Systems, devices, and methods for implanting and / or retrieving devices that controllably enhance diuresis.

Abstract

A delivery system for a blood flow occlusion system, including a handle, is provided. The handle includes a distal portion, a proximal portion, an actuator, and a carriage. The actuator is positioned between the proximal and distal portions. The actuator is movable (e.g., rotatable) relative to the outer surface of the handle. The carriage is positioned on the handle. The actuator is configured to move the carriage to deploy the blood flow occlusion system.

Description

TECHNICAL FIELD

[0001] Incorporation by Reference of All Priority Claim Applications 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 on September 14, 2023, which is hereby incorporated by reference in its entirety into the present specification. All applications for which foreign or domestic priority claims are identified in the Application Data Sheet filed with this application are hereby incorporated by reference into the present specification under 37 C.F.R. § 1.57.

[0002] The present disclosure relates to systems, devices and methods for implantation and / or retrieval of devices for treating heart failure, such as by controllably and selectively occluding, restricting and / or diverting flow within a patient's blood vessel. BACKGROUND ART

[0003] A problem identified in heart failure is fluid overload, where there is excessive pressure buildup in the venous system that causes the heart to fail to function properly as a pump. Reducing the total amount of fluid in the body, such as by administering diuretics, is one way to reduce fluid overload and improve cardiac function. Another way to improve cardiac function in heart failure is to shift the distribution of blood in the vasculature. Such a shift in blood distribution affects the preload of the heart, and as a result, effectively affects the pumping capacity of the heart. Furthermore, shifting venous blood volume away from the renal system and / or lymphatic vessels can promote diuresis, further reduce fluid overload, and improve cardiac function. SUMMARY OF THE INVENTION

[0004] Current non-pharmacological therapies aimed at reducing volume overload and / or preload lack constant controllability and / or adjustability. Furthermore, current methods for improving and / or controlling diuresis involve systemic administration of diuretics, which can significantly impact the patient's quality of life (QOL). More controllable methods for controlling diuresis are desired. To address these and other unaddressed needs, this disclosure describes various aspects of permanent implantable flow limiting systems, devices and methods for controlling and selectively occluding, restricting and / or bypassing intravascular flow in a patient. Furthermore, the permanent implantable flow limiting systems and devices described herein may be configured to cause partial and / or complete occlusion of a vessel from intravascular and / or extravascular sources. Such ability to constantly control occlusion of a patient's vessels may, for example, enable control of diuresis without systemic drug / medication.

[0005] Disclosed herein are permanent, implantable flow limiting systems for controlling and selectively occluding, restricting, and / or bypassing blood flow within a patient's blood vessels to reduce renal congestion and / or cardiac preload, as well as devices and methods for implanting and / or retrieving such systems.

[0006] In the above-described permanent implantable flow limiting system, or in other embodiments as described herein, one or more of the following features may be provided: In some embodiments, the system is adapted to deploy or retrieve an implant configured to controllably and selectively reduce central venous pressure and / or other venous pressures, which may include inferior vena cava pressure, renal venous pressure and / or pressures of other veins disclosed herein. In some embodiments, the system is adapted to promote renal circulation. In some embodiments, the system is adapted to promote or control diuresis. In some embodiments, the system is adapted to increase cardiac output. In some embodiments, the system is adapted to controllably and selectively occlude or bypass flow from the superior vena cava. In some embodiments, the system is adapted to controllably and selectively occlude or bypass flow from the inferior vena cava. In some embodiments, the system has a fluid-actuated implantable device. In some embodiments, the system has a thermally actuated implantable device. In some embodiments, the system includes a mechanically actuated implantable device. In some embodiments, the system further has a control unit configured to control occlude, limit, and / or bypass flow within the patient's blood vessels. In some embodiments, the control unit is configured to receive measurements from one or more pressure sensors placed within the patient, and the control unit is configured to control the occlusion, restriction, and / or diversion of blood flow in the patient's blood vessels based on the measurements. In some embodiments, the treatment provided by the system is operated digitally. In some embodiments, the treatment provided by the system is scheduled based on the time of day and / or the amount of time in a day.

[0007] In another embodiment, a delivery system for a blood flow occlusion system having a handle is provided herein. The handle has a distal portion, a proximal portion, an actuator, and a carriage. The actuator is located between the proximal and distal portions. The actuator is movable (e.g., rotatable) relative to the outer surface of the handle. The carriage is located within the handle. The actuator is configured to move the carriage to deploy the blood flow occlusion system.

[0008] In another embodiment, a delivery system for a blood flow occluder is provided, comprising 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 the 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 has a ring member having a gripping surface, a plurality of gripping features, and a plurality of gripping channels. The gripping surface is located on the outer circumference. Each of the plurality of gripping features has a fixed end coupled to the inner circumference of the ring member and a free end located radially inward from the fixed end. At least one of the plurality of channels is located between each gripping feature and the inner circumference of the ring member. The plurality of channels has a first end having a first width and a second end having a second width smaller than the first width. One of the plurality of actuator pins is located in each of the plurality of channels. The rotation of the lock actuator relative to the actuator pins moves multiple gripping features radially inward to a gripping position when multiple actuator pins are positioned at the second end of multiple channels. When multiple actuator pins are positioned at the first end of multiple channels, multiple gripping features can move radially outward to a release position.

[0009] In another embodiment, a delivery system for a blood flow occluder is provided, comprising 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 movably coupled to the handle. The lock actuator has a hand gripping structure, a lead gripping feature, and a guide surface. The hand gripping structure is positioned on the outer circumference of the lock actuator. The lead gripping feature has a fixed end positioned inside the hand gripping structure and a free end positioned away from the fixed end. The guide surface is positioned between the lead gripping feature and the projection. The guide surface has a first end having a first engaging portion and a second end having a second engaging portion. The projection is positioned adjacent to the guide. Movement of the lock actuator relative to the projection moves the lead gripping feature inward to a gripping position when the projection is positioned at the second end of the guide surface. The lead gripping feature is movable outward to a release position when the projection is positioned at the first end of the guide surface.

[0010] In another embodiment, a delivery system for a blood flow occluder is provided, comprising a handle and a lead lock coupled to the handle. The lead lock is configured to engage with a lead assembly of the blood flow occluder to control or prevent the movement of the lead assembly relative to the outer surface of the handle. The lead lock comprises a lumen, a clamp, and an actuator. The lumen is configured to receive at least a portion of the lead assembly. The clamp comprises a first clamping member and a second clamping member. The first clamping member is configured to engage with the lead assembly on the side of the lead assembly, and the second clamping member is configured to engage with the lead assembly. The actuator is configured to move the clamp from an unengaged state in which the lead assembly is movable relative to the outer surface of the handle, to an engaged state in which the clamp restricts the movement of the lead assembly relative to the outer surface of the handle.

[0011] In another embodiment, a lead retrieval system for a blood flow occluder is provided, comprising 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 form in which a lead positioned through the lead lock is held in a fixed position relative to the handle. The lead lock has a second form in which a lead positioned through the lead lock is movable relative to the handle. The lead extender device has a tubular shaft positioned in the distal portion of the lead extender device. The distal end of the tubular shaft of the lead extender device has an outer surface sized to slide through the lead lock to engage with the lead at or distal to the proximal end of the lead.

[0012] In another embodiment, an instrument for retrieving a blood flow occluder is provided, which includes a lead extender. The lead extender has a tubular shaft positioned distal to the lead extender. The tubular shaft has one or more teeth positioned on the inner surface of the tubular shaft. The teeth are inclined inward such that the free end of each of the one or more teeth is positioned proximal to the fixed end of each tooth and is positioned within the lumen of the tubular shaft. The teeth are configured to grip the outer surface of the lead of the blood flow occluder along its length, for example, distal to the lead cutting line or, if not cut, along its proximal length. The length and outer surface of the tubular shaft are dimensioned such that the proximal end of the lead extender may be positioned proximal to the handle of the retrieval device, allowing the lead extender to be inserted through the sheath and handle of the retrieval device.

[0013] In another embodiment, a device for retrieving a blood flow occluder is provided, which includes a lead extender. The lead extender has a proximal portion and a distal portion. The distal portion is configured to be embedded in the wall of the lead of the blood flow occluder at or distal to the cut end of the lead. The distal portion is dimensioned in length and outer surface to allow the lead extender to be inserted through the sheath and handle of the retrieval device, such that the proximal portion may be positioned proximal to the handle of the retrieval device.

[0014] In another embodiment, a method for retrieving a blood flow occluder is provided. In this method, the proximal length portion of the lead assembly of the blood flow occluder is accessed. Optionally, the lead assembly is cut distal to the proximal end of the lead assembly to form a cut end. The distal portion of the lead extender is advanced to engage with the proximal portion of the lead assembly. A dilator is advanced onto the distal portion of the lead extender positioned on the lead assembly. The dilator is replaced with a retrieval assembly having a retrieval sheath and a retrieval handle. The blood flow occluder is removed within the retrieval sheath.

[0015] For the purpose of summarizing this disclosure, specific aspects, advantages, and novel features of several embodiments are described herein. It should be understood that not all such advantages are necessarily achieved by any particular embodiment of the technology disclosed herein. Therefore, embodiments disclosed herein may be implemented or performed to achieve or optimize one or a group of advantages taught herein without necessarily achieving other advantages that may be taught or suggested herein.

[0016] Specific features of this disclosure are described below with reference to the drawings. The illustrated embodiments are intended to illustrate embodiments, but not to limit them. Various features of various disclosed embodiments can be combined to form further embodiments which are part of this disclosure. [Brief explanation of the drawing]

[0017] [Figure 1] This figure shows a permanent, implantable flow limiting system implanted in a patient, according to some aspects of the present disclosure. [Figure 2A] This figure shows an embodiment of a permanent, implantable flow limiting system according to some aspects of the present disclosure. [Figure 2B] This figure shows an implant embodiment of a permanent, implantable flow limiting system according to several aspects of the present disclosure. [Figure 2C] This figure shows an embodiment of a permanent, implantable flow limiting system according to some aspects of the present disclosure. [Figure 2D] This figure shows an embodiment of a permanent, implantable flow limiting system according to some aspects of the present disclosure. [Figure 3A] Figures 2A to 2D show various end views of the implant according to several aspects of this disclosure. [Figure 3B] Figures 2A to 2D show various end views of the implant according to several aspects of this disclosure. [Figure 3C] Figures 2A to 2D show various end views of the implant according to several aspects of this disclosure. [Figure 3D] These are end views of another embodiment of the implant shown in Figures 2A to 2D, according to some aspects of the present disclosure. [Figure 4] Figures 3A to 3D show the flat patterns of the expandable body of the implant according to some aspects of this disclosure. [Figure 5A] These are various diagrams of components of a permanent, embedded flow limiting system according to several aspects of the present disclosure. [Figure 5B] These are various diagrams of components of a permanent, embedded flow limiting system according to several aspects of the present disclosure. [Figure 6A] Figures 2A to 2D show the interactions of various components of a flow limiting system that operates the implants according to several aspects of this disclosure. [Figure 6B] FIG. 2 is a diagram illustrating the interaction of various components of a flow restriction system for actuating the implant of FIGS. 2A to 2D, in accordance with some aspects of the present disclosure. [Figure 6C] FIG. 2 is a diagram illustrating the interaction of various components of a flow restriction system for actuating the implant of FIGS. 2A to 2D, in accordance with some aspects of the present disclosure. [Figure 6D] FIG. 2 is a diagram illustrating the interaction of various components of a flow restriction system for actuating the implant of FIGS. 2A to 2D, in accordance with some aspects of the present disclosure. [Figure 7A] FIG. 3 is a diagram illustrating various embodiments of an implant of a flow restriction system with sensors positioned at various positions relative to a flow restrictor portion of the implant, in accordance with some aspects of the present disclosure. [Figure 7B] FIG. 3 is a diagram illustrating various embodiments of an implant of a flow restriction system with sensors positioned at various positions relative to a flow restrictor portion of the implant, in accordance with some aspects of the present disclosure. [Figure 7C] FIG. 3 is a diagram illustrating various embodiments of an implant of a flow restriction system with sensors positioned at various positions relative to a flow restrictor portion of the implant, in accordance with some aspects of the present disclosure. [Figure 8A] FIG. 4 is a diagram illustrating an embodiment of a shaft of an implantable flow restriction system, in accordance with some aspects of the present disclosure. [Figure 8B] FIG. 4 is a diagram illustrating an embodiment of a shaft of an implantable flow restriction system, in accordance with some aspects of the present disclosure. [Figure 9] FIG. 5 is 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 the present disclosure. [Figure 10A] FIG. 6 is a diagram illustrating an embodiment of a connector between components of a flow restriction system, in accordance with some aspects of the present disclosure. [Figure 10B] FIG. 6 is a diagram illustrating an embodiment of a connector between components of a flow restriction system, in accordance with some aspects of the present disclosure. [Figure 10C]This figure shows embodiments of connectors between components of a flow limiting system according to some aspects of the present disclosure. [Figure 11A] This figure shows embodiments of connectors between components of a flow limiting system according to some aspects of the present disclosure. [Figure 11B] This figure shows embodiments of connectors between components of a flow limiting system according to some aspects of the present disclosure. [Figure 12A] This figure shows embodiments of connectors between components of a flow limiting system according to some aspects of the present disclosure. [Figure 12B] This figure shows embodiments of connectors between components of a flow limiting system according to some aspects of the present disclosure. [Figure 12C] This figure shows embodiments of connectors between components of a flow limiting system according to some aspects of the present disclosure. [Figure 12D] This figure shows embodiments of connectors between components of a flow limiting system according to some aspects of the present disclosure. [Figures 13A-13B] This figure shows embodiments of implant assemblies having extenders for implantation, according to some aspects of the present disclosure. [Figure 14A] This figure shows embodiments of a device for testing the function of an implant during implantation, according to some aspects of the present disclosure. [Figure 14B] This figure shows embodiments of a device for testing the function of an implant during implantation, according to some aspects of the present disclosure. [Figure 14C] This figure shows embodiments of a device for testing the function of an implant during implantation, according to some aspects of the present disclosure. [Figure 14D] This figure shows embodiments of a device for testing the function of an implant during implantation, according to some aspects of the present disclosure. [Figure 15] This figure shows a method for embedding an embedded flow limiting system according to several aspects of the present disclosure. [Figure 15A]This diagram shows the steps of the implantation process, in which the distal tip of the sheath is positioned below the renal vein using a dilator. [Figure 15B] This figure shows the step after step 15A in which the dilator is removed. [Figure 15C] This figure shows the step after the step in Figure 15B, in which the delivery assembly with the implant inside is advanced within the sheath positioned in Figure 15A. [Figure 15D] This figure shows the step after the step in Figure 15C, in which the handle of the delivery device is coupled to the proximal hub of the sheath positioned in Figure 15A. [Figure 15E] This figure shows the step after step 15D, in which the handle actuator is rotated to retract the delivery sheath, allowing the implant to be exposed into the blood vessel. [Figure 15F] Figure 15E shows the implant emerging from the distal end of the delivery sheath during the steps shown, and the process of intravascular dilation beginning. [Figure 15G] Figure 15E shows one method at the end of the step, where the indicator has moved to a proximal position within the indicator groove of the handle. [Figure 15H] This figure shows the step after the step in Figure 15E, in which the implant lead assembly can be detached from the handle of the delivery system and subsequently coupled to the controller. [Figure 15I] This figure shows the step after the step in Figure 15E, where contrast agent is injected upstream of the implant, demonstrating the occlusion effect of the implant. [Figure 15J] This figure shows the step after the step in Figure 15E, where contrast agent is injected upstream of the implant, demonstrating the occlusion effect of the implant. [Figure 16A] This figure shows the development of an implantable flow limiting system according to several aspects of the present disclosure. [Figure 16B] This figure shows the development of an implantable flow limiting system according to several aspects of the present disclosure. [Figure 16C] This figure shows the development of an implantable flow limiting system according to several aspects of the present disclosure. [Figure 16D] This figure shows the development of an implantable flow limiting system according to several aspects of the present disclosure. [Figure 17] This figure shows guidelines for treating patients using implantable flow limiting systems according to some aspects of this disclosure. [Figure 18] This figure shows a manual method for using an embedded flow limiting system according to several aspects of the present disclosure. [Figure 19] This figure shows a semi-automatic method using an embedded flow limiting system according to several aspects of the present disclosure. [Figure 20] This figure shows an automated method using an embedded flow limiting system according to several aspects of the present disclosure. [Figures 21A-21B-21C] This figure shows embodiments of providing treatment using an embedded flow limiting system according to some aspects of the present disclosure. [Figure 22] This diagram is similar to Figure 15E, showing additional details of the delivery system. [Figure 22A] Figure 22 is a cross-sectional view of a portion of the delivery system shown. [Figure 22B] This figure shows one embodiment of a lead locking member positioned at the proximal end of one embodiment of a handle for selectively gripping the proximal portion of a lead assembly. [Figure 22C] This figure shows one embodiment of a lead locking member positioned at the proximal end of one embodiment of a handle for selectively gripping the proximal portion of a lead assembly. [Figure 22D] This figure shows one embodiment of a lead locking member positioned at the proximal end of one embodiment of a handle for selectively gripping the proximal portion of a lead assembly. [Figure 22E] This figure shows one embodiment of a lead locking member positioned at the proximal end of one embodiment of a handle for selectively gripping the proximal portion of a lead assembly. [Figure 22F] This is a side view of another embodiment of a handle for a delivery system. [Figure 22G] This figure shows another embodiment of a lead locking member positioned at the proximal end of one embodiment of a handle for selectively gripping the proximal portion of a lead assembly. [Figure 22H] This figure shows another embodiment of a lead locking member positioned at the proximal end of one embodiment of a handle for selectively gripping the proximal portion of a lead assembly. [Figure 22I] This figure shows another embodiment of a lead locking member positioned at the proximal end of one embodiment of a handle for selectively gripping the proximal portion of a lead assembly. [Figure 23] This figure shows an apparatus and method for retrieving an implant with a lead, and an instrument for extending the length of a lead assembly with a stump. [Figure 23A] This figure shows an apparatus and method for retrieving an implant with a lead, and an instrument for extending the length of a lead assembly with a stump. [Figure 23B] This figure shows an apparatus and method for retrieving an implant with a lead, and an instrument for extending the length of a lead assembly with a stump. [Figure 23C] This figure shows an apparatus and method for retrieving an implant with a lead, and an instrument for extending the length of a lead assembly with a stump. [Figure 23D] This figure shows an apparatus and method for retrieving an implant with a lead, and an instrument for extending the length of a lead assembly with a stump. [Figure 23E] This figure shows another embodiment of a device for retrieving an implant with a lead. [Figure 23F] This figure shows another embodiment of a device for retrieving an implant with a lead. [Modes for carrying out the invention]

[0018] Next, various features and advantages of this disclosure will be described with reference to the accompanying figures. The following description is merely illustrative and is not intended to limit the disclosure, its application or use in any way. This disclosure extends beyond the specifically disclosed embodiments and / or uses, and their apparent modifications and equivalents. Accordingly, the scope of this disclosure is not intended to be limited by the specific embodiments described below. Features of the illustrated embodiments can be modified, combined, removed and / or replaced in a manner that will be apparent to those skilled in the art by considering the principles disclosed herein. Furthermore, the embodiments disclosed herein may include several novel features, none of which alone are the cause of their desirable properties or essential for carrying out the systems, devices and / or methods disclosed herein.

[0019] Parts, components, features, and / or elements of permanent, embedded flow limiting systems and devices described herein, which may function identically or similarly across various embodiments, are identified using the same reference number followed by a different letter. Differences between the various embodiments are described herein.

[0020] This disclosure describes instruments and techniques for implanting various embodiments of permanent, implantable flow limiting systems, devices and methods for controlling and selectively occluding, restricting and / or bypassing blood flow within a patient's blood vessels. Implantable flow limiting systems may also be referred to herein as “blood flow occlusion systems.” Such systems, devices and methods can be used to alter the direction of flow and / or promote perfusion in one or more of a patient’s blood vessels and / or organs. In some situations, it may be advantageous to control and selectively occluding, restricting and / or bypassing blood flow within a patient’s blood vessels to reduce (or promote the reduction of) renal congestion, reduce (or promote the reduction of) hepatic congestion, reduce precardiac load, and / or reduce lymphatic / interstitial congestion. For example, a permanent, implantable flow limiting system adapted to control and selectively occlude and / or restrict a patient’s superior vena cava upstream of where it enters the patient’s right atrium can be used to reduce precardiac load. Such permanent implantable flow limiting systems may also be adapted to controllly and selectively reduce the central venous pressure and / or pressure of other veins disclosed herein and / or increase cardiac output. As another example, a permanent implantable flow limiting system adapted to controllly and selectively occlude and / or restrict the inferior vena cava of a patient can be used to alleviate renal congestion upstream of the point where the patient's renal veins connect with the inferior vena cava (e.g., below the point where the renal veins connect with the inferior vena cava). Such permanent implantable systems may also be adapted to controllly and selectively promote renal circulation, promote and / or control diuresis and / or reduce fluid volume excess. Various embodiments of permanent implantable flow limiting systems and devices described herein may be configured to be implanted in a patient for several months, a year, or several years. The instruments and techniques disclosed herein may be used to retrieve various embodiments of permanent implantable flow limiting systems and devices described herein.Furthermore, various embodiments of permanent implantable flow limiting systems and devices may be configured to control and selectively occlude, limit, and / or divert flow within a patient's blood vessels without the need for auxiliary devices or pumps.

[0021] The permanent implantable flow restriction systems, devices, and methods described herein may be adapted for percutaneous delivery. Thus, the systems and devices described herein may be configured to be delivered via a catheter or similar delivery device, may have a folded shape for delivery into the patient, and may expand from a folded shape to an expanded shape for implantation into the patient. Furthermore, the systems and devices described herein or their components may be adapted to be recoverable after placement for repositioning and / or removal from the body (e.g., by including a hook or other feature for retrieval). In some embodiments, the systems and devices described herein may be configured to be delivered and implanted within the patient's blood vessels. For example, the permanent implantable flow restriction system described herein may be percutaneously implanted in the patient's superior vena cava upstream of the patient's right atrium. Percutaneous implantation can be performed using the instruments disclosed herein. Such an implantable flow restriction system can be controlled to selectively occlude, restrict, and / or divert flow in the patient's superior vena cava (e.g., to reduce cardiac preload). As another example, a permanent implantable flow limiting system described herein can be implanted percutaneously in the patient's inferior vena cava upstream of the point where the patient's renal vein connects to the inferior vena cava. Such an implantable flow limiting system can be controlled to selectively occlude, limit, and / or divert flow within the patient's inferior vena cava (for example, to alleviate renal congestion).

[0022] The permanently implantable flow limiting systems, devices, and methods described herein can be operated in a variety of ways. Furthermore, the systems and devices described herein can be operated by direct connection (e.g., wires, fluid-communicating tubes) and / or advantageously remotely. As another example, a fluid-driven flow limiting device described herein, implanted in or adjacent to the inferior vena cava of a patient, can be operated by pushing a subcutaneously implanted fluid reservoir, to which the flow limiting device is fluid-connected. As yet another example, a heat-driven flow limiting device described herein, implanted in the superior vena cava of a patient, can be operated by heat through induction heating by a separate device implanted in the patient and / or a separate device outside the patient. Remote operation may provide a safer and more comfortable patient experience, including in terms of infection risk, compared to other methods which may include direct connection to / from the body.

[0023] The permanently implantable flow limiting systems and devices described herein can be configured to partially and / or completely occlude a target vessel. Furthermore, the systems and devices described herein can be configured not to occlude, or substantially not to occlude, a target vessel until activated. In other words, the systems and devices of this disclosure can substantially occlude all flow through a vessel, partially occlude flow through a vessel, and / or control substantially all flow through a vessel to be unobstructed. For example, a flow limiting system and / or device can be configured to occlude blood flow in a vessel in an adjustable range of 0 to 100 percent. In some embodiments of the systems and devices described herein, the implantable flow limiting system and / or device can be configured not to substantially occlude flow through a vessel unless activated to partially and / or completely close. In some cases, the systems and devices described herein can be configured to substantially occlude all and / or part of the flow through a vessel unless activated to open. Furthermore, in some embodiments, the systems and devices described herein may have a biasing force to partially close, but once implanted, can be fully opened by the blood flow in the target vessel. It should be understood that the permanent implantable flow limiting systems and devices of this disclosure may be configured to be controllable to provide a range of conditions, including but not limited to a state of substantially no obstruction of flow, and a state of substantially complete obstruction of intravascular flow. In some cases, such control may be binary (e.g., open or close) or stepwise (e.g., open, partial closure of varying degrees, or closed).

[0024] The permanently implantable flow restriction systems and devices described herein may be sized and configured for implantation in the target blood vessel of a patient, such as the superior vena cava (SVC) or inferior vena cava (IVC). Flow restriction devices, also referred herein as implants, occluders, and / or prostheses, may 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, or about 15 mm to about 30 mm, or may have a diameter greater than about 50 mm or less than about 5 mm, depending on the application. In some embodiments, implants as described herein may be oversized relative to the target blood vessel and therefore can exert an outward force on the blood vessel into which the implant is implanted (e.g., to enhance fixation within the blood vessel). Flow restriction devices may 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, or about 1 cm to about 3 cm, or may have a length longer than about 5 cm or a length shorter than about 0.5 cm, depending on the application.

[0025] A permanently implantable flow-limiting device as described herein, configured to be implanted in a patient's blood vessel, may generally comprise an expandable body (configured for percutaneous delivery as described herein) and a flow-limiter configured to control and selectively occlude, restrict and / or divert flow within the patient's blood vessel. The expandable body may have a proximal end, a distal end, and a lumen extending from the proximal end to the distal end. The expandable body may generally have a frame (which may also be called a stent) having an open-cell structure and / or a closed-cell structure. Furthermore, the expandable body may include features to assist in fixation and / or maintenance of placement within the body, such as a free tip that can extend in any direction relative to the implant, a barb and / or anchor. In some cases, such barbs and / or anchors may have a partial hook, a hook and / or a linear configuration. The expandable body may be made of a material configured to expand upon delivery, and such a material may be a shape-memory material such as nitinol. In some embodiments, the expandable body may be configured to fold / contract radially. Alternatively, or in addition, the expandable body may be configured to fold / contract laterally when pushed or pulled. In some modifications, the expandable body may be made of a material with little or no shape memory, and a balloon may be used to expand the expandable body for implantation. The expandable body may include one or more material layers, such as an inner material layer (e.g., inside its lumen) and / or an outer material layer (e.g., outside its lumen). Such inner and / or outer material layers may consist of ePTFE·PTFE·PET fabric, polyurethane, and / or similar materials. Furthermore, any of these layers may include an antithrombotic coating, a drug-eluting coating, and the like. In some embodiments, it is desirable to utilize materials and / or coatings that prevent intrusion within the implant in order to facilitate subsequent retrieval and / or removal of the implant.Conversely, in some cases, it is desirable to use materials and / or coatings that allow and / or promote penetration within the implant. An expandable body, such as the one described herein for one embodiment using a particular type of flow limiter, is not limited to being used only with that particular flow limiter, but may be used in other embodiments using other types of flow limiters. In some embodiments, the flow limiter may be formed integrally with the expandable body.

[0026] The flow restrictors (also referred to herein as “blood flow occluders”) of implants described herein can be sized and / or oriented in many ways with respect to an expandable body to which they are connected or formed together. For example, a flow restrictor can be sized such that, when fully operational, it completely or partially occludes the lumen of the expandable body to which it is connected or formed together. With respect to orientation, a flow restrictor may be configured to extend over the entire length of the expandable body to which it is connected or formed together, or to extend over a portion of the length of the expandable body. In the latter scenario, the flow restrictor can be positioned at the proximal end, distal end, or any position between them (e.g., midway or near the midway) of the expandable body. In some cases, the flow restrictor may be positioned adjacent to the distal or proximal end of the expandable body and may extend beyond the distal or proximal end of the expandable body, or similarly.

[0027] The implants or parts thereof described herein (e.g., implant flow limiters) may be configured to be fixed within a blood vessel in a patient's vascular system. In some embodiments, when a flow limiter implanted within a blood vessel in a patient's vascular system is activated, the flow limiter engages with the wall of the blood vessel to at least partially restrict the flow through the blood vessel and / or the lumen of the implant constituting the flow limiter. To engage with the wall of the blood vessel, the flow limiter or parts thereof may be attached to or fixed to the wall of the blood vessel (e.g., the inner wall of the blood vessel). Such attachment / fixation may include mechanical connections. For example, a flow limiter may include one or more anchors configured to attach / fix at least a portion of the flow limiter to at least a portion of the wall of the blood vessel (e.g., the inner wall of the blood vessel). In other examples, the flow limiter or parts thereof may be configured to at least partially bite into the wall of the blood vessel. In such examples, the flow limiter or parts thereof may have structures, materials and / or coatings that facilitate biting. Furthermore, in this example, such a flow limiter may include a structure having multiple columns, a structure having multiple columns with a mesh spanning the columns, or a structure having multiple columns with a material (e.g., porous or non-porous material) spanning the columns.

[0028] Vascular access for delivering a permanently implantable flow-limiting device as described herein may include the internal jugular vein, subclavian vein, femoral vein, and / or others. From such access points, the flow-limiting device may be advanced by a delivery device (e.g., a delivery catheter) within the patient's blood vessel until it reaches the desired implantation site, after which the flow-limiting device may be delivered and expanded for permanent implantation. As with standard imaging techniques, guidewires, introducers, etc., may be used for delivery. As described below, the delivery device may advance through an introducer sheath assembly. The delivery device may include a handle having a lead lock member configured to hold the lead assembly while the delivery sheath retracts. Furthermore, the flow-limiting devices herein may include radiopaque features to assist in delivery and implantation. Furthermore, the flow-limiting device may include features for indexing its delivery device to assist in enabling precise orientation of the flow-limiting device within the patient. For example, an implant may index its delivery device features (e.g., a logo or other marking) that remain outside the patient. A permanent, embedded flow limiting system may include a flow limiting device, a power source for operating the flow limiting device, a controller device, and a delivery device.

[0029] The permanent, implantable flow limiting systems and devices described herein may be configured for open-loop and / or closed-loop control. For example, the flow limiting systems and devices described herein may be operated manually, semi-automatically, and / or fully automatically. In some cases, the treatments provided by the flow limiting systems and devices described herein may be activated digitally through interaction with a smartphone, external terminal / device, etc. For example, if a patient wishes to induce diuresis, the patient may activate such therapy by pressing a button or touchscreen on a smartphone (e.g., the treatment can be activated digitally). In some embodiments, the flow limiting devices described herein include and / or can cooperate with sensors attached to or located away from the flow limiting device, which can provide physiological parameters of interest useful for controlling the flow limiting device. Such physiological parameters of interest may include pressure, flow rate, etc. As an example, a flow limiting device may have MEMS pressure sensors attached to its proximal end, its distal end, or both ends thereof, the pressure sensors configured to measure pressure at such locations relative to the flow limiting device (e.g., upstream, downstream, or both upstream and downstream). As another example, the MEMS pressure sensors may be located in blood vessels and / or organs away from the flow limiting device, and output pressure measurements at such locations for control of the flow limiting device. The sensors can be used to enable fully automated real-time control of the flow limiting devices described herein. Furthermore, absolute values ​​and / or differences in sensor data can be utilized.

[0030] The use of the permanent implantable flow limiting systems and devices described herein can be standardized across patients or, preferably, customized to individual patients, such as through prescriptions provided by healthcare providers. The treatment protocol may vary depending on the type of flow limiting device implanted, its type of operation, and / or where it is implanted. The flow limiting systems and devices described herein can be used continuously, every hour, multiple times a day, once a day, overnight, once every other day, once every few days, once a week, once a month, or as needed, or at any prescribed frequency. Furthermore, the treatment provided by the flow limiting systems and devices described herein may be based on the amount of time per day, the hours per day, the number of days per week, specific days of the week, etc. Furthermore, the implementation of the treatment may have a duration such as a few seconds, a few minutes, a few hours, or several days. For example, treatment using the flow limiting devices described herein may have durations of 15 minutes, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 5 hours, 12 hours, or any duration necessary or required for the intended use and desired results. Furthermore, treatment durations may vary in duration or be standardized. In some cases, treatment may be determined by an algorithm, which provides the duration and amount of flow limiting to be used. Such output from an algorithm may be performed manually, semi-automatically, or fully automatically. In some embodiments, treatments provided by the flow limiting systems and devices described herein may be based on venous pressure, such as inferior vena cava pressure, renal venous pressure, femoral venous pressure, and / or pressures of other veins disclosed herein. For example, treatment using the flow limiting devices described herein may be performed until a pressure threshold is met (e.g., treatment may be performed until the pressure of interest reaches or falls below the pressure threshold). Such a threshold may be, for example, about 8 mmHg for the inferior vena cava. In some embodiments, the treatment provided by the flow limiting systems and devices described herein may be based on a combination of duration and venous pressure.For example, the treatment using the flow limiting device described herein may be performed for a duration after the pressure threshold is met (e.g., if the inferior vena cava pressure falls below 8 mmHg, it may be turned off after 4 hours).

[0031] One or more permanently implantable flow limiting devices described herein can be implanted in a patient. In some cases, it may be beneficial to implant only one flow limiting device in a patient, or it may be beneficial to implant multiple flow limiting devices in a patient. When multiple flow limiting devices are implanted in a patient, they may work together as necessary to achieve the desired treatment outcome. Furthermore, flow limiting devices using the same or different modes of operation may be implanted in the same patient.

[0032] The permanent implantable flow limiting systems, devices, and methods disclosed herein are described in particular ways in which they may offer specific advantages, but such descriptions are not intended to be limiting. Permanent implantable flow limiting systems and devices can be implanted in various blood vessels and / or pathways in a patient, including the blood vessels of the patient's vascular system (e.g., veins, arteries), the patient's lymphatic system, the patient's reproductive system, and so on.

[0033] Any and all embodiments and / or features of the permanent embedded flow limiting systems, devices and methods described and / or illustrated herein may be applied to the various systems, devices and methods described and / or illustrated in U.S. Provisional Patent Application No. 63 / 331,496, filed on April 15, 2022, entitled “SYSTEMS AND METHODS FOR TREATING HEART FAILURE BY DIRECTING BLOOD FLOW THROUGH A SHUNT BETWEEN THE PULMONARY ARTERY AND THE AZYGOS VEIN,” and U.S. Patent Application No. 18 / 300,293, filed on April 13, 2023, entitled “SYSTEMS AND METHODS FOR TREATING HEART FAILURE BY REDIRECTING BLOOD FLOW IN THE AZYGOS VEIN,” both of which are incorporated herein by reference, and vice versa. For example, any and all embodiments and / or features of permanent implantable flow limiting systems, devices and methods described and / or illustrated herein, such as fluid, mechanical, or thermally operated flow limiters, can be applied to pulmonary artery-azygos vein shunts as described in the above-referenced applications. As another example, any and all embodiments and / or features of pulmonary artery-azygos vein shunts described and / or illustrated in U.S. Provisional Patent Application No. 63 / 331,496, such as adjustable shunts including a disc rotatable relative to a fixed frame to control the size of the opening through the shunt, can be applied to permanent implantable flow limiting systems, devices and methods described and / or illustrated herein. Furthermore, any and all embodiments and / or features of permanent implantable flow limiting systems, devices and methods described and / or illustrated herein can be applied to and / or used in atrial-septal shunts and / or pulmonary artery-superior vena cava shunts.

[0034] Figure 1 shows candidate locations for the implantation and placement of the implantable flow limiting system 5. The implantable flow limiting system 5 may be a mechanically actuated, permanent implantable flow limiting system 5. While some embodiments of the implantable flow limiting system 5 may be described as permanent systems, the components of the implantable flow limiting system may be used in acute systems. Also, some embodiments of the implant 500 of system 5 are described as mechanically actuated. This may include electromechanically actuated implants. Other actuation methods are also possible, such as fluid or gas-driven systems. At least some of these actuation devices engage with a lead assembly that may extend from the implantation site in the blood vessel to the outside of the blood vessel. The lead assembly may be delivered by a delivery system including a lead locking member and a handle.

[0035] An implantable flow limiting system 5 may include an implant 500 connected to a controller 50 (also referred to herein as the “control unit”) via, for example, a tube 570 and a shaft 590 (all of which are implantable), and an external device 15 for operating the system 5. In some embodiments, the tube 570 may be a catheter. In some embodiments, the implantable flow limiting system 5 includes the implant 500, the controller 50, the tube 570, and the shaft 590. The implant 500 may be placed in a blood vessel, and the tube 570 and shaft (and in some embodiments together with a lead assembly) may be placed in a blood vessel away from the device 500 using a delivery system described below. Figure 1 shows one implant 500 implanted upstream of the connection to the renal vein in a patient’s IVC. An implant 500 positioned upstream of the renal vein within the IVC can controllably and selectively occlude, restrict, and / or divert flow within the patient's IVC and connected blood vessels and / or organs to reduce renal congestion (or promote renal blood drainage), promote renal circulation, and / or control diuresis (e.g., increase diuresis). For this purpose, the implant 500 may have a flow limiter portion 550 and / or a flow limiter 560. Such a flow limiter portion 550 and / or flow limiter 560 may be actuated by a controller 50 via a shaft 590 and a tube 570, as further described herein.

[0036] The implant 500 can be implanted such that the flow limiter portion 550 is upstream of the other portions of the implant 500 (for example, the flow limiter portion 550 is the first portion of the implant 500 that receives the blood flow through the implant 500). In such a position, the shaft 590 and tube 570 can extend proximal to the implant 500, ascend the IVC, pass through the right atrium, enter the superior vena cava (SVC), pass through the subclavian vein (left subclavian vein in the illustration), exit the subclavian vein, and connect to a controller 50 that can be implanted in a subclavian subcutaneous pocket (for example, similar to the placement of a pacemaker). If multiple implants 500 are implanted in a patient, each can be connected to a single controller 50 via separate tubes 570 and shafts 590, or each can be connected to its own controller 50 via separate tubes 570 and shafts 590.

[0037] Figures 2A to 2D show various diagrams of embodiments of implant 500a, which may be implant 500 in an implantable flow limiting system 5. Figures 2A and 2C show side views, Figure 2B shows an end view of implant 500a in an unoccluded (e.g., open, non-operating) state, and Figure 3D shows a side view of implant 500a in a fully occluded (e.g., closed, operating) state. Figures 43A to 43D also show how implant 500a can be connected to tube 570a and shaft 590a for its operation. Implant 500a may have an expandable body 510a having a proximal end 511a, a distal end 512a, and a lumen 513a for receiving blood flow passing through it. The implant 500a can be connected to the first or distal end 572a of the tube 570a and may include a filter portion 520a, a radial support portion 540a (which may also be referred to herein as the “sealing portion” or “sealing region”), and a flow limiter portion 550a.

[0038] As shown in Figures 2A to 2D, the filter portion 520a is positioned adjacent to the proximal end 511a, the radial support portion 540a is connected to the filter portion 520a and positioned distal to the filter portion 520a, and the flow limiter portion 550a may be connected to the radial support portion 540a and positioned distal to the radial support portion 540a. The filter portion 520a can be configured to capture thrombi that may pass through the lumen 513a of the implant 500a and may include a plurality of supports 527a extending distally and radially outward from the connection between the tube 570a and the implant 500a.

[0039] The radial support portion 540a can be configured to fluid-seal to the inner wall of the IVC and may include a ring 545a extending in a V-shape along the periphery of the implant 500a. As shown, the ring 545a may include a plurality of ring supports 542a, where adjacent pairs of ring supports 542a are connected by a plurality of proximal vertices 543a and a plurality of distal vertices 544a. Further as shown, each of the plurality of proximal vertices 543a of the ring 545a of the radial support portion 540a may be connected to a support 527a of the filter portion 520a.

[0040] The flow limiter portion 550a may include a plurality of petal-shaped sections 560a configured to restrict / block the flow through the lumen 513a of the implant 500a when in operation. As illustrated, each petal-shaped section 560a may be formed by a pair of struts 562a extending distally from a pair of adjacent distal vertices 544a of the ring 545a of the radial support portion 540a and connected at the distal vertex 564a. Each of the plurality of petal-shaped sections 560 may also include a strut 566a extending proximal from its respective distal vertex 564, which may assist the petal-shaped section's ability to restrict flow when in use. Further illustrated, the flow limiter 550a may include a material 530a spanning each of the plurality of petal-shaped sections 560. The material 530a may include ePTFE·PTFE·PET cloth, polyurethane, and / or as described herein. The region between the multiple petal-like portions 560a may be free of material 530a. In some embodiments, material 530a may span the region between the multiple petal-like portions 560a. Material 530a may also span the radial support portion 540a to assist the ability of the implant 500a to fluidly seal against the inner wall of the IVC (or the inner wall of any other lumen / vascular vessel in which the implant is placed) and restrict / block blood flow during use. In some embodiments, as illustrated, the implant 500a may include multiple anchors 525a configured to fix the implant 500a within the IVC (or any other lumen / vascular vessel in which the implant is placed). Such anchors 525a may extend generally proximal from each of the multiple proximal vertices 543a of the ring 545a.

[0041] Continuing to refer to Figures 2A to 2D, each of the petal-shaped portions 560a can be connected to the shaft 590a by a connector. Various connectors are described herein, for example, sutures, wires, and supports. For example, each of the distal apex 564a of the petal-shaped portion 560a can be connected to a suture or wire 595a at one end of the suture or wire 595a, and the other end of the suture or wire 595a can be connected to the first end or distal end 592a of the shaft 590a, which extends through the lumen 513a of the implant 500a approximately through the center. Furthermore, as shown, the distal end 592a of the shaft 590a can be substantially longitudinally aligned with the distal apex 564a of the petal-shaped portion 560a when the implant 500a is in a non-operating / open state. In this relative position, a suture or wire 595a can extend substantially radially outward from the distal end 592a of the shaft 590a and connect to the distal apex 564a of the petal-shaped portion 560a. The shaft 590a can slide through the lumen of the tube 570a, as shown, and extend from its distal end 572a, and a foldable and extendable coupling 580a can fluidly seal the lumen of the tube 570a to the shaft 590a. The proximal end 571a (not shown) of the tube 570a can connect to the controller 50a, and the shaft 590a can extend from such proximal end 571a and connect operably to an actuator of the controller 50a. The actuator of the controller 50a can be activated to move the shaft 590a proximal to the tube 570a and implant 500a in order to activate the flow limiter portion 550a of implant 500a and at least partially block / limit the flow through the implant, thereby moving the distal apex 564a of the multiple petal-like portions 560a radially inward toward each other via the connection of the distal apex 564a to the suture or wire 595a and the connection to the distal end 592a of the shaft 590a. In other words, the proximal movement of the shaft 590a causes the petal-like portions 560a to converge and at least partially limit the flow through the lumen 513a of implant 500a, as shown in Figure 2D.For example, the petal-shaped portion 560a can be folded radially inward (e.g., hinged relative to the expandable body) with the distal apex 564a of the petal-shaped portion 560a forming the most distal tip of the implant 500a. During use, blood flow flows toward the outer surface of the petal-shaped portion 560a and is occluded by the outer surface of the petal-shaped portion 560a. In some embodiments, the flow limiter portion 550a (e.g., petal-shaped portion 560a) may be configured to be attached to or fixed to the wall of the blood vessel in which the implant 500a is implanted, and when activated, can pull in the wall of the blood vessel to at least partially restrict the flow through the blood vessel and / or lumen 513. For this purpose, as described herein, the flow limiter portion 550a (e.g., petal-shaped portion 560a) may include one or more anchors and / or may be configured to at least partially bite into the wall of the blood vessel.

[0042] The tube 570a may have an integral or composite structure. For example, the tube 570a may include a tube portion, a braided portion, and / or a liner. The tube 570a may be made of, for example, PEBAX. The liner, if included, may be made of PTFE, HDPE, or a silicone blend, and can facilitate the sliding motion of the shaft 590a within the tube 570a (for example, the liner can reduce friction within the tube 570a and the force required to slide the shaft 590a within the tube 570a). Connections between components of system 5, such as the tube 570a, the implant 500a, the foldable and extendable coupling 580a, and the shaft 590a, can be made by reflow (e.g., using PEBAX), heat shrinkage, etc.

[0043] Referring to the end view of implant 500a shown in Figure 2B, implant 500a can be configured such that a suture or wire 595a is substantially aligned with the support 527a of the filter portion 520a. Such substantial alignment may, if necessary, advantageously allow other intervention devices to pass through implant 500a. For example, such substantial alignment may allow a 28-French intervention device to pass through implant 500a.

[0044] The implant 500a in Figures 2A to 2D is shown having six petal-shaped parts 560a, six sutures or wires 595a connecting each of the six petal-shaped parts 560a to a shaft 590a, and a filter part 520a having six supports 527a. However, the implant 500a can be configured to have fewer or more of each of these numbers.

[0045] Figures 3A–3C show end views of implant 500a of Figures 2A–2D in various states of operation and restriction / blockage of flow through it. Figure 3A shows implant 500a in an inactive, unrestricted / unblocked / low-profile state; Figure 3B shows implant 500a in a partially activated, partially restricted / blocked / medium-profile state; and Figure 3C shows implant 500a in a fully activated, fully restricted / blocked / high-profile state. As shown throughout Figures 3A–3C, the lumen 513a of implant 500a (e.g., the lumen or opening of the flow restrictor portion 550a) can change from a roughly circular shape when inactive (Figure 3A) to a roughly star-shaped / radial shape when at least partially activated (Figure 3B), and to a substantially blocked lumen when fully activated (Figure 3C). In some embodiments, the lumen 513 of the implant 500a (e.g., the lumen or opening of the flow limiter portion 550a) may have a generally circular shape when not in operation, a generally circular shape when partially in operation, and a substantially closed lumen when fully in operation. When folded radially inward, the outer surface of each of the multiple petal-shaped portions 560a can block blood flow by the material 530a. In some embodiments, as shown in Figure 3D, the implant 500a may be configured such that its lumen 513a remains at least partially open even when the flow limiter portion 550a is fully in operation, for example, by forming elongated gaps 514a between each or at least some of the petal-shaped portions 560a.

[0046] Figure 4 shows a flat pattern of the expandable body 510a of the implant 500a in Figures 2A–2D, with the features described and identified earlier.

[0047] Figures 5A and 5B show various diagrams of the components of an implantable flow limiting system 5a, which can be implanted as shown above with respect to Figure 1. Figure 5A shows an implant 500a connected to a shaft 590a and a tube 570a. The implant 500a, shaft 590a, and tube 570a may be referred to herein as the implant assembly 501a. Figure 5B shows the implant 500a connected to the shaft 590a and tube 570a, which are then connected to a controller 50a. In other words, Figure 5B shows the implant assembly 501a connected to the controller 50a.

[0048] Figures 6A to 6D show the interactions of the various components of the implant assembly 501a for operating the implant 500a shown in Figures 2A to 2D, with the material 530a of the implant 500a removed for clarity. As described with respect to Figures 2A to 2D, each of the distal apex 564a of the petal-shaped portion 560a can be connected to a suture or wire 595a at one end of the suture or wire 595a, and the other end of the suture or wire 595a can be connected to the distal end 592a of the shaft 590a. As an example, the suture or wire 595a may be connected to the distal apex 564a through a small hole in the distal apex 564a, as shown. In addition to this example, the suture or wire 595a may be connected to the distal end 592a of the shaft 590a via a crimp (fold), as shown, but other forms of connection (e.g., by set screws, press-fit parts, adhesives, and / or threaded ends) are also possible and are considered to be within the scope of this disclosure. In some embodiments, the suture or wire 595a may extend from the distal end 592a of the shaft 590a, pass through a hole in the distal apex 564a of the petal-like portion 560a, and return to connect to the distal end 592a of the shaft 590a. In some embodiments, the suture or wire 595a may be formed integrally with the shaft 590a or may be part of the shaft 590a. For example, in embodiments in which the shaft 590a has a braided structure having a plurality of individual wires 593a, as described with respect to Figures 7A-7B, the suture or wire 595a may be one or more of such individual wires 593a.

[0049] Continuing to refer to Figures 6A to 6D, with material 530a removed so that it is not visible, a foldable and extendable coupling 580a is visible, configured to fluidly seal the tube 580a to the shaft 590a. In some embodiments, as illustrated, the foldable and extendable coupling 580a may extend around the shaft 590a so that no portion of the shaft 590a is exposed except for the portion where the shaft 590a is connected to the suture or wire 595a. Alternatively, in some embodiments, the foldable and extendable coupling 580a may extend around the shaft 590a so that no portion of the shaft 590a is exposed, which may include covering the location where the shaft 590a is connected to the suture or wire 595a. As illustrated, the foldable and extendable coupling 580a can be connected at its proximal end to the distal end 572a of the tube 570a, and at its distal end to the shaft 590a adjacent to the distal end 592a of the shaft 590a, thereby allowing the shaft 590a to slide and / or rotate within the coupling.

[0050] In some embodiments, as shown in Figures 6A and 6B, the implant 500a (e.g., the flow limiter portion 550a) may be actuated by longitudinal movement (e.g., proximal and distal movement) of the shaft 590a relative to the implant 500a. Such longitudinal movement may include sliding of the shaft 590a within the tube 570a. In the unactuated, unlimiting / unblocking state shown in Figure 6A, the shaft 590a is at its most distal position relative to the implant 500a, and the foldable and extendable coupling 580a is in its extended state. In the extended state, the foldable and extendable coupling 580a may have a generally linear shape as shown. As shown in Figure 6B, when the shaft 590a moves proximal within the tube 570a (for example, when the shaft 590a moves proximal to the tube 570a and the implant 500a), the shaft 590a pulls the petal-shaped portion 560a radially inward toward each other via the suture or wire 595a, thereby obstructing / restricting the flow through the implant 500a. In addition, such proximal movement of the shaft 590a causes the foldable and extendable coupling 580a to fold into a folded state. Furthermore, as shown in Figure 6B, when the shaft 590a is in the proximal position relative to the implant 500a, the suture or wire 595a may be oriented substantially longitudinally.

[0051] In some embodiments, as shown in Figures 6C and 6D, the implant 500a (e.g., the flow limiter portion 550a) can be actuated by rotating the shaft 590a relative to the implant 500a (e.g., clockwise or counterclockwise). Such rotation of the shaft 590a can cause a suture or wire 595a to wrap around the shaft 590a, thereby at least partially closing the flow limiter portion 550a. In other words, such rotation of the shaft 590a can cause a suture or wire 595a to wrap around the shaft 590a, thereby at least partially folding the multiple petal-shaped portions 560a radially inward. For this purpose, the implantable controller 50a may be configured to rotate the shaft 590a. Furthermore, in such embodiments, the tube 570a may be configured to rotate the shaft 590a within it. Furthermore, in such embodiments, the foldable and extendable coupling 580a can be configured to accommodate such rotational motion. Figures 6C and 6D show the state in which the petal-shaped portion 560a of the implant 500a is pulled at least partially radially inward as a result of the rotation of the shaft 590a, and Figure 6D shows the state in which the shaft 590a is rotated more than in Figure 6C.

[0052] Referring back to Figure 1, the implant 500a can be positioned in the IVC below the renal vein so that the distal apex 564a of the petal-shaped portion 560a is directed toward the incoming blood flow. In other words, the implant 500a can be implanted such that the flow-restricting portion 550a is upstream of the rest of the implant 500a (for example, so that the flow-restricting portion 550a is the first part of the implant 500a that receives the blood flow passing through it). In such a position, the shaft 590a and tube 570a may extend proximal to the implant 500a, ascend the IVC, pass through the right atrium, enter the superior vena cava (SVC), pass through the subclavian vein (left subclavian vein in the illustration), exit the subclavian vein, and connect to a controller 50a that can be implanted in a subclavian subcutaneous pocket (similar to the placement of a pacemaker, for example). Furthermore, such positioning of the flow limiter portion 550a having the petal-shaped portion 560a can provide a functional advantage in that, rather than allowing thrombi to pass through the implant 500a when the petal-shaped portion 560a is open (as may occur if the petal-shaped portion 560a is not oriented toward the flow of incoming blood), any thrombi that may form on the outer surface of the petal-shaped portion 560a when the implant 500a is activated / closed, or that are otherwise accumulating, are pushed toward the wall of the IVC when the petal-shaped portion 560a is open. In this way, any thrombi are guided toward the sealing region with the wall of the IVC around the implant 500a and are not guided through the implant 500a toward the heart.

[0053] In some embodiments, any of the flow limiting devices described herein (e.g., including at least implant 500a) can be used in cooperation with and / or with sensors located at a distance from the flow limiting device, which can provide physiological parameters of interest useful for controlling the flow limiting device. Such physiological parameters of interest may include pressure, flow rate, heart rate, and / or similar. As an example, a flow limiting device can be used with a pressure sensor placed in a blood vessel and / or organ at a distance from the flow limiting device to provide a measurement of pressure at such a location for controlling the flow limiting device. An example of an implantable sensor is a MEMS pressure sensor. A MEMS or other implantable pressure sensor may be a remote component of the flow limiting device or an independent sensor with a separate control system. In an example, a MEMS pressure sensor may be placed in the pulmonary artery to measure the pressure of the blood flowing through the pulmonary artery. A MEMS or other pressure sensor may include a separate electronic system configured to receive measurements from the MEMS pressure sensor (e.g., data indicating pressure). These measurements can be used by the patient, their physician, etc., to determine when the patient should receive treatment via the flow limiting device. In one embodiment, the MEMS pressure sensor may have a capacitive sensor. In another embodiment, the MEMS pressure sensor includes a barometer and may be powered by an external antenna (e.g., in the form of a high-frequency signal). For example, the external antenna may be contained within an antenna device, and when a patient places the antenna device against their body, a pressure measurement may be acquired and transmitted to an electronic system. In addition, or alternatively, the MEMS pressure sensor may include an inductor that can be used to create a circuit that generates a frequency, such as an LC circuit or an LC tank circuit. This frequency may be used to determine the pressure.

[0054] In some embodiments, the MEMS pressure sensor described above can be coupled to a portion of the flow limiting device described herein. For example, the flow limiting device may have the MEMS pressure sensor attached to its proximal end, distal end, both ends, its shaft, etc. In the example of implant 500a, the MEMS pressure sensor may be coupled to shaft 590a. The MEMS pressure sensor may be attached to / coupled to the flow limiting device using sutures, reflow, and / or similar. In this example, the MEMS pressure sensor is configured to measure the pressure at such locations relative to the flow limiting device (e.g., upstream, downstream, or both upstream and downstream). As described above, the MEMS pressure sensor can transmit the pressure measurement to a separate electronic system. In addition, or alternatively, the MEMS pressure sensor can transmit the measurement to a control system of the flow limiting device (e.g., controller 50a).

[0055] Figures 7A to 7C show implant 500a with sensors 600 positioned at various locations relative to the flow limiter portion 550a. The sensors 600 can be configured to measure intravascular pressure at their respective locations, thereby allowing the positioning of the sensors 600 relative to the flow limiter portion 550a to identify which vascular pressure is being measured, depending on the operating state of the flow limiter portion 550a. The sensors 600 may be positioned adjacent to the proximal end of implant 500a and the proximal end of the flow limiter portion 550a when operated as shown in Figure 7A (for example, so as to be attached to the tube 550a proximal to implant 500a), adjacent to the distal end of shaft 590a and the proximal end of the flow limiter portion 550a when operated as shown in Figure 7B, and / or positioned distal to the extension of shaft 590a and the flow limiter portion 550a when operated as shown in Figure 7C. When the flow limiter portion 550a of implant 500a is not activated (for example, when the implant is in an unrestricted / unoccluded state), the sensor 600 positioned as shown in any of Figures 7A to 7C measures substantially the same pressure. For example, when the flow limiter portion 550a of implant 500a is not activated, the sensor 600 positioned as shown in any of Figures 7A to 7C measures substantially the same inferior vena cava pressure. However, when the flow limiter portion 550a of implant 500a is activated, the sensor 600 positioned as shown in Figures 7A and 7B measures renal venous pressure (for example, because it can be positioned close to the renal vein), while the sensor 600 positioned as shown in Figure 7C measures femoral vein pressure. Implant 500a may include the sensor 600 at any of the positions shown in Figures 7A and 7B for measuring renal venous pressure. In some embodiments, the implant 500a may include multiple sensors 600, one of which is arranged to measure renal venous pressure as shown in Figures 7A and 7B, and another is arranged to measure femoral venous pressure as shown in Figure 7C. The sensors 600 of the implant 500a may be operably connected to the controller 50a, for example, via a wire extending between the sensor 600 and the controller 50a through a tube 570a.In some embodiments, the shaft 590a or a portion thereof can be operably connected to the sensor 600 and the controller 50a. The pressures and / or differences therebetween (e.g., differences between multiple sensors and / or differences between pressures measured over time) generated by the sensor 600 can be used to control the implant 500a.

[0056] Figures 8A and 8B show embodiments of the shaft 590 of the implantable flow limiting system 5 described herein. The shafts described below can be used in conjunction with any of the implants described herein. Figure 8A shows a side view of the shaft 590, and Figure 8B shows a perspective cross-sectional view of the shaft 590. As shown, the shaft 590 (which may also be referred to herein as “wire” or “cable”) may have a braided structure of a plurality of individual wires 593. In some embodiments, the plurality of individual wires 593 may be twisted together to form a bundle, and the shaft 590 may be made of a plurality of such bundles twisted together. In some embodiments, the shaft 590 may be made of a single wire, rod, hypotube, or laser-cut hypotube, depending on the application. For example, in a flow limiting system in which the shaft acts by pulling a portion of the implant to actuate its flow limiter, the shaft may be configured to pull and may have the same or similar form as shown in Figures 8A and 8B. In another example, in a flow limiting system where a shaft presses against a portion of an implant to activate its flow limiter, the shaft can be configured to press. In yet another example, in a flow limiting system where the shaft rotates to actuate the limiter, the shaft can be configured to rotate. In some embodiments, one or more wires 593 of the shaft 590 can be configured to transmit power and / or signals to and from one or more sensors 600 of the flow limiting system 5. The shaft 590 may be flexible and, in some embodiments, may have a lubricating coating or a lubricating surface to facilitate sliding movement within the tube 570, as described herein. Furthermore, the shaft 590 may be made of a biocompatible material (e.g., stainless steel).

[0057] Figure 9 shows a schematic diagram of certain features that can be incorporated not only into the embedded flow limiting system 5 but also into any other embodiment of the embedded flow limiting system described herein. As shown, the embedded controller 50 of the embedded flow limiting system 5 may include a processor 51, an actuator 52, a storage device 53, a power supply 54 and / or a communication module 55. Also, as shown, the external device 15 used to operate the embedded flow limiting system 5 may include a processor 16, a user interface 17, a storage device 18, a power supply 19 and a communication module 21. In some embodiments, the external device 15 may be a mobile phone, tablet, handheld device or mobile device, etc.

[0058] Processors 51 and 16 may be configured, in particular, 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, processor 51 can control the operation of the actuator 52 and sensor 600 of the permanent embedded flow limiting system 5. As another example, processor 51 can process signals and / or data received and / or acquired from the sensor 600 of the embedded flow limiting system 5. Furthermore, processor 51 can execute instructions to perform functions related to storing and / or transmitting such signals and / or data received and / or acquired from the sensor 600 of the embedded flow limiting system 5 (e.g., transmitting such signals and / or data to the external device 15). Processor 51 can execute instructions to perform functions related to storing and / or transmitting any or all of such received data.

[0059] The storage devices 53 and 18 may include, but are not limited to, one or more memory devices for storing data, including 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 may be, for example, processed and / or unprocessed data obtained from the embedded flow limiting system 5.

[0060] Communication modules 55 and 21 can facilitate communication (e.g., via wireless connection) not only between the embedded flow limiting system 5 (and / or its components such as the controller 50) and the external device 15, but also between the embedded flow limiting system and other separate devices such as separate monitoring devices, computing devices, electronic devices, and / or mobile devices. For example, communication module 55 can be configured to enable the embedded flow limiting system 5 to communicate wirelessly with the external device 15 and / or other devices, systems, and / or networks via any of a variety of communication protocols. Communication modules 55 and 21 can be configured to use any of a variety of wireless communication protocols such as Wi-Fi (802.11x), Bluetooth®, ZigBee®, Z-wave®, cellular, infrared, near-field communication (NFC), RFID, satellite transmission, proprietary protocols, or combinations thereof. Communication module 55 can enable the embedded flow limiting system 5 to transmit and / or receive data and / or commands between the embedded flow limiting system 5 and a separate computing device such as the external device 15. The communication module 55 can be configured to transmit processed and / or unprocessed data (e.g., data from the sensor 600) and / or other information to one or more separate computing devices (e.g., wirelessly), which may include, in particular, an external device 15, a patient monitor, a mobile device (e.g., an iOS or Android compatible smartphone, tablet, or laptop), a desktop computer, a server for display and / or further processing, or other computing or processing device.Such separate computing devices may be configured to store and / or further process received data and / or other information, to display information indicating received data and / or information, or to display information derived from 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 hospitals, caregivers (e.g., primary care physicians), and / or users (e.g., employers, schools, friends, family) who have permission to access patient data. As another example, the communication module 55 of the controller 50 of the implanted flow limiting system 5 may be configured to wirelessly transmit processed and / or unprocessed obtained data, information and / or other information (e.g., the operating status of the implant 500) to a mobile phone which may include one or more hardware processors configured to run an application that generates a graphical user interface that displays information representing processed or unprocessed data, information and / or other information obtained from the implanted flow limiting system 5. The communication modules 55 and 21 may be and / or include wireless transceivers.

[0061] Power supplies 54 and 19 can supply power to the respective hardware components of the embedded flow limiting system 5 and the external device 15 described herein. For example, power supply 54 of the controller 50 can supply power to the sensor 600, the communication module 55, the processor 51, and the actuator 52. In some embodiments, power supply 54 may have a battery, an inductive receiver / rectifier, or both. Power supply 19 may have a battery. In some embodiments, the external device 15 may also include an inductive transmitter for wirelessly transmitting power to the inductive receiver / rectifier (if included) of the embedded flow limiting system 5 (e.g., the controller 50). Any such battery may be rechargeable. For example, such a battery may be a lithium battery, a lithium polymer battery, a lithium-ion battery, a lithium-ion polymer battery, a lead-acid battery, a nickel-cadmium battery, or a nickel-metal hydride battery. In some embodiments, such a battery may be non-rechargeable.

[0062] The actuator 52 of the controller 50 of the implantable flow limiting system 5 may be configured to move a shaft 590 within the tube 570 for the operation of the flow limiter 560 and / or flow limiter portion 550 of the implant 500 (which may include any of the implants described herein). For example, the actuator 52 may be configured to slide the shaft 590 proximal and / or distally relative to the tube 570 and the implant 500. As another example, the actuator 52 may be configured to rotate the shaft 590 relative to the tube 570 and the implant 500. Furthermore, the actuator 52 may be configured to block / limit the flow through the implant 500 to a range of about 0% to about 100% by the flow limiter 560 and / or flow limiter portion 550 of the implant 500.

[0063] The user interface 17 of the external device 15 can be configured to allow the patient or their healthcare provider to interact with the external device 15 to control the implanted flow limiting system 5. The user interface may include buttons, a touchscreen, and / or a microphone for accepting physical touch and / or verbal input / commands.

[0064] Figures 10A to 10C show embodiments of a connector 700 between components of the flow limiting system 5. The connector 700 may be configured to removably connect, for example, the proximal end 592 of a shaft 590 to an actuator 51 of a controller 50. As shown in Figure 10A, the connector 700 may include a first component 710 and a second component 720 configured to be removably connected to one another via complementary features. Such a first component 710 and a second component 720 may be fixed to the proximal end 592 of the shaft 590 and the actuator 51, respectively, or vice versa. The first component 710 may be cylindrical in shape and have a circular recess 712 at one end thereof and a projection extending radially inward into the recess 712, visually indicated by a point 714 located on the outer surface of the first component 710. The second component 720 may be cylindrical in shape and have a circular rod-shaped projection 722 extending from one end thereof, sized to fit into the recess 712 of the first component 710. Furthermore, the projection 720 may have a slot 724 configured to receive a projection extending radially inward into the recess 712 of the first component 710. As shown in Figures 10A and 10B, the slot 724 extends longitudinally from the end of the projection 722 and then rotates by more than 90 degrees to align the slot 724 with point 714, and when the projection 722 is fully inserted into the recess 712, the first component 710 and the second component 720 can be rotated relative to each other in a first direction and fixed together (for example, the first and second components can remain connected by the interaction between the projection of the first component 710 and the slot 724 of the second component 720). Figure 10C shows a method for removing the first component 710 from the second component 720, which may include pushing the first component 710 and the second component 720 together, rotating the first component 710 and the second component 720 relative to each other in a second direction opposite to the first direction, and then separating the first component 710 and the second component 720 from each other.

[0065] Figures 11A and 11B show a modified example 700' of connector 700. Similar to connector 700, connector 700' may be configured to removably connect the proximal end 592 of shaft 590 to actuator 51 of controller 50. As shown in Figure 11A, connector 700' may include a first component 710' and a second component 720' configured to removably connect to one another via complementary features. The first component 710' is cylindrical and may have a circular recess 712 at one end of its side, similar to the first component 710. Instead of a projection and a point 714 indicating the location of such a projection, the first component 710' may include a slot 714' penetrating the wall of the first component, extending longitudinally from the end of the first component 710' having the recess 712' and then rotating by about 90 degrees or more. The second component 720' can be configured as a cylinder 722' sized to fit into a recess 712' of the first component 710', and may have a circular rod-shaped projection 724' extending radially outward from its outer surface, configured to fit into a slot 714'. To connect the first component 710' and the second component 720', the cylinder 722' can be fully inserted into the recess 712' with the projection 724' aligned with the slot 714', allowing the first component 710' and the second component 720' to rotate relative to each other in a first direction (for example, the interaction between the slot 714' of the first component 710' and the projection 724' of the second component 720' can keep the first and second components connected). To separate the first component 710' from the second component 720', the first component 710' and the second component 720' are pushed together and rotated relative to each other in a second direction opposite to the first direction, thereby separating the first component 710 and the second component 720 from each other.

[0066] Figures 12A to 12D show embodiments of a connector 750 between components of an embedded flow limiting system 5. The connector 750 may be configured to fluidize by removably connecting, for example, the proximal end 572 of a tube 570 to a controller 50 (for example, to the housing of the controller 50). For this purpose, the connector 750 may extend from the controller 50 (for example, from the housing of the controller 50). Figure 12A shows a tube 570 separated from the connector 750 but positioned for connection to the connector, Figure 12B shows a partial side view of the connector 750, Figure 12C shows an end view of the connector 750, and Figure 12D shows a side cross-sectional view of the connector 750. The connector 750 may have a body 751 having a generally cylindrical shape with a lumen 753 extending through it. The connector 750 may include a first component 760 having a longitudinal through-hole 762 configured to receive the proximal end 572 of a tube 570, and a second component 770 configured to receive the first component 760 (as shown, for example, in Figure 12D). Both the first and second components 760, 770 may be received by the body 751. The proximal end of the second component 770 may include a plurality of radially inwardly extending arms 772 configured to bias the first component 760 distally away from the second component 770. Such arms 772 may also be configured to grip the outer surface of the tube 570 when the tube 570 is inserted into the connector 750. To connect the tube 570 to the connector 750 and fluidize it, the proximal end 572 of the tube 570 can be fully inserted into the connector 750 through the through-hole 762 of the first component 760 until it can no longer be inserted. A third component 780, configured as a circumferential ring within the main body 751 located proximal to the first and second components 760 and 770, enables fluid sealing between the tube 570 and the connector 750. In this fully inserted position, the arm 772 of the second component 770 grips the outer surface of the tube 570, preventing it from being removed from the connector 750.To disconnect the tube 570 from the connector 750, the first component 760 is pushed inward into the connector 750 (for example, proximal to the connector 750), and the arm 772 is radially extended to the proximal end of the first component 760 to detach the arm from the tube 570, while the tube 570 is pulled out from the connector 750 (for example, distal to the connector 750).

[0067] Figures 13A and 13B show embodiments of an implant assembly 501 having an implant 500, a tube 570, and a shaft 590, with an extender 800 to assist in the implantation of the implant assembly 501. The illustrated implant 500, tube 570, and shaft 590 correspond to the implant 500a, tube 570a, and shaft 590a described herein, although in some embodiments they may be any implant described herein. The extender 800 may have a flexible tube attached to the tube 570 adjacent to its proximal end 572 and extending proximal therefrom. For example, the extender 800 may be made of PEBAX reflow-bonded onto the tube 570. In some embodiments, the extender 800 is a proximal extension of the tube 570. The extender 800 can advantageously provide healthcare providers implanting the implant assembly 501 with an extracorporeally graspable component to assist in the positioning and handling of the implant assembly 501 when implanting the implant assembly 501 into a patient. As shown in the enlarged view of Figure 13B, the extender can be cut along the cutting line 803 and removed from the implant assembly 501 when no longer needed (e.g., by sliding it proximal). In some embodiments, the extender 800 is configured to detach from the implant assembly 501 along the cutting line 803. When the extender 800 is removed, the proximal end 572 of the tube 572 may coincide with the cutting line 803. Also shown in Figures 13A and 13B is a device 850 for testing the function of the implant 500, which may extend proximal through the extender 800 and is described with respect to Figures 14A and 14B and 15.

[0068] Figures 14A and 14B show embodiments of a device 850 for testing the function of an implant 500 during implantation. As shown, the device 850 can be detachably connected to the proximal end 591 of the shaft 590 to pull and / or push the shaft 590 to actuate the flow limiter 560 and / or flow limiter portion 550 of the implant 500. For this purpose, the device 850 may include one of the components of the connector 700 described herein, such as the illustrated first component 710, for detachably connecting to other components of the connector 700, such as the illustrated second component 720 attached to the proximal end 592 of the shaft 590. In some embodiments, the device 850 may include the second component 720 of the connector 700, and the shaft 590 may have the first component 710 attached to the second component. Figure 14A shows the device 850 connected to the shaft 590, and Figure 14B shows the device 850 disconnected from the shaft 590. To facilitate pulling and / or pushing the shaft 590 via the device 850, the device 850 may include a proximal extension 855. As shown in Figures 14A and 14B, the proximal extension 855 may have a suture. In a modified version 850' of the device 850, as shown in Figures 71A and 71B, the proximal extension 855' may have a shaft. In some embodiments, the proximal extensions 855, 855' may have a wire, rod, hypotube, or laser-cut hypotube, depending on the needs of the application (e.g., depending on the need to pull or push the shaft 590 to test the operation of the flow limiter 560 and / or flow limiter portion 550 of the implant 500). Alternatively, or in addition to the above, to test the function of the implant 500, the device 850, 850' may also be used to assist in the removal of the implant 500, if necessary.For example, to remove the implant 500 from the patient, the implantable controller 50 is detached from the shaft 590 and tube 570, the devices 850,850' are connected to the shaft 590, the sheath is slid distally beyond the devices 850,850' and beyond the shaft 590, the sheath is slid beyond the implant 500 to fold the implant 500 within the sheath, and then the sheath containing the implant 500, shaft 590 and tube 570 is retracted proximal to the patient and removed from the patient. The devices 850,850' can advantageously provide a working length that assists in the extracorporeal removal of the implant assembly 501.

[0069] Figure 15 shows a method 900 for implanting an implantable flow limiting system 5. Method 900 can be applied to any embodiment of the implantable flow limiting system 5 and its components described herein. Furthermore, Method 900 may include other steps, and / or steps may be omitted. Method 900 can be performed in a cardiac catheterization laboratory under local or general anesthesia and can be performed minimally invasively.

[0070] Method 900 may include step 905 of accessing the patient's subclavian vein. The access point to the subclavian vein, which may be the right or left subclavian vein, may be formed at or near the junction of the middle third and inner third of the clavicle, where the first rib connects to the clavicle. The subclavian vein may be punctured blindly or under image guidance. Once access to the subclavian vein is established, a guidewire can be advanced from the subclavian vein through the superior vena cava (SVC) and through the right atrium into the inferior vena cava (IVC). A delivery system 1500, including a delivery sheath with a dilator (also referred to herein as a “delivery catheter”), can be positioned in the subclavian vein beyond the guidewire and into the inferior vena cava.

[0071] Method 900 may optionally include step 910, which involves identifying the renal vein. Identifying the renal vein can be done by fluoroscopy and intravascular staining using the delivery sheath during implantation, or by CT imaging before implantation. With the renal vein identified, the distal end of the delivery sheath can be positioned in the inferior vena cava below the renal vein (e.g., in the inferior vena cava upstream of the connection to the renal vein), and the dilator can be removed from the delivery sheath.

[0072] Method 900 may include a step 915 of implanting the implant assembly 501. In other words, step 915 may include implanting the implant 500 connected to the tube 570 and shaft 590. For this purpose, the implant assembly 501 can be inserted into a delivery system 1500 including a delivery sheath and delivered into the inferior vena cava so that the implant 500 is located below the renal vein. To assist in the delivery and handling of the implant assembly 501, an extender 800 may be optionally attached to the implant assembly 501, as described with respect to Figures 69A and 69B. The implant 500 can be repositioned as needed.

[0073] Figures 15A–15H illustrate the use of the delivery system 1500 for positioning the implant assembly 501. The implant assembly 501 includes a blood flow occluder (e.g., implant 500) as described above. Figure 15A shows step 915A in which the introducer shaft 1504 and dilator 1856 are advanced together from the percutaneous access site to a position in the IVC below or upstream of the renal vein (RenV). The dilator 1856 facilitates the passage of the wider introducer shaft 1504 through the extensible tissue. Figure 15B shows step 915B in which the dilator 1856 may be removed after the distal end of the introducer shaft 1504 has been positioned below the renal vein (RenV) as shown in Figure 15A. The proximal hub of the introducer is detached from the introducer hub 1506 and withdrawn proximal along the introducer shaft 1504. After the introducer shaft 1504 is removed, the lumen within the introducer shaft 1504 can be used to advance the implant assembly 501 to the distal end position of the introducer shaft 1504 as shown in Figure 15A.

[0074] Figure 15C shows step 915C, in which the delivery shaft 1510, with the implant assembly 501 and lead assembly 1560 inside, is further advanced into the patient. The distal end of the delivery shaft 1510 may be inserted into the proximal end of the introducer, for example, into the introducer hub 1506. By injecting fluid into the fluid port 1584, friction between the delivery shaft 1510 and the introducer shaft 1504 is reduced, making it easier to advance the delivery shaft 1510 through the introducer shaft 1504 to the position shown in Figure 15A, for example, below the renal vein (RenV). In some embodiments, the fluid port 1584 may include a one-way valve. Figure 15D shows step 915D, following step 915C. The handle 1508 located at the proximal end of the delivery shaft 1510 may be advanced adjacent to the introducer hub 1506, for example, immediately proximal thereto. The handle 1508 can be engaged with the introducer hub 1506, for example, by engaging the distal thread of the handle 1508 with the thread in the introducer hub 1506. When engaged in this way, the lead assembly 1560 has a proximal portion within the handle 1508, with a portion distal to this proximal portion extending from the handle 1508 into the delivery shaft 1510 and further extending into the patient's body through the introducer shaft 1504.

[0075] Figure 15E shows a further step 915E following step 915D, in which the implant assembly 501 is unfolded. The proximal end of the lead assembly 1560 extends outward from the handle 1508. The lead assembly 1560 may be locked in a locked position relative to the outer surface of the handle 1508 during step 915E. The lead assembly 1560 may be locked in the locked position by a lead locking member, which will be further described below with respect to Figures 22-22I. While the lead assembly 1560 is locked in the locked position, the actuator 1520 may be actuated, for example, by being rotated to retract the delivery shaft 1510 relative to the implant assembly 501. The implant assembly 501 may include an unfoldable, for example, self-unfolding structure, so that when released from the distal end of the delivery shaft 1510, the implant assembly 501 begins to unfold as shown in Figure 15F. The implant assembly 501 unfolds toward the inner wall of the vessel in which it is to be placed, to engage within the inner wall, for example, within the IVC.

[0076] Figure 15G shows step 915G following the complete deployment of the implant assembly 501. The actuator 1520 is rotated in the direction of the arrow shown in Figure 15G. Each partial rotation of the actuator 1520 adjusts the degree of retraction of the delivery shaft 1510. The deployment of the implant assembly 501 can be monitored by indicator 1544 without visualizing the implant assembly 501 in the blood vessel. Indicator 1544 is not mandatory and may not be included in the handle 1508 as shown in Figure 22F. If included, indicator 1544 may be configured to move linearly by an amount corresponding to the movement of the distal end of the delivery shaft 1510 as the actuator 1520 rotates. Indicator 1544 can move within indicator groove 1546 provided in the handle 1508. The movement of indicator 1544 may be synchronized with the movement of the delivery shaft 1510 by any suitable method or structure. In some embodiments, a magnetic field generated by a movable structure provided within the outer surface of the handle 1508 may be configured to couple with the indicator 1544. The magnetic field may move with the movement of the delivery shaft 1510. The magnetic field may also move with the movement of the actuator 1520, for example, with rotation. During or after step 915G, a reed locking member (e.g., reed locking member 1572 or reed locking member 1572') may be actuated to release the reed assembly 1560, allowing relative movement between the outer surface of the handle 1508 and the reed assembly 1560, for example, with respect to the cylindrical body in which the indicator groove 1546 is formed, or with respect to the cylindrical body to which the actuator 1520 is rotatably coupled.

[0077] Figure 15H shows step 915H after step 915G. After the lead lock member 1572 is released, the handle 1508 and delivery shaft 1510 are 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 becomes operational.

[0078] Once the implant 500 is deployed from the distal end of the delivery sheath, method 900 may optionally include a step 920 to test the function of the implant assembly 501. For this purpose, the implant 500 can be activated and its function tested using a device 850 for testing the function of the implant 500, as described with respect to Figures 14 to 14D (for example, the flow limiter 560 and / or flow limiter portion 550 of the implant 500 can be activated via device 850 to at least partially block the flow through the implant 500).

[0079] One method of this test is shown in Figures 15I to 15J. The blood flow occluding portion of the implant assembly 501 can be activated to an occluding configuration in which the petal-shaped portions 506a are deflected toward the center of the blood vessel, for example, by applying a tensile load to the shaft 590a to deflect the distal apex 564a of each petal-shaped portion 506a. This is sometimes referred to as the system being in an "activated" or "on" state. This deflection results in one of the configurations shown in Figures 2D and 3B to 3D. Subsequently, in step 920A, a contrast agent can be injected into the blood vessel upstream of the implant assembly 501. The contrast agent can be injected via a pigtail catheter PC positioned in one of several external iliac veins (as shown in Figure 15J). The occluding effect of the implant assembly 501 in one of the configurations shown in Figures 2D, 3B to 3D, and 21B can be visualized in an X-ray image as shown in Figure 15I. In this image, the blood vessels within the lowest region of the IVC, and even within the external iliac vein, are shown as dark, indicating that the contrast agent is retained upstream of the implant assembly 501. Furthermore, blood pressure decreases downstream of the implant assembly 501, for example, in the outflow region from the renal vein (RenV). This occlusive effect favorably increases blood flow through the renal artery and kidney, resulting in improved fluid removal from the patient.

[0080] Figure 15J shows step 920B, in which the occlusion effect test is complete, the tensile load on the shaft 590a is reduced or removed, and the distal apex 564a of each petal-shaped portion 506a returns to a non-deflected state. This is sometimes referred to as the system being in a "non-operational state" or "off." In the non-deflected state, the petal-shaped portions 506a are not positioned toward the center of the vessel. The implant assembly 501 can take the form of, for example, Figure 2A, Figure 6A, or Figure 21C. Figure 15J shows that the contrast agent injected by the pigtail catheter PC is allowed to flow downstream of the IVC through the lumen 513a of the implant assembly 501. When the implant assembly 501 is in a non-operational state, the pressure near the renal vein increases, but this pressure increase is well acceptable after the treatment period in which the implant assembly 501 was operational.

[0081] If the functional test is successful, the delivery sheath can be removed proximal to the implant assembly 501, leaving the implant assembly 501 in place within the patient. Removal of the delivery system 1500 is described above with respect to Figures 15G to 15H and below with respect to Figures 22 to 22I. If the functional test is unsuccessful, the implant assembly 501 can be removed from the patient by re-covering the implant 500 within the delivery sheath (for example, by moving the delivery sheath distally beyond the implant 500 and / or pulling the implant 500 proximal to the delivery sheath).

[0082] If used, method 900 may include a step 925 to remove the extender 800. This can be done by cutting or peeling the extender along the cutting line 803, as described with respect to Figures 13A and 13B. The device 850 for testing the function of the implant 500 may also be removed.

[0083] Method 900 may include step 930 of forming a subclavian subcutaneous pocket for the implantable controller 50 of system 5.

[0084] Method 900 may include a step 935 connecting the implant assembly 501 to the implantable controller 50, as described above with respect to Figure 15H. For this purpose, the shaft 590 of the lead assembly 1560 can be connected to the actuator 51 of the controller 50, as described with respect to Figures 10A-10C and 11A-11B. Furthermore, the tube 570 of the lead assembly 1560 may be connected to the controller 50, as described with respect to Figures 12A-12D.

[0085] Method 900 may include a step 940 for testing the functionality of the implanted flow limiting system 5. For this purpose, an external device 15 can be used to test the operation of the implant 500.

[0086] Once it is confirmed that the external device 15 can operate the system 5 correctly, method 900 may include a step of implanting an implantable controller 50. For this purpose, the implantable controller 50 can be inserted into the subcutaneous pocket formed in step 930. Sutures can then be performed to complete the implantation surgery.

[0087] In some embodiments, vascular access can be made via the femoral vein, radial vein, or any of the veins shown in Figure 1. Depending on the location of the vascular access, the implantable controller 50 can be implanted in a location other than those described in Method 900. Furthermore, depending on the location of the vascular access, the implant 500 can be configured as described with respect to implant 500a, or it can have the opposite configuration (for example, with the flow limiter 560 configured to be operated by inverting it and pushing the shaft 590 rather than pulling it).

[0088] Figures 16A to 16D show the deployment of the implant 500 of the embedded flow limiting system 5 from the distal end 1002 of the delivery sheath 1000. The delivery sheath 1000 may be the same as the delivery shaft 1510 described herein, except that it differs from the one described below. The deployment of the implant 500 described with respect to Figures 16A to 16D is applicable to any embodiment of the implant described herein.

[0089] As shown in Figure 16A, distal movement of the implant 500 relative to the distal end 1002 of the delivery sheath 1000 may result in the implant 500 extending beyond the distal end 1002 of the delivery sheath 1000. Such relative movement can be caused by maintaining the position of the implant 500 and retracting the delivery sheath 1000 proximal, by maintaining the position of the delivery sheath and extending the implant 500 distally from there, or both. Advantageously, as shown in Figure 16A, the configuration of the expandable frame 510 of the implant 500 allows the implant 500 to remain folded while extending distally beyond the distal end 1002 of the delivery sheath 1000. Such a configuration facilitates the repositioning of the implant as needed. For example, the implant 500 can remain folded while at least a portion of the radial support portion 540 remains inside the delivery sheath 1000.

[0090] Figures 16B and 16C illustrate the progressive radial expansion of implant 500 as it continues to expand distally beyond the distal end 1002 of the delivery sheath 1000. As shown, partial radial expansion of implant 500 can occur as a large portion of the filter portion 520 extends distally beyond the distal end 1002 of the delivery sheath 1000. Advantageously, as shown in Figure 16C, the anchor 525 can maintain a concealed position (e.g., extending at least partially radially inward) while implant 500 is in a partially expanded state. Such a configuration of implant 500 can assist in the repositioning of implant 500 within the blood vessel and / or in the retraction of implant 500 within the delivery sheath 1000 as needed.

[0091] Figure 16D shows the complete deployment of the implant 500 from the distal end 1002 of the delivery sheath. When fully deployed, the implant 500 can be fully expanded as shown. In this state, the anchor 525 can be positioned in a generally longitudinal orientation, which helps to secure the implant 500 within the blood vessel. Advantageously, the implant 500 can be configured to be retrieved and retracted into the delivery sheath 1000 even after it has been fully deployed from the delivery sheath, due to the configuration of the filter portion 520 which can push the proximal end of the implant 500 and the anchor 525 radially inward during proximal retraction.

[0092] Figure 17 shows guidelines 1100 for the treatment of a patient using the implantable flow limiting system 5 described herein. In some embodiments, guidelines 1100 can be applied to any of the flow limiting systems described herein. Guidelines 1100 may include assessing the patient's inferior vena cava pressure. If the inferior vena cava pressure is determined to be normal, no action by the system 5 may be necessary, as shown in the figure. Normal inferior vena cava pressure can be between approximately 0 mmHg and approximately 8 mmHg. If the inferior vena cava pressure is determined to be high, the system 5 may be activated, as shown in the figure. High inferior vena cava pressure can be above approximately 8 mmHg. The inferior vena cava pressure can be measured by the system 5 via a sensor 600. Furthermore, activation of the system can be performed via an external device 15 as described herein (e.g., digital wireless activation). If the inferior vena cava pressure remains high after activation of the system 5, the patient is advised to consult a medical professional / healthcare provider.

[0093] Figures 18–20 illustrate various methods of using the implantable flow limiting system 5 described herein. The methods described with respect to Figures 18–20 can be adapted to any of the flow limiting systems described herein. Furthermore, although the methods described with respect to Figures 18–20 are described to use a sensor 600 connected to the implant 500, the system 5 may include other sensors (e.g., sensors described herein) located near and / or away from the implant 500 for pressure measurement and control of the system 5. Furthermore, although the methods described with respect to Figures 18–20 are described as being performed by the patient to whom the system 5 is implanted, any step of such a method may be performed by the patient's medical professional / healthcare provider or authorized user.

[0094] Figure 18 shows a manual method 1200 (which may also be referred to as the “patient-initiated method”) using an implanted flow limiting system 5. Furthermore, method 1200 may include other steps, and / or steps may be omitted.

[0095] Manual method 1200 may include step 1205, which requests pressure measurement (e.g., renal venous pressure measurement or femoral venous pressure measurement). Such a request may be made by the patient using external device 15 or other separate electronic device as described herein (e.g., via wireless communication with system 5).

[0096] Manual method 1200 may include step 1210 in which system 5 measures pressure based on a request from step 1205. Such pressure measurement can be performed by a sensor 600 of system 5. For this purpose, a processor 51 of controller 50 may be operably connected to the pressure sensor 600 and configured to receive and process a signal from the pressure sensor 600 to calculate the pressure (e.g., of a patient's blood vessel). For example, an implant 500 having a sensor 600 connected to the implant 500, which is embedded in the inferior vena cava upstream of the renal vein, can be used to measure inferior vena cava pressure, renal venous pressure and / or femoral venous pressure (e.g., as described with respect to Figures 7A-7C). In other words, inferior vena cava pressure, renal venous pressure and / or femoral venous pressure can be measured from the implant 500.

[0097] The manual method 1200 may include a step 1215 in which the system 5 detects a pressure rise. For example, the system 5 may compare the pressure measured in step 1210 with a previously measured pressure and / or a pressure value in memory (e.g., in storage device 53) to determine whether the pressure has risen and / or is high / high pressure. The determination of high pressure may be performed according to the guideline 1100.

[0098] The manual method 1200 may include step 1220 in which, if a pressure increase is detected in step 1215, the system 5 notifies the patient of the pressure increase. To this end, the system 5 (e.g., controller 50) may send an instruction to an external device 15 indicating that the pressure has increased. Such pressures may include inferior vena cava pressure, renal venous pressure and / or femoral venous pressure. Furthermore, step 1220 may include notifying the patient via the external device 15 that the pressure has increased and / or become high / high pressure. This may include receiving an instruction from the external device 15 to activate the implant 500.

[0099] The manual method 1200 may include a step 1225 in which the system 5 is activated by a patient or the like. For this purpose, the patient can interact with an external device 15 (for example, via a user interface 17) to cause the implant 500 to activate. The activation of the implant 500 may include the activation of the flow limiter 560 and / or flow limiter portion 550 as described herein, thereby causing at least partial occlusion of the lumen 513 of the implant 500. Furthermore, the activation of the implant 500 may cause at least partial occlusion of blood flow through the blood vessels of the patient's vascular system. For example, in the case of an implant 500 implanted in the inferior vena cava below the patient's renal vein, activation of the implant 500 may cause at least partial occlusion of blood flow through the inferior vena cava.

[0100] The manual method 1200 may include a step 1230 to stop the operation of system 5. Stopping system 5 may include returning the implant 500 to a relaxed or free state, i.e., a non-operating state, or an unoccluded / unrestricted state, as described herein. Such stopping may be done manually, semi-automatically, or automatically. For example, system 5 may remain operational until it is stopped by interaction with an external device 15. In another example, system 5 may notify the patient that treatment is complete and provide a notification to stop system 5 from operating. Such a notification may be given in the same way as the pressure rise notification described in step 1220. In another embodiment, system 5 may remain operational for a duration of time, and system 5 may be stopped after such duration has elapsed. In yet another example, system 5 may remain operational as long as the pressure is high / remains high, and such determination may include periodic measurement of pressure.

[0101] Figure 19 shows a semi-automatic method 1300 (which may also be referred to as “patient-activated automatic detection”) using an embedded flow limiting system 5. Furthermore, method 1200 may include other steps and / or omit steps. Method 1300 may be similar to method 1200 in many respects. For example, method 1300 may include steps 1305, 1310, 1315, 1320 and 1325, which are the same as steps 1210, 1215, 1220, 1225 and 1230 of method 1200, respectively. Unlike the manual method 1200, the semi-automatic method 1300 may omit step 1205, which requests a pressure measurement. In the semi-automatic method 1300, where there is no such request for a pressure measurement, system 5 can automatically measure the pressure via system 5. Such automatic pressure measurements may occur based on a predetermined schedule or time interval, which may be the same or different depending on the time of day, the patient or other patient factors. Method 1300 can be described as semi-automatic in that the system 5 must be activated in step 1320.

[0102] Figure 20 shows an automated method 1400 (which may also be referred to as “closed-loop” or “fully closed-loop”) using an implanted flow limiting system 5. Method 1400 may be similar in many respects to Method 1300. For example, Method 1400 may include steps 1405, 1410, 1415 and 1420, which are the same as steps 1305, 1310, 1320 and 1325 of Method 1300, respectively. Unlike the semi-automated method 1300, the automated method 1400 can omit step 1320, in which the system is activated by the patient. In the automated method 1400, the system 5 can operate automatically and provide treatment without needing to be activated by the patient.

[0103] Figures 21A–21C illustrate embodiments of providing treatment using the implantable flow restriction system 5 described herein. The provision of treatment using system 5 described with respect to Figures 21A–21C is applicable to any of the methods described with respect to Figures 18–20. Figures 21A–21C show the implantation 500 of system 5 in the inferior vena cava below the renal vein of a patient. As shown in Figure 21A, system 5 detects elevated or elevated / high pressure in the inferior vena cava, renal venous pressure and / or femoral venous pressure. Elevated or elevated / high pressure in the renal venous pressure may result in reduced urine production. Depending on the method of use, system 5 can be operated manually, semi-automatically, or automatically. When activated, the implant 500 can at least partially occlude / restrict blood flow in the inferior vena cava as described herein and shown in Figure 21B (where the implant 500 is shown in an occluded / restricted state). Such placement of implant 500 in the inferior vena cava allows system 5 to be activated to reduce renal pressure (e.g., reduce renal venous pressure). This reduction in renal pressure can increase the patient's urine production (e.g., promote / increase diuresis). Additionally, activating system 5 can increase femoral pressure (e.g., femoral venous pressure). System 5 can be deactivated as shown in Figure 21C. When deactivated, implant 500 is substantially non-occlusive / unrestricted and does not substantially block / restrict blood flow through the implant. In other words, in the deactivated state, implant 500 can not substantially block / occlusive / restrict blood flow in the inferior vena cava. Such deactivation can reduce femoral pressure while substantially not affecting renal pressure or urine production (e.g., renal pressure and urine production may be normalized by deactivating system 5).

[0104] Any part of the implant described herein (e.g., the filter portion 520, the radial support portion 540, and the flow limiter portion 550) may be omitted, duplicated, or connected to one another in a different order. Furthermore, although the flow limiter portion 550 and / or the flow limiter 560 have been described as having a specific orientation with respect to the orientation of the implant 500 and / or the blood flow through the implant 500, such flow limiter portion 550 and / or the flow limiter 560 may be oriented in the opposite direction or in an orientation other than that shown herein. Furthermore, the features of the implant described herein can be implemented in any implant described herein. Furthermore, although some implants described herein have components for operation (e.g., tube 570, shaft 590) that are substantially centrally located within the associated lumen, such implants may be adapted so that such components are located around or along the sides of the implant in order to produce implants having a lumen that is substantially free of such components.

[0105] While systems, devices, and / or their components have been described as having a specific orientation and / or position when implanted in a patient, they are not intended to be limited to such orientation and / or position. For example, while systems, devices, and / or their components have been described as extending from the superior vena cava or a vein branching therefrom to the inferior vena cava, such systems, devices, and / or their components may extend from the femoral vein to the inferior vena cava. For example, while system 5 has been described as having an implantable controller 50 implanted in a subclavian subcutaneous pocket with the rest of the system extending through the superior vena cava into the inferior vena cava, the implantable controller 50 of system 5 may be adapted for implantation in a subcutaneous pocket in or near the patient's inguinal region with the rest of the system extending through the femoral vein into the inferior vena cava. In such embodiments, venous access may be through the patient's femoral vein. Furthermore, in such embodiments, the flow limiter of an implant of such a system may be configured similarly to, or inversely to, the flow limiter of implant 500 shown in Figure 1.

[0106] Figures 22 to 22I show further details of the delivery system 1500 used in connection with the method 900 described above. The delivery system 1500 is configured to position the implant assembly 501 by being inserted into the introducer hub 1506 and then advanced, for example, within the introducer shaft 1504. The delivery system 1500 includes a handle 1508 coupled to a delivery shaft 1510. The delivery shaft 1510 has a lumen extending from its distal end to its proximal end coupled to the handle 1508. The deployable portion of the implant assembly 501 can be positioned within the lumen near the distal end of the lumen. The lead assembly 1560 may extend through the lumen of the delivery shaft 1510 into the internal space of the handle 1508.

[0107] The delivery system 1500 includes a distal portion 1512 and a proximal portion 1516. The distal portion 1512 may have a threaded interface for engaging with the threaded interface of the introducer hub 1506. The proximal portion 1516 may have several functional sections. The proximal portion 1516 may include an actuator 1520 configured to move the introducer shaft 1504 relative to the handle 1508. The actuator 1520 may rotate about a longitudinal axis of the delivery system 1500, for example, an axis aligned with the central axis 1676 of the handle 1508. The actuator 1520 may rotate about an outer surface 1524 of the handle 1508. The outer surface 1524 can be positioned around and accommodate an internal space of the handle 1508 with additional functional components. The outer surface 1524 can accommodate an internal threaded cylinder 1528. The internally threaded cylinder 1528 may be positioned within the outer surface 1524. The internally threaded cylinder 1528 may be fixed to rotate relative to the actuator 1520 so as to rotate the internally threaded cylinder 1528 by the rotation of the actuator 1520. The internally threaded cylinder 1528 is fixed axially to the body, including the outer surface 1524.

[0108] The threads within the internally threaded cylinder 1528 form part of a mechanism that allows the delivery shaft 1510 to move relative to the handle 1508. The mechanism may also include a carriage 1532 configured to move along the central axis 1676. The carriage 1532 is capable of moving proximal or distal. The carriage 1532 may have external threads that engage with the internal threads of the internally threaded cylinder 1528. As further described below, the carriage 1532 is coupled to the proximal end of the delivery shaft 1510 such that the proximal movement of the carriage 1532 moves the proximal end of the delivery shaft 1510 and possibly its entire length proximal to the handle 1508. The proximal movement of the delivery shaft 1510 within the introducer shaft 1504 can be facilitated by flowing friction-reducing fluid into the fluid port 1584 of the introducer. By supplying fluid to the interface between the outer surface of the delivery shaft 1510 and the inner surface of the introducer shaft 1504, the force required to move the delivery shaft 1510, carriage 1532, and actuator 1520 is reduced. The friction-reducing fluid may be, for example, saline solution.

[0109] The position of the distal end of the delivery shaft 1510 can be observed by the handle 1508. The position of the delivery shaft 1510 corresponds to the state of the implant assembly 501, for example, whether it is compressed and held within the lumen, partially released (as shown in Figures 15F and 16A-16C), or fully extended (as shown in Figure 16D). The handle 1508 may optionally include an indicator 1544 movably positioned within an indicator groove 1546 of the handle 1508. The indicator 1544 is not mandatory. Figures 22 and 22A show an example of the handle 1508 with the indicator 1544, and Figure 22F shows an example of the handle 1508 without the indicator. If the indicator 1544 is included, the outer surface 1524 may surround the indicator groove 1546. The indicator track 1546 is defined by the outer surface 1524 and may extend at least partially through the outer surface 1524. The position of indicator 1544 may be configured to correspond to the position of carriage 1532. Indicator 1544 may be coupled to carriage 1532. Coupling of indicator 1544 and carriage 1532 can be achieved by remote action via a rotatable interface. This coupling can also be achieved via one or more solid walls. In one embodiment, indicator 1544 is magnetically coupled to a structure located within an internally threaded cylinder 1528. In one embodiment, carriage magnet 1540 is coupled to carriage 1532. Carriage magnet 1540 may be magnetically coupled to indicator 1544. In one embodiment, indicator 1544 includes a magnet that can be magnetically coupled to carriage 1532. The indicator 1544 may include a low-friction outer surface in which the magnet is housed, and for example, a low-friction underside, side, or interface surface positioned between the magnet and the indicator track 1546, so that the indicator 1544 moves smoothly within the indicator groove 1546 and sliding friction does not interfere with the magnetic coupling between the indicator 1544 and the carriage magnet 1540.In one embodiment, only one of the coupling structures between the indicator 1544 and the carriage 1532 is a magnet, while the other coupling structure between the indicator 1544 and the carriage 1532 is not a magnet but contains a magnetic material. The indicator 1544 may include a magnet configured to couple with the carriage magnet 1540. The carriage 1532 is fixed to rotate within an internally threaded cylinder 1528. The rotation of the first end 1628, caused by the rotation of the actuator 1520, moves the carriage 1532 proximal or distal along the central axis 1676. The carriage magnet 1540 maintains a rotationally aligned position with the indicator 1544. Magnetic attraction between the carriage magnet 1540 and the indicator 1544 causes the indicator 1544 to follow the proximal and distal movement of the carriage 1532, which may correspond one-to-one with the proximal and distal movement of the distal end of the delivery shaft 1510.

[0110] The carriage magnet 1540 may be embedded within the carriage 1532. The carriage magnet 1540 may be aligned with the outer edge of the threaded portion of the carriage 1532 so 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 positioned within the height of the threads of the internally threaded cylinder 1528. Figure 22A shows that the handle 1508 may include multiple carriage magnets 1540, for example, two. The carriage magnets 1540 may be positioned on the opposite side of the carriage 1532. The handle 1508 may include multiple indicators 1544, for example, two. The indicators 1544 may be positioned on the opposite side of the handle 1508. There may be multiple indicator grooves 1546, for example, two indicator grooves 1546. The indicator track 1546 may be positioned to penetrate the outer surface 1524 located on the opposite side of the handle 1508.

[0111] The carriage 1532 may include a shaft interface 1548 configured to securely connect the carriage 1532 to the delivery shaft 1510. The shaft interface 1548 may be located on the distal end 1552 of the carriage 1532. The shaft interface 1548 is configured to receive the proximal end 1556 of the delivery shaft 1510. A seal may be provided proximal to the proximal end 1556. A portion of the shaft interface 1548 may extend between the proximal end 1556 and the seal. The handle 1508 may include a lumen 1564 configured to receive the lead assembly 1560. The lumen 1564 may be located within the shaft 1568 held within the carriage 1532. The lead assembly 1560 can be screwed through the lumen 1564 such that a portion of the lead assembly 1560 is positioned proximal to the proximal end of the handle 1508, and a portion of the lead assembly 1560 is positioned distal to the distal portion 1512 of the handle 1508.

[0112] The handle 1508 may be configured to facilitate the sliding of the reed assembly 1560 against the handle and to lock the reed assembly 1560 against the handle 1508. The handle 1508 includes a fluid port 1584 located in the proximal portion 1516 of the handle 1508. The fluid port 1584 may allow saline solution or other lubricating fluid to flow into the handle 1508 to smooth the passage of components, such as the reed assembly 1560 within the shaft 1568. The handle 1508 includes a reed locking member located in the proximal portion 1516 of the handle 1508. The reed locking member can fix the reed assembly 1560 to the handle 1508 so as to prevent relative movement (e.g., relative sliding movement) between the reed assembly 1560 and the handle 1508. Figures 22 to 22E show a first implementation example of the lead lock member 1572, and Figures 22F to 22I show a second implementation example of the lead lock member 1572'. Both the lead lock member 1572 and 1572' can be used with the handle 1508, with or without the indicator 1544.

[0113] Referring first to Figures 22 to 22E, the lead lock member 1572 of the first example may include a knob 1576. The outer surface of the knob 1576 may be knurled to facilitate gripping and twisting operations against the handle 1508, for example, the proximal portion 1516 of the handle 1508. Whether the outer surface of the knob 1576 is knurled or smooth, it is an example of a hand grip structure. The knob 1576 may form a gripping surface.

[0114] The knob 1576 can be attached to the handle 1508 by at least partially one or more actuator pins 1588a. The actuator pin 1588a is a form of projection that may extend from the proximal end of the handle 1508. As will be further described below, the knob 1576 and the actuator pin 1588a together may form part of a locking actuator. The actuator pin 1588a may include a screw or post that can be embedded in the proximal surface of the body of the handle 1508 that forms the outer surface 1524. Figure 22B shows that there may be two actuator pins 1588a. In some embodiments, there may be three or more actuator pins 1588a. In some embodiments, there may be a single actuator pin 1588a. The actuator pin 1588a holds the knob 1576 on the proximal end 1556 of the handle 1508. The actuator pin 1588a defines the degree of rotation of the knob 1576 and controls the movement of the multiple gripping feature parts 1608.

[0115] The knob 1576 may be circular in shape and may include a ring member 1596 that forms the outer circumference 1604 of the knob 1576. The inner circumference 1616 of the knob 1576 may include a plurality of gripping features 1608. The plurality of gripping features 1608, also referred to herein as a locking configuration, may have both an unengaged and an engaged configuration. The plurality of gripping features 1608 are configured to selectively engage with and disengage from the outer surface of the lead assembly 1560. The plurality of gripping features 1608 may have a fixed end 1612 extending from the inner circumference 1616 of the ring member 1596 and a free end 1620 located on the opposite side of the fixed end 1612. The free end 1620 may have teeth 1672 for gripping the lead assembly 1560. The plurality of gripping features 1608 may include arms, such as cantilever arms extending circumferentially and radially from the ring member 1596. The multiple gripping features 1608 may have a spiral shape, for example, having radial and circumferential extensions. The free end 1620 may be offset radially inward and circumferentially from the fixed end 1612. The multiple gripping features 1608 may have outer surfaces that form one side of one of the multiple channels 1624 where the actuator pins 1588a are located. Each portion of the inner circumference 1616 may form the opposite side of the multiple channels 1624 where one of the actuator pins 1588a is located.

[0116] Each of the multiple channels 1624 has a somewhat kidney shape. Figure 22D shows that each of the multiple channels 1624 may have a first end 1628 having a first width 1632 and a second end 1636 having a second width 1640. The first end 1628 may include a circular recess having a first diameter. If the first end 1628 includes a circular recess, it may include the closed end of the multiple channel 1624. The second end 1636 may include a circular recess having a second diameter. The circular recess of the second end 1636 may be partially formed by the outer surfaces of the multiple gripping features 1608. The small gap between one end face of the multiple gripping features 1608 and one adjacent outer surface of the multiple gripping features 1608 may change in shape and width depending on whether the lead lock member 1572 is locked or unlocked. In the free state, the second width 1640 is smaller than the first width 1632. In the free state, the teeth 1672 are positioned away from the lead assembly 1560 as shown in Figure 22D. The movement of the ring member 1596, which forms part of the knob 1576 of the lead lock member 1572, is guided by the actuator pin 1588a and the multiple channels 1624. The width (e.g., diameter) of each actuator pin 1588a is approximately equal to or slightly smaller than the first width 1632. Thus, the actuator pins 1588a can be positioned within the first end 1628 and the multiple gripping features 1608 can be kept free, as shown, for example, in Figure 22D. In this free state, the multiple gripping features 1608 do not grip the lead assembly 1560. The lead assembly 1560 can slide freely relative to the handle 1508 (e.g., in the plane of the paper in Figure 22D). As described above, when saline solution or other lubricating fluid is supplied through the fluid port 1584, the lead assembly 1560 can slide with lower friction. The first end 1628 may have a rounded shape, for example, circular or semi-circular. The first end 1628 of each of the multiple channels 1624 may form a notch into which the actuator pin 1588a can engage.For example, a guide surface 1648 within each of the channels 1624, which are outward-facing surfaces of the multiple gripping features 1608 facing the inner circumference 1616, can be engaged by one of the multiple pins of the actuator pin 1588a. The guide surface 1648 may contact the side of the actuator pin 1588a or part of another projection extending from the handle 1508, and this contact may play a role in controlling the movement of the multiple gripping features 1608. In the free state, the radial gap between the guide surface 1648 and the inner circumference 1616 may be smaller than the width (e.g., diameter) of the actuator pin 1588a. Therefore, when the ring member 1596 of the knob 1576 is rotated in the direction of the arrow, the actuator pin 1588a moves from the first end 1628 to the second end 1636, causing the multiple gripping features 1608 to move away from the inner circumference 1616. This movement or operation of the multiple gripping features 1608 may cause the teeth 1672 to move toward the central axis 1676 of the handle 1508 in a direction toward which the teeth 1672 engage with the outer surface of the lead assembly 1560.

[0117] When the ring member 1596 moves completely relative to the actuator pin 1588a, the pin is positioned at the second end 1636. In the free state of the multiple gripping features 1608, the second width 1640 is smaller than the width (e.g., diameter) of the pin. However, when one of the multiple actuator pins 1588a is positioned at the second end 1636 of one channel of the multiple channels 1624, the multiple gripping features 1608 are deflected to the position shown in Figure 22E, and the teeth 1672 are pushed toward the central axis 1676. The teeth 1672 can take any suitable form. In one favorable configuration, the teeth 1672 are formed as a thread formed through the thickness of the multiple gripping features 1608 to the free end 1620. In this context, the thickness dimension is measured along the central axis 1676. Multiple gripping features 1608 are deflected at the second end 1636 such that the second end of the channel has a first width 1632 as shown in Figure 22E. The guide surface 1648 may have arc portions in the parts corresponding to the first end 1628 and the second end 1636. The guide surface 1648 may have a flatter arc or an inverse convexity between the first end 1628 and the second end 1636 compared to the convexity at the first end 1628 and the second end 1636.

[0118] The lead lock member 1572 may be configured to provide a locked and unlocked state reversibly and selectively. The transition from the unlocked state to the locked state is as described above. The transition from the locked state to the unlocked state can be achieved by rotating the knob 1576 in the opposite direction to the direction indicated by the arrow in Figure 22D. Such rotation moves each of the plurality of actuator pins 1588a from the second end 1636 of each of the plurality of channels 1624 toward the first end 1628 of each of the plurality of channels 1624, and possibly into the first end 1628. The plurality of gripping features 1608 may be configured to be spring-like or elastic so that the plurality of gripping features 1608 return to the position shown in Figure 22D when the actuator pins 1588a do not apply force to the guide surface 1648.

[0119] Figure 22B shows that a visual representation of the state of the lead lock member 1572 is provided to the user. The pointer on the outer circumference 1604 of the ring member 1596 moves with the movement of the ring member 1596. At the end of the range of motion where the actuator pin 1588a is located at the first end 1628 adjacent to the fixed end 1612, the lead lock member 1572 is unlocked. The pointer on the outer circumference 1604 directly points to an icon indicating the unlocked state formed on the proximal end 1556 of the outer surface 1524 of the handle 1508, for example, a lock icon where the locking part is released from the lock body. At the end of the range of motion where the actuator pin 1588a is located at the second end 1636 adjacent to the free end 1620, the lead lock member 1572 is locked. The pointer on the outer circumference 1604 directly points to an icon indicating the locked state on the outer surface 1524 of the handle 1508, for example, a lock icon where the locking part is engaged with the lock body. The arrows at both ends on the outer surface 1524 of the handle 1508 indicate to the user the direction of movement from the unlocked state to the locked state and from the locked state to the unlocked state.

[0120] Figure 22A shows that the distal and proximal surfaces of the knob 1576 may be recessed for different purposes. The distal recess on the knob 1576 is capable of receiving the proximal cylindrical projection of the handle 1508. The proximal cylindrical projection of the handle 1508 may be a fixture for securing the fluid port 1584 to the proximal portion 1516 of the handle 1508. The distal recess may be formed to have a cylindrical outer surface configured to guide the fluid port 1584 over the cylindrical outer surface of the fixture to which it is coupled. The projection and distal recess configuration may also form a proximal-distal gap between the proximal end 1556 of the outer surface 1524 of the handle 1508 and the knob 1576, so that the tubular body of the fluid port 1584 extends between these structures and a lubricant or cleaning fluid can flow into or through this gap into the handle 1508. The distal recess is visible in Figures 22A and 22C. The proximal recess is visible in Figures 22A and 22B. The proximal recess forms a space or height between the distal and proximal parts where the head of the actuator pin 1588a can be positioned, thereby preventing these heads from being exposed and from protruding beyond the proximal surface of the knob 1576. As a result, the proximal surface of the knob 1576 suppresses the tendency for the actuator pin 1588a to catch on or become entangled with other instruments or objects in the treatment area.

[0121] Figures 22F to 22I show a delivery system 1500 having a lead lock member 1572' of a second embodiment. The lead lock member 1572' may be coupled to the handle 1508 at a proximal portion 1516. For example, one or more fasteners may extend into the handle 1508 through the housing 1602 of the lead lock member 1572'. The lead lock member 1572' may include an actuator 1606 and a clamp 1622. The actuator 1606 can move the clamp 1622 between an engaged and disengaged state. In the engaged state, the clamp 1622 may fix the lead assembly 1560 to the handle 1508 to prevent relative movement (e.g., relative sliding movement) between the lead assembly 1560 and the handle 1508. In the disengaged state, the clamp 1622 may allow relative movement between the lead assembly 1560 and the handle 1508.

[0122] As shown at least in Figures 22H and 22I, the actuator 1606 may include a threaded member. The actuator 1606 may include a head 1610 and a shaft 1614. The shaft 1614 is coupled to the head 1610 and may have threads on its outer surface. The shaft 1614 may extend into the internal volume of the housing 1602. The shaft 1614 may screw-engage with the housing 1602. The head 1610 may be used to rotate the shaft 1614 relative to the housing 1602. By rotating the actuator 1606 in a first direction, the actuator 1606 can be further extended into the housing 1602, thereby moving the clamp 1622 from an unengaged state to an engaged state. By rotating the actuator 1606 in a second direction opposite to the first direction, the actuator 1606 can be retracted from the housing 1602, thereby moving the clamp 1622 from an engaged state to an unengaged state.

[0123] Referring subsequently to Figures 22H and 22I, the clamp 1622 may include a first clamping member 1626 and a second clamping member 1630. In some embodiments, the clamp 1622 includes only the first clamping member 1626. In the illustrated example, the first clamping member 1626 is located on the first side of the lumen 1618 extending through the housing 1602, and the second clamping member 1630 is located on the second side of the lumen 1618. The lumen 1618 may be axially aligned with the lumen 1564. For example, the central axis 1676 of the handle 1508 may be aligned with the central axis of the lumen 1618. As shown in Figure 22I, at least a portion of the lead assembly 1560 may be positioned within the lumen 1618 during deployment and / or retrieval of the lead assembly 1560. When the lead assembly 1560 is positioned within the lumen 1618, the first clamp member 1626 is positioned on the first side of the lead assembly 1560, and the second clamp member 1630 is positioned on the second side of the lead assembly 1560. In the engaged configuration, the clamp 1622 can apply pressure to a portion of the outer surface of the lead assembly 1560 to restrict the movement of the lead assembly 1560 relative to the handle 1508.

[0124] The first clamp member 1626 may include a first radial projection 1634 and a first disk 1638. The first end of the first radial projection 1634 may be positioned adjacent to the lumen 1618, and the opposite second end may be positioned adjacent to the actuator 1606. The first disk 1638 may extend from or be coupled to the first radial projection 1634 at its first end. The first radial projection 1634 may be an elongated cylinder having a smaller diameter than the first disk 1638. Thus, the first disk 1638 is an enlarged disk relative to the first radial projection 1634. In the engaged configuration, the first disk 1638 may extend at least partially into the lumen 1618. The first disk 1638 may include a first lead engagement surface 1642. The first lead engagement surface 1642 is a surface of the first clamp member 1626 configured to engage with the lead assembly 1560. The first clamp member 1626 may be movable relative to the housing 1602. The actuator 1606 can move the first clamp member 1626 toward and away from the lumen 1618. For example, the first clamp member 1626 may be coupled to the actuator 1606. In the illustrated example, the first clamp member 1626 is moved toward the lumen 1618 by rotating the actuator 1606 in a first direction, and the first clamp member 1626 is moved away from the lumen 1618 by rotating the actuator 1606 in a second direction. In the illustrated example, the first clamp member 1626 is coupled to the actuator 1606 via a first radial projection 1634. For example, the first radial projection 1634 extends into a coupling cylinder 1658 coupled to the shaft 1614 of the actuator 1606. Thus, linear movement of the actuator 1606 relative to the housing 1602 causes a corresponding linear movement of the first clamping member 1626. In some embodiments, the first clamping member 1626 may be configured to return from an engaged state to an unengaged state when the shaft 1614 does not further push the first clamping member 1626 into the lumen 1618.For example, the first clamping member 1626 may be elastic, such as a spring, so that it is biased to move away from the shaft 1676 when no force is applied from the actuator 1606. In such an embodiment, the actuator 1606 is not required to pull the first clamping member 1626 back from the engaged to the disengaged state. Instead, the first clamping member 1626 can be disengaged from the lead assembly 1560 by removing the force applied from the actuator 1606.

[0125] In the illustrated example, the second clamp member 1630 has a similar configuration to the first clamp member 1626. For example, the second clamp member 1630 may include a second radial projection 1646 and a second disk 1650. The first end of the second radial projection 1646 may be positioned adjacent to the lumen 1618, and the opposite second end may be positioned away from the lumen 1618. The second disk 1650 may extend from or be coupled to the second radial projection 1646 at its first end. The second radial projection 1646 may be an elongated cylinder having a smaller diameter than the second disk 1650. Thus, the second disk 1650 is an enlarged disk relative to the second radial projection 1646. The second disk 1650 may extend at least partially into the lumen 1618. The second disk 1650 may include a second lead engagement surface 1654. The second lead engagement surface 1654 is a surface of the second clamp member 1630 configured to engage with the lead assembly 1560. The second clamp member 1630 can be fixed to the housing 1602.

[0126] The lead engagement surfaces 1642 and 1654 of the clamp members 1626 and 1630 may have an enlarged area compared to the cross-sectional area of ​​the radial projections 1634 and 1646. When shown in cross-section, the clamp members 1626 and 1630 may be substantially T-shaped, as shown in Figures 22H and 22I. As described above, in the engagement configuration, a portion of the lead assembly 1560 is compressed or sandwiched between the clamp members 1626 and 1630, at which point the lead engagement surfaces 1642 and 1654 engage with the lead assembly 1560 on opposite sides. The lead engagement surfaces 1642 and 1654 may have a diameter larger than the maximum diameter of the lead assembly 1560. This configuration ensures that the lead assembly 1560 engages mainly with the clamp members 1626 and 1630 and does not engage with the wall of the lumen 1618 in the engagement configuration. Furthermore, this configuration makes it possible for the clamp members 1626 and 1630 to engage with the lead assembly 1560 even if the lead assembly 1560 is not perfectly aligned with the central axis 1676.

[0127] To transition the clamp 1622 from an unengaged state to an engaged state, the actuator 1606 can be rotated in a first direction. This rotation moves the first clamp member 1626 and the first lead engagement surface 1642 from a first position that allows the lead assembly 1560 to move within the lumen 1618 and / or slide along the first lead engagement surface 1642 to a second position that restricts the movement of the lead assembly 1560 along the first lead engagement surface 1642. In the second position, the lead assembly 1560 is engaged on both sides of the lead engagement surfaces 1642 and 1654 of the clamp members 1626 and 1630. In some embodiments, the clamp members 1626 and 1630 may be made from a compressible material such as silicone. As a result, as the first clamp member 1626 moves to the second position, the clamp members 1626,1630 are able to at least partially conform to the shape of the lead assembly 1560 when pressure is applied to the lead assembly 1560 in the engaged state. By partially conforming to the shape of the lead assembly 1560, the clamp members 1626,1630 can reduce the possibility of damage to the lead assembly 1560, which is particularly important during the deployment of the lead assembly 1560. In some cases, the second lead engagement surface 1654 can partially extend into the lumen 1618, thereby limiting the engagement between the lead assembly 1560 and the wall of the lumen 1618 when pressure is applied to the lead assembly 1560 via the first lead engagement surface 1642.

[0128] The lead lock member 1572' may offer certain advantages compared to the lead lock member 1572. As described above, the clamp members 1626 and 1630 can conform to the shape of the lead assembly 1560 to reduce the possibility of damage to the lead assembly 1560. As another example, the lead lock member 1572' may be configured to work with lead assemblies 1560 of various sizes. For example, since the first clamp member 1626 is movable relative to the housing 1602, the lead lock member 1572' can accommodate lead assemblies 1560 of different sizes. In some cases, the lead lock member 1572' may provide a stronger lock than the lead lock member 1572.

[0129] The above description of the delivery system 1500 related to Figures 22 to 22I should be considered in conjunction with the description of each step of method 900 related to Figures 15 to 15J.

[0130] Although the implant assemblies disclosed herein are configured for permanent use, some patients may not require the continued treatment provided by such assemblies. Figures 23–23F show various examples of lead retrieval systems 1740 that may be used to remove implant assemblies 501. The lead retrieval system 1740 may have or include one or more instruments to facilitate retrieval. For example, the lead retrieval system 1740 may include a lead extender 1768. Figures 23–23D show a first embodiment of the lead retrieval system 1740 including a lead extender 1768 of the first example. Figures 23E and 23F show a second embodiment of the lead retrieval system 1740 including a lead extender 1768' of the second example.

[0131] Referring first to Figure 23, the lead extender 1768 of the first example includes a tubular shaft 1772 extending from a proximal end to a distal portion 1776. The distal portion 1776 extends to a distal end having an opening configured to receive the proximal portion of the lead assembly 1560. One or more teeth 1780 are arranged on the 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 inclined inward toward the longitudinal axis 1832 of the lead extender 1768. For each tooth 1780, the free end 1788 is located proximal to the fixed end 1792. The teeth 1780 can be elastically deflected from a first inward inclined position to a second inward inclined position. The first inward inclined position is positioned at a higher angle than the second inward inclined position. The second medial inclination position is the position deflected by the insertion of the lead assembly 1560. Figure 23 shows the first medial inclination position in relation to the four most proximal teeth 1780. Figure 23 shows the second medial inclination position in relation to the six most distal teeth 1780.

[0132] Referring here to Figure 23E, the lead extender 1768' in the second example may include a tubular shaft 1772' extending from the proximal end to the distal portion 1776'. The lead extender 1768' may also include one or more projections 1780' extending from the distal end of the tubular shaft 1772'. Thus, one or more projections 1780' may form the most distal 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 embedded in the wall of the lead assembly 1560 at or distal to the lead cutting line 1840. For example, as shown in Figure 23F, the projection 1780' may be configured to be inserted into the lead assembly 1560 at or distal to the cutting line 1840 to engage with the inner surface of the tube 570 of the lead assembly 1560. When projection 1780' engages with tube 570, the lead retrieval system 1740 can support the tensile load during the withdrawal of the lead assembly 1560. To engage with tube 570, projection 1780' may be a threaded extension of lead extender 1768'. For example, projection 1780' may have one or more threads 1784' on it. Threads 1784' may have an outer diameter larger than the inner diameter of tube 570. Thus, as projection 1780' is advanced and rotated into lead assembly 1560, threads 1784' bite into the inner surface of tube 570, and lead extender 1768' is coupled to lead assembly 1560 via projection 1780', as shown in Figure 23F. In other embodiments, the projection 1780' does not include a screw 1784', and instead may include one or more teeth that extend outward along the projection 1780' or inward from the inner surface of the tubular shaft 1772', similar to the lead extender 1768.

[0133] Figures 23A and 23B show two steps in a method for retrieving the implant assembly 501. As described with respect to Figure 15H, the lead assembly 1560 is connected to the controller 50 at the end of the process of implanting the implant assembly 501. In one method, to initiate the retrieval of the implant assembly 501, the lead assembly 1560 is cut through the outer surface 1836 and through the entire thickness of the lead assembly 1560 adjacent to the controller 50. This causes the lead cut line 1840 to form a new proximal end based on the cutting process. Figures 23A and 23B show a retrieval method using a lead extender 1768, but a similar method can be performed using a lead extender 1768' as described below.

[0134] The process of cutting the lead assembly 1560 results in a very short externally accessible length for the patient. This short accessible length would not be sufficient to allow the delivery system 1500 to be used for the removal of the implant assembly 501. Lead extenders 1768, 1768' allow the delivery system 1500 to be used in a retrieval technique. In a retrieval technique, the proximal portion of the lead assembly 1560 extending distally from the lead cutting line 1840 or the cut end is guided to a position adjacent to the distal portion 1776, 1776' of the lead retrieval system 1740. When using the lead extender 1768, as shown in Figure 23B, the lead cutting line 1840 is then inserted into the opening at the end of the distal portion 1776 of the lead extender 1768, as indicated by the right-hand arrow in Figure 23. The lead cutting line 1840 is inserted along the longitudinal axis 1832, deflecting the six teeth 1780 from a first inward inclined position to a second inward inclined position, which is at a smaller angle than the first inward inclined position. The teeth 1780 are elastically biased toward the first inward inclined position, causing them to bite into the outer surface 1836 of the lead assembly 1560. The lead assembly 1560 may be further inserted into a lead extender 1768 to further enhance the grip on the outer surface 1836 adjacent to the lead cutting line 1840. When using the lead extender 1768', the projection 1780' may be inserted into the lead assembly 1560 at the lead cutting line 1840. The lead extender 1768' is then rotated relative to the lead assembly 1560, causing the threads 1784' of the projection 1780' to bite into the inner surface of the tube 570 of the lead assembly 1560. The projection 1780' may be further inserted into the lead assembly 1560 to further enhance the grip on the inner surface of the tube 570 adjacent to the lead cutting line 1840. Figure 23B shows that the lead extender 1768 is long enough to position the dilator 1856 on top of the lead extender 1768. The dilator 1856 may be the same as or similar to the dilator 1856 used in step 915A shown in Figure 15A. The dilator 1856 may have a lumen that accommodates the lead extender 1768.Similarly, the lead extender 1768 may have sufficient length to accommodate the dilator 1856 above the lead extender 1768'.

[0135] Figures 23C and 23D show another configuration of teeth formed on the tubular shaft 1772. The teeth may include a plurality of teeth 1824 within the tubular shaft 1772. The plurality of teeth 1824 may be arranged in rows, for example, including a plurality of rows of teeth 1828, for example, an array of rows of 2, 3, 4, 5, 6, or more than 6 teeth 1824. The plurality of teeth 1824 may have pointed tips 1820 as shown in Figure 23C. The pointed tips 1820 provide a stronger connection between the outer surface 1836 and the lead extender 1768. Figure 23D may show another embodiment in which each of the plurality of teeth 1836 includes a blunt tip 1816. The blunt tip 1816 includes a concave structure at the distal end of each of the plurality of teeth 1836.

[0136] The method using the lead extender 1768 is shown in Figures 23A and 23B as described above. Once the lead extender 1768 or lead extender 1768' is securely coupled to the cut end, for example, with the lead cut line 1840 positioned proximal to the opening at the distal end of the distal portion 1776 of the lead extender 1768, the dilator 1856 and the introducer shaft 1504 of the introducer sheath are advanced over the coupled lead extender 1768 and lead assembly 1560 and inserted into the patient as part of a process to provide access for the delivery system 1500. Once access is provided and the introducer shaft 1504 is positioned, the dilator 1856 can be removed from the patient. The dilator 1856 can be replaced with the delivery system 1500, which is also a retrieval system, as described herein. The delivery shaft 1510 (used as a retrieval shaft in this method) and handle 1508 are advanced over the proximal end of the lead extender 1768, over the junction between the lead cutting line 1840 and the distal portion 1776 of the lead extender 1768, and through the introducer shaft 1504, until the delivery shaft 1510 is advanced within the patient until its distal end is adjacent to the implant assembly 501. The delivery shaft 1510 may be advanced until the position of its distal end relative to the implant assembly 501 is confirmed by fluoroscopy (e.g., by visualization of radiopaque markers). To achieve this, the outer surfaces of the lead extenders 1768, 1768' are configured to be slidable relative to the lead lock member 1572 when the lead lock member 1572 is not in the locked position. Subsequently, the proximal portion of the lead extender 1768, 1768' or the severed lead assembly 1560 can be locked against the handle 1508 using the lead locking member 1572. Folding of the implant assembly 501 is initiated by advancing the carriage 1532 inside the handle 1508, which causes the distal end of the delivery shaft 1510 to slide over the implant assembly 501 and fold the implant assembly 501.Similar to deployment, if the indicator 1544 is included in the handle 1508, it can provide clinicians with direct and convenient feedback regarding the position of the distal end of the delivery shaft 1510 relative to the implant assembly 501.

[0137] The delivery system 1500 also serves as the retrieval system, the delivery shaft 1510 also serves as the retrieval shaft, and the handle 1508 serves as both a delivery handle and a retrieval handle, thus advantageously allowing the delivery and retrieval steps to be performed by the same system. This reduces the number of parts required for patient handling, simplifies the procedure, and allows clinicians to use many of the same instruments in both procedures.

[0138] Although the systems, devices, and / or components thereof are described and / or configured for permanent use, any system, device, and / or component thereof may be configured and / or used for acute use. For example, in some embodiments, an implantable controller or actuator, as described herein, may be placed outside the patient's body, while an implant operably connected to the controller or actuator, as described herein, may be implanted within the patient's blood vessels. In such embodiments, an external device may not be required to operate the system, and for example, the patient or user may operate the system through interaction with a controller located outside the patient.

[0139] Additional embodiments Clause 1. A delivery system for a blood flow occlusion system, the handle comprising: a handle having a distal portion, a proximal portion, an actuator disposed between the proximal portion and the distal portion, movable relative to the outer surface of the handle, the actuator being coupled to an internally threaded cylinder; a carriage disposed within the internally threaded cylinder, the carriage having an external thread formed on the carriage and a carriage magnet disposed on or adjacent to the external thread; and an indicator movably disposed on the proximal portion and magnetically engaged with the carriage magnet, the indicator moving with the movement of the carriage magnet to provide visual feedback of the position of a delivery shaft coupled to the carriage.

[0140] Clause 2. The delivery system according to Clause 1, having a shaft interface located distal to the carriage, wherein the shaft interface is configured to reliably engage with the proximal end of the delivery shaft of the delivery system.

[0141] Clause 3. The delivery system according to Clause 1, wherein the carriage has a lumen through which the lead assembly of the blood flow occlusion system can pass.

[0142] Clause 4. The delivery system according to Clause 1, further comprising a lead locking member configured to engage with the lead assembly of the blood flow occlusion system and to control or prevent the movement of the lead assembly relative to the outer surface of the handle when the carriage moves proximal or distal within the handle.

[0143] Clause 5. The delivery system according to Clause 4, wherein the lead lock member is engaged with the proximal end of the handle.

[0144] Clause 6. The delivery system according to Clause 5, wherein the lead locking member has a knob configured to rotate relative to the proximal end of the handle to transition one or more locking configurations from an unengaged state to an engaged state.

[0145] Clause 7. The delivery system according to Clause 1, further comprising a fluid port configured to allow injection of saline solution to facilitate the movement of the delivery shaft on the outer surface of the lead assembly when the actuator is moving.

[0146] Clause 8. A delivery system for a blood flow occluder, comprising: a handle having a proximal portion; a lead lock coupled to the proximal portion, comprising a plurality of actuator pins extending from the proximal end of the proximal portion of the handle; and a lock actuator rotatably coupled to the proximal end of the proximal portion of the handle, wherein the lock actuator comprises a ring member, the ring member comprising a gripping surface on its outer circumference, a plurality of gripping features, each gripping feature having a fixed end coupled to the inner circumference of the ring member and a free end positioned radially inward from the fixed end; and a plurality of channels, at least one of the plurality of channels being positioned between each gripping feature and the inner circumference of the ring member. A delivery system comprising: a lead lock having a plurality of channels, each having a first end having a first width and a second end having a second width smaller than the first width, wherein one actuator pin of the plurality of actuator pins is positioned in each of the plurality of channels, and rotation of the lock actuator relative to the actuator pin moves the plurality of gripping features radially inward to a gripping position when the plurality of actuator pins are positioned inward to a gripping position when the plurality of actuator pins are positioned inward to a release position when the plurality of gripping features are positioned inward to a release position when the plurality of actuator pins are positioned inward to a release position.

[0147] Clause 9. A delivery system for a blood flow occluder, comprising: a handle; a lead lock coupled to the handle, comprising: a lock actuator movably coupled to the handle, comprising: a hand gripping structure on the outer circumference of the lock actuator; a lead gripping feature having a fixed end located inside the hand gripping structure and a free end located away from the fixed end; a guide surface located between the lead gripping feature and the projection, comprising the guide surface having a first end having a first engaging portion and a second end having a second engaging portion; and the lead lock, wherein the projection is located adjacent to the guide, and movement of the lock actuator relative to the projection moves the lead gripping feature inward to a gripping position when the projection is located at the second end of the guide surface, and the lead gripping feature is movable outward to a release position when the projection is located at the first end of the guide surface.

[0148] Clause 10. A delivery system for a blood flow occluder according to Clause 9, wherein the lead lock is rotatably coupled to the proximal end of the handle.

[0149] Clause 11. A delivery system for a blood flow occluder according to Clause 10, wherein the projection is located on the proximal surface of the handle and the guide surface is in contact with the lateral portion of the projection.

[0150] Clause 12. The delivery system for the blood flow occlusion device of Clause 9, wherein the lead gripping feature includes teeth oriented toward the central axis of the handle.

[0151] Clause 13. A delivery system for a blood flow occluder according to Clause 12, wherein the teeth include screws facing the central axis of the handle.

[0152] Clause 14. A delivery system for a blood flow occluder according to Clause 9, wherein the lock actuator includes a ring rotatably mounted on the handle, and the guide surface is formed on the outer portion of the lead gripping feature including teeth configured to face the central axis of the ring.

[0153] Clause 15. The delivery system for a blood flow occluder according to Clause 14, wherein the lead gripping feature has an arm and further has at least one additional arm so as to form a plurality of arms extending inward from the inner surface of the ring, and each of the plurality of arms includes a guide surface formed on the outer portion of the corresponding arm and teeth away from a fixed end configured to face the central axis of the ring.

[0154] Clause 16. A delivery system for a blood flow occluder according to Clause 15, wherein the projection is a first projection and further has at least one additional projection to form a plurality of projections, and the guide surface of each arm forms one side of a channel that determines the position for positioning one of the plurality of projections when the projection moves relative to the lock actuator.

[0155] Clause 17. A delivery system for a blood flow occluder according to Clause 15, wherein the guide surface includes a first circular recess at the first end of the guide surface and a second circular recess at the second end of the guide surface.

[0156] Clause 18. The delivery system for the blood flow occlusion device of Clause 15, wherein the plurality of arms includes three arms.

[0157] Clause 19. Lead retrieval system for a blood flow occluder, comprising: a handle having a proximal portion; a lead lock coupled to the proximal portion, having a first form in which a lead positioned through the lead lock is held in a fixed position relative to the handle; and a second form in which a lead positioned through the lead lock is movable relative to the handle; a lead extender device having a tubular shaft positioned at the distal portion of the lead extender device; and a tubular shaft having one or more teeth positioned on the inner surface of the tubular shaft, wherein the one or more teeth are inclined inward such that the free end of each of the one or more teeth is positioned proximal to the fixed end of the tooth and is positioned within the lumen of the tubular shaft, wherein the distal end of the tubular shaft of the lead extender device has an outer surface sized to slide through the lead lock to engage with a lead distal to the proximal end of the lead or to engage with the lead extender device.

[0158] Clause 20. The lead retrieval system of Clause 19, wherein one or more teeth have a blunt tip at the free end of the tooth.

[0159] Clause 21. The lead retrieval system of Clause 19, wherein one or more teeth have pointed tips at the free ends of the teeth.

[0160] Clause 22. The lead retrieval system of Clause 19, wherein the one or more teeth include multiple teeth.

[0161] Clause 23. The lead retrieval system of Clause 22, wherein the plurality of teeth are arranged in a plurality of rows aligned along the longitudinal axis of the lead extender device.

[0162] Clause 24. An instrument for retrieving a blood flow occluder, comprising a lead extender having a tubular shaft, the tubular shaft being positioned distal to the lead extender, the tubular shaft having one or more teeth positioned on the inner surface of the tubular shaft, the one or more teeth being inclined inward so that the free end of each of the one or more teeth is positioned proximal to the fixed end of each tooth and is positioned within the lumen of the tubular shaft, the teeth being configured to grip the outer surface of the lead of the blood flow occluder, and the tubular shaft having a length and outer surface of such size that the lead extender can be inserted through the sheath and handle of a retrieval device so that the proximal end of the lead extender may be positioned proximal to the handle of the retrieval device.

[0163] Clause 25. The instrument of Clause 24, wherein one or more teeth have a blunt tip at the free end of the tooth.

[0164] Clause 26. The apparatus of Clause 24, wherein one or more teeth have pointed tips at the free ends of the teeth.

[0165] Clause 27. The appliance of Clause 24, wherein the one or more teeth include multiple teeth.

[0166] Clause 28. The apparatus of Clause 27, wherein the plurality of teeth are arranged in a plurality of rows aligned along the longitudinal axis of the lead extender.

[0167] Clause 29. A method for retrieving a blood flow occluder, comprising: accessing the proximal length portion of the lead assembly of the blood flow occluder; advancing the distal portion of the lead extender over the proximal portion of the lead assembly such that at least one inclined tooth is positioned in the lumen of the lead extender over the proximal portion of the lead assembly; advancing a dilator over the distal portion of the lead extender positioned on the lead assembly; replacing the dilator with a retrieval assembly having a retrieval sheath and a retrieval handle; and removing the blood flow occluder within the retrieval sheath.

[0168] Clause 30. The method of Clause 29, further comprising cutting the lead assembly distal to the proximal end of the lead assembly to form a cut end, advancing the distal portion of the lead extender over the cut end, and advancing the dilator over the cut end of the lead assembly.

[0169] Clause 31. The method of Clause 30, further comprising locking the portion of the lead assembly distal to the lead extender or the cut end against the outer surface of the retrieval handle, and then advancing the retrieval sheath over the blood flow occluder to fold the blood flow occluder.

[0170] Clause 32. A delivery system for a blood flow occlusion system, the delivery system having a handle having a distal portion, a proximal portion, an actuator positioned between the proximal portion and the distal portion and movable relative to the outer surface of the handle, and a carriage positioned within the handle, wherein the actuator is configured to move the carriage to deploy the blood flow occlusion system.

[0171] Clause 33. The delivery system of Clause 32, wherein the actuator is coupled to an internally threaded cylinder, the carriage is located within the internally threaded cylinder, and the carriage has external threads.

[0172] Clause 34. A delivery system according to Clause 32 or 33, further comprising an indicator movably positioned on the proximal portion and magnetically engaged with a carriage magnet positioned on or adjacent to the outer surface of the carriage, wherein the movement of the carriage magnet causes the indicator to move, thereby providing visual feedback of the position of a delivery shaft coupled to the carriage.

[0173] Clause 35. A delivery system according to any of Clauses 32 to 34, having a shaft interface located distal to the carriage, wherein the shaft interface is configured to reliably engage with the proximal end of the delivery shaft of the delivery system.

[0174] Clause 36. The delivery system of any of Clauses 32-35, wherein the carriage has a lumen through which the lead assembly of the blood flow occlusion system can pass.

[0175] Clause 37. A delivery system according to any of Clauses 32 to 36, further comprising a lead lock member configured to engage with the lead assembly of the blood flow occlusion system and to control or prevent the movement of the lead assembly relative to the outer surface of the handle when the carriage moves proximal or distal within the handle.

[0176] Clause 38. The delivery system of Clause 37, wherein the lead lock member is engaged with the proximal end of the handle.

[0177] Clause 39. The delivery system of Clause 38, wherein the lead locking member has a knob configured to rotate relative to the proximal end of the handle to transition one or more locking configurations from an unengaged state to an engaged state.

[0178] Clause 40. The delivery system of Clause 37 or Clause 38, wherein the lead locking member has a clamp having an unengaged form and an engaged form.

[0179] Clause 41. The delivery system of Clause 40, wherein the clamp comprises a first clamping member and a second clamping member, the first clamping member being configured to engage with the lead assembly on a first side and the second clamping member being configured to engage with the lead assembly on a second opposite side.

[0180] Clause 42. The delivery system of Clause 41, wherein the first clamping member and / or the second clamping member includes a radial projection having a first end positioned adjacent to the lumen and a second end opposite to the first end, and a lead engagement surface adjacent to the first end, the lead engagement surface having an enlarged area compared to the cross-sectional area of ​​the radial projection, and the lead engagement surface is movable by moving the radial projection from a first position that allows the lead assembly to slide along the lead engagement surface to a second position that restricts the movement of the lead assembly along the lead engagement surface.

[0181] Clause 43. The delivery system of Clause 42, wherein the lead engagement surface has a width or diameter greater than the maximum diameter of the lead assembly.

[0182] Clause 44. The delivery system of Clause 42 or Clause 43, wherein the first clamping member and / or the second clamping member have an enlarged disc positioned at the first end of the radial projection, the enlarged disc including the lead engagement surface, and the radial projection has an elongated cylinder having a smaller diameter than the enlarged disc.

[0183] Clause 45. A delivery system according to any of Clauses 40 to 44, wherein the lead lock member further comprises a threaded member, and rotation of the threaded member in a first direction relative to the outer surface of the handle causes the clamp to transition from the disengaged state to the engaged state.

[0184] Clause 46. The clamp is a delivery system of any of Clauses 40-45, comprising a compressible material.

[0185] Clause 47. The delivery system of Clause 46, wherein a portion of the clamp facing the lumen is configured to conform to the shape of the lead assembly when pressure is applied to the lead assembly in the engaged configuration.

[0186] Clause 48. A delivery system according to any of Clauses 32 to 47, further comprising a fluid port that allows for the injection of saline solution to facilitate the movement of the delivery shaft of the delivery system on the outer surface of the lead assembly of the blood flow occluder system when the actuator is moving.

[0187] Clause 49. A delivery system for a blood flow occluder, comprising: a handle having a proximal portion; a lead lock coupled to the proximal portion, comprising a plurality of actuator pins extending from the proximal end of the proximal portion of the handle; and a lock actuator rotatably coupled to the proximal end of the proximal portion of the handle, wherein the lock actuator comprises a ring member, the ring member having a gripping surface on its outer circumference, a plurality of gripping features, each gripping feature having a fixed end coupled to the inner circumference of the ring member and a free end positioned radially inward from the fixed end; and a plurality of channels, at least one of the plurality of channels disposed between each of the plurality of gripping features and the inner circumference of the ring member. A delivery system comprising: a plurality of channels, each having a first end having a first width and a second end having a second width smaller than the first width; a lead lock, each having a plurality of channels; a lock actuator, and one actuator pin of the plurality of actuator pins positioned in each of the plurality of channels; and rotation of the lock actuator relative to the actuator pin causes the plurality of gripping features to move radially inward to a gripping position when the plurality of actuator pins are positioned inward to a gripping position when the plurality of actuator pins are positioned inward to a release position when the plurality of gripping features are positioned inward to a release position when the plurality of actuator pins are positioned inward to a release position.

[0188] Clause 50. A delivery system for a blood flow occluder, comprising: a handle; a lead lock coupled to the handle, comprising: a lock actuator movably coupled to the handle, comprising: a hand gripping structure on the outer circumference of the lock actuator; a lead gripping feature having a fixed end located inside the hand gripping structure and a free end located away from the fixed end; a guide surface located between the lead gripping feature and the projection, comprising the guide surface having a first end having a first engaging portion and a second end having a second engaging portion; and the lead lock, wherein the projection is located adjacent to the guide, and movement of the lock actuator relative to the projection moves the lead gripping feature inward to a gripping position when the projection is located at the second end of the guide surface, and the lead gripping feature is movable outward to a release position when the projection is located at the first end of the guide surface.

[0189] Clause 51. The delivery system of Clause 50, wherein the lead lock is rotatably coupled to the proximal end of the handle.

[0190] Clause 52. The delivery system of Clause 51, wherein the projection is located on the proximal surface of the handle and the guide surface is in contact with the lateral portion of the projection.

[0191] Clause 53. A delivery system according to any of Clauses 50 to 52, wherein the lead gripping feature includes teeth oriented toward the central axis of the handle.

[0192] Clause 54. A delivery system according to any of Clauses 50 to 52, wherein the lead gripping feature includes a screw directed toward the central axis of the handle.

[0193] Clause 55. A delivery system according to any of Clauses 50 to 54, wherein the lock actuator includes a ring rotatably mounted on the handle, and the guide surface is formed on the outer portion of the lead gripping feature including teeth configured to face the central axis of the ring.

[0194] Clause 56. The delivery system of Clause 55, wherein the lead gripping feature has an arm and further has at least one additional arm so as to form a plurality of arms extending inward from the inner surface of the ring, and each of the plurality of arms includes a guide surface formed on the outer portion of the corresponding arm and teeth away from a fixed end configured to face the central axis of the ring.

[0195] Clause 57. The delivery system of Clause 56, wherein the projection is a first projection and further has at least one additional projection to form a plurality of projections, and the guide surface of each arm forms one side of a channel that determines a position for positioning one of the plurality of projections when the projection moves relative to the lock actuator.

[0196] Clause 58. The delivery system of Clause 56 or Clause 57, wherein the guide surface includes a first circular recess at the first end of the guide surface and a second circular recess at the second end of the guide surface.

[0197] Clause 59. The delivery system of any of Clauses 56-58, wherein the plurality of arms includes three arms.

[0198] Clause 60. A delivery system for a blood flow occluder, comprising: a handle; a lead lock coupled to the handle, the lead lock being configured to engage with a lead assembly of the blood flow occluder to control or prevent the movement of the lead assembly relative to the outer surface of the handle, the lead lock comprising: a lumen configured to receive at least a portion of the lead assembly; a clamp having a first clamp member and a second clamp member, the clamp having the first clamp member configured to engage with the lead assembly on the side of the lead assembly and the second clamp member configured to engage with the lead assembly; and an actuator, the actuator being configured to move the clamp from an unengaged state in which the lead assembly is movable relative to the outer surface of the handle to an engaged state in which the clamp restricts the movement of the lead assembly relative to the outer surface of the handle.

[0199] Clause 61. The delivery system of Clause 60, wherein the first clamping member and / or the second clamping member have a radial projection having a first end positioned adjacent to the lumen and a second end opposite to the first end, and a lead engagement surface adjacent to the first end, the lead engagement surface having an enlarged area compared to the cross-sectional area of ​​the radial projection, and the lead engagement surface is movable by moving the radial projection from a first position that allows the lead assembly to slide along the lead engagement surface to a second position that restricts the movement of the lead assembly along the lead engagement surface.

[0200] Clause 62. The delivery system of Clause 61, wherein the lead engagement surface has a width or diameter greater than the maximum diameter of the lead assembly.

[0201] Clause 63. The delivery system of Clause 61 or Clause 62, wherein the first clamping member and / or the second clamping member have an enlarged disc positioned at the first end of the radial projection, the enlarged disc including the lead engagement surface, and the radial projection has an elongated cylinder having a smaller diameter than the enlarged disc.

[0202] Clause 64. A delivery system according to any of Clauses 60 to 63, wherein the actuator has a threaded member, and rotation of the threaded member in a first direction relative to the outer surface of the handle causes the clamp to transition from the disengaged state to the engaged state.

[0203] Clause 65. The clamp is a delivery system of any of Clauses 60-64, comprising a compressible material.

[0204] Clause 66. A delivery system according to any of Clauses 60-65, wherein a portion of the clamp facing the lumen is configured to conform to the shape of the lead assembly when pressure is applied to the lead assembly in the engagement configuration.

[0205] 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, having a first form in which a lead disposed through the lead lock is held in a fixed position relative to the handle; and a second form in which a lead disposed through the lead lock is movable relative to the handle; and a lead extender device having a tubular shaft disposed at the distal portion of the lead extender device, wherein the distal end of the tubular shaft of the lead extender device has an outer surface sized to slide through the lead lock, and the distal end is configured to engage with the lead at or distal to the proximal end of the lead.

[0206] Clause 68. The lead retrieval system of Clause 67, wherein the tubular shaft has one or more teeth arranged on the inner surface of the tubular shaft, and the one or more teeth are inclined inward such that the free end of each of the one or more teeth is located proximal to the fixed end of each tooth and is located within the lumen of the tubular shaft.

[0207] Clause 69. The lead retrieval system of Clause 68, wherein one or more teeth have a blunt tip at the free end of the tooth.

[0208] Clause 70. The lead retrieval system of Clause 68, wherein one or more teeth have pointed tips at the free ends of the teeth.

[0209] Clause 71. The lead retrieval system of Clause 68, wherein the one or more teeth include multiple teeth.

[0210] Clause 72. The lead retrieval system of Clause 71, wherein the plurality of teeth are arranged in a plurality of rows aligned along the longitudinal axis of the lead extender device.

[0211] Clause 73. The lead retrieval system of Clause 67, wherein the lead extender device further has one or more projections extending from the distal end of the tubular shaft, the one or more projections being configured to engage with the surface of the lead.

[0212] Clause 74. The lead retrieval system of Clause 73, wherein the one or more projections include one or more screws positioned on the threaded extension of the lead extender device.

[0213] Clause 75. The lead retrieval system of Clause 74, wherein the threaded extension is configured to extend into the tube of the lead when engaged with the lead.

[0214] Clause 76. The lead retrieval system of Clause 75, wherein the outer diameter of the threads of the threaded extension is greater than the inner diameter of the tube of the lead.

[0215] Clause 77. The lead retrieval system of Clause 76, wherein the thread of the threaded extension is configured to bite into the wall of the tube when the lead extender device is rotated relative to the lead.

[0216] Clause 78. The lead retrieval system of Clause 73, wherein the one or more projections have teeth that are inclined inward such that the free end of each of the one or more teeth is positioned proximal to the fixed end of each tooth and is positioned within the lumen of the tubular shaft.

[0217] Clause 79. An instrument for retrieving a blood flow occluder, comprising a lead extender having a tubular shaft, the tubular shaft being positioned distal to the lead extender, the tubular shaft having one or more teeth positioned on the inner surface of the tubular shaft, the one or more teeth being inclined inward such that the free end of each of the one or more teeth is positioned proximal to the fixed end of each tooth and is positioned within the lumen of the tubular shaft, the one or more teeth being configured to grip the outer surface of the lead of the blood flow occluder, and the tubular shaft having a length and outer surface sized to allow the lead extender to be inserted through the sheath and handle of a retrieval device such that the proximal end of the lead extender may be positioned proximal to the handle of the retrieval device.

[0218] Clause 80. The apparatus of Clause 79, wherein one or more teeth have a blunt tip at the free end of the tooth.

[0219] Clause 81. The apparatus of Clause 79, wherein one or more teeth have pointed tips at the free ends of the teeth.

[0220] Clause 82. The appliance of Clause 79, wherein the one or more teeth include multiple teeth.

[0221] Clause 83. The apparatus of Clause 82, wherein the plurality of teeth are arranged in a plurality of rows aligned along the longitudinal axis of the lead extender.

[0222] Clause 84. An instrument for retrieving a blood flow occluder, comprising a lead extender having a proximal portion and a distal portion, wherein the distal portion is configured to be embedded in the wall of the lead of the blood flow occluder at or distal to the cut end of the lead, and the distal portion has a length and outer surface sized to allow the lead extender to be inserted through the sheath and handle of a retrieval device, such that the proximal portion may be positioned proximal to the handle of the retrieval device.

[0223] Clause 85. The apparatus of Clause 84, wherein the distal portion has one or more projections extending from the distal end, the one or more projections being configured to be inserted into the lead at the cut end or distal to the cut end so as to engage with the inner surface of the wall of the lead to support a tensile load during the withdrawal of the lead.

[0224] Clause 86. The apparatus of Clause 85, wherein the one or more projections include one or more screws positioned on the threaded extension of the lead extender.

[0225] Clause 87. The apparatus of Clause 86, wherein the outer diameter of one or more threads of the threaded extension is greater than the inner diameter of the wall of the lead.

[0226] Clause 88. The apparatus of Clause 87, wherein the one or more threads of the threaded extension are configured to bite into the inner surface of the wall of the lead when the lead extender is rotated relative to the lead.

[0227] Clause 89. The apparatus of Clause 85, wherein the one or more projections include one or more teeth positioned to extend inward on the inner surface of the tubular portion of the lead extender.

[0228] Clause 90. A method for retrieving a blood flow occluder, comprising: accessing the proximal length portion of the lead assembly of the blood flow occluder; advancing the distal portion of a lead extender to engage with the proximal portion of the lead assembly; advancing a dilator onto the distal portion of the lead extender positioned on the lead assembly; replacing the dilator with a retrieval assembly having a retrieval sheath and a retrieval handle; and removing the blood flow occluder within the retrieval sheath.

[0229] Clause 91. The method of Clause 90, further comprising advancing the distal portion of the lead extender above the proximal portion of the lead assembly such that at least one tooth inclined inward is positioned above the proximal portion of the lead assembly within the lumen of the lead extender.

[0230] Clause 92. The method of Clause 90, further comprising cutting the lead assembly distal to the proximal end of the lead assembly to form a cut end, advancing the distal portion of the lead extender over the cut end, and advancing the dilator over the cut end of the lead assembly.

[0231] Clause 93. The method of Clause 90, further comprising advancing the extended portion of the lead extender into or above the tube of the lead assembly.

[0232] Clause 94. The method of Clause 93, wherein the extension portion includes a threaded extension, and the method further includes rotating the lead extender relative to the lead assembly, the rotation of the lead extender causing the threads of the threaded extension to bite into the tube of the lead assembly.

[0233] Clause 95. In order to form a cut end, the lead assembly is cut distal to the proximal end of the lead assembly, The extended portion is advanced into or above the cut end, The method of Clause 93 or Clause 94, further comprising advancing the dilator onto the cut end of the lead assembly.

[0234] Clause 96. The method of Clause 92 or Clause 95, further comprising locking a portion of the lead assembly distal to the lead extender or the cut end against the outer surface of the retrieval handle, and then advancing the retrieval sheath over the occluder to fold the occluder.

[0235] Additional consideration and terminology Features, materials, properties, or groups described in connection with a particular aspect, embodiment, or example should be understood to be applicable to any other aspect, embodiment, or example described herein, unless otherwise incompatible. All features disclosed herein (including the appended claims, abstract, and drawings), or all steps of any method or process so so disclosed, may be combined in any combination, except for any combination in which at least some of such features or steps are mutually exclusive. Protection is not limited to the details of any of the aforementioned embodiments. Protection extends to any novel features or any novel combination of features disclosed herein (including any appended claims, abstract, and drawings), or any novel steps of any method or process so so disclosed.

[0236] While specific embodiments have been described, these embodiments are presented only as examples and are not intended to limit the scope of protection. In fact, the novel methods and systems described herein may be embodied in various other forms. Furthermore, various omissions, substitutions, and modifications may be made to the forms of the methods and systems described herein. Those skilled in the art will understand that in some embodiments, the actual steps taken in the illustrated or disclosed processes may differ from those shown in the figures. Depending on the embodiment, some of the steps described above may be omitted, and others may be added. For example, the actual steps or the order of steps taken in the disclosed process may differ from those shown in the figures. Depending on the embodiment, some of the steps described above may be omitted, and others may be added. Furthermore, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which are included within the scope of this disclosure.

[0237] This disclosure includes specific embodiments, examples, and uses, but it will be understood by those skilled in the art that this disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments or uses, including embodiments that do not provide all of the features and advantages described herein, as well as obvious modifications and equivalents thereof. Accordingly, the scope of this disclosure is not intended to be limited by the embodiments described herein and may be defined by claims presented herein or hereafter presented.

[0238] Conditional language such as "can, could" and "might or may" is generally intended to convey that a particular embodiment includes a particular feature, element, or step, while other embodiments do not, unless otherwise specified or understood to have a different meaning in the context in which it is used. Therefore, such conditional language is not generally intended to mean that a feature, element, or step is required in some way by one or more embodiments, or that one or more embodiments necessarily include logic, with or without user input or prompting, that determines whether these features, elements, or steps should be included in or performed by any particular embodiment. Terms such as "comprising," "including," and "having" are synonyms and are used comprehensively and openly, without excluding additional elements, features, actions, operations, etc. Furthermore, the term "or" is used in its inclusive sense (not exclusive), and for example, when used to connect a list of elements, the term "or" means one, some, or all of the elements in the list. Similarly, the term "and / or" referring to a list of two or more items encompasses all interpretations of this term, including any one of the items in the list, all of the items in the list, and any combination of the items in the list. In addition, as used herein, the terms "each, respectively," in addition to their usual meaning, may mean any subset of the set of elements to which the term "each, respectively" applies. Furthermore, when used in this application, the terms "as specified herein," "above," "below," and similar terms of importance refer to this application as a whole, and not to any particular part thereof.

[0239] Conjunctional phrases such as "at least one of X, Y, and Z" are generally understood in context to convey that an item, term, etc., may be any of X, Y, or Z, unless otherwise specified. Therefore, such conjunctional phrases are not generally intended to imply that a particular embodiment requires the presence of at least one X, at least one Y, and at least one Z.

[0240] As used herein, terms expressing degree, such as “approximately,” “about,” “generally,” and “substantially,” refer to values, quantities, or characteristics that are close to the stated values, quantities, or characteristics that still perform the desired function or achieve the desired result. For example, the terms “approximately,” “about,” “generally,” and “substantially” may refer to quantities less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the stated quantity. As another example, in certain embodiments, the terms “generally parallel” and “substantially parallel” refer to values, quantities, or characteristics that deviate from exactly parallel by only 15°, 10°, 5°, 3°, 1°, or 0.1° or less.

Claims

1. A delivery system for a blood flow occlusion system, It is a handle, The distal part, The proximal part and, An actuator disposed between the proximal portion and the distal portion, the actuator being movable relative to the outer surface of the handle, A carriage positioned within the aforementioned handle, Having the handle having, The actuator is configured to move the carriage to deploy the blood flow occlusion system, in a delivery system.

2. The delivery system according to claim 1, wherein the actuator is coupled to an internally threaded cylinder, the carriage is positioned inside the internally threaded cylinder, and the carriage has external threads.

3. The delivery system according to claim 1 or 2, further comprising an indicator movably disposed on the proximal portion and magnetically engaged with a carriage magnet disposed on or adjacent to the outer surface of the carriage, wherein the movement of the carriage magnet causes the indicator to move, thereby providing visual feedback of the position of a delivery shaft coupled to the carriage.

4. The delivery system according to any one of claims 1 to 3, having a shaft interface located distal to the carriage, wherein the shaft interface is configured to reliably engage with the proximal end of the delivery shaft of the delivery system.

5. The delivery system according to any one of claims 1 to 4, wherein the carriage has a lumen through which the lead assembly of the blood flow occlusion system can pass.

6. The delivery system according to any one of claims 1 to 5, further comprising a lead locking member configured to engage with the lead assembly of the blood flow occlusion system and to control or prevent the movement of the lead assembly relative to the outer surface of the handle when the carriage moves proximal or distal within the handle.

7. The delivery system according to claim 6, wherein the lead lock member is engaged with the proximal end of the handle.

8. The delivery system according to claim 7, wherein the lead lock member has a knob configured to rotate relative to the proximal end of the handle to transition one or more lock configurations from an unengaged state to an engaged state.

9. The delivery system according to claim 6 or 7, wherein the lead lock member has a clamp having a non-engaged form and an engaged form.

10. The delivery system according to claim 9, wherein the clamp comprises a first clamping member and a second clamping member, the first clamping member being configured to engage with the lead assembly on a first side, and the second clamping member being configured to engage with the lead assembly on a second side opposite to the lead assembly.

11. The delivery system according to claim 10, wherein the first clamping member and / or the second clamping member includes a radial projection having a first end positioned adjacent to the lumen and a second end opposite to the first end, and a lead engagement surface adjacent to the first end, the lead engagement surface having an enlarged area compared to the cross-sectional area of ​​the radial projection, and the lead engagement surface is movable by moving the radial projection from a first position that allows the lead assembly to slide along the lead engagement surface to a second position that restricts the movement of the lead assembly along the lead engagement surface.

12. The delivery system according to claim 11, wherein the lead engagement surface has a width or diameter greater than the maximum diameter of the lead assembly.

13. The delivery system according to claim 11 or 12, wherein the first clamping member and / or the second clamping member have an enlarged disc positioned at the first end of the radial projection, the enlarged disc includes the lead engagement surface, and the radial projection has an elongated cylinder having a smaller diameter than the enlarged disc.

14. The delivery system according to any one of claims 9 to 13, wherein the lead lock member further comprises a threaded member, and the clamp is moved from the disengaged state to the engaged state by rotation of the threaded member in a first direction relative to the outer surface of the handle.

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

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

17. The delivery system according to any one of claims 1 to 16, further comprising a fluid port that allows for the injection of saline solution to facilitate the movement of the delivery shaft of the delivery system on the outer surface of the lead assembly of the blood flow occlusion system when the actuator is moved.

18. A delivery system for a blood flow occlusion device, A handle having a proximal portion, A lead lock coupled to the aforementioned proximal portion, A plurality of actuator pins extending from the 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, wherein the lock actuator has a ring member, and the ring member is The gripping surface on the outer circumference, A plurality of gripping feature portions, each of which has a fixed end connected to the inner circumference of the ring member and a free end positioned radially inward of the fixed end, A plurality of channels, wherein at least one of the plurality of channels is positioned between each of the plurality of gripping feature portions and the inner circumference of the ring member, and the plurality of channels have a first end having a first width and a second end having a second width smaller than the first width, The lock actuator has, The read lock having, It has, One actuator pin of the plurality of actuator pins is located in each of the plurality of channels, A delivery system in which, by rotation of the lock actuator relative to the actuator pin, the plurality of gripping features are moved radially inward to a gripping position when the plurality of actuator pins are positioned at the second end of the plurality of channels, and the plurality of gripping features are moved radially outward to a release position when the plurality of actuator pins are positioned at the first end of the plurality of channels.

19. A delivery system for a blood flow occlusion device, The handlebars and A read lock coupled to the handle, A projection extending from the aforementioned handle, A lock actuator movably coupled to the handle, The hand gripping structure on the outer circumference of the lock actuator, A lead gripping feature having a fixed end positioned inside the hand gripping structure and a free end positioned away from the fixed end, A guide surface disposed between the lead gripping 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, The lock actuator having, The read lock having, It has, The aforementioned projection is positioned adjacent to the guide, A delivery system wherein the movement of the lock actuator relative to the projection moves the lead gripping feature inward to a gripping position when the projection is positioned at the second end of the guide surface, and the lead gripping feature is movable outward to a release position when the projection is positioned at the first end of the guide surface.

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

21. The delivery system according to claim 20, wherein the projection is located on the proximal surface of the handle, and the guide surface is in contact with the lateral portion of the projection.

22. The delivery system according to any one of claims 19 to 21, wherein the lead gripping feature includes teeth facing the central axis of the handle.

23. The delivery system according to any one of claims 19 to 21, wherein the lead gripping feature includes a screw directed toward the central axis of the handle.

24. The delivery system according to any one of claims 19 to 23, wherein the lock actuator includes a ring rotatably mounted on the handle, and the guide surface is formed on the outer portion of the lead gripping feature which includes teeth configured to face the central axis of the ring.

25. The delivery system according to claim 24, wherein the lead gripping feature has an arm and further has at least one additional arm so as to form a plurality of arms extending inward from the inner surface of the ring, and each of the plurality of arms includes a guide surface formed on the outer portion of the corresponding arm and teeth away from a fixed end configured to face the central axis of the ring.

26. The delivery system according to claim 25, wherein the projection is a first projection and further has at least one additional projection to form a plurality of projections, and the guide surface of each arm forms one side of a channel that determines a position for positioning one of the plurality of projections when the projection moves relative to the lock actuator.

27. The delivery system according to claim 25 or 26, wherein the guide surface includes a first circular recess at the first end of the guide surface and a second circular recess at the second end of the guide surface.

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

29. A delivery system for a blood flow occlusion device, The handlebars and A lead lock coupled to the handle, wherein the lead lock is configured to engage with the lead assembly of the blood flow occluder to control or prevent the movement of the lead assembly relative to the outer surface of the handle, and the lead lock is A lumen configured to receive at least a portion of the lead assembly, A clamp having a first clamping member and a second clamping member, wherein the first clamping member is configured to engage with the lead assembly on the side of the lead assembly, and the second clamping member is configured to engage with the lead assembly, An actuator comprising the actuator configured to move the clamp from a disengaged state in which the lead assembly is movable relative to the outer surface of the handle to an engaged state in which the clamp restricts the movement of the lead assembly relative to the outer surface of the handle, The read lock having, A delivery system having the following features.

30. The delivery system according to claim 29, wherein the first clamping member and / or the second clamping member have a radial projection having a first end positioned adjacent to the lumen and a second end opposite to the first end, and a lead engagement surface adjacent to the first end, the lead engagement surface having an area enlarged compared to the cross-sectional area of ​​the radial projection, and the lead engagement surface is movable by moving the radial projection from a first position that allows the lead assembly to slide along the lead engagement surface to a second position that restricts the movement of the lead assembly along the lead engagement surface.

31. The delivery system according to claim 30, wherein the lead engagement surface has a width or diameter greater than the maximum diameter of the lead assembly.

32. The delivery system according to claim 30 or 31, wherein the first clamping member and / or the second clamping member have an enlarged disc positioned at the first end of the radial projection, the enlarged disc includes the lead engagement surface, and the radial projection has an elongated cylinder having a smaller diameter than the enlarged disc.

33. The delivery system according to any one of claims 29 to 32, wherein the actuator has a threaded member, and the rotation of the threaded member in a first direction relative to the outer surface of the handle causes the clamp to move from the disengaged state to the engaged state.

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

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

36. A lead retrieval system for a blood flow occlusion device, A handle having a proximal portion, A reed lock coupled to the proximal portion, having a first form in which a reed arranged through the reed lock is held in a fixed position relative to the handle, and a second form in which a reed arranged through the reed lock is movable relative to the handle, A lead extender device comprising a lead extender device having a tubular shaft disposed in the distal portion of the lead extender device, It has, A lead retrieval system in which the distal end of the tubular shaft of the lead extender device has an outer surface sized to slide through the lead lock, and the distal end is configured to engage with the lead at or distal to the proximal end of the lead.

37. The lead retrieval system according to claim 36, wherein the tubular shaft has one or more teeth arranged on the inner surface of the tubular shaft, and the one or more teeth are inclined inward such that the free end of each of the one or more teeth is positioned proximal to the fixed end of each tooth and is positioned within the lumen of the tubular shaft.

38. The lead retrieval system according to claim 37, wherein one or more of the teeth have a blunt tip at the free end of the tooth.

39. The lead retrieval system according to claim 37, wherein one or more teeth have a pointed tip at the free end of each tooth.

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

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

42. The lead recovery system according to claim 36, wherein the lead extender device further has one or more projections extending from the distal end of the tubular shaft, the one or more projections being configured to engage with the surface of the lead.

43. The lead recovery system according to claim 42, wherein the one or more protrusions include one or more screws positioned on the threaded extension of the lead extender device.

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

45. The lead retrieval system according to claim 44, wherein the outer diameter of the thread of the threaded extension is larger than the inner diameter of the tube of the lead.

46. The lead retrieval system according to claim 45, wherein the thread of the threaded extension is configured to bite into the wall of the tube when the lead extender device is rotated relative to the lead.

47. The lead retrieval system according to claim 42, wherein the one or more projections have teeth that are inclined inward so that the free end of each of the one or more teeth is positioned proximal to the fixed end of each tooth and is positioned within the lumen of the tubular shaft.

48. A device for retrieving a blood flow occlusion device, A lead extender having a tubular shaft, wherein the tubular shaft is located in the distal portion of the lead extender, and the tubular shaft has one or more teeth located on the inner surface of the tubular shaft, wherein the one or more teeth are inclined inward such that the free end of each of the one or more teeth is located proximal to the fixed end of each tooth and is located within the lumen of the tubular shaft, It has, The one or more teeth are configured to grip the outer surface of the lead of the blood flow occlusion device, The instrument has a tubular shaft having a length and outer surface dimensioned to allow the lead extender to be inserted through the sheath and handle of a retrieval device, such that the proximal end of the lead extender may be positioned proximal to the handle of the retrieval device.

49. The instrument according to claim 48, wherein one or more of the teeth have a blunt tip at the free end of each tooth.

50. The instrument according to claim 48, wherein one or more of the teeth have pointed tips at their free ends.

51. The device according to claim 48, wherein the one or more teeth include multiple teeth.

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

53. A device for retrieving a blood flow occlusion device, A lead extender having a proximal portion and a distal portion, wherein the distal portion is configured to be embedded in the wall of the lead of the blood flow occluder at or distal to the cut end of the lead, The instrument has a length and outer surface dimensioned such that the distal portion can be positioned proximal to the handle of the retrieval device, allowing the lead extender to be inserted through the sheath and handle of the retrieval device.

54. The apparatus according to claim 53, wherein the distal portion has one or more projections extending from the distal end, and the one or more projections are configured to be inserted into the lead at the cut end or distal to the cut end so as to engage with the inner surface of the wall of the lead to support a tensile load during the withdrawal of the lead.

55. The device according to claim 54, wherein the one or more projections include one or more screws positioned on the threaded extension of the lead extender.

56. The device according to claim 55, wherein the outer diameter of one or more screws in the threaded extension is larger than the inner diameter of the wall of the lead.

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

58. The device according to claim 54, wherein the one or more projections include one or more teeth arranged to extend inward on the inner surface of the tubular portion of the lead extender.

59. A method for retrieving a blood flow occlusion device, Accessing the proximal portion of the lead assembly of the blood flow occlusion device, The distal portion of the lead extender is advanced to engage with the proximal portion of the lead assembly, The dilator is advanced onto the distal portion of the lead extender, which is positioned on the lead assembly. The dilator is replaced with a recovery assembly having a recovery sheath and a recovery handle. The blood flow occluder is removed within the recovery sheath, Methods that include...

60. The method according to claim 59, further comprising advancing the distal portion of the lead extender above the proximal portion of the lead assembly such that at least one tooth inclined inward is positioned above the proximal portion of the lead assembly within the lumen of the lead extender.

61. The method according to claim 59, further comprising: cutting the lead assembly distal to the proximal end of the lead assembly to form a cut end; advancing the distal portion of the lead extender over the cut end; and advancing the dilator over the cut end of the lead assembly.

62. The method according to claim 59, further comprising advancing the extended portion of the lead extender into or above the tube of the lead assembly.

63. The extension portion includes a threaded extension portion. The method according to claim 62, further comprising rotating the lead extender relative to the lead assembly, wherein the rotation of the lead extender causes the threads of the threaded extension to bite into the tube of the lead assembly.

64. In order to form a cut end, the lead assembly is cut distal to the proximal end of the lead assembly, The extended portion is advanced into or above the cut end, The method according to claim 62 or 63, further comprising advancing the dilator onto the cut end of the lead assembly.

65. The method according to claim 61 or 64, further comprising locking a portion of the lead assembly distal to the lead extender or the cut end against the outer surface of the retrieval handle, and then advancing the retrieval sheath over the blood flow occluder to fold the blood flow occluder.

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