Systems, devices, and methods for controllable enhancement of diuresis

Abstract

Various systems, devices, components and methods are disclosed for controllably and selectively occluding, restricting, and / or diverting flow within a patient's vasculature. The flow restriction systems can include an implant having a flow restrictor and an implantable controller having an actuator for actuating the flow restrictor. The implants can be severable from their respective controller and actuator. The implants can include a dual frame configuration to prevent tissue ingrowth into at least one of the frames.

Description

INQB.027WO PATENT SYSTEMS, DEVICES, AND METHODS FOR CONTROLLABLE ENHANCEMENT OF DIURESIS INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

[0001] The present application claims priority to U.S. Provisional Application No. 63 / 591,345, filed October 18, 2023. The above-listed application and any and all other applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present 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

[0003] An identified issue in heart failure is volume overload, wherein there is an excess of pressure built up in the venous system which can cause the heart to not work as well as a pump. Reducing the total volume of fluid in the body, such as by the administration of diuretics, is one method to reduce volume overload and improve heart function. Another way to improve heart function in heart failure is to shift the distribution of blood in the vascular system. Such a shift in the distribution of blood can affect the preload on the heart and thus the heart’s ability to pump effectively. Additionally, shifting venous blood volume away from the renal system and / or lymphatic ducts can enhance diuresis, further reducing volume overload and improving heart function. SUMMARY

[0004] Current nonpharmacological therapies aimed at reducing volume overload and / or reducing preload lack chronic controllability and / or adjustability. Additionally, current methods to improve and / or control diuresis include systemic application of diuretics, which can significantly affect patient quality of life. A more controllable method of controllingdiuresis is desired. To address these and other unmet needs, the present disclosure describes various implementations of chronic, implantable flow restriction systems, devices, and methods for controllably and selectively occluding, restricting, and / or diverting flow within a patient’s vasculature. The chronic, implantable flow restriction systems and devices described herein can be actuated in a variety of ways, including magnetically, fluidically including pneumatically, mechanically, via heat (e.g., induction heating), and / or via another energy source. Furthermore, the chronic, implantable flow restriction systems and devices described herein can be configured to provide partial and / or full occlusion of a vessel from within the vessel and / or external to the vessel. Such ability to chronically control the occlusion of a patient’s vessel(s) can allow, for example, the control of diuresis without systemic drugs / medication.

[0005] Disclosed herein is a chronic, implantable flow restriction system for controllably and selectively occluding, restricting and / or diverting flow within a patient’s vasculature to reduce renal congestion and / or to reduce cardiac preload. The system can have a leadless configuration in which operative components of the system are entirely disposed within the vasculature, though user interface and charging components may be provided for wireless interaction with the implanted operative components.

[0006] In the above chronic, implantable flow restriction system or in other implementations as described herein, one or more of the following features can also be provided. In some implementations, the system is adapted to controllably and selectively reduce central venous pressure and / or other venous pressure, which can include inferior vena cava pressure, renal venous pressure, and / or pressure of other veins disclosed herein. In some implementations the system is adapted to enhance renal circulation. In some implementations, the system is adapted to enhance or to control diuresis. In some implementations, the system is adapted to improve cardiac output. In some implementations, the system is adapted to controllably and selectively occlude or divert flow from the superior vena cava. In some implementations, the system is adapted to controllably and selectively occlude or divert flow from the inferior vena cava. In some implementations, the system comprises a magnetically actuated implantable device. In some implementations, the system comprises a fluidically actuated implantable device. In some implementations, the system comprises a heat actuated implantable device. In some implementations, the system comprises a mechanically actuatedimplantable device. In some implementations, the system comprises a mechanical cinching mechanism on an implantable stent. In some implementations, the system further comprises a control unit configured to control occluding, restricting and / or diverting flow within the patient’s vasculature. In some implementations, the control unit is configured to receive readings from one or more pressure sensors positioned within the patient, and the control unit is configured to control occluding, restricting and / or diverting flow within the patient’s vasculature based on the readings. In some implementations, therapy delivered by the system is digitally actuated. In some implementations, therapy delivered by the system is scheduled based on a time of a day and / or on an amount of time per day.

[0007] In one embodiment, a leadless flow restriction system is provided that can include an intravascular housing, a control unit, and a flow restrictor assembly. The intravascular housing can enclose an actuator. The actuator can include a motor configured to rotate a first shaft and a drive component coupled with a distal end of the first shaft. The control unit can be disposed in or can be coupled with the intravascular housing and with the motor. The flow restrictor assembly can include an expandable body, a flow restrictor, and a transfer shaft assembly. The expandable body can have a proximal end, a distal end, and a lumen extending longitudinally therethrough. The flow restrictor can be configured to adjustably occlude the lumen when the expandable body is in an expanded configuration. The transfer shaft assembly can comprise a transfer shaft that has a proximal end and a distal end. A driven component can be coupled with the proximal end of the transfer shaft. The distal end of the transfer shaft can be configured to connect to the flow restrictor. A coupling can be provided by the driven component and the drive component such that, in use, activation of the motor causes rotation of the transfer shaft through the coupling of the drive component and the driven component to cause the flow restrictor to adjustably occlude the lumen.

[0008] In another embodiment, a leadless flow restriction system can include an intravascular housing, a control unit, and a flow restrictor assembly. The intravascular housing can enclose an actuator that is configured to rotate a first shaft and a drive element coupled with a distal end of the first shaft. The control unit can be disposed in or coupled with the intravascular housing and with the actuator. The flow restrictor assembly can have an expandable body, a flow restrictor, and a transfer shaft. The expandable body can have a proximal end, a distal end, and a lumen that extends longitudinally therethrough. The flowrestrictor can be configured to adjustably occlude the lumen when the expandable body is in an expanded configuration. The transfer shaft assembly can have a transfer shaft that has a proximal end and a distal end and a driven element. The driven element can be coupled with the proximal end of the transfer shaft. The distal end of the transfer shaft can be configured to connect to the flow restrictor. The driven element can be engaged with the drive element such that, in use, activation of the actuator causes rotation or linear motion of the transfer shaft through a connection between the drive element and the driven element to cause the flow restrictor to adjustably occlude the lumen.

[0009] In another embodiment, a chronic, implantable flow restriction system is provided that can include an implant, a fixed structure and a shaft movingly coupled to the fixed structure. The implant can have a flow restrictor configured to adjustably achieve a low profile state and a high profile state. The flow restrictor can have a frame that has a first end, a paddle-forming span, and a second end. An occlusive material can be disposed across the paddle-forming span. The fixed structure can be coupled with the first end of the frame of the flow restrictor. The shaft can have a second aperture coupled with the second end of the frame. Movement of the shaft relative to the fixed structure can actuate the paddle-forming span from the low profile state to the high profile state.

[0010] Disclosed herein is a chronic, implantable flow restriction system comprising an implant, a tubing, and a shaft. The implant can comprise: an expandable body having a proximal end and a distal end and a lumen extending longitudinally therethrough, the expandable body also comprising a radial support portion; and a flow restrictor configured to adjustably occlude the lumen when actuated, the flow restrictor comprising: a plurality of petals each formed by a pair of struts that extend distally from the radial support portion and that join at a distal apex; and an occlusive member having a first portion spanning one or each of the plurality of petals and a second portion comprising a tension member having a first end comprising a continuous extension of the first portion of the occlusive member spanning the one or each of the plurality of petals and a second end opposite the first end. The tubing can be configured to connect the proximal end of the expandable body of the implant to a control unit. The shaft can be movingly disposed within the tubing, the shaft being coupled with the second end of the tension member. The chronic, implantable flow restriction system can beconfigured such that movement of the shaft within the tubing actuates the flow restrictor of the implant to adjustably occlude the lumen.

[0011] In the above chronic, implantable flow restriction system or in other implementations as described herein, one or more of the following features can also be provided. In some implementations, the occlusive member comprises an ePTFE layer. In some implementations, the ePTFE layer is disposed over a periphery of the expandable body and a periphery of the one or each of the plurality of petals. In some implementations, at least one of the petals comprises a frame distal apex and the occlusive member comprises an ePTFE layer distal apex, the first end of the tension member extending continuously from the ePTFE layer distal apex.

[0012] Disclosed herein is a chronic, implantable flow restriction system comprising an implant, a fixed structure, and a shaft. The implant can comprise a flow restrictor configured to be adjusted between a low profile state and a high profile state, the flow restrictor comprising: a plurality of petals each formed by a plurality of struts that extend distally from a radial support portion and that form a distal apex; and an occlusive member comprising a material spanning at least one of the plurality of petals and a tension member having a first end comprising a continuous extension of the material spanning the at least one of the plurality of petals and a second end opposite the first end. The fixed structure can be coupled with the radial support portion of the flow restrictor. The shaft can be movingly coupled with the fixed structure, the shaft having a free end coupled with the second end of the tension member. Movement of the shaft relative to the fixed structure can actuate the plurality of petals to cause the flow restrictor to adjust between the low profile state and the high profile state.

[0013] In the above chronic, implantable flow restriction system or in other implementations as described herein, one or more of the following features can also be provided. In some implementations, the fixed structure comprises a tubing and the shaft is disposed within the tubing, wherein movement of the shaft within the tubing applies a tension to the tension member to actuate the plurality of petals from the low profile state to the high profile state. In some implementations, rotation of the shaft within the tubing spools the second end of the tension member to apply a tension thereto to actuate the plurality of petals from the low profile state to the high profile state. In some implementations, the tubing is configured to couple to an extravascular controller. In some implementations, the fixed structure comprisesor is coupled with an intravascular housing configured to house a motor and a transmission configured to induce motion of the shaft responsive to motion of the motor. In some implementations, the system further comprises a control unit disposed in or coupled with the intravascular housing. In some implementations, the system further comprises a sensor configured to generate a signal indicative of pressure in a blood vessel, the signal being provided to the control unit. In some implementations, the flow restrictor at least partially occludes a lumen of the implant when adjusted to the high profile state.

[0014] Disclosed herein is a chronic, implantable flow restriction system comprising a first expandable body, a second expandable body, and a flow restrictor. The first expandable body can comprise a coupling feature disposed in an inner portion of the first expandable body, the first expandable body comprising a radial support portion configured to couple to an inner wall of a patient’s vasculature. The second expandable body can comprise a proximal end and a distal end and a lumen extending longitudinally therethrough, the second expandable body configured to engage or connect with the coupling feature of the first expandable body such that the second expandable body is suspended away from the inner wall of the patient’s vasculature when the second expandable body is engaged or connected with the coupling feature of the first expandable body. The flow restrictor can be coupled with the second expandable body, the flow restrictor configured to adjustably occlude the lumen of the second expandable body.

[0015] In the above chronic, implantable flow restriction system or in other implementations as described herein, one or more of the following features can also be provided. In some implementations, the coupling feature is a first coupling feature and the second expandable body comprises a second coupling feature configured to engage or connect with the first coupling feature when the second expandable body is expanded within the first expandable body. In some implementations, the first coupling feature comprises a plurality of frame projections, each projection of the plurality of projections having a fixed end extending from the radial support portion of the first expandable body and a free end disposed proximally of the fixed end, the free end being enlarged relative to the fixed end. In some implementations, each of the free ends comprise a circular aperture. In some implementations, the plurality of frame projections are angled inward toward a central area of a lumen formed within the first expandable body when the first expandable body is expanded. In some implementations, theplurality of frame projections comprises a first plurality of frame projections and wherein the second coupling feature comprises a second plurality of frame projections having a fixed end disposed adjacent to the proximal end of the second expandable body and a free end disposed distally of the fixed end, the free end of at least some of the frame projections of the second plurality of frame projections being configured to be received in an annular space between the frame projections of the first plurality of frame projections and the inner wall of the patient’s vasculature when the second expandable frame is expanded within the first expandable frame when in use. In some implementations, the second coupling feature comprises a plurality of frame projections having a fixed end disposed adjacent to the proximal end of the second expandable body and a free end disposed distally of the fixed end, the free end of frame projections of the plurality of frame projections configured to be received in an annular space between the first coupling feature and the inner wall of the patient’s vasculature when the second expandable body is expanded within the first expandable body when in use. In some implementations, the frame projections of the plurality of frame projections of the second coupling feature are angled outward and away from the lumen of the second expandable body when the second expandable body is expanded. In some implementations, the second coupling feature comprises a plurality of second circular apertures configured to connect to the circular apertures of the plurality of frame projections of the first coupling feature via a suture or a wire. In some implementations, the first expandable body comprises a filter portion disposed adjacent a proximal end thereof configured to capture thrombus, the filter portion comprising a plurality of struts that extend radially outward and distally from a connection between the proximal end of the first expandable body and a fixed structure of the system when the first expandable body is expanded. In some implementations, the connection is configured to connect to a tubing configured to extend from the first expandable body to outside the patient’s vasculature. In some implementations, the connection is configured to connect to an intravascular housing configured to house a motor. In some implementations, the flow restrictor comprises a plurality of petals comprising a plurality of struts that extend distally of a radial support portion of the second expandable body and that join at a distal apex. In some implementations, an occlusive material spans each of the plurality of petals of the second expandable body, the first expandable body suspending the occlusive material away from the inner wall of the patient’s vasculature when the second expandable body is engaged or coupledwith the coupling feature of the first expandable body. In some implementations, the flow restrictor is configured to hinge relative to the second expandable body. In some implementations, the second expandable body is configured to hinge relative to the first expandable body about the coupling feature of the first expandable body when the flow restrictor adjustably occludes the lumen. In some implementations, a circumferential gap is formed between the second expandable body and the first expandable body when the second expandable body is engaged or connected with the coupling feature of the first expandable body. In some implementations, the flow restrictor is further configured to adjustably occlude the circumferential gap. In some implementations, the second expandable body is configured to adjustably occlude the circumferential gap when the flow restrictor adjustably occludes the lumen.

[0016] Disclosed herein is a chronic, implantable flow restriction system comprising an implant, a tubing, and a shaft. The implant can comprise an expandable body having a proximal end and a distal end and a lumen extending longitudinally therethrough, and a flow restrictor configured to adjustably occlude the lumen when the expandable body is in an expanded configuration. The tubing can be configured to releasably connect at least a portion of the expandable body of the implant to a control unit. The shaft can be moveable relative to the tubing configured to connect an actuator of the control unit to the flow restrictor. Movement of the shaft relative to the tubing can cause the flow restrictor of the implant to adjustably occlude the lumen.

[0017] In the above chronic, implantable flow restriction system or in other implementations as described herein, one or more of the following features can also be provided. In some implementations, the system further comprises a plurality of struts that extend radially outward and distally from a first connection between the tubing and the proximal end of the expandable body, the expandable body further comprising a radial support portion disposed distal of and releasably connected to the plurality of struts, the radial support portion configured to fluidically seal against an inner wall of a patient’s vasculature. In some implementations, the plurality of struts form a filter portion of the implant. In some implementations, the system further comprises a severable connection disposed between a distal end of the struts of the plurality of struts and a proximal end of the radial support portion. In some implementations, a distal portion of the struts of the plurality of struts comprise a distalaperture and a proximal portion of the radial support portion comprises a proximal aperture, and further comprising a suture looped through the distal aperture and the proximal aperture. In some implementations, the suture is configured to be severed to release the plurality of struts and the tubing from the radial support portion such that the plurality of struts and the tubing can be moved proximally while leaving the radial support portion within the patient’s vasculature. In some implementations, the proximal aperture of the radial support portion is disposed around a barb configured to anchor the radial support portion with the inner wall of the patient’s vasculature. In some implementations, the system further comprises a severable connection disposed between a proximal end of the struts of the plurality of struts and the tubing. In some implementations, the severable connection comprises a suture looped through an aperture at a proximal end of each strut of the plurality of struts. In some implementations, the suture is further looped through a suture connection feature of the tubing.

[0018] Disclosed herein is a chronic, implantable flow restriction system comprising an implant, a tubing, and a shaft. The implant can comprise an expandable body having a proximal end and a distal end and a lumen extending longitudinally therethrough, and a flow restrictor configured to adjustably occlude the lumen when the expandable body is in an expanded configuration. The tubing can be configured to releasably connect the expandable body of the implant to a control unit. The shaft can be moveable relative to the tubing and can be configured to connect an actuator of the control unit to the flow restrictor. Movement of the shaft relative to the tubing can cause the flow restrictor of the implant to adjustably occlude the lumen. The implant can include a severable connection that, when severed, is configured to separate the tubing from at least a portion of the expandable body of the implant.

[0019] In the above chronic, implantable flow restriction system or in other implementations as described herein, one or more of the following features can also be provided. In some implementations, the system further comprises a plurality of struts that extend radially outward and distally from a first connection between the tubing and the proximal end of the expandable body, the expandable body further comprising a radial support portion disposed distal of and releasably connected to the plurality of struts, the radial support portion configured to fluidically seal against an inner wall of a patient’s vasculature. In some implementations, the plurality of struts form a filter portion of the implant. In some implementations, the severable connection is disposed between a distal end of the struts of theplurality of struts and a proximal end of the radial support portion. In some implementations, the system further comprises a material configured to releasably connect the distal end of the struts of the plurality of struts and the proximal end of the radial support portion. In some implementations, the material is configured to be severed to release the plurality of struts and the tubing from the radial support portion such that the plurality of struts and the tubing can be moved proximally while leaving the radial support portion within the patient’s vasculature. In some implementations, a distal portion of the struts of the plurality of struts comprise a distal aperture and a proximal portion of the radial support portion comprises a proximal aperture, and the system further comprises a suture looped through the distal aperture and the proximal aperture. In some implementations, the suture is configured to be severed to release the plurality of struts and the tubing from the radial support portion such that the plurality of struts and the tubing can be moved proximally while leaving the radial support portion within the patient’s vasculature. In some implementations, the system further comprises a material configured to releasably connect the distal end of the struts of the plurality of struts and the proximal end of the radial support portion. In some implementations, the material and the suture are configured to be severed to release the plurality of struts and the tubing from the radial support portion such that the plurality of struts and the tubing can be moved proximally while leaving the radial support portion within the patient’s vasculature. In some implementations, the proximal aperture of the radial support portion is disposed around a barb configured to anchor the radial support portion with the inner wall of the patient’s vasculature. In some implementations, the severable connection is disposed between a proximal end of the struts of the plurality of struts and the tubing. In some implementations, the severable connection comprises a suture looped through an aperture at a proximal end of each strut of the plurality of struts. In some implementations, the suture is further looped through a suture connection feature of the tubing. In some implementations, the severable connection comprises a material configured to releasably connect the proximal end of each strut of the plurality of struts to the tubing.

[0020] For purposes of summarizing the disclosure, certain aspects, advantages and novel features of several implementations have been described herein. It is to be understood that not necessarily all such advantages are achieved in accordance with any particular implementation of the technology disclosed herein. Thus, the implementations disclosed hereincan be implemented or carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other advantages that can be taught or suggested herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Certain features of this disclosure are described below with reference to the drawings. The illustrated implementations are intended to illustrate, but not to limit, the implementations. Various features of the different disclosed implementations can be combined to form further implementations, which are part of this disclosure.

[0022] FIG. 1 illustrates a chronic, implantable flow restriction system that is implanted within a patient in accordance with some aspects of this disclosure.

[0023] FIGS. 2A-2D illustrate an implementation of an implant of a chronic, implantable flow restriction system in accordance with some aspects of this disclosure.

[0024] FIGS.3A-3C illustrate various end views of the implant of FIGS.2A-2D in accordance with some aspects of this disclosure.

[0025] FIG.3D illustrates an end view of another implementation of the implant of FIGS.2A-2D in accordance with some aspects of this disclosure.

[0026] FIGS. 3E-3F illustrate various views of a variant of the implant of FIGS. 2A-2D in accordance with some aspects of this disclosure.

[0027] FIG.4 illustrates a flat pattern of view of the expandable body of the implant of FIGS.2A-2D in accordance with some aspects of this disclosure.

[0028] FIGS. 5A-5B illustrate various views of components of a chronic, implantable flow restriction system in accordance with some aspects of this disclosure.

[0029] FIGS. 6A-6D illustrate interaction of various components of a flow restriction system to actuate the implant of FIGS. 2A-2D in accordance with some aspects of this disclosure.

[0030] FIGS. 7A-7C illustrate various implementations of an implant of a flow restriction system with a sensor located in various positions relative to a flow restrictor portion of the implant in accordance with some aspects of this disclosure.

[0031] FIG. 8 illustrates an implementation of an implant of an implantable flow restriction system in accordance with some aspects of this disclosure.

[0032] FIG. 9 illustrates an implementation of an implant of an implantable flow restriction system in accordance with some aspects of this disclosure.

[0033] FIGS. 10A-10B illustrate an implementation of an implant of an implantable flow restriction system in accordance with some aspects of this disclosure.

[0034] FIG.11 illustrates an implementation of an implant of an implantable flow restriction system in accordance with some aspects of this disclosure.

[0035] FIG.12 illustrates an implementation of an implant of an implantable flow restriction system in accordance with some aspects of this disclosure.

[0036] FIG.13 illustrates an implementation of an implant of an implantable flow restriction system in accordance with some aspects of this disclosure.

[0037] FIGS. 14A-14C illustrate interaction of various components of an implementation of a flow restriction system to actuate an implant thereof in accordance with some aspects of this disclosure.

[0038] FIGS. 15A-15B illustrate an implementation of an implant of an implantable flow restriction system in accordance with some aspects of this disclosure.

[0039] FIGS. 16A-16B illustrate an implementation of an implant of an implantable flow restriction system in accordance with some aspects of this disclosure.

[0040] FIGS. 17A-17C illustrate an implementation of an implant of an implantable flow restriction system in accordance with some aspects of this disclosure.

[0041] FIG.18 illustrates an implementation of an implant of an implantable flow restriction system in accordance with some aspects of this disclosure.

[0042] FIGS. 19-19F illustrate various implementations of a releasable implant of an implantable flow restriction system in accordance with some aspects of this disclosure.

[0043] FIGS. 20A-20C illustrate an implementation of an implant of an implantable flow restriction system in accordance with some aspects of this disclosure.

[0044] FIG.21 illustrates an implementation of an implant of an implantable flow restriction system in accordance with some aspects of this disclosure.

[0045] FIG.22 illustrates an implementation of an implant of an implantable flow restriction system in accordance with some aspects of this disclosure.

[0046] FIGS. 23A-23B illustrate an implementation of a shaft of an implantable flow restriction system in accordance with some aspects of this disclosure.

[0047] FIG.24 illustrates a schematic diagram of certain features of an implantable controller and an external device of an implantable flow restriction system in accordance with some aspects of this disclosure.

[0048] FIGS. 25A-25C illustrate an implementation of a connector between components of a flow restriction system in accordance with some aspects of this disclosure.

[0049] FIGS. 26A-26B illustrate an implementation of a connector between components of a flow restriction system in accordance with some aspects of this disclosure.

[0050] FIGS. 27A-27D illustrate an implementation of a connector between components of a flow restriction system in accordance with some aspects of this disclosure.

[0051] FIGS.28A-28B illustrate an implementation of an implant assembly having an extender for implantation in accordance with some aspects of this disclosure.

[0052] FIGS.29A-29B illustrate an implementation of a device for testing function of an implant during implantation thereof in accordance with some aspects of this disclosure.

[0053] FIGS.30A-30B illustrate an implementation of a device for testing function of an implant during implantation thereof in accordance with some aspects of this disclosure.

[0054] FIG. 31 illustrates a method of implanting an implantable flow restriction system in accordance with some aspects of this disclosure.

[0055] FIGS.32A-32D illustrate deployment of an implant of an implantable flow restriction system in accordance with some aspects of this disclosure.

[0056] FIG.33 illustrates a guideline for treatment of a patient using an implantable flow restriction system in accordance with some aspects of this disclosure.

[0057] FIG.34 illustrates a manual method of using an implantable flow restriction system in accordance with some aspects of this disclosure.

[0058] FIG. 35 illustrates a semi-automatic method of using an implantable flow restriction system in accordance with some aspects of this disclosure.

[0059] FIG. 36 illustrates an automatic method of using an implantable flow restriction system in accordance with some aspects of this disclosure.

[0060] FIGS.37A-37C illustrate an implementation of delivering therapy using an implantable flow restriction system in accordance with some aspects of this disclosure.

[0061] FIG.38 is a perspective view of a leadless flow restriction system.

[0062] FIG.39 is a longitudinal cross-section of the leadless flow restriction system of FIG.38.

[0063] FIG.40 is a view of details of an actuator including a magnetic coupling for driving rotation of a transfer shaft.

[0064] FIGS.41-42B illustrate a flow restriction system actuatable by a fraction of a rotation between a flow permitting configuration and a flow restricting configuration.

[0065] FIGS.43A-43D illustrate a flow restriction system actuatable by twisting a distal portion of a frame supporting an occlusive material relative to a proximal portion thereof to induce a spiral shape in the frame.

[0066] FIGS. 44-44A illustrate a flow restriction system actuatable by reducing a spacing between a distal portion and a proximal portion of a flow restrictor with a braided portion, causing the braided portion to change from a longer and thinner configuration to a shorter and wider configuration.

[0067] FIGS. 45-45A illustrate a flow restriction system actuatable by reducing a spacing between a distal portion and a proximal portion of a flow restrictor with a frame structure, causing the frame structure to change from a longer and thinner configuration to a shorter and wider configuration.

[0068] FIGS 46A-46B illustrate an implementation of an anchor frame of a dual frame implant of an implantable flow restriction system in accordance with some aspects of this disclosure.

[0069] FIGS 47A-47C illustrate implementations of an occlusion frame of a dual frame implant of an implantable flow restriction system in accordance with some aspects of this disclosure.

[0070] FIGS 48A-48B illustrate an implementation of a dual frame implant of an implantable flow restriction system in accordance with some aspects of this disclosure.

[0071] FIG. 48C illustrates a variant of the dual frame implant of FIGS. 48A-48B in accordance with some aspects of this disclosure.

[0072] FIGS 49A-49B illustrate an implementation of a dual frame implant of an implantable flow restriction system in accordance with some aspects of this disclosure.

[0073] FIG. 49C illustrates a variant of the dual frame implant of FIGS. 49A-49B in accordance with some aspects of this disclosure.

[0074] FIGS.50A-50C illustrate various end views of the implants of FIGS. 48A- 48B and FIGS.49A-49B in accordance with some aspects of this disclosure.

[0075] FIG.50D illustrates an end view of the implants of FIG.48C and FIG.49C in accordance with some aspects of this disclosure. DETAILED DESCRIPTION

[0076] Various features and advantages of this disclosure will now be described with reference to the accompanying figures. The following description is merely illustrative in nature and is in no way intended to limit the disclosure, its application, or uses. This disclosure extends beyond the specifically disclosed implementations and / or uses and obvious modifications and equivalents thereof. Thus, it is intended that the scope of this disclosure should not be limited by any particular implementations described below. The features of the illustrated implementations can be modified, combined, removed, and / or substituted as will be apparent to those of ordinary skill in the art upon consideration of the principles disclosed herein. Furthermore, implementations disclosed herein can include several novel features, no single one of which is solely responsible for its desirable attributes or which is essential to practicing the systems, devices, and / or methods disclosed herein.

[0077] Parts, components, features, and / or elements of the chronic, implantable flow restriction systems and devices described herein that can function the same or similarly across various implementations are identified using the same reference numerals with a different letter added after the reference numerals. Differences between the various implementations are discussed herein.

[0078] The present disclosure describes various implementations of chronic, implantable flow restriction systems, devices, and methods for controllably and selectively occluding, restricting, and / or diverting flow within a patient’s vasculature. Such systems, devices, and methods can be used to redirect flow and / or enhance perfusion within the patient’s vasculature and / or one or more of the patient’s organs. In some circumstances, it can be advantageous to controllably and selectively occlude, restrict, and / or divert flow within a patient’s vasculature to reduce renal congestion (or promote renal decongestion), to reduce hepatic congestion (or promote hepatic decongestion), to reduce cardiac preload, and / or to reduce lymphatic / interstitial congestion. For example, a chronically implantable flowrestriction system adapted to controllably and selectively occlude and / or restrict a patient’s superior vena cava upstream of where the superior vena cava enters the patient’s right atrium can be used to reduce cardiac preload. Such a chronically implantable flow restriction system can also be adapted to controllably and selectively reduce central venous pressure and / or pressure of other veins disclosed herein and / or improve cardiac output. As another example, a chronically implantable flow restriction system adapted to controllably and selectively occlude and / or restrict a patient’s inferior vena cava upstream of where the patient’s renal veins connect with the inferior vena cava (e.g., below where the renal veins connect with the inferior vena cava) can be used to reduce renal congestion. Such a chronically implanted system can also be adapted to controllably and selectively enhance renal circulation, enhance and / or control diuresis, and / or reduce volume overload. The various implementations of chronic, implantable flow restriction systems and devices described herein can be configured to be implanted within a patient for months, a year, or years. Furthermore, the various implementations of chronic, implantable flow restriction systems and devices can be configured to controllably and selectively occlude, restrict, and / or divert flow within a patient’s vasculature without an assist device or a pump.

[0079] The chronic, implantable flow restriction systems, devices, and methods described herein can be adapted for percutaneous delivery. As such, the systems and devices described herein can be configured to be delivered via a catheter or a similar delivery device and can have a collapsed configuration for delivery into a patient and can expand from the collapsed configuration to an expanded configuration for implantation within the patient. Additionally, the systems and devices or components thereof described herein can be adapted to be retrievable after deployment, such as for repositioning and / or for removal from the body (e.g., by including a hook or other feature for retrieval). In some implementations, the systems and devices described herein can be configured to be delivered and implanted within the patient’s vasculature. In many cases, the operative components of such systems and devices can be fully disposed within the vasculature such that only extracorporeal components for controlling or charging are disposed outside the vasculature and outside the body. For example, in some cases an intravascular housing is provided that houses a motor or other actuator for adjusting the configuration of an occluding element in various phases. A chronic, implantable flow restriction system as described herein can be percutaneously implantedwithin a superior vena cava of a patient upstream of a right atrium of the patient. Such an implantable flow restriction system can be controlled to selectively occlude, restrict, and / or divert flow within the patient’s superior vena cava (e.g., to reduce cardiac preload). As another example, a chronic, implantable flow restriction system as described herein can be percutaneously implanted within an inferior vena cava of a patient upstream of where renal veins of the patient connect with the inferior vena cava. Such an implantable flow restriction system can be controlled to selectively occlude, restrict, and / or divert flow within the patient’s inferior vena cava (e.g., to reduce renal congestion). In some such variants, the implantable flow restriction system includes an intravascular housing for enclosing a motor or other actuator to be positioned in the inferior vena cava, e.g., below (upstream of) the renal veins

[0080] The chronic, implantable flow restriction systems, devices, and methods described herein can be actuated in a variety of ways. Without limitation, the systems and devices of the present disclosure can be actuated magnetically including electromagnetically, fluidically including pneumatically, mechanically, via heat (e.g., induction heating), and / or via another energy source. Furthermore, the systems and devices described herein can be actuated by direct connection (e.g., a wire, a tube in fluid communication) and / or advantageously remotely. For example, a magnetically actuated flow restriction device as described herein implanted in a patient’s superior vena cava can be actuated by a magnet on the patient’s back. As another example, a fluidically actuated flow restriction device as described herein implanted within or external and adjacent to a patient’s inferior vena cava can be actuated by pressing into a subcutaneously implanted fluid reservoir fluidically connected to the flow restriction device. In another example, a heat actuated flow restriction device as described herein implanted in a patient’s superior vena cava can be actuated by heat due to induction heating via a separate device implanted within the patient and / or a separate device external to the patient. Remote actuation can provide for a safer and more pleasant patient experience, including in regard to infection risk versus other ways that may include a direct connection into / out of the body.

[0081] The chronic, implantable flow restriction systems and devices described herein can be configured to partially occlude and / or fully occlude a target vessel. Additionally, the systems and devices described herein can be configured to not occlude or substantially not occlude a target vessel until actuated. In other words, the systems and devices of the presentdisclosure can be controlled to substantially occlude all flow through a vessel, occlude partial flow through the vessel, and / or allow substantially all flow through the vessel unimpeded. For example, a flow restriction system and / or device can be configured to adjustably occlude blood flow in a vessel in a range of 0 to 100 percent. In some implementations of the systems and devices described herein, an implantable flow restriction system and / or device can be configured to not substantially occlude flow through a vessel unless actuated to close partially and / or fully. In some cases, the systems and devices described herein can be configured to substantially occlude all and / or partial flow through a vessel unless actuated to open. Furthermore, in some implementations, the systems and devices described herein can have a bias to be partially closed, however once implanted they can open fully due to the flow of blood in the target vessel. It should be understood that the chronic, implantable flow restriction systems and devices of the present disclosure can be configured to be controllable so as provide between and including substantially no occlusion of flow to substantially full occlusion to flow within a vessel. In some cases, such control can be binary (e.g., open or closed) or graded (e.g., open, various degrees of partially closed, or closed).

[0082] The chronic, implantable flow restriction systems and devices described herein can be sized and configured for implantation within a target vessel of interest of a patient, such as a superior vena cava (SVC), an inferior vena cava (IVC), and others. A flow restriction device, which can also be referred to herein as an implant, an occluder, and / or a prosthetic, can have an expanded (e.g., implanted) diameter in the range of about 5 mm to about 50 mm, about 10 mm to about 40 mm, about 15 mm to about 30 mm, or it can have a diameter greater than about 50 mm or less than about 5 mm depending on the application. In some implementations, an implant as described herein can be oversized for the vessel of interest and thus impart an outward force on the vessel in which it is implanted (e.g., to improve anchoring within the vessel). A flow restriction device can have an expanded (e.g., implanted) length in the range of about 0.5 cm to about 5 cm, about 0.75 cm to about 4 cm, about 1 cm to about 3 cm, or it can have a length greater than about 5 cm or less than about 0.5 cm depending on the application.

[0083] The chronic, implantable flow restriction devices described herein configured for implantation within a vessel of a patient can generally include an expandable body (configured for percutaneous delivery as described herein) and a flow restrictorconfigured to controllably and selectively occlude, restrict, and / or divert flow within the patient’s vasculature. The expandable body can have a proximal end, a distal end, and a lumen extending from the proximal end to the distal end. The expandable body can generally comprise a frame (which can also be referred to as a stent) having an open cell and / or a closed cell structure. Furthermore, the expandable body can include features to aid in anchoring and / or maintaining its placement within the body, such as free apices, barbs, and / or anchors, which can extend in any direction relative to the implant. In some cases, such barbs and / or anchors can comprise a partial hook, hook, and / or straight configuration. The expandable body can be made of a material configured to expand upon delivery, and as such can comprise a shape memory material such as nitinol. In some implementations, the expandable body can be configured to radially collapse / crimp. Alternatively, or in addition, the expandable body can be configured to collapse / crimp sideways upon being pushed or pulled. In some variations, the expandable body can comprise a material without or with little shape memory, and a 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., within its lumen) and / or an outer material layer (e.g., external to its lumen). Such inner and / or outer material layers can comprise ePTFE, PTFE, PET cloth, polyeurethane, and / or the like. Additionally, any of such layers can include an anti-thrombotic coating, a drug-eluting coating, or the like. In some implementations, it is desirable to utilize a material and / or coating to prevent ingrowth within the implant to aid in later implant retrieval and / or removal. Conversely, in some cases it is desirable to utilize a material and / or coating to allow and / or promote ingrowth within the implant. Expandable bodies as described herein for one implementation with a particular type of flow restrictor are not limited to only being utilized with that particular flow restrictor, and may be used in other implementations with other types of flow restrictors. In some implementations, a flow restrictor can be integrally formed with an expandable body.

[0084] A flow restrictor of an implant as described herein can be sized and / or oriented in a number of ways relative to the expandable body it connects to or is formed with. For example, a flow restrictor can be sized to fully or partially occlude the lumen of the expandable body it connects to or is formed with upon full actuation. Regarding orientation, a flow restrictor can be configured to span the entire length of the expandable body it connects to or is formed with or configured to span a part of the length of the expandable body. In thelatter scenario, the flow restrictor can be oriented at the proximal end, the distal end, or anywhere in between (e.g., the middle or near the middle) of the expandable body. In some instances, the flow restrictor can be positioned adjacent the distal or proximal end of the expandable body, extend beyond the distal or proximal end of the expandable body, or the like.

[0085] The implants described herein or portions thereof (e.g., a flow restrictor of an implant) can be configured to secure within a vessel of the patient’s vasculature. In some implementations, activating a flow restrictor implanted in a vessel of the patient’s vasculature causes the flow restrictor to pull in a wall of the vessel to at least partially restrict flow through the vessel and / or a lumen of the implant comprising the flow restrictor. To pull in a wall of the vessel, a flow restrictor or portions thereof can attach or secure to the wall of the vessel (e.g., an inner wall of the vessel). Such attachment / securement can include a mechanical attachment. For example, a flow restrictor can include one or more anchors configured to attach / secure at least a portion of the flow restrictor with at least a portion of a wall of a vessel (e.g., an inner wall of the vessel). As another example, a flow restrictor or a portion thereof can be configured to ingrow at least partially into the wall of the vessel. In such an example, the flow restrictor or a portion thereof can have a structure, material, and / or coating that promotes ingrowth. Further to this example, such flow restrictor can include a structure having struts, a structure having struts with a mesh spanning the struts, or a structure having struts with a material (e.g., a porous or a non-porous material) spanning the struts.

[0086] Vascular access for the delivery of a chronic, implantable flow restriction device as described herein can include an internal jugular vein, a subclavian vein, a femoral vein, and / or others. From such access points, a flow restriction device can be advanced within the patient’s vasculature by a delivery device (e.g., a delivery catheter) until the desired location of implantation is reached, thereupon the flow restriction device can be delivered and expanded for chronic implantation. A guidewire, introducers, etc. can be utilized for delivery, as well as standard imaging methods. Furthermore, the flow restriction devices herein can include radiopaque features to aid in delivery and implantation. Additionally, the flow restriction devices can include features for indexing to its delivery device to help enable precise orientation of the flow restriction device within the patient. For example, an implant can be indexed to a feature of its delivery device that remains external to the patient (e.g., a logo orother marking). A chronic, implantable flow restriction system can comprise a flow restriction device, a source for actuating the flow restriction device, and a delivery device.

[0087] The chronic, implantable flow restriction systems and devices described herein can be configured for open-loop and / or closed-loop control. For example, the flow restriction systems and devices described herein can be actuated manually, semi-automatically, and / or fully automatically. In some cases, therapy provided by the flow restriction systems and devices described herein can be digitally actuated, such as by interaction with a smart phone, an external terminal / device, or the like. For example, if a patient desires to enhance diuresis, they can activate such therapy via a press of a button or touchscreen of their smart phone (e.g., therapy can be digitally actuated). In some implementations, the flow restriction devices described herein can comprise and / or work with sensors attached to or located remote from the flow restriction device that can provide physiological parameters of interest useful for control of the flow restriction device. Such physiological parameters of interest can include pressure, flow rate, etc. As an example, a flow restriction device can have a MEMS pressure sensor attached to its proximal end, its distal end, or both of its ends, the pressure sensor configured to measure the pressure at such location relative to the flow restriction device (e.g., upstream, downstream, both upstream and downstream, etc.). As another example, MEMS pressure sensors can be located within vessels and / or organs remote from the flow restriction device and provide a measure of the pressure at such locations for the control of the flow restriction device. Sensors can be utilized to allow for fully-automatic, real-time control of the flow restriction devices described herein. Furthermore, absolute values of sensor data and / or differentials of sensor data can be utilized.

[0088] Utilization of the chronic, implantable flow restriction systems and devices described herein can be standardized across patients or preferably customized to an individual patient, such as via a prescription provided by a care provider. Treatment protocols can vary depending on the type of flow restriction device implanted, its type of actuation, and / or the location in which it is implanted. The flow restriction systems and devices described herein can be utilized 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 as needed or prescribed. Additionally, therapy provided by the flow restriction systems and devices described herein can be based on an amount of time per day, the time of day, a number of daysper week, specific days of the week, and the like. Furthermore, instances of treatment can have a duration of seconds, minutes, hours, days, etc. For example, treatment using a flow restriction 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 of time necessary or required for the intended use and desired outcome. Additionally, treatment times can vary in their duration or they can be standardized. In some cases, treatment can be determined via an algorithm, with such algorithm providing a duration and amount of flow restriction to be utilized. Such output from an algorithm can be implemented manually, semi-automatically, or fully-automatically. In some implementations, therapy provided by the flow restriction systems and devices described herein can be based on venous pressure, such as inferior vena cava pressure, renal venous pressure, femoral venous pressure, and / or pressure of other veins disclosed herein. For example, treatment using a flow restriction device described herein can be applied until a pressure threshold is met (e.g., treatment can be applied until a pressure of interest reaches or falls below a pressure threshold). Such threshold can be, for example, about 8 mmHg for the inferior vena cava. In some implementations, therapy provided by the flow restriction systems and devices described herein can be based on a combination of a duration and a venous pressure. For example, treatment using a flow restriction device described herein can be applied for a duration of time after a pressure threshold is met (e.g., once inferior vena cava pressure gets below 8 mmHg, turn off after 4 hours).

[0089] One or more chronic, implantable flow restriction devices as described herein can be implanted within a patient. In some cases, it can be beneficial to have only one flow restriction device implanted within a patient, or it can be beneficial to have multiple flow restriction devices implanted within a patient. If multiple flow restriction devices are implanted within a patient, such devices can work together as needed to achieve the treatment outcome desired. Furthermore, flow restriction devices that utilize the same or different forms of actuation can be implanted within the same patient.

[0090] Although the chronic, implantable flow restriction systems, devices, and methods disclosed herein are described in a particular manner which can provide certain advantages, such description is not intended to be limiting. The chronic, implantable flow restriction systems and devices can be implanted in various vessels and / or passageways of apatient, including vessels (e.g., veins, arteries) of the patient’s vascular system, the patient’s lymphatic system, the patient’s reproductive system, etc.

[0091] Any and / or all of the implementations and / or features of the chronic, implantable flow restriction systems, devices, and methods described and / or illustrated herein can be applied to the various systems, devices, and methods described and / or illustrated in U.S. Provisional Patent Application No. US63 / 331,496, filed April 15, 2022, titled “SYSTEMS AND METHODS FOR TREATING HEART FAILURE BY DIRECTING BLOOD FLOW THROUGH A SHUNT BETWEEN THE PULMONARY ARTERY AND THE AZYGOS VEIN” and in U.S. Patent Application No.18 / 300,293, filed April 13, 2023, titled “SYSTEMS AND METHODS FOR TREATING HEART FAILURE BY REDIRECTING BLOOD FLOW IN THE AZYGOS VEIN,” the entire contents of which are hereby incorporated by reference in their entirety, and vice versa. For example, any and / or all of the implementations and / or features of the chronic, implantable flow restriction systems, devices, and methods described and / or illustrated herein can be applied in a pulmonary artery to azygos vein shunt as described in the above-referenced applications. As another example, any and / or all of the implementations and / or features of a shunt between a pulmonary artery and an azygos vein as described and / or illustrated in U.S. Provisional Patent Application No. US63 / 311,496 and / or in U.S. Patent Application No. 18 / 300,293, such as an adjustable shunt including a rotatable disk that can rotate relative to a stationary frame to control the size of an opening through the shunt, can be applied to the chronic, implantable flow restriction systems, devices, and methods described and / or illustrated herein. Additionally, any and / or all of the implementations and / or features of the chronic, implantable flow restriction systems, devices, and methods described and / or illustrated herein can be applied to and / or used in atrial-septal shunts and / or pulmonary artery-to-superior vena cava shunts. Any and / or all of the implementations and / or features of the chronic, implantable flow restriction systems, devices, and methods described and / or illustrated herein can be applied to and / or used in the various systems, devices, and methods described and / or illustrated in U.S. Provisional Patent Application No. US63 / 336924, filed April 29, 2022, titled “SYSTEMS, DEVICES, AND METHODS FOR CONTROLLABLY AND SELECTIVELY OCCLUDING, RESTRICTING, AND DIVERTING FLOW WITHIN A PATIENT'S VASCULATURE,” in U.S. Provisional Patent Application No. US63 / 484635, filed February 13, 2023, titled “SYSTEMS, DEVICES, AND METHODS FORCONTROLLABLY AND SELECTIVELY OCCLUDING, RESTRICTING, AND DIVERTING FLOW WITHIN A PATIENT’S VASCULATURE,” in U.S Patent Application No. US18 / 300076, filed April 13, 2023, titled “SYSTEMS, DEVICES, AND METHODS FOR CONTROLLABLY AND SELECTIVELY OCCLUDING, RESTRICTING, AND DIVERTING FLOW WITHIN A PATIENT'S VASCULATURE,” in U.S. Provisional Patent Application No. US63 / 512152, filed July 6, 2023, titled “SYSTEMS, DEVICES, AND METHODS FOR CONTROLLING AN IMPLANTABLE FLOW RESTRICTION SYSTEM,” in U.S. Provisional Patent Application No. US63 / 667040, filed July 2, 2024, titled “SYSTEMS, DEVICES, AND METHODS FOR CONTROLLING AN IMPLANTABLE FLOW RESTRICTION SYSTEM,” in PCT Application No. PCT / US2024 / 036769, filed July 3, 2024, titled “SYSTEMS, DEVICES, AND METHODS FOR CONTROLLING AN IMPLANTABLE FLOW RESTRICTION SYSTEM,” in U.S. Provisional Patent Application No. US63 / 582723, filed September 14, 2023, titled “LEADLESS SYSTEMS, DEVICES, AND METHODS FOR CONTROLLABLE ENHANCEMENT OF DIURESIS,” in PCT Application No. PCT / US2024 / 046253, filed September 11, 2024, titled “LEADLESS SYSTEMS, DEVICES, AND METHODS FOR CONTROLLABLE ENHANCEMENT OF DIURESIS,” and in U.S. Provisional Patent Application No. 63 / 591304, filed October 18, 2023, titled “SYSTEMS, DEVICES, AND METHODS FOR CONTROLLING AN IMPLANTABLE FLOW RESTRICTION SYSTEM,” the entire contents of which are hereby incorporated by reference in their entirety, and vice versa.

[0092] FIG. 1 illustrates a potential location for implantation and placement of an implantable flow restriction system 5 or an implantable leadless flow restriction system 1500. The implantable flow restriction system 5 can be a mechanically-actuated, chronic implantable flow restriction system 5. While certain implementations of the implantable flow restriction system 5 may be described as a chronic system, components of the implantable flow restriction system could be used in an acute system. Moreover, certain implementations of the implant 500 of the implantable flow system 5 are described as being mechanically actuated. This may include electromechanically-actuated implants. Other actuation methods are also possible, for example a fluid or gas driven system. Although FIGS. 1-37C and FIGS. 46A-50D discuss extensive embodiments of flow restriction systems that can be implemented and controlled with an elongate lead, these embodiments are largely relevant to leadless systems discussed inFIGS. 38-45A. Any feature of the systems of FIGS. 1-37C and FIGS. 46A-50D not wholly incompatible with the leadless concepts can be combined with features of the leadless embodiments and leadless embodiment features of FIGS. 38-45A can be combined with compatible features of the systems of FIGS.1-37C and FIGS.46A-50D.

[0093] An implantable flow restriction system 5 can include an implant 500 connected to a controller 50 (which can also be referred to herein as a “control unit”), for example via tubing 570 and shaft 590 (which can all be implanted), and an external device 15 for operating the system 5. In some implementations, the implantable flow restriction system 5 includes the implant 500, the controller 50, the tubing 570, and the shaft 590. In some embodiments discussed further below, the controller can be integrated into an intravascular housing and the tubing may be shortened or eliminated completely. Shown in FIG. 1 is one implant 500 implanted within the patient's IVC upstream of its connection to the renal veins (e.g., below the renal veins). An implant 500 placed in the IVC upstream of the renal veins can controllably and selectively occlude, restrict 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 to control diuresis (e.g., to increase diuresis). For this, the implant 500 can have a flow restrictor portion 550 and / or a flow restrictor 560. Such flow restrictor portion 550 and / or flow restrictor 560 can be actuated by the controller 50 via shaft 590 and tubing 570 as described further herein. Similar to FIGS.38-45A, the implant 500 can be controlled intravascularly in leadless configurations.

[0094] The implant 500 can be implanted such that the flow restrictor portion 550 is upstream of the other portions of the implant 500 (e.g., the flow restrictor portion 550 is the first portion of the implant 500 to receive blood flow therethrough). In such position, the shaft 590 and tubing 570 can extend proximally from the implant 500 up the IVC, through the right atrium, into the superior vena cava (SVC), through a subclavian vein (left subclavian as shown), and out the subclavian vein to connect with the controller 50 that can be implanted in an infraclavicular subcutaneous pocket (e.g., similar to placement of a pacemaker). In the case of multiple implants 500 being implanted within the patient, each can connect to a single controller 50 via separate tubing 570 and shaft 590, or each can connect to their own controller 50 via separate tubing 570 and shaft 590. Or in the case of a leadless configuration, thecontroller 50 can be on each one of several leadless flow restrictor systems or one of several leadless units can be controlled by a single controller 50.

[0095] FIGS. 2A-2D illustrate various views of an implementation of an implant 500a, which can be the implant 500 in the implantable flow restriction system 5. FIGS. 2A and 2C show side views, FIG. 2B shows an end view of the implant 500a in a non-occluding (e.g., open, unactuated) state, and FIG. 2D shows a side view of the implant 500a in a fully occluding (e.g., closed, actuated) state. FIGS.2A-2D also illustrate how the implant 500a can connect with the tubing 570a and the shaft 590a for operation thereof. The implant 500a can comprise an expandable body 510a having a proximal end 511a, a distal end 512a, and a lumen 513a for receiving blood flow therethrough. The implant 500a can connect to a distal end 572a of the tubing 570a and can include a filter portion 520a, a radial support portion 540a (which can also be referred to herein as a “sealing portion” or “sealing zone”), and a flow restrictor portion 550a. In a leadless configuration, the tubing 570a may be replaced by an intravascular housing which can enclose a motor or actuator and be coupled with the filter portion 520a.

[0096] As shown in FIGS. 2A-2D, the filter portion 520a can be positioned adjacent the proximal end 511a, the radial support portion 540a can connect to and be positioned distal of the filter portion 520a, and the flow restrictor portion 550a can connect to and be positioned distal of the radial support portion 540a. The filter portion 520a can be configured to capture thrombus that may pass through the lumen 513a of the implant 500a and can include a plurality of struts 527a that extend distally and radially outward from the connection between the tubing 570a and the implant 500a.

[0097] The radial support portion 540a can be configured to fluidically seal against the inner wall of the IVC and can include a ring 545a that extends along a circumference of the implant 500a in a chevron pattern. As shown, the ring 545a can include a plurality of ring struts 542a, wherein adjacent pairs of ring struts 542a join at a plurality of proximal apexes 543a and a plurality of distal apexes 544a. Further as shown, each of the plurality of proximal apexes 543a of the ring 545a of the radial support portion 540a can be connected to a strut 527a of the filter portion 520a.

[0098] The flow restrictor portion 550a can include a plurality of petals 560a configured to restrict / occlude flow through the lumen 513a of the implant 500a when actuated. As shown, each of the petals 560a can be formed by a pair of struts 562a that extend distallyfrom adjacent pairs of distal apexes 544a of the ring 545a of the radial support portion 540a and that join at a distal apex 564a. Each of the plurality of petals 560a can also include a strut 566a that extends proximally from their respective distal apex 564a, which can aid in the ability of the petals to restrict flow when in use. Further as shown, the flow restrictor portion 550a can include a material 530a (which can also be referred to herein as an “occlusive member”) that spans one or more (e.g., each) of the plurality of petals 560a. The material 530a can comprise ePTFE, PTFE, PET cloth, polyeurethane, and / or the like as described herein. Regions between the plurality of petals 560a can be free of the material 530a. In some implementations, the material 530a can span regions between the plurality of petals 560a. The material 530a can also span the radial support portion 540a to aid in the ability of the implant 500a to fluidically seal against the inner wall of the IVC (or an inner wall of any other lumen / vessel in which it is placed) and restrict / block blood flow when in use. In some implementations and as shown, the implant 500a can include a plurality of anchors 525a configured to anchor the implant 500a within the IVC (or any other lumen / vessel in which it is placed). Such anchors 525a can extend in a generally proximal direction from each of the plurality of proximal apexes 543a of the ring 545a.

[0099] With continued reference to FIGS. 2A-2D, each of the petals 560a can connect to the shaft 590a by a connector. Various connectors are described herein, for example, a suture, wire, strut, or otherwise. For example, each of the distal apexes 564a of the petals 560a can connect to a suture or wire 595a at one end of the suture or wire 595a, and the other end of the suture or wire 595a can connect to a distal end 592a of the shaft 590a that extends generally centrally through the lumen 513a of the implant 500a. Further as shown, the distal end 592a of the shaft 590a can substantially longitudinally align with the distal apexes 564a of the petals 560a in the unactuated / open state of the implant 500a. With such relative position, the sutures or wires 595a can extend in a substantially radially outward direction from the distal end 592a of the shaft 590a to connect to the distal apexes 564a of the petals 560a. The shaft 590a can slidably and / or rotatably move through a lumen of the tubing 570a and extend out the distal end 572a thereof as shown, and a collapsible and extendible coupling 580a can fluidically seal the lumen of the tubing 570a with the shaft 590a. A proximal end 571a of the tubing 570a (not shown) can connect with the controller 50a, and the shaft 590a can extend out such proximal end 571a and operably connect with an actuator of the controller50a. In leadless configurations discussed below in connection with FIGS. 38-45A, an intravascular housing can enclose or be coupled with a controller or control unit, and a transfer shaft similar to the shaft 590a can be coupled with the housing. To operate the flow restrictor portion 550a of the implant 500a and at least partially occlude / restrict flow therethrough, the actuator of the controller 50a can be actuated to cause the shaft 590a to move proximally and / or rotate relative to the tubing 570a (or in the case of leadless configurations, to rotate or move proximally or distally relative to the intravascular housing) and implant 500a, causing the distal apexes 564a of the plurality of petals 560a to move radially inward towards one another via the connection of the distal apexes 564a to the suture or wire 595a and to the distal end 592a of the shaft 590a. In other words, proximal movement and / or rotation of the shaft 590a can cause the petals 560a to come together and at least partially restrict flow through the lumen 513a of the implant 500a, such as shown in FIG. 2D. For example, the petals 560a can fold radially inward (e.g., hinge relative to the expandable body) with the distal apexes 564a of the petals 560a forming the distal-most tip of implant 500a. In use, blood can flow toward and can be occluded by exterior surfaces of the petals 560a. In some implementations, the flow restrictor portion 550a (e.g., the petals 560a) can be configured to attach or secure to a wall of the vessel in which the implant 500a is implanted, and when actuated can pull in the wall of the vessel to at least partially restrict flow through the vessel and / or lumen 513a. For this, and as described herein, the flow restrictor portion 550a (e.g., the petals 560a) can include one or more anchors and / or be configured to ingrow at least partially into the wall of the vessel.

[0100] Tubing 570a can comprise a unitary or a composite structure. For example, tubing 570a can include a tubing portion, a braided portion, and / or a liner. The tubing 570a can comprise, for example, PEBAX. A liner, if included, can comprise PTFE, HDPE, or a silicone blend and can facilitate sliding motion of the shaft 590a within the tubing 570a (e.g., the liner can reduce friction within the tubing 570a and force required to slide and / or rotate the shaft 590a within the tubing 570a). Connections between components of the system 5, such as the tubing 570a, implant 500a, collapsible and extendible coupling 580a, and shaft 590a, can be made via reflow (e.g., with PEBAX), heat shrink, or the like.

[0101] With reference to the end view of the implant 500a shown in FIG. 2B, the implant 500a can be configured such that the sutures or wires 595a substantially align with the struts 527a of the filter portion 520a. Such substantial alignment can advantageously allowother interventional devices to pass through the implant 500a if needed. For example, such substantial alignment can allow for a 28 French interventional device to pass through the implant 500a.

[0102] While the implant 500a of FIGS. 2A-2D is shown as having 6 petals 560a, 6 sutures or wires 595a connecting each of the 6 petals 560a to the shaft 590a, and a filter portion 520a having 6 struts 527a, the implant 500a can be configured to have less than or greater than these numbers of each.

[0103] FIGS. 3A-3C illustrate end views of the implant 500a of FIGS. 2A-2D in various states of actuation and restriction / occlusion of flow therethrough. FIG. 3A shows the implant 500a in its unactuated, non-restricting / non-occluding state, FIG.3B shows the implant 500a in a partially actuated, partially restricting / occluding state, and FIG.3C shows the implant 500a in a fully actuated, fully restricting / occluding state. As shown through FIGS.3A-3C, the lumen 513a of the implant 500a (e.g., the lumen or opening of the flow restrictor portion 550a) can change from a generally circular shape (FIG. 3A) when unactuated, to a generally star / stellate shape when at least partially actuated (FIG.3B), to a substantially blocked lumen when fully actuated (FIG.3C). In some implementations, the lumen 513a of the implant 500a (e.g., the lumen or opening of the flow restrictor portion 550a) can have a generally circular shape when unactuated, a generally circular shape when partially actuated, and a substantially blocked lumen when fully actuated. When folded radially inward, an exterior surface of the each of the plurality of petals 560a can block blood flow via material 530a. In some implementations, such as shown in FIG. 3D, the implant 500a can be configured such that its lumen 513a can remain at least partially open even when the flow restrictor portion 550a is fully actuated, such as by the formation of elongate gaps 514a between each of or between at least some of the petals 560a.

[0104] FIGS.3E-3F illustrate various views of an implant 500a’ that is a variant of the implant 500a discussed with respect to FIGS.2A-3D. FIG.3E illustrates a side view of the implant 500a’ prior to attaching it to other components of the system and FIG. 3F illustrates an end view of the implant 500a’. The implant 500a’ can be the same or similar to and / or incorporate any of the features described with respect to the implant 500a. For example, the implant 500a’ can have an expandable body 510a’ having a filter portion 520a’, a radial support portion 540a’, and a flow restrictor portion 550a’ including a plurality of petals 560a’configured to restrict / occlude flow through a lumen 513a’ of the implant 500a’ when actuated the same or similar to the expandable body 510a having the filter portion 520a, the radial support portion 540a, and the flow restrictor portion 550a of the implant 500a. Furthermore, the petals 560a’ of implant 500a’ can each be formed by a pair of struts 562a’ that extend distally from the radial support portion 540a’ and that join at a distal apex 564a’ the same or similar to such features described with respect to implant 500a. The implant 500a’ can couple with the tubing 570a and be actuated by the shaft 590a the same or similar to the implant 500a (or the implant 500a’ can couple with intravascular housing 1504 described herein below).

[0105] Different than the implant 500a, the flow restrictor 550a’ of implant 500a’ can include a material (e.g., occlusive member) 530a’ having a first portion 530a1’ and a second portion 530a2’. The material 530a’ can comprise ePTFE, PTFE, PET cloth, polyeurethane, and / or the like as described herein. The first portion 530a1’ of material 530a’ can span one or more (e.g., each) of the plurality of petals 560a’ similar or the same as the material 530a described with respect to implant 500a. The second portion 530a2’ of material 530a’ can comprise a tension member having a first end 531a’ comprising a continuous extension of the first portion 530a1’ and a second end 532a’ opposite the first end 531a’. Such second end 532a’ can be coupled to the distal end 592a of the shaft 590a. In this way, each of the distal apexes 564a’ of the petals 560a’ can operably connect to the distal end 592a of the shaft 590a via the second portion 530a2’. In other words, the second portion 530a2’ of material 530a’ can replace the suture or wire 595a of implant 500a.

[0106] To operate the flow restrictor portion 550a’ of the implant 500a’ and at least partially occlude / restrict flow therethrough, the actuator of the controller 50a can be actuated to cause the shaft 590a to move proximally and / or rotate relative to the tubing 570a (or in the case of leadless configurations, to rotate or move proximally or distally relative to the intravascular housing) and implant 500a’, causing the distal apexes 564a’ of the plurality of petals 560a’ to move radially inward towards one another via the second portion 530a2’ of material 530a’ that extends from the distal apexes 564a’ and connects to the distal end 592a of the shaft 590a. In other words, proximal movement and / or rotation of the shaft 590a can cause the petals 560a’ to come together and at least partially restrict flow through the lumen 513a’ of the implant 500a’.

[0107] FIG. 4 illustrates a flat pattern of view of the expandable body 510a of the implant 500a of FIGS.2A-2D with aspects previously discussed identified.

[0108] FIGS. 5A-5B illustrate various views of components of the implantable flow restriction system 5a, which can be implanted as shown and described with respect to FIG. 1. FIG. 5A shows the implant 500a connected to the shaft 590a and tubing 570a. The implant 500a, the shaft 590a, and the tubing 570a can be referred to herein as an implant assembly 501a. FIG.5B shows the implant 500a connected to the shaft 590a and tubing 570a, which are in turn connected to the controller 50a. In other words, FIG. 5B shows the implant assembly 501a connected to the controller 50a. As discussed below in connection with FIGS. 38-45A, leadless configurations can eliminate the extensive length of the tubing 570a and the shaft 590a can be greatly shortened to be disposed distal of or to extend from a distal portion of an intravascular housing.

[0109] FIGS. 6A-6D illustrate interaction of various components of the implant assembly 501a to actuate the implant 500a of FIGS. 2A-2D, with the material 530a of the implant 500a removed for clarity. As described with respect to FIGS.2A-2D, each of the distal apexes 564a of the petals 560a can connect to the suture or wire 595a at one end of the suture or wire 595a, and the other end of the suture or wire 595a can connect to the distal end 592a of the shaft 590a. As an example, the sutures or wires 595a can connect to the distal apexes 564a via eyelets at the distal apexes 564a as shown. Further to this example, the sutures or wires 595a can connect to the distal end 592a of the shaft 590a via a crimp as shown, although other forms of connection are possible and are considered within the scope of this disclosure (e.g., via a set screw, press fit component, adhesive, and / or threaded end). In some implementations, the suture or wire 595a can extend from the distal end 592a of the shaft 590a, pass through an eyelet at the distal apex 564a of a petal 560a, and double back and connect to the distal end 592a of the shaft 590a. In some implementations, the suture or wire 595a can be integrally formed or a part of the shaft 590a. For example, in implementations in which the shaft 590a has a braided structure comprising a plurality of individual wires 593 as described with respect to FIGS.23A-23B, the suture or wire 595a can be one or more of such individual wires 593.

[0110] With continued reference to FIGS.6A-6D, with the material 530a removed from view, the collapsible and extendible coupling 580a configured to fluidically seal thetubing 580a with the shaft 590a can be seen. In some implementations and as shown, the collapsible and extendible coupling 580a can extend around the shaft 590a such that no portion of the shaft 590a is exposed except for where the shaft 590a is connected to the sutures or wires 595a. Alternatively, in some implementations the collapsible and extendible coupling 580a can extend around the shaft 590a such that no portion of the shaft 590a is exposed, which can include covering where the shaft 590a is connected to the sutures or wires 595a. As shown, the collapsible and extendible coupling 580a can connect at its proximal end to the distal end 572a of the tubing 570a, and it can connect at its distal end to the shaft 590a adjacent its distal end 592a, which can allow for sliding and / or rotational movement of the shaft 590a therewithin.

[0111] In some implementations and as shown in FIGS. 6A-6B, 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. Such longitudinal movement can include a sliding of the shaft 590a within the tubing 570a or in the case of a leadless embodiment relative to an intravascular housing. In the unactuated, non- restricting / non-occluding state shown in FIG. 6A, the shaft 590a is in its distal-most position relative to the implant 500a and the collapsible and extendible coupling 580a is in its extended state. In its extended state, the collapsible and extendible coupling 580a can have a generally straight configuration as shown. Upon proximal movement of the shaft 590a within the tubing 570a as shown in FIG. 6B (e.g., upon proximal movement of the shaft 590a relative to the tubing 570a and implant 500a) or relative to an intravascular housing, the shaft 590a pulls the petals 560a radially inward towards one another via the sutures or wires 595a to occlude / restrict flow through the implant 500a. Such proximal movement of the shaft 590a also causes the collapsible and extendible coupling 580a to collapse into its collapsed state. Furthermore, and as shown in FIG. 6B, when the shaft 590a is in its proximal-most position relative to the implant 500a, the sutures or wires 595a can be oriented substantially longitudinally.

[0112] In some implementations and as shown in FIGS. 6C-6D, the implant 500a (e.g., the flow restrictor portion 550a) can be actuated by rotating the shaft 590a (e.g., clockwise or counterclockwise) relative to the implant 500a. Such rotation of the shaft 590a can cause the sutures or wires 595a to spool about the shaft 590a or twist and at least partiallyclose the flow restrictor portion 550a. In other words, such rotation of the shaft 590a can cause the sutures or wires 595a to spool about the shaft 590a or twist and cause the petals 560a to at least partially fold radially inward. For this, the implantable controller 50a can be configured to rotate the shaft 590a. Furthermore, in such implementations the tubing 570a can be configured for rotational movement of the shaft 590a therewithin. In leadless implementations, an intravascular housing can be configured for rotational movement of the shaft 590a relative thereto. Additionally, in such implementations the collapsible and extendable coupling 580a can be configured for such rotational movement. FIGS. 6C-6D each show the petals 560a of the implant 500a pulled at least partially radially inward as a result of the shaft 590a being rotated, with FIG.6D showing the shaft 590a in a more rotated state than as shown in FIG.6C.

[0113] Referring back to FIG.1, the implant 500a can be positioned within the IVC below the renal veins such that the distal apexes 564a of the petals 560a are aimed towards the incoming flow of blood. In other words, the implant 500a can be implanted such that the flow restrictor portion 550a is upstream of the other portions of the implant 500a (e.g., the flow restrictor portion 550a is the first portion of the implant 500a to receive blood flow therethrough). In such position, the shaft 590a and tubing 570a can extend proximally from the implant 500a up the IVC, through the right atrium, into the superior vena cava (SVC), through a subclavian vein (left subclavian as shown), and out the subclavian vein to connect with the controller 50a that can be implanted in an infraclavicular subcutaneous pocket (e.g., similar to placement of a pacemaker). In a leadless configuration, rather than the tubing 570a extending in this manner, an intravascular housing can have a proximal end that can be positioned in the IVC, e.g., in the vicinity of and in some cases upstream of the renal veins if the flow restrictor portion 550a is upstream of the renal veins. Furthermore, such positioning of the flow restrictor portion 550a comprising the petals 560a can provide for a functional benefit of pushing any thrombi that may form or otherwise be gathered at the outer surface of the petals 560a when the implant 500a is actuated / closed towards the wall of the IVC upon opening of the petals 560a rather than allowing such thrombi to pass through the implant 500a upon opening of the petals 560a (such as may occur if the petals 560a were not aimed towards the incoming flow of blood). In this way, any thrombi are directed towards the sealing area around the implant 500a with the wall of the IVC and not through the implant 500a and towards the heart.

[0114] In some implementations, any of the flow restriction devices described herein (e.g., including at least implant 500a) may work with and / or be used in conjunction with sensors that are located remote from the flow restriction device that can provide physiological parameters of interest useful for control of the flow restriction device. Such physiological parameters of interest can include pressure, flow rate, heart rate, and / or the like. As an example, a flow restriction device can be used with a pressure sensor located within vessels and / or organs remote from the flow restriction device and provide a measure of the pressure at such locations for the control of the flow restriction device. One example of an implantable sensor is a MEMS pressure sensor. The MEMS or other implantable pressure sensor may be a remote component of the flow restriction device or may be an independent sensor with a separate control system. In one example, the MEMS pressure sensor may be located in the pulmonary artery and may measure the pressure of blood flowing through the pulmonary artery. The MEMS or other pressure sensor may include a separate electronics system that is configured to receive readings (e.g., data indicative of pressure) from the MEMS pressure sensor. These readings may be used by the patient, the patient’s physician, etc. to determine when the patient should receive treatment via the flow restriction device. In one example, the MEMS pressure sensor may comprise 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 radiofrequency signals). For example, the external antenna may be contained within an antenna device and a pressure reading may be taken and transmitted to the electronics system when the patient holds the antenna device against their body. Additionally, or alternatively, the MEMS pressure sensor may include an inductor that can be used to create a circuit that creates a frequency, e.g., an LC circuit or LC tank circuit. The frequency may then be used to determine the pressure.

[0115] In some implementations, the MEMS pressure sensor described above may be coupled to a portion of the flow restriction devices described herein. As an example, a flow restriction device can have the MEMS pressure sensor attached to its proximal end, its distal end, both of its ends, its shaft, and / or the like. In the example of implant 500a, the MEMS pressure sensor may be coupled to the shaft 590a. The MEMS pressure sensor may be tied to / coupled to the flow restriction device with suture, reflow, and / or the like. In this example, the MEMS pressure sensor would be configured to measure the pressure at such locationrelative to the flow restriction device (e.g., upstream, downstream, both upstream and downstream, etc.). As noted above, the MEMS pressure sensor may transmit the pressure readings to a separate electronics system. Additionally or alternatively, the MEMS pressure sensor may transmit readings to a control system of the flow restriction device (e.g., the controller 50a).

[0116] FIGS. 7A-7C show the implant 500a with a sensor 600 located in various positions relative to the flow restrictor portion 550a. The sensor 600 can be configured to measure the pressure within the vasculature at its location, and as such the placement of the sensor 600 relative to the flow restrictor portion 550a can determine which vascular pressure is being measured depending on the activation state of the flow restrictor portion 550a. The sensor 600 can be located adjacent the proximal end of the implant 500a (e.g., such as attached to the tubing 570a proximal to the implant 500a) and proximal of the flow restrictor portion 550a if it were to be actuated as shown in FIG.7A, located adjacent the distal end of the shaft 590a and proximal of the flow restrictor portion 550a if it were to be actuated as shown in FIG. 7B, and / or located on an extension of the shaft 590a and distal of the flow restrictor portion 550a if it were to be actuated as shown in FIG. 7C. When the flow restrictor portion 550a of the implant 500a is unactuated (e.g., the implant is in a non-restricting / non-occluding state), the sensor 600 positioned as shown in any of FIGS. 7A-7C would measure substantially the same pressure. For example, when the flow restrictor portion 550a of the implant 500a is unactuated, the sensor 600 positioned as shown in any of FIGS. 7A-7C would measure substantially the same IVC pressure. When the flow restrictor portion 550a of the implant 500a is actuated, however, the sensor 600 positioned as shown in FIGS.7A-7B would measure the renal venous pressure (e.g., since it can be positioned proximate the renal veins), whereas the sensor 600 positioned as shown in FIG. 7C would measure the femoral venous pressure. The implant 500a can include the sensor 600 in either of the positions as shown in FIGS.7A- 7B where it would measure the renal venous pressure. In some implementations, the implant 500a can include more than one sensor 600, with one located as shown in FIGS. 7A-7B to measure renal venous pressure, and one located as shown in FIG. 48C to measure femoral venous pressure. The sensor(s) 600 of the implant 500a can operably connect with the controller 50a, for example, via wire(s) that extend between the sensor(s) 600 and the controller 50a through the tubing 570a. The sensor(s) 600 of the implant 500a can operably connect witha control unit disposed in or coupled with an intravascular housing via wire(s) that extend between the sensor(s) 600 and the control unit through the intravascular housing, as discussed further below in connection with FIGS. 38-45A. In some implementations, the shaft 590a or a portion thereof can operably connect the sensor(s) 600 with the controller 50a. Pressures determined from signals generated by the sensor(s) 600 and / or differentials thereof (e.g., differentials between multiple sensors, and / or differentials between pressures determined through time) can be utilized in the control of the implant 500a.

[0117] FIG. 8 illustrates another implementation of an implant 500b that can be used in connection with implantable flow restriction system 5. The implant 500b can be the same or similar to and / or incorporate any of the features described with respect to the implant 500a. For example, the implant 500b can have an expandable body 510b having a filter portion 520b, a radial support portion 540b, and a flow restrictor portion 550b the same or similar to the expandable body 510a having the filter portion 520a, the radial support portion 540a, and the flow restrictor portion 550a of the implant 500a. FIG. 8 shows a side view of the expandable body 510a of the implant 500b without material covering the flow restrictor portion 550b. Different than the implant 500a, the expandable body 510b of the implant 500b can include distally extending struts 546 and / or proximally extending struts 547. The distally extending struts 546 can extend distally from the proximal apexes 543b of the radial support portion 540b in a generally longitudinal direction as shown. Furthermore, the distally extending struts 546 can be configured to enhance sealing of the implant 500b with a wall of the vessel (e.g., the wall of the IVC) in which the implant 500b is implanted. The proximally extending struts 547 can extend proximally from the distal apexes 544b of the radial support portion 540b in a generally longitudinal direction as shown. Furthermore, the proximally extending struts 547 can be configured to enhance sealing of the implant 500b with a wall of the vessel (e.g., the wall of the IVC) in which the implant 500b is implanted. In some implementations, the implant 500b includes only the distally extending struts 546. The implant 500a can include distally extending struts and / or proximally extending struts similar or the same as the distally extending struts 546 and proximally extending struts 547.

[0118] FIG. 9 illustrates another implementation of an implant 500c that can be used in connection with implantable flow restriction system 5. The implant 500c can be similar to and / or incorporate any of the features described with respect to the other implants describedherein, such as implants 500a and 500b. For example, the implant 500c can have an expandable body 510c having a filter portion 520c, a radial support portion 540c, and a flow restrictor portion 550c similar to the expandable body 510a having the filter portion 520a, the radial support portion 540a, and the flow restrictor portion 550a of the implant 500a. FIG. 8 shows a side view of the expandable body 510c of the implant 500c connected to shaft 590c and tubing 570c with collapsible and extendible coupling 580c that can be the same or similar to the shaft 590a, tubing 570a, and collapsible and extendible coupling 580a described with respect to implant 500a. Different than the implant 500a, the flow restrictor portion 550c can be connected to and located between the filter portion 520c and the radial support portion 540c as shown. In such arrangement, blood flowing through an implanted implant 500c would flow first through the radial support portion 540c rather than the flow restrictor portion as in implant 500a. Actuation of the flow restrictor portion 550c comprising petals 560c can be the same or similar to that described with respect to the flow restrictor portion 550a of implant 500a (e.g., via sutures or wires 595c connected between shaft 590c and distal apexes 564a of petals 560a). Furthermore, the implant 500c can similarly be positioned within the IVC below the renal veins such that the distal apexes 564c of the petals 560c are aimed towards the incoming flow of blood.

[0119] FIGS. 10A-10B illustrate another implementation of an implant 500d that can be used in connection with implantable flow restriction system 5. The implant 500d can be similar to and / or incorporate any of the features described with respect to the other implants described herein, such as implants 500a, 500b, and 500c. For example, the implant 500d can have an expandable body 510d having a filter portion 520d, a radial support portion 540d, and a flow restrictor portion 550d similar to the expandable body 510c having the filter portion 520c, the radial support portion 540c, and the flow restrictor portion 550c of the implant 500c. FIGS.10A-10B show side views of the expandable body 510d of the implant 500d connected to shaft 590d and tubing 570d and can incorporate a collapsible and extendible coupling (not shown) that can be the same or similar to the shaft 590a, tubing 570a, and collapsible and extendible coupling 580a described with respect to implant 500a. Material spanning petals 560d of the flow restrictor portion 550d has been removed to show features of the implant 500d. Similar to the implant 500c, the flow restrictor portion 550d can be connected to and located between the filter portion 520d and the radial support portion 540d as shown. In sucharrangement, blood flowing through an implanted implant 500d would flow first through the radial support portion 540d before encountering the flow restrictor portion 550d (similar to implant 500c). Different than the implants 500a and 500c, the implant 500d includes struts 595d rather than suture or wire 595a and 595c connecting apexes 564d of the petals 560d to the shaft 590d. Such struts 595d can be integrally formed with the expandable body 510d. With struts 595d, actuation of the flow restrictor portion 550d comprising petals 560d can be similar to that described with respect to the flow restrictor portion 550a of implant 500a. As shown, flow restrictor portion 550d can be oriented in an opposite direction than the flow restrictor portions 550a, 550b, and 550c such that apexes 564d are aimed away from the incoming flow of blood when in use. With such orientation, actuation of the flow restrictor portion 550d can occur via distal movement of the shaft 590d (e.g., pushing) rather than proximal movement of the shaft 590d (e.g., pulling). In some implementations, however, the flow restrictor portion can be oriented the same as the flow restrictor portions 550a, 550b, and 550c such that apexes 564d are aimed towards the incoming flow of blood when in use. FIG. 10A shows an unactuated implant 500d (e.g., the flow restrictor portion 550d is in a non- restricting / non-occluding state) and FIG. 10B shows a partially actuated implant 500d (e.g., the flow restrictor portion 550d is in a partially restricting / occluding state).

[0120] FIG. 11 illustrates another implementation of an implant 500e that can be used in connection with implantable flow restriction system 5. The implant 500e can be similar to and / or incorporate any of the features described with respect to the other implants described herein, such as implants 500a, 500b, 500c, and 500d. Different than the other implants described herein, the implant 500e can have an expandable body 510e having filter portions 520e and 520e’ at proximal and distal ends thereof with a combined radial support portion 540e and flow restrictor portion 550e connected thereto and in between such filter portions 520e, 520e’. FIG. 11 shows a side view of the expandable body 510e of the implant 500e connected to shaft 590e and tubing 570e and can incorporate a collapsible and extendible coupling (not shown) that can be the same or similar to the shaft 590a, tubing 570a, and collapsible and extendible coupling 580a described with respect to implant 500a. Material spanning petals 560e of the flow restrictor portion 550e has been removed to show features of the implant 500e. The flow restrictor portion 550e can include petals 560e as shown, which can be oriented such that proximal movement of the shaft 590e causes the petals 560e tocollapse radially inward to occlude / restrict flow through the implant 500e (e.g., the petals 560e can be pulled inward to close via sutures or wires 595e connected between the ends of the petals and the distal end of the shaft 590e as described herein in related implementations). Arranged as such, blood flowing through an implanted implant 500e would flow first through the filter portion 520e’, through the combined radial support portion 540e and flow restrictor portion 550e, and through the filter portion 520e. Furthermore, the implant 500e can similarly be positioned within the IVC below the renal veins such that the ends of the petals 560e are aimed towards the incoming flow of blood. Also shown, the implant 500e can include anchors 525e that extend generally proximally and anchors 525e’ that extend generally distally where the combined radial support portion 540e and flow restrictor portion 550e meet the filter portions 520e and 520e’. As with other embodiments described above, the implant 500e can be used in a leadless configuration with an intravascular housing replacing the tubing 570e and a transfer shaft moving relative to the housing similar to the movement of the shaft 590e relative to the tubing to move the petals 560e between an occluding / restricting configuration and a higher flow configuration.

[0121] FIG. 12 illustrates another implementation of an implant 500f that can be used in connection with implantable flow restriction system 5. The implant 500f can be similar to and / or incorporate any of the features described with respect to the other implants described herein, such as implants 500a, 500b, 500c, 500d, and 500e. Similar to the implant 500e, the implant 500f can have an expandable body 510f having filter portions 520f and 520f’ at proximal and distal ends of thereof with a combined radial support portion 540f and flow restrictor portion 550f connected thereto and in between such filter portions 520f, 520f’. FIG. 53 shows a side view of the expandable body 510f of the implant 500f connected to shaft 590f and tubing 570f and can incorporate a collapsible and extendible coupling (not shown) that can be the same or similar to the shaft 590a, tubing 570a, and collapsible and extendible coupling 580a described with respect to implant 500a. Furthermore, FIG.12 shows the implant 500f in an unactuated state (e.g., non-restricting / non-occluding state). Material 530f is shown spanning petals 560f of the flow restrictor portion 550f, which can be the same or similar to the material 530a of implant 500a. As shown, flow restrictor portion 550f can be oriented in an opposite direction than the flow restrictor portions 550a, 550b, 550c, and 550e such that apexes 564f of the petals 560f are aimed away from the incoming flow of blood when in use.With such orientation, actuation of the flow restrictor portion 550f can occur via distal movement of the shaft 590f (e.g., pushing) rather than proximal movement of the shaft 590f (e.g., pulling). In some implementations, however, the flow restrictor portion can be oriented the same as the flow restrictor portions 550a, 550b, 550c, and 550e such that apexes 564f are aimed towards the incoming flow of blood when in use. Also shown, the implant 500f can include anchors 525f that extend generally proximally and anchors 525f’ that extend generally distally where the combined radial support portion 540f and flow restrictor portion 550f meet the filter portions 520f and 520f’. As with other embodiments described above, the implant 500f can be used in a leadless configuration with an intravascular housing and a transfer shaft moving relative to the housing similar to the movement of the shaft 590f to move the petals 560f between an occluding / restricting configuration and a higher flow configuration.

[0122] FIG. 13 illustrates another implementation of an implant 500g that can be used in connection with implantable flow restriction system 5. The implant 500g can be similar to and / or incorporate any of the features described with respect to the other implants described herein, such as implants 500a, 500b, 500c, 500d, 500e, and 500f. Similar to the implant 500f, the implant 500g can have an expandable body 510g having filter portions 520g and 520g’ at proximal and distal ends of thereof with a radial support portion 540g connected thereto and in between such filter portions 520g, 520g’. Different than implants 500a-500f, the implant 500g can include a flow restrictor 560g that is not integrally formed with expandable body 510g. The flow restrictor 560g of implant 500g can be disposed within the lumen 513g of the implant 500g (e.g., substantially centered within lumen 513g) and be configured to attach to a distal end or distal portion of the tubing 570g. As shown, the flow restrictor 560g can comprise a balloon that can expand from a collapsed configuration to at least partially block flow through the lumen 513g. Actuation (e.g., expansion) of the balloon flow restrictor 560g can occur via distal movement of the shaft 590g relative to the implant 500g, wherein the shaft 590g enters the balloon flow restrictor 560g and causes it to expand (e.g., the shaft can assume a three dimensional shape to at least partially fill the balloon flow restrictor 560g, causing it to expand). The shaft 590g can be moved relative to tubing 570g. In some embodiments, the implant 500g has a leadless configuration in which an intravascular housing is coupled with the shaft 590g, which may be referred to herein as a transfer shaft. The balloon flow restrictor 560g can collapse upon retraction of the shaft 590g (e.g., proximal movement of the shaft 590grelative to the implant 500g). In some implementations, the implant 500g can be fluidically actuated (e.g., the balloon flow restrictor 560g can be fluidically actuated) to at least partially restrict flow through the lumen 513g.

[0123] FIGS. 14A-14C illustrate another implementation of an implant 500h that can be used in connection with implantable flow restriction system 5. The implant 500h can be similar to and / or incorporate any of the features described with respect to the other implants described herein, such as implants 500a, 500b, 500c, 500d, 500e, and 500f. Similar to the implant 500e, the implant 500h can have an expandable body 510h having filter portions 520h and 520h’ at proximal and distal ends of thereof with a combined radial support portion 540h and flow restrictor portion 550h connected thereto and in between such filter portions 520h, 520h’. FIGS. 14A-14C show side views of the expandable body 510h of the implant 500h connected to shaft 590h and tubing 570h and can incorporate a collapsible and extendible coupling 580h that can be the same or similar to the shaft 590a, tubing 570a, and collapsible and extendible coupling 580a described with respect to implant 500a. FIG. 14A shows the implant 500h in an unactuated state (e.g., non-restricting / non-occluding state), FIG.14B shows the implant 500h in a partially actuated state (e.g., partially restricting / occluding state), and FIG. 14C shows the implant 500h in a fully actuated state (e.g., restricting / occluding state). Material spanning petals 560h of the flow restrictor portion 550h has been removed to show features of the implant 500h and interaction between such features during actuation. Furthermore, and similar to implants 500a, 500b, 500c, and 500e, apexes 564h of petals 560h can point in the distal direction (e.g., when in the unactuated state). Similar to actuation of the flow restrictor portion 550a of implant 500a, FIGS. 14A-14C show that proximal movement of shaft 590h relative to tubing 570h and implant 500h can actuate the flow restrictor portion 550h to occlude / restrict flow through the implant 500h. Specifically, proximal movement of the shaft 590h can pull the apexes 564h of petals 560h of flow restrictor portion 550h radially inwards via sutures or wires 595h connected therebetween. FIGS.14A-14C also show how the collapsible and extendible coupling 580h can extend and collapse during actuation of the implant 500h (e.g., the same or similar to that described with respect to collapsible and extendible coupling 580a of implant 500a). Although the forgoing description of the implant 500h describes distal and proximal movement of the shaft 590h relative to the tubing 570b, the implant 500h can be configured with a leadless configuration in which an intravascular housingis provided. The shaft 590h can be configured to move relative to the intravascular housing to achieve the states of FIGS.14A-14C.

[0124] FIGS. 15A-15B illustrate another implementation of an implant 500i that can be used in connection with implantable flow restriction system 5. FIG. 15A shows the implant 500i in an unactuated state, and FIG.15B shows the implant in an actuated state. The implant 500i can be similar to and / or incorporate any of the features described with respect to the other implants described herein, such as implants 500a, 500b, 500c, 500d, 500e, 500f, and 500h. Similar to the implant 500e, the implant 500i can have an expandable body 510i having filter portions 520i and 520i’ at proximal and distal ends of thereof with a radial support portion 540i connected thereto and in between such filter portions 520i, 520'. Different than implants 500a-500f and 500h, the implant 500i can include a flow restrictor 560i that is not integrally formed with the expandable body 510i. The flow restrictor 560i of implant 500i can be disposed within the lumen 513i of the implant 500i and be configured to attach to a distal end of the shaft 590i and include struts 562i that extend radially outward from such connection to the distal end of the shaft 590i. Furthermore, the flow restrictor 560i can include material 530i spanning between struts 562i to form an umbrella-like flow restrictor 560i. Sutures or wires 595i can connect radially outward ends of the struts 562i to a fixed point adjacent the distal end of tubing 570i. To actuate the flow restrictor 560i and at least partially occlude / restrict flow through the implant 500i, the shaft 590i can be moved proximally relative to the tubing 570i (or in the case of a leadless configuration, relative to an intravascular housing as discussed further below) and expandable frame 510i, allowing a biasing force of the radially outward oriented struts 562i to expand the flow restrictor 560i (e.g., opening the umbrella-like flow restrictor 560i). To return the flow restrictor 560i to its unactuated state, the shaft 590i can be moved distally relative to the tubing 570i (or in the case of a leadless configuration, relative to the intravascular housing) and expandable frame 510i, causing the struts 562i to collapse radially inward (e.g., closing the umbrella-like flow restrictor 560i). While not shown, the implant 500i can also include a collapsible and extendible coupling 580i similar to the collapsible and extendible coupling 580a of implant 500a for fluidically sealing the shaft 590i with the tubing 570i and allowing longitudinal movement (e.g., distal and proximal movement) therebetween.

[0125] In a variant, the flow restrictor 560i can be fixed to a distal extension of tubing 570i and the radially outward ends of the struts 562i can connect via sutures or wires 595i to a distal end of a movable shaft 590i movingly disposed within the tubing 570i (or in an intravascular housing, in a leadless configuration). In such arrangement, the flow restrictor 560i can be actuated by distal movement of such shaft 590i relative to the expandable body 510i and tubing 570i (or intravascular housing), allowing a biasing force of the radially outward oriented struts 562i to expand the flow restrictor 560i (e.g., opening the umbrella-like flow restrictor 560i). To return the flow restrictor 560i to its unactuated state, the shaft 590i can be moved proximally relative to the tubing 570i (or intravascular housing) and expandable frame 510i, causing the struts 562i to collapse radially inward (e.g., closing the umbrella-like flow restrictor 560i).

[0126] FIGS. 16A-16B illustrate another implementation of an implant 500j that can be used in connection with implantable flow restriction system 5. FIG. 16A shows the implant 500j in an unactuated state (e.g., non-occluding / non-restricting state), and FIG. 16B shows the implant 500j in an actuated state (e.g., at least partially occluding / restricting state). The implant 500j can be similar to and / or incorporate any of the features described with respect to the other implants described herein, such as implants 500a, 500b, 500c, 500d, 500e, 500f, 500h, and 500i. Similar to the implant 500i, the implant 500j can have an expandable body 510j having filter portions 520j and 520j’ at proximal and distal ends of thereof with a radial support portion 540j connected thereto and in between such filter portions 520j, 520j’. The implant 500j can include a flow restrictor 560j that can be integrally formed with the expandable body 510j or connected thereto. The flow restrictor 560j of implant 500j can be disposed within the lumen 513j of the implant 500j and be configured to attach at its proximal end to the proximal end of the expandable frame 510j. Furthermore and as shown in FIG.16A, the flow restrictor 560j can include struts 562j that extend generally longitudinally and distally from the proximal end of the expandable frame 510j in the unactuated state (e.g., non- occluding / non-restricting state) of the implant 500j. The flow restrictor 560j can include material 530j spanning between struts 562j to form an umbrella-like flow restrictor 560j. Sutures or wires 595j can connect distal ends of the struts 562j to a distal end of a shaft 590j configured to slidingly move within tubing 570j (or in the case of a leadless configuration, within an intravascular housing). The shaft 590j is hidden from view within tubing 570j. Toactuate the flow restrictor 560j and at least partially occlude / restrict flow through the implant 500j, the shaft 590j can be moved proximally relative to the tubing 570j (or relative to the intravascular housing) and expandable frame 510j, pulling the distal ends of the struts 562j via sutures or wires 595j and causing them to bend radially outward. Such radially outward movement of the distal ends of the struts 562j can open the umbrella-like flow restrictor 560j as shown in FIG. 16B, which with material 530j can at least partially occlude / restrict flow through the implant 500j.

[0127] FIGS. 17A-17C illustrate another implementation of an implant 500k that can be used in connection with implantable flow restriction system 5. FIG. 17A shows the implant 500k in an unactuated state (e.g., non-occluding / non-restricting state), FIG.17B shows the implant 500k in a partially actuated state, and FIG. 17C shows the implant 500k in an actuated state (e.g., at least partially occluding / restricting state). The implant 500k can be similar to and / or incorporate any of the features described with respect to the other implants described herein, such as implants 500a, 500b, 500c, 500d, 500e, 500f, 500h, 500i, and 500j. Similar to the implant 500j, the implant 500k can have an expandable body 510k having filter portions 520k and 520k’ at proximal and distal ends of thereof with a radial support portion 540k connected thereto and in between such filter portions. Different than some of the implants described herein, the implant 500k can include a flow restrictor 560k that is not integrally formed with the expandable body 510k. The flow restrictor 560k of implant 500k can be disposed within the lumen 513k of the implant 500k and be configured to extend out of and retract within tubing 570k as shown. For this, the flow restrictor 560k can attach to a distal end of shaft 590k (not visible since it is inside tubing 570k) and comprise an expandable frame made of struts 562k having material 530k spanning such struts 562k to form a generally umbrella-like flow restrictor 560k. To actuate the flow restrictor 560k and at least partially occlude / restrict flow through the implant 500k, the shaft 590k can be moved distally relative to the tubing 570k and expandable frame 510k, allowing the flow restrictor 560k to extend distally out of tubing 570k and expand (e.g., opening the umbrella-like flow restrictor 560k). To return the flow restrictor 560k to its unactuated state, the shaft 590k can be moved proximally relative to the tubing 570k and expandable frame 510k, causing the expandable frame having struts 562k to collapse as it retracts within tubing 570k (e.g., closing the umbrella-like flow restrictor 560i).

[0128] FIG. 18 illustrates another implementation of an implant 500l that can be used in connection with implantable flow restriction system 5. FIG.18 shows the implant 500l in an actuated state (e.g., at least partially occluding / restricting state). The implant 500l can be the same as the implant 500k except the flow restrictor 560l of implant 500l can comprise an expandable coil configured to attain a three dimensional shape upon expansion as shown. Actuation of the flow restrictor 560l is also the same as the that of flow restrictor 560k described herein. For example, to actuate the flow restrictor 560l and at least partially occlude / restrict flow through the implant 500l, the shaft 590l can be moved distally relative to the tubing 570l (or in the case of leadless configuration, distally relative to an intravascular housing) and expandable frame 510l, allowing the flow restrictor 560l to extend distally out of tubing 570l (or out of or relative to the intravascular housing) and expand (e.g., allowing the expandable coil to assume a three dimensional shape). To return the flow restrictor 560l to its unactuated state, the shaft 590l can be moved proximally relative to the tubing 570l (or intravascular housing) and expandable frame 510l, causing the expandable coil to collapse as it retracts within tubing 570l.

[0129] FIG.19 illustrates an implementation of a releasable implant 500m that can be used in connection with implantable flow restriction system 5. The implant 500m shown can be similar to or the same as the implant 500c described with respect to FIG. 9, however it can be adapted to release from tubing 570m and shaft 590m. Any of the implants described herein can be adapted to be releasable. A releasable implant can allow removal of such implant from the patient if needed. In some implementations, at least a portion of the implantable flow restriction system 5 can be removed from a patient when the system includes a releasable implant. For example, a releasable implant can allow removal of the tubing, shaft, and / or controller of the system and / or intravascular housing (in the case of a leadless configuration) from the patient if needed. To release the implant 500m from the tubing 570m (or from an intravascular housing), the connection between the implant 500m and the tubing 570m (or intravascular housing) can be severed as shown. In some implementations, severing the connection between the implant 500m and tubing 570m (or intravascular housing) can include pulling the tubing 570m (or intravascular housing) while maintaining the implant 500m in place, causing the implant 500m to break away from the tubing 570m. In some implementations, severing the connection between the implant 500m and tubing 570m (orintravascular housing) can include peeling away or cutting an outer wrap or membrane that attaches the implant 500m to the tubing 570m (or intravascular housing). Such peeling away or cutting can be performed by another interventional device or via a pull string that can be contained within the tubing 570m (or intravascular housing) and accessible at a proximal end of the tubing 570m (or intravascular housing). To release the implant 500m from the shaft 590m, the connection between the sutures or wires 595m and the implant 500m can be severed as shown. In some implementations, severing the connection between the sutures or wires 595m and the implant 500m can include cutting or heating the sutures or wires 595m via another interventional device. In some implementations, severing the connection between the sutures or wires 595m and the implant 500m can include pushing the shaft 590m distally past the implant 500m to cause the sutures or wires 595m to disconnect from the implant 500m (e.g., the connection between the sutures or wires 595m and the implant 500m can be configured to remain intact as long as the shaft 590m does not extend past the distal end of the implant 500m). In some implementations, to release the implant 500m from the tubing 570m (or intravascular housing) and shaft 590m, the connection between the implant 500m and shaft 590m is severed first, followed by severing the connection between the implant 500m and tubing 570m (or intravascular housing). In some implementations, to release the implant 500m from the tubing 570m (or intravascular housing) and shaft 590m, the connection between the implant 500m and tubing 570m (or intravascular housing) is severed first, followed by severing the connection between the implant 500m and shaft 590m.

[0130] FIGS. 19A-19B illustrate another implementation of a releasable implant 500m’ that can be used in connection with implantable flow restriction system 5 or any of the implantable flow restriction systems described herein (including the leadless systems described herein). The implant 500m’ shown can be similar to or the same as the implant 500a described with respect to FIGS.2A-3D, however it can be adapted to release from tubing 570a and shaft 590a (or intravascular housing 1504 described herein below). Such release of the implant 500a from the tubing 570a can be accomplished by severing a severable connection formed therebetween as described herein. As shown in the side view of implant 500m’ in FIG.19A, a portion of the expandable body 510m’ of the implant 500m’ (e.g., a proximal end) can be constrained to form a connection (for example, a severable or releasable connection) with the tubing 570a (tubing 570a not shown). For example, a proximal end of struts 527m’ that extendproximally from a radial support portion 540m’ of the expandable body 510m’ can be constrained to form a connection with the tubing 570a. For this, the proximal end of struts 527m’ can include an aperture 528m’ configured to receive a string or suture therethrough. Such a string or suture can be looped through the apertures 528m’ to constrain the struts 527m’ about the tubing 570a. Such constraining of the proximal ends of struts 527m’ can cause the struts to bend radially inward as shown in FIG. 19A. Furthermore, such constraining of the proximal end of struts 527m’ can cause the struts 527m’ to form a filter portion 520m’ of the implant 500m’ as described herein. In some implementations, the tubing 570a can include a suture connection feature (e.g. an aperture), and the string or suture used to constrain the implant 500m’ upon tubing 570a can be further looped through such suture connection feature. In some implementations, the tubing 570a can include one or more protrusions distal of and / or proximal of where the proximal ends of struts 527m’ collapse upon the tubing 570a, such protrusion(s) configured to act as physical stops to prevent proximal and / or distal movement of the implant 500m’ when the implant 500m’ is connected thereto. In some implementations, the tubing 570a can include a recess where the proximal ends of struts 527m’ collapse upon the tubing 570a, such recess configured to receive at least a portion of the proximal ends of struts 527m’ and prevent proximal and / or distal movement of the implant 500m’ when the implant 500m’ is connected thereto. In some implementations, a material (for example, reflow of material) can releasably secure the proximal ends of struts 527m’ to the tubing 570a. Such material can releasably secure the proximal ends of struts 527m’ to the tubing 570a in addition to suture or instead of suture. FIG. 19B shows a side view of the implant 500m’ in its resting / unconstrained state. For example, upon severing (for example, cutting) the string, suture, and / or material that can constrain the proximal ends of struts 527m’ about tubing 570a, the struts 527m’ can extend radially outward as shown. Such configuration can advantageously allow the implant 500m’ to stay implanted in the patient without having a portion thereof blocking or remaining in a flow path created by the implant 500m’.

[0131] FIGS. 19C-19F illustrate another implementation of a releasable implant 500m’’ that can be used in connection with implantable flow restriction system 5 or any of the implantable flow restriction systems described herein (including the leadless systems described herein). The implant 500m’’ shown can be similar to or the same as the implant 500a described with respect to FIGS.2A-3D, however it can be adapted such that at least a portion thereof canbe released (for example, severed) from tubing 570a and shaft 590a (or intravascular housing 1504 described herein below). As shown in the side view of implant 500m’’ in FIG. 19C, a plurality of struts 527m’’ can extend distally and radially outward from a proximal end 511m’’ of the expandable body 510m’’ (e.g., the end that can connect to tubing 570a or intravascular housing 1504 as described herein). The struts 527m’’ can be configured to releasably connect to a radial support portion 540m’’ of the implant 500m’’. For example, distal ends 529m’’ of struts 527m’’ can be configured to releasably connect to a proximal end 541m’’ of radial support portion 540m’’. For this, a distal portion of the struts 527m’’ can have a distal aperture 528m’’ and a proximal portion of the radial support portion 540m’’ can have a proximal aperture 542m’’. The proximal aperture 542m’’ of the radial support portion 540m’’ can be disposed around a barb 525m’’ configured to anchor the radial support portion 540m’’ with an inner wall of the patient’s vasculature. As shown in FIG. 19D, a suture 523m’’ can be looped between the distal aperture 528m’’ and the proximal aperture 542m’’ to form the releasable connection (“releasable connection” can also be referred to herein as “severable connection”). In some implementations and as shown in FIG. 19E, a material 531m’’ (for example, reflow of material) can releasably connect (for example, extend around and / or between) the distal ends 529m’’ of struts 527m’’ and the proximal end 541m’’ of radial support portion 540m’’. In such implementations, the distal apertures 528m’’ of struts 527m’’ can be omitted or included. In some implementations, both a suture 523m’’ and a material 531m’’ can releasable connect the distal ends 529m’’ of struts 527m’’ and the proximal end 541m’’ of radial support portion 540m’’. To severe the connection(s), such suture 523m’’ and / or material 531m’’ can be cut, thereby releasing the struts 527m’’ from the rest of the implant 500m’’ as shown in FIG. 19F. The suture 523m’’ and / or material 531m’’ can be severed (for example, cut) by an interventional device. Such an interventional device can comprise a cutter (e.g., the struts 527m’’ can be received by an interventional device and the suture 523m’’ and / or material 531m’’ cut via a cutter disposed within such interventional device). The struts 527m’’ can form a filter portion of the implant 500m’’ as described herein. In some implementations, the implant 500m’’ can be formed from implant 500a by creating the distal apertures 528m’’ in the plurality of struts 527a, cutting the plurality of struts 527a distal of such distal apertures 528m’’, and suturing apertures 528m’’, 542m’’ together. In some implementations, the implant 500m’’ can be formed from implant 500a by cutting the plurality of struts 527a adjacent theirends 529m’’ and connecting the implant back together at such cuts via a material and / or a suture (such as material 531m’’ and / or suture 528m’’).

[0132] Any of the systems described herein can be configured to include one or more of the releasable and / or severable connections described with respect to FIGS. 19-19F. Furthermore, such releasable and / or severable connections can be implemented in various portions of a system as described herein, such as in various portions of an implant (for example, between a filter portion and a radial support portion, between a flow restrictor portion and a radial support portion), various portions of a tubing (for example, at or adjacent a proximal or distal end of the tubing), various portions of a shaft or wire (for example, at or adjacent a proximal or distal end of the shaft or wire), and any connection(s) therebetween (for example, connection between a tubing and an implant, connection between a shaft or wire or actuator and an implant, connection between a tubing and an implantable controller, connection between a shaft or wire and an implantable controller, connection between an implant and portion of a leadless system).

[0133] FIGS.20A-20C illustrate another implementation of an implant 500n. FIG. 20A shows a side view of the implant 500n in an unactuated state (e.g., non-occluding / non- restricting state), FIG.20B shows a side view of the implant 500n in an actuated state (e.g., at least partially occluding / restricting state), and FIG.20C shows an end view of the implant 500n in an unactuated state. The implant 500n can be similar to and / or incorporate any of the features described with respect to the other implants described herein. As shown, the implant 500n can comprise an expandable body 510n having a proximal end 511n, a distal end 512n, and a lumen 513n for receiving blood flow therethrough. The implant 500n can include a filter portion 520n, a radial support portion 540n, and a flow restrictor portion 550n, a radial support portion 540n’, and a filter portion 520n’. Furthermore, the implant 500n can include a material 530n spanning at least the flow restrictor portion 550o (as shown, the material 530n spans the flow restrictor portion 550n and the radial support portions 540n, 540n’). The flow restrictor portion 550n can be configured to occlude / restrict flow by being cinched radially inward as shown in FIG. 20B via suture or wire 595n. Such suture or wire 595n can wrap around the flow restrictor portion 550n and / or pass through eyelets of struts 562n that make up the flow restrictor portion 550n. While not shown, the implant 500n can connect to tubing 570n at its proximal end 511n. Such tubing 570n can connect to the implant 500n at a position that issubstantially central to the lumen 513n (as shown for at least some of the other implementations of implants 500 described herein). In some implementations, such tubing 570n can connect to implant 500n at a position along a circumference of the implant 500n (e.g., at a side of the implant 500n). The suture or wire 595n can extend from around the flow restrictor portion 550n and through the tubing 570n to connect to the actuator of the controller 50 for actuation of the implant 500n. In some implementations, the suture or wire 595n can connect to a shaft 590n that extends through the tubing 570n such as described herein for other implementations for actuation of the implant 500n. In such implementations, a collapsible and extendible coupling 580n similar to other collapsible and extendible couplings described herein can be used to fluidically seal the shaft 590n with the tubing 570n. A leadless version of the implant 500n can be provided by coupling a shaft coupled with an intravascular housing with the suture or wire 595n. A proximal ring of the filter portion 520n can be coupled to the intravascular housing to secure the flow restrictor.

[0134] FIG. 21 illustrates another implementation of an implant 500o. FIG. 21 shows a perspective view of the implant 500o in an unactuated state (e.g., non-occluding / non- restricting state). The implant 500o can be similar to and / or incorporate any of the features described with respect to implant 500n and the other implants described herein. As shown, the implant 500o can comprise an expandable body 510o having a proximal end 511o, a distal end 512o, and a lumen 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 than the implant 500n, the implant 500o can omit filter portion(s) adjacent its proximal and distal ends. While not shown, the implant 500o can include a material 530o spanning at least the flow restrictor portion 550o. In some implementations a material 530o can span the flow restrictor portion 550o and the radial support portions 540o, 540o’. Similar to the flow restrictor portion 550n of implant 500n, the flow restrictor portion 550o can be configured to occlude / restrict flow by being cinched radially inward via suture or wire 595o. Such suture or wire 595o can wrap around the flow restrictor portion 550o and / or pass through eyelets 596o of struts 562o that make up the flow restrictor portion 550o. While not shown, the implant 500o can connect to tubing 570o or to an intravascular housing in a leadless variant at its proximal end 511o. Such tubing 570o or housing can connect to the implant 500o at a position along a circumference of the implant 500o (e.g., at a side of the implant 500o). Thesuture or wire 595o can extend from around the flow restrictor portion 550o and through the tubing 570o to connect to the actuator of the controller 50 for actuation of the implant 500o. In a leadless version the suture or wire 595o could couple to a shaft moved or rotated by a motor disposed in the housing. In some implementations, the suture or wire 595o can connect to a shaft 590o that extends through the tubing 570o such as described herein for other implementations for actuation of the implant 500o. In such implementations, a collapsible and extendible coupling 580o similar to other collapsible and extendible couplings described herein can be used to fluidically seal the shaft 590o with the tubing 570o. As shown in FIG. 21, the implant 500o can include anchors 525o and 525o’ at proximal and distal ends thereof, respectively. The anchors 525o and 525o’ can have a hook-like configuration to facilitate anchoring the implant 500o in a vessel. In some implementations, the implant 500o or features thereof can be used as or incorporated into a shunt (e.g., a pulmonary artery to azygos vein shunt as described in U.S. Provisional Patent Application No. US63 / 331,496 incorporated by reference herein).

[0135] FIG. 22 illustrates an implementation of anchors 525p of an implant 500p of an implantable flow restriction system 5. The implant 500p can be the same or similar to implant 500a described herein except for the configuration of the anchors 525p. As shown, the anchors 525p can have a circular configuration with a break in such circle to allow the anchors 525p to pass over and accept within such circle at least a portion of the expandible frame 510p of the implant 500p. For example, the anchors 525p are shown accepting a portion of the expandible frame 510p where the radial support portion 540p and the flow restrictor portion 550p meet, however the anchors 525p can be located along and / or accept any portion of the implant 500p. Also shown in FIG. 22, at the break in the circular configuration of the anchors 525p, the anchors 525p can have portions 527p that extend generally outward from such circle and substantially in the same plane as such circle. Such portions 527p can extend generally parallel with one another as shown, or they can extend at angles to one another. Such portions 527p can facilitate anchoring of the implant 500p in a vessel or shunt. In a leadless version the proximal ring of the filter portion 520p can be secured to an intravascular housing.

[0136] FIGS. 23A-23B illustrate an implementation of the shaft 590 of the implantable flow restriction systems 5 described herein. The shafts described below can be used in connection with any of the implants described herein. FIG.23A shows a side view andFIG. 23B shows a perspective cross-sectional view of the shaft 590. As shown, the shaft 590 (which can also be referred to as a “wire” or “cable” herein) can have a braided structure comprising a plurality of individual wires 593. In some implementations, a plurality of individual wires 593 can be twisted upon one another to form a bundle, and the shaft 590 can be made of a plurality of such bundles twisted upon one another. In some implementations, the 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 flow restrictions systems that actuate via the shaft pulling on a portion of an implant to actuate a flow restrictor thereof, the shaft can be configured for tension and may have a form the same as or similar to that shown in FIGS. 23A-23B. As another example, for flow restrictions systems that actuate via the shaft pushing on a portion of an implant to actuate a flow restrictor thereof, the shaft can be configured for compression. In another example, for flow restriction systems that actuate via the shaft rotating, the shaft can be configured for rotation. In some implementations, one or more wires 593 of the shaft 590 can be configured to transmit power and / or signals to and / or from one more sensors 600 of a flow restriction system 5 or a modified embodiment of that system with a leadless implant as disclosed herein. The shaft 590 can be flexible and in some implementations have a lubricious coating or have a lubricious surface to facilitate sliding movement within tubing 570 as described herein. Furthermore, the shaft 590 can be made of biocompatible material (e.g., stainless steel).

[0137] FIG. 24 illustrates a schematic diagram of certain features which can be incorporated in the implantable flow restriction system 5 as well as any other implementations of the implantable flow restriction systems described herein. As shown, an implantable controller 50 of the implantable flow restriction system 5 can include a processor 51, an actuator 52, a storage device 53, a power source 54, and / or a communication module 55. Also shown, an external device 15 used to operate the implantable flow restriction system 5 can include a processor 16, a user interface 17, a storage device 18, a power source 19, and a communication module 21. In some implementations, the external device 15 can be a mobile phone, a tablet, a handheld or mobile device, or otherwise. In a leadless embodiment, the processor 51, the actuator 52, the storage device 53, the power source 54, and / or the communication module 55 can be integrated into an intravascular housing.

[0138] The processors 51 and 16 can be configured, among other things, 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. For example, the processor 51 can control operation of the actuator 52 and the sensor(s) 600 of the chronic, implantable flow restriction system 5. As another example, the processor 51 can process signals and / or data received and / or obtained from the sensor(s) 600 of the implantable flow restriction system 5. Further, the processor 51 can execute instructions to perform functions related to storing and / or transmitting such signals and / or data received and / or obtained from the sensor(s) 600 of the implantable flow restriction system 5 or the pressure sensor 1628 of the leadless devices disclosed below (e.g., such as transmitting such signals and / or data to external device 15). The processor 51 can execute instructions to perform functions related to storing and / or transmitting any or all of such received data.

[0139] The storage devices 53 and 18 can include one or more memory devices that store data, including without limitation, 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), and the like. Such stored data can be processed and / or unprocessed data obtained from the implantable flow restriction system 5, for example.

[0140] The communication modules 55 and 21 can facilitate communication (e.g., via wireless connection) between the implantable flow restriction system 5 or variations including leadless implants (and / or components thereof, such as controller 50) and external device 15 as well as 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 flow restriction system 5 to wirelessly communicate with external device 15 and / or other devices, systems, and / or networks over 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), Bluetooth®, ZigBee®, Z-wave®, cellular telephony, infrared, near-field communications (NFC), RFID, satellite transmission, proprietary protocols, combinations of the same, and the like. The communication module 55 can allow data and / or instructions to be transmitted and / or received to and / or from the implantable flow restriction system 5 and separate computing devices, such as the externaldevice 15. The communication module 55 can be configured to transmit (for example, wirelessly) processed and / or unprocessed data (e.g., data from sensor(s) 600) and / or other information to one or more separate computing devices, which can include, among others, external device 15, a patient monitor, a mobile device (for example, an iOS or Android enabled smartphone, tablet, laptop), a desktop computer, a server or other computing or processing device for display and / or further processing, among other things. Such separate computing devices can be configured to store and / or further process the received data and / or other information, to display information indicative of or derived from the received data and / or information, and / or to transmit information -- including displays, alarms, alerts, and notifications -- to various other types of computing devices and / or systems that can be associated with a hospital, a caregiver (for example, a primary care provider), and / or a user (for example, an employer, a school, friends, family) that have permission to access the patient’s data. As another example, the communication module 55 of the controller 50 of the implantable flow restriction system 5 can be configured to wirelessly transmit processed and / or unprocessed obtained data, information and / or other information (for example, a status of actuation of an 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 displaying information representative of the processed or unprocessed data, information and / or other information obtained from the implantable flow restriction system 5. The communication modules 55 and 21 can be and / or include a wireless transceiver.

[0141] The power sources 54 and 19 can provide power for hardware components of the implantable flow restriction system 5 and the external device 15, respectively, described herein. For example, the power source 54 of the controller 50 can provide power to the sensor(s) 600, the communication module 55, the processor 51, and the actuator 52. In some implementations, the power source 54 can comprise a battery, an induction receiver / rectifier, or both. The power source 19 can comprise a battery. In some implementations, the external device 15 can also include an induction transmitter to wirelessly transmit power to an induction receiver / rectifier of the implantable flow restriction system 5 (e.g., of the controller 50) if included. Any of such batteries can be rechargeable. For example, such batteries can be a lithium, a lithium polymer, a lithium-ion, a lithium-ion polymer, a lead-acid, a nickel-cadmium, or a nickel-metal hydride battery. In some implementations, such batteries can be non-rechargeable.

[0142] The actuator 52 of the controller 50 of the implantable flow restriction system 5 can be configured to move shaft 590 within tubing 570 for actuation of flow restrictor 560 and / or flow restrictor portion 550 of implant 500 (which can include any of the implants described herein). For example, the actuator 52 can be configured to slidingly move shaft 590 proximally and / or distally relative to the tubing 570 and implant 500. As another example, the actuator 52 can be configured to rotationally move shaft 590 relative to the tubing 570 and the implant 500. Furthermore, the actuator 52 can be configured to cause flow restrictor 560 and / or flow restrictor portion 550 of implant 500 to occlude / restrict flow through the implant 500 in a range of from and including about 0% to about 100%. The actuator 52 is a motor 1512 in some leadless embodiments discussed below.

[0143] The user interface 17 of the external device 15 can be configured to allow a patient or their care provider to interact with the external device 15 for control of the implantable flow restriction system 5. The user interface can include button(s), a touch screen, and / or a microphone to accept physical touch and / or verbal input / commands.

[0144] FIGS. 25A-25C illustrate an implementation of a connector 700 between components of a flow restriction system 5. The connector 700 can be configured, for example, to releasably connect a proximal end 592 of the shaft 590 to the actuator 51 of the controller 50. The connector 700 can be configured, for example, to releasably connect a proximal end of a transfer shaft 1552a to a transmission component coupled to a motor 1512 in a leadless version. As shown in FIG. 25A, the connector 700 can include a first component 710 and a second component 720 configured to releasably connect with one another via complementary features. Such first component 710 and second component 720 can be secured to the proximal end 592 of the shaft 590 and the actuator 51, respectively, or vice versa. The first component 710 be configured as a cylinder and can have a circular recess 712 at one of its ends and a protrusion extending radially inward into the recess 712 that is marked visually by point 714 located on an external surface of the first component 710. The second component 720 can be configured as a cylinder and can have a circular rod-like protrusion 722 extending from one of its ends sized to fit within the recess 712 of the first component 710. Furthermore, the protrusion 722 can have a slot 724 configured to receive the protrusion extending radiallyinward into the recess 712 of the first component 710. As shown in FIGS. 25A-25B, the slot 724 can extend in a longitudinal direction from the end of the protrusion 722 then turn about 90 degrees or more so that, upon alignment of the slot 724 with the point 714 and upon full insertion of the protrusion 722 into recess 712, the first component 710 and the second component 720 can be rotated in a first direction relative to one another to secure the first component 710 and the second component 720 together (e.g., the first and second components can stay connected via interaction between the protrusion of the first component 710 and the slot 724 of the second component 720). FIG. 25C shows how to release the first component 710 from the second component 720, which can include pressing the first component 710 and the second component 720 together, rotating the first component 710 and the second component 720 relative to one another in a second direction that is opposite the first direction, and then separating the first component 710 and the second component 720 from one another.

[0145] FIGS. 26A-26B illustrate a variant 700’ of the connector 700. Like the connector 700, the connector 700’ can be configured to releasably connect a proximal end 592 of the shaft 590 to the actuator 51 of the controller 50. As shown in FIG. 26A, the connector 700’ can include a first component 710’ and a second component 720’ configured to releasably connect with one another via complementary features. The first component 710’ can be configured as a cylinder and can have a circular recess 712 at one of its ends similar to the first component 710. Instead of a protrusion and point 714 marking the location of such protrusion, the first component 710’ can include a slot 714’ through a wall of the first component that extends longitudinally from the end of the first component 710’ having the recess 712’ then turns about 90 degrees or more. The second component 720’ can be configured as a cylinder 722’ sized to fit within the recess 712’ of the first component 710’ and can have a circular rod- like protrusion 724’ extending radially outward from its external surface configured to fit within the slot 714’. To connect the first component 710’ and the second component 720’ to one another, the cylinder 722’ can be inserted fully into the recess 712’ with the protrusion 724’ aligned with the slot 714’ and the first component 710’ and the second component 720’ can be rotated in a first direction relative to one another (e.g., the first and second components can stay connected via 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 bepressed together and rotated relative to one another in a second direction that is opposite the first direction, then the first component 710 and the second component 720 can be separated from one another.

[0146] FIGS. 27A-27D illustrate an implementation of a connector 750 between components of an implantable flow restriction system 5. The connector 750 can be configured, for example, to releasably connect and fluidically seal a proximal end 572 of the tubing 570 to the controller 50 (e.g., to a housing of the controller 50). For this, the connector 750 can extend from the controller 50 (e.g., extend from the housing of the controller 50). FIG. 27A shows the tubing 570 separated from the connector 750 but in a position for connecting thereto, FIG. 27B shows a side view of a portion of the connector 750, FIG. 27C shows an end view of the connector 750, and FIG. 27D shows a cross-sectional side view of the connector 750. The connector 750 can have a main body 751 having a generally cylindrical shape with a lumen 753 extending therethrough. The connector 750 can include a first component 760 having a longitudinal through hole 762 configured to receive the proximal end 572 of tubing 570 and a second component 770 configured to receive the first component 760 (e.g., shown in FIG. 27D). Both the first and second components 760, 770 can be received by the main body 751. A proximal end of the second component 770 can include a plurality of radially inward extending arms 772 configured to bias the first component 760 in a direction distally away from the second component 770. Such arms 772 can also be configured to grab onto an external surface of the tubing 570 when the tubing 570 is inserted into the connector 750. To connect and fluidically seal the tubing 570 with the connector 750, the proximal end 572 of tubing 570 can be inserted fully into the connector 750 via the through hole 762 of the first component 760 until it cannot be inserted any further. A fluidic seal can be made between the tubing 570 and the connector 750 via a third component 780 configured as a circumferential ring within the main body 751 located proximal to the first and second components 760, 770. In such fully inserted position, the arms 772 of the second component 770 can grab onto the external surface of the tubing 570 and prevent it from releasing from the connector 750. To release the connection between the tubing 570 and the connector 750, the first component 760 can be pressed inward into the connector 750 (e.g., pressed proximally into the connector 750), causing a proximal end of the first component 760 to radially expand the arms 772 and releasethem from the tubing 570, while the tubing 570 is pulled out of the connector 750 (e.g., moved distally relative to the connector 750).

[0147] FIGS. 28A-28B illustrate an implementation of an implant assembly 501 comprising the implant 500, tubing 570, and shaft 590 having an extender 800 to aid in implantation of the implant assembly 501. The implant 500, tubing 570, and shaft 590 shown correspond to implant 500a, tubing 570a, and shaft 590a described herein, although in some implementations they can be any of the implants described herein. The extender 800 can comprise a flexible tube that attaches to the tubing 570 adjacent its proximal end 572 and extends proximally therefrom. For example, the extender 800 can comprise PEBAX that is reflowed on tubing 570. In some implementations, the extender 800 is a proximal continuation of the tubing 570. The extender 800 can advantageously provide the care provider that is implanting the implant assembly 501 a component that can be grasped outside the body to aid in positioning and handling of the implant assembly 501 during its implantation in the patient. As shown in the magnified view of FIG. 28B, the extender can be cut at cutline 803 and removed from the implant assembly 501 (e.g., by sliding it proximally) when no longer needed. In some implementations, the extender 800 is configured to peel away from the implant assembly 501 at cutline 803. Once the extender 800 is removed, the proximal end 572 of tubing 570 can coincide with the cutline 803. Also shown in FIGS. 28A-28B is a device 850 for testing function of the implant 500, which can extend proximally through the extender 800 and which will be described with respect to FIGS.29A-29B, FIGS. 30A-30B, and FIG.31.

[0148] FIGS. 29A-29B illustrate an implementation of a device 850 for testing function of the implant 500 during implantation thereof. As shown, the device 850 can releasably connect to the proximal end 591 of the shaft 590 for pulling, pushing, and / or rotating the shaft 590 to actuate flow restrictor 560 and / or flow restrictor portion 550 of implant 500. For this, the device 850 can include one of the components of the connector 700 described herein, such as first component 710 as shown to releasably connect with the other of the components of the connector 700, such as the second component 720 shown attached to the proximal end 592 of shaft 590. In some implementations, 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.29A shows the device 850 connected to the shaft 590, whereas FIG. 29B shows the device 850 disconnected from the shaft 590. To facilitate pulling, pushing,and / or rotating the shaft 590 via device 850, the device 850 can include a proximal extension 855. As shown in FIGS. 29A-29B, the proximal extension 855 can comprise suture. In a variant 850’ of the device 850 such as is shown in FIGS. 30A-30B, the proximal extension 855’ can comprise a shaft. In some implementations, the proximal extension 855, 855’ can comprise 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, push, and / or rotate on the shaft 590 for testing actuation of the flow restrictor 560 and / or flow restrictor portion 550 of implant 500). Alternatively, or in addition, to testing function of the implant 500, the device 850, 850’ can also be used to aid in removal of the implant 500 if needed. For example, to remove an implant 500 from a patient, the implantable controller 50 can be disconnected from the shaft 590 and tubing 570, the device 850, 850’ can be connected to the shaft 590, a sheath can be slid over the device 850, 850’ and distally over the shaft 590 and tubing 570 in the body, the sheath can be slid over the implant 500 and cause it to collapse within the sheath, and then the sheath with the implant 500, shaft 590, and tubing 570 therein can be retracted proximally from and out of the patient. The device 850, 850’ can advantageously provide a working length to aid in removal of the implant assembly 501 out of the body.

[0149] FIG. 31 illustrates a method 900 of implanting an implantable flow restriction system 5. The method 900 can be applied to any of the implementations of the implantable flow restriction systems 5 and components thereof described herein. Furthermore, the method 900 can include other steps and / or omit steps. The method 900 can be performed in a cardiac catheterization lab under local or general anesthesia and can be performed in a minimally invasive manner.

[0150] The method 900 can include the step 905 of accessing a subclavian vein of the patient. The access point to the subclavian vein, which can be the right or left subclavian vein, can be made at or near the junction of the middle and inner thirds, where the first rib and the clavicle are joined. The subclavian vein can be blindly punctured or under imaging guidance. Once access to the subclavian vein is made, a guide wire can 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 (which can also be referred to as a “delivery catheter" herein) with dilator can be placed into the subclavian vein over the guide wire and into the IVC.

[0151] The method 900 can optionally include the step 910 of identifying the renal veins. Identifying the renal veins can be performed via fluoroscopy and intravascular dye via the delivery sheath during implantation, or it can be performed prior to implantation via CT imaging. With the renal veins identified, the distal end of the delivery sheath can be placed in the IVC below the renal veins (e.g., in the IVC upstream of its connection to the renal veins) and the dilator can be removed from the delivery sheath.

[0152] The method 900 can include the step 915 of implanting the implant assembly 501. In other words, the step 915 can include implanting the implant 500 connected to tubing 570 and shaft 590. For this, the implant assembly 501 can be inserted into the delivery sheath and delivered into the IVC with the implant 500 being positioned below the renal veins. To aid in delivery and handling of the implant assembly 501, the extender 800 can be optionally attached to the implant assembly 501 as described with respect to FIGS. 28A-28B. Repositioning of the implant 500 can be performed if needed.

[0153] Once the implant 500 has been deployed out the distal end of the delivery sheath, the method 900 can optionally include the step 920 of testing function of the implant assembly 501. For this, the device 850 for testing function of the implant 500 as described with respect to FIGS.29A-29B and FIGS.30A-30B can be utilized to actuate the implant 500 and test its function (e.g., the flow restrictor 560 and / or flow restrictor portion 550 of the implant 500 can be actuated via the device 850 to at least partially occlude flow through the implant 500). If the functional test is a success the delivery sheath can be removed proximally from the implant assembly 501 leaving the implant assembly 501 in place in the patient. If the functional test is not successful, the implant 500 can be resheathed within the delivery sheath (e.g., by distal movement of the delivery sheath over the implant 500 and / or pulling the implant 500 proximally relative to the delivery sheath) and the implant assembly 501 removed from the patient.

[0154] Where used, the method 900 can include the step 925 of removing the extender 800. This can be performed by either cutting the extender at cutline 803 or peeling it away at cutline 803 as described with respect to FIGS. 28A-28B. The device 850 for testing function of the implant 500 can also be removed.

[0155] The method 900 can include the step 930 of creating an infraclavicular subcutaneous pocket for the implantable controller 50 of the system 5.

[0156] The method 900 can include the step 935 of connecting the implant assembly 501 to the implantable controller 50. For this, the shaft 590 can be connected to the actuator 51 of the controller 50 as described with respect to FIGS. 25A-25C and FIGS. 26A- 26B. Additionally, the tubing 570 can be connected to the controller 50 as described with respect to FIGS.27A-27D.

[0157] The method 900 can include the step 940 of testing function of the implantable flow restriction system 5. For this, the external device 15 can be used to test operation of the implant 500.

[0158] With confirmation that the external device 15 can successfully operate the system 5, the method 900 can include the step of implanting the implantable controller 50. For this, the implantable controller 50 can be inserted into the subcutaneous pocket made in step 930. Closure can be performed and the implantation procedure concluded.

[0159] In some implementations, vascular access can be made via a femoral vein, a radial vein, or any of the veins shown in FIG. 1. Depending on the location of vascular access, the implantable controller 50 can be implanted in locations other than described in method 900. Furthermore, depending on the location of vascular access, the implant 500 can be configured as described with respect to implant 500a, or it can have a reverse configuration (e.g., with the flow restrictor 560 flipped and configured to be operated by push of shaft 590 rather than pull of shaft 590).

[0160] FIGS. 32A-32D illustrate deployment of implant 500 of an implantable flow restriction system 5 out a distal end 1002 of a delivery sheath 1000. The deployment of the implant 500 described with respect to FIGS. 32A-32D can be applicable to any of the implementations of the implants described herein.

[0161] As shown in FIG. 32A, distal movement of the implant 500 relative to the distal end 1002 of the delivery sheath 1000 can lead to the implant 500 extending out the distal end 1002 of the delivery sheath 1000. Such relative movement can occur by maintain the position of the implant 500 and proximally retracting the delivery sheath 1000, by maintaining the position of the delivery sheath and distally extending the implant 500 therefrom, or both. Advantageously and as shown in FIG. 32A, the implant 500 can remain collapsed upon itself while extending distally past the distal end 1002 of the delivery sheath 1000 due to the configuration of the expandible frame 510 of the implant 500. Such configuration can facilitateimplant repositioning if needed. For example, the implant 500 can remain collapsed upon itself while at least a portion of the radial support portion 540 remains inside the delivery sheath 1000.

[0162] FIGS.32B-32C show progressive radial expansion of the implant 500 upon continued distal extension of the implant 500 or a leadless configuration as discussed herein past the distal end 1002 of the delivery sheath 1000. As shown, partial radial expansion of the implant 500 can 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 shown in FIG. 32C, the anchors 525 can maintain a tucked position (e.g., extending at least partially radially inward) while the implant 500 is in a partially expanded state. Such configuration of the implant 500 can aid in repositioning of the implant 500 within a vessel if needed and / or retraction of the implant 500 back within the delivery sheath 1000 if needed.

[0163] FIG.32D shows full deployment of the implant 500 out the distal end 1002 of the delivery sheath. Upon being fully deployed, the implant 500 can attain its fully expanded state as shown. In such state, the anchors 525 can assume their generally longitudinally oriented position to help anchor the implant 500 within a vessel. Advantageously, the implant 500 can be configured to be retrieved and retracted back within the delivery sheath 1000 even after full deployment therefrom due to the configuration of the filter portion 520 that can cause the proximal end of the implant 500 as well as the anchors 525 to tuck radially inward upon proximal retraction.

[0164] FIG. 33 illustrates a guideline 1100 for treatment of a patient using the implantable flow restriction system 5 described herein. In some implementations, the guideline 1100 can apply to any of the flow restriction systems described herein. The guideline 1100 can include assessing the IVC pressure of the patient. If the IVC pressure is determined to be normal, no action may be required by the system 5 as shown. Normal IVC pressure can be a pressure of between about 0 mmHg and about 8 mmHg. If the IVC pressure is determined to be high, the system 5 can be activated as shown. High IVC pressure can be a pressure of greater than about 8 mmHg. The IVC pressure can be measured by the system 5 via sensor(s) 600. Furthermore, activation of the system can occur via the external device 15 as described herein (e.g., digital, wireless activation). If the IVC pressure remains high after activation ofthe system 5, a patient can be recommended to consult with their medical professional / care provider.

[0165] FIGS. 34-36 illustrate various methods of using the implantable flow restriction system 5 and the leadless systems described herein. The methods described with respect to FIGS. 34-36 can be adapted to any of the flow restriction systems described herein. Furthermore, while the methods described with respect to FIGS. 34-36 are described using sensor(s) 600 connected to the implant 500, the system 5 can include other sensors proximate the implant 500 and / or remote from the implant 500 for pressure determination(s) and control of the system 5. Additionally, while the methods described with respect to FIGS. 34-36 have been described as being performed by a patient having the system 5 implanted, any steps of such methods can be performed by a medical professional / care provider of the patient or an authorized user.

[0166] FIG.34 illustrates a manual method 1200 (which can also be referred to as a “patient driven method”) of using an implantable flow restriction system 5 or a leadless system as disclosed herein. Furthermore, the method 1200 can include other steps and / or omit steps.

[0167] The manual method 1200 can include a step 1205 of requesting a pressure measurement (e.g., a renal venous pressure measurement or a femoral venous pressure measurement). Such a request can be made by the patient using the external device 15 or other separate electronic device as described herein (e.g., via wireless communication with the system 5).

[0168] The manual method 1200 can include a step 1210 of the system 5 measuring the pressure based on the request from step 1205. Such pressure measurement can be measured via the sensor(s) 600 of the system 5. For this, the processor 51 of controller 50 can be operably connected to the pressure sensor(s) 600 and configured to receive and process a signal from the pressure sensor(s) 600 to determine the pressure (e.g., of the patient’s vasculature). For example, an implant 500 that is implanted in the IVC upstream of the renal veins having a sensor 600 connected thereto can be used to measure an IVC pressure, a renal venous pressure, and / or a femoral venous pressure (e.g., as described with respect to FIGS. 7A-7C). In other words, an IVC pressure, a renal venous pressure, and / or a femoral venous pressure can be measured from the implant 500.

[0169] The manual method 1200 can include a step 1215 of the system 5 detecting a pressure increase. For example, the system 5 can compare the pressure measured in step 1210 to a previously measured pressure and / or to a pressure value in memory (e.g., in storage device 53) to determine if the pressure has increased and / or is elevated / high. Determination of a high pressure can be performed according to the guideline 1100.

[0170] The manual method 1200 can include a step 1220 of the system 5 notifying the patient of a pressure increase if detected in step 1215. For this, the system 5 (e.g., the controller 50) can transmit to the external device 15 an indication that the pressure has increased. Such pressure can include the IVC pressure, the renal venous pressure, and / or the femoral venous pressure. Furthermore, the step 1220 can include notifying the patient, via external device 15, that the pressure has increased and / or is elevated / high. This can include receiving, from the external device 15, an instruction to activate the implant 500.

[0171] The manual method 1200 can include a step 1225 of activating the system 5, such as by the patient. For this, the patient can interact with the external device 15 (e.g., via user interface 17) to cause actuation of the implant 500. Actuation of the implant 500 can include actuation of flow restrictor 560 and / or flow restrictor portion 550 as described herein, which can at least partially occlude the lumen 513 of the implant 500. Furthermore, actuation of the implant 500 can at least partially occlude the flow of blood through a vessel in the patient’s vasculature. For example, for an implant 500 implanted in the IVC below the renal veins of the patient, activating the implant 500 can cause the implant 500 to at least partially occlude blood flow through the IVC.

[0172] The manual method 1200 can include a step 1230 of deactivating the system 5. Deactivation of the system 5 can include returning the implant 500 to its unactivated, non- occluding / non-restricting state as described herein. Such deactivation can occur manually, semi-automatically, or automatically. For example, the system 5 can remain activated until deactivated by interaction with external device 15. As another example, the system 5 can notify the patient that therapy is complete and present a notification to deactivate the system 5. Such notification can occur similar to the notification of pressure increase described in step 1220. In another example, the system 5 can remain activated for a duration of time, and the system 5 can deactivate after such duration of time has passed. In yet another example, thesystem 5 can remain activated for as long as the pressure remains elevated / high, which can include periodic measurements of the pressure for such determination.

[0173] FIG. 35 illustrates a semi-automatic method 1300 (which can also be referred to as a “auto-sense with patient activation”) of using an implantable flow restriction system 5 or any of the leadless systems disclosed herein. Furthermore, the method 1200 can include other steps and / or omit steps. The method 1300 can be similar to the method 1200 in many respects. For example, the method 1300 can include steps 1305, 1310, 1315, 1320, and 1325 that are the same as the steps 1210, 1215, 1220, 1225, and 1230 of method 1200, respectively. Different than the manual method 1200, the semi-automatic method 1300 can omit the step 1205 of requesting a pressure measurement. In the semi-automatic method 1300 without such a request for a pressure measurement, the system 5 can automatically measure pressure via the system 5. Such automatic pressure measurement can occur based on a predetermined schedule or time interval, which can be the same or different depending on the time of day, the patient, or other factors of the patient. The method 1300 can be referred to semi-automatic in that the system 5 must be activated in step 1320.

[0174] FIG.36 illustrates an automatic method 1400 (which can also be referred to as a “closed loop” or “fully closed loop”) of using an implantable flow restriction system 5 or any of the leadless systems disclosed herein. The method 1400 can be similar to the method 1300 in many respects. For example, the method 1400 can include steps 1405, 1410, 1415, and 1420 that are the same as the steps 1305, 1310, 1320, and 1325 of method 1300, respectively. Different than the semi-automatic method 1300, the automatic method 1400 can omit the step 1320 of the system being activated by the patient. In the automatic method 1400 without such a need to be activated by the patient, the system 5 can automatically activate to provide therapy.

[0175] FIGS.37A-37C illustrate an implementation of delivering therapy using the implantable flow restriction system 5 described herein. The delivery of therapy using the system 5 described with respect to FIGS. 37A-37C can apply to any of the methods described with respect to FIGS.34-36. FIGS.37A-37C show the implant 500 of system 5 in the IVC of a patient below the renal veins. As indicated in FIG. 37A, the system 5 has detected an increased or elevated / high IVC pressure, renal venous pressure, and / or femoral venous pressure. Concomitant with the increased or elevated / high renal venous pressure, urineproduction may be reduced. Depending on the method of use, the system 5 can be activated manually, semi-automatically, or automatically. When activated, the implant 500 can at least partially occlude / restrict blood flow in the IVC as described herein and as shown in FIG. 37B (wherein the implant 500 is shown in an occluding / restricting state). By such placement of the implant 500 in the IVC, when activated the system 5 can reduce renal pressure (e.g., reduce renal venous pressure). Such a reduction in renal pressure can increase urine production of the patient (e.g., enhance / increase diuresis). Also, when activated the system 5 can increase femoral pressure (e.g., femoral venous pressure). The system 5 can be deactivated as shown in FIG. 37C. When deactivated, the implant 500 can assume its substantially non- occluding / non-restricting state and not substantially block / restrict blood flow therethrough. In other words, in the deactivated state the implant 500 may not substantially block / occlude / restrict blood flow in the IVC. Such deactivation can decrease femoral pressure while not substantially affecting renal pressure or urine production (e.g., renal pressure and urine production may normalize upon deactivation of the system 5).

[0176] Any portions of the implants described herein (e.g., filter portion(s) 520, radial support portion(s) 540, and flow restrictor portion(s) 550) can be omitted, duplicated, or connected to one another in different orders. Furthermore, while the flow restrictor portions 550 and / or flow restrictors 560 have been described as having certain orientations with regard to aspects of the implants 500 and / or the flow of blood traveling therethrough, such flow restrictor portions 550 and / or flow restrictors 560 can be oriented in a reverse manner or in other ways than shown. Furthermore, features of the implants described herein can be implemented in any of the implants described herein. Additionally, the while some implants described herein are shown and described as having components for their actuation that are substantially centrally located within their associated lumen (e.g., tubing 570, shaft 590), such implants can be adapted such that such components are located along a circumference or side of the implant to produce an implant having a lumen substantially free of such components.

[0177] Although systems, devices, and / or components thereof have been described as having particular orientations and / or locations when implanted within a patient, such orientations and / or locations are not intended to be limiting. For example, while systems, devices, and / or components thereof have been described as extending from the superior vena cava or veins branching therefrom to the inferior vena cava, such systems, devices, and / orcomponents thereof can extend from a femoral vein to the inferior vena cava. For example, while the system 5 has been described as having an implantable controller 50 implanted in an infraclavicular subcutaneous pocket with other portions of the system extending through the superior vena cava and into the inferior vena cava, the implantable controller 50 of system 5 can be adapted for implantation in a subcutaneous pocket in or near the groin of the patient with other portions of the system extending through a femoral vein and into the inferior vena cava. In such implementations, venous access can be through a femoral vein of the patient. Furthermore, in such implementations, the flow restrictor of an implant of such system can be configured similar to or in a reverse manner to the flow restrictor of the implant 500 shown in FIG.1.

[0178] Many implants are disclosed above that can be configured with a lead or in a leadless configuration. FIGS.38-40 show features of a leadless flow restriction system 1500 in connection with a particular flow restrictor. Flow restrictors disclosed herein can also be combined with other features of the leadless flow restriction system 1500 discussed below. The leadless flow restriction system 1500 can include an intravascular housing 1504 located generally at the proximal end of the leadless flow restriction system. The intravascular housing 1504 can have a distal portion coupled with a flow restrictor 1532a. The flow restriction system 1532 is a functional part of an implant 1564 configured to modulate flow. The intravascular housing 1504 can have a proximal portion that can be a free end of the leadless flow restriction system 1500. The leadless flow restriction system 1500 can be applied such that the intravascular housing 1504 is downstream of the flow restrictor 1532a, e.g., if the vascular location is approached from a downstream direction. The leadless flow restriction system 1500 can be applied such that the intravascular housing 1504 is upstream of the flow restrictor 1532a, e.g., if the vascular location is approached from an upstream direction. The intravascular housing 1504 can be positioned within the vasculature such that the leadless flow restriction system 1500 is entirely within a blood vessel or within two adjacent sections of vasculature. The intravascular housing 1504 enables all operational components of the leadless system to be placed in blood vessel(s), although charging and manual control accessories can be placed outside the patient to interact with the leadless flow restriction system 1500 wirelessly.

[0179] The intravascular housing 1504 can enclose at least a portion of an actuator 1508. The actuator 1508 can include a motor 1512 that can be operated to move the flow restrictor 1532a between flow-permitting and flow restricting positions. The motor 1512 can be disposed in a space enclosed by the intravascular housing 1504, e.g., a fluid tight space that excludes ingress of blood when the leadless flow restriction system 1500 is disposed in the patient. An output motion of the motor 1512 can be transferred by a transmission 1514 from the motor to a flow restriction system 1532 disposed generally at a distal end of the leadless flow restriction system 1500. The flow restriction system 1532 is sometimes referred to herein as a flow restrictor assembly. The transmission 1514 can include a first shaft 1516, which can be an output shaft of the motor 1512 or a shaft of a gear train (e.g., to step up or down rotational speed or to offset a rotational axis from the axis of the first shaft 1516) coupled thereto. A gear train can be provided to step up or down rotational speed or to offset a rotational axis of another shaft coupled to the gear train from the axis of the first shaft 1516. A distal end 1524 of the first shaft 1516 can have a magnet 1520 coupled therewith. The magnet 1520 is an example of a drive component or drive element in that it conveys a torque to a driven component of the system. The magnet 1520 can be part of a magnetic coupling 1560 involving a second magnet and so is sometimes referred to herein as the first magnet 1520. The first magnet 1520 can be a permanent magnet. The first magnet 1520 can be mounted to the first shaft 1516 in any suitable manner, e.g., having a annular shape to be press-fit or otherwise secured to the outside surface of the first shaft 1516. The first magnet 1520 can include two or more magnet elements disposed around the first shaft 1516. The intravascular housing 1504 can form a fluid tight seal enclosing one or more of, e.g., all of the motor 1512, the transmission 1514 and the first shaft 1516. The intravascular housing 1504 can enclose the distal end 1524 of the first shaft 1516 and the first magnet 1520 mounted thereto. A cap, distal cover, or distal surface of the intravascular housing 1504 can extend across the distal face of the first magnet 1520 providing a small gap for clearance. The clearance, if provided, can prevent the first magnet 1520 from contacting a surface of the cap, distal cover, or distal surface that extends across the first magnet 1520. A projection 1612 can be disposed at an enclosed distal end of the intravascular housing 1504, e.g., projecting from the cap, distal cover, or distal surface of the intravascular housing 1504. The projection 1612 can form a portion of a bearing for supporting rotation of a transfer shaft assembly 1552 as discussed further below. The transfer shaft assembly 1552can be guided in rotation by the projection 1612. The projection 1612 can support controlled motion of portions of a transmission comprising a first magnet disposed in the intravascular housing. The projection 1612 can provide a bearing such that the second magnet can be journaled thereon or thereby.

[0180] In the illustrated embodiment, the leadless flow restriction system 1500 includes an additional sealed portion at a proximal end thereof. The additional sealed portion can include or house a control unit 1528 configured to control occluding, restricting and / or diverting flow within the patient’s vasculature. The control unit 1528 can include or provide the same functionality as the controller (or control unit) 50. In contrast to the controller 50, the control unit 1528 is configured to be deployed and to operate from within a blood vessel. The control unit 1528 can include a processor 1636. In some methods, the control of the occluding, restricting and / or diverting flow is prompted by external signals that can be received by a communication module 1640, which can also be part of the control unit 1528. The control unit 1528 can be powered by a battery 1652. Each of the processor 1636, the communication module 1640, and the battery 1652 can be disposed within the additional sealed portion at the proximal end of the intravascular housing 1504. The additional sealed portion can be formed or provided within a continuation of the internal volume of the intravascular housing 1504 that houses the motor 1512. The additional sealed portion can be formed by providing a cured epoxy volume around one or more of the processor 1636, the communication module 1640, and the battery 1652. The cured epoxy volume can be coupled with a proximal or side surface of the intravascular housing 1504, e.g., a portion of the intravascular housing that encloses the volume that houses the motor 1512.

[0181] The flow restriction system 1532 coupled with the actuator 1508 can have a number of functionally distinct components, similar to the components of the flow restrictors discussed above. Any of the flow restrictors of the flow restriction implants discussed above can be substituted for the flow restriction system 1532. The flow restriction system 1532 can have an expandable body 1536 disposed between a proximal end 1540 and a distal end 1544 of the flow restriction system 1532. The expandable body 1536 is configured for low profile delivery (e.g., within a catheter body) and is configured to expand to a larger profile to engage a blood vessel wall, e.g., to engage a wall of the IVC as discussed above. When the expandable body 1536 engages the wall and the expandable body 1536 is in a non-restricting configurationa lumen 1548 is provided within the interior of the expandable body 1536. The lumen 1548 allows blood to flow in a largely unrestricted manner through the expandable body 1536 when the leadless flow restriction system 1500 is not restricting flow.

[0182] The expandable body 1536 further includes a filter portion 1568, a radial support portion 1584, and a flow restrictor 1532a. The filter portion 1568 is configured to capture thrombus that may flow through or along the expandable body 1536 of the leadless flow restriction system 1500. The filter portion 1568 includes a plurality of struts 1576 that are disposed between the intravascular housing 1504 and the expandable body 1536. The struts 1576 include a connection 1580 at a proximal end thereof. The connection 1580 is configured to secure the struts 1576 to the intravascular housing 1504. In one embodiment the connection 1580 includes a ring that is coupled to proximal ends of the struts 1576 and that is coupled to a portion of the intravascular housing 1504, e.g., to an outside distal surface of the housing. In another embodiment, the connection 1580 is provided by individual connection points, e.g., welds, formed between the proximal ends of the struts 1576 and a distal portion of the intravascular housing 1504.

[0183] A connection 1582 disposed at a distal end of the struts 1576 connects the struts 1576 to a radial support portion 1584 of the expandable body 1536. The connection 1582 can be a continuous expanse of material, which can arise from when the struts 1576 and the radial support portion 1584 are formed from a single segment of material. In some embodiments, the connection 1582 is a length of material between the struts 1576 and a radial support portion 1584. Such a length of material can form an inflection from a direction angled relative to a longitudinal axis of the intravascular housing 1504 to a direction aligned with, e.g., parallel to the longitudinal axis of the housing.

[0184] In some embodiments the expandable body 1536 is configured such that when it expands it applies sufficient radial outward force to the internal surface of a blood vessel that the flow restriction system 1532 can be anchored in a selected location in the blood vessel. In some embodiments, an anchor or anchors 1648 can be provided to secure the flow restriction system 1532 at the selected location. The anchors 1648 can be formed at or adjacent to the connection 1582. The anchors 1648 can be a barb portion formed in the width of the connection 1582 disposed between the struts 1576 and the radial support portion 1584. The anchors 1648 can have a fixed end contiguous with, e.g., as a continuous expanse of materialof the radial support portion 1584. The anchors 1648 can have a free end opposite the fixed end. The free end of the anchors 1648 can be oriented toward the intravascular housing 1504. The anchors 1648 can be oriented in a direction aligned with blood flow in the vessel in which the leadless flow restriction system 1500 is to be disposed, e.g., with the free end downstream of the location of the fixed end of the anchors 1648.

[0185] The radial support portion 1584 can comprise one or a plurality of, e.g., six elongate struts. Each strut of the radial support portion 1584 can extend distally of one of the struts 1576. The radial support portion 1584 can extend from or distal of the connection 1582 to a free end disposed distally of the connection 1582. In some variants the radial support portion 1584 extends distal of the struts 1576. The radial support portion 1584 can have an axial section that is aligned with, e.g., parallel to, the longitudinal axis of the intravascular housing 1504. The connection 1582 can include a branch point that is distal to the anchors 1648, if provided. The radial support portion 1584 can extend from a proximal end disposed at the branch point to a distal free end distal of the branch point. The radial support portion 1584 can have length that has a stiffness such that transverse loading on the flow restrictor 1532a to create a flow restricting configuration does not cause a same amount of inward deflection of the radial support portion 1584 as occurs at a distal end of the components of the flow restrictor 1532a.

[0186] The flow restrictor 1532a can include a petal-like configuration. The flow restrictor 1532a can include one or a plurality of petals 1596. The petals 1596 can be formed by struts, e.g., two struts bounding an area that tapers to a narrower width in a distal direction. Two adjacent struts of each of the petals 1596 can meet at a distal apex 1600. In some configurations, each of the petals 1596 is formed by a diamond or rhombus shaped opening between four struts. In other configurations, each of the petals 1596 is formed by other combinations of struts, e.g., polygons of other shapes between struts. A proximal two of the four struts can extend distally and in opposing circumferential directions from a branch point of the connection 1582 discussed above. A distal two of the struts can extend distally from distal ends of the proximal two struts toward each other in converging circumferential directions. The distal two struts meet at the distal apex 1600. The petals 1596 can be configured such that a distal portion thereof including the distal apex 1600 is more flexible and more deflectable than a proximal portion thereof near the connection 1582 and the branchpoint. As a result, the petals 1596 may bend or deflect radially inwardly under a load applied to the distal apex 1600 of the petals 1596. The petals 1596 can be configured such that when fully deflected edges of the distal two struts of adjacent petals move adjacent to each other and may even touch. The petals 1596 can be enclosed by a material 1604 that spans between the struts of each cell forming individual petals 1596. When fully deflected the material 1604 of adjacent petals 1596 together can form a continuous expanse of material around the periphery of the deflected petals 1596. When fully deflected the material 1604 of adjacent petals 1596 together can form a much smaller aperture along the edges of the petals.

[0187] In the illustrated embodiment a suture or a wire 1608 is connected to the distal apex 1600 of each of the petals 1596 at one end and is coupled with a transfer shaft assembly 1552 at a second end opposite to the first end. Movement of the transfer shaft assembly 1552, as discussed below, causes the suture or a wire 1608 to apply a tension load to the distal apex 1600 of each of the petals 1596 to deflect each of the petals. Although the suture or a wire 1608 is illustrated, the tension member can have other configurations so long as it is able to bear a tension load without yielding or without excessive elongation.

[0188] The petals 1596 can be moved by applying a tension to and with the suture or a wire 1608. As discussed above, this movement is by movement of the transfer shaft assembly 1552 which is shown in FIG. 39. The transfer shaft assembly 1552 is disposed at least partially in the lumen 1548 of the expandable body 1536. The transfer shaft assembly 1552 includes a transfer shaft 1552a that is coupled to a second magnet 1556. The magnet 1556 is an example of a driven component or driven element in that it is driven by a drive component or drive element in a transmission or torque coupling of the system. As discussed above, the first magnet 1520 and the second magnet 1556 form a magnetic coupling 1560. The magnetic coupling 1560 is provided by magnetic attraction between the second magnet 1556 and the first magnet 1520. In variations, one of the magnets need not be a magnet but rather can be a formed of a material that is attracted to a magnetic field, e.g., to the magnetic field of one magnet of a magnetic coupling.

[0189] In the illustrated embodiment the second magnet 1556 includes a recess 1616 that is configured to receive the projection 1612 of the intravascular housing 1504. The connection between the projection 1612 and the recess 1616 forms a rotational bearing by which rotational movement of the second magnet 1556 and the transfer shaft assembly 1552is controlled. As the motor 1512 outputs rotational movement the distal end 1524 of the first shaft 1516 is rotated. This rotation rotates the first magnet 1520. The first magnet 1520 is magnetically coupled to the second magnet 1556 (or other structure responsive to the magnetic field of the first magnet 1520) so that this rotation also rotates the second magnet 1556 (or other structure). The second magnet 1556 is connected to the transfer shaft 1552a of the transfer shaft assembly 1552 so that the rotation output by the motor 1512 causes rotation of the transfer shaft 1552a.

[0190] The transfer shaft 1552a can include a distal connection feature for connecting the transfer shaft 1552a to the suture or wire 1608. The distal connection feature of the transfer shaft 1552a can include a second aperture 1700 formed at a distal end thereof. Ends of the suture or wire 1608 opposite to ends coupled with the distal apex(es) 1600 can be anchored to or at the second aperture 1700. These ends can be anchored in any other way, e.g., to an outside surface of the transfer shaft 1552a or to a spool or other device that can gather the suture or wire 1608 in an organized way if a significant length of the suture or wire 1608 is to be wound up. In other embodiment, the rotation output by the motor 1512 can be converted into linear motion such that the suture or wire 1608 can be pulled to deflect the petals 1596, as discussed above. The petals 1596 can be elastic such that deflection stores strain energy that can be used later undeflect the petals 1596 when the tension in the suture or wire 1608 is reduced, e.g., by distal linear motion of the transfer shaft 1552a if a transmission assembly is provided to convert the rotation motion of an output shaft of the motor 1512 into linear motion.

[0191] As discussed above, the leadless flow restriction system 1500 can include components that facilitate control of the system. The system architecture of the embodiment of FIG. 1 can be employed in the leadless flow restriction system 1500 and the description of the same is incorporated here. The leadless flow restriction system 1500 has a pressure sensor 1628 that is configured to detect pressure in the vasculature. The pressure sensor 1628 is configured to output at least one signal responsive to measured pressure. The pressure that is sensed can be central venous pressure or can be pressure at a particular location within the venous vasculature, e.g., within the IVC or adjacent to renal vein outflow. The pressure sensor 1628 can be disposed proximal of the flow restriction system 1532, e.g., on the intravascular housing 1504 or on an extension of the portion of the intravascular housing 1504 that housesthe motor 1512. The pressure sensor 1628 can be coupled to the flow restriction system 1532 in other locations, e.g., distal of the transfer shaft assembly 1552, coupled to the filter portion 1568 or coupled to the proximal two struts of the petals 1596 in various variations. The pressure sensor can be of any type, e.g., a MEMS pressure sensor as discussed above. The signal from the sensor can be provided to a processor 1636 that is coupled with the intravascular housing 1504. The processor 1636 can be disposed proximal of the flow restriction system 1532, e.g., on the intravascular housing 1504 or on an extension of the portion of the intravascular housing 1504 that houses the motor 1512. A communication module 1640 can be provided that can be in communication with the processor 1636. The processor 1636 can be disposed proximal of the flow restriction system 1532, e.g., on the intravascular housing 1504 or on an extension of the portion of the intravascular housing 1504 that houses the motor 1512. The control unit 1528 can include one or more of the communication module 1640, the processor 1636, and the pressure sensor 1628. Any one or more of the components of the control unit 1528 can be powered by a battery 1652 which can be disposed proximal of the flow restriction system 1532, e.g., on the intravascular housing 1504 or on an extension of the portion of the intravascular housing 1504 that houses the motor 1512. The battery 1652 can be configured to be charged by induction charging.

[0192] The communication module 1640 can communicate with the external device 15 discussed in connection with FIG. 1. A signal from the external device 15 can include an instruction for the leadless flow restriction system 1500 to commence restricting flow in the IVC. That signal can be received by the communication module 1640. The processor 1636 can generate a signal to the motor 1512 to activate to rotate the first shaft 1516 to cause the distal end 1524 and the first magnet 1520 coupled therewith to rotate. The magnetic coupling 1560 can cause the second magnet 1556 to rotate with the first magnet 1520 which causes the transfer shaft 1552a of the transfer shaft assembly 1552 to rotate. This rotation can cause a tension load to be applied to the suture or a wire 1608 which can cause the distal apex 1600 of each of the petals 1596 to deflect radially inwardly.

[0193] In other control protocols, the processor 1636 can receive a signal from the pressure sensor 1628. The signal can be analyzed and the need for a therapy involving restricting flow can be identified. Thereafter, the processor 1636 can generate a signal to the motor 1512 to activate to rotate the first shaft 1516, which results in rotation of the transfershaft 1552a and in tension being applied to the suture or wire 1608. The tension causes the distal apex 1600 to deflect radially inwardly, following the pressure sensor prompted signal.

[0194] FIGS.41-42B illustrate a variant of a frame member flow restriction system that can be incorporated into the leadless flow restriction system 1500. The flow restriction system of FIGS. 41-42B can be configured to prevent, minimize or reduce tissue ingrowth from the wall of a vessel V in which the flow restriction system is deployed. The system of FIGS. 41-42B can have a plurality of frame members 1656. The frame member 1656 can include a first frame member 1656a, a second frame member 1656b, a third frame member 1656c, a fourth frame member 1656d, a fifth frame member 1656e, and a sixth frame member 1656f. In other variations there can be more or fewer than six frame members. FIGS. 41 and 41A show low profile states or low profile configurations of the frame members 1656 (sometimes referred to herein as an “off” configuration or position), in which the frame members extend in a spoke-like manner radially outwardly from a central portion of the vessel V toward and in some cases into contact with a wall of the vessel V. Blood flow is relatively unimpeded, in pie-shaped segments extending between the adjacent frame member 1656 and between the wall of the vessel V and the central area of the vessel V.

[0195] Each of the frame members 1656 has a first end 1668 and a second end 1676. A paddle-forming span 1672 extends between the first end 1668 and the second end 1676. An area bounded by the paddle-forming span 1672 is paddle shaped, e.g., narrower adjacent to the first end 1668 and the second end 1676 and wider opposite to the ends 1668, 1676. The paddle-forming span 1672 and ends 1668, 1676 can be formed of a nitinol (or other shape member material) wire. The bounded area within the paddle-forming span 1672 is enclosed by an occlusive material 1680 that covers the space and that is generally impermeable to blood flow through the material. The occlusive material 1680 can be formed of ePTFE or other biocompatible flexible material.

[0196] The frame members 1656 with occlusive material 1680 are connected to a flow restriction system that includes a fixed structure 1696 and a shaft 1698. The fixed structure 1696 can include an outer cylinder non-rotationally coupled to the intravascular housing 1504. The shaft 1698 can comprise another cylinder within the fixed structure 1696 that is coupled with the motor 1512. In variations, the outer cylinder can be coupled with a motor and rotatable and the inner cylinder can be rotationally fixed to the intravascular housing1504. FIG. 41B shows that each of the fixed structure 1696 and the shaft 1698 includes an array of holes for connecting to any one or more of the frame member 1656a-1656f. The first end 1668 can be fitted into one of the holes in the shaft 1698. The second end 1676 can be fitted into an adjacent hole on the fixed structure 1696. For example, a drive element such as the first magnet 1520 can be coupled with an output shaft of the motor 1512 and the first magnet can drive a second magnet 1556 that is coupled with an end of the shaft 1698 disposed opposite to the end coupled with the first end 1668 of the frame member 1656. This arrangement allows the motor 1512 to rotate the shaft 1698. As the shaft 1698 rotates, the shaft can move from a first rotational position 1660 (seen in FIG. 41B) to a second rotational position 1664 (seen in FIG. 42B). This rotation moves the first end 1668 from a position in which the first end 1668 is radially aligned with the second end 1676 (which corresponds to a low profile state of the frame members 1656) to a position that is circumferentially offset from the first rotational position 1660. In the second rotational position 1664, the first end 1668 is radially mis-aligned relative to the second end 1676. The paddle-forming span 1672 is configured such that the misalignment of the first end 1668 from the second end 1676 causes the frame member 1656 to twist to an occluding configuration (sometimes referred to herein as “on”) as seen in FIGS. 42-42B. This position corresponds to a high profile state or high profile configuration of the frame members 1656.

[0197] When actuated to the configuration of FIGS. 42-42B, each frame member 1656 of a plurality of frame members forms a part of an arcuate periphery configured to be disposed adjacent to and even to touch the wall of the vessel V. The plurality of frame members 1656 together can form a continuous or substantially continuous arcuate edge or surface 1684. The substantial continuity can provide sufficient blocking of blood flowing from upstream in the vasculature to reduce pressure downstream of the flow restriction system of FIGS. 41-42B, even if there is some leakage around seams between adjacent frame members 1656 and / or through the inner periphery or around the outer periphery. The blocking of blood is largely provided by a continuous annular occlusive surface 1712 that can span between inner and outer peripheries of the combined structure of the frame members 1656a-1656f when the flow restriction system of FIGS. 41-42B is actuated to the flow restricting or “on” configuration of FIGS. 42-42B. In the illustrated embodiment, the continuous annular occlusive surface 1712 forms when six frame members of frame member 1656 actuate to thehigh profile state in which adjacent frame members 1656 at least partially overlap to form the annular or arcuate surface configured to oppose blood flow. The overlapping occurs when the radially outer portion 1736 of one of the frame member 1656 extends underneath the edge of the frame member 1656 extending from the first end 1668 to the paddle-forming span 1672. Due to the tapered shape of the frame member 1656, a greater degree of overlap occurs near the periphery, e.g., near the arcuate surface 1684 in some embodiments.

[0198] One advantage of the flow restriction system of FIGS. 41-42B is that the frame member 1656 each have a tapered shape 1716. The tapered shape 1716 provides a widest arcuate end 1720 formed by the paddle-forming span 1672 opposite to the first end 1668 and the second end 1676. The tapered shape 1716 provides a narrowest end 1724 formed by the paddle-forming span 1672 adjacent to the first end 1668 and the second end 1676. By providing this form, the frame member 1656 is near to and / or contacts the blood vessel wall in the non-restricting state (see, e.g., FIG 41A) over only a short length of the paddle-forming span 1672, e.g., near the widest arcuate end 1720. This allows a gap to form between radially outer portion 1736 between the widest arcuate end 1720 and the narrowest end 1724. This gap facilitates limiting contact with the vessel wall and / or limiting the degree of, minimizing or preventing ingrowth into the vessel wall.

[0199] Another advantage of the flow restriction system of FIGS. 41-42B is that the movement from the non-restricting or “off” configuration, as illustrated in FIG.41A, to the flow restricting or “on” configuration, as illustrated in FIG. 42A, can be achieved by a small rotational displacement. In the illustrated embodiment, there are six frame members 1656. Other embodiments have four, five, seven, eight, nine, ten or more than ten spaced frame members 1656. The frame members 1656, however many employed, can be equally spaced about the circumference of the fixed structure 1696 and / or the shaft 1698 as seen in FIG.41A. Actuating the members from the off to the on position can be achieved by a rotation of less than 360 degrees, e.g., of about 90 degrees, about 72 degrees, about 60 degrees, about 51 degrees, about 45 degrees, about 40 degrees, about 36 degrees or even a non-zero rotation of less than 36 degrees. A higher number of petals would allow for an even smaller rotational motion to move between on and off states. By limiting the amount of rotation required, the flow restriction system incorporating the frame members 1656 can greatly reduce the amount of energy needed to operate the leadless flow restriction system. Reducing energyconsumption can allow a battery to operate longer between charges or to be made smaller which is helpful for a leadless configuration and is still useful in a lead-based configuration. In a lead-based configuration, the fixed structure 1696 can be a portion of or coupled with the tubing 570 discussed above and the shaft 1698 can be a portion of or coupled with the shaft 590.

[0200] FIGS. 43A-43C illustrate another embodiment of components of a flow restrictor that can be used in the leadless flow restriction system 1500. In this embodiment, frame members can be provided that are able to elastically reversibly return from a high profile flow restricting or “on” configuration to a low profile flow permitting or “off” configuration. The component illustrated can be part of a flow restriction system as described elsewhere herein, e.g., in connection with FIGS.38-40. One or more frames 1760 (e.g., four frames 1760 as illustrated) is provided that extends from a first (proximal) end to a second (distal) end 1764 of the frame. The second end 1764 can be coupled to a ring that can also be connected to additional frames, e.g., to three additional frames as illustrated in FIG.43A. A paddle-forming span can extend between the first and second ends of the frame 1760. A occlusive material can extend from the frame 1760 inward to an inner periphery of the frame 1760. The second end 1764 can be coupled to the transfer shaft assembly 1552, e.g., to a distal end of the transfer shaft 1552a illustrated in FIGS. 38-40. A first end of the frame 1760 can be coupled to the intravascular housing 1504 of the leadless flow restriction system 1500. In one example the interior of the ring at the second end 1764 is threaded and a portion of the transfer shaft 1552a is threaded such that rotation of the shaft translates the ring adjacent to the second end 1764 proximally while the first end of the frame 1760 is held in position along the longitudinal axis of the transfer shaft 1552a. The movement of the second end 1764 can be controlled such that rotation of the transfer shaft 1552a from a first rotational position to a second rotational position shortens and widens the paddle-forming span of the frame 1760. Rotation from the first rotational position to the second rotational position can induce an elastically reversible high profile spiral shape within the paddle-forming span. Upon shortening the frame 1760 changes from the configuration of FIG.43A where the paddle-forming span is aligned axially with the longitudinal axis of the transfer shaft 1552a to a spiral shape 1768 where at least a middle portion of the paddle-forming span extends circumferentially around the longitudinal axis of the transfer shaft 1552a. The frame 1760 is resiliently compressible such that movingthe transfer shaft 1552a from the second rotational position to the first rotational position lengthens and thins the paddle-forming span. The frame 1760 can return from the shape of FIG. 43C to the shape of FIG 43A. FIG. 43B shows the “off” position in which blood would be permitted to flow between the adjacent frames 1760. FIG.43D shows the “on” position in which the occlusive material 1770 would block flow by being stretched across the passages that are open in FIG.43B.

[0201] In one variation the second end 1764 of the frame 1760 can be held in an fixed position along a longitudinal axis of the transfer shaft 1552a while the first end of the frame 1760 opposite the second end 1764 can include a threaded ring such that the first end moves distally relative to the second end 1764 causing the frame 1760 to actuate from the configuration of FIG.43A-43B to the configuration of FIGS.43C-43D.

[0202] FIGS. 44-45A illustrate embodiments where a proximal end of a flow restrictor can be coupled to a fixed structure, such as the intravascular housing 1504 of the leadless flow restriction system 1500 and a distal end can be moveable upon the motor 1512 outputting a rotational motion. The transfer shaft 1552a can be rotated by rotation of the motor 1512. A distal end of the transfer shaft 1552a can be threaded and disposed through an internally threaded ring (not shown but similar to the ring disposed at the second end 1764 in FIG. 43A). The rotation of the shaft can pull the distal ring proximally resulting in the flow restrictor 1780 being shortened and widened as in FIG.44A to provide an “on” configuration. Rotation of the shaft in a second direction opposite to the first direction can urge the distal ring distally resulting in the flow restrictor 1780 being lengthened and thinned as in FIG. 44 to provide an “off” configuration. Similarly, a flow restrictor frame 1784 similar to the frame 1760 can be configured to be shortened and widened when a threaded structure at the distal end (e.g., the ring disposed at the second end 1764 in FIG. 43A) is pulled proximally by rotation of the transfer shaft 1552a in a first direction. A flow restrictor frame 1784 including a frame 1788 can be configured to be lengthened and thinned when a threaded structure at the distal end (e.g., the ring disposed at the second end 1764 in FIG. 43A) is urged distally by rotation of the transfer shaft 1552a in a second direction opposite to the first direction. A proximal portion of the flow restrictor frame 1784 can include a connection to the intravascular housing 1504. An outer structure can be provided around the flow restrictor frame 1784 that can be structurally and functionally similar to the distal and proximal filter portions of theexpandable body 510e in FIG. 11 and similar structures described above in connection with FIGS. 12-18. The description of those features are incorporated here in their entirety. Also, the features of the flow restrictor 1784 can be used in any of the embodiments of FIGS.11-18 in a lead-based configuration. As with the embodiment of FIGS. 43A-43D, the embodiments of 44-45A can operate by holding a distal portion fixed and providing a threaded interface at a proximal connection location (e.g., at a proximal ring). As such, the flow restrictor 1780 can be actuated from the configuration of FIG. 44 to the configuration of FIG. 44A by moving a proximal connection (e.g., a ring) distally toward an axially fixed distal connection (e.g., a ring). The flow restrictor frame 1784 can be actuated from the configuration of FIG. 45 to the configuration of FIG. 45A by moving a proximal connection (e.g., a ring) distally toward an axially fixed distal connection (e.g., a ring).

[0203] FIGS 46A-46B illustrate an implementation of an anchor frame 510r (which can also be referred to herein as a “first expandable body”) of a dual frame implant 500q that can be used in connection with implantable flow restriction system 5 or any of the implantable flow restriction systems described herein (including the leadless systems described herein). FIG.46A shows a side view of the anchor frame 510r in an expanded configuration, and FIG. 46B shows a flat pattern view of the anchor frame 510r. The anchor frame 510r can be similar to and can include any of the functionality of the expandable body 510a of implant 500a described herein. For example, the anchor frame 510r can be configured to connect to tubing 570a or intravascular housing 1504 at a proximal end 511r thereof. Furthermore, the anchor frame 510r can include a filter portion 520r comprising struts 527r and a radial support portion 540r comprising ring 545r with struts 542r the same or similar to the filter portion 520a and radial support portion 540a of implant 500a. The anchor frame 510r can also include anchors 525r the same or similar to the anchors 525a described with respect to implant 500a. Different than the expandable body 510a, the radial support portion 540r of anchor frame 510r can also include a ring 545r’ with struts 542r’ connected to a distal end of ring 545r / struts 542r as shown. Also different than the expandable body 510a, the anchor frame 510r can include one or more coupling features disposed in an inner portion thereof. Such coupling features can comprise a plurality of frame projections 515r that extend from the ring 545r of the radial support portion 540r and / or a plurality of frame projections 515r’ that extend from the ring 545r’ of the radial support portion. As shown, such frame projections 515r can extend from adistal end of ring 545r, and such frame projections 515r’ can extend from a distal end of ring 545r’. The frame projections 515r, 515r’ can have free ends that are disposed radially inward of their fixed ends connected to the rings 545r, 545r’. In some implementations, the frame projections 515r, 515r’ can have free ends that are disposed proximally of their fixed ends connected to the rings 545r, 545r’. In other words, the frame projections 515r, 515r’ can be angled inward (and in some implementations angled in the proximal direction) toward a central area of a lumen 513r formed within the anchor frame 510r when expanded. The free ends of frame projections 515r, 515r’ can include an aperture 516r, 516r’ (e.g., a circular aperture). In some implementations, the anchor frame 510r only includes frame projections 515r and not frame projections 515r’. In some implementations, the anchor frame 510r only includes frame projections 515r’ and not frame projections 515r. The inclusion of either frame projections 515r or frame projection 515r’ can determine where an associated occlusion frame 510s as described herein will be positioned relative to anchor frame 510r (such as shown in FIGS.48A- 49C). The frame projection 515r, 515r’ can advantageously engage with or connect with such occlusion frame 510s to suspend the occlusion frame 510s away from an inner wall of the patient’s vasculature when the anchor frame 510r is implanted within the patient’s vasculature. In some implementations, the anchor frame 510r can be configured to allow tissue ingrowth. In some implementations, the anchor frame 510r can be configured to resist tissue ingrowth.

[0200] FIGS. 47A-47B illustrate an implementation of an occlusion frame 510s (which can also be referred to herein as a “second expandable body”) of the dual frame implant 500q. FIG. 47A shows a side view of the occlusion frame 510s in an expanded configuration, and FIG.47B shows a flat pattern view of the occlusion frame 510s. The occlusion frame 510s can be similar to and can include any of the functionality of the expandable body 510a of implant 500a described herein. For example, the occlusion frame 510s can include a radial support portion 540s comprising one or more rings 545s with struts 542s the same or similar to the radial support portion 540a of implant 500a. Furthermore, the occlusion frame 510s can include a flow restrictor portion 550s comprising a plurality of petals 560s with struts 562s and material 530s the same or similar to the flow restrictor portion 550a of implant 500a. Distal ends of the petals 560s can operably connect with shaft 590a as described with respect to implant 500a (e.g, via suture or wire 595a) to actuate the flow restrictor portion 550s (e.g., and cause the petals 560s to hinge relative to the radial support portion 540s and adjustably occludelumen 513s of occlusion frame 510s). Different than the expandable body 510a, the occlusion frame 510s can be configured to engage with or connect with the anchor frame 510r described herein (e.g., via coupling features of anchor frame 510r such as frame projections 515r and / or 515r’). For this, the occlusion frame 510s can be configured to fit within the lumen 513r of anchor frame 510r (e.g., occlusion frame 510s can have an overall outer diameter that is smaller than an inner diameter of anchor frame 510r). In addition, the occlusion frame 510s can include a coupling feature configured to engage or connect with the coupling feature of anchor frame 510r. For example and as shown in at least FIG.47A, the coupling feature of occlusion frame 510s can include a plurality of apertures 516s (e.g., circular apertures) configured to connect with the apertures 516r or 516r’ of the frame projections 515r or 515r’ of anchor frame 510r. Such connection between apertures 516s and 516r or 516r’ can be made via suture. As another example and as shown in the schematic view of FIG. 47C, the coupling feature of occlusion frame 510s can include a plurality of frame projections 515s that extend outward and away from the lumen 513s of the occlusion frame 510s. Further to this example, such frame projections 515s can have a free end disposed distal of their connection to the occlusion frame 510s (e.g., the frame projections 515s can extend outward and distally). With such configuration, the occlusion frame 510s can engage with the anchor frame 510r via interaction between their associated frame projections 515s and 515r or 515r’ (e.g., the frame projections 515s can be received in an annular space between the frame projections 515r or 515r’ and the inner wall of the patient’s vasculature when the occlusion frame 510s is expanded within the anchor frame 510r when in use). In some implementations, the anchor frame 510r can include a connection feature similar or the same as apertures 516s and the occlusion frame 510s can include the connection feature frame projections 515s, such connection features configured to engage with or connect to one another as described with respect to apertures 516s and frame projections 510r (e.g, via suture) to suspend occlusion frame 510s within anchor frame 510r. In some implementations, the anchor frame 510r and occlusion frame 510s can be configured to be separable from one another after implantation within a vessel of the patient.

[0204] FIGS 48A-48B illustrate an implementation of the dual frame implant 500q with the anchor frame 510r and occlusion frame 510s connected to one another by suture via apertures 516r of frame projections 515r and apertures 516s. FIGS. 48A-48B also show the dual frame implant 500q connected to tubing 570a and shaft 590a as described with respect toimplant 500a. In some implementations, the dual frame implant 500q can connect to intravascular housing 1504 and be configured for use with a leadless flow restrictor system as described herein. FIG. 48A shows the occlusion frame 510s in an unactuated / non-occluding configuration, and FIG. 48B shows the occlusion frame 510s in an actuated / occluding configuration. As can be seen in FIGS. 48A-48B, a gap 518q (e.g., a circumferential gap) is formed between the anchor frame 510r and the occlusion frame 510s when connected to one another, which can advantageously prevent tissue from growing into the occlusion frame 510s when in use. In some cases, the gap 518q (e.g., a circumferential gap) formed between the anchor frame 510r and the occlusion frame 510s when connected to one another can advantageously prevent, reduce, and / or delay tissue ingrowth into the occlusion frame 510s when in use. As shown in FIG. 48B, such gap 518q between the anchor frame 510r and the occlusion frame 510s can remain when the occlusion frame 510s is at least partially actuated (e.g., even when fully actuated). In some implementations, and as shown in FIG. 48C, the occlusion frame 510s can be configured to at least partially occlude such gap 518q between the anchor frame 510r and the occlusion frame 510s when the flow restrictor portion 550s of the occlusion frame 510s is at least partially actuated. For instance, the gap 518q can be fully occluded upon full actuation of the flow restrictor portion 550s of occlusion frame 510s. For this, the occlusion frame 510s can be configured to hinge about its connection to the anchor frame 510r as shown in FIG. 48C (e.g., hinge relative to the anchor frame 510r about the coupling feature thereof). Tissue ingrowth can be reduced, delayed, or prevented even though contact between the covering of the occlusion frame 510s and the vessel wall may occur because the full occlusion upon full actuation can be transient. When not actuated the gap 518q can be restored and blood flow through the gap can reduce, delay or prevent ingrowth.

[0205] As shown in FIGS.48A-48C, greater than about 50% of the flow restrictor portion 550s of occlusion frame 510s can be positioned within the anchor frame 510r when the occlusion frame 510s is connected to the anchor frame 510r via suture by apertures 516s of the occlusion frame 510s and apertures 516r of frame projections 515r of the anchor frame 510r. In some implementations, greater than about 60%, greater than about 70%, greater than about 80%, or greater than about 90% of the flow restrictor portion 550s of occlusion frame 510s can be positioned within the anchor frame 510r when the occlusion frame 510s is connected to the anchor frame 510r via suture by apertures 516s of the occlusion frame 510s and apertures 516rof frame projections 515r of the anchor frame 510r. In some implementations, a hinge point between the petals 560s of flow restrictor portion 550s and the radial support portion 540s of the occlusion frame 510s can be positioned proximate a distal end of the ring 545r and / or proximate a proximal end of the ring 545r’ of the anchor frame 510r when the occlusion frame 510s is connected to the anchor frame 510r via suture by apertures 516s of the occlusion frame 510s and apertures 516r of frame projections 515r of the anchor frame 510r.

[0206] FIGS 49A-49C illustrate implementations of the dual frame implant 500q that are identical to the implementations described with respect to FIGS. 48A-48C except the anchor frame 510r and occlusion frame 510s are connected to one another by suture via apertures 516r’ of frame projections 515r’ and apertures 516s. In variations, the apertures 516r’ of frame projections 515r’ can be the only apertures for coupling the anchor frame 510r to the occlusion frame 510s, e.g., the apertures 516r and frame projections 515r can be omitted. Such alternative connection between the anchor frame 510r and occlusion frame 510s disposes the occlusion frame 510s more distal of the anchor frame 510r than as shown in FIGS. 48A- 48C. Furthermore, such alternative connection can cause the flow restrictor portion 550s of occlusion frame 510s to extend distally beyond the anchor frame 510r more so than if the apertures 516s of occlusion frame 510s were connected instead to the apertures 516r of frame projections 515r of anchor frame 510r. In some implementations, less than about 20%, less than about 30%, less than about 40%, less than about 50%, less than about 60%, less than about 70%, less than about 80%, or less than about 90% of the flow restrictor portion 550s of occlusion frame 510s can be positioned within the anchor frame 510r when the occlusion frame 510s is connected to the anchor frame 510r via suture by apertures 516s of the occlusion frame 510s and apertures 516r’ of frame projections 515r’ of the anchor frame 510r. In some implementations, a hinge point between the petals 560s of flow restrictor portion 550s and the radial support portion 540s of the occlusion frame 510s can be positioned proximate a distal end of the ring 545r’ of the anchor frame 510r when the occlusion frame 510s is connected to the anchor frame 510r via suture by apertures 516s of the occlusion frame 510s and apertures 516r’ of frame projections 515r’ of the anchor frame 510r. In some implementations, at least a portion of the flow restrictor portion 550s (e.g., a distal portion thereof) can ingrow with a wall of the vessel that implant 550q is implanted within when the occlusion frame 510s isconnected to the anchor frame 510r via suture by apertures 516s of the occlusion frame 510s and apertures 516r’ of frame projections 515r’ of the anchor frame 510r.

[0207] FIGS. 50A-50C illustrate end views of the dual frame implant 500q of FIGS. 46A-49C in various states of actuation and restriction / occlusion of flow therethrough. FIG. 50A shows the occlusion frame 510s of implant 500q in its unactuated, non- restricting / non-occluding state, FIG. 50B shows the occlusion frame 510s of implant 500q in a partially actuated, partially restricting / occluding state, and FIG. 50C shows the occlusion frame 510s of implant 500q in a fully actuated, fully restricting / occluding state. As shown through FIGS. 50A-50C, the lumen 513s of the occlusion frame 510s of implant 500q (e.g., the lumen or opening of the flow restrictor portion 550s) can change from a generally circular shape (FIG. 50A) when unactuated, to a generally star / stellate shape when at least partially actuated (FIG.50B), to a substantially blocked lumen when fully actuated (FIG.50C). In some implementations (not shown), the lumen 513s of the occlusion frame 510s of implant 500q (e.g., the lumen or opening of the flow restrictor portion 550s) 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, an exterior surface of the each of the plurality of petals 560s can block blood flow via material 530s. As described with respect to at least FIGS. 48A-48B, the gap 518q (e.g., circumferential gap) between anchor frame 510r and occlusion frame 510s can remain when the flow restrictor portion 550s of occlusion frame 510s is at least partially actuated. In some implementations, and as described with respect to at least FIG.48C, the gap 518q between anchor frame 510r and occlusion frame 510s can be at least partially occluded (e.g., fully occluded) as shown in FIG. 50D when the flow restrictor portion 550s of occlusion frame 510s is at least partially actuated.

[0208] Although systems, devices, and / or components thereof have been described and / or configured for chronic use, any of the systems, devices, and / or components thereof can be configured for acute use and / or used for acutely. For example, in some implementations an implantable controller or actuator as described herein can be positioned outside a patient’s body while an implant operably connected thereto is implanted within the patient’s vasculature as described herein. In such implementations, an external device may not be required to operate the system, for example, the patient or a user can operate the system via interaction with the controller that resides outside the patient.

[0209] Some of the features or advantages encompassed by one or more of the above implementations, or other aspects of the present application, include, but are not limited to, one or more of the following: x an implant configured to controllably and selectively occlude, restrict and / or divert flow within a patient’s vasculature x a source of actuation configured to actuate the implant x the implant can be configured to adjustably occlude blood flow in the vasculature in a range of 0 to 100 percent x the implant can be configured for percutaneous delivery x the implant can be configured for surgical implantation x the implant can be positioned intravenously o the implant can be biased open and actuated to close o the implant can be biased closed and actuated to open o the implant can be biased partially closed and configured to open fully when positioned intravenously due to blood flow in the vasculature and actuated to close o the implant can comprise an expandable body and a flow restrictor, the expandable body configured to engage an interior wall of a vessel of the patient and position the flow restrictor in a blood flow path of the vessel o the implant can comprise an expandable body with a flow restrictor integrally formed therewith o the source of actuation can comprise a magnet and the implant can be magnetically actuated ^ the source of actuation can be configured to actuate the implant from outside the patient’s body o the source of actuation can comprise an electromagnet and / or the implant can be magnetically actuated ^ the source of actuation can be implanted within the patient and / or located external to the patient ^ the source of actuation can be implanted within a vessel adjacent the vessel in which the occluding element is positioned ^ the source of actuation can be implanted in an interstitial space adjacent the vessel in which the occluding element is positionedthe source of actuation can comprise a fluid reservoir connected to the flow restrictor of the implant and the implant can be fluidically actuated ^ the fluid reservoir can connect to the flow restrictor of the implant via tubing ^ the fluid of the fluid reservoir can comprise air and / or a biologically compatible liquid including saline ^ the fluid reservoir can be implanted subcutaneously x the fluid reservoir can include a port configured to allow fluid to be removed and / or added to the fluid reservoir for controlling the actuation of the implant ^ compression of the fluid reservoir can actuate the implant the source of actuation can comprise a source of energy configured to actuate the implant via heat ^ the source of energy can comprise ultrasound, microwaves, and / or a magnetic field generator (such as an electromagnet) ^ the implant can include an inductive coil configured to interact with the source of actuation for controlling the occlusion of the implant the source of actuation can comprise an actuator configured to actuate the implant mechanically the implant can be configured to be positioned in an IVC of a patient upstream of the renal veins ^ the implant can be configured to adjustably enhance renal circulation and / or improve diuresis the implant can be configured to be positioned in an IVC of a patient upstream of the hepatic veins ^ the implant can be configured to adjustably enhance hepatic circulation and / or improve liver function the implant can be configured to be positioned in an SVC of a patient upstream of the right atrium the implant can be configured to adjustably decrease cardiac preload, decrease central venous pressure and / or pressure of other veins disclosed herein, and / or increase cardiac outputAdditional Embodiments 1. A chronic, implantable leadless flow restriction system for controllably and selectively occluding, restricting and / or diverting flow within a patient’s vasculature to reduce renal congestion and / or to reduce cardiac preload. 2. The system of any one of the preceding Embodiments, wherein the system is adapted to controllably and selectively reduce central venous pressure or other venous pressure. 3. The system of any one of the preceding Embodiments, wherein the system is adapted to enhance renal circulation. 4. The system of any one of the preceding Embodiments, wherein the system is adapted to enhance or to control diuresis. 5. The system of any one of the preceding Embodiments, wherein the system is adapted to improve cardiac output. 6. The system of any one of the preceding Embodiments, wherein the system is adapted to controllably and selectively occlude or divert flow from the superior vena cava. 7. The system of any one of the preceding Embodiments, wherein the system is adapted to controllably and selectively occlude or divert flow from the inferior vena cava. 8. The system of any one of Embodiments 1-7, wherein the system comprises a magnetically actuated implantable device. 9. The system of any one of Embodiments 1-7, wherein the system comprises a fluidically actuated implantable device. 10. The system of any one of Embodiments 1-7, wherein the system comprises a heat actuated implantable device. 11. The system of any one of Embodiments 1-7, wherein the system comprises a mechanically actuated implantable device. 12. The system of any one of Embodiments 1-7, wherein the system comprises an intravascular housing enclosing a control unit. 13. The system of any one of Embodiments 1-7, wherein the system comprises a mechanical cinching mechanism on an implantable stent.14. The system of any one of the preceding Embodiments, further comprising a control unit configured to control occluding, restricting and / or diverting flow within the patient’s vasculature. 15. The system of Embodiment 14, wherein the control unit is configured to receive readings from one or more pressure sensors positioned within the patient, and wherein the control unit is configured to control occluding, restricting and / or diverting flow within the patient’s vasculature based on the readings. 16. The system of any of Embodiments 14-15, wherein therapy delivered by the system is digitally actuated. 17. The system of any one of the preceding Embodiments, wherein therapy delivered by the system is scheduled based on a time of a day and / or on an amount of time per day. 18. A chronic, implantable leadless flow restriction system for controllably and selectively occluding, restricting and / or diverting flow of a patient’s vasculature, the system comprising: an implant comprising: an expandable body comprising a proximal end and a distal end and a lumen extending from the proximal end to the distal end, wherein the expandable body is configured to collapse to a collapsed configuration for delivery into a patient and to expand from the collapsed configuration to an expanded configuration for implantation within the patient; and a flow restrictor connected to the expandable body, the flow restrictor configured to adjustably occlude the lumen when the expandable body is in the expanded configuration. 19. The system of Embodiment 18, wherein the expandable body comprises an expandable metallic frame comprising a plurality of struts and defining a plurality of collapsible cells. 20. The system of Embodiments 19, wherein one or more of the plurality of struts of the expandable body are aligned diagonally relative to a longitudinal axis of the implant. 21. The system of any one of Embodiments 18-20, wherein the expandable body is configured to collapse sideways and / or via elongation.22. The system of any one of Embodiments 18-19, wherein the expandable body is configured to collapse radially. 23. The system of any one of Embodiments 19-22, wherein one or more of the plurality of struts of the expandable body coalesce at an end of the implant that is offset relative to a central longitudinal axis of the implant. 24. The system of any one of Embodiments 18-23, wherein the flow restrictor comprises a magnet and the implant is magnetically actuated. 25. The system of Embodiment 24, wherein the flow restrictor is configured to move between a first, non-occluding position and a second, at least partially occluding position that at least partially blocks the lumen. 26. The system of any one of Embodiments 24-25, wherein the flow restrictor comprises one or more struts connecting the magnet to the expandable body and a material spanning the one or more struts. 27. The system of any one of Embodiments 24-26, further comprising a magnetic field source configured to actuate the implant. 28. The system of Embodiment 27, wherein the magnetic field source is configured to be implanted within an interstitial space and / or a vessel adjacent the implant. 29. The system of Embodiment 27, wherein the magnetic field source is configured to be positioned 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 fluidically actuated. 31. The system of Embodiment 30, wherein the balloon is configured to expand from a non-actuated state to an actuated state that at least partially blocks the lumen. 32. The system of any one of Embodiments 30-31, wherein the balloon is configured as a prolate or oblate spheroid. 33. The system of any one of Embodiments 30-31, wherein the balloon is configured as an elongate partial circle that is adhered to an interior of the expandable body and / or to a mounting portion of the expandable body. 34. The system of any one of Embodiments 30-31, wherein the balloon is configured as a cylinder with a through opening that is adhered to an interior of the expandable body and / or to a mounting portion of the expandable body.35. The system of any one of Embodiments 30-34, wherein the expandable body comprises an inner body and an outer body, and the balloon is disposed in between the inner body and the outer body. 36. The system of 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 it from flow going through the lumen. 38. The system of any one of Embodiments 35-37, wherein the inner body is configured to have a smooth inner surface. 39. The system of any one of Embodiments 35-38, wherein the inner body is configured to deflect inwards and at least partially occlude the lumen when the balloon is actuated. 40. The system of any one of Embodiments 30-39, further comprising tubing and a fluid reservoir fluidically connected to the balloon. 41. The system of Embodiment 40, wherein the fluid reservoir is configured to be implanted subcutaneously or within the vasculature. 42. The system of any one of Embodiments 40-41, wherein the tubing is connected coaxial with the balloon. 43. The system of any one of Embodiments 40-41, wherein the tubing is connected off-center and / or tangent to the balloon. 44. The system of any one of Embodiments 30-43, wherein the expandable body further comprises a plurality of struts and / or a membrane positioned downstream of the balloon in relation to a direction of flow within the implant and located within a flow path of the lumen, the plurality of struts and / or membrane configured to filter and / or capture thrombus. 45. The system of any one of Embodiments 31-44, wherein the flow restrictor further comprises a shaft configured to cover the balloon when the balloon is in its non-actuated state. 46. The system of Embodiment 45, wherein the shaft is configured to hide the balloon from flow through the lumen when the balloon is in its non-actuated state.47. The system of any one of Embodiments 18-23, wherein the flow restrictor comprises a material, a balloon, and / or a wire configured to change shape upon heating and the implant is heat actuated. 48. The system of any one of Embodiments 18-23, wherein the flow restrictor comprises a material, a balloon, and / or a wire configured to change shape upon movement and the implant is mechanically actuated. 49. The system of any one of Embodiments 18-23, wherein the flow restrictor comprises a shape memory material configured to at least partially occlude the lumen when mechanically actuated. 50. A method of treating heart failure of a patient, the method comprising occluding, restricting and / or diverting flow using the system of any one of the preceding Embodiments. 51. A system comprising one or more features of the foregoing description. 52. An implantable flow restriction device comprising one or more features of the foregoing description. 53. A method of occluding, restricting and / or diverting blood within a patient’s vasculature comprising one or more features of the foregoing description. 54. A chronic, implantable leadless flow restriction system comprising: an implant configured to be implanted in an inferior vena cava of a patient upstream of renal veins of the patient and adjustably occlude the inferior vena cava; and an implantable control unit disposed in or coupled to an intravascular housing of the implant, 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 operably connected to the processor and configured to wirelessly communicate with an external device. 55. The system of Embodiment 54, wherein the implant comprises:an expandable body having a proximal end and a distal end and a lumen extending longitudinally therethrough; and a flow restrictor configured to hinge relative to the expandable body to at least partially restrict flow through the lumen. 56. The system of Embodiment 55, wherein the flow restrictor comprises struts and a material spanning the struts, the material configured to block blood flow. 57. The system of any one of Embodiments 55-56, wherein the flow restrictor is positioned adjacent the distal end of the expandable body such that, when implanted in the inferior vena cava, the flow restrictor is upstream of the expandable body with respect to blood flow. 58. The system of any one of Embodiments 55-57, wherein the implant further comprises a filter portion disposed adjacent the proximal end of the expandable body, the filter portion configured to capture thrombus. 59. The system of any one of Embodiments 54-58, wherein the implant comprises a pressure sensor operably connectable to the processor of the implantable control unit. 60. The system of Embodiment 59, wherein the implantable control unit is configured to wirelessly transmit pressure readings from the pressure sensor to the external device. 61. The system of any one of Embodiments 54-60, further comprising the external device. 62. The system of any one of Embodiments 54-61, wherein the external device comprises a handheld or mobile device. 63. The system of any one of Embodiments 54-62, wherein actuation of the actuator to cause the implant to adjustably occlude the inferior vena cava is controlled via the external device. 64. The system of Embodiment 63, wherein said actuation via the external device is controlled by the patient or a user. 65. The system of any one of Embodiments 55-64, wherein the flow restrictor has a non-circular opening when at least partially restricting flow through the lumen. 66. The system of any one of Embodiments 54-65, wherein the system does not include an assist device or a pump.67. The system of any one of Embodiments 54-66, wherein the implantable control unit is configured to be removably connectable to the implant. 68. The system of any one of Embodiments 54-67, wherein the implant is configured to be actuated mechanically by a wire. 69. A chronic, implantable leadless flow restriction system comprising: an implantable control unit coupled to or disposed within an intravascular housing having an actuator disposed therein; an implant comprising an expandable body having a proximal end coupled to the intravascular housing a distal end and a lumen extending longitudinally therethrough, and a flow restrictor configured to adjustably occlude the lumen when the expandable body is in an expanded configuration; and a shaft movingly disposed within or coupled to the housing configured to connect the actuator to the flow restrictor of the implant; wherein actuation of the actuator moves the shaft within or relative to the housing to cause the flow restrictor of the implant to adjustably occlude the lumen. 70. The system of Embodiment 69, wherein the expandable body of the implant further comprises: a filter portion disposed adjacent the proximal end configured to capture thrombus, the filter portion comprising a plurality of struts that extend radially outward and distally from the connection between the proximal end of the expandable body and the housing; and a radial support portion connected to and disposed distal of the filter portion, the radial support portion configured to fluidically seal against an inner wall of the patient’s vasculature. 71. The system of Embodiment 70, wherein the flow restrictor is connected to and extends distally from the radial support portion. 72. The system of any one of Embodiments 69-71, wherein the flow restrictor is integrally formed with the expandable body. 73. The system of any one of Embodiments 70-72, wherein the flow restrictor comprises:a plurality of petals each formed by a pair of struts that extend distally from the radial support portion and that join at a distal apex; and a material spanning each of the plurality of petals. 74. The system of Embodiment 73, wherein the flow restrictor comprises three petals or more. 75. The system of any one of Embodiments 73-74, wherein the material further spans at least a portion of the radial support portion. 76. The system of any one of Embodiments 73-75, wherein a distal end of each of the petals of the flow restrictor connect to a distal end of the shaft via a suture or a wire, and wherein proximal sliding or rotation of the shaft causes the suture or the wire to pull the distal end of each of the petals of the flow restrictor towards one another to at least partially occlude the lumen. 77. The system of any one of Embodiments 69-76, wherein a distal end of the housing is fluidically sealed with the shaft. 78. The system of any one of Embodiments 69-77, wherein the implant is configured to be implanted in an inferior vena cava of the patient below renal veins of the patient and a distal end of the flow restrictor positioned to first receive blood flow therethrough. 79. The system of any one of Embodiments 69-78, further comprising one or more pressure sensors configured to measure a pressure of the patient’s vasculature and output at least one signal responsive to the measured pressure. 80. The system of Embodiment 79, wherein the one or more pressure sensors comprise a pressure sensor configured to measure a renal pressure of the patient. 81. The system of Embodiment 80, wherein the pressure sensor configured to measure the renal pressure of the patient is disposed proximal of the flow restrictor. 82. The system of any one of Embodiments 80-81, wherein the pressure sensor configured to measure the renal pressure of the patient is disposed adjacent the proximal end of the expandable body or the proximal end of the housing. 83. The system of Embodiments 79, wherein the one or more pressure sensors comprise a pressure sensor configured to measure an inferior vena cava pressure of the patient.84. The system of Embodiment 83, wherein the pressure sensor configured to measure the inferior vena cava pressure of the patient is disposed proximal or distal of the flow restrictor. 85. The system of any one of Embodiments 83-84, wherein the pressure sensor configured to measure the inferior vena cava pressure of the patient is disposed adjacent the distal end of the expandable body. 86. The system of any one of Embodiments 79-85, wherein the implantable control unit further comprises a processor, wherein the processor is operably connectable to the one or more pressure sensors and configured to receive and process the at least one signal to determine the pressure of the patient’s vasculature. 87. The system of Embodiment 86, wherein the implantable control unit further comprises a communication module operably connected to the processor and configured to wirelessly communicate with an external device. 88. The system of Embodiment 87, wherein the communication module transmits the determined pressure of the patient’s vasculature to the external device. 89. The system of Embodiment 88, wherein the processor is operably connected to the actuator of the implantable control unit, and based on the determined pressure, the patient or a user can digitally actuate the actuator via the external device and thereby cause the flow restrictor of the implant to adjustably occlude the lumen. 90. The system of any one of Embodiments 87-89, further comprising the external device. 91. The system of any one of Embodiments 69-89, wherein the expandable body further comprises one or more anchors configured to anchor the implant within the patient’s vasculature. 92. The system of any one of Embodiments 69-91, wherein the implantable control unit is configured to be powered by a battery disposed within the housing. 93. The system of Embodiment 92, wherein the battery is configured to be charged by induction charging. 94. The system of any one of Embodiments 68-91, wherein the implantable control unit is configured to be powered by induction. 95. An implantable leadless flow restriction system comprising:an implant comprising: an expandable body comprising a metallic frame having a proximal end and a distal end and a lumen extending longitudinally therethrough; and a flow restrictor comprising: a plurality of petals each formed by struts; and a material spanning each of the plurality of petals; wherein the flow restrictor is configured to hinge relative to the expandable body to at least partially restrict flow through the lumen; and an implantable control unit comprising: a processor configured to receive an instruction to actuate an actuator configured to operably connect with the flow restrictor of the implant; and a communication module operably connected to the processor and configured to wirelessly communicate with an external device; wherein actuation of the actuator causes the flow restrictor to at least partially restrict flow through the lumen. 96. The system of Embodiment 95, further comprising: a housing configured to connect the proximal end of the expandable body of the implant to the implantable control unit; and a shaft movingly disposed within or relative to the housing 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 or relative the housing to cause the flow restrictor of the implant to at least partially restrict flow through the lumen. 97. The system of any one of Embodiments 95-96, wherein the implant further comprises a filter portion disposed adjacent the proximal end of the expandable body, the filter portion configured to capture thrombus. 98. The system of any one of Embodiments 95-97, wherein the struts that form each of the plurality of petals comprise a pair of struts that extend distally from the expandable body and join at a distal apex.99. The system of any one of Embodiments 95-98, wherein the implant comprises a pressure sensor operably connectable to the processor of the implantable control unit. 100. The system of Embodiment 99, wherein the implantable control unit is configured to wirelessly transmit pressure readings from the pressure sensor to the external device. 101. The system of any one of Embodiments 95-100, further comprising the external device. 102. The system of any one of Embodiments 95-101, wherein the external device comprises a handheld or mobile device. 103. The system of any one of Embodiments 95-102, wherein actuation of the actuator to cause the flow restrictor to at least partially restrict flow through the lumen is controlled via the external device. 104. The system of any one of Embodiments 95-103, wherein the implant is configured to be implanted in an inferior vena cava of a patient upstream of renal veins of the patient and adjustably occlude blood flow in the inferior vena cava when the flow restrictor at least partially restricts flow through the lumen of the implant. 105. The system of any one of Embodiments 95-104, wherein, when implanted in a patient, the flow restrictor of the implant is configured to be positioned upstream of the expandable body with respect to flow through the lumen. 106. The system of any one of Embodiments 95-105, wherein when hinged relative to the expandable body, an exterior surface of the plurality of petals is configured to occlude blood flow. 107. An implantable leadless flow restriction system comprising: an implant comprising: an expandable body having a proximal end and a distal end and a lumen extending longitudinally therethrough; and a flow restrictor configured to be secured within a vessel of a patient’s vasculature; and an implantable control unit comprising: an actuator configured to operably connect with the flow restrictor of the implant;a processor configured to receive an instruction to actuate the actuator; and a communication module operably connected to the processor and configured to wirelessly communicate with an external device; wherein actuation of the actuator causes the flow restrictor to pull in a wall of the vessel to at least partially restrict flow through the lumen. 108. The system of Embodiment 107, further comprising: a housing configured to connect the proximal end of the expandable body of the implant to the implantable control unit; and a shaft movingly disposed within or relative the housing 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 or relative to cause the flow restrictor of the implant to pull in the wall of the vessel to at least partially restrict flow through the lumen. 109. The system of any one of Embodiments 107-108, wherein the flow restrictor comprises a plurality of petals each formed by struts and configured to hinge relative to the expandable body. 110. The system of any one of Embodiments 107-109, wherein the struts that form each of the plurality of petals comprise a pair of struts that extend distally from the expandable body and join at a distal apex. 111. The system of any one of Embodiments 109-110, wherein the flow restrictor further comprises a material spanning each of the plurality of petals. 112. The system of any one of Embodiments 107-111, wherein the flow restrictor is configured to ingrow at least partially into the vessel wall. 113. The system of any one of Embodiments 107-112, wherein the flow restrictor further comprises one or more anchors configured to secure the flow restrictor to the vessel wall. 114. The system of any one of Embodiments 107-113, wherein the implant comprises a pressure sensor operably connectable to the processor of the implantable control unit.115. The system of Embodiment 114, wherein the implantable control unit is configured to wirelessly transmit pressure readings from the pressure sensor to the external device. 116. The system of any one of Embodiments 107-115, further comprising the external device. 117. The system of any one of Embodiments 107-116, wherein the external device comprises a handheld or mobile device. 118. The system of any one of Embodiments 107-117, wherein actuation of the actuator to cause the flow restrictor to pull in the wall of the vessel to at least partially restrict flow through the lumen is controlled via the external device. 119. The system of any one of Embodiments 107-118, wherein the implant is configured to be implanted in an inferior vena cava of the patient upstream of renal veins of the patient and adjustably occlude blood flow in the inferior vena cava when the flow restrictor pulls in a wall of the inferior vena cava to at least partially restrict flow through the lumen of the implant. 120. The system of any one of Embodiments 107-119, wherein, when implanted in the patient, the flow restrictor of the implant is configured to be positioned upstream of the expandable body with respect to flow through the lumen. 121. The system of any one of Embodiments 107-120, wherein the system does not include an assist device or a pump. 122. A method for implanting a chronic, implantable flow restriction system in a patient, the method comprising: implanting an implant in an inferior vena cava of the patient below renal veins of the patient, the implant configured to at least partially occlude the inferior vena cava upon actuation; implanting an implantable controller intravascularly; and operably connecting the implant to the implantable controller, the implantable controller comprising an actuator configured to actuate the implant for at least partially occluding the inferior vena cava and a processor configured to receive an instruction to actuate the actuator.123. The method of Embodiment 122, wherein the implant is operably connected to the implantable controller prior to implanting the implantable controller. 124. The method of any one of Embodiments 122-123, further comprising accessing a subclavian vein of the patient. 125. The method of any one of Embodiments 122-124, further comprising testing actuation of the implant after its implantation in the inferior vena cava and before operably connecting the implant to the implantable controller. 126. The method of any one of Embodiments 122-125, wherein implanting the implantable controller comprises implanting a housing within the vasculature, the implantable controller disposed in or coupled with a portion of the housing. 127. The method of any one of Embodiments 122-126, wherein the implantable controller further comprises a communication module operably connected to the processor and configured to wirelessly communicate with an external device. 128. The method of any one of Embodiments 122-127, further comprising actuating the implant to at least partially occlude the inferior vena cava. 129. The method of any one of Embodiments 122-128, wherein actuating the implant comprises receiving an instruction from an external device. 130. The method of any one of Embodiments 122-129, wherein the implant comprises: an expandable body having a proximal end and a distal end and a lumen extending longitudinally therethrough; and a flow restrictor configured to hinge relative to the expandable body to at least partially restrict flow through the lumen. 131. The method of Embodiment 130, wherein the flow restrictor is positioned adjacent 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. 132. The method of any one of Embodiments 129-131, wherein the implantable flow restriction system further comprises: a housing extending from the implant configured to connect to or enclose the implantable controller; anda shaft movingly disposed within or over the housing configured to operatively connect the actuator with the flow restrictor of the implant; wherein operably connecting the implant to the implantable controller comprises: connecting the housing to the implantable controller; and connecting the shaft to the actuator. 133. The method of Embodiment 132, further comprising implanting the housing and the shaft such that they are disposed in the inferior vena cava, at least a portion of a superior vena cava, or adjacent to the femoral vein of the patient. 134. The method of any one of Embodiments 130-133, wherein the implant further comprises a pressure sensor disposed downstream of the flow restrictor in regard to a direction of blood flow in the inferior vena cava, the pressure sensor configured to measure pressure. 135. The method of Embodiment 134, wherein the pressure sensor is positioned adjacent the renal veins of the patient when the implant is implanted in the inferior vena cava below the renal veins. 136. The method of any one of Embodiments 122-135, further comprising removing the implant and the implantable controller from the patient. 137. A method of controllably and selectively occluding, restricting and / or diverting flow of a patient’s vasculature, the method comprising: measuring an inferior vena cava pressure from an implant implanted in the inferior vena cava of the patient upstream of renal veins of the patient; transmitting the inferior vena cava pressure from an intravascular controller positioned within the patient to an external device; receiving, by the intravascular controller from the external device, an instruction to activate the implant; and activating the implant; wherein activating the implant causes the implant to at least partially occlude blood flow through the inferior vena cava. 138. The method of Embodiment 138, wherein activating the implant to at least partially occlude blood flow through the inferior vena cava enhances renal circulation.139. The method of any one of Embodiments 137-138, wherein activating the implant to at least partially occlude blood flow through the inferior vena cava enhances diuresis. 140. The method of any one of Embodiments 137-139, wherein activating the implant to at least partially occlude blood flow through the inferior vena cava reduces renal venous pressure. 141. The method of any one of Embodiments 137-140, wherein activating the implant to at least partially occlude blood flow through the inferior vena cava reduces cardiac preload. 142. The method of any one of Embodiments 137-141, further comprising measuring a renal venous pressure from the implant when blood flow through the inferior vena cava is at least partially occluded by the implant. 143. The method of any one of Embodiments 137-142, further comprising: detecting an increase in the inferior vena cava pressure; and transmitting, to the external device, an indication the inferior vena cava pressure has increased. 144. The method of any one of Embodiments 137-142, further comprising: detecting the inferior vena cava pressure has reached a threshold value; and transmitting, to the external device, an indication the inferior vena cava pressure has reached the threshold value. 145. The method of any one of Embodiments 137-144, wherein the implant comprises: a flow restrictor configured to at least partially occlude blood flow through the inferior vena cava when the implant is activated; and a pressure sensor disposed downstream of the flow restrictor in regard to a direction of blood flow in the inferior vena cava, the pressure sensor configured to measure said pressure. 146. The method of any one of Embodiments 137-144, wherein the implant comprises: a flow restrictor configured to at least partially occlude blood flow through the inferior vena cava when the implant is activated; anda pressure sensor disposed upstream of the flow restrictor in regard to a direction of blood flow in the inferior vena cava, the pressure sensor configured to measure said pressure. 147. The method of any one of Embodiments 137-144, wherein the implant comprises: a flow restrictor configured to at least partially occlude blood flow through the inferior vena cava when the implant is activated; and a pressure sensor disposed downstream of the flow restrictor in regard to a direction of blood flow in the inferior vena cava, and a pressure sensor disposed upstream of the flow restrictor in regard to a direction of blood flow in the inferior vena cava. 148. The method of any one of Embodiments 137-147, wherein activation of the implant is controlled via the external device. 149. The method of any one of Embodiments 137-148, wherein the instruction to activate the implant is wirelessly received from the external device. 150. The method of any one of Embodiments 137-149, further comprising receiving, from the external device, an instruction to deactivate the implant, wherein deactivating the implant causes the implant to not occlude blood flow through the inferior vena cava. 151. The method of any one of Embodiments 137-150, further comprising deactivating the implant after a duration of time. 152. The method of any one of Embodiments 137-150, further comprising deactivating the implant after the pressure measured from the implant reaches a threshold value. 153. The method of any one of Embodiments 137-152, further comprising deactivating the implant after a duration of time after the pressure measured from the implant reaches a threshold value. 154. The method of any one of Embodiments 137-153, wherein the intravascular controller comprises: a communication module configured to wirelessly communicate with the external device;a processor operably connected to the communication module, the processor configured to receive the instruction to activate the implant; and the processor operably coupled to an actuator configured to activate the implant. 155. The method of any one of Embodiments 145-154, wherein activating the implant comprises causing the flow restrictor to hinge relative to an expandable body of the implant to at least partially occlude blood flow through the inferior vena cava. 156. The method of any one of Embodiments 137-155, wherein activating the implant comprises mechanically activating the implant by a wire. 157. A method of controllably and selectively occluding, restricting and / or diverting flow of a patient’s vasculature, the method comprising: activating a leadless flow restrictor implanted in a vessel of the patient’s vasculature, wherein activating the flow restrictor causes the flow restrictor to pull in a wall of the vessel to at least partially restrict flow through the vessel. 158. The method of Embodiment 157, wherein the flow restrictor is implanted in an inferior vena cava of the patient upstream of renal veins of the patient, and wherein activating the flow restrictor causes the flow restrictor to pull in a wall of the inferior vena cava to at least partially restrict flow through the inferior vena cava. 159. The method of Embodiment 158, wherein activating the flow restrictor to cause the flow restrictor to pull in the wall of the inferior vena cava to at least partially restrict flow through the inferior vena cava enhances renal circulation. 160. The method of any one of Embodiments 158-159, wherein activating the flow restrictor to cause the flow restrictor to pull in the wall of the inferior vena cava to at least partially restrict flow through the inferior vena cava enhances diuresis. 161. The method of any one of Embodiments 158-160, wherein activating the flow restrictor to cause the flow restrictor to pull in the wall of the inferior vena cava to at least partially restrict flow through the inferior vena cava reduces renal venous pressure. 162. The method of any one of Embodiments 158-161, wherein activating the flow restrictor to cause the flow restrictor to pull in the wall of the inferior vena cava to at least partially restrict flow through the inferior vena cava reduces cardiac preload.163. The method of any one of Embodiments 158-162, further comprising measuring an inferior venous pressure from an implant comprising the flow restrictor. 164. The method of Embodiment 163, further comprising transmitting the inferior venous pressure from an implantable controller positioned within the patient to an external device. 165. The method of Embodiment 164, further comprising receiving, by the implantable controller from the external device, an instruction to activate the flow restrictor. 166. The method of any one of Embodiments 163-165, further comprising measuring a renal venous pressure from the implant comprising the flow restrictor when flow through the inferior vena cava is at least partially restricted. 167. The method of any one of Embodiments 164-166, further comprising: detecting an increase in the inferior vena cava pressure; and transmitting, to the external device, an indication the inferior vena cava pressure has increased. 168. The method of any one of Embodiments 164-166, further comprising: detecting the inferior vena cava pressure has reached a threshold value; and transmitting, to the external device, an indication the inferior vena cava pressure has reached the threshold value. 169. The method of any one of Embodiments 164-168, wherein activation of the flow restrictor is controlled via the external device. 170. The method of any one of Embodiments 165-169, wherein the instruction to activate the flow restrictor is wirelessly received from the external device. 171. The method of any one of Embodiments 165-170further comprising receiving, from the external device, an instruction to deactivate the flow restrictor, wherein deactivating the flow restrictor causes the wall of the inferior vena cava to not occlude flow through the inferior vena cava. 172. The method of any one of Embodiments 157-171, further comprising deactivating the flow restrictor after a duration of time. 173. The method of any one of Embodiments 157-172, further comprising deactivating the flow restrictor after the pressure measured from the implant reaches a threshold value.174. The method of any one of Embodiments 163-173, further comprising deactivating the implant after a duration of time after the pressure measured from the implant reaches a threshold value. 175. The method of any one of Embodiments 164-174, wherein the implantable controller comprises: a communication module configured to wirelessly communicate with the external device; a processor operably connected to the communication module, the processor configured to receive the instruction to activate the flow restrictor; and an actuator operably connected to the processor, the actuator configured to activate the flow restrictor. 176. The method of any one of Embodiments 157-175, wherein activating the flow restrictor comprises causing the flow restrictor to hinge relative to an expandable body of an implant comprising the flow restrictor. 177. The method of any one of Embodiments 157-176, wherein activating the flow restrictor comprises mechanically activating the flow restrictor by a wire. 178. An implant configured to be implanted in a patient for controllably and selectively occluding, restricting and / or diverting flow of 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 filter portion disposed adjacent the proximal end configured to capture thrombus; and a flow restrictor extending from the distal end of the expandable body, the flow restrictor configured to adjustably occlude the lumen when the expandable body is in an expanded configuration; wherein when implanted, the flow restrictor is configured to be positioned upstream of the expandable body with respect to blood flow and is controlled without leads extending to outside the vasculature. 179. The implant of Embodiment 178, wherein the filter portion comprises a plurality of struts that extend proximally and radially inward.180. The implant of Embodiment 179, wherein the expandable body of the implant further comprises a radial support portion connected to and disposed distal of the filter portion, the radial support portion configured to fluidically seal against an inner wall of the patient’s vasculature. 181. The implant of Embodiment 180, wherein the flow restrictor is connected to and extends distally from the radial support portion. 182. The implant of any one of Embodiments 178-181, wherein the flow restrictor is integrally formed with the expandable body. 183. The implant of any one of Embodiments 178-182, wherein the flow restrictor comprises a plurality of petals configured to fold radially inward to adjustable occlude the lumen, wherein when folded radially inward, an exterior surface of the plurality of petals is configured to occlude blood flow. 184. The implant of Embodiment 183, wherein each of the plurality of petals is formed by a pair of struts that extend from the expandable body and join at a distal apex. 185. The implant of any one of Embodiments 183-184, wherein the flow restrictor comprises three petals or more. 186. The implant of any one of Embodiments 183-185, wherein the flow restrictor carries an occlusive material, and wherein regions between the plurality of petals are free of the occlusive material. 187. The implant of any one of Embodiments 183-185, wherein the flow restrictor carries an occlusive material, and wherein the occlusive material spans the plurality of petals and regions between the plurality of petals. 188. The implant of any one of Embodiments 186-187, wherein the occlusive material further spans at least a portion of the expandable body. 189. The implant of any one of Embodiments 178-188, wherein the flow restrictor has a non-circular opening when at least partially occluding the lumen. 190. The implant of any one of Embodiments 178-189, wherein the flow restrictor has a stellate shaped opening when at least partially occluding the lumen. 191. The implant of any one of Embodiments 178-190, wherein the implant further comprises a pressure sensor.192. The implant of Embodiment 191, wherein the pressure sensor is disposed proximal of the flow restrictor. 193. The implant of any one of Embodiments 180-192, further comprising an anchor that extends proximally from the radial support portion, the anchor configured to anchor the implant within the patient’s vasculature. 194. The implant of any one of Embodiments 178-193, wherein the implant is configured to be implanted in an inferior vena cava of the patient. 195. A system comprising the implant of any one of Embodiments 180-194 and a delivery sheath configured to implant the implant. 196. The system of Embodiment 195, wherein the implant is configured to remain in a collapsed configuration when extending out of the delivery sheath while at least a portion of the radial support portion remains inside the delivery sheath. 197. A leadless implant configured to be implanted in a patient for occluding, restricting and / or diverting flow of the patient’s vasculature, the implant comprising: an expandable body comprising a metallic frame having a proximal end and a distal end and a lumen extending longitudinally therethrough; and a flow restrictor comprising: a plurality of petals each formed by a pair of struts that extend distally from the expandable body and join at a distal apex; and a material spanning each of the plurality of petals; wherein the flow restrictor is configured to fold radially inward to at least partially restrict flow through the lumen. 198. The implant of Embodiment 197, wherein the expandable body of the implant further comprises a filter portion disposed adjacent the proximal end configured to capture thrombus. 199. The implant of Embodiment 198, wherein the expandable body of the implant further comprises a radial support portion connected to and disposed distal of the filter portion, the radial support portion configured to fluidically seal against an inner wall of the patient’s vasculature. 200. The implant of any one of Embodiments 197-199, wherein the flow restrictor is integrally formed with the expandable body.201. The implant of any one of Embodiments 197-200, wherein when folded radially inward, an exterior surface of the plurality of petals of the flow restrictor is configured to occlude blood flow. 202. The implant of any one of Embodiments 197-201, wherein the flow restrictor comprises three petals or more. 203. The implant of any one of Embodiments 197-202, wherein regions between the plurality of petals are free of the material. 204. The implant of any one of Embodiments 197-202, wherein the material further spans regions between the plurality of petals. 205. The implant of any one of Embodiments 197-204, wherein the material further spans at least a portion of the expandable body. 206. The implant of any one of Embodiments 197-205, wherein the flow restrictor has a non-circular opening when at least partially occluding the lumen. 207. The implant of any one of Embodiments 197-206, wherein the flow restrictor has a stellate shaped opening when at least partially occluding the lumen. 208. The implant of any one of Embodiments 197-207, wherein the implant further comprises a pressure sensor. 209. The implant of Embodiment 208, wherein the pressure sensor is disposed proximal of the flow restrictor. 210. The implant of any one of Embodiments 199-209, further comprising an anchor that extends proximally from the radial support portion, the anchor configured to anchor the implant within the patient’s vasculature. 211. The implant of any one of Embodiments 197-210, wherein the implant is configured to be implanted in an inferior vena cava of the patient. 212. The implant of any one of Embodiments 197-211, wherein when implanted, the flow restrictor is configured to be positioned upstream of the expandable body with respect to blood flow. 213. A system comprising the implant of any one of Embodiments 199-212 and a delivery sheath configured to implant the implant.214. The system of Embodiment 213, wherein the implant is configured to remain in a collapsed configuration when extending out of the delivery sheath while at least a portion of the radial support portion remains inside the delivery sheath. 215. A leadless implant configured to be implanted in a patient for occluding, restricting and / or diverting flow of 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 flow restrictor configured to be secured within a vessel of the patient’s vasculature; wherein activation of the flow restrictor causes the flow restrictor to pull in a wall of the vessel to at least partially restrict flow through the lumen. 216. The implant of Embodiment 215, wherein the flow restrictor comprises a plurality of petals each formed by struts and configured to hinge relative to the expandable body. 217. The implant of Embodiment 216, wherein the struts that form each of the plurality of petals comprise a pair of struts that extend distally from the expandable body and join at a distal apex. 218. The implant of any one of Embodiments 216-217, wherein the flow restrictor further comprises a material spanning each of the plurality of petals. 219. The implant of any one of Embodiments 215-218, wherein the flow restrictor is configured to ingrow at least partially into the vessel wall. 220. The implant of any one of Embodiments 215-219, wherein the flow restrictor further comprises one or more anchors configured to secure the flow restrictor to the vessel wall. 221. The implant of any one of Embodiments 215-220, wherein the flow restrictor is integrally formed with the expandable body. 222. The implant of any one of Embodiments 215-221, wherein the implant comprises a pressure sensor configured to measure pressure. 223. The implant of Embodiment 222, wherein the pressure sensor is disposed proximal of the flow restrictor.224. The implant of any one of Embodiments 215-223, wherein the expandable body of the implant further comprises a filter portion disposed adjacent the proximal end of the expandable body, the filter portion configured to capture thrombus. 225. The implant of Embodiment 224, wherein the filter portion comprises a plurality of struts that extend proximally and radially inward. 226. The implant of any one of Embodiments 215-225, wherein the implant is configured to be implanted in an inferior vena cava of the patient. 227. The implant of any one of Embodiments 215-226, wherein when implanted, the flow restrictor is configured to be positioned upstream of the expandable body with respect to flow through the lumen of the implant. 228. A method of controllably and selectively occluding, restricting and / or diverting flow of a patient’s vasculature, the method comprising: receiving, by an implantable controller positioned intravascularly within the patient from an external device, an instruction to activate an implant implanted in an inferior vena cava of the patient upstream of renal veins of the patient; and activating the implant; wherein activating the implant causes the implant to at least partially occlude blood flow through the inferior vena cava. 229. The method of Embodiment 228, wherein activating the implant to at least partially occlude blood flow through the inferior vena cava enhances renal circulation. 230. The method of any one of Embodiments 228-229, wherein activating the implant to at least partially occlude blood flow through the inferior vena cava enhances diuresis. 231. The method of any one of Embodiments 228-230, wherein activating the implant to at least partially occlude blood flow through the inferior vena cava reduces renal venous pressure. 232. The method of any one of Embodiments 228-231, wherein activating the implant to at least partially occlude blood flow through the inferior vena cava reduces cardiac preload. 233. The method of any one of Embodiments 228-232, wherein the implant comprises:a flow restrictor configured to at least partially occlude blood flow through the inferior vena cava when the implant is activated; and a pressure sensor disposed downstream of the flow restrictor in regard to a direction of blood flow in the inferior vena cava. 234. The method of any one of Embodiments 228-232, wherein the implant comprises: a flow restrictor configured to at least partially occlude blood flow through the inferior vena cava when the implant is activated; and a pressure sensor disposed upstream of the flow restrictor in regard to a direction of blood flow in the inferior vena cava. 235. The method of any one of Embodiments 228-232, wherein the implant comprises: a flow restrictor configured to at least partially occlude blood flow through the inferior vena cava when the implant is activated; a pressure sensor disposed downstream of the flow restrictor in regard to a direction of blood flow in the inferior vena cava; and a pressure sensor disposed upstream of the flow restrictor in regard to a direction of blood flow in the inferior vena cava. 236. The method of any one of Embodiments 228-235, further comprising: measuring an inferior vena cava pressure from the implant; and transmitting the inferior vena cava pressure from the implantable controller to the external device. 237. The method of any one of Embodiments 228-236, further comprising: measuring a renal venous pressure from the implant when blood flow through the inferior vena cava is at least partially occluded by the implant; and transmitting the renal venous pressure from the implantable controller to the external device. 238. The method of any one of Embodiments 236-237, further comprising: detecting an increase in the inferior vena cava pressure; and transmitting, to the external device, an indication the inferior vena cava pressure has increased.239. The method of any one of Embodiments 236-238, further comprising: detecting the inferior vena cava pressure has reached a threshold value; and transmitting, to the external device, an indication the inferior vena cava pressure has reached the threshold value. 240. The method of any one of Embodiments 228-239, wherein activation of the implant is controlled via the external device. 241. The method of any one of Embodiments 228-240, wherein the instruction to activate the implant is wirelessly received from the external device. 242. The method of any one of Embodiments 228-241, further comprising receiving, from the external device, an instruction to deactivate the implant, wherein deactivating the implant causes the implant to not occlude blood flow through the inferior vena cava. 243. The method of any one of Embodiments 228-242, further comprising deactivating the implant after a duration of time. 244. The method of any one of Embodiments 236-243, further comprising deactivating the implant after the pressure measured from the implant reaches a threshold value. 245. The method of any one of Embodiments 236-243, further comprising deactivating the implant after a duration of time after the pressure measured from the implant reaches a threshold value. 246. The method of any one of Embodiments 236-245, wherein the implantable controller comprises: a communication module configured to wirelessly communicate with the external device; a processor operably connected to the communication module, the processor configured to receive the instruction to activate the implant; and an actuator operably connected to the processor, the actuator configured to activate the implant. 247. The method of any one of Embodiments 233-246, wherein activating the implant comprises causing the flow restrictor to hinge relative to an expandable body of the implant to at least partially occlude blood flow through the inferior vena cava.248. The method of any one of Embodiments 228-247, wherein activating the implant comprises mechanically activating the implant by a wire. 249. A chronic, implantable leadless flow restriction system comprising: an implant configured to be implanted in a vessel, lumen, or orifice of a patient and adjustably occlude the vessel, lumen, or orifice; and an implantable control unit operably connectable to the implant via a housing, the implantable control unit comprising: a processor configured to receive an instruction to actuate an actuator, wherein actuation of the actuator causes the implant to adjustably occlude the vessel, lumen, or orifice; and a communication module operably connected to the processor and configured to wirelessly communicate with an external device. 250. The system of any one of Embodiments 54-58, further comprising a pressure sensor operably connectable to the processor of the implantable control unit and / or operably coupled to a separate device to provide pressure readings useful in operating the implantable control unit. Additional Considerations and Terminology

[0210] Features, materials, characteristics, or groups described in conjunction with a particular aspect, implementation, or example are to be understood to be applicable to any other aspect, implementation or example described herein unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features or steps are mutually exclusive. The protection is not restricted to the details of any foregoing implementations. The protection extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

[0211] While certain implementations have been described, these implementations have been presented by way of example only, and are not intended to limit the scope of protection. Indeed, the novel methods and systems described herein may be embodied in avariety of other forms. Furthermore, various omissions, substitutions and changes in the form of the methods and systems described herein may be made. Those skilled in the art will appreciate that in some implementations, the actual steps taken in the processes illustrated or disclosed may differ from those shown in the figures. Depending on the implementation, certain of the steps described above may be removed, others may be added. For example, the actual steps or order of steps taken in the disclosed processes may differ from those shown in the figure. Depending on the implementation, certain of the steps described above may be removed, others may be added. Furthermore, the features and attributes of the specific implementations disclosed above may be combined in different ways to form additional implementations, all of which fall within the scope of the present disclosure.

[0212] Although the present disclosure includes certain implementations, examples and applications, it will be understood by those skilled in the art that the present disclosure extends beyond the specifically disclosed implementations to other alternative implementations or uses and obvious modifications and equivalents thereof, including implementations which do not provide all of the features and advantages set forth herein. Accordingly, the scope of the present disclosure is not intended to be limited by the described implementations, and may be defined by claims as presented herein or as presented in the future.

[0213] Conditional language, such as “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain implementations include, while other implementations do not include, certain features, elements, or steps. Thus, such conditional language is not generally intended to imply that features, elements, or steps are in any way required for one or more implementations or that one or more implementations necessarily include logic for deciding, with or without user input or prompting, whether these features, elements, or steps are included or are to be performed in any particular implementation. The terms “comprising,” “including,” “having,” and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Likewise, the term “and / or” in reference to a list of two or more items, covers all of thefollowing interpretations of the word: any one of the items in the list, all of the items in the list, and any combination of the items in the list. Further, the term “each,” as used herein, in addition to having its ordinary meaning, can mean any subset of a set of elements to which the term “each” is applied. Additionally, the words “herein,” “above,” "below," and words of similar import, when used in this application, refer to this application as a whole and not to any particular portions of this application.

[0214] Conjunctive language such as the phrase “at least one of X, Y, and Z,” unless specifically stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that certain implementations require the presence of at least one of X, at least one of Y, and at least one of Z.

[0215] Language of degree used herein, such as the terms “approximately,” “about,” “generally,” and “substantially” as used herein represent a value, amount, or characteristic close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, “generally,” and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount. As another example, in certain implementations, the terms “generally parallel” and “substantially parallel” refer to a value, amount, or characteristic that departs from exactly parallel by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degree.

Claims

WHAT IS CLAIMED IS:

1. A chronic, implantable flow restriction system comprising: an implant comprising: an expandable body having a proximal end and a distal end and a lumen extending longitudinally therethrough, the expandable body also comprising a radial support portion; and a flow restrictor configured to adjustably occlude the lumen when actuated, the flow restrictor comprising: a plurality of petals each formed by a pair of struts that extend distally from the radial support portion and that join at a distal apex; and an occlusive member having a first portion spanning one or each of the plurality of petals and a second portion comprising a tension member having a first end comprising a continuous extension of the first portion of the occlusive member spanning the one or each of the plurality of petals and a second end opposite the first end; a tubing configured to connect the proximal end of the expandable body of the implant to a control unit; and a shaft movingly disposed within the tubing, the shaft being coupled with the second end of the tension member; wherein the chronic, implantable flow restriction system is configured such that movement of the shaft within the tubing actuates the flow restrictor of the implant to adjustably occlude the lumen.

2. The system of Claim 1, wherein the occlusive member comprises an ePTFE layer.

3. The system of Claim 2, wherein the ePTFE layer is disposed over a periphery of the expandable body and a periphery of the one or each of the plurality of petals.

4. The system of any one of Claims 2-3, wherein at least one of the petals comprises a frame distal apex and the occlusive member comprises an ePTFE layer distal apex, the first end of the tension member extending continuously from the ePTFE layer distal apex.

5. A chronic, implantable flow restriction system comprising:an implant comprising a flow restrictor configured to be adjusted between a low profile state and a high profile state, the flow restrictor comprising: a plurality of petals each formed by a plurality of struts that extend distally from a radial support portion and that form a distal apex; and an occlusive member comprising a material spanning at least one of the plurality of petals and a tension member having a first end comprising a continuous extension of the material spanning the at least one of the plurality of petals and a second end opposite the first end; a fixed structure coupled with the radial support portion of the flow restrictor; and a shaft movingly coupled with the fixed structure, the shaft having a free end coupled with the second end of the tension member; wherein movement of the shaft relative to the fixed structure actuates the plurality of petals to cause the flow restrictor to adjust between the low profile state and the high profile state.

6. The system of Claim 5, wherein the fixed structure comprises a tubing and the shaft is disposed within the tubing, wherein movement of the shaft within the tubing applies a tension to the tension member to actuate the plurality of petals from the low profile state to the high profile state.

7. The system of Claim 6, wherein rotation of the shaft within the tubing spools the second end of the tension member to apply a tension thereto to actuate the plurality of petals from the low profile state to the high profile state.

8. The system of any one of Claims 6-7, wherein the tubing is configured to couple to an extravascular controller.

9. The system of Claim 5, wherein the fixed structure comprises or is coupled with an intravascular housing configured to house a motor and a transmission configured to induce motion of the shaft responsive to motion of the motor.

10. The system of Claim 9, further comprising a control unit disposed in or coupled with the intravascular housing.

11. The system of Claim 10, further comprising a sensor configured to generate a signal indicative of pressure in a blood vessel, the signal being provided to the control unit.

12. The system of any one of Claims 5-11, wherein the flow restrictor at least partially occludes a lumen of the implant when adjusted to the high profile state.

13. A chronic, implantable flow restriction system comprising: a first expandable body comprising a coupling feature disposed in an inner portion of the first expandable body, the first expandable body comprising a radial support portion configured to couple to an inner wall of a patient’s vasculature; a second expandable body comprising a proximal end and a distal end and a lumen extending longitudinally therethrough, the second expandable body configured to engage or connect with the coupling feature of the first expandable body such that the second expandable body is suspended away from the inner wall of the patient’s vasculature when the second expandable body is engaged or connected with the coupling feature of the first expandable body; and a flow restrictor coupled with the second expandable body, the flow restrictor configured to adjustably occlude the lumen of the second expandable body.

14. The system of Claim 13, wherein the coupling feature is a first coupling feature and the second expandable body comprises a second coupling feature configured to engage or connect with the first coupling feature when the second expandable body is expanded within the first expandable body.

15. The system of Claim 14, wherein the first coupling feature comprises a plurality of frame projections, each projection of the plurality of projections having a fixed end extending from the radial support portion of the first expandable body and a free end disposed proximally of the fixed end, the free end being enlarged relative to the fixed end.

16. The system of Claim 15, wherein each of the free ends comprise a circular aperture.

17. The system of any one of Claims 15-16, wherein the plurality of frame projections are angled inward toward a central area of a lumen formed within the first expandable body when the first expandable body is expanded.

18. The system of any one of Claims 15-17, wherein the plurality of frame projections comprises a first plurality of frame projections and wherein the second coupling feature comprises a second plurality of frame projections having a fixed end disposed adjacent to the proximal end of the second expandable body and a free end disposed distally of the fixedend, the free end of at least some of the frame projections of the second plurality of frame projections being configured to be received in an annular space between the frame projections of the first plurality of frame projections and the inner wall of the patient’s vasculature when the second expandable frame is expanded within the first expandable frame when in use.

19. The system of Claim 14, wherein the second coupling feature comprises a plurality of frame projections having a fixed end disposed adjacent to the proximal end of the second expandable body and a free end disposed distally of the fixed end, the free end of frame projections of the plurality of frame projections configured to be received in an annular space between the first coupling feature and the inner wall of the patient’s vasculature when the second expandable body is expanded within the first expandable body when in use.

20. The system of Claim 19, wherein the frame projections of the plurality of frame projections of the second coupling feature are angled outward and away from the lumen of the second expandable body when the second expandable body is expanded.

21. The system of Claim 16, wherein the second coupling feature comprises a plurality of second circular apertures configured to connect to the circular apertures of the plurality of frame projections of the first coupling feature via a suture or a wire.

22. The system of any one of Claims 13-21, wherein the first expandable body comprises a filter portion disposed adjacent a proximal end thereof configured to capture thrombus, the filter portion comprising a plurality of struts that extend radially outward and distally from a connection between the proximal end of the first expandable body and a fixed structure of the system when the first expandable body is expanded.

23. The system of Claim 22, wherein the connection is configured to connect to a tubing configured to extend from the first expandable body to outside the patient’s vasculature.

24. The system of Claim 22, wherein the connection is configured to connect to an intravascular housing configured to house a motor.

25. The system of any one of Claims 13-24, wherein the flow restrictor comprises a plurality of petals comprising a plurality of struts that extend distally of a radial support portion of the second expandable body and that join at a distal apex.

26. The system of claim 25, wherein an occlusive material spans each of the plurality of petals of the second expandable body, the first expandable body suspending theocclusive material away from the inner wall of the patient’s vasculature when the second expandable body is engaged or coupled with the coupling feature of the first expandable body.

27. The system of any one of Claims 13-26, wherein the flow restrictor is configured to hinge relative to the second expandable body.

28. The system of any one of Claims 13-27, wherein the second expandable body is configured to hinge relative to the first expandable body about the coupling feature of the first expandable body when the flow restrictor adjustably occludes the lumen.

29. The system of any one of Claims 13-28, wherein a circumferential gap is formed between the second expandable body and the first expandable body when the second expandable body is engaged or connected with the coupling feature of the first expandable body.

30. The system of Claim 29, wherein the flow restrictor is further configured to adjustably occlude the circumferential gap.

31. The system of any one of Claims 29-30, wherein the second expandable body is configured to adjustably occlude the circumferential gap when the flow restrictor adjustably occludes the lumen.

32. A chronic, implantable flow restriction system comprising: an implant comprising an expandable body having a proximal end and a distal end and a lumen extending longitudinally therethrough, and a flow restrictor configured to adjustably occlude the lumen when the expandable body is in an expanded configuration; a tubing configured to releasably connect the expandable body of the implant to a control unit; and a shaft moveable relative to the tubing configured to connect an actuator of the control unit to the flow restrictor; wherein movement of the shaft relative to the tubing causes the flow restrictor of the implant to adjustably occlude the lumen; and wherein the implant includes a severable connection that, when severed, is configured to separate the tubing from at least a portion of the expandable body of the implant.

33. The system of Claim 32, further comprising a plurality of struts that extend radially outward and distally from a first connection between the tubing and the proximal end of the expandable body, the expandable body further comprising a radial support portion disposed distal of and releasably connected to the plurality of struts, the radial support portion configured to fluidically seal against an inner wall of a patient’s vasculature.

34. The system of Claim 33, wherein the plurality of struts form a filter portion of the implant.

35. The system of any one of Claims 33-34, wherein the severable connection is disposed between a distal end of the struts of the plurality of struts and a proximal end of the radial support portion.

36. The system of Claim 35, further comprising a material configured to releasably connect the distal end of the struts of the plurality of struts and the proximal end of the radial support portion.

37. The system of Claim 36, wherein the material is configured to be severed to release the plurality of struts and the tubing from the radial support portion such that the plurality of struts and the tubing can be moved proximally while leaving the radial support portion within the patient’s vasculature.

38. The system of Claim 35, wherein a distal portion of the struts of the plurality of struts comprise a distal aperture and a proximal portion of the radial support portion comprises a proximal aperture, and further comprising a suture looped through the distal aperture and the proximal aperture.

39. The system of Claim 38, wherein the suture is configured to be severed to release the plurality of struts and the tubing from the radial support portion such that the plurality of struts and the tubing can be moved proximally while leaving the radial support portion within the patient’s vasculature.

40. The system of any one of Claims 38-39, further comprising a material configured to releasably connect the distal end of the struts of the plurality of struts and the proximal end of the radial support portion.

41. The system of Claim 40, wherein the material and the suture are configured to be severed to release the plurality of struts and the tubing from the radial support portion suchthat the plurality of struts and the tubing can be moved proximally while leaving the radial support portion within the patient’s vasculature.

42. The system of any one of Claims 38-41, wherein the proximal aperture of the radial support portion is disposed around a barb configured to anchor the radial support portion with the inner wall of the patient’s vasculature.

43. The system of Claim 33, wherein the severable connection is disposed between a proximal end of the struts of the plurality of struts and the tubing.

44. The system of Claim 43, wherein the severable connection comprises a suture looped through an aperture at a proximal end of each strut of the plurality of struts.

45. The system of Claim 44, wherein the suture is further looped through a suture connection feature of the tubing.

46. The system of Claims 43-45, wherein the severable connection comprises a material configured to releasably connect the proximal end of each strut of the plurality of struts to the tubing.

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