 connected thereto may be used to measure IVC pressure, renal vein pressure, and / or femoral vein pressure (e.g., as described with respect to FIG. 1 ). FIG. 48A to FIG. 48C In other words, IVC pressure, renal vein pressure, and / or femoral vein pressure may be measured from implant 500.

[0269] Manual method 1200 may include step 1215 where system 5 detects an increase in pressure. For example, system 5 may compare the pressure measured in step 1210 with previously measured pressures and / or with pressure values ​​in memory (e.g., in storage device 53) to determine if pressure has increased and / or is elevated / high. Determination of high pressure may be made according to guideline 1100.

[0270] The manual method 1200 may include a step 1220 where the system 5 notifies the patient of the pressure increase if an increase in pressure is detected in step 1215. To this end, the system 5 (e.g., the controller 50) may send an indication to the external device 15 that the pressure has increased. The pressure may include IVC pressure, renal vein pressure, and / or femoral vein pressure. In addition, step 1220 may include notifying the patient, via the external device 15, that the pressure has increased and / or is elevated / high. This may include receiving an instruction from the external device 15 to activate the implant 500.

[0271] The manual method 1200 may include a step 1225 such as activating the system 5 by the 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. The actuation of the implant 500 may include actuation of the restrictor 560 and / or the restrictor portion 550 as described herein, which may at least partially block the lumen 513 of the implant 500. In addition, the actuation of the implant 500 may at least partially block blood flow through a blood vessel in the patient's vasculature. For example, for an implant 500 implanted in the IVC below the patient's renal vein, activating the implant 500 may cause the implant 500 to at least partially block blood flow through the IVC.

[0272] Manual method 1200 may include step 1230 of deactivating system 5. Deactivation of system 5 may include returning implant 500 to its unactivated, non-blocked / non-restricted state, as described herein. This deactivation may occur manually, semi-automatically, or automatically. For example, system 5 may remain activated until deactivated by interaction with external device 15. As another example, system 5 may notify the patient that treatment is complete and give a notification of deactivating system 5. This notification may occur similarly to the notification of pressure increase described in step 1220. In another example, system 5 may remain activated for a duration, and system 5 may deactivate after this duration. In yet another example, system 5 may remain activated as long as pressure remains elevated / high, which may include periodic measurements of pressure for this determination.

[0273] Fig.76A semi-automatic method 1300 (which may also be referred to as "automatic sensing with patient activation") using an implantable flow limiting system 5 is shown. In addition, 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 that are the same as steps 1210, 1215, 1220, 1225, and 1230 of method 1200, respectively. Unlike manual method 1200, semi-automatic method 1300 may omit step 1205 of requesting pressure measurement. In the semi-automatic method 1300 without the pressure measurement request, system 5 may automatically measure pressure via system 5. The automatic pressure measurement 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. Method 1300 may be referred to as semi-automatic because system 5 must be activated in step 1320.

[0274] Fig.77 An automatic method 1400 (which may also be referred to as a "closed loop" or "full closed loop") using an implantable flow limiting system 5 is shown. Method 1400 may be similar to method 1300 in many respects. For example, method 1400 may include steps 1405, 1410, 1415, and 1420 that are the same as steps 1305, 1310, 1320, and 1325 of method 1300, respectively. Unlike semi-automatic method 1300, automatic method 1400 may omit step 1320 of activating the system by the patient. In automatic method 1400, activation by the patient is not required, and system 5 may be automatically activated to provide treatment.

[0275] Figures 78A to 78C An embodiment of using the implantable flow restriction system 5 described herein to deliver therapy is shown. Figures 78A to 78C The therapeutic delivery system 5 described herein can be applied to Figure 75 to Figure 77 Any of the methods described. Figures 78A to 78C An implant 500 of system 5 is shown in the IVC below the renal vein of a patient. Fig.78A As shown, the system 5 has detected an increased or elevated / high IVC pressure, renal vein pressure, and / or femoral vein pressure. With increased or elevated / high 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 be used as described herein and as Fig.78BAs shown in FIG. 5 (where implant 500 is shown in an occluding / restricting state), the implant 500 at least partially occludes / restricts blood flow in the IVC. By placing implant 500 in the IVC, when activated, system 5 can reduce renal pressure (e.g., reduce renal vein pressure). This reduction in renal pressure can increase urine production in the patient (e.g., enhance / increase diuresis). Moreover, when activated, system 5 can increase femoral pressure (e.g., femoral vein pressure). System 5 can Fig.78C When deactivated, implant 500 may assume its substantially non-blocking / non-restricting state and substantially not block / restrict blood flow therethrough. In other words, in the deactivated state, implant 500 may substantially not block / block / restrict blood flow in the IVC. This deactivation may reduce femoral pressure while substantially not affecting renal pressure or urine production (e.g., renal pressure and urine production may normalize after system 5 is deactivated).

[0276] Any part of implant as described herein (for example, filtering part 520, radial support part 540 and restrictor part 550) can omit, repeat or be connected to each other in different order.In addition, although restrictor part 550 and / or restrictor 560 have been described as having about implant 500 aspect and / or some orientation of blood flow traveling through therein, these restrictor parts 550 and / or restrictor 560 can be oriented in opposite manner or in other ways different from shown.In addition, the feature part in implant as described herein can be realized in any implant in implant as described herein.In addition, although some implants as described herein are shown and described as having parts for their actuation, these parts are basically located in their associated inner chamber (for example, pipe 570, shaft 590) centered, but these implants can be suitable for making these parts be positioned along the circumference of implant or one side, to produce the implant with the inner chamber without these parts basically.

[0277] Although systems, devices and / or components thereof have been described as having particular orientations and / or positions when implanted in a patient, these orientations and / or positions are not intended to be limiting. For example, although systems, devices and / or components thereof have been described as extending from the superior vena cava or a vein branching from the superior vena cava to the inferior vena cava, these systems, devices and / or components thereof may extend from the femoral vein to the inferior vena cava. For example, although system 5 has been described as having an implantable controller 50 implanted in a subcutaneous pocket beneath the clavicle, with the remainder 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 to be implanted in a subcutaneous pocket in or near the patient's groin, with the remainder of the system extending through the femoral vein and into the inferior vena cava. In these embodiments, venous access may be through the patient's femoral vein. Additionally, in these embodiments, the flow restrictor of the implant of the system may be located adjacent to the femoral vein. Fig.42The flow restrictor of implant 500 shown in FIG. 5 is configured in a similar or opposite manner.

[0278] Although systems, devices, and / or components thereof have been described and / or configured for long-term use, any of the systems, devices, and / or components thereof may be configured for acute use and / or for use in acute situations. For example, in some embodiments, an implantable controller or actuator as described herein may be located outside the patient's body, and an implant effectively connected thereto is implanted within the patient's vascular system as described herein. In these embodiments, an external device may not be required to operate the system, for example, a patient or user may operate the system via interaction with a controller located outside the patient's body.

[0279] Some of the features or advantages encompassed by one or more of the above embodiments or other aspects of the present application include, but are not limited to, one or more of the following: An implant configured to controllably and selectively occlude, restrict and / or redirect flow within a patient's vasculature ● an actuation source configured to actuate the implant The implant can be configured to adjustably occlude blood flow in the vasculature within a range of 0% to 100% ●The implant can be configured for percutaneous delivery ●The implant can be configured for surgical implantation ●The implant can be positioned intravenously ○The implant can be biased open and actuated closed ○The implant can be biased closed and actuated open o The implant may be biased partially closed and configured to fully open when positioned intravenously due to blood flow within the vasculature and actuated closed o The implant may include an expandable body and a flow restrictor, the expandable body being configured to engage an inner wall of a blood vessel of the patient and to position the flow restrictor in a blood flow path of the blood vessel o The implant may include an expandable body, wherein the flow restrictor is integrally formed with the expandable body o The actuation source may include a magnet, and the implant may be magnetically actuated ■ The actuation source may be configured to actuate the implant from outside the patient's body o The actuation source may include an electromagnet, and the implant may be magnetically actuated ■The actuation source can be implanted in the patient and / or located outside the patient ■The actuation source can be implanted in a blood vessel adjacent to the blood vessel where the occluding element is located ■ The actuation source can be implanted in the interstitial space adjacent to the vessel where the occluding element is located o The actuation source may include a fluid reservoir connected to the flow restrictor of the implant, and the implant may be fluid actuated ■The fluid reservoir can be connected to the flow restrictor of the implant via a tube ■The fluid in the fluid reservoir may include air and / or a biocompatible liquid including saline ■The fluid reservoir can be implanted subcutaneously The fluid reservoir may include a port configured to allow fluid to be removed and / or added to the fluid reservoir to control the actuation of the implant ■ Squeezing the fluid reservoir can actuate the implant o The actuation source may include an energy source configured to actuate the implant via heat ■The energy source may include ultrasound, microwaves and / or magnetic field generators (such as electromagnets) ■ The implant may include an induction coil configured to interact with the actuation source to control the occlusion of the implant o The actuation source may include an actuator configured to mechanically actuate the implant ○ The implant can be configured to be located in the patient's IVC upstream of the renal vein ■The implant can be configured to adjustably enhance renal circulation and / or improve diuresis ○ The implant can be configured to be located in the patient's IVC upstream of the hepatic vein ■The implant can be configured to adjustably enhance liver circulation and / or improve liver function ○ The implant can be configured to be located in the patient's SVC upstream of the right atrium o The implant may be configured to adjustably reduce cardiac preload, reduce central venous pressure and / or other venous pressures disclosed herein, and / or increase cardiac output ●The implant can be configured to be positioned outside of a vein o The actuation source may include a fluid reservoir connected to the flow restrictor of the implant, and the implant may be fluid actuated ■ The fluid reservoir may be fluidly connected to the flow restrictor of the implant via a tube ■The fluid in the fluid reservoir may include air and / or a biocompatible liquid including saline ■The fluid reservoir can be implanted subcutaneously The fluid reservoir may include a port configured to allow fluid to be removed and / or added to the fluid reservoir to control the actuation of the implant o The implant can be configured to be positioned adjacent to the outer wall of the patient's IVC o The implant can adjustably compress a portion of the outer wall of the IVC to adjustably occlude blood flow within the IVC Other Implementations 1. A chronically implantable flow limiting system for controllably and selectively occluding, restricting and / or diverting flow within a patient's vasculature to reduce renal congestion and / or relieve cardiac preload. 2. A system according to any of the preceding embodiments, wherein the system is adapted to controllably and selectively reduce central venous pressure or other venous pressure. 3. A system according to any of the preceding embodiments, wherein the system is suitable for enhancing renal circulation. 4. The system according to any one of the preceding embodiments, wherein the system is suitable for enhancing or controlling diuresis. 5. A system according to any of the preceding embodiments, wherein the system is adapted to increase cardiac output. 6. A system according to any of the preceding embodiments, wherein the system is adapted to controllably and selectively occlude or divert flow from the superior vena cava. 7. A system according to any of the preceding embodiments, wherein the system is adapted to controllably and selectively occlude or divert flow from the inferior vena cava. 8. A system according to any of embodiments 1-7, wherein the system includes a magnetically actuated implantable device. 9. A system according to any one of embodiments 1-7, wherein the system includes a fluid-actuated implantable device. 10. A system according to any one of embodiments 1-7, wherein the system includes a thermally actuated implantable device. 11. A system according to any one of embodiments 1-7, wherein the system comprises a mechanically actuated implantable device. 12. A system according to any one of embodiments 1-7, wherein the system includes an implantable device configured to be delivered extravenously to at least partially surround a vein of the patient or to be positioned adjacent to a vein of the patient. 13. A system according to any one of embodiments 1-7, wherein the system includes a mechanical tightening mechanism on the implantable stent. 14. The system according to any of the preceding embodiments, further comprising a control unit configured to control occlusion, restriction and / or diversion of flow within the patient's vasculature. 15. A system according to embodiment 14, wherein the control unit is configured to receive readings from one or more pressure sensors located within the patient's body, and wherein the control unit is configured to control obstruction, restriction and / or diversion of flow within the patient's vascular system based on the readings. 16. A system according to any of embodiments 14-15, wherein the therapy delivered by the system is digitally actuated. 17. A system according to any of the preceding embodiments, wherein the treatment delivered by the system is scheduled based on the time of day and / or the amount of time per day. 18. A chronically implantable flow limiting system for controllably and selectively occluding, restricting and / or diverting flow in a patient's vasculature, the system comprising: An implant, the implant comprising: An expandable body comprising a proximal end and a distal end and an inner cavity extending from the proximal end to the distal end, wherein the expandable body is configured to contract to a contracted state for delivery into a patient's body, and to expand from the contracted state to an expanded state for implantation into the patient's body; and a flow restrictor connected to the expandable body, the flow restrictor being configured to adjustably block the inner cavity when the expandable body is in the expanded state. 19. A system according to embodiment 18, wherein the expandable body comprises an expandable metal frame, which comprises a plurality of struts and defines a plurality of contractible units. 20. The system of embodiment 19, wherein one or more of the plurality of struts of the expandable body are diagonally aligned relative to a longitudinal axis of the implant. 21. A system according to any one of embodiments 18-20, wherein the expandable body is configured to contract laterally and / or via extension. 22. A system according to any of embodiments 18-19, wherein the expandable body is configured to radially contract. 23. A system according to any of embodiments 19-22, wherein one or more of the plurality of struts of the expandable body are converged at an end of the implant that is offset relative to a central longitudinal axis of the implant. 24. A system according to any of embodiments 18-23, wherein the current limiter comprises a magnet and the implant is magnetically actuated. 25. A system according to embodiment 24, wherein the flow restrictor is configured to move between a first non-blocking position and a second at least partially blocking position that at least partially blocks the inner cavity. 26. A system according to any of embodiments 24-25, wherein the flow restrictor includes one or more struts connecting the magnet to the expandable body and material spanning the one or more struts. 27. A system according to any one of embodiments 24-26, further comprising a magnetic field source configured to actuate the implant. 28. A system according to embodiment 27, wherein the magnetic field source is configured to be implanted in an interstitial space and / or a blood vessel adjacent to the implant. 29. A system according to embodiment 27, wherein the magnetic field source is configured to be located outside the patient's body. 30. The system of any one of embodiments 18-23, wherein the flow restrictor comprises a balloon and the implant is fluid-actuated. 31. A system according to embodiment 30, wherein the balloon is configured to expand from a non-actuated state to an actuated state that at least partially blocks the inner cavity. 32. A system according to any of embodiments 30-31, wherein the balloon is constructed as a prolate or oblate spheroid. 33. A system according to any of embodiments 30-31, wherein the balloon is constructed as an elongated partial circle that is adhered to the interior of the expandable body and / or the mounting portion of the expandable body. 34. A system according to any of embodiments 30-31, wherein the balloon is constructed as a cylinder having a through opening, and the cylinder is adhered to the interior of the expandable body and / or the mounting portion of the expandable body. 35. A system according to any one of embodiments 30-34, wherein the expandable body includes an inner body and an outer body, and the balloon is disposed between the inner body and the outer body. 36. A system according to embodiment 35, wherein the inner body is configured to be more compliant than the outer body. 37. The system of any one of embodiments 35-36, wherein the inner body is configured to encapsulate the balloon and hide the balloon from the flow through the lumen. 38. A system according to any one of embodiments 35-37, wherein the inner body is configured to have a smooth inner surface. 39. A system according to any of embodiments 35-38, wherein the inner body is configured to deflect inwardly and at least partially block the inner cavity when the balloon is actuated. 40. The system of any one of embodiments 30-39, further comprising a tube and a fluid reservoir fluidly connected to the balloon. 41. A system according to embodiment 40, wherein the fluid reservoir is configured to be implanted subcutaneously. 42. A system according to any of embodiments 40-41, wherein the tube is coaxially connected to the balloon. 43. A system according to any of embodiments 40-41, wherein the tube is eccentrically and / or tangentially connected to the balloon. 44. A system according to any one of embodiments 30-43, wherein the expandable body further comprises a plurality of st...

Claims

1. A long-term implantable current limiting system, the current limiting system comprising: an implant configured to be implanted in the inferior vena cava of the patient upstream of a renal vein of the patient and to adjustably occlude the inferior vena cava; and an implantable control unit operatively connected to the implant via a tube, the implantable control unit comprising: an actuator, wherein actuation of the actuator causes the implant to adjustably occlude the inferior vena cava; a processor configured to receive an instruction to actuate the actuator; and A communication module is operatively connected to the processor and configured to communicate wirelessly with an external device.

2. The system of claim 1, wherein the implant comprises: an expandable body having proximal and distal ends and a lumen extending longitudinally therethrough; and A flow restrictor is configured to articulate relative to the expandable body to at least partially restrict flow through the lumen.

3. The system of claim 2, wherein the flow restrictor comprises struts and a material spanning the struts, the material being configured to block blood flow.

4. A system according to any one of claims 2-3, wherein the flow restrictor is positioned adjacent to the distal end of the expandable body so that when implanted in the inferior vena cava, the flow restrictor is upstream of the expandable body relative to blood flow.

5. The system of any one of claims 2-4, wherein the implant further comprises a filter portion disposed adjacent to the proximal end of the expandable body, the filter portion being configured to capture a thrombus.

6. The system of any one of claims 1-5, wherein the implant comprises a pressure sensor operatively connected to the processor of the implantable control unit.

7. The system of claim 6, wherein the implantable control unit is configured to wirelessly transmit pressure readings from the pressure sensor to the external device.

8. The system according to any one of claims 1 to 7, further comprising the external device.

9. The system according to any one of claims 1-8, wherein the external device comprises a handheld device or a mobile device.

10. The system of any one of claims 1-9, wherein actuation of the actuator is controlled via the external device to cause the implant to adjustably occlude the inferior vena cava.

11. The system of claim 10, wherein the actuation via the external device is controlled by the patient or user.

12. The system of any one of claims 2-11, wherein the flow restrictor has a non-circular opening when at least partially restricting flow through the lumen.

13. The system of any one of claims 1-12, wherein the system does not include auxiliary equipment or pumps.

14. The system of any one of claims 1-13, wherein the implantable control unit is configured to be removably connected to the implant.

15. The system of any one of claims 1-14, wherein the implant is configured to be mechanically actuated by a wire.

16. A long-term implantable current limiting system, the current limiting system comprising: An implantable control unit, the implantable control unit comprising a housing and an actuator disposed within the housing; an implant comprising an expandable body having proximal and distal ends and a lumen extending longitudinally therethrough, and a flow restrictor configured to adjustably occlude the lumen when the expandable body is in an expanded state; a tube configured to connect the proximal end of the expandable body of the implant to the housing of the implantable control unit; and a shaft movably disposed within the tube, the shaft being configured to connect the actuator of the implantable control unit to the flow restrictor of the implant; wherein actuation of the actuator of the implantable control unit moves the shaft within the tube such that the flow restrictor of the implant adjustably occludes the lumen.

17. The system of claim 16, wherein the expandable body of the implant further comprises: a filter portion disposed adjacent the proximal end, the filter portion configured to capture thrombi, the filter portion comprising a plurality of struts extending radially outward and distally from the connection between the proximal end of the expandable body and the tube; and A radial support portion is connected to the filtering portion and disposed distally of the filtering portion, the radial support portion being configured to form a fluid seal on an inner wall of the patient's vasculature.

18. The system of claim 17, wherein the flow restrictor is connected to the radial support portion and extends distally from the radial support portion.

19. The system of any one of claims 16-18, wherein the flow restrictor is integrally formed with the expandable body.

20. The system of any one of claims 17-19, wherein the flow restrictor comprises: a plurality of petals, each petal formed by a pair of struts extending distally from the radial support portion and joined at a distal apex; and A material spanning each of the plurality of petals.

21. The system of claim 20, wherein the flow restrictor comprises three or more petals.

22. The system of any one of claims 20-21, wherein the material also spans at least a portion of the radial support portion.

23. A system according to any one of claims 20-22, wherein the distal end of each of the flaps of the flow restrictor is connected to the distal end of the shaft via a suture or a thread, and wherein the shaft slides or rotates proximally within the tube so that the suture or the thread pulls the distal ends of each of the flaps of the flow restrictor toward each other to at least partially block the inner cavity.

24. The system of any one of claims 16-23, wherein the distal end of the tube forms a fluid seal with the shaft via a retractable and extendable flexible coupling.

25. The system of any one of claims 16-24, wherein the implant is configured to be implanted in the inferior vena cava of the patient below the patient's renal veins, and the distal end of the flow restrictor is positioned to first receive blood flow therethrough.

26. The system of any one of claims 16-25, further comprising one or more pressure sensors configured to measure pressure of the patient's vasculature and output at least one signal in response to the measured pressure.

27. The system of claim 26, wherein the one or more pressure sensors include a pressure sensor configured to measure renal pressure of the patient.

28. The system of claim 27, wherein the pressure sensor configured to measure the renal pressure of the patient is disposed proximal to the flow restrictor.

29. The system of any one of claims 27-28, wherein the pressure sensor configured to measure the renal pressure of the patient is disposed adjacent to the proximal end of the expandable body or the distal end of the tube.

30. The system of claim 26, wherein the one or more pressure sensors include a pressure sensor configured to measure inferior vena cava pressure of the patient.

31. The system of claim 30, wherein the pressure sensor configured to measure the inferior vena cava pressure of the patient is disposed proximal or distal to the flow restrictor.

32. The system of any one of claims 30-31, wherein the pressure sensor configured to measure the inferior vena cava pressure of the patient is disposed adjacent to the distal end of the expandable body.

33. The system of any one of claims 26-32, wherein the implantable control unit further comprises a processor, wherein the processor is operatively connected to the one or more pressure sensors and is configured to receive and process the at least one signal to determine the pressure of the patient's vascular system.

34. The system of claim 33, wherein the implantable control unit further comprises a communication module operatively connected to the processor and configured to communicate wirelessly with an external device.

35. The system of claim 34, wherein the communication module transmits the determined pressure of the patient's vasculature to the external device.

36. A system according to claim 35, wherein the processor is operatively connected to the actuator of the implantable control unit, and based on the determined pressure, the patient or user is able to digitally actuate the actuator via the external device to cause the flow restrictor of the implant to adjustably block the inner cavity.

37. The system of any one of claims 34-36, further comprising the external device.

38. The system of any one of claims 16-36, wherein the expandable body further comprises one or more anchors configured to anchor the implant within the patient's vasculature.

39. The system of any one of claims 16-38, wherein the implantable control unit is configured to be powered by a battery disposed within the housing.

40. The system of claim 39, wherein the battery is configured to be charged by inductive charging.

41. The system of any one of claims 15-38, wherein the implantable control unit is configured to be powered by induction.

42. An implantable current limiting system, comprising: An implant, comprising: an expandable body comprising a metal frame having proximal and distal ends and a lumen extending longitudinally therethrough; and A current limiter, the current limiter comprising: a plurality of petals, each petal being formed by a strut; and a material spanning each petal of the plurality of petals; wherein the flow restrictor is configured to articulate relative to the expandable body to at least partially restrict flow through the lumen; and An implantable control unit, the implantable control unit comprising: an actuator configured to be operatively coupled to the flow restrictor of the implant; a processor configured to receive an instruction to actuate the actuator; and a communication module operatively connected to the processor and configured to communicate wirelessly with an external device; Wherein actuation of the actuator causes the flow restrictor to at least partially restrict flow through the lumen.

43. The system of claim 42, further comprising: a tube configured to connect the proximal end of the expandable body of the implant to the implantable control unit; and a shaft movably disposed within the tube, the shaft being configured to connect the actuator of the implantable control unit to the flow restrictor of the implant; Wherein actuation of the actuator of the implantable control unit moves the shaft within the tube such that the flow restrictor of the implant at least partially restricts flow through the lumen.

44. The system of any one of claims 42-43, wherein the implant further comprises a filter portion disposed adjacent to the proximal end of the expandable body, the filter portion being configured to capture a thrombus.

45. The system of any one of claims 42-44, wherein the struts forming each of the plurality of petals include a pair of struts extending distally from the expandable body and joined at a distal apex.

46. ​​The system of any one of claims 42-45, wherein the implant comprises a pressure sensor operatively connected to the processor of the implantable control unit.

47. The system of claim 46, wherein the implantable control unit is configured to wirelessly transmit pressure readings from the pressure sensor to the external device.

48. The system of any one of claims 42-47, further comprising the external device.

49. The system of any one of claims 42-48, wherein the external device comprises a handheld device or a mobile device.

50. The system of any one of claims 42-49, wherein actuation of the actuator is controlled via the external device such that the flow restrictor at least partially restricts flow through the lumen.

51. A system according to any one of claims 42-50, wherein the implant is configured to be implanted in the inferior vena cava of the patient upstream of the patient's renal vein, and blood flow in the inferior vena cava can be adjusted to be blocked when the flow restrictor at least partially restricts flow through the inner cavity of the implant.

52. The system of any one of claims 42-51, wherein the flow restrictor of the implant is configured to be located upstream of the expandable body relative to flow through the lumen when implanted in a patient.

53. The system of any one of claims 42-52, wherein an outer surface of the plurality of petals is configured to occlude blood flow when articulated relative to the expandable body.

54. An implantable current limiting system, comprising: An implant, comprising: an expandable body having proximal and distal ends and a lumen extending longitudinally therethrough; and a flow restrictor configured to be secured within a blood vessel of the patient's vasculature; and An implantable control unit, the implantable control unit comprising: an actuator configured to be operatively coupled to the flow restrictor of the implant; a processor configured to receive an instruction to actuate the actuator; and a communication module operatively connected to the processor and configured to communicate wirelessly with an external device; Wherein actuation of the actuator causes the flow restrictor to pull the wall of the blood vessel inward to at least partially restrict flow through the lumen.

55. The system of claim 54, further comprising: a tube configured to connect the proximal end of the expandable body of the implant to the implantable control unit; and a shaft movably disposed within the tube, the shaft being configured to connect the actuator of the implantable control unit to the flow restrictor of the implant; Wherein actuation of the actuator of the implantable control unit moves the shaft within the tube such that the flow restrictor of the implant pulls the wall of the blood vessel inwardly to at least partially restrict flow through the lumen.

56. The system of any one of claims 54-55, wherein the flow restrictor comprises a plurality of petals, each petal being formed by a strut and configured to articulate relative to the expandable body.

57. The system of any one of claims 54-56, wherein the struts forming each of the plurality of petals include a pair of struts extending distally from the expandable body and joined at a distal apex.

58. The system of any one of claims 56-57, wherein the flow restrictor further comprises material spanning each of the plurality of petals.

59. The system of any one of claims 54-58, wherein the flow restrictor is configured to at least partially grow inwardly into the vessel wall.

60. The system of any one of claims 54-59, wherein the flow restrictor further comprises one or more anchors configured to secure the flow restrictor to the vessel wall.

61. The system of any one of claims 54-60, wherein the implant comprises a pressure sensor operatively connected to the processor of the implantable control unit.

62. The system of claim 61, wherein the implantable control unit is configured to wirelessly transmit pressure readings from the pressure sensor to the external device.

63. The system of any one of claims 54-62, further comprising the external device.

64. The system of any one of claims 54-63, wherein the external device comprises a handheld device or a mobile device.

65. The system of any one of claims 54-64, wherein actuation of the actuator is controlled via the external device to cause the flow restrictor to pull the wall of the blood vessel inwardly to at least partially restrict flow through the lumen.

66. A system according to any one of claims 54-65, wherein the implant is configured to be implanted in the inferior vena cava of the patient upstream of the patient's renal vein and to adjustably block blood flow in the inferior vena cava when the flow restrictor pulls the wall of the inferior vena cava inward to at least partially restrict flow through the inner lumen of the implant.

67. The system of any one of claims 54-66, wherein the flow restrictor of the implant is configured to be upstream of the expandable body relative to flow through the lumen when implanted in the patient.

68. The system of any one of claims 54-67, wherein the system does not include an auxiliary device or a pump.

69. An implant configured to be implanted in a patient for controllably and selectively occluding, restricting and / or diverting flow in the patient's vasculature, the implant comprising: an expandable body having a proximal end and a distal end and a lumen extending longitudinally therethrough, and a filtering portion disposed adjacent the proximal end, the filtering portion configured to capture a thrombus; and a flow restrictor extending from the distal end of the expandable body, the flow restrictor being configured to adjustably block the lumen when the expandable body is in an expanded state; Wherein when implanted, the flow restrictor is configured to be located upstream of the expandable body relative to blood flow.

70. The implant of claim 69 wherein the filtering portion comprises a plurality of struts extending proximally and radially inwardly.

71. An implant according to claim 70, wherein the expandable body of the implant further comprises a radial support portion, which is connected to the filtering portion and disposed distally of the filtering portion, and the radial support portion is configured to form a fluid seal on the inner wall of the patient's vascular system.

72. The implant of claim 71 wherein the flow restrictor is connected to the radial support portion and extends distally from the radial support portion.

73. The implant of any one of claims 69-72, wherein the flow restrictor is integrally formed with the expandable body.

74. An implant according to any one of claims 69-73, wherein the flow restrictor includes a plurality of flaps configured to fold radially inward to adjustably block the inner cavity, wherein when folded radially inward, outer surfaces of the plurality of flaps are configured to block blood flow.

75. The implant of claim 74 wherein each of the plurality of petals is formed by a pair of struts extending from the expandable body and joined at a distal apex.

76. The implant of any one of claims 74-75, wherein the flow restrictor comprises three or more petals.

77. The implant of any one of claims 74-76, wherein the flow restrictor is provided with an obstruction material, and wherein the areas between the plurality of petals are free of the obstruction material.

78. The implant of any one of claims 74-76, wherein the flow restrictor carries an obstruction material, and wherein the obstruction material spans the plurality of petals and areas between the plurality of petals.

79. An implant according to any one of claims 77-78, wherein the occluding material also spans at least a portion of the expandable body.

80. The implant of any one of claims 69-79, wherein the flow restrictor has a non-circular opening when at least partially blocking the lumen.

81. The implant of any one of claims 69-80, wherein the flow restrictor has a star-shaped opening when at least partially blocking the lumen.

82. The implant of any one of claims 69-81, wherein the implant further comprises a pressure sensor.

83. The implant of claim 82, wherein the pressure sensor is disposed proximal to the flow restrictor.

84. The implant of any one of claims 71-83, further comprising an anchor extending proximally from the radial support portion, the anchor being configured to anchor the implant within the patient's vasculature.

85. The implant of any one of claims 69-84, wherein the implant is configured to be implanted in the inferior vena cava of the patient.

86. A system comprising an implant according to any one of claims 71-85 and a delivery sheath configured to implant the implant.

87. The system of claim 86, wherein the implant is configured to, when extended outside the delivery sheath, remain in a contracted state while at least a portion of the radial support portion remains inside the delivery sheath.

88. An implant configured to be implanted in a patient for occluding, restricting and / or diverting flow in the patient's vasculature, the implant comprising: an expandable body comprising a metal frame having a proximal end and a distal end and a lumen extending longitudinally therethrough; and A current limiter, the current limiter comprising: a plurality of petals, each petal formed by a pair of struts extending distally from the expandable body and joined at a distal apex; and a material spanning each petal of the plurality of petals; Wherein the flow restrictor is configured to fold radially inward to at least partially restrict flow through the lumen.

89. The implant of claim 88, wherein the expandable body of the implant further comprises a filter portion disposed adjacent to the proximal end, the filter portion being configured to capture a thrombus.

90. An implant according to claim 89, wherein the expandable body of the implant further comprises a radial support portion, which is connected to the filtering portion and disposed distally of the filtering portion, and the radial support portion is configured to form a fluid seal on the inner wall of the patient's vascular system.

91. The implant of any one of claims 88-90, wherein the flow restrictor is integrally formed with the expandable body.

92. The implant of any one of claims 88-91, wherein the outer surface of the plurality of petals of the flow restrictor are configured to obstruct blood flow when folded radially inward.

93. The implant of any one of claims 88-92, wherein the flow restrictor comprises three or more petals.

94. The implant of any one of claims 88-93, wherein areas between the plurality of petals are free of the material.

95. An implant according to any one of claims 88-93, wherein the material also spans the areas between the plurality of petals.

96. The implant of any one of claims 88-95, wherein the material also spans at least a portion of the expandable body.

97. An implant according to any one of claims 88-96, wherein the flow restrictor has a non-circular opening when at least partially blocking the inner cavity.

98. The implant of any one of claims 88-97, wherein the flow restrictor has a star-shaped opening when at least partially blocking the lumen.

99. The implant of any one of claims 88-98, wherein the implant further comprises a pressure sensor.

100. The implant of claim 99, wherein the pressure sensor is disposed proximal to the flow restrictor.

101. The implant of any one of claims 90-100, further comprising an anchor extending proximally from the radial support portion, the anchor being configured to anchor the implant within the patient's vascular system.

102. The implant of any one of claims 88-101, wherein the implant is configured to be implanted in the inferior vena cava of the patient.

103. The implant of any one of claims 88-102, wherein when implanted, the flow restrictor is configured to be located upstream of the expandable body relative to blood flow.

104. A system comprising an implant according to any one of claims 90-103 and a delivery sheath configured to implant the implant.

105. The system of claim 104, wherein the implant is configured to, when extended outside the delivery sheath, remain in a contracted state while at least a portion of the radial support portion remains within the delivery sheath.

106. An implant configured to be implanted in a patient for occluding, restricting and / or diverting flow in the patient's vasculature, the implant comprising: an expandable body having proximal and distal ends and a lumen extending longitudinally therethrough; and a flow restrictor configured to be secured within a blood vessel of the patient's vasculature; Wherein activation of the flow restrictor causes the flow restrictor to pull the wall of the blood vessel inward to at least partially restrict flow through the lumen.

107. The implant of claim 106, wherein the flow restrictor comprises a plurality of petals, each petal being formed by a strut and configured to articulate relative to the expandable body.

108. The system of claim 107, wherein the struts forming each of the plurality of petals comprise a pair of struts extending distally from the expandable body and joined at a distal apex.

109. The implant of any one of claims 107-108, wherein the flow restrictor further comprises material spanning each of the plurality of petals.

110. The implant of any one of claims 106-109, wherein the flow restrictor is configured to at least partially grow inwardly into the vessel wall.

111. The implant of any one of claims 106-110, wherein the flow restrictor further comprises one or more anchors configured to secure the flow restrictor to the vessel wall.

112. The implant of any one of claims 106-111, wherein the flow restrictor is integrally formed with the expandable body.

113. The implant of any one of claims 106-112, wherein the implant comprises a pressure sensor configured to measure pressure.

114. The implant of claim 113, wherein the pressure sensor is disposed proximal to the flow restrictor.

115. An implant according to any one of claims 106-114, wherein the expandable body of the implant further comprises a filter portion, the filter portion being disposed adjacent to the proximal end of the expandable body, the filter portion being configured to capture a thrombus.

116. The implant of claim 115, wherein the filtering portion comprises a plurality of struts extending proximally and radially inwardly.

117. The implant of any one of claims 106-116, wherein the implant is configured to be implanted in the inferior vena cava of the patient.

118. An implant according to any one of claims 106-117, wherein when implanted, the flow restrictor is configured to be located upstream of the expandable body relative to flow through the inner cavity of the implant.

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