Systems, devices, and methods for implanting and / or retrieving devices for controllable enhancement of diuresis

Abstract

A delivery system for a blood flow occluder system is provided that includes a handle. The handle includes a distal portion, a proximal portion, an actuator, and a carriage. The actuator is positioned between the proximal portion and the distal portion. The actuator is moveable (e.g., rotatable) relative to an external surface of the handle. The carriage is disposed in the handle. The actuator is configured to cause movement of the carriage to deploy the blood flow occluder system.

Description

SYSTEMS, DEVICES, AND METHODS FOR IMPLANTING AND / OR RETRIEVING DEVICES FOR CONTROLLABLE ENHANCEMENT OF DIURESISINCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

[0001] This application claims the benefit of priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 63 / 582,726, filed September 14, 2023, which is hereby incorporated by reference herein in its entirety. Any and all 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 implanting and / or retrieving devices for treating heart failure, such as by 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. 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 and instruments and methods for implanting and / or retrieving such a system.

[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 deploy or retrieve an implant configured 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 fluidically actuated implantable device. In some implementations, the system comprises a heat actuated implantable device. In some implementations, the system comprises a mechanically actuated implantable device. 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 thesystem 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 another embodiment, a delivery system for a blood flow occluder system is provided herein that includes a handle. The handle includes a distal portion, a proximal portion, an actuator, and a carriage. The actuator is positioned between the proximal portion and the distal portion. The actuator is moveable (e.g., rotatable) relative to an external surface of the handle. The carriage is disposed in the handle. The actuator is configured to cause movement of the carriage to deploy the blood flow occluder system.

[0008] In another embodiment, a delivery system for blood flow occluder is provided that includes a handle having a proximal portion and a lead lock. The lead lock is coupled to the proximal portion. The lead lock has a plurality of actuator pins and a lock actuator. The plurality of actuator pins extend from a proximal end of the proximal portion of the handle. The lock actuator is rotatably coupled to the proximal end of the proximal portion of the handle. The lock actuator comprising a ring member that has a grip surface, a plurality of grip features, and a plurality of grip channels. The grip surface is disposed at an outer periphery. Each grip feature of the plurality of grip features has a fixed end coupled with an inner periphery of the ring member and a free end disposed radially inward of the fixed end. At least one channel of the plurality of channels is disposed between each of the grip features and the inner periphery of the ring member. The channels have a first end having a first width and a second end having a second width less than the first width. One actuator pin of the plurality of actuator pins is disposed in each one of the channels. Rotation of the lock actuator relative to the actuator pins moves the grip features radially inwardly to a gripping position when the actuator pins are disposed at the second end of the channels. The grip features are moveable radially outwardly to a release position when the actuator pins are disposed at the first end of the channels.

[0009] In another embodiment, a delivery system for blood flow occluder is provided that includes a handle and a lead lock coupled to the handle. The lead lock has a projection extending from the handle and a lock actuator. The lock actuator is moveably coupled to the handle. The lock actuator comprises a hand grip structure, a lead grip feature, and a guide surface. The hand grip structure is disposed at an outer periphery of the lock actuator. The lead grip feature has a fixed end disposed inward of the hand grip structure anda free end disposed away from the fixed end. The guide surface is disposed between the lead grip feature and the projection. The guide surface has a first end having a first engagement portion and a second end having a second engagement portion. The projection is disposed adjacent to the guide surface. Movement of the lock actuator relative to the projection moves the lead grip feature inwardly to a gripping position when the projection is disposed at the second end of the guide surface. The lead grip feature is moveable outwardly to a release position when the projection is disposed at the first end of the guide surface.

[0010] In another embodiment, a delivery system for blood flow occluder is provided that includes a handle and a lead lock coupled to the handle. The lead lock is configured to engage a lead assembly of the blood flow occluder to control or prevent movement of the lead assembly relative to an external surface of the handle. The lead lock has a lumen, a clamp, and an actuator. The lumen is configured to receive at least a portion of the lead assembly. The clamp has a first clamp member and a second clamp member. The first clamp member is configured to engage the lead assembly on a side thereof and the second clamp member configured to engage the lead assembly. The actuator is configured to transform the clamp from a disengaged configuration where the lead assembly can move relative to the external surface of the handle to an engaged configuration where the clamp restricts movement of the lead assembly relative to the external surface of the handle.

[0011] In another embodiment, a lead retrieval system for blood flow occluder is provided that include a handle having a proximal portion, a lead lock and a lead extender device. The lead lock is coupled to the proximal portion. The lead lock has a first configuration in which a lead disposed therethrough is held in a fixed position relative to the handle. The lead lock has a second configuration in which the lead disposed therethrough is moveable relative to the handle. The lead extender device has a tubular shaft disposed on a distal portion thereof. The distal end of the tubular shaft of the lead extender device has an outer surface sized to be slideable through the lead lock to engage the lead at or distal of the proximal end of the lead.

[0012] In another embodiment, a tool for retrieving a blood flow occluder is provided that includes a lead extender. The lead extender has a tubular shaft disposed at a distal portion thereof. The tubular shaft has one or more teeth disposed on an inner surface thereof. The teeth are angled inwardly such that a free end of each tooth of the one or more teeth isdisposed proximally of a fixed end of the tooth and is disposed within a lumen of the tubular shaft. The teeth arc configured to grip an external surface of a lead of a blood flow occluder, e.g., distal to a lead cut line or along the proximal length if not cut. The tubular shaft has a length and an outer surface sized to enable the lead extender to be inserted through a sheath and handle of a retrieval device such that a proximal end of the lead extender can be disposed proximal of the handle of the retrieval device.

[0013] In another embodiment, a tool for retrieving a blood flow occluder is provided that includes a lead extender. The lead extender has a proximal portion and a distal portion. The distal portion is configured to be embedded in a wall of a lead of the blood flow occluder at or distal to a severed end of the lead. The distal portion has a length and an outer surface sized to enable the lead extender to be inserted through a sheath and handle of a retrieval device such that the proximal portion can be disposed proximal of the handle of the retrieval device.

[0014] In another embodiment, a method of retrieving a blood flow occluder is provided. In the method, a proximal length of a lead assembly of the blood flow occluder is accessed. Optionally, the lead assembly distal to a proximal end of the lead assembly is severed to create a severed end. A distal portion of a lead extender is advanced to engage a proximal portion of the lead assembly (or the severed end if the lead assembly is severed). A dilator is advanced over the distal portion of the lead extender that is disposed over the lead assembly. The dilator is exchanged for a retrieval assembly including a retrieval sheath and a retrieval handle. The blood flow occluder is removed within the retrieval sheath.

[0015] 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 herein can 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.BRTEF DESCRIPTION OF THE DRAWINGS

[0016] Certain features of this disclosure arc 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.

[0017] FIG. 1 illustrates a chronic, implantable flow restriction system that is implanted within the patient in accordance with some aspects of this disclosure.

[0018] FIGS. 2A-2D illustrate an implementation of an implant of a chronic, implantable flow restriction system in accordance with some aspects of this disclosure.

[0019] FIGS. 3A-3C illustrate various end views of the implant of FIGS. 2A-2D in accordance with some aspects of this disclosure.

[0020] FIG. 3D illustrates an end view of another implementation of the implant ofFIGS. 2A-2D in accordance with some aspects of this disclosure.

[0021] FIG. 4 illustrates a flat pattern of view of the expandable body of the implant of FIGS. 3A-3D in accordance with some aspects of this disclosure.

[0022] FIGS. 5A-5B illustrate various views of components of a chronic, implantable flow restriction system in accordance with some aspects of this disclosure.

[0023] 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.

[0024] 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.

[0025] FIGS. 8A-8B illustrate an implementation of a shaft of an implantable flow restriction system in accordance with some aspects of this disclosure.

[0026] FIG. 9 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.

[0027] FIGS. 10 A- 10C illustrate an implementation of a connector between components of a flow restriction system in accordance with some aspects of this disclosure.

[0028] FIGS. 1 1A- 11B illustrate an implementation of a connector between components of a flow restriction system in accordance with some aspects of this disclosure.

[0029] FIGS. 12A-12D illustrate an implementation of a connector between components of a flow restriction system in accordance with some aspects of this disclosure.

[0030] FIGS. 13A-13B illustrate an implementation of an implant assembly having an extender for implantation in accordance with some aspects of this disclosure.

[0031] FIGS. 14A-14D illustrate an implementation of a device for testing function of an implant during implantation thereof in accordance with some aspects of this disclosure.

[0032] FIG. 15 illustrates a method of implanting an implantable flow restriction system in accordance with some aspects of this disclosure.

[0033] FIG. 15A illustrates a step of an implantation process in which a dilator is used to position a distal tip of a sheath below a renal vein.

[0034] FIG. 15B illustrates a step after the step of FIG. 15A in which the dilator is removed.

[0035] FIG. 15C illustrates a step after the step of FIG. 15B in which a delivery assembly with an implant disposed therein is advanced into the sheath positioned in FIG. 15A.

[0036] FIG. 15D illustrates a step after the step of FIG. 15C in which a handle of a delivery device is coupled with a proximal hub of the sheath positioned in FIG. 15 A.

[0037] FIG. 15E illustrates a step after the step of FIG. 15D in which an actuator of the handle is rotated to pull back a delivery sheath to allow an implant to be exposed in a vessel.

[0038] FIG. 15F illustrates the implant emerging from a distal end of the delivery sheath during the step illustrated in FIG. 15E and expansion commencing in the vessel.

[0039] FIG. 15G illustrates the end of the step of FIG. 15E in one technique in which an indicator has moved to a proximal location within an indicator track of the handle.

[0040] FIG. 15H illustrates a step after the step of FIG. 15E in which a lead assembly of the implant is disconnected from a handle of a delivery system and may thereafter be coupled to a controller.

[0041] FIG. 151- 15J illustrate steps after the step of FIG. 15E in which contrast fluid is injected upstream of the implant and an occlusive effect of the implant is demonstrated.

[0042] FIGS. 16A-16D illustrate deployment of an implant of an implantable flow restriction system in accordance with some aspects of this disclosure.

[0043] FIG. 17 illustrates a guideline for treatment of a patient using an implantable flow restriction system in accordance with some aspects of this disclosure.

[0044] FIG. 18 illustrates a manual method of using an implantable flow restriction system in accordance with some aspects of this disclosure.

[0045] FIG. 19 illustrates a semi-automatic method of using an implantable flow restriction system in accordance with some aspects of this disclosure.

[0046] FIG. 20 illustrates an automatic method of using an implantable flow restriction system in accordance with some aspects of this disclosure.

[0047] FIGS. 21A-21C illustrate an implementation of delivering therapy using an implantable flow restriction system in accordance with some aspects of this disclosure.

[0048] FIG. 22 is a view similar to the view of FIG. 15E, illustrating additional details of the delivery system.

[0049] FIG. 22A is a cross-sectional view of the portion of the delivery system illustrated in FIG. 22.

[0050] FIGS. 22B-22E illustrate an embodiment of a lead lock component disposed at a proximal end of one embodiment of a handle for selectively gripping a proximal portion of a lead assembly.

[0051] FIG. 22F illustrates a side view of another embodiment of a handle for the delivery system.

[0052] FIGS. 22G-22I illustrate another embodiment of a lead lock component disposed at a proximal end of one embodiment of a handle for selectively gripping a proximal portion of a lead assembly.

[0053] FIGS. 23-23D illustrate apparatuses and methods for retrieving an implant with a lead and an instrument for extending a length of a lead assembly with a severed end.

[0054] FIGS. 23E and 23F illustrate another embodiment of an apparatus for retrieving an implant with a lead.DETAILED DESCRIPTION

[0055] 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.

[0056] 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.

[0057] The present disclosure describes instruments and techniques for implanting 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 implantable flow restriction systems may also be referred to herein as “blood flow occluder systems”. 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 flow restriction 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 andselectively 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. The instruments and techniques disclosed herein can be used to retrieve the various implementations of chronic, implantable flow restriction systems and devices described herein. 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.

[0058] 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. For example, a chronic, implantable flow restriction system as described herein can be percutaneously implanted within a superior vena cava of a patient upstream of a right atrium of the patient. Percutaneous implantation can be achieved with instruments disclosed herein. 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 animplantable flow restriction system can be controlled to selectively occlude, restrict, and / or divert flow within the patient’s inferior vena cava (c.g., to reduce renal congestion).

[0059] The chronic, implantable flow restriction systems, devices, and methods described herein can be actuated in a variety of ways. 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. 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.

[0060] 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 present disclosure 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 flowwithin 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).

[0061] 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.

[0062] 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 restrictor configured 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 ballooncan 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.

[0063] A flow restrictor (also referred to herein as a “blood flow occluder”) 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 the latter 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.

[0064] 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 atleast 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.

[0065] 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. As discussed below, the delivery devices can be advanced through an introducer sheath assembly. The delivery devices can include a handle that has a lead lock component configured to hold a lead assembly while a delivery sheath is being retracted. 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 or other 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.

[0066] 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 devicesdescribed 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.

[0067] 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 days per 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, renalvenous 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).

[0068] 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.

[0069] 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 a patient, including vessels (e.g., veins, arteries) of the patient’s vascular system, the patient’s lymphatic system, the patient’s reproductive system, etc.

[0070] 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 byreference in its 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, such as a flow restrictor actuated fluidically, mechanically, and / or via heat, 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, 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.

[0071] FIG. 1 illustrates a potential location for implantation and placement of an implantable flow restriction system 5. 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. At least some of these actuation devices engage a lead assembly that can extend from the implantation site within the vasculature to outside the vasculature. The lead assembly is capable of being delivered by a delivery system that includes a lead lock component and a handle.

[0072] 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. The implant 500 can be placed inside the vasculature and the tubing 570 and shaft (together a lead assemblyin some embodiments) can be placed through the vasculature remote from the device 500 using a delivery system discussed below. 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.

[0073] 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.

[0074] 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. 43A-43D 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 51 la, 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.

[0075] 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.

[0076] 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 stmt 527a of the filter portion 520a.

[0077] 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 distally from 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 550a can include a material 530a that spans each of the plurality of petals 560. The material 530a can comprise ePTFE, PTFE, PET cloth, polyeurethane, and / or the like as described herein. Regions between the plurality of petals 560 can be free of the material 530a. In some implementations, the material 530a can span regions between the plurality of petals 560. 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 extendin a generally proximal direction from each of the plurality of proximal apexes 543a of the ring 545a.

[0078] 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 595 a, 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 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 controller 50a. 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 relative to the tubing 570a 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 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 flows toward and is occluded by exterior surfaces of the petals 560a. In some implementations, the How 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., thepetals 560a) can include one or more anchors and / or be configured to ingrow at least partially into the wall of the vessel.

[0079] 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 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.

[0080] 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 allow other 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.

[0081] 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.

[0082] 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 substantiallyblocked 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.

[0083] 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.

[0084] FIGS. 5A-5B illustrate various views of components of the implantable flow restriction system 5a, which can be implanted as shown above 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.

[0085] 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 describedwith respect to FIGS. 8A-8B, the suture or wire 595a can be one or more of such individual wires 593.

[0086] With continued reference to FIGS. 6A-6D, with the material 530a removed from view, the collapsible and extendible coupling 580a configured to fluidically seal the tubing 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 there within.

[0087] 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. 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), 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.

[0088] 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 590acan cause the sutures or wires 595a to spool about the shaft 590a or twist and at least partially close 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. Additionally, in such implementations the collapsible and extendable coupling 580a can be configured for such rotational movement. FIG. 47C-47D 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.

[0089] 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). 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.

[0090] 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 physiologicalparameters 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.

[0091] 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 location relative 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 pressuresensor may transmit readings to a control system of the flow restriction device (e.g., the controller 50a).

[0092] 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. 48C. 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. 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.

[0093] FIGS. 8A-8B 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. 8A shows a side view and FIG. 8B 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. 8A-8B. 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. 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).

[0094] FIG. 9 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 acommunication module 21. Tn some implementations, the external device 15 can be a mobile phone, a tablet, a handheld or mobile device, or otherwise.

[0095] 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 (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.

[0096] 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.

[0097] The communication modules 55 and 21 can facilitate communication (e.g., via wireless connection) between the implantable flow restriction system 5 (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 (802.1 lx), 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 andseparate computing devices, such as the external device 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.

[0098] 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-rcchargcablc .

[0099] 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%.

[0100] 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.

[0101] FIGS. 10A-10C 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. As shown in FIG. 10A, 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 720 can have a slot 724 configured to receive the protrusion extending radially inward into the recess 712 of the first component 710. As shown in FIGS. 10A-10B, 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 theprotrusion 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. 10C 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.

[0102] FIGS. 11A-11B 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. 11 A, 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 rodlike 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 be pressed 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.

[0103] FIGS. 12A-12D 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. 12A shows the tubing 570 separated from the connector 750 but in a position for connecting thereto, FIG. 12B shows a side view of a portion of the connector 750, FIG. 12C shows an end view of the connector 750, and FIG. 12D 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. 12D). 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 release them from the tubing 570, while the tubing 570 is pulled out of the connector 750 (e.g., moved distally relative to the connector 750).

[0104] FIGS. 13A-13B illustrate an implementation of an implant assembly 501 comprising the implant 500, tubing 570, and shaft 590 having an extender 800 to aid inimplantation 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. 13B, 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 572 can coincide with the cutline 803. Also shown in FIGS. 13A-13B is a device 850 fortesting function of the implant 500, which can extend proximally through the extender 800 and which will be described with respect to FIGS. 14A-14D and FIG. 15.

[0105] FIGS. 14A-14B 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 and / or pushing 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. 14A shows the device 850 connected to the shaft 590, whereas FIG. 14B shows the device 850 disconnected from the shaft 590. To facilitate pulling and / or pushing the shaft 590 via device 850, the device 850 can include a proximal extension 855. As shown in FIGS. 14A-14B, the proximal extension 855 can comprise suture. In a variant 850’ of the device 850 such as is shown in FIGS. 14C-14D, the proximal extension 855’ can comprise a shaft. In some implementations, the proximal extension 855, 855’ can comprise a wire, a rod, a hypotube, ora laser cut hypotube depending on the needs of the application (e.g., depending on the need to pull or push 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.

[0106] FIG. 15 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.

[0107] 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 system 1500 including 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.

[0108] 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 inthe 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.

[0109] 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 system 1500 including a 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. 13A-13B. Repositioning of the implant 500 can be performed if needed.

[0110] FIGS. 15A-15H show the use of the delivery system 1500 to position the implant assembly 501. The implant assembly 501 includes a blood flow occluder (e.g., implant 500), as discussed above. FIG. 15A discloses a step 915A in which an introducer shaft 1504 and a dilator 1856 are advanced together from a percutaneous access site to a position in the IVC below or upstream of the renal veins RenV. The dilator 1856 facilitates passing the wider introducer shaft 1504 into distensible tissue. FIG. 15B shows in a step 915B that after the distal end of the introducer shaft 1504 is placed below the renal veins RenV as shown in FIG. 15A, the dilator 1856 can be removed. A proximal hub of the introducer can be un-coupled from the introducer hub 1506 and pulled proximally along with the introducer shaft 1504. After the introducer shaft 1504 has been removed, a lumen in the introducer shaft 1504 can be used to advance the implant assembly 501 to the position of the distal end of the introducer shaft 1504 seen in FIG. 15 A.

[0111] FIG. 15C shows a further step 915C in which the lumen is used to advance the delivery shaft 1510 having the implant assembly 501 and lead assembly 1560 disposed therein into the patient. The distal end of the delivery shaft 1510 can be inserted into a proximal end of the introducer, e.g., into the introducer hub 1506. A fluid can be injected into the fluid port 1584 to reduce the friction between the delivery shaft 1510 and the introducer shaft 1504 to facilitate advancement of the delivery shaft 1510 through the introducer shaft 1504 to the position shown in FIG. 15A, e.g., below the renal veins RenV. In some implementations, the fluid port 1584 can include a one-way valve. FIG. 15D shows a step 915D following the step 915C. A handle 1508 disposed at the proximal end of the delivery shaft 1510 can be advanced adjacent to, e.g., just proximal of, the introducer hub 1506. The handle 1508 can be engagedwith the introducer hub 1506, e.g., by engaging distal threads with the handle 1508 with threads in the introducer hub 1506. When so engaged, the lead assembly 1560 has a proximal portion in the handle 1508 and a portion distal this proximal portion extending out of the handle 1508 into the delivery shaft 1510 and through the introducer shaft 1504 into the patient.

[0112] FIG. 15E shows a further step 915E following the step 915D in which the implant assembly 501 is deployed. A proximal end of the lead assembly 1560 extends outside of the handle 1508. The lead assembly 1560 can be locked in position relative to an external surface of the handle 1508 during the step 915E. The lead assembly 1560 can be locked in place by a lead lock component discussed further below in connection with FIGS. 22-221. While the lead assembly 1560 is locked in place, the actuator 1520 can be actuated, e.g., rotated to cause the delivery shaft 1510 to be retracted relative to the implant assembly 501. The implant assembly 501 can include expandable, e.g., self-expandable structures, such that when released from the distal end of the delivery shaft 1510 the implant assembly 501 begins to expand, as shown in FIG. 15F. The implant assembly 501 expands toward and into engagement with the interior wall of the vessel in which it is deployed, e.g., into engagement with the IVC.

[0113] FIG. 15G shows a step 915G following full deployment of the implant assembly 501. The actuator 1520 has been rotated in the direction of the arrows seen in FIG. 15G. Each partial revolution of the actuator 1520 causes a degree of retraction of the delivery shaft 1510. Deployment of the implant assembly 501 can be monitored without requiring any visualization of the implant assembly 501 within the vessel by way of an indicator 1544. The indicator 1544 is not required and may not be included in the handle 1508, as shown in FIG. 22F. When included, the indicator 1544 can be configured to move linearly by an amount corresponding to the movement of the distal end of the delivery shaft 1510 upon rotation of the actuator 1520. The indicator 1544 can move in an indicator track 1546 provided on the handle 1508. The movement of the indicator 1544 can be synchronized with movement of the delivery shaft 1510 by any suitable technique or structure. In one embodiment, a magnetic field generated by a moveable structure within an exterior surface of the handle 1508 can be configured to couple with the indicator 1544. The magnetic field can move with motion of the delivery shaft 1510. The magnetic field can move with motion of, e.g., rotation of, the actuator 1520. During or after the step 915G, a lead lock component (e.g., lead lock component 1572 or lead lock component 1572’) can be actuated to release the lead assembly 1560 to allowrelative motion between an exterior surface of the handle 1508 and the lead assembly 1560, c.g., between a cylindrical body within which the indicator track 1546 is formed, or between a cylindrical body with which the actuator 1520 is rotatably coupled.

[0114] FIG. 15H illustrates a step 915H after the step 915G. Following unlocking of the lead lock component 1572, the handle 1508 and the delivery shaft 1510 can be removed from the proximal end of the lead assembly 1560 and the lead assembly 1560 can be secured to the controller 50. Once the lead assembly 1560 is connected to the controller 50, the implant assembly 501 can be put into operation.

[0115] 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. 14A-14D 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).

[0116] One approach to this testing is illustrated in FIG. 15I-15J. The blood occluding portion of the implant assembly 501 can be actuated to an occlusive configuration, e.g., with the petals 506a deflected toward the central portion of the blood vessel such as by applying a tension load on the shaft 590a to deflect the distal apex 564a of each petal 506a. This is sometimes referred to as the system being “activated” or “on.” This deflection provides the configuration of any of FIGS. 2D and 3B-3D. Thereafter, in a step 920A, a contrast media can be injected into the vasculature upstream of the implant assembly 501. The contrast media can be injected via a pigtail catheter PC disposed in one of the external iliac veins (seen in FIG. 15J). The occlusive effect of the implant assembly 501 in the configuration of any of FIGS. 2D, 3B-3D, and 21B is visible in an x-ray image as shown in FIG. 151. The vasculature in the lowest regions of the IVC and also in the external iliac veins is darkened in this image demonstrating the contrast media being retained upstream of the implant assembly 501. The blood pressure is also lessened downstream of the implant assembly 501, e.g., in the area of outflow from the renal veins RenV. The occlusive effect beneficially enhances flow through the renal arteries and kidneys, which enhances fluid removal from the patient.

[0117] FIG. 15J shows a step 920B in which the testing of the occlusive effect is completed and the tension load on the shaft 590a is lessened or eliminated, allowing the distalapex 564a of each of the petals 506a to return to an undeflected state. This is sometimes referred to as the system being “deactivated” or “off.” In the undcflcctcd state, the petals 506a are not positioned toward the center of the vessel. The implant assembly 501 may be configured as in FIG. 2A, 6A, or 21C, for example. FIG. 151 shows that the contrast injected by the pigtail catheter PC is allowed to flow through the lumen 513a of the implant assembly 501 and downstream thereof in the IVC. While deactivation of the implant assembly 501 will result in an increase in pressure in the vicinity of the renal veins, the increased pressure can be well tolerated following the treatment period when the implant assembly 501 was activated.

[0118] 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. Removal of the delivery system 1500 is discussed above in connection with FIGS. 15G-15H and below in connection with FIGS. 22-221. 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 can be removed from the patient.

[0119] 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. 13A-13B. The device 850 for testing function of the implant 500 can also be removed.

[0120] The method 900 can include the step 930 of creating an infraclavicular subcutaneous pocket for the implantable controller 50 of the system 5.

[0121] The method 900 can include the step 935 of connecting the implant assembly 501 to the implantable controller 50 as discussed above in connection with FIG. 15H. For this, the shaft 590 of the lead assembly 1560 can be connected to the actuator 51 of the controller 50 as described with respect to FIGS. 10A-10C and FIGS. 11A-11B. Additionally, the tubing 570 of the lead assembly 1560 can be connected to the controller 50 as described with respect to FIGS. 12A-12D.

[0122] 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.

[0123] 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.

[0124] 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).

[0125] FIGS. 16A-16D illustrate deployment of implant 500 of an implantable flow restriction system 5 out a distal end 1002 of a delivery sheath 1000. The delivery sheath 1000 can be similar to the delivery shaft 1510 discussed herein, except as described differently below. The deployment of the implant 500 described with respect to FIGS. 16A-16D can be applicable to any of the implementations of the implants described herein.

[0126] As shown in FIG. 16A, 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. 16A, 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 facilitate implant 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.

[0127] FIGS. 16B-16C show progressive radial expansion of the implant 500 upon continued distal extension of the implant 500 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. 16C, the anchors 525 can maintain a tucked position (c.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.

[0128] FIG. 16D 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.

[0129] FIG. 17 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 of the system 5, a patient can be recommended to consult with their medical professional / care provider.

[0130] FIGS. 18-20 illustrate various methods of using the implantable flow restriction system 5 described herein. The methods described with respect to FIGS. 18-20 can be adapted to any of the flow restriction systems described herein. Furthermore, while the methods described with respect to FIGS. 18-20 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 (e.g.,such as sensors described herein). Additionally, while the methods described with respect to FIGS. 18-20 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.

[0131] FIG. 18 illustrates a manual method 1200 (which can also be referred to as a “patient driven method”) of using an implantable flow restriction system 5. Furthermore, the method 1200 can include other steps and / or omit steps.

[0132] 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).

[0133] 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.

[0134] 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.

[0135] 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 thefemoral venous pressure. Furthermore, the step 1220 can include notifying the patient, via external device 15, that the pressure has increased and / or is clcvatcd / high. This can include receiving, from the external device 15, an instruction to activate the implant 500.

[0136] 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.

[0137] 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 relaxed or free state, or to a deactivated, 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, the system 5 can remain activated for as long as the pressure remains elevated / high, which can include periodic measurements of the pressure for such determination.

[0138] FIG. 19 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. 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.

[0139] FIG. 20 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. 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.

[0140] FIGS. 21 A-21C 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. 21A-21C can apply to any of the methods described with respect to FIGS. 18-20. FIGS. 21A-21C show the implant 500 of system 5 in the IVC of a patient below the renal veins. As indicated in FIG. 21A, 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, urine production may be reduced. Depending on the method of use, the system 5 can be activated manually, semi-automatically, or automatically. When activated, the implant 500 can at least partially occlude / restrict blood flow in the IVC as described herein and as shown in FIG. 21B (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. 21C. 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, inthe 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).

[0141] 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 regal’d 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.

[0142] 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 / or components 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.

[0143] FIGS. 22-221 illustrate further details of the delivery system 1500 used in connection with the method 900 described above. The delivery system 1500 is configured to place an implant assembly 501, e.g., by being advanced through an introducer shaft 1504 after being inserted into an introducer hub 1506. The delivery system 1500 includes a handle 1508 coupled to a delivery shaft 1510. The delivery shaft 1510 has a lumen that extends from a distal end to a proximal end coupled with the handle 1508. The expandable portion of the implant assembly 501 can be disposed in the lumen near the distal end of the lumen. The lead assembly 1560 can extend through the lumen of the delivery shaft 1510 and into an internal space of the handle 1508.

[0144] The delivery system 1500 includes a distal portion 1512 and a proximal portion 1516. The distal portion 1512 can have a threaded interface for engaging a threaded interface of an introducer hub 1506. The proximal portion 1516 can have several functional sections. The proximal portion 1516 can have an actuator 1520 configured to move the introducer shaft 1504 relative to the handle 1508. The actuator 1520 can be rotated about a longitudinal axis of the delivery system 1500, e.g., an axis aligned with a central axis 1676 of the handle 1508. The actuator 1520 can be rotated relative to an external surface 1524 of the handle 1508. The external surface 1524 can be disposed about and can enclose an internal space of the handle 1508 with additional functional components. The external surface 1524 can enclose an internally threaded cylinder 1528. The internally threaded cylinder 1528 can be disposed in the external surface 1524. The internally threaded cylinder 1528 can be rotationally fixed to the actuator 1520 such that rotation of the actuator 1520 rotates the internally threaded cylinder 1528. The internally threaded cylinder 1528 is axially fixed relative to the body including the external surface 1524.

[0145] Threads in the internally threaded cylinder 1528 form a portion of a mechanism configured to enable movement of the delivery shaft 1510 relative to the handle 1508. The mechanism can also include a carriage 1532 configured to move along the central axis 1676. The carriage 1532 can move in a proximal or distal direction. The carriage 1532 can have external threads that engage the internal threads of the internally threaded cylinder 1528. As discussed further below, the carriage 1532 is coupled to a proximal end of the delivery shaft 1510 such that proximal movement of the carriage 1532 moves the proximal end and in some cases the entire length of the delivery shaft 1510 proximally relative to the handle 1508. Theproximal movement of the delivery shaft 1510 within the introducer shaft 1504 can be facilitated by flowing a friction reducing fluid into a fluid port 1584 of the introducer. By providing fluid in the interface between an outside surface of the delivery shaft 1510 and the inside surface of the introducer shaft 1504, the force needed to move the delivery shaft 1510, the carriage 1532, and the actuator 1520 is reduced. The friction reducing fluid can be saline, for example.

[0146] The position of the distal end of the delivery shaft 1510 can be observed at the handle 1508. The position of the delivery shaft 1510 corresponds to the state of the implant assembly 501, e.g., whether it is held compressed within the lumen of the delivery shaft 1510 or partially released (as in FIG. 15F and FIGS. 16A-16C) or fully deployed (as in FIG. 16D). The handle 1508 can optionally include an indicator 1544 moveably disposed in an indicator track 1546 of the handle 1508. The indicator 1544 is not required. FIGS. 22 and 22A show an example of the handle 1508 that includes the indicator 1544 and FIG. 22F shows an example of the handle 1508 that does not include an indicator. When the indicator 1544 is included, the external surface 1524 can surround the indicator track 1546. The indicator track 1546 can be defined by and at least partially extend through the external surface 1524. The position of the indicator 1544 can be configured to correspond to the position of the carriage 1532. The indicator 1544 can be coupled to the carriage 1532. The linkage of the indicator 1544 to the carriage 1532 can be achieved through remote action through a rotatable interface. The linkage of the indicator 1544 to the carriage 1532 can be achieved through one or more solid walls. In one embodiment, the indicator 1544 is magnetically coupled to a structure disposed within the internally threaded cylinder 1528. In one embodiment, a carriage magnet 1540 is coupled with the carriage 1532. The carriage magnet 1540 can be magnetically coupled to the indicator 1544. In one embodiment, the indicator 1544 comprises a magnet that can be magnetically coupled to the carriage 1532. The indicator 1544 can include a low friction outer surface within which the magnet is enclosed, e.g., a low friction lower, side or interface surface disposed between the magnet and the indicator track 1546 such that the sliding of the indicator 1544 in the indicator track 1546 is smooth and any sliding friction does not disrupt the magnetic connection between the indicator 1544 and the carriage magnet 1540. In one embodiment, only one of the indicator 1544 and a coupling structure of the carriage 1532 is a magnet while the other of the indicator 1544 and the coupling structure of the carriage 1532 is not a magnet butcomprises a magnetically attracted material. The indicator 1544 can include a magnet that is configured to couple to the carriage magnet 1540. The carriage 1532 is rotationally fixed within the internally threaded cylinder 1528. Rotation of the first end 1628 caused by rotation of the actuator 1520 causes the carriage 1532 to translate proximally or distally along the central axis 1676. The carriage magnet 1540 remains rotationally aligned with the indicator 1544. The magnetic attraction between the carriage magnet 1540 and the indicator 1544 causes the indicator 1544 to follow the proximal and distal motion of the carriage 1532, which can correspond one-to-one to proximal and distal motion of the distal end of the delivery shaft 1510.

[0147] The carriage magnet 1540 can be embedded in the carriage 1532. The carriage magnet 1540 can be aligned with an outer edge of the threads of the carriage 1532 such that the magnet is as close as possible to the indicator 1544. In one embodiment, at least a portion of the carriage magnet 1540 is disposed within the height of the threads of the internally threaded cylinder 1528. FIG. 22A shows that the handle 1508 can include a plurality of, e.g., two carriage magnets 1540. The carriage magnets 1540 can be disposed on opposite sides of the carriage 1532. The handle 1508 can include a plurality of, e.g., two indicators 1544. The indicators 1544 can be disposed on opposite sides of the handle 1508. There can be a plurality of indicator track 1546, e.g., two indicator track 1546. The indicator track 1546 can be disposed through the external surface 1524 on opposite sides of the handle 1508.

[0148] The carriage 1532 can include a shaft interface 1548 configured to securely couple the carriage 1532 to the delivery shaft 1510. The shaft interface 1548 can be disposed on a distal side 1552 of the carriage 1532. The shaft interface 1548 is configured to receive the proximal end 1556 of the delivery shaft 1510. A seal can be provided proximal of the proximal end 1556. A portion of the shaft interface 1548 can extend between the proximal end 1556 and the seal. The handle 1508 can include a lumen 1564 configured to receive the lead assembly 1560. The lumen 1564 can be disposed in a shaft 1568 held in the carriage 1532. The lead assembly 1560 can threaded through the lumen 1564 such that a portion of the lead assembly 1560 is proximal of the proximal end of the handle 1508 and a portion of the lead assembly 1560 is distal of the distal portion 1512 of the handle 1508.

[0149] The handle 1508 can be configured to facilitate sliding of the lead assembly 1560 relative thereto and can be configured to lock the lead assembly 1560 relative to thehandle 1508. The handle 1508 includes a fluid port 1584 disposed in the proximal portion 1516 of the handle 1508. The fluid port 1584 can enable saline or another lubricating fluid to flow into the handle 1508 to lubricate passage of a component, e.g., the lead assembly 1560 within the shaft 1568. The handle 1508 includes a lead lock component disposed at the proximal portion 1516 of the handle 1508. The lead lock component can fix the lead assembly 1560 to the handle 1508 such that relative motion (e.g., relative sliding motion) between the lead assembly 1560 and the handle 1508 is prevented. FIGS. 22-22E illustrate a first implementation of a lead lock component 1572 and FIGS. 22F-22I illustrate a second implementation of a lead lock component 1572’. Either lead lock component 1572, 1572’ can be used with the handle 1508, whether an indicator 1544 is included or not.

[0150] With reference to FIGS. 22-22E first, the first example lead lock component 1572 can include a knob 1576. The knob 1576 can have an outer peripheral surface that is knurled to facilitate grasping and twisting of the knob 1576 relative to the handle 1508, e.g., relative to the proximal portion 1516 of the handle 1508. The outer peripheral surface of the knob 1576, whether knurled or smooth, is an example of a hand grip structure. The knob 1576 can form a grip surface.

[0151] The mounting of the knob 1576 to the handle 1508 can be achieved at least in part by one or a plurality of actuator pins 1588a. The actuator pins 1588a are one form of projections that can be provided to extend from a proximal end of the handle 1508. As discussed further below, the knob 1576 and the actuator pins 1588a can together form parts of a lock actuator. The actuator pins 1588a can comprise screws or posts that can be embedded in a proximal surface of the body of the handle 1508 forming the external surface 1524. FIG. 22B shows that there can be two actuator pins 1588a. In some embodiments there are three or more than three actuator pins 1588a. In some embodiments there is a single actuator pin 1588a. The actuator pins 1588a hold the knob 1576 on the proximal end 1556 of the handle 1508. The actuator pins 1588a define a degree of rotation of the knob 1576 and also control movement of plurality of grip features 1608.

[0152] The knob 1576 can have a circular shape and can include a ring member 1596 forming an outer periphery 1604 of the knob 1576. An inner periphery 1616 of the knob 1576 can include a plurality of grip features 1608. The plurality of grip features 1608 are also referred to herein as locking features and can have a disengaged configuration and an engagedconfiguration. The plurality of grip features 1608 are configured to selectively engage and disengage an outer surface of the lead assembly 1560. The plurality of grip features 1608 can include a fixed end 1612 extending from the inner periphery 1616 and a free end 1620 disposed opposite to the fixed end 1612. The free end 1620 can have teeth 1672 disposed thereon for gripping the lead assembly 1560. The plurality of grip features 1608 can comprise arms, e.g., cantilevered arms that are circumferentially and radially extending from ring member 1596. The plurality of grip features 1608 can comprise a spiral shape, e.g., having a radial and circumferential extent. The free end 1620 can be radially inward from and circumferentially offset from the fixed end 1612. The plurality of grip features 1608 can have an outer surface that forms one side of one of a plurality of channels 1624 in which the actuator pins 1588a are disposed. Portions of the inner periphery 1616 can form an opposite side of the plurality of channels 1624 in which one of the actuator pins 1588a is disposed.

[0153] The plurality of channels 1624 are each somewhat kidney bean shaped. FIG. 22D shows that the plurality of channels 1624 can have a first end 1628 that has a first width 1632 and a second end 1636 having a second width 1640. The first end 1628 can comprise a circular depression with first diameter. The first end 1628 when comprising a circular depression can include a closed end of a channel the plurality of channels 1624. The second end 1636 can comprise a circular depression with a second diameter. The circular depression at the second end 1636 may be formed in part by an outside surface of the plurality of grip features 1608. A small gap between an end surface of one of the plurality of grip features 1608 and an inside surface of an adjacent one of plurality of grip features 1608 can change shape and extent depending on the locked or un-locked state of the lead lock component 1572. In a free state, the second width 1640 is smaller than the first width 1632. In the free state, the teeth 1672 are disposed away from the lead assembly 1560 as seen in FIG. 22D. Movement of the ring member 1596 forming part of knob 1576 of the lead lock component 1572 is guided by the actuator pins 1588a and the plurality of channels 1624. The width (e.g., diameter) of each of the actuator pins 1588a is approximately equal to or slightly smaller than the first width 1632. As such that actuator pins 1588a can be disposed in the first end 1628 while permitting the plurality of grip features 1608 to be in a free state, e.g., as shown in FIG. 22D. In this state the plurality of grip features 1608 do not grip the lead assembly 1560. The lead assembly 1560 can freely slide relative to the handle 1508 (e.g., into and out of the page in FIG. 22D). Asnoted above, the lead assembly 1560 can slide with lower friction if saline or another lubricating fluid is provided through the fluid port 1584. The first end 1628 can have a rounded shape, e.g., circular or semicircular. The first end 1628 of each of the channels of the plurality of channels 1624 can form a notch into which the actuator pins 1588a can be engaged. A guide surface 1648 in each of the plurality of channels 1624, e.g., an outward surface of the plurality of grip features 1608 facing the inner periphery 1616, can be engaged by one of the pins of the actuator pins 1588a. The guide surface 1648 can contact a side surface or portion of the actuator pins 1588a or other projections extending from the handle 1508 whereby the contact can play a role in controlling movement of the plurality of grip features 1608. In the free state, the radial gap between the guide surface 1648 and the inner periphery 1616 can be less than the width (e.g., diameter) of the actuator pins 1588a. As such, rotation of the ring member 1596 of the knob 1576 in the direction of the arrow, which moves the actuator pins 1588a out of the first end 1628 and toward the second end 1636, can move the plurality of grip features 1608 away from the inner periphery 1616. This movement or actuation of the plurality of grip features 1608 can move the teeth 1672 toward the central axis 1676 of the handle 1508 and in a direction toward engagement of the teeth 1672 with the outside surface of the lead assembly 1560.

[0154] A complete movement of the ring member 1596 relative to the actuator pins 1588a causes the pins to be located in the second end 1636. The second width 1640 is less than the pin width (e.g., diameter) in the free state of the plurality of grip features 1608. But when one of the pins of the actuator pins 1588a is disposed in the second end 1636 of one channel of the plurality of channels 1624, the plurality of grip features 1608 are deflected to the position of FIG. 22E with the teeth 1672 urged toward the central axis 1676. The teeth 1672 can take any suitable form. In one advantageous configuration, the teeth 1672 are formed as threads formed through the thickness of the plurality of grip features 1608 at the free end 1620 thereof. In this context, the thickness dimension is measured along the central axis 1676. The plurality of grip features 1608 are deflected at the second end 1636 such that the second end of the channel has the first width 1632 as shown in FIG. 22E. The guide surface 1648 can have circular arc portions at portions corresponding to the first end 1628 and the second end 1636. The guide surface 1648 can have a flatter arc surface or even a reverse convexity between the first end 1628 and the second end 1636 as compared with the convexity at the first end 1628 and the second end 1636.

[0155] The lead lock component 1572 can be configured to reversibly and selectively provide the locked and un-lockcd configuration. The movement from un-lockcd to locked configurations has been discussed above. Movement from locked to un-locked can be achieved by rotating the knob 1576 in a direction opposite to the direction of rotation indicated by the arrow in FIG. 22D. Such rotation would move each pin of the actuator pins 1588a from the second end 1636 of each channel of the plurality of channels 1624 toward, and in some cases into, the first end 1628 of each channel of the plurality of channels 1624. The plurality of grip features 1608 can be spring-like or resilient such that in the absence of the application of a force by the actuator pins 1588a to the guide surface 1648, the plurality of grip features 1608 relax to the position shown in FIG. 22D.

[0156] FIG. 22B shows that the user is provided with visual indicators of the state of the lead lock component 1572. A pointer on outer periphery 1604 of the ring member 1596 moves with movement of the ring member 1596. At the extent of motion where the actuator pins 1588a are disposed in the first end 1628 adjacent to the fixed end 1612, the lead lock component 1572 is un-locked. The pointer on the outer periphery 1604 points directly to an icon signaling an un-locked state formed on the proximal end 1556 of the external surface 1524 of the handle 1508, e.g., to a lock icon with the locking portion disengaged from the lock body. At the extent of motion where the actuator pins 1588a are disposed in second end 1636 adjacent to the free end 1620, the lead lock component 1572 is locked. The pointer on the outer periphery 1604 points directly to an icon on the external surface 1524 of the handle 1508 signaling a locked state, e.g., to a lock icon with the locking portion engaged from the lock body. A doubled headed arrow on the external surface 1524 of the handle 1508 shows the user the direction to move from the un-locked state to the locked state and the locked state to the un-locked state.

[0157] FIG. 22A shows that distal and proximal faces of the knob 1576 can be recessed for different purposes. The distal recess on the knob 1576 can allow a proximal cylindrical projection of the handle 1508. The proximal cylindrical projection of the handle 1508 can be a fixture for securing the fluid port 1584 to the proximal portion 1516 of the handle 1508. The distal recess can be formed with a cylindrical outer surface configured to be guided over a cylindrical outer surface of a fixture to which the fluid port 1584 is coupled. The projection and distal recess construction can provide a proximal-distal gap between theproximal end 1556 of the external surface 1524 of the handle 1508 and the knob 1576 such that a tubular body of the fluid port 1584 can extend between these structures for flow of a lubricant or washing fluid into this gap or through this gap and into the handle 1508. The distal recess is visible in FIGS. 22A and 22C. A proximal recess is visible in FIGS. 22A and 22B. The proximal recess provides a distal-proximal space or height in which the heads of the actuator pins 1588a can be positioned such that these heads are less exposed and do not project beyond the proximal face of the knob 1576. As such, the proximal face of the knob 1576 limits the tendency of the actuator pins 1588a to snag or catch on other instruments or objects in the procedural area.

[0158] FIGS. 22F-22I show the delivery system 1500 with the second example lead lock component 1572’. The lead lock component 1572’ can be coupled to the handle 1508 at the proximal portion 1516. For example, one or more fasteners can extend through a housing 1602 of the lead lock component 1572’ and into the handle 1508. The lead lock component 1572’ can include an actuator 1606 and a clamp 1622. The actuator 1606 can move the clamp 1622 between an engaged configuration and a disengaged configuration. In the engaged configuration, the clamp 1622 can fix the lead assembly 1560 to the handle 1508 such that relative motion (e.g., relative sliding motion) between the lead assembly 1560 and the handle 1508 is prevented. In the disengaged configuration, the clamp 1622 can allow relative motion between the lead assembly 1560 and the handle 1508.

[0159] As shown in at least FIGS. 22H and 221, the actuator 1606 can comprise a threaded member. The actuator 1606 can include a head 1610 and a shaft 1614. The shaft 1614 can be coupled to the head 1610 and can include threads on its outer surface. The shaft 1614 can extend into an internal volume of the housing 1602. The shaft 1614 can be threadedly engaged with the housing 1602. The head 1610 can be used to rotate the shaft 1614 relative to the housing 1602. Rotation of the actuator 1606 in a first direction causes the actuator 1606 to extend further into the housing 1602, which can transform the clamp 1622 from the disengaged configuration to the engaged configuration. Rotation of the actuator 1606 in a second direction opposite the first direction causes the actuator 1606 to retract from the housing 1602, which can transform the clamp 1622 from the engaged configuration to the disengaged configuration.

[0160] With continued reference to FIGS. 22H and 221, the clamp 1622 can include a first clamp member 1626 and a second clamp member 1630. In some implementations, theclamp 1622 only includes the first clamp member 1626. In the illustrated example, the first clamp member 1626 is disposed on a first side of a lumen 1618 that extends through the housing 1602 and the second clamp member 1630 is disposed on a second side of the lumen 1618. The lumen 1618 can be axially aligned with the lumen 1564. For example, the central axis 1676 of the handle 1508 can be aligned with the central axis of the lumen 1618. As shown in FIG. 221, at least a portion of the lead assembly 1560 can be disposed in the lumen 1618 during deployment and / or retrieval of the lead assembly 1560. When the lead assembly 1560 is positioned in the lumen 1618, the first clamp member 1626 is disposed on a first side of the lead assembly 1560 and the second clamp member 1630 is disposed on a second side of the lead assembly 1560. In the engaged configuration, the clamp 1622 can apply a pressure to a portion of an outer surface of the lead assembly 1560 to restrict the movement of the lead assembly 1560 relative to the handle 1508.

[0161] The first clamp member 1626 can comprise a first radial projection 1634 and a first disc 1638. A first end of the first radial projection 1634 can be disposed adjacent to the lumen 1618 and a second opposite end of the first radial projection 1634 can be disposed adjacent the actuator 1606. The first disc 1638 can extend from or be coupled to the first radial projection 1634 at the first end. The first radial projection 1634 can be an elongate cylinder having a smaller diameter than the first disc 1638. As such, the first disc 1638 is an enlarged disc relative to the first radial projection 1634. The first disc 1638 can extend at least partially into the lumen 1618 in the engaged configuration. The first disc 1638 can include a first lead engagement surface 1642. The first lead engagement surface 1642 is the surface of the first clamp member 1626 that is configured to engage the lead assembly 1560. The first clamp member 1626 can be moveable relative to the housing 1602. The actuator 1606 can drive the movement of the first clamp member 1626 towards the lumen 1618 and away from the lumen 1618. For example, the first clamp member 1626 may be coupled to the actuator 1606. In the illustrated example, rotation of the actuator 1606 in the first direction causes the first clamp member 1626 to move towards the lumen 1618 and rotation of the actuator 1606 in the second direction causes the first clamp member 1626 to move away from the lumen 1618. In the illustrated example, the first clamp member 1626 is coupled to the actuator 1606 via the first radial projection 1634. For example, the first radial projection 1634 extends into a coupling cylinder 1658 that is coupled to the shaft 1614 of the actuator 1606. As such, linear movementof the actuator 1606 relative to the housing 1602 causes corresponding linear movement of the first clamp member 1626. In some implementations, the first clamp member 1626 can be configured to return to the disengaged configuration from the engaged configuration when the shaft 1614 is not pushing the first clamp member 1626 further into the lumen 1618. For example, the first clamp member 1626 can be resilient, like a spring, such that the first clamp member 1626 is biased to move away from axis 1676 in the absence of an applied force from the actuator 1606. In such an implementation, the actuator 1606 is not required to pull the first clamp member 1626 from the engaged configuration to the disengaged configuration. Instead, the applied force from the actuator 1606 can be removed to cause the first clamp member 1626 to disengage the lead assembly 1560.

[0162] In the illustrated example, the second clamp member 1630 has a similar construction to the first clamp member 1626. For example, the second clamp member 1630 can include a second radial projection 1646 and a second disc 1650. A first end of the second radial projection 1646 can be disposed adjacent to the lumen 1618 and a second opposite end of the second radial projection 1646 can be disposed away from the lumen 1618. The second disc 1650 can extend from or be coupled to the second radial projection 1646 at the first end. The second radial projection 1646 can be an elongate cylinder having a smaller diameter than the second disc 1650. As such, the second disc 1650 is an enlarged disc relative to the second radial projection 1646. The second disc 1650 can extend at least partially into the lumen 1618. The second disc 1650 can include a second lead engagement surface 1654. The second lead engagement surface 1654 is the surface of the second clamp member 1630 that is configured to engage the lead assembly 1560. The second clamp member 1630 can be fixed relative to the housing 1602.

[0163] The lead engagement surfaces 1642, 1654 of the clamp members 1626, 1630 can have an enlarged area compared to a cross-sectional area of the radial projections 1634, 1646. When shown in cross-section, the clamp members 1626, 1630 can be substantially T-shaped, as shown in FIGS. 22H and 221. As explained above, in the engaged configuration, a portion of the lead assembly 1560 can be compressed or sandwiched between the clamp members 1626, 1630, with the lead engagement surfaces 1642, 1654 engaging the lead assembly 1560 on opposite sides. The lead engagement surfaces 1642, 1654 can have diameters that are larger than a maximum diameter of the lead assembly 1560. Thisarrangement can ensure that the lead assembly 1560 primarily engages the clamp members 1626, 1630 and not the walls of the lumen 1618 in the engaged configuration. Such an arrangement can also allow the clamp members 1626, 1630 to engage the lead assembly 1560 even when the lead assembly 1560 is not perfectly aligned with the central axis 1676.

[0164] To transform the clamp 1622 from the disengaged configuration to the engaged configuration, the actuator 1606 can be rotated in the first direction. This rotation causes the first clamp member 1626 and the first lead engagement surface 1642 to move from a first position that allowed the lead assembly 1560 to move within the lumen 1618 and / or to slide along the first lead engagement surface 1642, to a second position where movement of the lead assembly 1560 along the first lead engagement surface 1642 is restricted. In the second position, the lead assembly 1560 is engaged on both sides with the lead engagement surfaces 1642, 1654 of the clamp members 1626, 1630. In some implementations, the clamp members 1626, 1630 can be made of a compressible material, such as silicone. As such, as the first clamp member 1626 moves to the second position, the clamp members 1626, 1630 can at least partially conform to the shape of the lead assembly 1560 when applying pressure to the lead assembly 1560 in the engaged configuration. By partially conforming to the shape of the lead assembly 1560, the clamp members 1626, 1630 can reduce the likelihood of damage to the lead assembly 1560, which is particularly important during deployment of the lead assembly 1560. In some cases, the second lead engagement surface 1654 extends partially into the lumen 1618, which can limit engagement between lead assembly 1560 and the walls of the lumen 1618 as pressure is applied to the lead assembly 1560 via the first lead engagement surface 1642.

[0165] The lead lock component 1572’ can provide certain advantages over the lead lock component 1572. As described above, the clamp members 1626, 1630 can conform to the shape of the lead assembly 1560 to reduce the likelihood of damage to the lead assembly 1560. In another example, the lead lock component 1572’ can be configured to work with a variety of sized lead assembly 1560. For example, because the first clamp member 1626 is moveable relative to the housing 1602, the lead lock component 1572’ can accommodate different sized lead assemblies 1560. In some cases, a tighter lock can be achieved with the lead lock component 1572’ compared to the lead lock component 1572.

[0166] The foregoing discussion of the delivery system 1500 in connection with FIGS. 22-221 should be considered in combination with the discussion of steps of the method 900 in connection with FIGS. 15-15J.

[0167] Although the implant assemblies disclosed herein are configured for chronic use, some patients may not continue to need the therapy provided by the assemblies. FIGS. 23-23F show different examples of a lead retrieval system 1740 that can be used to remove the implant assembly 501. The lead retrieval system 1740 can comprise or can include one or more tools to facilitate retrieval. For example, the lead retrieval system 1740 can include a lead extender 1768. FIGS. 23-23D show a first implementation of the lead retrieval system 1740 that includes a first example lead extender 1768. FIGS. 23E and 23F show a second implementation of the lead retrieval system 1740 that includes a second example 1768’.

[0168] With reference first to FIG. 23, the first example lead extender 1768 includes a tubular shaft 1772 that extends from a proximal end to a distal portion 1776. The distal portion 1776 extends to a distal end with an opening that is configured to receive a proximal portion of a lead assembly 1560. One or a plurality of teeth 1780 are disposed on an inner surface of the tubular body of the lead extender 1768. The teeth 1780 extend between a free end 1788 and a fixed end 1792. The teeth 1780 are angled inwardly toward a longitudinal axis 1832 of the lead extender 1768. The free end 1788 are disposed proximal of the fixed end 1792 for each of the teeth 1780. The teeth 1780 are resiliently deflectable from a first inwardly angled position to a second inwardly angled position. The first inwardly angled position is disposed at a higher angle than the second inwardly angled position. The second inwardly angled position is on in which the teeth 1780 have been deflected by insertion of the lead assembly 1560. FIG. 23 shows that first inwardly angled position in connection with four proximal most of the teeth 1780. FIG. 23 shows that second inwardly angled position in connection with six distal most of the teeth 1780.

[0169] Referring now to FIG. 23E, the second example lead extender 1768’ can include a tubular shaft 1772’ that extends from a proximal end to a distal portion 1776’. The lead extender 1768’ can also include one or more projections 1780’ that extend from a distal end of the tubular shaft 1772’. Accordingly, the one or more projections 1780’ can form the distal most portion of the lead extender 1768’. In the illustrated example, the second example 1768’ includes a single projection 1780’. The projection 1780’ is configured to be embeddedin a wall of the lead assembly 1560 at or distal to the lead cut line 1840. For example, as shown in FIG.23F, the projection 1780’ can be configured to be inserted into the lead assembly 1560 at or distal to the cut line 1840 to engage an inner surface of the tubing 570 of the lead assembly 1560. When the projection 1780’ engages the tubing 570, the lead retrieval system 1740 can support a tension load during the withdrawal of the lead assembly 1560. To engage the tubing 570, the projection 1780’ can be a threaded extension of the lead extender 1768’ . For example, the projection 1780’ can have one or more threads 1784’disposed thereon. The threads 1784’ can have a greater outer diameter than the inner diameter of the tubing 570 of the lead assembly 1560. Accordingly, as the projection 1780’ is advanced and rotated into the lead assembly 1560, the threads 1784’ can cut into the inner surface of the tubing 570, causing the lead extender 1768’ to be coupled to the lead assembly 1560 via the projection 1780’, as shown in FIG. 23F. In other implementations, the projection 1780’ may not include threads 1784’ and may instead include one or more teeth extending outward along the projection 1780’ or inward of an inner surface of the tubular shaft 1772’, similar to the lead extender 1768.

[0170] FIGS. 23A-23B show two steps of a method for retrieving the implant assembly 501. As noted above in connection FIG. 15H, the lead assembly 1560 is connected to the controller 50 at the end of the process for implanting the implant assembly 501. In one method, to begin retrieving the implant assembly 501, the lead assembly 1560 is cut through the external surface 1836 and through the entire thickness of the lead assembly 1560 adjacent to the controller 50. This results in a lead cut line 1840 forming a new proximal end based on the cutting process. While FIGS. 23A and 23B show the retrieval method using the lead extender 1768, a similar method can be performed using the lead extender 1768’, as described below.

[0171] The process of cutting the lead assembly 1560 provides a very short accessible length outside the patient. The short accessible length would not be long enough to allow for the use of the delivery system 1500 for removal of the implant assembly 501. The lead extenders 1768, 1768’ enables the delivery system 1500 to be used in a retrieval technique. In a removal technique, a proximal portion of the lead assembly 1560 extending distally from the lead cut line 1840 or severed end is brought into adjacency with the distal portion 1776, 1776’ of the lead retrieval system 1740. As shown in FIG. 23B, when using the lead extender 1768, the lead cut line 1840 is then inserted into the opening at the end of the distal portion1776 of the lead extender 1768, as indicated by the arrow to the right of FIG. 23. The lead cut line 1840 is inserted along the longitudinal axis 1832 deflecting the six teeth 1780 from the first inwardly angled position to the second inwardly angled position, which is at a smaller angle than the first inwardly angled position. The teeth 1780 are resiliently biased toward the first inwardly angled position and as such the teeth 1780 bite into the external surface 1836 of the lead assembly 1560. The lead assembly 1560 can be inserted farther into the lead extender 1768 to further enhance the grip on the external surface 1836 adjacent to the lead cut line 1840. When using the lead extender 1768’, the projection 1780’ can be inserted into the lead assembly 1560 at the lead cut line 1840. The lead extender 1768’ can then be rotated relative to the lead assembly 1560 such that the threads 1784’ of the projection 1780’ cut into internal surface of the tubing 570 of the lead assembly 1560. The projection 1780’ can be inserted farther into the lead assembly 1560 to further enhance the grip on the internal surface of the tubing 570 adjacent to the lead cut line 1840. FIG. 23B shows that the lead extender 1768 can be long enough for a dilator 1856 to be placed over the lead extender 1768. The dilator 1856 can be the same or similar to the dilator 1856 used in step 915A illustrated in FIG. 15A. The dilator 1856 can have a lumen to accommodate the lead extender 1768. Similarly, the lead extender 1768 can be long enough for the dilator 1856 to be placed over the lead extender 1768’.

[0172] FIGS. 23C and 23D illustrate additional configurations of the teeth formed in the tubular shaft 1772. The teeth can include a plurality of teeth 1824 in the tubular shaft 1772. The plurality of teeth 1824 can be arranged in rows, e.g., can include an array of rows 1828 of teeth, e.g., two, three, four, five, six, or more than six rows of teeth 1824. Each row in the array of rows 1828 can include one or more tooth, e.g., two, three, four, or more than four plurality of teeth 1824. The plurality of teeth 1824 can have a pointed tip 1820 as shown in FIG. 23C. The pointed tip 1820 provides a more aggressive connection between the external surface 1836 and the lead extender 1768. FIG. 23D shows another embodiment in which the plurality of teeth 1824 each include a blunt tip 1816. The blunt tip 1816 includes a concave structure at a distal end of each tooth of the plurality of teeth 1824.

[0173] The technique for using the lead extender 1768 is illustrated in FIGS. 23A and 23B as discussed above. Once the lead extender 1768 or the lead extender 1768’ is securely coupled to the severed end, e.g., with the lead cut line 1840 proximal of the distal end openingof the distal portion 1776 of the lead extender 1768, the dilator 1856 and an introducer shaft 1504 of an introducer sheath can be advanced over the combined lead extender 1768 and lead assembly 1560 into the patient as part of providing access for the delivery system 1500. Once the access is provided and the introducer shaft 1504 are positioned, the dilator 1856 can be removed from the patient. The dilator 1856 can be exchanged for the delivery system 1500, which is also a retrieval system, as discussed herein. The delivery shaft 1510 (used in this method as a retrieval shaft) and handle 1508 can be advanced over the proximal end of the lead extender 1768 and advanced over the junction of the lead cut line 1840 and the distal portion 1776 of the lead extender 1768 and through the introducer shaft 1504 until the delivery shaft 1510 is within the patient with the distal end thereof adjacent to at the implant assembly 501. The delivery shaft 1510 can be advanced until the position of the distal tip relative to the implant assembly 501 is confirmed by fluoroscopy (e.g., by visualization of a radiopaque marker). To achieve this, the outer surface of the lead extenders 1768, 1768’ are configured to be slideable relative to lead lock component 1572 when the lead lock component is not in the locked configuration. Thereafter, the lead extender 1768, 1768’ or the proximal portion of the cut lead assembly 1560 can be locked to the handle 1508 using the lead lock component 1572. Collapsing the implant assembly 501 can commence by advancing the carriage 1532 within the interior of the handle 1508 which causes the distal tip of the delivery shaft 1510 to slide over the implant assembly 501, collapsing the implant assembly 501. As with deployment, the indicator 1544 can provide convenient direct feedback to the clinician as to the position of the distal end of the delivery shaft 1510 relative to the implant assembly 501, when included in the handle 1508.

[0174] The delivery and retrieval steps are advantageously performed by the same system such that the delivery system 1500 is also the retrieval system, the delivery shaft 1510 is also the retrieval shaft, and the handle 1508 is a delivery handle and a retrieval handle. This reduces the number of components needed to attend to patients and also simplifies the procedures such that the clinician can interact with many of the same instruments for both procedures.

[0175] 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 animplantable 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.Additional Embodiments

[0176] Clause 1. A delivery system for blood flow occluder system, comprising: a handle comprising: a distal portion; a proximal portion; an actuator positioned between the proximal portion and the distal portion, the actuator moveable relative to an external surface of the handle, the actuator coupled to an internally threaded cylinder; and a carriage disposed in the internally threaded cylinder having an external thread formed thereon and a carriage magnet disposed at or adjacent to the external thread; and an indicator moveably disposed on the proximal portion and magnetically engaged with the carriage magnet such that movement of the carriage magnet moves the indicator to provide visual feedback of a location of a delivery shaft coupled with the carriage.

[0177] Clause 2. The delivery system of clause 1, comprising a shaft interface disposed on a distal side of the carriage, the shaft interface configured to securely engage a proximal end of the delivery shaft of the delivery system.

[0178] Clause 3. The delivery system of clause 1, wherein the carriage comprises a lumen configured to allow a lead assembly of the blood flow occluder system to be passed therethrough.

[0179] Clause 4. The delivery system of clause 1, further comprising a lead lock component configured to engage a lead assembly to control or prevent movement of the lead assembly relative to the external surface of the handle as the carriage moves within the handle in a proximal or a distal direction.

[0180] Clause 5. The delivery system of clause 4, wherein the lead lock component is engaged with a proximal end of the handle.

[0181] Clause 6. The delivery system of clause 5, wherein the lead lock component comprises a knob configured to rotate relative to the proximal end of the handle to move one or more locking features from a disengaged configuration to an engaged configuration.

[0182] Clause 7. The delivery system of clause 1 , further comprising a fluid port configured to allow injection of saline to facilitate movement of the delivery shaft over an external surface of a lead assembly upon movement of the actuator.

[0183] Clause 8. A delivery system for blood flow occluder, comprising: a handle having a proximal portion; and a lead lock coupled to the proximal portion, the lead lock comprising: a plurality of actuator pins extending from a proximal end of the proximal portion of the handle; a lock actuator rotatably coupled to the proximal end of the proximal portion of the handle, the lock actuator comprising a ring member having: a grip surface at an outer periphery; a plurality of grip features, each grip feature having a fixed end coupled with an inner periphery of the ring member and a free end disposed radially inward of the fixed end; and a plurality of channels, at least one channel of the plurality of channels disposed between each of the grip features and the inner periphery of the ring member, the channels having a first end having a first width and a second end having a second width less than the first width; wherein one actuator pin of the plurality of actuator pins is disposed in each one of the channels; and wherein rotation of the lock actuator relative to the actuator pins moves the grip features radially inwardly to a gripping position when the actuator pins are disposed at the second end of the channels, the grip features are moveable radially outwardly to a release position when the actuator pins are disposed at the first end of the channels.

[0184] Clause 9. A delivery system for blood flow occluder, comprising: a handle; and a lead lock coupled to the handle, the lead lock comprising: a projection extending from the handle; a lock actuator moveably coupled to the handle, the lock actuator comprising: a hand grip structure at an outer periphery of the lock actuator; a lead grip feature having a fixed end disposed inward of the hand grip structure and a free end disposed away from the fixed end; and a guide surface disposed between the lead grip feature and the projection, the guide surface having a first end having a first engagement portion and a second end having a second engagement portion; wherein the projection is disposed adjacent to the guide surface; and wherein movement of the lock actuator relative to the projection moves the lead grip feature inwardly to a gripping position when the projection is disposed at the second end of the guide surface, the lead grip feature is moveable outwardly to a release position when the projection is disposed at the first end of the guide surface.

[0185] Clause 10. The delivery system for blood flow occluder of clause 9, wherein the lead lock is rotatably coupled to a proximal end of the handle.

[0186] Clause 11. The delivery system for blood flow occluder of clause 10, wherein the projection is disposed on a proximal surface of the handle, the guide surface contacting a side portion of the projection.

[0187] Clause 12. The delivery system for blood flow occluder of clause 9, wherein the lead grip feature comprises teeth facing a central axis of the handle.

[0188] Clause 13. The delivery system for blood flow occluder of clause 12, wherein the teeth comprise threads facing a central axis of the handle.

[0189] Clause 14. The delivery system for blood flow occluder of clause 9, wherein the lock actuator comprises a ring rotatably mounted to the handle, the guide surface formed on an outer portion of the lead grip feature comprising teeth configured to face a central axis of the ring.

[0190] Clause 15. The delivery system for blood flow occluder of clause 14, wherein the lead grip feature comprises an arm and further comprising at least one additional arm such that there is a plurality of arms extending inwardly from an inner surface of the ring, each arm of the plurality of arms comprising a guide surface formed on an outer portion of the corresponding arm and teeth disposed away from fixed ends configured to face a central axis of the ring.

[0191] Clause 16. The delivery system for blood flow occluder of clause 15, wherein the projection is a first projection and further comprising at least one additional projection such that there is a plurality of projections, wherein the guide surface of each arm forms one side of a channel which defined positions for locating one projection of the plurality of projections upon movement relative movement of the projection and the lock actuator.

[0192] Clause 17. The delivery system for blood flow occluder of clause 15, wherein the guide surface comprises a first circular depression at the first end of the guide surface and a second circular depression at the second end of the guide surface.

[0193] Clause 18. The delivery system for blood flow occluder of clause 15, wherein the plurality of arms comprises three arms.

[0194] Clause 19. A lead retrieval system for blood flow occluder, comprising: a handle having a proximal portion; a lead lock coupled to the proximal portion, the lead lockhaving a first configuration in which a lead disposed therethrough is held in a fixed position relative to the handle and a second configuration in which the lead disposed therethrough is moveable relative to the handle; and a lead extender device comprising a tubular shaft disposed on a distal portion thereof, the tubular shaft comprising one or more teeth disposed on an inner surface thereof, the one or more teeth being angled inwardly such that a free end of each tooth of the one or more teeth is disposed proximally of a fixed end of the tooth and is disposed within a lumen of the tubular shaft; wherein the distal end of the tubular shaft of the lead extender device has an outer surface sized to be slideable through the lead lock to engage the lead distal of the proximal end of the lead or to engage the lead extender device.

[0195] Clause 20. The lead retrieval system of clause 19, wherein the one or more teeth comprises a blunt tip at the free end thereof.

[0196] Clause 21. The lead retrieval system of clause 19, wherein the one or more teeth comprises a pointed tip at the free end thereof.

[0197] Clause 22. The lead retrieval system of clause 19, wherein the one or more teeth comprises a plurality of teeth.

[0198] Clause 23. The lead retrieval system of clause 22, wherein the plurality of teeth are arranged in rows aligned along a longitudinal axis of the lead extender.

[0199] Clause 24. A tool for retrieving a blood flow occluder, comprising: a lead extender comprising a tubular shaft disposed at a distal portion thereof, the tubular shaft comprising one or more teeth disposed on an inner surface thereof, the teeth being angled inwardly such that a free end of each tooth of the one or more teeth is disposed proximally of a fixed end of the tooth and is disposed within a lumen of the tubular shaft; wherein the teeth are configured to grip an external surface of a lead of an blood flow occluder; wherein the tubular shaft has a length and an outer surface size to enable the lead extender to be inserted through a sheath and handle of a retrieval device such that a proximal end of the lead extender can be disposed proximal of the handle of the retrieval device.

[0200] Clause 25. The tool of clause 24, wherein the one or more teeth comprises a blunt tip at the free end thereof.

[0201] Clause 26. The tool of clause 24, wherein the one or more teeth comprises a pointed tip at the free end thereof.

[0202] Clause 27. The tool of clause 24, wherein the one or more teeth comprises a plurality of teeth.

[0203] Clause 28. The tool of clause 27, wherein the plurality of teeth are arranged in rows aligned along a longitudinal axis of the lead extender.

[0204] Clause 29. A method of retrieving a blood flow occluder, comprising: accessing a proximal length of a lead assembly of the blood flow occluder; advancing a distal portion of a lead extender over a proximal portion of the lead assembly such that at lest one tooth angled inwardly into a lumen of the lead extender is disposed over the proximal portion of the lead assembly; advancing a dilator over the distal portion of the lead extender that is disposed over the lead assembly; exchanging the dilator for a retrieval assembly comprising a retrieval sheath and a retrieval handle; and removing the blood flow occluder within the retrieval sheath.

[0205] Clause 30. The method of clause 29, further comprising severing the lead assembly distal to a proximal end of the lead assembly to create a severed end, advancing the distal portion of the lead extender over the severed end, and advancing the dilator over the severed end of the lead assembly.

[0206] Clause 31. The method of clause 30, locking a portion of the lead extender or the lead assembly distal to the severed end relative to an external surface of the retrieval handle and thereafter advancing the retrieval sheath over the blood flow occluder to collapse the blood flow occluder.

[0207] Clause 32. A delivery system for a blood flow occluder system, comprising: a handle comprising: a distal portion; a proximal portion; an actuator positioned between the proximal portion and the distal portion, the actuator moveable relative to an external surface of the handle; and a carriage disposed in the handle, wherein the actuator is configured to cause movement of the carriage to deploy the blood flow occluder system.

[0208] Clause 33. The delivery system of clause 32, wherein the actuator is coupled to an internally threaded cylinder, wherein the carriage is disposed in the internally threaded cylinder, the carriage having an external thread formed thereon.

[0209] Clause 34. The delivery system of clause 32 or clause 33, further comprising an indicator moveably disposed on the proximal portion and magnetically engaged with a carriage magnet disposed at or adjacent to an external surface of the carriage such thatmovement of the carriage magnet moves the indicator to provide visual feedback of a location of a delivery shaft coupled with the carriage.

[0210] Clause 35. The delivery system of any of clauses 32 to 34, comprising a shaft interface disposed on a distal side of the carriage, the shaft interface configured to securely engage a proximal end of a delivery shaft of the delivery system.

[0211] Clause 36. The delivery system of any of clauses 32 to 35, wherein the carriage comprises a lumen configured to allow a lead assembly of the blood flow occluder system to be passed therethrough.

[0212] Clause 37. The delivery system of any of clauses 32 to 36, further comprising a lead lock component configured to engage a lead assembly of the blood flow occluder system to control or prevent movement of the lead assembly relative to the external surface of the handle as the carriage moves within the handle in a proximal or a distal direction.

[0213] Clause 38. The delivery system of clause 37, wherein the lead lock component is engaged with a proximal end of the handle.

[0214] Clause 39. The delivery system of clause 38, wherein the lead lock component comprises a knob configured to rotate relative to the proximal end of the handle to move one or more locking features from a disengaged configuration to an engaged configuration.

[0215] Clause 40. The delivery system of clause 37 or clause 38, wherein the lead lock component comprises a clamp comprising a disengaged configuration and an engaged configuration.

[0216] Clause 41. The delivery system of clause 40, wherein the clamp comprises a first clamp member and a second clamp member, the first clamp member configured to engage the lead assembly on a first side and the second clamp member configured to engage the lead assembly on an opposite second side in the engaged configuration.

[0217] Clause 42. The delivery system of clause 41, wherein the first clamp member and / or the second clamp member comprises a radial projection having a first end disposed adjacent to the lumen and a second end opposite the first end and a lead engagement surface adjacent to the first end, the lead engagement surface comprising an enlarged area compared to a cross-sectional area of the radial projection, the lead engagement surface being moveable by moving the radial projection from a first position allowing the lead assembly toslide along the lead engagement surface to a second position restricting movement of the lead assembly along the lead engagement surface.

[0218] Clause 43. The delivery system of clause 42, wherein the lead engagement surface has a width or diameter that is larger than a maximum diameter of the lead assembly.

[0219] Clause 44. The delivery system of clause 42 or clause 43, wherein the first clamp member and / or the second clamp member comprises an enlarged disc disposed at the first end of the radial projection, the enlarged disc comprising the lead engagement surface, and wherein the radial projection comprises an elongate cylinder having a smaller diameter than the enlarged disc.

[0220] Clause 45. The delivery system of any of clauses 40 to 44, wherein the lead lock component further comprises a threaded member, wherein rotation of the threaded member in a first direction relative to the external surface of the handle transforms the clamp from the disengaged configuration to the engaged configuration.

[0221] Clause 46. The delivery system of any of clauses 40 to 45, wherein the clamp comprises a compressible material.

[0222] Clause 47. The delivery system of clause 46, wherein a portion of the clamp facing the lumen is configured to conform to a shape of the lead assembly when applying pressure to the lead assembly in the engaged configuration.

[0223] Clause 48. The delivery system of any of clauses 32 to 47, further comprising a fluid port configured to allow injection of saline to facilitate movement of a delivery shaft of the delivery system over an external surface of a lead assembly of the blood flow occluder system upon movement of the actuator.

[0224] Clause 49. A delivery system for a blood flow occluder, comprising: a handle having a proximal portion; and a lead lock coupled to the proximal portion, the lead lock comprising: a plurality of actuator pins extending from a proximal end of the proximal portion of the handle; a lock actuator rotatably coupled to the proximal end of the proximal portion of the handle, the lock actuator comprising a ring member having: a grip surface at an outer periphery; a plurality of grip features, each grip feature having a fixed end coupled with an inner periphery of the ring member and a free end disposed radially inward of the fixed end; and a plurality of channels, at least one channel of the plurality of channels disposed between each grip feature of the plurality of grip features and the inner periphery of the ring member,the plurality of channels having a first end having a first width and a second end having a second width less than the first width; wherein one actuator pin of the plurality of actuator pins is disposed in each one of the plurality of channels; and wherein rotation of the lock actuator relative to the plurality of actuator pins moves the plurality of grip features radially inwardly to a gripping position when the plurality of actuator pins are disposed at the second ends of the plurality of channels, the plurality of grip features arc moveable radially outwardly to a release position when the plurality of actuator pins are disposed at the first ends of the plurality of channels.

[0225] Clause 50. A delivery system for a blood flow occluder, comprising: a handle; and a lead lock coupled to the handle, the lead lock comprising: a projection extending from the handle; a lock actuator moveably coupled to the handle, the lock actuator comprising: a hand grip structure at an outer periphery of the lock actuator; a lead grip feature having a fixed end disposed inward of the hand grip structure and a free end disposed away from the fixed end; and a guide surface disposed between the lead grip feature and the projection, the guide surface having a first end having a first engagement portion and a second end having a second engagement portion; wherein the projection is disposed adjacent to the guide surface; and wherein movement of the lock actuator relative to the projection moves the lead grip feature inwardly to a gripping position when the projection is disposed at the second end of the guide surface, the lead grip feature is moveable outwardly to a release position when the projection is disposed at the first end of the guide surface.

[0226] Clause 51. The delivery system of clause 50, wherein the lead lock is rotatably coupled to a proximal end of the handle.

[0227] Clause 52. The delivery system of clause 51, wherein the projection is disposed on a proximal surface of the handle, the guide surface contacting a side portion of the projection.

[0228] Clause 53. The delivery system of any of clauses 50 to 52, wherein the lead grip feature comprises teeth facing a central axis of the handle.

[0229] Clause 54. The delivery system of any of clauses 50 to 52, wherein the lead grip feature comprise threads facing a central axis of the handle.

[0230] Clause 55. The delivery system of any of clauses 50 to 54, wherein the lock actuator comprises a ring rotatably mounted to the handle, the guide surface formed on an outer portion of the lead grip feature comprising teeth configured to face a central axis of the ring.

[0231] Clause 56. The delivery system of clause 55, wherein the lead grip feature comprises an arm and further comprising at least one additional arm such that there is a plurality of arms extending inwardly from an inner surface of the ring, each arm of the plurality of arms comprising a guide surface formed on an outer portion of the corresponding arm and teeth disposed away from fixed ends configured to face a central axis of the ring.

[0232] Clause 57. The delivery system of clause 56, wherein the projection is a first projection and further comprising at least one additional projection such that there is a plurality of projections, wherein the guide surface of each arm forms one side of a channel which defined positions for locating one projection of the plurality of projections upon movement relative movement of the projection and the lock actuator.

[0233] Clause 58. The delivery system of clause 56 or clause 57, wherein the guide surface comprises a first circular depression at the first end of the guide surface and a second circular depression at the second end of the guide surface.

[0234] Clause 59. The delivery system of any of clauses 56 to 58, wherein the plurality of arms comprises three arms.

[0235] Clause 60. A delivery system for a blood flow occluder, comprising: a handle; and a lead lock coupled to the handle, the lead lock configured to engage a lead assembly of the blood flow occluder to control or prevent movement of the lead assembly relative to an external surface of the handle, the lead lock comprising: a lumen configured to receive at least a portion of the lead assembly; a clamp comprising a first clamp member and a second clamp member, the first clamp member configured to engage the lead assembly on a side thereof and the second clamp member configured to engage the lead assembly; and an actuator, the actuator configured to transform the clamp from a disengaged configuration where the lead assembly can move relative to the external surface of the handle to an engaged configuration where the clamp restricts movement of the lead assembly relative to the external surface of the handle.

[0236] Clause 61. The delivery system of clause 60, wherein the first clamp member and / or the second clamp member comprises a radial projection having a first enddisposed adjacent to the lumen and a second end opposite the first end and a lead engagement surface adjacent to the first end, the lead engagement surface comprising an enlarged area compared to a cross-sectional area of the radial projection, the lead engagement surface being moveable by moving the radial projection from a first position allowing the lead assembly to slide along the lead engagement surface to a second position restricting movement of the lead assembly along the lead engagement surface.

[0237] Clause 62. The delivery system of clause 61, wherein the lead engagement surface has a width or diameter that is larger than a maximum diameter of the lead assembly.

[0238] Clause 63. The delivery system of clause 61 or clause 62, wherein the first clamp member and / or the second clamp member comprises an enlarged disc disposed at the first end of the radial projection, the enlarged disc comprising the lead engagement surface, and wherein the radial projection comprises an elongate cylinder having a smaller diameter than the enlarged disc.

[0239] Clause 64. The delivery system of any of clauses 60 to 63, wherein the actuator comprises a threaded member, wherein rotation of the threaded member in a first direction relative to the external surface of the handle transforms the clamp from the disengaged configuration to the engaged configuration.

[0240] Clause 65. The delivery system of any of clauses 60 to 64, wherein the clamp comprises a compressible material.

[0241] Clause 66. The delivery system of any of clauses 60 to 65, wherein a portion of the clamp facing the lumen is configured to conform to a shape of the lead assembly when applying pressure to the lead assembly in the engaged configuration.

[0242] Clause 67. A lead retrieval system for a blood flow occluder, comprising: a handle having a proximal portion; a lead lock coupled to the proximal portion, the lead lock having a first configuration in which a lead disposed therethrough is held in a fixed position relative to the handle and a second configuration in which the lead disposed therethrough is moveable relative to the handle; and a lead extender device comprising a tubular' shaft disposed on a distal portion thereof, wherein a distal end of the tubular shaft of the lead extender device has an outer surface sized to be slideable through the lead lock, the distal end configured to engage the lead at or distal of a proximal end of the lead.

[0243] Clause 68. The lead retrieval system of clause 67, wherein the tubular shaft comprises one or more teeth disposed on an inner surface thereof, the one or more teeth being angled inwardly such that a free end of each tooth of the one or more teeth is disposed proximally of a fixed end of each tooth and is disposed within a lumen of the tubular shaft.

[0244] Clause 69. The lead retrieval system of clause 68, wherein the one or more teeth comprises a blunt tip at the free end thereof.

[0245] Clause 70. The lead retrieval system of clause 68, wherein the one or more teeth comprises a pointed tip at the free end thereof.

[0246] Clause 71. The lead retrieval system of clause 68, wherein the one or more teeth comprises a plurality of teeth.

[0247] Clause 72. The lead retrieval system of clause 71, wherein the plurality of teeth are arranged in rows aligned along a longitudinal axis of the lead extender device.

[0248] Clause 73. The lead retrieval system of clause 67, wherein the lead extender device further comprises one or more projections extending from a distal end of the tubular shaft, the one or more projections configured to engage a surface of the lead.

[0249] Clause 74. The lead retrieval system of clause 73, wherein the one or more projections comprises one or more threads disposed on a threaded extension of the lead extender device.

[0250] Clause 75. The lead retrieval system of clause 74, wherein the threaded extension is configured to extend into tubing of the lead when engaged with the lead.

[0251] Clause 76. The lead retrieval system of clause 75, wherein an outer diameter of threads of the threaded extension is greater than an inner diameter of the tubing of the lead.

[0252] Clause 77. The lead retrieval system of clause 76, wherein the threads of the threaded extension are configured to cut into a wall of the tubing when the lead extender device is rotated relative to the lead.

[0253] Clause 78. The lead retrieval system of clause 73, wherein the one or more projections comprises teeth angled inwardly such that a free end of each tooth of the one or more teeth is disposed proximally of a fixed end of each tooth and is disposed within a lumen of the tubular shaft.

[0254] Clause 79. A tool for retrieving a blood flow occluder, comprising: a lead extender comprising a tubular shaft disposed at a distal portion thereof, the tubular shaftcomprising one or more teeth disposed on an inner surface thereof, the one or more teeth being angled inwardly such that a free end of each tooth of the one or more teeth is disposed proximally of a fixed end of each tooth and is disposed within a lumen of the tubular shaft; wherein the one or more teeth are configured to grip an external surface of a lead of the blood flow occluder; wherein the tubular shaft has a length and an outer surface sized to enable the lead extender to be inserted through a sheath and handle of a retrieval device such that a proximal end of the lead extender can be disposed proximal of the handle of the retrieval device.

[0255] Clause 80. The tool of clause 79, wherein the one or more teeth comprises a blunt tip at the free end thereof.

[0256] Clause 81. The tool of clause 79, wherein the one or more teeth comprises a pointed tip at the free end thereof.

[0257] Clause 82. The tool of clause 79, wherein the one or more teeth comprises a plurality of teeth.

[0258] Clause 83. The tool of clause 82, wherein the plurality of teeth are arranged in rows aligned along a longitudinal axis of the lead extender.

[0259] Clause 84. A tool for retrieving a blood flow occluder, comprising: a lead extender comprising a proximal portion and a distal portion, the distal portion configured to be embedded in a wall of a lead of the blood flow occluder at or distal to a severed end of the lead, wherein the distal portion has a length and an outer surface sized to enable the lead extender to be inserted through a sheath and handle of a retrieval device such that the proximal portion can be disposed proximal of the handle of the retrieval device.

[0260] Clause 85. The tool of clause 84, wherein the distal portion comprises one or more projections extending from a distal end, the one or more projections configured to be inserted into the lead at or distal to the severed end to engage an inner surface of the wall of the lead to support a tension load during withdrawal of the lead.

[0261] Clause 86. The tool of clause 85, wherein the one or more projections comprises one or more threads disposed on a threaded extension of the lead extender.

[0262] Clause 87. The tool of clause 86, wherein an outer diameter of the one or more threads of the threaded extension is greater than an inner diameter of the wall of the lead.

[0263] Clause 88. The tool of clause 87, wherein the one or more threads of the threaded extension arc configured to cut into the inner surface of the wall of the lead when the lead extender is rotated relative to the lead.

[0264] Clause 89. The tool of clause 85, wherein the one or more projections comprises one or more teeth disposed on and extending inward of an inner surface of a tubular portion of the lead extender.

[0265] Clause 90. A method of retrieving a blood flow occluder, comprising: accessing a proximal length of a lead assembly of the blood flow occluder; advancing a distal portion of a lead extender to engage a proximal portion of the lead assembly; advancing a dilator over the distal portion of the lead extender that is disposed over the lead assembly; exchanging the dilator for a retrieval assembly comprising a retrieval sheath and a retrieval handle; and removing the blood flow occluder within the retrieval sheath.

[0266] Clause 91. The method of clause 90, further comprising: advancing the distal portion of the lead extender over the proximal portion of the lead assembly such that at least one tooth angled inwardly into a lumen of the lead extender is disposed over the proximal portion of the lead assembly.

[0267] Clause 92. The method of clause 90, further comprising: severing the lead assembly distal to a proximal end of the lead assembly to create a severed end, advancing the distal portion of the lead extender over the severed end, and advancing the dilator over the severed end of the lead assembly.

[0268] Clause 93. The method of clause 90, further comprising: advancing an extension of the lead extender into or onto tubing of the lead assembly.

[0269] Clause 94. The method of clause 93, wherein the extension comprises a threaded extension and further comprising: rotating the lead extender relative to the lead assembly, wherein rotation of the lead extender causes threads of the threaded extension to cut into the tubing of the lead assembly.

[0270] Clause 95. The method of clause 93 or clause 94, further comprising: severing the lead assembly distal to a proximal end of the lead assembly to create a severed end; advancing the extension into or onto the severed end; and advancing the dilator over the severed end of the lead assembly.

[0271] Clause 96. The method of clause 92 or clause 95, locking a portion of the lead extender or the lead assembly distal to the severed end relative to an external surface of the retrieval handle and thereafter advancing the retrieval sheath over the blood flow occluder to collapse the blood flow occluder.Additional Considerations and Terminology

[0272] 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.

[0273] 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 a variety of other forms. Furthermore, various omissions, substitutions and changes in the form of the methods and systems described herein may be made. Those skilled in the art will appreciate that in some 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.

[0274] Although the present disclosure includes certain implementations, examples and applications, it will be understood by those skilled in the art that the present disclosureextends 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.

[0275] 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 the following interpretations of the word: any one of the items in the list, all of the items in the list, and any combination of the items in the list. Further, the term “each,” as used herein, in addition to having its ordinary meaning, can mean any subset of a set of elements to which the term “each” is applied. Additionally, the words “herein,” “above,” "below," and words of similar import, when used in this application, refer to this application as a whole and not to any particular portions of this application.

[0276] 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.

[0277] 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 delivery system for a blood flow occluder system, comprising: a handle comprising: a distal portion; a proximal portion; an actuator positioned between the proximal portion and the distal portion, the actuator moveable relative to an external surface of the handle; and a camage disposed in the handle, wherein the actuator is configured to cause movement of the carriage to deploy the blood flow occluder system.

2. The delivery system of claim 1, wherein the actuator is coupled to an internally threaded cylinder, wherein the carriage is disposed in the internally threaded cylinder, the carriage having an external thread formed thereon.

3. The delivery system of claim 1 or claim 2, further comprising an indicator moveably disposed on the proximal portion and magnetically engaged with a carriage magnet disposed at or adjacent to an external surface of the carriage such that movement of the carriage magnet moves the indicator to provide visual feedback of a location of a delivery shaft coupled with the carriage.

4. The delivery system of any of claims 1 to 3, comprising a shaft interface disposed on a distal side of the carriage, the shaft interface configured to securely engage a proximal end of a delivery shaft of the delivery system.

5. The delivery system of any of claims 1 to 4, wherein the carriage comprises a lumen configured to allow a lead assembly of the blood flow occluder system to be passed therethrough.

6. The delivery system of any of claims 1 to 5, further comprising a lead lock component configured to engage a lead assembly of the blood flow occluder system to control or prevent movement of the lead assembly relative to the external surface of the handle as the carriage moves within the handle in a proximal or a distal direction.

7. The delivery system of claim 6, wherein the lead lock component is engaged with a proximal end of the handle.

8. The delivery system of claim 7, wherein the lead lock component comprises a knob configured to rotate relative to the proximal end of the handle to move one or more locking features from a disengaged configuration to an engaged configuration.

9. The delivery system of claim 6 or claim 7, wherein the lead lock component comprises a clamp comprising a disengaged configuration and an engaged configuration.

10. The delivery system of claim 9, wherein the clamp comprises a first clamp member and a second clamp member, the first clamp member configured to engage the lead assembly on a first side and the second clamp member configured to engage the lead assembly on an opposite second side in the engaged configuration.

11. The delivery system of Claim 10, wherein the first clamp member and / or the second clamp member comprises a radial projection having a first end disposed adjacent to the lumen and a second end opposite the first end and a lead engagement surface adjacent to the first end, the lead engagement surface comprising an enlarged area compared to a cross-sectional area of the radial projection, the lead engagement surface being moveable by moving the radial projection from a first position allowing the lead assembly to slide along the lead engagement surface to a second position restricting movement of the lead assembly along the lead engagement surface.

12. The delivery system of claim 11, wherein the lead engagement surface has a width or diameter that is larger than a maximum diameter of the lead assembly.

13. The delivery system of claim 11 or claim 12, wherein the first clamp member and / or the second clamp member comprises an enlarged disc disposed at the first end of the radial projection, the enlarged disc comprising the lead engagement surface, and wherein the radial projection comprises an elongate cylinder having a smaller diameter than the enlarged disc.

14. The delivery system of any of claims 9 to 13, wherein the lead lock component further comprises a threaded member, wherein rotation of the threaded member in a first direction relative to the external surface of the handle transforms the clamp from the disengaged configuration to the engaged configuration.

15. The delivery system of any of claims 9 to 14, wherein the clamp comprises a compressible material.

16. The delivery system of claim 15, wherein a portion of the clamp facing the lumen is configured to conform to a shape of the lead assembly when applying pressure to the lead assembly in the engaged configuration.

17. The delivery system of any of claims 1 to 16, further comprising a fluid port configured to allow injection of saline to facilitate movement of a delivery shaft of the delivery system over an external surface of a lead assembly of the blood flow occluder system upon movement of the actuator.

18. A delivery system for a blood flow occluder, comprising: a handle having a proximal portion; and a lead lock coupled to the proximal portion, the lead lock comprising: a plurality of actuator pins extending from a proximal end of the proximal portion of the handle; a lock actuator rotatably coupled to the proximal end of the proximal portion of the handle, the lock actuator comprising a ring member having: a grip surface at an outer periphery; a plurality of grip features, each grip feature having a fixed end coupled with an inner periphery of the ring member and a free end disposed radially inward of the fixed end; and a plurality of channels, at least one channel of the plurality of channels disposed between each grip feature of the plurality of grip features and the inner periphery of the ring member, the plurality of channels having a first end having a first width and a second end having a second width less than the first width; wherein one actuator pin of the plurality of actuator pins is disposed in each one of the plurality of channels; and wherein rotation of the lock actuator relative to the plurality of actuator pins moves the plurality of grip features radially inwardly to a gripping position when the plurality of actuator pins are disposed at the second ends of the plurality of channels, the plurality of grip features are moveable radially outwardly to a release position when the plurality of actuator pins are disposed at the first ends of the plurality of channels.

19. A delivery system for a blood flow occluder, comprising: a handle; and a lead lock coupled to the handle, the lead lock comprising: a projection extending from the handle; a lock actuator moveably coupled to the handle, the lock actuator comprising: a hand grip structure at an outer periphery of the lock actuator; a lead grip feature having a fixed end disposed inward of the hand grip structure and a free end disposed away from the fixed end; and a guide surface disposed between the lead grip feature and the projection, the guide surface having a first end having a first engagement portion and a second end having a second engagement portion; wherein the projection is disposed adjacent to the guide surface; and wherein movement of the lock actuator relative to the projection moves the lead grip feature inwardly to a gripping position when the projection is disposed at the second end of the guide surface, the lead grip feature is moveable outwardly to a release position when the projection is disposed at the first end of the guide surface.

20. The delivery system of claim 19, wherein the lead lock is rotatably coupled to a proximal end of the handle.

21. The delivery system of claim 20, wherein the projection is disposed on a proximal surface of the handle, the guide surface contacting a side portion of the projection.

22. The delivery system of any of claims 19 to 21, wherein the lead grip feature comprises teeth facing a central axis of the handle.

23. The delivery system of any of claims 19 to 21, wherein the lead grip feature comprise threads facing a central axis of the handle.

24. The delivery system of any of claims 19 to 23, wherein the lock actuator comprises a ring rotatably mounted to the handle, the guide surface formed on an outer portion of the lead grip feature comprising teeth configured to face a central axis of the ring.

25. The delivery system of claim 24, wherein the lead grip feature comprises an arm and further comprising at least one additional arm such that there is a plurality of arms extending inwardly from an inner surface of the ring, each arm of the plurality of arms comprising a guide surface formed on an outer portion of the corresponding arm and teeth disposed away from fixed ends configured to face a central axis of the ring.

26. The delivery system of claim 25, wherein the projection is a first projection and further comprising at least one additional projection such that there is a plurality of projections, wherein the guide surface of each arm forms one side of a channel which defined positions for locating one projection of the plurality of projections upon movement relative movement of the projection and the lock actuator.

27. The delivery system of claim 25 or claim 26, wherein the guide surface comprises a first circular depression at the first end of the guide surface and a second circular depression at the second end of the guide surface.

28. The delivery system of any of claims 25 to 27, wherein the plurality of arms comprises three arms.

29. A delivery system for a blood flow occluder, comprising: a handle; and a lead lock coupled to the handle, the lead lock configured to engage a lead assembly of the blood flow occluder to control or prevent movement of the lead assembly relative to an external surface of the handle, the lead lock comprising: a lumen configured to receive at least a portion of the lead assembly; a clamp comprising a first clamp member and a second clamp member, the first clamp member configured to engage the lead assembly on a side thereof and the second clamp member configured to engage the lead assembly; and an actuator, the actuator configured to transform the clamp from a disengaged configuration where the lead assembly can move relative to the external surface of the handle to an engaged configuration where the clamp restricts movement of the lead assembly relative to the external surface of the handle.

30. The delivery system of claim 29, wherein the first clamp member and / or the second clamp member comprises a radial projection having a first end disposed adjacent to the lumen-SO-and a second end opposite the first end and a lead engagement surface adjacent to the first end, the lead engagement surface comprising an enlarged area compared to a cross-sectional area of the radial projection, the lead engagement surface being moveable by moving the radial projection from a first position allowing the lead assembly to slide along the lead engagement surface to a second position restricting movement of the lead assembly along the lead engagement surface.

31. The delivery system of claim 30, wherein the lead engagement surface has a width or diameter that is larger than a maximum diameter of the lead assembly.

32. The delivery system of claim 30 or claim 31 , wherein the first clamp member and / or the second clamp member comprises an enlarged disc disposed at the first end of the radial projection, the enlarged disc comprising the lead engagement surface, and wherein the radial projection comprises an elongate cylinder having a smaller diameter than the enlarged disc.

33. The delivery system of any of claims 29 to 32, wherein the actuator comprises a threaded member, wherein rotation of the threaded member in a first direction relative to the external surface of the handle transforms the clamp from the disengaged configuration to the engaged configuration.

34. The delivery system of any of claims 29 to 33, wherein the clamp comprises a compressible material.

35. The delivery system of any of claims 29 to 34, wherein a portion of the clamp facing the lumen is configured to conform to a shape of the lead assembly when applying pressure to the lead assembly in the engaged configuration.

36. A lead retrieval system for a blood flow occluder, comprising: a handle having a proximal portion; a lead lock coupled to the proximal portion, the lead lock having a first configuration in which a lead disposed therethrough is held in a fixed position relative to the handle and a second configuration in which the lead disposed therethrough is moveable relative to the handle; and a lead extender device comprising a tubular shaft disposed on a distal portion thereof,wherein a distal end of the tubular shaft of the lead extender device has an outer surface sized to be slidcablc through the lead lock, the distal end configured to engage the lead at or distal of a proximal end of the lead.

37. The lead retrieval system of claim 36, wherein the tubular shaft comprises one or more teeth disposed on an inner surface thereof, the one or more teeth being angled inwardly such that a free end of each tooth of the one or more teeth is disposed proximally of a fixed end of each tooth and is disposed within a lumen of the tubular shaft.

38. The lead retrieval system of claim 37, wherein the one or more teeth comprises a blunt tip at the free end thereof.

39. The lead retrieval system of claim 37, wherein the one or more teeth comprises a pointed tip at the free end thereof.

40. The lead retrieval system of claim 37, wherein the one or more teeth comprises a plurality of teeth.

41. The lead retrieval system of claim 40, wherein the plurality of teeth are arranged in rows aligned along a longitudinal axis of the lead extender device.

42. The lead retrieval system of claim 36, wherein the lead extender device further comprises one or more projections extending from a distal end of the tubular shaft, the one or more projections configured to engage a surface of the lead.

43. The lead retrieval system of claim 42, wherein the one or more projections comprises one or more threads disposed on a threaded extension of the lead extender device.

44. The lead retrieval system of claim 43, wherein the threaded extension is configured to extend into tubing of the lead when engaged with the lead.

45. The lead retrieval system of claim 44, wherein an outer diameter of threads of the threaded extension is greater than an inner diameter of the tubing of the lead.

46. The lead retrieval system of claim 45, wherein the threads of the threaded extension are configured to cut into a wall of the tubing when the lead extender device is rotated relative to the lead.

47. The lead retrieval system of claim 42, wherein the one or more projections comprises teeth angled inwardly such that a free end of each tooth of the one or more teeth is disposed proximally of a fixed end of each tooth and is disposed within a lumen of the tubular shaft.

48. A tool for retrieving a blood flow occluder, comprising: a lead extender comprising a tubular shaft disposed at a distal portion thereof, the tubular shaft comprising one or more teeth disposed on an inner surface thereof, the one or more teeth being angled inwardly such that a free end of each tooth of the one or more teeth is disposed proximally of a fixed end of each tooth and is disposed within a lumen of the tubular shaft; wherein the one or more teeth are configured to grip an external surface of a lead of the blood flow occluder; wherein the tubular shaft has a length and an outer surface sized to enable the lead extender to be inserted through a sheath and handle of a retrieval device such that a proximal end of the lead extender can be disposed proximal of the handle of the retrieval device.

49. The tool of claim 48, wherein the one or more teeth comprises a blunt tip at the free end thereof.

50. The tool of claim 48, wherein the one or more teeth comprises a pointed tip at the free end thereof.

51. The tool of claim 48, wherein the one or more teeth comprises a plurality of teeth.

52. The tool of claim 51, wherein the plurality of teeth are arranged in rows aligned along a longitudinal axis of the lead extender.

53. A tool for retrieving a blood flow occluder, comprising: a lead extender comprising a proximal portion and a distal portion, the distal portion configured to be embedded in a wall of a lead of the blood flow occluder at or distal to a severed end of the lead, wherein the distal portion has a length and an outer surface sized to enable the lead extender to be inserted through a sheath and handle of a retrieval device such that the proximal portion can be disposed proximal of the handle of the retrieval device.

54. The tool of claim 53, wherein the distal portion comprises one or more projections extending from a distal end, the one or more projections configured to be inserted into the lead at or distal to the severed end to engage an inner surface of the wall of the lead to support a tension load during withdrawal of the lead.

55. The tool of claim 54, wherein the one or more projections comprises one or more threads disposed on a threaded extension of the lead extender.

56. The tool of claim 55, wherein an outer diameter of the one or more threads of the threaded extension is greater than an inner diameter of the wall of the lead.

57. The tool of claim 56, wherein the one or more threads of the threaded extension are configured to cut into the inner surface of the wall of the lead when the lead extender is rotated relative to the lead.

58. The tool of claim 54, wherein the one or more projections comprises one or more teeth disposed on and extending inward of an inner surface of a tubular portion of the lead extender.

59. A method of retrieving a blood flow occluder, comprising: accessing a proximal length of a lead assembly of the blood flow occluder; advancing a distal portion of a lead extender to engage a proximal portion of the lead assembly; advancing a dilator over the distal portion of the lead extender that is disposed over the lead assembly; exchanging the dilator for a retrieval assembly comprising a retrieval sheath and a retrieval handle; and removing the blood flow occluder within the retrieval sheath.

60. The method of claim 59, further comprising: advancing the distal portion of the lead extender over the proximal portion of the lead assembly such that at least one tooth angled inwardly into a lumen of the lead extender is disposed over the proximal portion of the lead assembly.

61. The method of claim 59, further comprising: severing the lead assembly distal to a proximal end of the lead assembly to create a severed end, advancing the distal portion of the lead extender over the severed end, and advancing the dilator over the severed end of the lead assembly.

62. The method of claim 59, further comprising: advancing an extension of the lead extender into or onto tubing of the lead assembly.

63. The method of claim 62, wherein the extension comprises a threaded extension and further comprising: rotating the lead extender relative to the lead assembly, wherein rotation of the lead extender causes threads of the threaded extension to cut into the tubing of the lead assembly.

64. The method of claim 62 or claim 63, further comprising: severing the lead assembly distal to a proximal end of the lead assembly to create a severed end; advancing the extension into or onto the severed end; and advancing the dilator over the severed end of the lead assembly.

65. The method of claim 61 or claim 64, locking a portion of the lead extender or the lead assembly distal to the severed end relative to an external surface of the retrieval handle and thereafter advancing the retrieval sheath over the blood flow occluder to collapse the blood flow occluder.

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