Apparatus and method for controlling fluid flow in a delivery device

Abstract

For many patients, it can be difficult to properly size and shape the artificial valve. [Solution] A method and system for providing a consistent flow of fluid through the lumen of a delivery device is disclosed. In one embodiment, the delivery device may include an outer shaft configured to hold an artificial implant in a delivery configuration; an inner shaft disposed within the outer shaft, coupled to the end of the artificial implant, and configured to move axially relative to the outer shaft; and a sleeve shaft disposed within the outer shaft and configured to cover the artificial implant in the delivery configuration. In some embodiments, the inner shaft may include one or more defined openings therein, extending between the inner and outer surfaces of the inner shaft, and configured to fluidly connect the inner lumen of the inner shaft to a lumen located between the outer surface of the inner shaft and the inner surface of the sleeve shaft.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 113,322, filed November 13, 2020, which is hereby incorporated by reference in its entirety.

[0002] This disclosure relates to a delivery device for a docking device configured to secure an artificial valve to a native heart valve and associated flow system.

Background Art

[0003] Artificial valves can be used to treat heart valve disorders. Native heart valves (e.g., aortic valve, pulmonary valve, tricuspid valve, and mitral valve) function to prevent backflow while allowing forward blood flow. These heart valves can be impaired by congenital, inflammatory, infectious conditions, etc. Such conditions can ultimately lead to severe cardiovascular disorders or death. Such disorders could, in the past, be treated by surgical repair or replacement of the valve during open - heart surgery.

[0004] Trans - catheter techniques for introducing and implanting an artificial heart valve using a catheter in a less invasive manner than open - heart surgery can reduce the complications associated with open - heart surgery. In this technique, the artificial valve is mounted in a compressed state at the distal end portion of a delivery device and can be advanced through the patient's blood vessels until the valve reaches the implantation site. The valve at the distal end portion of the delivery device can then be expanded to its functional size at the site of the defective native valve, such as by inflating a balloon to which the valve is attached. As another method, the valve can have an elastic self - expanding stent or frame that expands the valve to its functional size when the valve is advanced from a delivery sheath at the distal end of the delivery device. The valve can optionally be balloon - expandable, self - expandable, mechanically expandable frames, and / or frames expandable in multiple ways or in combination of ways.

[0005] Transcatheter heart valves (THVs) can be appropriately sized to fit inside many natural aortic valves. However, natural mitral and tricuspid valves can have different shapes from typical aortic valves, and the anatomical structure of mitral and tricuspid valves can vary considerably from person to person. Therefore, appropriately sizing and shaping prosthetic valves can be challenging for many patients. Furthermore, when treating valve regurgitation, the surrounding tissues may not be strong enough to hold certain types of valves in their desired position. [Prior art documents] [Patent Documents]

[0006] [Patent Document 1] International Application No. PCT / US20 / 36577 [Patent Document 2] U.S. Patent Application Publication No. 2018 / 0318079 [Patent Document 3] U.S. Patent Application Publication No. 2018 / 0263764 [Patent Document 4] U.S. Patent Application Publication No. 2018 / 0177594 [Patent Document 5] International Application No. PCT / US20 / 36577 [Overview of the project] [Problems that the invention aims to solve]

[0007] In some embodiments, the docking device may be initially implanted within the natural valve, receiving the prosthetic valve and configured to fix (e.g., anchor) the prosthetic valve in a desired position within the natural valve. For example, the docking device may form a more rounded and / or stable fixation site at the annulus of the natural valve into which the prosthetic valve can be expanded and implanted. A transcatheter delivery device may be used to deliver the docking device to the implantation site. The docking device may be located within the delivery device, coaxial with additional components of the delivery device. Multiple lumens may be located between the coaxial components of the delivery device, and flush fluid may be supplied to these lumens during the implantation procedure to reduce or prevent thrombosis between components, including around the docking device. However, since these lumens may have different resistances from one another, and the resistance of the lumens may change during the implantation procedure, maintaining a constant flow of flush fluid through the various lumens can be difficult. Therefore, improvements to the transcatheter delivery device are desirable to ensure a specific flow of fluid through the various lumens of the delivery device for the purpose of preventing thrombus formation. [Means for solving the problem]

[0008] This specification describes docking devices, artificial heart valves, delivery devices, and methods for implanting docking devices and artificial heart valves within docking devices. This specification also describes embodiments of delivery devices, flow mechanisms, and related methods for providing a consistent flow of fluid through a lumen of a flow system. In some embodiments, the lumen is part of a delivery device configured to deliver the docking device to a target implantation site in a patient. The docking device may be configured to receive the artificial valve therein and to securely hold the artificial valve in place at the implantation site. By providing a consistent flow of fluid through the lumen of such a delivery device, blood stagnation within the delivery device can be reduced or avoided, thereby reducing thrombus formation.

[0009] In one typical embodiment, the delivery device includes an outer shaft configured to hold an artificial implant in a delivery configuration, an inner shaft positioned within the outer shaft and configured to connect with the end of the artificial implant and move axially relative to the outer shaft, and a sleeve shaft positioned within the outer shaft, the portion of which of the sleeve shaft is positioned between the outer shaft and the inner shaft, and the sleeve shaft is configured to cover the artificial implant in a delivery configuration. The inner shaft extends between its inner and outer surfaces and includes one or more defined openings therein, configured to fluidly connect the inner lumen of the inner shaft to a lumen positioned between the outer surface of the inner shaft and the inner surface of the sleeve shaft.

[0010] In another representative embodiment, the delivery device includes an outer shaft configured to hold an artificial implant in a delivery configuration, and an inner shaft positioned within the outer shaft, coupled to the end of the artificial implant, and configured to move axially relative to the outer shaft, the inner shaft comprising a rigid main tube and a polymer distal end portion comprising a flexible polymer and extending distally to the main tube. The polymer distal end portion comprises one or more defined openings therein, extending between the inner and outer surfaces of the polymer distal end portion. The delivery device further includes a sleeve shaft positioned within the outer shaft, a portion of which is positioned between the outer shaft and the inner shaft, and the sleeve shaft is configured to cover the artificial implant in a delivery configuration.

[0011] In another representative embodiment, the delivery device includes an outer shaft configured to hold an artificial implant in a delivery configuration, and an inner shaft positioned within the outer shaft, coupled to the end of the artificial implant, and configured to move axially relative to the outer shaft. The inner shaft comprises a rigid main tube including a distal end portion covered by an outer polymer layer, a polymer distal end portion comprising a flexible polymer, positioned distal to the main tube and continuous with the outer polymer layer, and one or more openings between the outer surface and the inner surface of the inner shaft, extending through the outer polymer layer and the main tube. The delivery device further comprises a sleeve shaft positioned within the outer shaft, a portion of which is positioned between the outer shaft and the inner shaft, and the sleeve shaft is configured to cover the artificial implant in a delivery configuration.

[0012] The various novel inventions of this disclosure may be used in combination or separately. This summary of the invention is provided to introduce a selection of concepts in a simplified form, which will be further described in the following modes for carrying out the invention. This summary is not intended to identify any major or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The aforementioned and other purposes, features, and advantages of this disclosure will become more apparent from the following modes for carrying out the invention, the claims, and the accompanying drawings. [Brief explanation of the drawing]

[0013] [Figure 1] Figure 1 schematically shows a docking device delivery device for implanting an artificial heart valve docking device into a patient's mitral valve, according to one embodiment. [Figure 2A] Figure 2A schematically shows the docking device from Figure 1 fully implanted in the patient's mitral valve after the delivery device of the docking device has been removed from the patient. [Figure 2B] Figure 2B schematically shows an artificial heart valve delivery device, according to one embodiment, which implants the artificial heart valve in the docking device shown in Figure 2A into the patient's mitral valve. [Figure 3] FIG. 3 is a side perspective view of a docking device having a spiral configuration according to one embodiment. [Figure 4] FIG. 4 is a side view of an exemplary embodiment of a delivery device for a docking device, the delivery device including a handle assembly and an outer shaft extending distally from the handle assembly. [Figure 5] FIG. 5 is a side view of a hub assembly of the handle assembly of the delivery device of FIG. 4. [Figure 6] FIG. 6 is a first cross-sectional view of the hub assembly of FIG. 5 showing a fluid flow through the lumen of the handle assembly. [Figure 7] FIG. 7 is a second cross-sectional view of a more detailed view of the hub assembly of FIG. 6 showing a fluid flow through the lumen of the handle assembly. [Figure 8] FIG. 8 is a cross-sectional perspective view of a portion of the delivery device of FIG. 4 disposed between the distal end portion of the delivery device and the hub assembly, showing the flow of fluid through the internal components of the delivery device. [Figure 9A] FIG. 9A is a cross-sectional view of the distal end portion of the delivery device of FIG. 4, showing the flow of fluid through the internal components of the delivery device when the pusher shaft is disposed at a distance from the docking device. [Figure 9B] FIG. 9B is another cross-sectional view of the distal end portion of the delivery device of FIG. 4, showing the flow of fluid through the internal components of the delivery device when the pusher shaft is disposed relative to the docking device. [Figure 10] FIG. 10 is a perspective view of the distal end portion of the delivery device of FIG. 4, showing an exemplary docking device deployed from the outer shaft of the delivery device and covered by a sleeve shaft of the delivery device. [Figure 11] FIG. 11 is a perspective view of the distal end portion of the delivery device of FIG. 4, showing the exemplary docking device of FIG. 10 deployed from the outer shaft of the delivery device with the sleeve shaft removed from the docking device. [Figure 12]FIG. 12 is a top perspective view of an embodiment of a flow mechanism configured to maintain a consistent relative flow rate between two or more flow paths, the flow mechanism including two paddle gears rotatably coupled to each other. [Figure 13] FIG. 13 is a side perspective view of the flow mechanism of FIG. 12. [Figure 14] FIG. 14 is a top view of the flow mechanism of FIG. 12, showing the flow of fluid through the flow mechanism. [Figure 15] FIG. 15 is a top view of another embodiment of a flow mechanism, including paddle gears with different diameters. [Figure 16] FIG. 16 is a top view of another embodiment of a flow mechanism, including paddle gears with paddles having different geometric shapes. [Figure 17] FIG. 17 is a perspective view of another embodiment of a flow mechanism, including three or more flow paths and two corresponding paddle gears. [Figure 18] FIG. 18 is a perspective view of another embodiment of a flow mechanism, including four flow paths and four paddle gears, each paddle gear including a paddle rotatably coupled to a common rotating member shared by the paddles of another paddle gear. [Figure 19] FIG. 19 is a perspective view of another embodiment of a flow mechanism, including a spacer disposed between a first paddle of a first paddle gear and a second paddle of a second paddle gear. [Figure 20] FIG. 20 is a perspective view of another embodiment of a flow mechanism, including two paddle gears with paddles disposed at an offset height. [Figure 21] FIG. 21 is a top view of an exemplary embodiment of a single fluid supply coupled to the flow mechanism of FIG. 12. [Figure 22] FIG. 22 is a top view of another embodiment of a flow mechanism, including a drive member configured to drive the rotation of the paddle gears of the flow mechanism at a specific speed. [Figure 23] FIG. 23 shows an exemplary arrangement of a flow throttle configured to control the flow of fluid into two flow lumens of a delivery device disposed within the hub assembly of FIG. 7. [Figure 24]Figure 24 is a perspective view of an embodiment of a flow throttle configured to control the flow of fluid into at least two separate flow lumens. [Figure 25] Figure 25 is an end view of the flow throttle shown in Figure 24. [Figure 26] Figure 26 is a cross-sectional view of the flow throttle of Figure 24, which is positioned within the larger lumen of the two flow lumens and sealed around the smaller lumen of the two flow lumens. [Figure 27] Figure 27 is an end view of another embodiment of a flow throttle configured to control the flow of fluid into at least three separate flow lumens. [Figure 28] Figure 28 is an end view of another embodiment of a flow throttle configured to control the flow of fluid into at least two separate flow lumens. [Figure 29] Figure 29 is a schematic diagram showing four main components of an exemplary pusher shaft for a docking device. [Figure 30] Figure 30 is a side cross-sectional view of an embodiment of a pusher shaft in a delivery device for a docking device. [Figure 31] Figure 31 is a side cross-sectional view of the exemplary distal end of the pusher shaft shown in Figure 30. [Figure 32] Figure 32 is a proximal end view of the pusher shaft shown in Figure 30. [Figure 33] Figure 33 is a side view of the main pipe of the pusher shaft shown in Figure 30. [Figure 34] Figure 34 is a cross-sectional side view of an exemplary arrangement of the pusher shaft of Figure 30, assembled together with the sleeve shaft and outer shaft of the delivery device by the assembly of the first configuration during the deployment of the docking device from the delivery device. [Figure 35] Figure 35 is a cross-sectional side view of the pusher shaft and sleeve shaft assembly from Figure 34, where the assembly after the sleeve shaft has been retracted from the deployed docking device is the second configuration. [Figure 36]Figure 36 is a perspective view of an embodiment of a pusher shaft with a distal end, the distal end containing a slot located therein. [Figure 37] Figure 37 is a lateral view of the distal tip of Figure 36. [Figure 38] Figure 38 is a perspective view of another embodiment of the distal tip of the pusher shaft, which includes two slots located therein. [Figure 39] Figure 39 is a perspective view of another embodiment of the distal end of a pusher shaft, which includes a slot with a varying width located therein. [Figure 40] Figure 40 is a lateral view of the distal tip of Figure 39. [Figure 41] Figure 41 is a side view of an embodiment in which the distal end portion of the main tube of a pusher shaft has one or more openings located therein that are configured to provide a path for fluid to flow out of the pusher shaft. [Figure 42] Figure 42 is a side view of another embodiment of the distal end portion of the main tube of a pusher shaft, which has multiple openings located therein that are configured to provide a path for fluid to flow out of the pusher shaft. [Figure 43] Figure 43 is a cross-sectional side view of an embodiment in which the distal end portion of a pusher shaft includes a distal tip having one or more openings configured to provide one or more additional passageways for fluid to flow out of the pusher shaft. [Figure 44] Figure 44 is a side view of the distal end portion of the pusher shaft shown in Figure 43. [Figure 45] Figure 45 is a cross-sectional side view of another embodiment of the distal end portion of a pusher shaft, which includes a polymer tip having one or more openings positioned therein, configured to provide one or more additional channels through which fluid flows out of the pusher shaft. [Figure 46] Figure 46 is a perspective view of the distal end portion of the pusher shaft shown in Figure 45. [Figure 47]Figure 47 is a cross-sectional view of the distal end of the delivery device, showing the fluid flow through the internal components of the delivery device when the pusher shafts of Figures 45 and 46 are positioned relative to the docking device. [Figure 48] Figure 48 is a side cross-sectional view of an exemplary sleeve shaft for a delivery device for a docking device. [Figure 49] Figure 49 is a perspective view of the proximal section of the sleeve shaft shown in Figure 48. [Figure 50] Figure 50 is a perspective view of an exemplary hemostatic seal configured to seal around the sleeve shaft of a delivery device for a docking device. [Figure 51] Figure 51 is a perspective view of the hemostatic seal of Figure 50 positioned around the cut portion of the sleeve shaft of Figure 49. [Figure 52] Figure 52 is a perspective view of a sleeve shaft arranged around the pusher shaft of a delivery device for a docking device, where the proximal extension of the pusher shaft extends outward from the opening of the cut portion of the sleeve shaft. [Figure 53] Figure 53 is a cross-sectional view of the cut portion of the sleeve shaft shown in Figure 52, showing the sharp edges of the cut surface. [Figure 54A] Figure 54A is a schematic diagram showing laser irradiation of the cut surface of the cut portion shown in Figure 53, in order to melt and round the sharp edges of the cut surface. [Figure 54B] Figure 54B is a schematic diagram showing the rounded surface achieved by the laser irradiated in Figure 54A. [Figure 55] Figure 55 is a perspective view of an exemplary cut portion of a sleeve shaft, showing the first portion of the cut before laser irradiation and the second portion of the sleeve shaft after laser irradiation, where laser irradiation results in rounded edges and / or rounded surfaces on the cut surface of the cut portion. [Figure 56] Figure 56 is a schematic diagram showing the bits of a deburring machine applied to and traveling along the cut surfaces of the cut portions in Figure 53 to deburr and / or round the sharp edges of the cut surfaces. [Modes for carrying out the invention]

[0014] General Considerations For the purposes of this specification, specific aspects, advantages, and novel features of the embodiments of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Rather, this disclosure covers all novel and non-obvious features and aspects of the various disclosed embodiments, both individually and in various combinations and partial combinations. The methods, apparatus, and systems are not limited to any particular aspect or feature, or any combination thereof, nor is it required that any particular advantage or problem be solved by any one or more of the disclosed embodiments.

[0015] While some of the operations in the disclosed embodiments are described in a specific sequential order for convenience of presentation, it should be understood that this method of description includes reordering unless a specific order is required by the specific terms set forth below. For example, operations described sequentially may, in some cases, be rearranged or performed simultaneously. Furthermore, for simplification, the accompanying drawings may not show various ways in which the disclosed methods may be used in combination with other methods. In addition, terms such as “provide” or “achieve” are sometimes used in this specification to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation and will be readily recognizable to those skilled in the art.

[0016] In this application and claims, the singular forms "a," "an," and "the" include the plural form unless the context otherwise explicitly indicates. In addition, the term "includes" means "comprises." Furthermore, the terms "coupled" and "associated" generally mean to be connected or joined physically, mechanically, chemically, electromagnetically, and / or electrically, and do not exclude the existence of intermediate elements between connected or associated items unless otherwise specified.

[0017] As used in this specification, the term "proximal" refers to a location, orientation, or part of the device that is closer to the user and further away from the implantation site. As used herein, the term "distal" refers to a location, orientation, or part of the device that is further away from the user and closer to the implantation site. For example, proximal movement of the device is moving the device away from the implantation site and toward the user (e.g., out of the patient's body), while distal movement of the device is moving the device away from the user and toward the implantation site (e.g., inside the patient's body). Unless otherwise explicitly defined, the terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions.

[0018] Examples of the disclosed technology This specification describes various systems, apparatus, and methods that may be used in or with delivery devices for docking devices in some embodiments. In some embodiments, such systems, apparatus, and / or methods can provide a consistent flow of fluid through two or more lumens of the delivery device.

[0019] In some embodiments, the delivery device may be configured to deliver and implant the docking device to an implantation site, such as the annulus of a natural valve. The docking device may be configured to more securely hold the expandable prosthetic valve (e.g., a transcatheter heart valve) implanted within the docking device at the annulus of a natural valve. For example, the docking device may provide or form a more rounded and / or stable anchoring site, landing zone, or implantation zone at the implantation site, allowing the prosthetic valve to be expanded or otherwise implanted. By providing such an anchoring or docking device, replacement prosthetic valves can be more securely implanted and held at the annulus of various valves, including the mitral valve annulus, which does not naturally have a rounded cross-section.

[0020] In some embodiments, the docking device may be located within the outer shaft of the delivery device, and a sleeve shaft (also referred to herein as a delivery sleeve) may cover / enclose the docking device within the delivery device and during implantation at the target implant site. A pusher shaft may be located within the outer shaft proximal to the docking device and configured to push the docking device out of the outer shaft and position the docking device at the target implant site. The sleeve shaft may also enclose the pusher shaft within the outer shaft of the delivery device. After positioning the docking device at the target implant site, the sleeve shaft may be removed from the docking device and re-stored within the outer shaft of the delivery device.

[0021] A fluid (e.g., a flushing fluid such as heparinized saline) can be supplied to a pusher shaft lumen defined within the pusher shaft and to a delivery shaft lumen defined between the sleeve shaft and the outer shaft of the delivery device. The fluid from the pusher shaft lumen can then flow to the sleeve shaft lumen defined between the docking device and the sleeve shaft, and between the sleeve shaft and the pusher shaft. By providing a consistent flow of fluid through these lumens of the delivery device, blood stagnation within the delivery device can be reduced or avoided, thereby reducing or preventing thrombus formation.

[0022] An exemplary transcatheter heart valve replacement procedure is shown in schematic diagrams in Figures 1 to 2B, in which a first exemplary delivery device is used to deliver the docking device to the annulus of the natural valve, and then a second exemplary delivery device is used to deliver the transcatheter heart valve (THV) inside the docking device.

[0023] A missing native heart valve can be replaced with a transcatheter heart valve (THV), as introduced above. However, such THVs may not be able to secure themselves adequately to the native tissue (e.g., to the leaflets and / or annulus of the native heart valve), and may migrate undesirably to the native tissue, leading to paravalvular leakage, valve dysfunction, and / or other problems. Therefore, a docking device may be first implanted in the annulus of the native valve, and then the THV may be implanted within the docking device, helping to secure the THV to the native tissue and provide a seal between the native tissue and the THV.

[0024] Figures 1 to 2B illustrate an exemplary transcatheter heart valve replacement procedure using a docking device according to one embodiment. In this procedure, the user first delivers and implants the docking device into the patient's natural heart valve using a docking device delivery device (Figure 1), then, after implanting the docking device, removes the docking device delivery device from the patient (Figure 2A), and finally, implants the prosthetic valve into the implanted docking device using a prosthetic valve delivery device (Figure 2B).

[0025] Figure 1 shows the first stage of an exemplary mitral valve replacement, in which the docking device 10 is implanted into the mitral valve 12 of the patient's heart 14 using a docking device delivery device 18 (which may also be referred to herein as “catheter” and / or “docking device delivery device”).

[0026] Generally, the delivery device 18 of a docking device comprises a delivery shaft 20, a handle 22, and a pusher assembly 24. The delivery shaft 20 extends into the patient's vascular system and is configured to provide a passage for the docking device 10 to reach the implantation site (e.g., the mitral valve 12). Specifically, the delivery shaft 20 may be configured to be advanced by the user through the patient's vascular system to the implantation site and may be configured to receive and / or hold the docking device 10 within it. In some embodiments, the delivery shaft 20 may comprise an outer sheath or shaft defining a lumen, and the pusher assembly 24 and / or the docking device 10 may be configured to receive and / or advance within this lumen.

[0027] The handle 22 is configured to be grasped and / or otherwise held by the user in order to advance the delivery shaft 20 through the patient's vascular system. Specifically, the handle 22 is connected to the proximal end 26 of the delivery shaft 20 and is configured to remain accessible to the user (e.g., outside the patient 16) during the docking device implantation procedure. In this way, the user can advance the delivery shaft 20 through the patient's vascular system by applying force (e.g., pushing) to the handle 22. In some embodiments, the delivery shaft 20 may be configured to carry the pusher assembly 24 and / or the docking device 10 as it advances through the patient's vascular system. In this way, the docking device 10 and / or the pusher assembly 24 can advance through the patient's vascular system in the same direction and at the same speed as the delivery shaft 20 as the user grasps the handle 22 and pushes the delivery shaft 20 deeper into the patient's vascular system.

[0028] In some embodiments, the handle 22 may include one or more articulated members 28 configured to help navigate the delivery shaft 20 through the patient's vascular system. Specifically, the articulated members 28 may include one or more knobs, buttons, wheels, and / or other types of physically adjustable control members configured to be adjusted by the user to bend, curve, twist, rotate, and / or otherwise join the distal end 30 of the delivery shaft 20, thereby helping to navigate the delivery shaft 20 through the patient's vascular system.

[0029] The pusher assembly 24 is configured to deploy and / or implant the docking device 10 at the implantation site (e.g., a natural valve). Specifically, the pusher assembly 24 is configured to be adjusted by the user to advance the docking device 10 through the delivery shaft 20 and push the docking device 10 out of the distal end 30 of the delivery shaft 20. As described above, the pusher assembly 24 may be configured to extend through the delivery shaft 20 into the lumen defined by the outer sheath of the delivery shaft 20. The pusher assembly 24 may also be coupled to the docking device 10, so that as the pusher assembly 24 advances through the delivery shaft 20, the pusher assembly 24 pushes the docking device 10 through and / or out of the delivery shaft 20. In other words, the docking device 10 is maintained, held, and / or otherwise connected to the pusher assembly 24, so that it can move forward through and / or out of the delivery shaft 20 in the same direction and at the same speed as the pusher assembly 24.

[0030] The pusher assembly 24 comprises a pusher shaft 32, which in some embodiments may include a sleeve shaft 34. The pusher shaft 32 is configured to advance the docking device 10 through the delivery shaft 20 and outward from the distal end 30 of the delivery shaft 20, while the sleeve shaft 34, if included, may be configured to cover the docking device 10 within the delivery shaft 20 while pushing the docking device 10 outward from the delivery shaft 20 and positioning the docking device 10 at the implantation site. In some embodiments, the pusher shaft 32 may be covered by the sleeve shaft 34 and may be located within the outer shaft or connector of the pusher handle (or hub assembly) 36 (for example, as shown in Figures 5 to 7, as further described below).

[0031] In some embodiments, the pusher assembly 24 may include a pusher handle (which may also be referred to herein as a “hub assembly”) 36 connected to the pusher shaft 32 and configured to be gripped and pushed by the user to move the pusher shaft 32 axially relative to the delivery shaft 20 (for example, to push the pusher shaft 32 to and / or out of the distal end 30 of the delivery shaft 20). The sleeve shaft 34 may be configured to be retracted and / or withdrawn from the docking device 10 after the docking device 10 has been positioned at the implantation site. For example, the pusher assembly 24 may include a sleeve handle 38 connected to the sleeve shaft 34 and configured to be pulled out by the user to retract the sleeve shaft 34 relative to the pusher shaft 32 (for example, to move it axially).

[0032] The pusher assembly 24 may be detachably connected to the docking device 10, and thus, once the docking device 10 is deployed at the implant site, it may be configured to be released, detached, separated, and / or otherwise removed from the docking device 10. As just one example, the pusher assembly 24 (e.g., the pusher shaft 32) may be detachably connected to the docking device 10 via weaving thread, string, twisted thread, suture, or other suitable material that is bonded to or sutured to the docking device 10.

[0033] In some embodiments, the pusher assembly 24 includes a suture lock assembly 40 configured to receive and / or hold a thread or other suitable material connected to the docking device 10 via a suture. Thus, the thread or other suitable material forming the suture may extend from the docking device 10, through the pusher assembly 24, to the suture lock assembly 40. The suture lock assembly 40 may also be configured to cut the thread, thereby freeing, detaching, separating, and / or otherwise removing the docking device 10 from the pusher assembly 24. For example, the suture lock assembly 40 may include a cutting mechanism configured to be adjusted by the user to cut the thread.

[0034] Further details of the docking device delivery device and its modifications are described below with reference to Figures 4 to 11 and are also described in Patent Document 1, which is incorporated herein by reference in its entirety.

[0035] Before inserting the docking device's delivery device 18 into the patient's vascular system, the user may first incise the patient's body to access the blood vessel 42. For example, in the embodiment shown in Figure 1, the user may incise the patient's groin to access the femoral vein. Thus, in such an embodiment, the blood vessel 42 may be the femoral vein.

[0036] After making an incision in the blood vessel 42, the user may insert an introducer device 44, a guidewire 46, and / or other devices (e.g., an insertion shaft 20, a pusher shaft 32, and / or a sleeve shaft 34 of the delivery device 18 of a docking device, a catheter, and / or other delivery devices, a docking device 10, an artificial valve, etc.) into the blood vessel 42 through the incision. The introducer device 44 (which may include an introducer sheath) is configured to facilitate the percutaneous introduction of the guidewire 46 and / or other devices (e.g., the delivery device 18 of a docking device) into and through the blood vessel 42, and may extend through only a portion of the blood vessel 42 even when fully inserted by the user (i.e., it may extend through the blood vessel 42 toward the heart 14 but may stop before reaching the heart 14). On the other hand, the guidewire 46 is configured to guide the delivery device (e.g., the delivery device 18 for the docking device, the delivery device for the prosthetic valve, the catheter, etc.) and their associated devices (e.g., the docking device, the prosthetic heart valve, etc.) to the implantation site within the heart 14, and thus can consistently extend through the blood vessels 42 to the left atrium 48 of the heart 14. Specifically, the user can advance the guidewire 46 through the blood vessels 42 (e.g., through the femoral vein and the inferior vena cava) to the right atrium 50 of the heart 14. The user can make a small incision in the atrial septum 52 of the heart 14 and pass the guidewire 46 from the right atrium 50 to the left atrium 48 of the heart 14, and then advance the guidewire 46 through the incision in the atrial septum 52 to the left atrium 48. Therefore, the guidewire 46 may provide a path that the delivery device 18 of the docking device can follow to ensure that it does not perforate the walls of the blood vessels 42 and / or other vascular tissues as it advances through the patient's vascular system.

[0037] After positioning the guidewire 46 within the left atrium 48, the user may insert the docking device's delivery device 18 (e.g., delivery shaft 20) into the patient 16 by advancing the docking device's delivery device 18 through the introducer device 44 and over the guidewire 46. The user can then continue to advance the docking device's delivery device 18 along the guidewire 46 through the patient's vascular system until the docking device's delivery device 18 reaches the left atrium 48, as shown in Figure 1. Specifically, the user may advance the delivery shaft 20 of the docking device's delivery device 18 by grasping and applying force (e.g., pushing) the handle 22 of the docking device's delivery device 18. While advancing the delivery shaft 20 through the patient's vascular system, the user may adjust one or more articulated members 28 of the handle 22 to navigate various rotations, angles, stenoses, and / or other obstructions within the patient's vascular system.

[0038] Once the delivery shaft 20 reaches the left atrium 48, the user can use the handle 22 (e.g., the articulator 28) to position the distal end 30 of the delivery shaft 20 at and / or near the posteromedial commissure of the mitral valve 12. The user can then use the pusher assembly 24 to push the docking device 10 out of the distal end 30 of the delivery shaft 20, deploying and / or implanting the docking device 10 onto the mitral valve 12. For example, the user can actuate the pusher handle 36 to move the pusher shaft 32 axially distal to the delivery shaft 20, thereby deploying the docking device 10 (which may be covered by the sleeve shaft 34) out of the delivery shaft 20 and moving it to the desired position at the implantation site.

[0039] In some embodiments, the docking device 10 may be constructed from, formed from, and / or include, a shape memory material so that when the docking device exits the delivery shaft 20 and is no longer constrained by the delivery shaft 20, it can return to its original pre-formed shape. In one embodiment, the docking device 10 may originally be formed as a coil so that when it exits the delivery shaft 20 and returns to its original coiled configuration (for example, as shown in Figure 3, further described below), it can wrap around the ventricular side of the valve leaflet.

[0040] The user can push the ventricular portion of the docking device 10 (i.e., the portion of the docking device 10 configured to be positioned / placed within the left ventricle 56 and / or on the ventricular side of the mitral valve leaflets) and then release the remaining portion of the docking device 10 (the atrial portion of the docking device 10) from the delivery shaft 20 in the left atrium 48. Specifically, the user can retract the delivery shaft 20 relative to the docking device 10, away from the lateral side of the posteromedial commissure of the mitral valve 12. In some embodiments, the user can maintain the position of the pusher shaft 32 (e.g., by applying a holding and / or pushing force onto the pusher shaft 32) while retracting the delivery shaft 20 so that it is withdrawn and / or otherwise retracted relative to the docking device 10 and the pusher shaft 32. In this way, the pusher shaft 32 can hold the docking device 10 in place while the user retracts the delivery shaft 20, thereby releasing the docking device 10 from the delivery shaft 20. In some embodiments, the user may also retract the sleeve shaft 34 from the docking device 10, expose the docking device 10, and in some embodiments, deploy the expandable sleeve of the docking device 10.

[0041] After deploying and / or implanting the docking device 10, the user may separate and / or otherwise remove the docking device delivery device 18 from the docking device 10 by, for example, cutting the threads sutured to the docking device 10. As just one example, the user may cut the threads using the cutting mechanism of the suture lock assembly 40. Once the docking device 10 is removed from the docking device delivery device 18, the user can retract the entire docking device delivery device 18 (delivery shaft 20, handle 22, and pusher assembly 24) from the patient 16, thereby enabling the user to deliver and implant the THV to the mitral valve 12. For example, the docking device 10 and the THV may be delivered by two different separate delivery devices, and therefore the user may need to remove the docking device delivery device 18 from the patient 16 to make space for the THV delivery device. In another embodiment, the user may need to remove the docking device delivery device 18 from the patient 16 and load the THV onto the delivery device. In any embodiment, the user may need to remove the docking device's delivery device 18 from the patient 16 before implanting the THV.

[0042] Figure 2A illustrates this second stage in mitral valve replacement, where the docking device 10 is fully deployed and implanted in the mitral valve 12, and the delivery device 18 (including the delivery shaft 20) of the docking device is removed from the patient 16, leaving only the guidewire 46 and introducer device 44 inside the patient 16. The introducer device 44 remains inside the patient 16 and can assist in the percutaneous insertion of the THV and valve delivery device into the patient 16, while the guidewire 46 remains within the patient's vascular system and can assist in advancing the THV and valve delivery device through the patient's vascular system. Specifically, the guidewire 46 can ensure that the THV and valve delivery device do not perforate the walls of the blood vessels 42 and / or other vascular tissues as they advance through the patient's vascular system. In some embodiments, the user may advance the guidewire 46 through the mitral valve 12 into the left ventricle 56, ensuring that the guidewire 46 consistently and reliably guides the THV and valve delivery device to the docking device 10 up to the mitral valve 12.

[0043] As shown in Figure 2A, the docking device 10 may be configured to wrap around the ventricular side of the mitral valve leaflets of the mitral valve 12 and compress the leaflets radially inward (i.e., radially compress the leaflets) in order to adjust the size and / or shape of the opening between the two leaflets of the mitral valve 12. For example, the docking device 10 may be configured to reduce the size and / or change the shape of the opening of the mitral valve 12 in order to more closely match the cross-sectional shape and / or external shape of the THV (e.g., to make the opening more circular for a cylindrical THV). By contracting the mitral valve 12 in this way, the docking device 10 may provide a tighter fit between the THV and the valve 12, i.e., a better seal.

[0044] Figure 2B shows the third stage in a mitral valve replacement procedure, in which the user delivers and / or implants an artificial heart valve 54 (which may also be referred to herein as “heart valve,” “transcatheter heart valve,” or simply “THV,” “replacement heart valve,” and / or “artificial mitral valve”) into the docking device 10 and / or the mitral valve 12 using an artificial heart valve delivery device 58. Thus, the docking device 10 and the artificial heart valve 54 may be delivered on different delivery devices at different stages in a mitral valve replacement procedure. Specifically, the docking device 10 may be delivered to the mitral valve 12 by the docking device delivery device 18 during the first stage of the mitral valve replacement procedure, and thereafter the artificial heart valve 54 may be delivered by the artificial heart valve delivery device 58.

[0045] The artificial heart valve delivery device 58 comprises a delivery shaft 60 and a handle 62 connected to the proximal end 64 of the delivery shaft 60. The delivery shaft 60 is configured to extend into the patient's vascular system to deliver, implant, expand, and / or otherwise deploy the artificial heart valve 54 in the docking device 10 to the mitral valve 12. The handle 62 may be identical or similar to the handle 22 of the delivery device 18 of the docking device and similarly configured to be grasped and / or otherwise held by the user to advance the delivery shaft 60 through the patient's vascular system.

[0046] In some embodiments, the handle 62 may include one or more articulated members 66 configured to help navigate the delivery shaft 60 through the patient's vascular system. Specifically, the articulated members 66 may include one or more knobs, buttons, wheels, and / or other types of physically adjustable control members configured to be adjusted by the user to bend, curve, twist, rotate, and / or otherwise join the distal end 68 of the delivery shaft 60, thereby helping to navigate the delivery shaft 60 through the patient's vascular system.

[0047] In some embodiments, the artificial heart valve delivery device 58 may include an expansion mechanism 70 configured to radially expand and deploy the artificial heart valve 54. For example, the expansion mechanism 70 may include an inflatable balloon configured to inflate in order to radially expand the artificial heart valve 54 within the docking device 10. The expansion mechanism 70 may be contained within and / or connected to the delivery shaft 60, at the distal end 68 of the delivery shaft 60 and / or proximal thereto. In other embodiments, the artificial heart valve 54 may be self-expanding and configured to radially expand on its own without the expansion mechanism 70. In other embodiments, the artificial heart valve 54 may be mechanically expandable, and the artificial heart valve delivery device 58 may include one or more mechanical actuators configured to radially expand the artificial heart valve 54.

[0048] The artificial heart valve 54 may be connected to the delivery shaft 60 at and / or adjacent to its distal end 68. In embodiments in which the artificial heart valve delivery device 58 includes an expansion mechanism 70, the artificial heart valve 54 may be mounted on the expansion mechanism 70 in a radially compressed configuration. In some embodiments, the artificial heart valve 54 may be removably connected to the delivery shaft 60, so that the artificial heart valve 54 expands radially from the artificial heart valve delivery device 58 and, after being deployed, the artificial heart valve delivery device 58 can be retracted away from the implanted artificial heart valve 54 and removed from the patient 16.

[0049] The artificial heart valve 54 is configured to be received and / or held within the docking device 10. That is, the docking device 10 is configured to receive the artificial heart valve 54 and to help secure the artificial heart valve 54 to the mitral valve 12. As will be described in more detail below, the docking device 10 is also configured to provide a seal between the artificial heart valve 54 and the mitral valve leaflets to reduce perivalvular leakage around the artificial heart valve 54. Specifically, as introduced above, the docking device 10 may initially deflate the leaflets of the mitral valve 12. The artificial heart valve 54 may then press its leaflets against the docking device 10 as it expands radially within the docking device 10 (e.g., by the expansion of the expansion mechanism 70). Thus, the docking device 10 and the artificial heart valve 54 may be configured to clamp the leaflets of the mitral valve 12 when the artificial heart valve 54 expands within the docking device 10. In this way, the docking device 10 can provide a seal between the leaflets of the mitral valve 12 and the artificial heart valve 54.

[0050] In some embodiments, one or more of the delivery devices 18 of the docking device, the delivery device 58 of the artificial heart valve, and / or the introducer device 44 may be provided with one or more flushing ports 72 (Figure 1) configured to supply flushing fluid to their lumen (e.g., the delivery shaft 20 of the delivery device 18 of the docking device, the delivery shaft 60 of the delivery device 58 of the artificial heart valve, and / or the lumen of the introducer device 44), thereby reducing the possibility of blood clot (e.g., thrombus) formation.

[0051] Similar to the delivery of the docking device 10, the user may insert the artificial heart valve delivery device 58 (e.g., delivery shaft 60) into the patient 16 by advancing the artificial heart valve delivery device 58 over the guidewire 46 through the introducer device 44. The user may continue to advance the artificial heart valve delivery device 58 along the guidewire 46 (through the patient's vascular system) until the artificial heart valve delivery device 58 reaches the mitral valve 12, as shown in Figure 2B. Specifically, the user may advance the delivery shaft 60 of the artificial heart valve delivery device 58 by grasping the handle 62 of the artificial heart valve delivery device 58 and applying force (e.g., pushing). While advancing the delivery shaft 60 through the patient's mitral vascular system, the user may adjust one or more articulated members 66 of the handle 62 to navigate various rotations, angles, stenoses, and / or other obstructions within the patient's vascular system.

[0052] The user may advance the delivery shaft 60 along the guidewire 46 until the artificial heart valve 54 and / or expansion mechanism 70 are positioned / placed within the docking device 10 and / or mitral valve 12. For example, the user may advance the delivery shaft 60 along the guidewire 46 until the delivery shaft 60 extends through the mitral valve 12 so that the distal end 68 of the delivery shaft 60 is positioned / placed within the left ventricle 56. Once the artificial heart valve 54 is properly positioned / placed within the docking device 10, the user may radially expand the artificial heart valve 54 to its fully expanded position or configuration, using the expansion mechanism 70 or the like. In some embodiments, the user may lock the artificial heart valve 54 in its fully expanded position (e.g., by a locking mechanism) to prevent the valve from collapsing. After expanding and deploying the artificial heart valve 54, the user may separate the delivery shaft 60 from the artificial heart valve 54 and / or remove it by other means, and remove the delivery shaft 60 from the patient.

[0053] Figures 1 to 2B specifically illustrate mitral valve replacement, but it should be understood that the same and / or similar procedures can be used to replace other heart valves (e.g., tricuspid valve, pulmonary valve, and / or aortic valve). Furthermore, the same and / or similar delivery devices (e.g., docking device delivery device 18, prosthetic valve delivery device 58, introducer device 44, and / or guidewire 46), docking device (e.g., docking device 10), replacement heart valve (e.g., prosthetic heart valve 54), and / or components can be used to replace these other heart valves.

[0054] For example, when replacing a natural tricuspid valve, the user can also access the right atrium 50 via the femoral vein, but does not need to cross the atrial septum 52 to enter the left atrium 48. Instead, the user can leave the guidewire 46 in the right atrium 50 and perform the same and / or similar docking device implantation process on the tricuspid valve. Specifically, the user can push the docking device 10 out of the delivery shaft 20 around the ventricular side of the tricuspid valve leaflets, freeing the rest of the docking device 10 from the delivery shaft 20 in the right atrium 50, and then remove the delivery shaft 20 of the docking device delivery device 18 from the patient 16. The user can then advance the guidewire 46 through the tricuspid valve into the right ventricle and perform the same and / or similar artificial heart valve implantation process on the tricuspid valve within the docking device 10. Specifically, the user may advance the delivery shaft 60 of the artificial heart valve delivery device 58 along the guidewire 46 through the patient's vascular system until the artificial heart valve 54 is positioned / placed within the docking device 10 and the tricuspid valve. The user may then expand the artificial heart valve 54 within the docking device 10 before removing the artificial heart valve delivery device 58 from the patient 16. In another embodiment, the user may perform the same and / or similar process to replace the aortic valve, but access the aortic valve from the outflow side via the femoral artery.

[0055] Furthermore, while Figures 1 to 2B show mitral valve replacement surgery where the mitral valve 12 is accessed from the left atrium 48 via the right atrium 50 and femoral vein, it should be understood that the mitral valve 12 can be alternatively accessed from the left ventricle 56. For example, a user may access the mitral valve 12 from the left ventricle 56 via the aortic valve by advancing one or more delivery devices through the arteries to the aortic valve, and then through the aortic valve to the left ventricle 56.

[0056] Figure 3 shows an embodiment of a docking device 100 configured to receive an artificial heart valve. For example, the docking device 100 may be implanted within the annulus of a natural valve, as described above with reference to Figures 1 and 2A. As shown in Figures 1 to 2B, the docking device 100 may be configured to house and secure the artificial valve within the docking device, thereby fixing the artificial valve to the annulus of the natural valve.

[0057] Referring to Figure 3, the docking device 100 may include two main components: a coil 102 and a guard member 104 covering at least a portion of the coil 102. In certain embodiments, the coil 102 may include a shape memory material (e.g., nitinol), and as a result, the docking device 100 (and the coil 102) is movable from a substantially linear configuration (also referred to as the “delivery configuration”) when placed within a delivery sleeve (e.g., sleeve shaft) of a delivery device (as described more fully below) to a helical configuration (also referred to as the “deployed configuration”, as shown in Figure 3) after being removed from the delivery sleeve (e.g., sleeve shaft).

[0058] The coil 102 has a proximal end 102p and a distal end 102d. The body of the coil 102 between the proximal end 102p and the distal end 102d may form a substantially linear delivery configuration (e.g., without coiled or looped portions) to maintain a small radial shape when moving through the patient's vascular system, when placed within a delivery sleeve (e.g., during delivery of the docking device to the patient's vascular system). After being removed from the delivery sleeve and unfolded at the implant site, the coil 102 may move from the delivery configuration to a helical unfolded configuration and wrap around the natural tissue adjacent to the implant site. For example, when implanting the docking device at the location of a natural valve, the coil 102 may be configured to surround the natural valve leaflets of the natural valve (and the chordae tendineae connecting the natural valve leaflets to the adjacent papillary muscles (if present)).

[0059] The docking device 100 may be detachably coupled to the delivery device. In certain embodiments, the docking device 100 may be coupled to the delivery device via a release suture (as further described later with reference to Figures 4 and 11) which may be coupled to the docking device 100 and configured to be cut for removal. In one embodiment, the release suture may be coupled to the docking device 100 through a through-hole or eye hole located adjacent to the proximal end 102p of the coil. In another embodiment, the release suture may be coupled around a circumferential recess located adjacent to the proximal end 102p of the coil 102.

[0060] In some embodiments, the deployable docking device 100 may be configured to fit into the position of the mitral valve. In other embodiments, the docking device may also be shaped and / or adapted for implantation in the position of other natural valves, such as the tricuspid valve. In some embodiments, the geometric shape of the docking device 100 may be configured to engage with a natural anatomical structure, which may provide, for example, improved stability and reduced relative movement between the docking device 100, the artificial valve docked therein, and / or the natural anatomical structure. Such reduced relative movement may, among other things, prevent material decomposition of the components of the docking device 100 and / or the artificial valve docked therein, and / or prevent damage or trauma to natural tissue.

[0061] As shown in Figure 3, the unfolded coil 102 may include a leading rotating section 106 (or "leading coil"), a central region 108, and a stabilizing rotating section 110 (or "stabilizing coil"). The central region 108 may have one or more helical rotating sections having substantially equal inner diameters. The leading rotating section 106 may extend from the distal end of the central region 108 and have a diameter larger than the diameter of the central region 108 (in one or more configurations). The stabilizing rotating section 110 may extend from the proximal end of the central region 108 and have a diameter larger than the diameter of the central region 108 (in one or more configurations).

[0062] In certain embodiments, the central region 108 may include multiple helical rotating sections, such as a proximal rotating section 108p connected to a stabilizing rotating section 110, a distal rotating section 108d connected to a leading rotating section 106, and one or more intermediate rotating sections 108m positioned between the proximal rotating section 108p and the distal rotating section 108d. In the embodiment shown in Figure 3, there is only one intermediate rotating section 108m between the proximal rotating section 108p and the distal rotating section 108d. In other embodiments, there are multiple intermediate rotating sections 108m between the proximal rotating section 108p and the distal rotating section 108d. Some of the helical rotating sections in the central region 108 may be full-rotating sections (i.e., 360-degree rotations). In some embodiments, the proximal rotating section 108p and / or the distal rotating section 108d may be partial rotating sections (e.g., rotating less than 360 degrees, such as 180 degrees and 270 degrees).

[0063] The size of the docking device 100 may generally be selected based on the size of the desired prosthetic valve to be implanted in the patient. In certain embodiments, the central region 108 may be configured to hold a radially expandable prosthetic valve. For example, the inner diameter of the helical rotating portion within the central region 108 may be configured to be smaller than the outer diameter of the prosthetic valve when the prosthetic valve is radially expanded, so that additional radial tension acts between the central region 108 and the prosthetic valve to hold the prosthetic valve in place. The helical rotating portions in the central region 108 (e.g., 108p, 108m, 108d) are also referred to herein as “functional rotating portions”.

[0064] The stabilizing rotator 110 may be configured to help stabilize the docking device 100 in a desired position. For example, the radial dimension of the stabilizing rotator 110 may be significantly larger than the radial dimension of the coil in the central region 108, so that the stabilizing rotator 110 flares outward sufficiently to abut or press against the wall of the circulatory system, thereby improving the ability of the docking device 100 to remain in a desired position before implantation of the prosthetic valve. In some embodiments, the diameter of the stabilizing rotator 110 is preferably larger than the annulus, natural valve surface, and atrium for good stabilization. In some embodiments, the stabilizing rotator 110 may be a full rotator (i.e., rotates about 360 degrees). In some embodiments, the stabilizing rotator 110 may be a partial rotator (e.g., rotates between about 180 and about 270 degrees).

[0065] In one particular embodiment, when the docking device 100 is implanted in the position of the natural prosthetic valve, the functional rotating portion of the central region 108 may be substantially located in the left ventricle, and the stabilizing rotating portion 110 may be substantially located in the left atrium. The stabilizing rotating portion 110 may be configured to provide one or more contact points or contact areas between the docking device 100 and the left atrial wall, such as at least three contact points in the left atrium or full contact with the left atrial wall. In a particular embodiment, the contact points between the docking device 100 and the left atrial wall may form a plane substantially parallel to the plane of the natural mitral valve.

[0066] As described above, the leading rotator 106 may have a larger radial dimension than the helical rotator within the central region 108. The leading rotator 106 can help guide the coil 102 more appropriately and easily around and / or through the geometric shape of the chordae tendineae and around all the natural valve leaflets of a natural valve (e.g., a natural mitral valve, tricuspid valve, etc.). For example, once the guiding rotator 106 is navigated around the desired natural tissue, the rest of the coil of the docking device 100 (e.g., the functional rotator) can also be guided around the same mechanism. In some embodiments, the leading rotator 106 may be a full rotator (i.e., rotating about 360 degrees). In some embodiments, the leading rotator 106 may be a partial rotator (e.g., rotating between about 180 and about 270 degrees). In some embodiments, if the artificial valve is radially expanded within the central region 108 of the coil, the functional rotator of the central region 108 may be further radially expanded. As a result, the leading rotating part 106 is pulled in the proximal direction and can become part of the functional rotating part in the central region 108.

[0067] In certain embodiments, at least a portion of the coil 102 may be enclosed by a first cover. The first cover may be composed of a variety of natural and / or synthetic materials. In one particular embodiment, the first cover may include expanded polytetrafluoroethylene (ePTFE). In certain embodiments, the first cover is configured to be fixedly attached to the coil 102 (e.g., by a textured surface resist, sutures, glue, thermal bonding, or any other means) such that relative axial movement between the first cover and the coil 102 is restricted or prohibited.

[0068] The guard member 104 may constitute part of a cover assembly for the docking device 100. In some embodiments, the cover assembly may also include a first cover.

[0069] In a typical embodiment as shown in Figure 3, when the docking device 100 is in a deployed configuration, the guard member 104 may be configured to cover a portion of the stabilizing rotation portion 110 of the coil 102. In a particular embodiment, the guard member 104 may be configured to cover at least a portion of the central region 108 of the coil 102, such as a portion of the proximal rotation portion 108p. In a particular embodiment, the guard member 104 may extend over the entire coil 102.

[0070] In some embodiments, the guard member 104 may expand radially to help prevent and / or reduce leakage around the valve. Specifically, the guard member 104 may be configured to expand radially so that an improved seal is formed closer to and / or against the artificial valve deployed within the docking device 100. In some embodiments, the guard member 104 may be configured to prevent and / or inhibit leakage at locations where the docking device 100 intersects with the leaflets of the natural valve (e.g., at the commissus of the natural valve).

[0071] In another embodiment, if the docking device 100 is deployed over the natural atrioventricular valve and the guard member 104 primarily covers a portion of the stabilizing rotation section 110 and / or a portion of the central region 108, the guard member 104 may help cover the atrial side of the atrioventricular valve, thereby preventing and / or inhibiting blood from leaking through the natural valve leaflets, commissures and / or around the outside of the prosthetic valve by preventing blood in the atrium from flowing from the ventricle towards the atrium (i.e., antegrade blood flow) except through the prosthetic valve.

[0072] In some embodiments, the guard member 104 may be positioned on the ventricular side of the atrioventricular valve to prevent and / or inhibit blood from leaking through the natural valve leaflets, commissures and / or around the outside of the prosthetic valve by blocking ventricular blood from flowing from the ventricles towards the atria (i.e., retrograde blood flow).

[0073] In some embodiments, the distal end portion 104d of the guard member 104 may be fixedly connected to the coil 102 (for example, via a distal suture), and the proximal end portion 104p of the guard member 104 may be axially movable relative to the coil 102.

[0074] In certain embodiments, when the guard member 104 is radially expanded, the proximal end portion 104p of the guard member 104 may have a tapered shape as shown in Figure 3, and as a result, the diameter of the proximal end portion 104p gradually increases from the proximal end of the guard member 104 to the distal body portion of the guard member 104. This helps to facilitate, for example, loading the docking device into the delivery sleeve (e.g., sleeve shaft) of the delivery device, and / or retrieving and / or repositioning the docking device to the delivery device during the implantation procedure.

[0075] Figures 4–11 show embodiments of a delivery device (which may also be called a delivery system) 220 configured to deliver a docking device (such as the docking device 100 described above with reference to Figure 3) to a target implantation site (e.g., the heart and / or natural valve of an animal, human, cadaver, cadaveric heart, anthropomorphic ghost, and / or homogeneous entity). In some embodiments, the delivery device 220 may be a transcatheter delivery device that can be used to guide the delivery of the docking device through the patient's vascular system, as described above with reference to Figures 1 and 2A.

[0076] An exemplary delivery device 220 is shown in Figure 4, and a docking device 232 is at least partially deployed from the distal end of the delivery device 220 (for illustrative purposes, e.g.). In some embodiments, the docking device 232 may be the docking device 100 described above with reference to Figure 3. The delivery device 220 may include a handle assembly 200 and an outer shaft (e.g., a delivery catheter) 260 extending distally from the handle assembly 200. The handle assembly 200 may include a handle 222 and a hub assembly 230 extending from the proximal end of the handle 222. A more detailed diagram of the hub assembly 230 is shown in Figure 5, as will be further described below. Furthermore, Figures 6 and 7 are cross-sectional views showing an embodiment of the internal components of the hub assembly 230 and the flow of flash fluid through the internal components of the hub assembly 230. Figures 8 and 9A show the flow of flash fluid distal to the handle assembly 200, through the internal components of the delivery device 220, including the distal end portion of the delivery device 220 (Figures 9A and 9B) and a portion of the delivery device 220 positioned between the distal end portion and the hub assembly 230 (Figure 8).

[0077] As shown in Figure 4, the handle assembly 200 may include a handle 222 which includes one or more knobs, buttons, wheels, etc. For example, as shown in Figure 4, the handle 222 may include knobs 224 and 226 which can be configured to control the bending of a delivery system (e.g., an outer shaft 260). The outer shaft 260 extends distally from the handle 222, while the hub assembly 230 extends proximal to the handle 222. Further details regarding delivery systems and devices, such as a delivery device 220 configured to deliver the docking device to a target implantation site, can be found in Patent Documents 2-4, all of which are incorporated herein by reference in their entirety.

[0078] During delivery of some docking devices to the target implantation site, the docking device may capture, snag on, and / or be obstructed by parts of the natural tissue, such as the heart wall, trabecular meshwork, natural valve leaflets, chordae tendineae, or similar. This can be due to a combination of factors, including friction between the docking device and the natural tissue, capture of the distal or tip of the docking device by the trabecular meshwork and / or tendons of the natural tissue, and a size difference between the inner diameter of the functional rotational portion of the docking device and the outer diameter of the natural valve leaflets.

[0079] Some docking devices may have a woven or braided texture and / or covering on their outer surface to increase friction (for example, to increase the retention force between the docking device and the artificial valve deployed and implanted therein, as described above with reference to Figure 2B). However, this friction can cause problems when advancing the docking device around and / or through its natural tissue (for example, increased resistance to moving the docking device around the natural tissue and / or adhesion or capture of the docking device on the natural tissue).

[0080] Once the docking device becomes lodged in an obstruction such as a natural valve leaflet, chordae tendineae, and / or trabecular fiber, the physician, surgeon, or other medical professional or user may need to retract the docking device into the delivery device (e.g., delivery device 220) and attempt to deploy the docking device again. However, this method can cause damage to the natural tissue due to the texture or braids present on the docking device, which rub against and / or capture tissue portions and pull them back into the delivery device, potentially damaging or hindering the movement of the delivery device. Furthermore, this can increase the time required for deployment and implantation procedures.

[0081] To address these challenges, the docking device (e.g., docking device 232 in Figure 4) may be configured to have a lubricated outer surface (e.g., on the entire docking device or on specific parts of the docking device such as the functional rotator) during delivery and implantation in the natural tissue, and a higher friction outer surface, at least on the functional coil / rotator portion, after implantation and during subsequent deployment within the artificial valve.

[0082] In some embodiments, this can be achieved by a removable lubricating sleeve or sheath that can be positioned on the docking device during delivery and retracted from the docking device after the docking device is in the desired position at the implantation site. In some embodiments, the lubricating or low-friction sleeve / sheath can be incorporated into the delivery device, such as the delivery device 220 in Figure 4.

[0083] For example, the delivery device 220 may include a pusher shaft 290 (Figures 4-11) and a sleeve shaft 280 (Figures 5-11), which are coaxially arranged within the outer shaft 260 and each having a portion extending into the handle assembly 200. The pusher shaft 290 may be configured to deploy a docking device 232 from inside the distal end portion of the outer shaft 260 when it reaches the target implantation site, and the sleeve shaft 280 may be configured to cover the docking device 232 while it is positioned at the target implantation site (Figure 11) inside the delivery device 220. Furthermore, the delivery device 220 may be configured to adjust the axial position of the sleeve shaft 280 in order to detach the sleeve portion (e.g., the distal section) of the sleeve shaft 280 from the docking device 232 after implantation at the target implantation site, as will be further described below. Figures 10 and 11 are perspective views showing an exemplary docking device 232 deployed from the outer shaft 260 of a delivery device 220, covered by the distal (or sleeve) portion 282 of the sleeve shaft 280 (Figure 10), after the sleeve shaft 280 has been re-hoisted onto the outer shaft 260 (Figure 11).

[0084] As shown in Figures 4 and 11, the docking device 232 may be connected to the delivery device 220 via a release suture (or other recovery line including a string, yarn, or other material which may be tied around the docking device and configured to be cut for removal) 236 which may extend through the pusher shaft 290 during delivery. As further described below with reference to Figure 5, the release suture 236 may extend through the delivery device 220, through the inner lumen of the pusher shaft 290, to the suture lock assembly 206 of the delivery device 220.

[0085] As shown in Figures 4 and 5, the hub assembly 230 may include a suture lock assembly (e.g., a suture lock) 206 and a sleeve handle attached thereto. A first embodiment of the sleeve handle 234 is shown in Figure 4, and a second embodiment of the sleeve handle 208 is shown in Figure 5. The hub assembly 230 may be configured to control together the pusher shaft 290 and the sleeve shaft 280 of the delivery device 220 (e.g., to move them together axially), while the sleeve handle (sleeve handle 234 in Figure 4 and sleeve handle 208 in Figure 5) may control the axial position of the sleeve shaft 280 relative to the pusher shaft 290. In this way, by manipulating the various components of the handle assembly 200, the operation of components located within the outer shaft 260 can be actuated and controlled. In some embodiments, as shown in Figures 4 and 5, the hub assembly 230 may be connected to the handle 222 via a connector 240.

[0086] Further details relating to suture lock assemblies and pusher shaft and sleeve shaft assemblies for delivery devices for docking devices are described in Patent Document 5, which is incorporated herein by reference in its entirety. Further embodiments of pusher shafts for delivery devices, such as delivery device 220, are described below with reference to Figures 29 to 43.

[0087] As shown in Figures 4 to 7, and as will be further described later, the handle assembly 200 may further include one or more flushing ports for supplying flushing fluid to one or more lumens located within the delivery device 220 (e.g., annular lumens positioned between the coaxial components of the delivery device 220) in order to reduce potential thrombus formation. One embodiment in which the delivery device 220 includes three flushing ports (e.g., flushing ports 210, 216, and 218) is shown in Figures 4, 6, and 7. In alternative embodiments, the delivery device 220 may not include flushing port 216 (e.g., as shown in Figures 5 and 23, and as will be further described below).

[0088] Figure 5 shows in more detail one embodiment of a hub assembly 230 for the delivery device 220. In some embodiments, as shown in Figure 5, the hub assembly 230 may include a Y-shaped connector (e.g., adapter) having a straight section (e.g., a straight conduit) 202 and at least one branch (e.g., a branch conduit) 204 (but in some examples, it may include multiple branches). In some embodiments, a suture lock assembly (e.g., a suture lock) 206 may be attached to the branch 204, and a sleeve handle (e.g., a sleeve operating handle) 208 may be located at the proximal end of the straight section 202.

[0089] The hub assembly 230 may be adapted and configured such that the proximal extension 291 of the pusher shaft 290 (or another similar pusher shaft) extends to a suture lock assembly 206 located at the end of the branch 204, while the cut portion 288 (which may also be referred to as the proximal portion) of the sleeve shaft 280 extends to a sleeve handle 208 located at the end of the straight section 202. This configuration allows a medical professional to deploy the docking device (e.g., the docking device 232 in Figure 4) by manipulating the position of the handle assembly 200 (e.g., moving it axially), and to retract the sleeve shaft 280 (detached from the implanted docking device and away from it) by pulling it axially back on the sleeve handle 208.

[0090] Thus, the sleeve shaft 280 and the pusher shaft 290 may be configured to function together, and as a result, when deploying and positioning the docking device to the natural valve (for example, by moving the entire hub assembly 230 axially forward and / or backward), they may not only move together simultaneously, but also be independently movable so that the pusher shaft 290 can hold the docking device in place while the sleeve shaft 280 is detached from the docking device and stored (for example, by holding the hub assembly 230 in place relative to the outer shaft 260 of the delivery device 220 and / or the rest of the delivery device 220 and / or the docking device while the sleeve shaft 280 is pulled proximal on the sleeve handle 208 to remove it). As introduced above, shown in Figures 34 and 35 and further described below, the sleeve shaft 280 and the pusher shaft 290 may be coaxial along part, all, or most of the delivery device 220 to facilitate this cooperative interaction.

[0091] As described above, and as shown in Figures 4 to 7, the handle assembly 200 may include one or more flushing ports or fluid ports, such as flushing ports 210, 216, and 218, configured to receive fluid and deliver the received fluid to selected lumens (e.g., annular spaces) located between coaxial components extending axially in the delivery device 220. For example, the flushing port configurations shown in Figures 4 to 7, and various other flow system embodiments detailed herein, may allow for flushing and / or constant flow of fluid through selected lumens of the delivery device 220 during implantation procedures to reduce or prevent thrombosis between components, including around the docking device.

[0092] For example, as shown in Figure 9A, a schematic diagram of the distal end portion of the delivery device 220, various lumens formed between the docking device 232, the pusher shaft 290, the sleeve shaft 280, and the outer shaft 260 are configured to receive fluid during the delivery and implantation procedure.

[0093] The first pusher shaft lumen 201 may be formed inside the pusher shaft (for example, inside the main section 292 of the pusher shaft 290). The pusher shaft lumen 201 can receive fluid from a first fluid source which may be fluid-connected to a portion of the handle assembly (for example, a branch 204, as further described below). The flash fluid flow 203 passing through the pusher shaft lumen 201 may travel along the length of the main section 292 of the pusher shaft 290 to the distal end 293 of the pusher shaft 290. If the distal end 293 of the pusher shaft 290 is spaced away from the proximal end of the docking device 232, as shown in Figure 9A, at least a portion of the flash fluid flow 203 may flow into the first portion 205 of the second sleeve shaft lumen 211, which is positioned as a flash fluid flow 207 between the outer surface of the docking device 232 and the inner surface of the distal section 282 of the sleeve shaft 280. Furthermore, in some embodiments, a portion of the flushing fluid flow 203 may also flow into a second portion 209 of the sleeve shaft lumen 211, which is positioned as a flushing fluid flow 213 between the outer surface of the pusher shaft 290 and the inner surface of the sleeve shaft 280. In this way, the same first fluid source can supply flushing fluid to the pusher shaft lumen 201, the first portion 205 of the sleeve shaft lumen 211, and the second portion 209 of the sleeve shaft lumen 211, respectively, via the pusher shaft lumen 201.

[0094] As shown in Figure 9A, the third delivery shaft lumen 215 may be formed within an annular space formed between the inner surface of the outer shaft 260 and the outer surface of the sleeve shaft 280. The delivery shaft lumen 215 may receive fluid from one or more second fluid sources and / or first fluid sources, which may be fluid-connected to a portion of the handle assembly (e.g., the branch 204 and / or handle 222, as further described below). Fluid from one or more of these sources may result in a flush fluid flow 217 that flows through the delivery shaft lumen 215 to the distal end of the outer shaft 260.

[0095] By providing a fluid (e.g., a flush fluid) to the aforementioned lumen, thrombosis on and around the docking device 232 and other concentric portions of the docking device 220 can be reduced or prevented during the deployment of the docking device 232 from the delivery device 220 and the implantation of the docking device 232 at the target implantation site.

[0096] Figures 4–7 show different embodiments of possible fluid (e.g., flushing) port arrangements configured to supply the flash fluid to the lumen described above with reference to Figure 9A. Furthermore, Figure 8 shows the flow of the flash fluid through a portion of the delivery device 220 positioned between the hub assembly 230 (Figures 4–7) and the distal end portion of the delivery system (Figure 9A).

[0097] In a first embodiment of the flushing port arrangement, the handle assembly 200 may include two flushing ports (also referred to herein as fluid ports) located on a branch 204 (which may be referred to as a suture lock branch) of the hub assembly 230, one of which provides a flushing fluid flow 203 to the pusher shaft lumen 201, and the other providing a flushing fluid flow 217 to the delivery shaft lumen 215. For example, the two flushing ports on the branch 204 may include a first flushing port 210 and a second flushing port 216, with the first flushing port 210 positioned proximal to the second flushing port 216 on the branch 204 (Figures 6 and 7). In some embodiments, the position of the second flushing port 216 on the branch 204 may be closer to or further away from the first flushing port 210 than shown in Figures 6 and 7. Additionally or alternatively, in some embodiments, the first flushing port 210 may be located more proximal along the branch 204, such as at the free end of the branch 204, and / or may be connected to the suture lock assembly 206.

[0098] As shown in Figures 5 to 7, the first flushing port 210 has an internal flow lumen that is fluidly connected to an internal cavity 250 within the branch 204. The open proximal end 252 of the proximal extension 291 of the pusher shaft 290 may be fluidly connected to and / or located within the internal cavity 250 (as shown in Figures 5 to 7). The proximal extension 291 is guided through the branch 204 to the straight section 202 of the hub assembly 230 and connected to the main tube 292 of the pusher shaft 290 (Figures 6 and 7). Thus, the pusher shaft lumen 201 is formed by and within the main tube 292 and the proximal extension 291. Therefore, the flush fluid flow 203 from the first flushing port 210 enters the lumen 201 of the pusher shaft at the proximal end 252 of the proximal extension 291 and continues through it to the distal end 293 (as shown in Figure 9A) of the main tube 292 of the pusher shaft 290.

[0099] The second flushing port 216 surrounds the outside of the proximal extension 291 within the branch 204 and has an internal flow lumen that is fluid-connected to an elongated space or cavity 254 (which may be annular along at least a portion of the cavity) that extends into the straight section 202, in the space between the inner surface of the cut portion 288 of the proximal section 284 of the sleeve shaft 280 and the proximal extension 291 (Figures 6 and 7). Thus, the flush fluid flow 217 from the second flushing port 216 can enter the cavity 254 and flow through the cavity 254 around the proximal extension 291 into the annular cavity 219 (Figures 6 and 8). The flush fluid flow 217 can flow through the annular cavity 219, as shown in Figures 34 and 35 (further described below), exit the distal end of the shell 294 of the pusher shaft 290, and enter the delivery shaft lumen 215.

[0100] In some embodiments, as shown in Figures 4 and 6, the delivery shaft lumen 215 may be supplied with additional flushing fluid from a third flushing port 218 (in addition to the fluid from the second flushing port 216) which is fluid-connected to an annular cavity 219 downstream (e.g., distal) of the plug 296 of the pusher shaft 290 (further details of the components of the pusher shaft 290, including the plug 296 and shell 294, are described below with reference to Figures 29 to 33). Thus, in some embodiments, supplemental flushing fluid 221 may be combined with the flushing fluid flow 217 (Figure 6) and supplied to the delivery shaft lumen 215.

[0101] In some embodiments, the third flushing port 218 may be located on a portion of the handle 222, as shown in Figures 4 and 6. In alternative embodiments, the third flushing port 218 may be located more distally on the handle than shown in Figures 4 and 6. In some embodiments, the third flushing port 218 may not be used during the implantation procedure, but instead may be used only to flush the lumen 215 of the delivery shaft before inserting the delivery device 220 into the patient.

[0102] In some embodiments, the delivery device 220 may not include a third flushing port 218.

[0103] Various embodiments of the hub assembly 230, including the first embodiment of the flushing port arrangement described above, may include a gasket 223 located within the branch 204 between the two flushing ports of the branch 204, creating a separate fluid flow lumen supplied by the two flushing ports of the branch 204 (e.g., the first flushing port 210 and the second flushing port 216, as shown in Figures 5-7). For example, the gasket 223 may be configured as a disc with a single (e.g., central in some examples) hole configured to tightly receive the proximal extension 291 therein. The gasket 223 may further be configured to provide a seal between the internal cavity 250 and cavity 254 without including any additional holes. As a result, all of the flush fluid flow 203 entering the internal cavity 250 from the first flushing port 210 may enter the pusher shaft lumen 201 without entering the cavity 254 and without flowing into the delivery shaft lumen 215. Similarly, all of the flash fluid flow 217 entering the cavity 254 from the second flushing port 216 can enter the annular cavity 219 and the delivery shaft lumen 215.

[0104] In a second embodiment of the flushing port arrangement, the handle assembly 200 may include two flushing ports located on a branch 204 (which may be referred to as a suture lock branch) of the hub assembly 230, one of which provides a flushing fluid flow 203 to the pusher shaft lumen 201, and the other providing a flushing fluid flow 217 to the delivery shaft lumen 215. However, in the second embodiment, the flushing port that provides the flushing fluid flow 203 to the pusher shaft lumen 201 may be located at the end of the suture lock assembly 206, at the proximal end of the branch 204.

[0105] Embodiments of flushing port arrangements having multiple flushing ports, such as the first and second embodiments described above, may be supplied with flushing fluid independently (e.g., using two separate fluid sources) or together with a common fluid source. For example, in some embodiments, each flushing port (e.g., the first flushing port 210 and the second flushing port 216) may be supplied with flushing fluid from two separate injection pumps (one of which is fluid-coupled to each of the flushing ports) or from a separate set of fluid sources. In alternative embodiments, as shown in Figure 6, a single injection device (e.g., a pump) 225 may be connected to multiple flushing ports, such as through a Y-connector 227 that connects a single fluid line to the multiple flushing ports.

[0106] In some cases, it may be desirable to provide a constant flow of fluid (e.g., a flushing fluid such as heparinized saline) through the pusher shaft lumen 201 and the delivery shaft lumen 215, respectively, to avoid fluid stagnation within the delivery device 220, which may in some cases lead to thrombosis. In some cases, thrombi may contribute to patient complications if removed during docking. Furthermore, thrombi can increase the force generated during the removal of the distal portion of the sleeve shaft 280 from the docking device, causing increased friction between the sleeve shaft 280 and the docking device.

[0107] Therefore, in the case of two dedicated flushing ports or fluid ports (e.g., flushing port 210 and flushing port 216 as described above), it may be desirable to individually control the fluid flow to each of the two fluid ports in order to ensure a relatively constant or consistent flow through the pusher shaft lumen 201 and the delivery shaft lumen 215. In one embodiment, two separate injection devices (e.g., pumps) can be used to provide a specific flow rate of flushing fluid to the pusher shaft lumen 201 and the delivery shaft lumen 215. However, such a configuration, unlike control with only a single device, can be more complex to control and increase treatment costs and / or settling time. If only a single flow supply (e.g., injection device) is used for the two flushing ports, the amount of fluid entering each flushing port is not controlled and rather depends on the resistance of each flow lumen (e.g., pusher shaft lumen 201 and delivery shaft lumen 215). However, the resistance of the pusher shaft lumen 201 and the delivery shaft lumen 215, as well as the resistance ratio between each of the pusher shaft lumen 201 and the delivery shaft lumen 215, may change during processing. In some embodiments, the pusher shaft lumen 201 may have increased resistance compared to the delivery shaft lumen 215. Therefore, flow from a single fluid source may preferentially flow through the delivery shaft lumen 215, thereby increasing the risk of thrombus formation in the pusher shaft lumen 201 and / or the sleeve shaft lumen 211.

[0108] Therefore, in some embodiments, it may be desirable to maintain or equalize the fluid flow rate in each of the two flushing ports (e.g., a first flushing port 210 and a second flushing port 216) and through each of their respective lumens (e.g., a pusher shaft lumen 201 and a delivery shaft lumen 215) so that a target flow rate is achieved in all flow lumens of the delivery device in which thrombus formation can be reduced or prevented. Embodiments of flow mechanisms configured to provide a consistent flow ratio between two or more flow paths (e.g., a first flushing port 210 up to the pusher shaft lumen 201 and a second flushing port 216 up to the delivery shaft lumen 215) are described below with reference to Figures 12 to 22. As a result, a consistent relative fluid flow rate between the two flushing ports can be achieved independently of fluctuating resistance in each of the flow paths (e.g., a pusher shaft lumen 201 and a delivery shaft lumen 215).

[0109] As used herein, “flow ratio” may be defined as the ratio of the first flow rate of the fluid through the first channel to the first flow rate of the fluid through the second channel. Thus, although the individual flow rates may vary, the ratio of the first flow rate to the second flow rate may be maintained at a constant or consistent ratio, as further described herein.

[0110] Referring here to Figures 12 to 22, embodiments of the mechanical flow mechanism are configured to maintain a consistent relative flow rate (or flow rate ratio) between two or more flow paths, independent of fluctuating resistance in the two or more flow paths. In some embodiments, embodiments of the flow mechanism described below with reference to Figures 12 to 22 can be used to control the flow of fluid into two or more flow lumens within a delivery device for portable devices such as the pusher shaft lumen and delivery shaft lumen of the delivery device 220 (as shown in Figures 5 to 9A). In some embodiments, embodiments of the flow mechanism described below with reference to Figures 12 to 22 can be used to control the flow of fluid through two or more flow paths in an alternative flow system (e.g., two or more parallel flow paths in an alternative flow system).

[0111] Figures 12 to 14 show embodiments of a flow mechanism 300 configured to maintain a consistent relative flow rate between two or more flow paths (e.g., a consistent flow rate ratio in two or more flow paths). Figure 12 shows a top perspective view of the flow mechanism 300, Figure 13 shows a side perspective view of the flow mechanism 300, and Figure 14 shows a top view of the flow mechanism 300, also showing the fluid flow through the flow mechanism 300.

[0112] The flow mechanism 300 comprises a housing (e.g., an outer housing) 302 and at least two paddle gears disposed within the housing 302. The housing defines at least two flow paths, each flow path corresponding to one of the at least two paddle gears.

[0113] For example, as shown in Figures 12 to 14, the housing 302 comprises a first end 320, a second end 322, and a central portion 324 positioned between the first end 320 and the second end 322. In some embodiments, the first end portion 320 may be an outlet end portion (as shown in Figure 14) including two or more conduits (e.g., outlet or outlet conduits) 326 (two shown in the embodiments of Figures 12 to 14) configured to guide the flow away from the flow mechanism 300 and away from the corresponding paddle gear. The second end portion 322 may be an inlet end portion including two or more conduits (e.g., inlet or inlet conduits) 328 (two shown in the embodiments of Figures 12 to 14) configured to receive the flow from the fluid source and guide the flow to the corresponding paddle gear. However, in alternative embodiments, conduit 326 may instead be configured as an inlet, and conduit 328 may instead be configured as an outlet.

[0114] The housing 302 of the flow mechanism 300 defines a first flow path 304 and a second flow path 306. The first flow path 304 and the second flow path 306 are configured to receive fluid and are fluid-separated from each other (for example, no flow interaction or mixing occurs between the fluid in the first flow path 304 and the fluid in the second flow path 306).

[0115] The first flow path 304 may be fluid-connected to a first paddle gear 308 located within a central portion 324 of the housing 302. The first flow path 304 is defined by a first inner channel 312 formed in the housing 302 between a first inlet opening (also referred to as the inlet) 314 and a first outlet opening (also referred to as the outlet) 316. In some embodiments, the first inner channel 312 may have a relatively constant inner diameter. In some embodiments, the first inner channel 312 may have a larger diameter (or stepped) portion 313 within a first end portion 320 that connects to the first outlet opening 316. As a result, a flow connector or conduit of the fluid system, or a flow connector or conduit connected to the fluid system, may extend into the first outlet opening 316 and the larger diameter portion 313 of the first inner channel 312, thereby connecting the flow mechanism 300 to a conduit or flow path of the fluid system configured to receive a volume of fluid measured from the first flow path 304.

[0116] Similarly, the second flow path 306 may be fluid-connected to a second paddle gear 310 located within the central portion 324 of the housing 302. The second flow path 306 is defined by a second inner channel 330 formed in the housing 302 between a second inlet opening (also referred to as the inlet) 332 and a second outlet opening (also referred to as the outlet) 334. In some embodiments, the second inner channel 330 may have a relatively constant inner diameter. In some embodiments, the second inner channel 330 may have a larger diameter (or stepped) portion 331 within the first end portion 320 that connects to the second outlet opening 334. As a result, a flow connector or conduit of the fluid system, or a flow connector or conduit connected to the fluid system, may extend into the second outlet opening 334 and the larger diameter portion 331 of the second inner channel 330, thereby connecting the flow mechanism 300 to a conduit or flow path of the fluid system configured to receive a volume of fluid measured from the second flow path 306.

[0117] In some embodiments, one or both of the conduits 328 at the second end 322 may have a smaller diameter (or stepped) portion 336 configured to receive a flow connector or flow conduit thereon, thereby connecting the flow mechanism 300 to a flow conduit or flow conduit connected thereto to a fluid supply unit or fluid source.

[0118] The housing 302 may further define at least two cavities, each of which is configured to receive a paddle gear therein. For example, as shown in Figures 12 to 14, the housing 302 defines a first cavity 338, a first paddle gear 308 located within the first cavity 338, and a second cavity 340, a second paddle gear 310 located within the second cavity 340. The first cavity 338 may be fluid-connected to a first inner channel 312, and the second cavity 340 may be fluid-connected to a second inner channel 330. Furthermore, as shown in Figures 12 to 14, the first inner channel 312 (and thus the first flow path 304) may extend on both sides of the first cavity 338, and the second inner channel 330 (and thus the second flow path 306) may extend on both sides of the second cavity 340. In some embodiments, the first channel 304 may extend through the first cavity 338, and the second channel 306 may extend through the second cavity 340.

[0119] In Figures 12–14 (and similarly for other embodiments shown in Figures 15–22), the internal portions of the housing 302, including the first channel 304, the second channel 306, the first cavity 338, and the second cavity 340, are shown with dashed lines to indicate their internal orientation relative to the outside of the housing 302. Note that the first paddle gear 308 and the second paddle gear 310 are also located inside the housing 302, but these components are shown with solid lines for clarity.

[0120] The first paddle gear 308 includes a first paddle 342 and a first gear 344, which are rotatably connected to each other and configured to rotate around a rotation axis 345. In some embodiments, as shown in Figures 12 to 14, the first gear 344 includes a plurality of teeth 346 around its circumference. The first paddle 342 may include a plurality of arms 348 extending radially outward from a central portion 350 of the paddle 342. A cavity 352, configured to receive fluid and rotate (when the first gear 344 rotates), is formed between adjacent arms 348 of the first paddle 342 and the wall of a portion of the first cavity 338 in which the first paddle 342 is positioned. The volume of the cavity 352 defines a predetermined metered volume of fluid through which the first paddle gear 308 is configured to flow via the first channel 304. The volume of the cavity 352 may be defined by the geometric shape of the first paddle 342. For example, the volume of the cavity 352 can be increased by increasing the length of the arm 348 (e.g., the length defined radially with respect to the axis of rotation 345), increasing the height of the arm 348 (and the height of the first paddle 342, e.g., defined along a direction parallel to the axis of rotation 345), and / or decreasing the width of the arm 348 (e.g., the width defined circumferentially). In this way, the geometric shape of the first paddle 342 can be selected according to a specified metered volume of fluid (or a specified flow rate of fluid, e.g., volume / time) provided through the first flow path 304. The volume of fluid 354 in one of the cavities 352 is shown in Figure 14, as will be further described below.

[0121] Similarly, the second paddle gear 310 includes a second paddle 356 and a second gear 358, which are rotatably connected to each other and configured to rotate around a rotation axis 355. In some embodiments, as shown in Figures 12–14, the second gear 358 includes a plurality of teeth 360 around its circumference. The second paddle 356 may include a plurality of arms 362 extending radially outward from a central portion 364 of the second paddle 356. A cavity 366, configured to receive fluid and rotate (when the second gear 358 rotates), is formed between adjacent arms 362 of the second paddle 356 and the wall of a portion of the second cavity 340 in which the second paddle 356 is positioned. The volume of the cavity 366 defines a predetermined metered volume of fluid, which the second paddle gear 310 is configured to flow through the second flow path 306. The volume of the cavity 366 can be defined by the geometric shape of the second paddle 356, as described above with reference to the first paddle 342. Thus, the geometric shape of the second paddle 356 can be selected according to a specified metered volume of fluid, provided through the second flow path 306.

[0122] In some embodiments, as shown in Figures 12 to 14, the teeth 346 of the first gear 344 may mesh and engage with the teeth 360 of the second gear 358. Thus, the first gear 344 and the second gear 358 can rotate together (for example, when the first gear 344 rotates, the second gear 358 rotates, and vice versa). Thus, as will be further described below, the rotation of the first paddle gear 308 and the rotation of the second paddle gear 310 are linked to each other. In some embodiments, as shown in Figure 14, the first gear 344 may rotate in a first direction 370 (for example, counterclockwise in Figure 14), and the second gear 358 may rotate in a second direction 372 (for example, clockwise in Figure 14), where the second direction 372 is opposite to the first direction 370.

[0123] In other embodiments, additional toothed gears may be positioned between the first gear 344 and the second gear 358 in meshing engagement with each other, thereby allowing the first gear 344 and the second gear 358 to rotate in the same direction.

[0124] Figure 14 shows an exemplary fluid flow through the flow mechanism 300. In Figure 14, the flow of fluid (e.g., a flush fluid such as heparinized saline configured to reduce thrombus formation and / or another fluid) is indicated by arrow 368. As shown in Figure 14, the fluid enters the first inner channel 312 and the second inner channel 330 at the first inlet opening 314 and the second inlet opening 332, respectively. The fluid indicated by arrow 368 then continues through the first channel 304 and the second channel to the first cavity 338 and the second cavity 340. The cavities 352 and 366 formed by the first paddle 342 and the second paddle 356, respectively, can capture the inflow fluid from the inlet ends of the first channel 304 and the second channel 306, which then rotate the first paddle gear 308 and the second paddle gear 310.

[0125] In one embodiment, as shown in Figure 14, a fluid flow can enter one of the cavities 352 formed by the first paddle 342 (for example, a cavity 352 located adjacent to the opening between the first cavity 338 and the inlet end of the first inner channel 312). The volume of fluid 354 in this cavity 352 then moves toward the outlet end of the first inner channel 312 as the cavity 352 rotates due to the rotation of the first paddle gear 308. Thus, cavities 352 and 366 may be referred to herein as rotating cavities. When the cavity 352 containing the volume of fluid 354 reaches the opening between the first cavity 338 and the outlet end of the first inner channel 312, the volume of fluid 354 is discharged toward the outlet end of the first inner channel 312 toward the first flow outlet opening 316. A similar fluid flow occurs through the second paddle gear 310, as shown in Figure 14.

[0126] The gear ratio between the first gear 344 and the second gear 358 can determine the respective volumes (and therefore, the respective flow rates) of the fluid metered into the first flow path 304 and the second flow path 306. For example, as shown in Figures 12 to 14, the gear ratio can be 1:1, and therefore the volumes of the fluid metered through the first flow path 304 and the second flow path 306 (for example, the volume of fluid 354 shown in Figure 14) may be the same. Similarly, the flow rates of the fluid through the first flow path 304 and the second flow path 306 may be the same (they may have a flow rate ratio of 1:1).

[0127] In this embodiment, the flow rate of the fluid through the first channel 304, the flow rate of the fluid through the second channel 306, and the flow conduits connected and configured to receive the metered flow from the first and second channels 306 (e.g., via conduits or outlets 326) may be the same or substantially the same. For example, the ratio (e.g., 1:1 in this case) of a predetermined volume of fluid metered through the first channel 304 to a predetermined volume of fluid metered through the second channel 306 is kept constant during the rotation of the first paddle gear 308 and the second paddle gear 310. Thus, even if separate flow conduits or channels connected to the flow mechanism 300 and configured to receive fluid through the flow mechanism 300 have different resistances, each can receive a constant flow rate of fluid through the flow mechanism 300.

[0128] In other embodiments, if the first gear 344 and the second gear 358 have different diameters, but the geometric shapes of the first paddle 342 and the second paddle 356 remain the same, thereby providing different gear ratios, the volumes of fluid metered through the first flow path 304 and the second flow path 306 will be different. In this way, the geometric shapes of the gears of the paddle gears of the flow mechanism 300 can be varied based on the specified volume of metered fluid supplied to different flow paths or conduits through which the flow mechanism 300 is connected.

[0129] An exemplary flow mechanism 400 having paddle gears with gears of different diameters is shown in Figure 15. The flow mechanism 400 may be similar to the flow mechanisms 300 in Figures 12–14, except that the first paddle gear 402 has a first gear 404 with a larger diameter than the second paddle gear 310 and the first paddle gear 308 of the flow mechanism 300.

[0130] For example, as shown in Figure 15, the flow mechanism 400 includes a first paddle gear 402 with a first gear 404 having a first diameter 406, and a second paddle gear 310 with a second gear 358 having a second diameter 408, where the first diameter 406 is larger than the second diameter 408. The geometric shapes of the first paddle 342 of the first paddle gear 402 and the second paddle 356 of the second paddle gear 310 can be identical. As a result, the gear ratio between the first gear 404 and the second gear 358 can be greater than 1:1 (e.g., 1.2:1, 1.5:1, etc.). Consequently, during one full rotation of the second paddle gear 310, the first paddle gear 402 does not complete a full rotation (due to its larger diameter). Therefore, in the embodiment shown in Figure 15, the first paddle gear 402 can provide a smaller metered volume of fluid within a set time frame than the second paddle gear 310. In other words, the first paddle gear 402 can provide a smaller flow rate (e.g., volume / time) of fluid than the second paddle gear 310.

[0131] As introduced above, the volumes of the cavities 352 and 366 formed between the housing 302 and the first and second paddle gears 308 and 310, respectively, can also define a predetermined volume (or flow rate) of metered fluid through the first channel 304 and the second channel 306. Since the volumes of the cavities 352 and 366 can be defined by the geometric shapes of the first paddle 342 and the second paddle 356, respectively, the volumes of the cavities 352 and / or 366 can be changed by changing the geometric shapes of the first paddle 342 and / or the second paddle 356.

[0132] Figure 16 shows an exemplary flow mechanism 500 having a paddle gear with paddles having different geometric shapes, and thus showing differently sized cavities between the housing 302 and the corresponding paddles. The flow mechanism 500 may be similar to the flow mechanisms 300 of Figures 12-14, except that the second paddle gear 502 has a second paddle 504 with a geometric shape that defines a cavity 508 having a larger volume than the cavity 352 defined by the geometric shape of the first paddle 342 of the first paddle gear 308 (in contrast to the flow mechanism 300 in which cavities 352 and 366 may have the same volume).

[0133] For example, as shown in Figure 16, the first paddle 342 has an arm 348 with a first length 510 and a first width 512, and the second paddle 504 has an arm 506 with a second length 514 and a second width 516, where the second length 514 is longer than the first length 510 and the second width 516 is shorter than the first width 512. Thus, the cavity 508 defined by the second paddle 504 has a larger volume than the cavity 352 defined by the first paddle 342. As a result, the first paddle gear 308 can provide a smaller metered volume (e.g., fluid flow rate) of fluid within a set time frame than the second paddle gear 502.

[0134] Thus, the geometric shapes of the paddles and / or gears of two or more paddle gears in a flow mechanism can be selected to provide various specified flow ratios between two or more flow paths corresponding to the two or more paddle gears.

[0135] In some embodiments, as shown in Figure 17, the flow mechanism 600 (which may be similar to the flow mechanism 300) may have three or more flow channels and three or more corresponding paddle gears, thereby providing a constant flow ratio between the three or more flow channels.

[0136] For example, as shown in Figure 17, the flow mechanism 600 includes a housing 610 defining a first flow path 304, a second flow path 306, and a third flow path 602. The flow mechanism 600 may further include three paddle gears, including a first paddle gear 308 fluid-coupled to the first flow path 304, a second paddle gear 310 fluid-coupled to the second flow path 306, and a third paddle gear 604 fluid-coupled to the third flow path 602. Similar to the flow mechanism 300 in Figures 12-14, each paddle gear in the flow mechanism 600 may include a paddle and gears rotatably coupled to each other.

[0137] As shown in Figure 17, the first paddle gear 308, the second paddle gear 310, and the third paddle gear 604 may be arranged adjacent to each other within the housing 610. Furthermore, all the gears of the first paddle gear 308, the second paddle gear 310, and the third paddle gear 604 may mesh and engage with each other. For example, as shown in Figure 17, the second gear 358 is arranged to mesh and engage with the first gear 344 and the third gear 606 of the third paddle gear 604.

[0138] In other embodiments, the flow mechanism 600 described herein and other flow mechanisms may have a different number of paddle gears and corresponding flow paths, such as four, five, etc.

[0139] In some embodiments, additional flow channels may be included in the flow mechanism by including a paddle gear with paddles positioned on either side of a common gear. For example, Figure 18 shows an exemplary flow mechanism 700 including four flow channels and four paddle gears, each paddle gear including a paddle rotatably connected to a common rotating member (e.g., a gear) shared by the paddles of another paddle gear. The paddles and gears of the paddle gears of the flow mechanism 700 may be configured similarly to the paddles and gears of the first and second paddle gears 308 and 310 of the flow mechanism 300 in Figures 12–14, except that the two paddles may share a common gear to which they are rotatably connected.

[0140] For example, as shown in Figure 18, the flow mechanism 700 includes a housing 722 and a first paddle gear 702, a second paddle gear 704, a third paddle gear 706, and a fourth paddle gear 708 located within the housing 722. Each of the first, second, third, and fourth paddle gears 702, 704, 706, and 708 includes a paddle 724 (which may be configured similarly to the first paddle 342 and second paddle 356 in Figures 12-14) rotatably connected to a common rotatable member shared by two paddles 724. In the embodiment of Figure 18, the common rotatable member is a gear, and the flow mechanism 700 includes a first gear 710 and a second gear 712.

[0141] The paddle 724 of the first paddle gear 702 is fluid-connected to a first flow path 714 formed in the housing 722; the paddle 724 of the second paddle gear 704 is fluid-connected to a second flow path 716 formed in the housing 722; the paddle 724 of the third paddle gear 706 is fluid-connected to a third flow path 718 formed in the housing 722; and the paddle 724 of the fourth paddle gear 708 is fluid-connected to a fourth flow path 720 formed in the fluid path 722. Thus, the flow mechanism 700 can be configured to measure flow in four flow paths (for example, four separate flow paths or lumens of a flow system connected to the flow mechanism 700).

[0142] As shown in Figure 18, the paddle 724 of the first paddle gear 702 is positioned on the first side of the first gear 710, and the paddle 724 of the second paddle gear 704 is positioned on the second side opposite the first gear 710. The paddles 724 of the first paddle gear 702 and the second paddle gear 704 can each be rotatably coupled to the first gear 710. As a result, the first gear 710 and the paddles 724 of the first paddle gear 702 and the second paddle gear 704 are all rotatable together (for example, as one), thereby providing an identical and constant flow rate of fluid through the first passage 714 and the second passage 716.

[0143] Similarly, the paddle 724 of the third paddle gear 706 is positioned on the first side of the second gear 712, and the paddle 724 of the fourth paddle gear 708 is positioned on the second side opposite the second gear 712. The paddles 724 of the third paddle gear 706 and the fourth paddle gear 708 can each be rotatably coupled to the second gear 712. As a result, the second gear 712 and the paddles 724 of the third paddle gear 706 and the fourth paddle gear 708 are all rotatable together (for example, as one), thereby providing an identical and constant flow rate of fluid through the third passage 718 and the fourth passage 720.

[0144] In some embodiments, as shown in Figure 18, the teeth of the first gear 710 mesh with the teeth of the adjacent second gear 712, thereby linking the rotation of the first paddle gear 702 and the second paddle gear 704, as well as the third paddle gear 706 and the fourth paddle gear 708, to maintain a consistent flow ratio among the four flow paths.

[0145] In other embodiments, a common rotating member positioned between the paddles of two paddle gears may be a spacer instead of a gear (for example, the spacer may be configured as a toothless cylinder or block), thereby providing the same flow rate of fluid to two fluid passages (for example, for paddles of the same geometric shape) through which the two paddle gears are fluid-connected.

[0146] For example, as shown in Figure 19, the flow mechanism 800 may include a spacer 802 positioned between the first paddle 804 of the first paddle gear 806 and the second paddle 808 of the second paddle gear 810 within the housing 812. The first paddle 804 may be fluid-coupled to a first flow path 814 formed in the housing 812, and the second paddle 808 may be fluid-coupled to a second flow path 816 formed in the housing 812.

[0147] Since both the first paddle 804 and the second paddle 808 can be rotatably connected to the spacer 802, the first paddle 804 and the second paddle 808 can rotate together (for example, when fluid flows into the first channel 814 and the second channel 816), and the same flow rate of fluid can be supplied through the first channel 814 and the second channel 816 (for example, if the first paddle 804 and the second paddle 808 have cavities of the same size). In some embodiments, as described above, the geometric shape of one of the first paddle 804 and the second paddle 808 can be modified to increase or decrease the volume of fluid, and therefore the flow rate of fluid supplied to the corresponding channel.

[0148] In some embodiments, additional channels and paddles, separated by additional spacers, may be added to the flow mechanism 800 to create additional channels for connecting to separate conduits or lumens of the flow system (for example, additional spacers and paddles may be added to the flow mechanism 800 to create three separate channels, all rotating together at the same rotational speed).

[0149] In some embodiments, a paddle on one paddle gear may be positioned at an offset height relative to the paddles on adjacent paddle gears in order to accommodate a paddle having an outer diameter larger than the outer diameter of the gear to which it is connected. For example, as shown in Figure 20, the flow mechanism 900 may include a first paddle gear 904 which includes a first paddle 906 rotatably connected to a first gear 908, the first paddle 906 being positioned axially with respect to the rotation axis 910 of the first paddle gear 904 and spaced apart from the first gear 908. In some embodiments, the first paddle 906 may be rotatably connected to the first gear 908 via an elongated central shaft 912 relative to the combined height (measured axially) of the first paddle 906 and the first gear 908.

[0150] The flow mechanism 900 may further include a second paddle gear 914, which includes a second paddle 916 rotatably coupled to a second gear 918. As shown in Figure 20, the first gear 908 and the second gear 918 may be positioned adjacent to each other and may mesh and engage with each other. Furthermore, the first paddle 906 may be axially offset from the second paddle 916 (for example, the first paddle 906 and the second paddle 916 may be positioned at different heights). As a result, the outer diameters 920 of the first paddle 906 and the second paddle 916 may be larger than the outer diameters 922 of their respective gears (excluding the gear teeth), as shown in Figure 20.

[0151] In this way, the total volume of fluid per unit time or the flow rate of fluid passing through each channel of a flow mechanism (such as one of the flow mechanisms described above, referring to Figures 12 to 20) may be variable, but the flow rate ratio between the channels of the flow mechanism may remain constant. This may be due to the synchronized rotation of the paddles of the paddle gear, as mentioned above.

[0152] In some embodiments, any of the flow mechanisms described herein may be used with a single fluid supply, such as a single injection pump configured to provide a flow-controlled fluid to all inlets of the flow mechanism, thereby providing a consistent and predictable flow rate of fluid out of each outlet of the flow mechanism. For example, Figure 21 shows an exemplary embodiment of a single injection pump 1000 fluid-connected to an inlet conduit 328 of a flow mechanism 300. For example, as shown in Figure 21, pipes or flow conduits 1002 may extend from the single injection pump 1000 to the inlet conduit 328 and to the first flow path 304 and second flow path 306 of the flow mechanism 300.

[0153] Furthermore, in some embodiments, as shown in Figure 21, the first conduit 1006 may be fluid-connected to the first outlet conduit 1010 of the flow mechanism 300, and the second conduit 1004 may be fluid-connected to the second outlet conduit 1012 of the flow mechanism 300. Thus, the metered flow from the first paddle gear 308 may flow into the first conduit 1006, and the metered flow from the second paddle gear 310 may flow into the second conduit 1004.

[0154] In some embodiments, the first conduit 1006 may be the first flushing port 210 of the delivery device 220 (or a flow conduit connected to the first flushing port 210), and the second conduit 1004 may be the second flushing port 216 of the delivery device 220 (or a flow conduit connected to the second flushing port 216) (Figures 4 to 7).

[0155] In some embodiments, as shown in Figure 22, the flow mechanism 1100 (which may be similar to any of the flow mechanisms described herein with reference to Figures 12 to 21) may include a drive member configured to drive the rotation of paddle gears (e.g., a first paddle gear 308 and a second paddle gear 310, as exemplified in Figure 22) at a specified speed. In some embodiments, as shown in Figure 22, the drive member may be configured as a toothed gear (e.g., a toothed drive gear) 1102 that meshes and engages with at least one gear of the paddle gears of the flow mechanism 1100. For example, as shown in Figure 22, the toothed gear 1102 meshes and engages with the first gear 344 of the first paddle gear 308, and the first gear 344 meshes and engages with the second gear 358 of the second paddle gear 310. As a result, driving (e.g., rotating) the toothed gear 1102 drives the rotation of the first gear 344 and the second gear 358.

[0156] In some embodiments, the toothed gear 1102 or other drive member may be part of or coupled to a drive mechanism such as a motor. In this way, the drive member (e.g., the toothed gear 1102) can drive the rotation of the paddle gear of the flow mechanism 1100 at a set speed. Instead of, or in addition to, the toothed gear and / or drive mechanism, a fluid pressure difference can be used to drive the rotation of the paddle gear of the flow mechanism at a set speed.

[0157] In some embodiments, as shown in Figure 22, the flow channels of the flow mechanism 1100 (e.g., flow channels 304 and 306) may each be connected to different fluid sources (e.g., fluid reservoirs), such as a first fluid source 1104 and a second fluid source 1106. In other embodiments, the flow channels of the flow mechanism 1100 may each be connected to the same fluid source (e.g., fluid reservoir).

[0158] In this way, the flow mechanism described above, with reference to Figures 12 to 22, can be configured to maintain a consistent relative flow rate between two or more flow channels. As a result, the flow of fluid through two or more flow channels of the flow mechanism and two or more parallel flow channels fluid-connected to it can be maintained at a specified flow rate ratio.

[0159] In some embodiments, such flow mechanisms can be implemented in a delivery device configured to deliver a docking device, such as the delivery device 220 in Figures 4–11. For example, flow mechanisms such as flow mechanism 300 (Figures 12–14), flow mechanism 400 (Figure 15), flow mechanism 500 (Figure 16), flow mechanism 800 (Figure 19), flow mechanism 900 (Figure 20), or flow mechanism 1100 (Figure 22) can be fluid-coupled to the pusher shaft lumen 201 (e.g., via a first flushing port 210) and the delivery shaft lumen 215 (e.g., via a second flushing port 216). As a result, a fluid of consistent relative flow rate can be supplied to the pusher shaft lumen 201 and the delivery shaft lumen 215 regardless of the fluctuating resistance between the pusher shaft lumen 201 and the delivery shaft lumen 215 and the resistance changing between them.

[0160] Refer to Figures 12 to 22 and note that the different flow mechanism embodiments described above can be combined in any combination to form a flow mechanism configured to provide a consistent relative flow rate between a specified number of flow channels.

[0161] Referring again to Figures 4 to 7, in a third embodiment of the flushing port arrangement for the delivery device 220, the handle assembly 200 may include a single flushing port located on the branch 204 of the hub assembly 230, the single flushing port being configured to provide both a flushing fluid flow 203 to the pusher shaft lumen 201 and a flushing fluid flow 217 to the delivery shaft lumen 215. For example, a particular configuration, referring to Figures 4 to 9A, may allow all of the aforementioned lumen to be flushed by only one flushing line, such as the first flushing port 210.

[0162] In such embodiments, a single flushing port can supply fluid to two separate lumens (pusher shaft lumen 201 and delivery shaft lumen 215) by incorporating a flow throttle into a branch 204 which includes two or more openings configured to supply fluid from the single flushing port to a separate pusher shaft lumen 201 and delivery shaft lumen 215. Embodiments of such flow throttles are further described below with reference to Figures 23–28.

[0163] For example, in some embodiments, the flow throttle may be located at the location shown in Figures 6 and 7 (e.g., instead of the gasket 223 and without the second flushing port 216), or further downstream of the location where the gasket 223 is shown (e.g., the proximal end of the proximal extension 291).

[0164] Figures 24 and 25 show different diagrams of an embodiment of a flow throttle 1200 configured to control the flow of fluid from a single fluid source to two separate (e.g., fluid-separated) flow lumens (or flow paths). Figure 26 shows an exemplary cross-sectional view of the flow throttle 1200, positioned in the larger of the two flow lumens and sealed around the smaller of the two flow lumens. An exemplary arrangement of the flow throttle 1200 within the hub assembly 230 of the delivery device 220 is shown in Figure 23.

[0165] First, referring to Figures 24 and 25, a perspective view (Figure 24) and an end view (Figure 25) of the flow throttle 1200 are shown. The flow throttle 1200 may comprise a compressible sealing member 1202 and a rigid base material 1204.

[0166] In some embodiments, the rigid substrate 1204 may be at least partially embedded within the compressible sealing member 1202, as further described below. In some embodiments, the compressible sealing member 1202 is overmolded on and / or around a portion of the rigid substrate 1204.

[0167] As shown in Figures 24 and 25, portions of the rigid substrate 1204 (e.g., portions of the second portion 1230 and the first portion 1216) that are located inside the compressible sealing member 1202 are indicated by dashed lines to show their internal arrangement. In Figure 26 (as will be further described below), a cross-sectional view of the flow throttle 1200, cut along the midpoint of the length 1210 of the compressible sealing member 1202, is shown positioned within the larger flow lumen. Thus, in this figure, the rigid substrate 1204 (including portions 1216 and 1230) is indicated by solid lines.

[0168] The compressible sealing member 1202 may include a compressible material configured to compress or change shape under pressure. In some embodiments, the compressible material of the compressible sealing member 1202 is silicone. In other embodiments, the compressible material of the compressible sealing member 1202 is another compressible material, such as another compressible polymer material (e.g., neoprene, fluorocarbon rubber, etc.).

[0169] The compressible sealing member 1202 may comprise a body 1206 defining a first opening 1208 extending through a length 1210 of the compressible sealing member 1202 (Figure 24). For example, the first opening 1208 may be configured as an elongated opening extending through the entire length 1210 of the compressible sealing member 1202. The length 1210 may be in a direction parallel to the axial direction of the first central longitudinal axis 1207 of the first opening 1208.

[0170] In some embodiments, when the flow throttle 1200 is incorporated into the flow system, the length 1210 may be positioned parallel to the direction of flow through the parallel flow lumens of the flow system.

[0171] The first opening 1208 of the compressible sealing member 1202 may have a first diameter 1212 (Figure 25). The first opening 1208 may be spaced apart from the outer surface 1214 (and outer circumference) of the compressible sealing member 1202. In some embodiments, the first opening 1208 may be spaced apart from the outer surface 1214 around its entire circumference.

[0172] In some embodiments, as shown in Figures 24 to 26, the compressible sealing member 1202 is cylindrical and its outer surface 1214 is curved. In other embodiments, the compressible sealing member 1202 may have a different shape, such as elliptical, square, rectangular, or similar. The shape of the compressible sealing member 1202 may be selected based on the specific shape of the flow conduit or flow lumen in which the compressible sealing member 1202 is placed.

[0173] The rigid substrate 1204 may include a relatively rigid material that is rigider than the material of the compressible sealing member 1202. For example, the rigid substrate 1204 may include a biocompatible, rigid plastic, or metallic material. In other embodiments, the rigid substrate 1204 may include another incompressible material configured to retain its shape under pressure (e.g., not compressible). As further described below, in some embodiments, the rigid substrate 1204 can provide a structure to the compressible sealing member 1202.

[0174] As shown in Figures 24 and 25, the rigid substrate 1204 may include a first portion 1216 embedded within the compressible sealing member 1202 and extending through the length 1210 of the compressible sealing member 1202. The first portion 1216 may have a first surface 1218 and a second surface 1220 positioned on both ends of the first portion 1216. The first surface 1218 and the second surface 1220 may be positioned perpendicular to the direction parallel to the length 1210 and may be located outside the compressible sealing member 1202.

[0175] For example, in some embodiments, the first surface 1218 of the first portion 1216 of the rigid substrate 1204 may be coplanar with the first surface 1222 of the compressible sealing member 1202 (Figures 24 and 25). In other embodiments, the first surface 1218 of the first portion 1216 may extend outward from and beyond the first surface 1222 of the compressible sealing member 1202.

[0176] Furthermore, in some embodiments, the second surface 1220 of the first portion 1216 of the rigid substrate 1204 may be coplanar with the second surface 1224 of the compressible sealing member 1202 (Figure 24). In other embodiments, the second surface 1220 of the first portion 1216 may extend outward from the second surface 1224 of the compressible sealing member 1202, beyond it.

[0177] A first portion 1216 of the rigid substrate 1204 may define a second opening 1226 having a second diameter 1228 (Figure 25). In some embodiments, the second opening 1226 may extend through the length of the first portion 1216, which may be the same as the length 1210 of the compressible sealing member.

[0178] In some embodiments, as shown in Figure 25, the second diameter 1228 of the second opening 1226 may be smaller than the first diameter 1212 of the first opening 1208. In other embodiments, the first diameter 1212 and the second diameter 1228 may be the same, or the first diameter 1212 may be smaller than the second diameter 1228.

[0179] In some embodiments, as shown in Figures 24 to 26, the first opening 1208 and the second opening 1226 are radially offset and / or spaced apart from each other. For example, the first opening 1208 may have a first central longitudinal axis 1207, and the second opening 1226 may have a second central longitudinal axis 1225 (Figure 24). The first central longitudinal axis 1207 and the second central longitudinal axis 1225 may be offset from each other (e.g., not overlapping).

[0180] The rigid substrate 1204 may further comprise a second portion 1230 embedded within a compressible sealing member 1202. The second portion 1230 may extend outward from the first portion 1216. As shown in Figures 24 to 26, the second portion 1230 may extend circumferentially outward from the first portion 1216 and surround at least a portion of the first opening 1208.

[0181] In some embodiments, the second portion 1230 surrounds the first portion 1216 and extends circumferentially outward from either side of the first portion 1216. For example, in some embodiments, the second portion 1230 may comprise an extension or wing portion 1232 extending from either side of the first portion 1216 (Figures 24 and 25). As shown in Figures 24 and 25, the wing portion 1232 extends circumferentially outward from the first portion 1216 (for example, circumferentially 1231 as shown in Figure 25) and surrounds the first opening 1208 at least partially (for example, around 100 degrees to about 170 degrees around the circumference of the first opening 1208).

[0182] In other embodiments, the second portion 1230 may include an extension or wing portion that further extends around and surrounds a larger portion of the first opening 1208, such as surrounding the first opening 1208 for about 180 to 360 degrees around its circumference. An embodiment of such an arrangement is shown in Figure 28, as will be further described below.

[0183] In some embodiments, each wing portion 1232 may include an opening 1234 defined therein. The opening 1234 can increase the bond between the compressible sealing member 1202 and the rigid substrate 1204. For example, while the compressible sealing member 1202 is being formed around the rigid substrate 1204 (e.g., during overmolding), the material of the compressible sealing member 1202 may enter the opening 1234, thereby increasing the contact between the compressible sealing member 1202 and the rigid substrate and firmly holding the first portion 1216 and the second portion 1230 of the rigid substrate 1204 in place within the compressible sealing member 1202.

[0184] For example, the geometric shape of the wing portion 1232 and / or opening 1234 may be configured to hold the rigid substrate 1204 in place within the compressible sealing member 1202. In other embodiments, the wing portion 1232 may include additional openings 1234 beyond those shown in Figures 24 and 25 (for example, in embodiments where the wing portion 1232 extends further around the first opening 1208, each wing portion 1232 may include multiple openings 1234 and / or more elongated or wider openings 1234).

[0185] In other embodiments, the rigid substrate 1204 may not have the wing portion 1232 and / or the entire second portion 1230.

[0186] The rigid substrate 1204 may further comprise a third portion or extension member 1236 extending axially outward from the first portion 1216 on one side of the compressible sealing member 1202. As shown in Figure 24, the extension member 1236 extends axially outward from the first surface 1218 of the first portion 1216 and is located outside the compressible sealing member 1202.

[0187] In some embodiments, the first portion 1216, the second portion 1230, and the extension member of the rigid base material 1204 are formed as a single unit (e.g., molded).

[0188] The extension member 1236 may be configured to act as a “key” that can be received within a receiving member (e.g., a recess) of the flow system in order to hold the flow throttle 1200 in place (e.g., to hold the flow throttle in a specified circumferential orientation). In this way, in some embodiments, the extension member 1236 ensures that a specified alignment within the flow system is achieved during assembly.

[0189] As shown in Figures 24 and 25, the extension member 1236 may be elongated and have a trapezoidal cross-section, but with two curved edges. In other embodiments, the extension member 1236 may have a different shape, such as having a cross-section with a square, triangular, or rectangular shape. Thus, the extension member 1236 may have a specified shape that is configured to fit into a recess of a corresponding shape in the flow system in which the flow throttle 1200 is located.

[0190] In other embodiments, the rigid substrate 1204 may include a plurality of extendable members 1236. In yet another embodiment, the rigid substrate 1204 may not include any extendable members 1236.

[0191] In some embodiments, as shown in Figures 24 to 26, the compressible sealing member 1202 may extend radially outside (e.g., beyond) the first portion 1216 and the second portion 1230 of the rigid substrate 1204, such that the material of the compressible sealing member 1202 forms a continuous outer surface (e.g., outer surface 1214) around the flow throttle 1200. As a result, radial compression of the flow throttle 1200 is possible (e.g., to increase sealing inside and around the components of the flow system in which the flow throttle 1200 is located). The radial distance between the outer diameter 1242 and / or the outer surface 1214 of the compressible sealing member 1202 and the first portion 1216 and / or the second portion 1230 of the rigid substrate 1204 (Figure 26) may be selected or adjusted based on a specified amount of radial compression of the flow throttle 1200 when positioned within a flow conduit or component of a flow system.

[0192] In some embodiments, the compressible sealing member 1202 extends axially beyond the first surface 1218 and the second surface 1220 of the first portion 1216 of the rigid substrate 1204, thereby enabling axial compression of the compressible sealing member 1202. Thus, in some embodiments, the length 1210 of the compressible sealing member 1202 may be longer than the axial length of the first portion 1216.

[0193] In one exemplary embodiment, as shown in Figure 23, the flow throttle 1200 may be located within the branch 204 of the hub assembly 230 of the delivery device 220, between two flushing ports on the branch 204. As shown in Figure 23, the extension member 1236 may extend into a recess 1238 defined within the branch 204, thereby locking the flow throttle 1200 in place.

[0194] As also shown in Figure 23, the proximal extension 291 of the pusher shaft 290 extends through the first opening 1208 and can be sealed therein, and the cavity 254 can be fluid-connected to the second opening 1226. For example, as shown in Figure 23, the second opening 1226 may be located between the cavity 254 and the internal cavity 250, and may be fluid-connected to each of them, thereby restricting the fluid from the first flushing port 210 to the cavity 254 (which may be fluid-connected to the lumen of the delivery shaft as described above).

[0195] In other embodiments, the flow throttle 1200 may be positioned further downstream of the branch 204 by the outer surface 1214 of a compressible sealing member 1202 positioned against the inner surface 1240 of the branch 204 (Figure 23) (for example, in face-to-face contact).

[0196] In other embodiments, the flow throttle 1200 may be used in other flow systems that include two or more separate flow paths.

[0197] Figure 26 shows another exemplary embodiment of a flow throttle 1200 located within an outer conduit 1250 (e.g., the conduit of branch 204 in Figure 23). Specifically, Figure 26 is a cross-sectional view of a flow throttle 1200 located within an outer lumen (e.g., cavity 254 in Figure 23) defined by the inner surface 1254 of the outer conduit 1250, cut along the middle or midpoint of the flow throttle 1200. The flow throttle 1200 may be configured to separate the fluid from the outer lumen of the outer conduit 1250 from the inner lumen of the inner conduit 1256, as will be further described below.

[0198] As shown in Figure 26, the outer surface 1214 of the flow throttle 1200 (and the compressible sealing member 1202) may be in face-to-face contact with the inner surface 1254 of the outer conduit 1250. For example, the outer diameter 1242 of the compressible sealing member 1202 and the flow throttle 1200 within the outer conduit 1250 may be the same as the inner diameter of the outer conduit 1250 (which may be, for example, the outer diameter of the outer lumen).

[0199] As shown in Figure 26, the inner conduit 1256 (e.g., the proximal extension 291 of the pusher shaft 290 in Figure 23) extends through the first opening 1208 of the compressible sealing member 1202. The inner diameter 1258 of the inner conduit 1256 defines the inner lumen (e.g., the inner flow lumen or flow path) 1260. The outer diameter of the inner conduit 1256 may be the same as the first diameter 1212 of the first opening 1208 (as shown in Figure 26) when positioned within the first opening 1208. For example, as shown in Figure 26, the outer surface 1262 of the inner conduit 1256 may be in face contact with the inner surface 1264 of the compressible sealing member 1202 that defines the first opening 1208.

[0200] In this way, the outer surface 1214 of the compressible sealing member 1202 can seal against the inner surface 1254 of the outer conduit 1250, and the inner surface 1264 of the compressible sealing member 1202 defining the first opening 1208 can seal against the outer surface 1262 of the inner conduit 1256.

[0201] In some embodiments, the inner lumen 1260 may have greater resistance (e.g., flow resistance or resistance to flow) than the outer lumen.

[0202] As shown in Figure 26, the second diameter 1228 of the second opening 1226 in the rigid substrate 1204 is smaller than the outer diameter of the outer lumen (formed between the outer conduit 1250 and the inner conduit 1256). As a result, the smaller second opening 1226 can limit the amount of fluid that can pass through the flow throttle 1200 into the larger outer lumen. In this way, the flow is throttled into the larger outer lumen, while the flow can pass into the inner lumen 1260 without throttling (e.g., without restriction).

[0203] Since the second opening 1226 is formed within the rigid (incompressible) substrate 1204, its size (e.g., the second diameter 1228) is not affected by the axial and / or radial compression of the compressible sealing member 1202.

[0204] In some embodiments, the second diameter 1228 of the second opening 1226 may be selected based on the difference in size and / or resistance between the outer lumen and the inner lumen 1260. For example, the second diameter 1228 may be selected such that the difference in resistance between the inner lumen 1260 and the outer lumen is at a level that results in continuous flow through each of the outer and inner lumen 1260. In some embodiments, the second diameter 1228 may be selected such that a specified relative flow rate between the inner lumen 1260 and the outer lumen is achieved.

[0205] Figure 27 shows an end view of another embodiment of the flow throttle 1300. In some embodiments, the flow throttle 1300 is similar to the flow throttle 1200 in Figures 24-26. The flow throttle 1300 may comprise a compressible sealing member 1302 and a rigid substrate 1204. The compressible sealing member 1302 may be similar to the compressible sealing member 1202 of the flow throttle 1200 (Figures 24-26), except that the compressible sealing member 1302 defines two openings within it, including a first opening 1304 and a second opening 1306, instead of only one opening (e.g., the first opening 1208 of the flow throttle 1200). As a result, the flow throttle 1300 may be configured to receive two flow conduits, one passing through each of the first opening 1304 and the second opening 1306, thereby separating the two flow conduits from each other.

[0206] In some embodiments, the spacing between the first opening 1304 and the second opening 1306, and / or the spacing between the first opening 1304 and the second opening 1306 within the compressible sealing member 1302, can be adjusted based on the configuration of the flow system in which it is intended to be placed.

[0207] In other embodiments, the rigid substrate 1204 may have two or more second openings 1226 (e.g., two, three, or similar) for additional flow lumens.

[0208] In other embodiments, the flow throttle may include a plurality of rigid substrates 1204 spaced apart from each other within a compressible sealing member, thereby accommodating an additional flow lumen.

[0209] Figure 28 shows an end view of another embodiment of the flow throttle 1400, which includes a compressible sealing member 1202 and a rigid substrate 1402. In some embodiments, the flow throttle 1400 may be similar to the flow throttles 1200 in Figures 24–26, except that the rigid substrate 1402 includes a second portion 1404 that surrounds and extends around the entire circumference of a first opening 1208. The second portion 1404 may include one or more openings 1406 (two are shown in Figure 28, but three or more or one or fewer openings are also possible). In this way, the second portion 1404 of the rigid substrate 1402 may be configured as a ring completely covered by the compressible material of the compressible sealing member 1202.

[0210] Referring here to Figures 29 to 33, embodiments of a pusher shaft 1500 for a delivery device configured to deliver a docking device (such as one of the docking devices described herein) are shown. For example, the pusher shaft 1500 may be a pusher shaft 290 included in a delivery device 220, as shown in Figures 4 to 11.

[0211] Figure 29 schematically shows the four main components of the pusher shaft 1500, and Figure 30 shows a more detailed embodiment of the pusher shaft 1500. An exemplary distal end side view of the pusher shaft 1500 is shown in Figure 31, and a proximal end view of the pusher shaft 1500 is shown in Figure 32. Figure 33 shows the main tube 1502 (Figure 21E) of the pusher shaft 1500 alone (which may be a hypotube in some embodiments). These figures of the pusher shaft 1500 show the central longitudinal axis 1501 of the pusher shaft 1500.

[0212] In some embodiments, the central longitudinal axis 1501 of the pusher shaft 1500 may be coaxial with the central longitudinal axis of the sleeve shaft (e.g., sleeve shaft 280) and outer shaft (e.g., outer shaft) 260 of the delivery device (e.g., delivery device 220) when it is located within the delivery device, as will be further described below with reference to Figures 34 and 35.

[0213] As shown in Figures 29 to 33, an exemplary pusher shaft 1500 may comprise four sections or components, including a main tube (e.g., a shaft) 1502 (Figures 29 to 33), a shell 1504 (Figures 29, 30, and 32), a plug 1506 (Figures 29, 30, and 32), and a proximal extension 1510 (which may be similar to the proximal extension 291 shown in Figures 5 to 7, as shown in Figures 29 and 30).

[0214] The main tube 1502 may be configured to advance and retract a docking device (such as one of the docking devices described herein) and to house a release suture that secures the docking device to the pusher shaft. The shell 1504 may enclose a portion of the main tube 1502, and the plug 1506 may connect the main tube 1502 to the shell 1504 and serve as a stop for the sleeve shaft. The proximal extension 1510 may be configured to guide the pusher shaft 1500 from the inside of the sleeve shaft to the outside of the sleeve shaft, thereby operating the two shafts in parallel with each other and reducing the overall length of the delivery device (for example, as shown in Figures 4 to 7).

[0215] The main tube 1502 may extend from the distal end of the outer shaft of the delivery device (e.g., the outer shaft 260 shown in Figure 4) to the handle assembly of the delivery device (e.g., the handle assembly 200 shown in Figures 4 and 5). As shown in Figures 29 and 30, the pusher shaft 1500 may include a proximal end portion 1512, which may include the interface between the main tube 1502, the shell 1504, the plug 1506, and the proximal extension 1510. In some embodiments, as shown in Figures 6 and 7, the proximal end portion 1512 of the pusher shaft 1500 may be located within or near the hub assembly of the handle assembly of the delivery device (e.g., the hub assembly 230). Thus, the main tube 1502 may be an elongated tube extending along most of the delivery device.

[0216] In some embodiments, the main tube 1502 may be a hypotube. A hypotube is a component that can be used for the deployment of a docking device and is still described in Patent Document 2, entitled "Deployment systems, tools, and methods for delivery an anchoring device for a prosthetic valve," which is incorporated herein by reference in its entirety. In some embodiments, the main tube 1502 may include a biocompatible metal such as stainless steel.

[0217] In various embodiments, the main tube 1502 (shown in more detail by Figure 33) is a relatively rigid tube that provides column strength to activate (e.g., deploy) the docking device from the delivery device.

[0218] The main tube 1502 may include a distal end 1514 configured to connect to a docking device, and a proximal end 1516 attached to a proximal extension 1510 (as shown in Figures 29, 30, and 33, and described later).

[0219] In some embodiments, as shown in Figure 33, the main pipe 1502 may have a distal section 1518 that includes a plurality of cuts 1520, configured to provide the main pipe 1502 with increased flexibility at its distal end. Thus, the distal section 1518 may be referred to as a flexible section or portion of the main pipe 1502.

[0220] In some embodiments, the cut section 1520 may be a laser-cut section formed by laser cutting the surface (e.g., outer surface) of the main tube 1502. In alternative embodiments, the cut section 1520 may be a different type of cut section formed by a different cutting process (e.g., into the outer surface of the main tube 1502 via etching, scoring, through cutting, etc.). The width and depth of the cut section 1520 may be configured to add a specified amount of flexibility to the main tube 1502.

[0221] In some embodiments, each of the cut sections 1520 may be a through cut that penetrates the entire main pipe 1502 (for example, from one side to the other in a direction perpendicular to the central longitudinal axis 1501). In some embodiments, the width of each cut section 1520 may be approximately 0.05 mm. In some embodiments, the width of each cut section 1520 may be in the range of 0.03 mm to 0.08 mm.

[0222] In some embodiments, the spacing between adjacent cuts 1520 may vary along the length of the distal section 1518. For example, as shown in Figure 33, adjacent cuts 1520 may be positioned so that they are closest together at the distal end 1514, and then the spacing between adjacent cuts 1520 may increase from the distal end 1514 to the proximal end of the distal section 1518.

[0223] In some embodiments, the cut portion 1520 may be formed as a helical thread cut into (and through) the outer surface of the distal section 1518 of the main pipe 1502. Thus, in these embodiments, the spacing or distance between adjacent cut portions 1520 may be defined as the pitch of the cut portions. As shown in Figure 33, the first portion 1522 of the distal section 1518 may have a pitch in the range of 0.4 mm to 0.64 mm, the second portion 1524 of the distal section 1518 may have a pitch in the range of 0.64 mm to 1.2 mm, the third portion 1526 of the distal section 1518 may have a pitch in the range of 1.2 mm, and the fourth portion 1528 of the distal section 1518 may have a pitch in the range of 1.2 mm to 3.0 mm. In some embodiments, the pitch of the first section 1522 may increase along its length from 0.4 mm (at its distal end 1514) to 0.64 mm; the pitch of the second section 1524 may increase along its length from 0.64 mm to 1.2 mm; the pitch of the third section 1526 is approximately 1.2 mm along its length; and the pitch of the fourth section 1528 may increase along its length from 1.2 mm to 3.0 mm. The above pitch values ​​for the distal section 1518 are illustrative, and other pitches are possible, which may be selected to provide the main tube 1502 with an amount of increased flexibility at its distal end 1514 and decreased flexibility along the length of the distal section 1518. Thus, the distal section 1518 may be configured to bend and / or curve together with the outer shaft 2260 of the delivery system as it is navigated through the patient's medial lumen to the target implantation site.

[0224] The main tube 1502 may include one or more parts or sections, in some embodiments, that include a plurality of openings 1534 configured to allow bonding of an outer flexible polymer layer (e.g., a coating or jacket) positioned along a portion of the outer surface of the main tube 1502 to an inner liner positioned along the inner surface of the main tube 1502. At the same time, the openings 1534 may be configured to maintain the rigidity of the pusher shaft 1500.

[0225] The embodiment of the main pipe 1502 shown in Figure 33 includes a first section 1530 and a second section 1532 spaced apart from each other, each containing one or more openings 1534 extending through the thickness of the main pipe 1502 (e.g., through holes extending from the outer surface 1545 through thereto to the inner surface of the main pipe 1502). The openings 1534 may be spaced apart around the periphery of the main pipe 1502. In some embodiments, as shown in Figure 33, each opening 1534 may extend through the entire main pipe 1502, thereby creating two openings 1534 spaced 180 degrees apart from each other around the periphery of the main pipe 1502. Furthermore, in some embodiments, adjacent pairs of openings 1534 may be offset from each other by 90 degrees (e.g., as shown in Figure 33, the first section 1530 may contain 20 openings).

[0226] The size and / or shape of each opening 1534, as well as the number and spacing between each opening 1534 in the first section 1530 and the second section 1532, may be selected so that the outer flexible polymer layer bonds (e.g.) to the inner liner, and the main tube 1502 is positioned between them to provide rigidity to the pusher shaft 1500. For example, the openings 1534 may be circular with diameters ranging from 0.4 mm to 0.6 mm. In some embodiments, the diameter of the openings 1534 may be about 0.5 mm. In some embodiments, the openings 1534 may have other shapes, such as elliptical, square, rectangular, star-shaped, triangular, or similar.

[0227] In some embodiments, along the length of the first section 1530 and the second section 1532, the openings may be spaced apart from each other by a first (center-to-center) distance 1552, and each pair of openings 1534 in the same axial position may be spaced apart from adjacent pairs of openings 1534 by a second distance 1554. In some embodiments, the first distance 1552 is about 2 mm and the second distance 1554 is about 1.0 mm. In some embodiments, the first distance 1552 is in the range of 1.5 mm to 2.5 mm and the second distance 1554 is in the range of 0.5 mm to 1.5 mm. In some embodiments, the second distance 1554 is half the first distance 1552. In alternative embodiments, a different number of openings 1534 and / or relative spacing between the openings 1534 and arrangement of the openings 1534 are possible than those shown in Figure 33 and described above, while still providing a suitable bond between the inner liner and the outer flexible polymer, and providing rigidity to the pusher shaft 1500.

[0228] As shown in Figure 33, the second section 1532 may be located at the proximal end 1516 of the main pipe 1502 and may contain fewer openings 1534 than the first section 1530. However, in alternative embodiments, the second section 1532 may contain more openings 1534 than shown in Figure 33. In some embodiments, the first section 1530 may contain 20 openings 1534, and the second section 1532 may contain 8 openings. In other embodiments, the first section 1530 may contain 21 or more or 19 or fewer openings 1534, and the second section 1532 may contain 9 or more or 7 or fewer openings 1534.

[0229] As shown in Figure 33, the main pipe 1502 may include a third section 1536 that is located between the first section 1530 and the second section 1532, which does not include the opening 1534.

[0230] In some embodiments, as further described below, the main tube 1502 may include an intermediate section 1535 located proximal to the distal section 1518 (e.g., including a cut section 1520) and distal to or part of the first section 1530. As further described below, the intermediate section 1535 may include one or more openings 1537 defined on the outer surface 1545, which may be of various sizes, configured to allow fluid flow from the inside of the main tube 1502 (e.g., the pusher shaft lumen 1555 as shown in Figures 34 and 35) into the lumen surrounding the pusher shaft 1500 when the pusher shaft 1500 is located within the sleeve shaft of a delivery device (e.g., a delivery device 220). The outer surface 1545 of the main tube 1502 on which one or more openings 1537 are located may be an outer circumferential surface where a line perpendicular to the outer surface 1545 intersects the central longitudinal axis 1901.

[0231] Figure 30 shows an exemplary embodiment of the components of the pusher shaft 1500. As shown in Figure 30, the pusher shaft 1500 may include an inner liner 1538 that covers the inner surface of the main tube 1502 and forms the inner surface of the proximal extension 1510. In some embodiments, the inner liner 1538 may extend along the entire length of the pusher shaft 1500. In some embodiments, the inner liner may be relatively thin and may include a polymer material such as PTFE. For example, the thickness of the inner liner 1538 may be in the range of 0.012 mm to 0.064 mm.

[0232] Furthermore, in some embodiments, a portion of the pusher shaft 1500 may include an outer polymer layer (also referred to as an outer coating or jacket) 1540. The outer polymer layer 1540 may be a flexible polymer, as will be further described below. In some embodiments, the outer polymer layer 1540 is located on the fourth section 1542 of the main tube 1502 (the fourth section 1542 including the distal section 1518 and the first section 1530), while the third section 1536 of the main tube 1502 does not include the outer polymer layer 1540 (Figures 30, 31, and 33).

[0233] In some embodiments, the outer polymer layer 1540 may also be included in a second section 1532 of the main tube 1502, forming the outer layer of the proximal extension 1510. For example, the proximal extension 1510 may comprise an inner liner 1538 and the outer polymer layer 1540 (Figure 30).

[0234] In some embodiments, the outer polymer layer 1540 can be reflowed over the cut section 1520 and the opening 1534.

[0235] In certain embodiments, the outer polymer layer 1540 may comprise a polyetheramide block copolymer or a blend of two or more polyetheramide block copolymers. The polymers of the outer polymer layer 1540 may have a Shore D hardness measured according to ISO 868:2003 of about 60 to about 75, about 65 to about 75, about 70 to about 75, or about 72. In some embodiments, the outer polymer layer 1540 may have a flexural modulus measured according to ISO 178:2010 of about 350 MPa to about 550 MPa, about 450 MPa to about 550 MPa, about 500 MPa to about 550 MPa, about 500 MPa to about 525 MPa, about 510 MPa to about 520 MPa, about 500 MPa, about 505 MPa, about 510 MPa, about 515 MPa, about 520 MPa, or about 525 MPa. In certain embodiments, the outer polymer layer 1540 may be a blend of one or more of the following: PEBAX® grades 7033 and 7233 (Arkema SA, France) and VESTAMID® grades E62, E72, and EX9200 (Evonik Industries AG, Germany). In some embodiments, the outer polymer layer 1540 may be PEBAX® 7233. In other embodiments, the outer polymer layer 1540 may be VESTAMID® EX9200.

[0236] In some embodiments, the main tube 1502 may have a uniform inner diameter ranging from about 1.0 mm to about 1.34 mm from its distal end 1514 to its proximal end 1516, while its outer diameter may be about 1.8 mm to 2.0 mm in the proximal and distal sections (for example,+ It can vary within a range of 0.2 mm.

[0237] An example of the distal tip 1541 of the pusher shaft 1500 is shown in Figure 31. In some embodiments, the distal tip 1541 includes a more flexible polymer tip or distal end portion 1544 containing a flexible polymer. In some embodiments, the polymer distal end portion 1544 may contain the same flexible material as the outer polymer layer 1540 and / or may be continuous with the outer polymer layer 1540. Thus, the polymer distal end portion 1544 of the distal tip 1541 may be reflowed onto the distal end 1514 of the main tube 1502 and bonded to the inner liner 1538.

[0238] As shown in Figures 29, 30, and 32, the inner diameter 1548 of the shell 1504 is larger than the outer diameter 1550 of the main tube 1502, thereby forming an annular cavity 1546 (radially) between the main tube 1502 and the shell 1504. Thus, the proximal section 284 of the sleeve shaft 280 can slide within the annular cavity (e.g., space) 1546, as further described below with reference to Figures 34 and 35. Furthermore, within the hub assembly, the fluid supplied to the lumen outside the proximal extension 1510 (e.g., flush fluid) flows through the annular cavity 1546, exits the distal end of the shell as indicated by arrow 217 in Figure 29, and enters the lumen between the sleeve shaft 280 and the outer shaft 260 of the delivery device (e.g., the delivery shaft lumen 215 shown in Figure 9A), as described above with reference to Figures 6 to 9A.

[0239] The plug 1506 may be configured to be positioned within the annular cavity 1546 at the proximal end 1505 of the shell 1504 (as shown in Figures 29, 30, and 32). In some embodiments, the plug 1506 may have a length 1507 extending in the direction of the central longitudinal axis 1501 (as shown in Figure 29). In some embodiments, the length 1507 is in the range of 3.0 mm to 9.0 mm, 4.0 mm to 8.0 mm, 5.0 mm to 7.0 mm, or 5.5 mm to 6.5 mm. In some embodiments, the length 1507 is approximately 6.0 mm.

[0240] The plug 1506 may be configured to "close" or fill a portion of the annular cavity 1546 at its proximal end 1505, while leaving the rest of the annular cavity open to receive a cut portion of the sleeve shaft (for example, a cut portion 288 of the sleeve shaft 280 shown in Figures 5-7). For example, as shown in Figure 32, in some embodiments, the plug 1506 of the pusher shaft 1500 may include an annular portion 1572 and a crescent-shaped portion 1574 extending radially outward from one side of the annular portion 1572. The inner diameter 1576 of the annular portion 1572 may be selected so that the annular portion 1572 surrounds the outer surface 1545 of the main shaft 1502, and the outer diameter 1578 of the crescent-shaped portion 1574 may be selected so that the crescent-shaped portion 1574 fills the annular space 1546 (Figure 29). For example, the inner diameter 1576 may be selected to be slightly larger than the outer diameter 1550 of the main shaft 1502, and the outer diameter 1578 may be selected to be slightly smaller than the inner diameter 1548 of the shell 1504 (Figure 29). In some embodiments, the inner diameter 1576 is approximately 1.81 mm and the outer diameter 1578 is approximately 3.42 mm. The arc length of the crescent-shaped portion 1574 may be in the range of 60 to 140 degrees, 80 to 120 degrees, 90 to 110 degrees, or 95 to 105 degrees.

[0241] In certain embodiments, the shell 1504 and the plug 1506 may be welded to the main pipe 1502, and the cut portion of the sleeve shaft may be slidable between the main pipe 1502 and the shell 1504. For example, as shown in Figure 32, a first weld 1580 may fix the annular portion 1572 of the plug 1506 to the main pipe 1502, and a second weld 1582 may fix the crescent portion 1572 of the plug 1506 to the shell 1504. In some embodiments, each of the welds 1580 and 1582 may be a tack weld that does not extend along the entire mating surface between the plug 1506, the main shaft 1502, and the shell 1504.

[0242] Figure 30 shows a proximal extension 1510 extending distally from the second section 1932 of the main tube 1502. As described above, the proximal extension 1510 provides flexibility to the pusher shaft 1500 so that it can be guided from the inside of the sleeve shaft (e.g., the cut portion) to the outside of the sleeve shaft, thereby allowing the two shafts to operate in parallel. In many embodiments, as described above, the proximal extension 1510 can be made from a flexible polymer. In certain embodiments, the flexible polymer is a polyetheramide block copolymer such as PEBAX® grades 2533, 3533, 4033, 4533, 5533, 6333, and 7033, as well as 7233 (Arkema SA, France) and VESTAMID® grades E40, E47, E55, E62, E72, and EX9200 (Evonik Industries AG, Germany), or a blend of two or more polyetheramide block copolymers.

[0243] Referring here to Figures 34 and 35, an exemplary arrangement of the pusher shaft 1500 assembled together with the sleeve shaft 280 and outer shaft 260 of the delivery device 220 (e.g., pusher shaft and sleeve shaft assembly 1600) is shown. As introduced above, the pusher shaft 1500 and the sleeve shaft 280 may be coaxial with each other at least within the outer shaft 260 (e.g., the catheter portion) of the delivery device (e.g., the delivery device 220 in Figures 4 to 8).

[0244] As shown in Figures 34 and 35, the sleeve shaft 280 may be configured to cover (e.g., surround) the docking device 232, and the pusher shaft 1500 and the sleeve shaft 280 together may be configured to unfold the docking device 70 232 from the outer shaft 260 of the delivery device when it reaches the target implantation site. Figures 34 and 35 illustrate different stages of the implantation process.

[0245] For example, Figures 34 and 35 show how the proximal section 1604 of the sleeve shaft 280, including the cut portion 288, passes through the proximal end portion 1512 of the pusher shaft 1500 between the main tube 1502 and the shell 1504 within the annular cavity 1546.

[0246] Specifically, Figure 34 shows an embodiment of a first configuration of the pusher shaft and sleeve shaft assembly 1600 before or during deployment of the docking device 232, where the sleeve shaft 280 is positioned on top of the docking device 232, and the end surface 279 of the tube 285 of the sleeve shaft 280 is positioned away from the plug 1506.

[0247] While the docking device 232 is deployed from the outer shaft 260 of the delivery device, the pusher shaft 1500 and the sleeve shaft 280 may move together axially with the docking device 232. For example, by pressing the pusher shaft 1500 against the docking device 232 and acting to move it outward from the outer shaft 260, the sleeve shaft 280 may move together with the pusher shaft 1500 and the docking device 232. Thus, the docking device 232 may remain covered by the distal section 282 of the sleeve shaft 280 while the docking device 232 is pushed into place at the target implantation site via the pusher shaft 1500.

[0248] In some embodiments, as shown in Figure 34, the outer shaft 260 may have a first inner diameter 1650 at its distal end and a second inner diameter 1652 at its more proximal end. The second inner diameter 1652 may be larger than the first inner diameter 1650 to accommodate a wider shell 1504 within it.

[0249] Furthermore, the distal tip 1612 of the distal section 282 of the sleeve shaft 280 may extend distally (e.g., past) the distal end 1654 of the docking device 232 during delivery and implantation of the covered docking device 232 at the target implantation site, thereby providing a non-invasive tip by the distal section 282 of the sleeve shaft 280.

[0250] FIG. 35 shows a second configuration of the pusher shaft and sleeve shaft assembly 1600 after deploying the docking device 232 from the outer shaft 260 at the target implantation site and retracting the sleeve shaft 280 away from the implanted docking device 232. As shown in FIG. 35, after implanting the docking device 232 at the target implantation site, at its desired position, the sleeve shaft 280 can be pulled away from the docking device 232 and retracted again into the outer shaft 260. In some embodiments, as shown in FIG. 35, further retraction into the delivery device may stop when the end surface 1645 of the sleeve shaft 280 contacts the plug 1506.

[0251] Further details regarding the pusher shaft and sleeve shaft assembly for a delivery device for a docking device, including the various materials and structures of the components, are described in Patent Document 1, which application is incorporated herein by reference in its entirety.

[0252] As introduced above, referring to FIGS. 5 - 9A, a space or lumen is formed between various components of a delivery device including a pusher shaft. Such a lumen can include a pusher shaft lumen (e.g., pusher shaft lumen 201 shown in FIG. 9A and pusher shaft lumen 1555 shown in FIGS. 34 and 35) defined by the inner surface of the main conduit of the pusher shaft and the delivery shaft lumen (e.g., delivery shaft lumen 215 shown in FIG. 9A). As described above referring to FIG. 9A, the pusher shaft lumen can supply fluid to a sleeve shaft lumen (e.g., sleeve shaft lumen 211 shown in FIG. 9 and sleeve shaft lumen 1557 shown in FIGS. 34 and 35) formed between the sleeve shaft and the docking device and between the pusher shaft and the sleeve shaft.

[0253] As described herein, by maintaining a consistent flow of fluid throughout these lumens of the delivery device, blood stagnation can be reduced or avoided, thereby preventing thrombus. However, as shown in FIGS. 34 and 35, the distal tip 1541 of the pusher shaft 1500 can be disposed adjacent to the proximal end of the docking device 232. This arrangement can also be seen in the embodiment of FIG. 9B where the distal end 293 of the pusher shaft 290 is disposed (e.g., in contact) relative to the proximal end of the docking device 232.

[0254] At various stages during the implantation procedure, the proximal end of the docking device 232 can compress the distal end or tip of the pusher shaft (e.g., the distal tip 1541 of the pusher shaft 1500) with various amounts of force. Due to this mismatch in the interaction between the distal tip 1541 of the pusher shaft 1500 and the docking device 232, various amounts of fluid can result in flowing out from the pusher shaft lumen 1555 into the sleeve shaft lumen 1557 (FIGS. 34 and 35).

[0255] In some embodiments, the docking device 232 completely occludes the lumen of the pusher shaft (for example, by being pushed up against the distal tip 1541), thereby stopping all flow out of the pusher shaft lumen and preventing fluid from reaching the sleeve shaft lumen. For example, as shown in Figure 9B, when the distal end 293 of the pusher shaft 290 is pushed up against the docking device 232, the flash fluid flow 203 is prevented from leaving the pusher shaft lumen 201 and reaching the sleeve shaft lumen 211. This may increase the risk of thrombosis.

[0256] Therefore, it may be desirable to create an additional flow path between the lumen of the pusher shaft and the lumen of the sleeve shaft so that the fluid can reach and flow through the sleeve shaft and prevent thrombosis (for example, even when the distal end of the pusher shaft abuts the proximal end of the docking device, so that the docking device at least partially or completely prevents the fluid from leaving the distal end of the pusher shaft).

[0257] Figures 36–44 show various modifications and / or embodiments of the pusher shaft 1500 of Figures 29–35, which provide additional flow paths from the pusher shaft lumen 1555 (e.g., inside the main tube 1502 and the distal tip 1541) to the outside, thereby increasing fluid communication between the pusher shaft lumen 1555 and the sleeve shaft lumen 1557.

[0258] In some embodiments, as introduced above with reference to Figure 33, and also shown in Figures 34 and 35, one or more openings 1537 can be included in the intermediate section 1535 of the main tube 1502. One or more openings 1537 may extend through the thickness of each of the main tube 1502, the inner liner 1538, and the outer polymer layer 1540. For example, each opening 1537 may extend through it between the inner surface 1563 and the outer surface 1561 of the pusher shaft 1500 (e.g., the outer surface defined by the outer polymer layer 1540 and the inner surface defined by the inner liner 1538). As a result, when the pusher shaft 1500 is contained within the pusher shaft and sleeve shaft assembly 1600 of Figures 34 and 35 (or another pusher shaft and sleeve shaft assembly of another delivery device), fluid can pass through one or more openings 1537 from the pusher shaft lumen 1555 to the sleeve shaft lumen 1557.

[0259] In some embodiments, as shown in Figure 33, one or more openings 1537 may be located within the proximal pusher shaft 1500 in the cut portion 1520 of the distal section 1518.

[0260] In some embodiments, the intermediate section 1536 may include only one opening 1537, multiple openings 1537 located in the same axial position (for example, two openings 1537 positioned 180 degrees apart from each other, as shown in Figures 34 and 35), multiple openings 1537 spaced apart from each other axially along the intermediate section (as shown in Figure 33), or a combination thereof. In some embodiments, the intermediate section 1536 may include at least two openings 1537 spaced apart from each other around the pusher shaft 1500.

[0261] In some embodiments, one or more openings 1537 may have varying sizes (e.g., diameters), as shown in Figure 33. In some embodiments, if the pusher shaft 1500 includes multiple openings 1537, all openings 1537 may have the same size, or one or more of the multiple openings 1537 may have different sizes.

[0262] In some embodiments, one or more openings 1537 may be the same size as opening 1534 (Figure 33). In other embodiments, one or more openings 1537 may be larger or smaller than opening 1534.

[0263] In some embodiments, one or more openings 1537 may be circular. In other embodiments, one or more openings 1537 may have different shapes, such as square, rectangular, elliptical, rectangular, slit-shaped, or similar (or different openings 1537 may have different shapes).

[0264] In some embodiments, one or more openings 1537 may be cut into the pusher shaft 1500 through the main tube 1502 and the surrounding inner liner 1538 and outer polymer layer 1540. In some embodiments, one or more openings 1537 may be fabricated by laser cutting through the pusher shaft 1500.

[0265] Figures 36–40 show embodiments of the distal tip of the pusher shaft 1500, which have one or more slots located therein configured to provide a path for fluid to flow out of the pusher shaft (for example, out of the pusher shaft lumen to the sleeve shaft lumen 1557, as shown in Figures 34 and 35). The distal tips shown in Figures 36–40 may be identical or similar to the distal tip 1541 shown in Figure 31, except that they include one or more slots extending through the thickness of the distal tip of the pusher shaft 1500.

[0266] In some embodiments, the slots described below with reference to Figures 36–40 may be cut into the assembled pusher shaft 1500 (e.g., the pusher shaft 1500 shown in Figures 30 and 31). In some embodiments, the slots may be fabricated by a laser cutting process. In some embodiments, as further described below, if the slot(s) extend into the main tube 1502 of the pusher shaft (e.g., beyond the polymer distal end portion 1544), the laser setting for cutting the slots may be set to cut metal (e.g., stainless steel).

[0267] Figures 36 and 37 show an embodiment of the distal tip 1700 of a pusher shaft 1500, including a slot 1702 cut into the distal tip 1700. Figure 36 is a perspective view of the distal tip 1700, and Figure 37 is a side view of the distal tip 1700.

[0268] In some embodiments, as shown in Figures 36 and 37, the slot 1702 may extend from the distal end 1704 of the distal tip 1700 to a certain distance (e.g., axial distance) away from the distal end 1704 (and toward the distal tip 1700), where the distance is the axial length 1706 of the slot 1702.

[0269] In some embodiments, the shaft length 1706 may be selected to extend through the polymer distal end portion 1544 (Figure 31) and the distal portion of the main tube 1502. In other embodiments, the shaft length 1706 may be selected to extend only through the polymer distal end portion 1544 and not through the main tube 1502.

[0270] In some embodiments, the slot 1702 may have a depth 1708 (radially) so as to extend through the thickness of the distal tip 1700. For example, the slot 1702 may extend through it between the inner surface 1714 and the outer surface 1716 of the distal tip 1700 (and the pusher shaft 1500).

[0271] In some embodiments, slot 1702 may have a width 1710. The width 1710 may be less than the overall diameter 1712 of the distal tip 1700 (as shown in FIG. 37). In some embodiments, the width 1710 may be uniform along the axial length 1706. In other embodiments, the width 1710 may be uniform along most of the axial length 1706.

[0272] The axial length 1706 and the width 1710 may be selected based on the desired flow rate between the pusher shaft lumen and the sleeve shaft lumen (e.g., by increasing these dimensions, the flow path provided between the pusher shaft lumen and the sleeve shaft lumen may be increased). In some embodiments, the axial length 1706 and the width 1710 may also be selected to maintain the structural integrity of the distal tip 1700.

[0273] FIG. 38 shows another embodiment of the distal tip 1800 of the pusher shaft 1500, including two slots 1702 cut into the distal tip 1800. As shown in FIG. 38, in some embodiments, the two slots 1702 may be positioned 180 degrees apart from each other around the perimeter of the distal tip 1800.

[0274] In some embodiments, both slots 1702 may have the same axial length 1706 and width 1710. In other embodiments, the two slots 1702 may have different axial lengths 1706 and / or widths 1710.

[0275] The plurality of slots 1702 allows the distal tip 1800 to provide additional fluid flow from the pusher shaft lumen to the sleeve shaft lumen compared to the distal tip 1700 of FIGS. 36 and 37. However, the distal tip 1800 of FIG. 38 may have an increased risk of opening (e.g., spreading) the polymeric distal end portion 1544 of the distal tip 1800 due to the plurality of slots 1702, which may cause problems upon release of the docking device after positioning at the target implantation site.

[0276] Figures 39 and 40 show another embodiment of the distal tip 1900 of the pusher shaft 1500, which includes one or more slots 1902 (one shown in Figures 39 and 40) cut into the distal tip 1900. The slot 1902 may be similar to the slot 1702 as described above, but the slot 1902 may have a width that increases from the distal end 1904 of the distal tip 1900 to the proximal end 1906 of the slot 1902. This configuration of the slot 1902 reduces stress concentration at the distal tip 1900 due to excessive suture tension of the sutures extending from the pusher shaft to the docking device, and reduces the risk of opening the distal tip 1900, compared to the more uniform width of the slot 1702 in Figures 36-38.

[0277] As shown in Figure 40, the slot 1902 may have one or more customizable dimensions, including an axial length of 1908, a first (narrower) width of 1910, and a second (wider) width of 1912. The second width 1912 (at the proximal end 1906) may be wider than the first width 1910 (at the distal end 1904) and smaller than the total diameter 1712 of the distal tip 1900. As described above, these dimensions of the slot 1902 may be selected based on a specified (e.g., desired) flow rate between the pusher shaft lumen and the sleeve shaft lumen, and the maximum dimension that can maintain the structural integrity of the distal tip 1900 (e.g., reducing the risk of opening or expansion of the distal tip 1900).

[0278] In some embodiments, the distal tip 1900 may include a single slot 1902, as shown in Figure 39. In other embodiments, the distal tip 1900 may include two or more slots 1902 spaced apart around the distal tip 1900 (similar to the embodiment shown in Figure 38, for example).

[0279] In some embodiments, one or more slots 1902 may have a (radial) depth 1914 so as to extend through the thickness of the distal tip 1900. For example, a slot 1902 may extend through it between the inner surface 1916 and the outer surface 1918 of the distal tip 1900 (and the pusher shaft 1500).

[0280] Figures 41 and 42 show an embodiment of the distal end portion 2000 of the main tube 1502 of the pusher shaft 1500, which has one or more openings 2002 positioned therein that are configured to provide a path for fluid to flow out of the pusher shaft (for example, out of the lumen of the pusher shaft to the lumen of the sleeve shaft 1557, as shown in Figures 34 and 35). One or more openings 2002 may extend through the thickness of the main tube 1502, the inner liner 1538, and the outer polymer layer 1540, respectively (Figure 31). For example, each opening 2002 may extend through it between the inner and outer surfaces of the pusher shaft 1500 (for example, the inner surface 1563 and the outer surface 1561 as shown in Figure 34) (for example, the outer surface may be defined by the outer polymer layer 1540, and the inner surface may be defined by the inner liner 1538). As a result, when the pusher shaft 1500 is contained within the pusher shaft and sleeve shaft assembly 1600 shown in Figures 34 and 35 (or another pusher shaft and sleeve shaft assembly of another delivery device), fluid can pass from the pusher shaft lumen 1555 to the sleeve shaft lumen 1557 through one or more openings 1537.

[0281] As shown in Figures 41 and 42, one or more openings 2002 may be located at the distal end 1514 of the main tube 1502 distal to the cut portion 1520. Furthermore, one or more openings 2002 may be located proximal to the polymer distal end portion 1544, as shown in Figure 31.

[0282] In some embodiments, one or more openings 2002 may include at least two openings 2002 spaced apart from each other around the distal end portion 2000.

[0283] Figure 41 shows an embodiment in which the distal end portion 2000 includes one or two openings 2002 (for example, one opening 2002 may be cut through the entire pusher shaft, thereby creating two openings 2002 positioned 180 degrees apart from each other around the periphery of the distal end portion 2000).

[0284] Figure 42 shows another embodiment in which the distal end portion 2000 includes a plurality of openings 2002 spaced apart around the distal end portion 2000. In some embodiments, the diameter or width of the openings 2002 may be smaller than one or more of the openings 2002 in Figure 41.

[0285] The opening 2002 may have various sizes (e.g., diameter or width) and / or shapes (e.g., circular, square, elliptical, rectangular, or similar, as shown in Figures 41 and 42). The size and / or shape of each of one or more openings 2002 may be selected to achieve a desired fluid flow from the pusher shaft lumen outward into the sleeve shaft lumen.

[0286] Figures 43 and 44 show embodiments of a distal end portion (e.g., tip or tip portion) 2100 of a pusher shaft 1500 configured to provide one or more additional paths for fluid to flow out of the pusher shaft (e.g., out of the pusher shaft lumen 1555 to the sleeve shaft lumen 1557, as shown in Figures 34 and 35). Figure 43 is a cross-sectional view, and Figure 44 is a side view of the distal end portion 2100, including the distal tip 2102 positioned around the distal end portion 2104 of the main tube 1502 of the pusher shaft 1500, the outer polymer layer 1540 reflowed over the distal tip 2102, and a portion of the main tube 1502 positioned proximal to the distal tip 2102.

[0287] In some embodiments, as shown in Figure 43, the distal tip 2102 may be positioned around and / or connected to the distal end portion 2104 of the main tube 1502. The outer polymer layer 1540 may surround (e.g., cover) the main tube 1502 and a portion of the distal tip 2102 (e.g., the proximal portion, which may be the majority). The tip portion 2106 of the distal tip 2102 may extend distally beyond the main tube 1502. Furthermore, as shown in Figures 43 and 44, the tip portion 2106 is not covered by the outer polymer layer 1540.

[0288] The tip portion 2106 of the distal tip 2102 may include one or more openings 2108 located therein (Figures 43 and 44). One or more openings 2108 may extend through the thickness of the distal tip 2102 (Figure 43).

[0289] In some embodiments, one or more openings 2108 may be spaced apart from one another around the periphery of the tip portion 2106 (Figure 44). One or more openings 2108 may have various sizes and / or shapes (e.g., circular, square, rectangular, or similar).

[0290] In other embodiments, instead of multiple openings 2108, the tip portion 2106 may include one or more slots or elongated openings located therein, extending through the thickness of the distal tip 2102.

[0291] The distal tip 2102 can be molded or extruded from a polymer material (e.g., nylon).

[0292] In some embodiments, one or more openings 2108 may be die-cut or laser-cut into a molded or extruded distal tip 2102.

[0293] In some embodiments, the assembled pusher shaft 1500 may be modified to include a distal tip 2102. For example, the outer polymer layer 1540 may be cut / removed at the distal tip 1541, exposing the distal end portion 2104 of the main tube 1502. The distal tip 2102 may then be attached around the distal end portion 2104 of the main tube 1502. The outer polymer layer 1540 may then be re-flowed onto the outer surface of the distal tip 2102, but the tip portion 2106 remains uncovered, thereby leaving one or more openings 2108 exposed.

[0294] Figures 45 to 47 show another embodiment of the distal end portion (e.g., distal tip or tip portion) 2200 of the pusher shaft 1500, configured to provide one or more additional paths for fluid to flow out of the pusher shaft (e.g., out of the pusher shaft lumen 1555 to the sleeve shaft lumen 1557, as shown in Figures 34 and 35).

[0295] The distal end portion 2200 may include a more flexible polymer tip (or distal end) 2202 comprising a flexible polymer (e.g., identical or similar to the polymer tip 1544 shown in Figure 31, as described above). In some embodiments, the polymer tip 2202 may comprise the same flexible material as the outer polymer layer 1540 of the pusher shaft 1500 and / or be continuous with them (e.g., as described above with reference to Figure 31). Thus, the polymer tip 2202 may be reflowed onto the distal end 1514 of the main tube 1502 of the pusher shaft 1500 and bonded to the inner liner 1538.

[0296] In the embodiments shown in Figures 45 to 47, one or more openings 2204 may be located on the distal polymer tip 2202 of the main tube 1502, and each of the one or more openings 2204 has a radially extending central axis. In some embodiments, each of the one or more openings 2204 may extend from the outer surface 2206 of the polymer tip 2202 to the inner surface 2212 of the inner liner 1538, thereby extending through the respective thicknesses of the polymer tip 2202 and the inner liner 1538.

[0297] In other embodiments, if the polymer tip 2202 does not include an inner liner 1538, each of the one or more openings 2204 may extend through the thickness of the polymer tip 2202 from the outer surface 2206 to the inner surface of the polymer tip 2202.

[0298] In some embodiments, one or more openings 2204 may be located around the polymer tip 2202, as shown in the cross-sectional and perspective views of Figures 45 and 46, respectively. For example, the polymer tip 2202 may contain one to twelve openings 2204 (or two to six in certain examples). The openings 2204 may include a variety of sizes and may be spaced apart from one another around the polymer tip 2202. In some embodiments, all openings may include a uniform size (e.g., diameter) and / or be evenly distributed relative to one another (e.g., three openings spaced 120 degrees apart). In other embodiments, one or more of the openings may be larger or smaller than one or more of the other openings and / or may not be evenly distributed relative to one another.

[0299] Referring here to Figures 48 and 49, more detailed embodiments of the sleeve shaft 280 are shown. In some embodiments, as shown in Figure 48, the sleeve shaft 280 comprises three sections: a distal section 282 (or sleeve section) containing a lubricating sleeve for covering the docking device during deployment; a proximal section 284 used to operate or actuate the sleeve position; and a central section 281 for connecting the distal section 282 and the proximal section 284. A portion of the proximal section 284 may be located in a handle assembly (as described above with reference to Figures 5-7). Furthermore, at least a portion of the central section 281 and the proximal section 284 may surround a pusher shaft (e.g., the pusher shaft 290 shown in Figures 6-8 and / or the pusher shaft 1500 shown in Figures 34 and 35).

[0300] The sleeve shaft 280 may be formed from multiple components and / or materials. In some embodiments, the sleeve shaft 280 may be formed from a flexible polymer jacket 283 (Figure 48), a rigid tube 285 (Figures 48 and 49), an inner liner 287 (Figure 48), and a metal braid 289 (Figure 48) (which may be part of the polymer jacket 283 or embedded within a part thereof). As shown in Figure 48, the polymer jacket 283 may be part of the distal section 282 and the central section 281, the inner liner 287 may extend along the distal section 282 and the central section 281 and form their inner surfaces, and the tube 285 may form the proximal section 284 and have a portion extending to the proximal part of the central section 281. Thus, each of the distal section 282, the proximal section 284, and the central section 281 of the sleeve shaft 280 may contain different layer and material compositions.

[0301] The proximal section 284 of the sleeve shaft 280 is designed to be more rigid and provide column strength to actuate the position of the distal section 282 relative to the docking device by pressing the central section 281 and distal section 282 with the docking device (e.g., docking device 232) and housing the distal section 282 after the docking device has surrounded the natural tissue. Because the proximal section 284 of the sleeve shaft 280 surrounds the pusher shaft (e.g., the pusher shaft 1500 shown in Figures 34 and 35, or the pusher shaft 290 shown in Figures 6 to 9B), the structure may be shaped and configured to be a more rigid, substantially tubular structure. For example, the proximal section 284 may be formed by a relatively rigid tube 285 (Figures 48 and 49). In some embodiments, the tube 285 may be constructed from a surgical-grade metal such as stainless steel. In some embodiments, the tube 285 may be a hypotube.

[0302] The pipe 285 may include a first section 271 (Figure 49) (which may form the entirety of the proximal section 284) and a second section 273 extending to the central section 281 (Figures 48 and 49). The first section 271 includes a cut portion 288 having a cross-section (in a plane perpendicular to the central longitudinal axis 275 of the sleeve shaft 280) that is not a perfect circle (e.g., open and not forming a closed pipe), as introduced above. The remaining portion of the pipe 285 may be tubular (e.g., a closed pipe with a relatively circular cross-section). Thus, the pipe 285 may be a hollow pipe having a perfectly circular cross-section in its second section 273, a partially circular cross-section in the distal portion of the first section 271, and a cut portion 288 (which may also be referred to as the rail of the sleeve shaft 280).

[0303] As described above with reference to Figures 5 to 7, the cut portion 288 of the sleeve shaft 280 extends to the hub assembly 230 of the handle assembly 200, and a portion of the pusher shaft 290 (e.g., the proximal extension 291) extends along the inner surface of the cut portion 288 (also shown in Figure 52). The cut (e.g., open) outer shape of the cut portion 288 allows the proximal extension 291 of the pusher shaft 290 (or any other pusher shaft described herein) to extend outward from the gap 277 (or opening) formed in the cut portion 288 (Figures 49 and 52) and branch at an angle to the cut portion 288 to the branch portion 204 of the hub assembly 230. Thus, the pusher shaft 290 and the sleeve shaft 280 can be operated in parallel with each other as described above.

[0304] In some embodiments, as shown in Figures 49 and 51-53, the cut portion 288 may have a substantially U-shaped or C-shaped cross-section, with a portion of the complete tubular structure removed. For example, the cut portion 288 may form an open channel or conduit with a void 277 (Figures 49, 52, and 53). In various embodiments, the cut portion 288 may be cut using a laser, but any other means for removing a portion of the tubular structure may also be used.

[0305] The end surface 279 is formed on the entire tubular portion of the first section 271 at the interface between the cut portion 288 and the remaining portion of the first section 271 (e.g., exposed) (Figure 49). This end surface 279 may be positioned perpendicular to the central longitudinal axis 275 and may be configured to share surface contact with the stop element (e.g., plug 1506) of the pusher shaft (e.g., as shown in Figure 35 above).

[0306] The proximal section 284 of the sleeve shaft 280 can be cut to form a partially circular cross-section of the cut portion 288. In some embodiments, the proximal section 284 may be cut by electrical discharge machining (EDM cutting). However, cutting the tube 285 in this manner may leave relatively flat (planar) cut surfaces 2306 on both sides of the gap 277, each cut surface 2306 having a first edge 2302 on the outer diameter of the cut portion 288 (e.g., the corner between the cut surface 2306 of the cut portion 288 and the inner surface 2308 of the cut portion 288 of the tube 285) and a second edge 2304 on the inner diameter of the cut portion 288 (e.g., the corner between the cut surface 2306 and the outer surface 2310 of the cut portion 288 of the tube 285). For example, the first edge 2302 and the second edge 2304 are angled and not rounded.

[0307] In some embodiments, the relatively sharp inner and outer edges (first edge 2302 and second edge 2304) on the cut surface 2306 of the cut portion 288 of the sleeve shaft 280 may be rounded and / or deburred to eliminate or reduce the sharpness of the first edge 2302 and second edge 2304.

[0308] By creating a more rounded and smoother edge at the cut surface 2306, a smoother interface may be possible between the mating component and the cut portion 288. For example, the first edge 2302 (outer edge) and / or the second edge 2304 can be joined to various gaskets, seals, and / or washers positioned around the cut portion 288 of the tube 285 of the sleeve shaft 280.

[0309] For example, as shown in Figures 50 and 51, the hemostatic seal 2400 may be used to seal around a cut portion 288 of the proximal section 284 of the sleeve shaft 280 proximal to a sleeve operating handle (e.g., the sleeve handle 208 shown in Figure 5). As can be seen in Figure 50, the hemostatic seal 2400 may have an opening 2406 in the shape of the cross-section of the cut portion 288 of the sleeve shaft 280, such as a U-shaped or C-shaped or incomplete (e.g., partial) valve ring, configured to receive the cut portion 288 therein and seal all sides of the sleeve shaft 280. Figure 51 shows an embodiment of the hemostatic seal 2400 positioned within a straight section 202 of a hub assembly 230. In some embodiments, as shown in Figure 51, two hard washers 2402 and 2404 may support the respective ends of the hemostatic seal 2400. The hard washers 2402 and 2404 may have the same external shape as the hemostatic seal 2400 in order to maintain the integrity of the hemostatic seal 2400. The hard washers 2402 and 2404 can apply inward pressure to the hemostatic seal 2400, ensuring a seal between the hemostatic seal 2400 and the cut portion 288 of the sleeve shaft 280.

[0310] Therefore, it is desirable to reduce or eliminate sharp corners or edges at the inner and outer edges (first edge 2302 and second edge 2304) of the cut portion 288 to create smoother edges for joining with the mating component. In some embodiments, it may be desirable to form completely rounded edges at the first and second edges 2302 and 2304 of the cut portion 288.

[0311] In some embodiments, the first and second edges 2302 and 2304 may be rounded by laser. For example, Figures 54A and 54B illustrate an exemplary process for rounding and / or deburring relatively sharp cutting edges (first edge 2302 and second edge 2304) on the cut surface 2306 of the cut portion 288, thereby forming fully rounded edges or corners, or at least deburred edges, on the cut surface 2306 (or a fully rounded and / or deburred cut surface 2306 without sharp edges).

[0312] For example, a laser 2312 (e.g., a laser beam) may be directed onto the cut surface 2306 and irradiated for a predetermined time and / or at a predetermined power setting, so that the metal of the cut portion 288 of the sleeve shaft 280 at the cut surface 2306 is melted and reflowed toward / on a first edge 2302 and a second edge 2304, such as the rounded surface 2314 shown in Figure 54B (indicated by arrow 2320 in Figure 54A). The laser may be irradiated onto the cut surface in one, two, three, or more passes to a flat edge, a first edge, a second edge, or both, in order to achieve the desired roundness. The rounded surface 2314 may be defined by a first rounded corner 2316 (or edge) on the inner surface 2308 of the cut portion 288 and a second rounded corner 2318 on the outer surface 2310 of the cut portion 288. In some embodiments, the rounded surface 2314 may be a completely rounded surface without sharp corners or edges. For example, the first rounded corner 2316 and the second rounded corner 2318 may be continuous with each other and with the inner surface 2308 and outer surface 2310, so that the rounded surface 2314 is formed as a completely rounded surface along the edge of the cut portion 288 of the sleeve shaft 280. In some embodiments, the rounded surface 2314 may be curved between the inner surface 2308 and the outer surface 2310.

[0313] Figure 55 shows an exemplary cut portion 288 of a sleeve shaft 280, where the first portion 2326 of the cut surface 2306 is untreated (e.g., no laser welding or ablation has been applied), resulting in the first edge 2302 and the second edge 2304 remaining relatively sharp, and the second portion 2328 of the cut surface 2306 has been laser-treated (e.g., as described above with reference to Figures 54A and 54B). As shown in Figure 55, a perfectly rounded surface 2314 can be achieved by laser, thereby creating a smoother edge for the cut portion 288.

[0314] The process described above, shown in Figures 54A and 54B, may be referred to as the laser welding reflow process. In some embodiments, the laser welding reflow process described above may be used to form a rounded surface 2314, which may be a completely rounded surface or edge; in other embodiments, the process may be used to deburr the first edge 2302 and the second edge 2304 of the cut surface 2306 to a selected radius (which may or may not result in a completely rounded edge on the cut surface 2306). In some embodiments, such a process may form a rounded edge (similar to the first and second corners 2316 and 2318) with a more planar surface extending between the rounded edges.

[0315] In other embodiments, the relatively sharp first edge 2302 and second edge 2304 of the cut surface 2306 of the cut portion 288 of the sleeve shaft 280 (Figures 52 and 53) may be rounded and / or deburred by deburring (or deburring biting). For example, Figure 56 shows an exemplary deburring process for rounding and / or deburring the relatively sharp cut edges on the cut surface 2306 (first edge 2302 and second edge 2304) of the cut portion 288, thereby forming a fully rounded edge or corner, or at least a deburred edge, on the cut surface 2306 (or a fully rounded and / or deburred cut surface 2306 without sharp edges).

[0316] For example, the deburring bit 2350 may be applied to and moved along the cut surface 2306 to deburr and / or round the first edge 2302 and the second edge 2304 (Figure 56). In some embodiments, the deburring bit 2350 may have a rounded edge 2352 on one or both sides of the deburring bit 2350 (as shown in Figure 56), which is shaped and sized to deburr the first edge 2302 and the second edge 2304 and / or to produce a rounded edge or surface 2314 (e.g., having a specific radius of curvature) as shown in Figure 54B.

[0317] Figure 56 shows a deburring machine bit 2350 for deburring and / or rounding a first (inner) edge 2302 on one side of the cut portion 288, and a second (outer) edge 2304 on the other opposite side of the cut portion 288. Thus, in some embodiments, multiple passages of the deburring machine bit 2350 may be required to deburr the first and second edges 2302 and 2304 on both sides of the cut portion 288.

[0318] In further embodiments, the relatively sharp first edge 2302 and second edge 2304 of the cut surface 2306 of the cut portion 288 of the sleeve shaft 280 (Figures 52 and 53) may be rounded and / or deburred by one or more of the following: bead blasting, electropolishing, sinker electrical discharge machining (EDM), electrochemical machining (ECM), and / or burlytic deburring.

[0319] Additional embodiments of the disclosed technology In consideration of the above-described implementation of the subject matter to be disclosed, this application discloses the following additional embodiments. Note that a single feature of an embodiment, or two or more features of an embodiment that are incorporated in combination, or optionally combined with one or more features of one or more further embodiments, constitutes a further embodiment similarly included within the disclosure of this application.

[0320] Example 1. A flow mechanism comprising a housing defining at least two flow paths, and at least two paddle gears disposed within the housing and rotatably engaged with each other, wherein each of the at least two paddle gears is fluid-coupled to one of the at least two flow paths, forming a rotating cavity between the housing and the paddle arm of the paddle gear, configured to measure a predetermined volume of fluid passing through the flow path to which the paddle gear is fluid-coupled, and the flow mechanism is configured to maintain a constant flow ratio between the at least two flow paths.

[0321] Example 2. At least two flow channels are fluid-separated from each other by a flow mechanism, in any embodiment of this specification, particularly the flow mechanism described in Embodiment 1.

[0322] Example 3. For each paddle gear, the paddle arm of the paddle gear extends radially outward from the central portion of the paddle, in the flow mechanism described in any embodiment of this specification, particularly Embodiment 1 or Embodiment 2.

[0323] Example 4. For each paddle gear, each rotating cavity is formed between two adjacent arms of the paddle arm and the wall of the cavity in the housing where the paddle gear is located, in any embodiment of this specification, in particular any one of Embodiments 1 to 3, of the flow mechanism.

[0324] Example 5. A flow mechanism according to any embodiment of this specification, particularly any one of Examples 1 to 4, comprising at least two paddle gears, a first paddle gear including a first paddle fluid-coupled to a first flow path of at least two flow paths, and a second paddle gear including a second paddle fluid-coupled to a second flow path of at least two flow paths.

[0325] Example 6. A flow mechanism according to any embodiment of this specification, particularly Embodiment 5, wherein the first paddle gear includes a first gear rotatably connected to a first paddle, and the second paddle gear includes a second gear rotatably connected to a second paddle, the teeth of the first gear meshing and engaging with the teeth of the second gear.

[0326] Example 7. The gear ratio between the first gear and the second gear is 1:1, in any embodiment of this specification, particularly the flow mechanism described in Embodiment 6.

[0327] Example 8. The flow mechanism described in any embodiment of this specification, particularly Embodiment 6, wherein the gear ratio between the first gear and the second gear is not 1:1, and the diameter of the first gear is different from the diameter of the second gear.

[0328] Example 9. The flow mechanism according to any embodiment of this specification, in particular any one of embodiments 6 to 8, wherein at least two paddle gears include a third paddle gear that meshes and engages with one of the first gear and the second gear, and the first paddle gear, the second paddle gear, and the third paddle gear are arranged adjacent to each other within a housing.

[0329] Example 10. A flow mechanism according to any embodiment of this specification, in particular any one of embodiments 6 to 9, further comprising a toothed drive gear that meshes with and engages with one of the first gear and the second gear, wherein the toothed drive gear is configured to drive the rotation of at least two paddle gears at a selected speed.

[0330] Example 11. A flow mechanism according to any embodiment of this specification, particularly Embodiment 5, wherein the first paddle and the second paddle are rotatably connected to each other by a common rotatable member of the first paddle gear and the second paddle gear.

[0331] Example 12. A common rotatable member is a first gear having teeth, the teeth of which mesh with and engage with an adjacent second gear rotatably connected to a third paddle and a fourth paddle, the third paddle being fluid-coupled to a third flow path of at least two flow paths, and the fourth paddle being fluid-coupled to a fourth flow path of at least two flow paths, in any embodiment of this specification, particularly Embodiment 11.

[0332] Example 13. A common rotatable member is a toothless spacer, which is positioned between a first paddle and a second paddle in any embodiment of this specification, particularly the flow mechanism described in Embodiment 11.

[0333] Example 14. A system, a delivery device, comprising: a delivery device, a first flow lumen having a first resistance, and a second flow lumen having a second resistance less than the first resistance, the second flow lumen being coaxial with the first flow lumen and surrounding the first flow lumen; and a flow mechanism configured to provide a consistent relative flow rate of fluid to and between the first and second flow lumen, comprising: a rotatable first paddle gear fluid-coupled to a first flow path defined by the housing of the flow mechanism and fluid-coupled to the first flow lumen, and fluid-coupled to a first flow path; and a rotatable second paddle gear fluid-coupled to a second flow path defined by the housing of the flow mechanism and fluid-coupled to the second flow lumen, wherein the rotation of the first paddle gear and the rotation of the second paddle gear are linked by meshing engagement between the respective gears of the first paddle gear and the second paddle gear.

[0334] Example 15. The delivery device further comprises a first fluid port fluid-connected to a first flow lumen and a second fluid port fluid-connected to a second flow lumen, wherein the first outlet of the first flow path is fluid-connected to the first fluid port and the second outlet of the second flow path is fluid-connected to the second fluid port, as described in any embodiment of this specification, particularly the system described in Embodiment 14.

[0335] Example 16. The first and second flow channels of the flow mechanism are fluid-separated from each other, as described in any embodiment of this specification, particularly Example 14 or Example 15.

[0336] Example 17. A system according to any embodiment of this specification, in particular any one of Examples 14 to 16, wherein the first paddle gear includes a first paddle and a first gear rotatably coupled to it, and the second paddle gear includes a second paddle and a second gear rotatably coupled to it, and the first gear and the second gear each include teeth that mesh and engage with each other.

[0337] Example 18. A system according to any embodiment of this specification, particularly Embodiment 17, wherein a first paddle is located in a first cavity defined by a housing, and a first flow path extends through the first cavity to one side of the first cavity, and a second paddle is located in a second cavity defined by a housing, and a second flow path extends through the second cavity to one side of the second cavity.

[0338] Example 19. A system according to any embodiment of this specification, particularly Example 18, wherein a first rotating cavity having a first volume is formed between the arm of a first paddle and the wall of the first cavity, and a second rotating cavity having a second volume is formed between the arm of a second paddle and the wall of the second cavity.

[0339] Example 20. The first volume and the second volume are identical in any of the embodiments of this specification, particularly the system described in Example 19.

[0340] Example 21. The system described in any of the embodiments herein, particularly Example 19, wherein the first volume is greater than the second volume.

[0341] Example 22. The system according to any embodiment of this specification, in particular any one of Examples 14 to 21, wherein the diameter of the first gear of the first paddle gear is smaller than the diameter of the second gear of the second paddle gear.

[0342] Example 23. A first flow lumen is defined by the inner surface of the first shaft of the delivery device, and a second flow lumen is defined between the outer surface of the first shaft of the delivery device and the inner surface of the second shaft, and the first shaft and the second shaft are arranged coaxially with each other within the outer shaft of the delivery device, as described in any embodiment of this specification, any one of Examples 14 to 22.

[0343] Example 24. A method comprising the steps of flowing a fluid through an inner pusher shaft lumen extending from the inside of the pusher shaft of a delivery device to the distal end of the pusher shaft, wherein the pusher shaft is coaxial with and at least partially located inside the sleeve shaft of the delivery device, and the sleeve shaft and pusher shaft are located within an outer shaft of the delivery device extending distally from the handle assembly of the delivery device, the sleeve shaft including a distal section that surrounds and covers a docking device within the outer shaft, and flowing the fluid from the pusher shaft lumen through a formation between the outer surface of the docking device and the inner surface of the distal section of the sleeve shaft A method comprising the steps of: flowing fluid into a sleeve shaft lumen; flowing the fluid through a delivery shaft lumen formed between the outer surface of the sleeve shaft and the inner surface of the outer shaft; and maintaining a consistent flow ratio of fluid to and between the pusher shaft lumen and the delivery shaft lumen by a single flow mechanism fluid-coupled to the pusher shaft lumen and the delivery shaft lumen, wherein the first rotatable paddle gear is fluid-coupled to the pusher shaft lumen and the second rotatable paddle gear is fluid-coupled to the pusher shaft lumen and the delivery shaft lumen.

[0344] Example 25. The method according to any embodiment herein, particularly the method of Example 24, wherein the resistance to flow in the lumen of the pusher shaft is greater than the resistance to flow in the lumen of the delivery shaft.

[0345] Example 26. The method according to any embodiment of this specification, particularly Example 24 or Example 25, wherein the step of flowing a fluid through the lumen of the delivery shaft includes the steps of flowing the fluid from a first flushing port connected to a conduit of the hub assembly of the delivery device to a first cavity formed between the outer surface of the pusher shaft and the inner surface of the conduit, and flowing the fluid from the first cavity to the lumen of the delivery shaft.

[0346] Example 27. The method according to any embodiment of this specification, particularly the method of Example 26, wherein the step of flowing fluid through the lumen of the pusher shaft to the lumen of the sleeve shaft includes the step of flowing fluid from a second flushing port connected to a conduit, which is in direct fluid communication with the lumen of the pusher shaft and is proximal to the location where the first flushing port is connected to the conduit.

[0347] Example 28. The method according to any embodiment of this specification, particularly Embodiment 27, wherein the step of flowing fluid through the lumen of the pusher shaft includes providing a first flow rate of fluid from a first flow path fluid-connected to a first paddle gear to a second flushing port, and the step of flowing fluid through the lumen of the delivery shaft includes providing a second flow rate of fluid from a second flow path fluid-connected to a second paddle gear to the first flushing port, and the consistent flow rate ratio of the fluid is the flow rate ratio of the first flow rate of the fluid to the second flow rate of the fluid.

[0348] Example 29. A flow throttle comprising: a compressible sealing member defining a first opening extending through the length of the compressible sealing member, the length of which is defined axially with respect to the central longitudinal axis of the first opening; and a rigid substrate comprising: a first portion embedded within the compressible sealing member and extending through the length of the compressible sealing member and defining a second opening; and a second portion embedded within the compressible sealing member and extending outward from the first portion and surrounding at least a portion of the first opening.

[0349] Example 30. A flow throttle according to any embodiment of this specification, particularly embodiment 29, wherein the first opening is radially offset from the second opening such that the central longitudinal axis of the first opening and the central longitudinal axis of the second opening are offset from each other.

[0350] Example 31. The flow throttle according to any embodiment of this specification, particularly Example 29 or Example 30, wherein the first opening has a larger diameter than the second opening.

[0351] Example 32. The second part is a flow throttle according to any embodiment of this specification, in particular any one of Examples 29 to 31, which includes one or more openings defined therein, configured to increase the bond between a compressible sealing member and a rigid substrate.

[0352] Example 33. A flow throttle according to any embodiment of this specification, particularly any one of Examples 29 to 32, further comprising a rigid substrate axially outward from a first portion, an extension member extending outward from one side of the compressible sealing member, and a compressible sealing member.

[0353] Example 34. A flow throttle according to any embodiment of this specification, particularly any one of Examples 29 to 33, wherein the compressible sealing member comprises a compressible material and the rigid substrate comprises an incompressible material.

[0354] Example 35. The compressible sealing member is a flow throttle according to any embodiment of this specification, particularly any one of Examples 29 to 34, comprising silicone.

[0355] Example 36. A compressible sealing member is overmolded onto a first portion and a second portion of a rigid substrate in a flow throttle according to any embodiment of this specification, particularly any one of Examples 29 to 35.

[0356] Example 37. The flow throttle according to any embodiment of this specification, particularly any one of Examples 29 to 36, wherein the compressible sealing member has a curved outer surface positioned radially outward of the rigid substrate.

[0357] Example 38. The second portion of the rigid substrate surrounds the entire circumference of the first opening, as described in any embodiment of this specification, particularly any one of Examples 29 to 37.

[0358] Example 39. A compressible sealing member defines a third opening spaced apart from a first opening, in a flow throttle according to any embodiment of this specification, particularly any one of Examples 29 to 38.

[0359] Example 40. A flow throttle according to any embodiment of this specification, particularly any one of Examples 29 to 39, wherein the outer surface of a compressible sealing member is configured to seal a first flow conduit of the flow system, and the first opening is configured to seal a second flow conduit of the flow system.

[0360] Example 41. A delivery device comprising: a first flow conduit defining a first flow lumen having a first resistance; a second flow conduit coaxial with and surrounding the first flow conduit, the second flow lumen being defined between the first and second flow conduits, the second flow lumen having a second resistance less than the first resistance; a fluid port fluid-connected to the first and second flow lumen and configured to receive fluid; and a flow throttle located downstream of the fluid port and configured to fluid-separate the first and second flow lumen from each other, wherein the flow throttle comprises a compressible sealing member defining a first opening sealed around the first flow conduit, and a rigid substrate defining a second opening fluid-connecting the fluid port to the second flow lumen, the compressible sealing member being overmolded on the rigid substrate, and the first opening having a larger diameter than the second opening.

[0361] Example 42. The flow throttle is positioned within the second flow lumen by the outer surface of a compressible sealing member that is in face-to-face contact with the inner surface of the second flow conduit, as described in any embodiment of this specification, particularly Embodiment 41 of the delivery apparatus.

[0362] Example 43. A delivery device according to any embodiment of this specification, particularly Embodiment 41 or Embodiment 42, wherein a first flow conduit extends through a first opening, and the outer surface of the first flow conduit is in face-to-face contact with the inner surface of a compressible sealing member defining the first opening.

[0363] Example 44. The first flow conduit is a proximal extension of the pusher shaft of the delivery device, according to any embodiment of this specification, particularly any one of Examples 41 to 43.

[0364] Example 45. A delivery device according to any embodiment of this specification, particularly any one of Examples 41 to 44, wherein the compressible sealing member comprises a compressible material and the rigid substrate comprises an incompressible material.

[0365] Example 46. The rigid substrate includes an extension member extending axially outward from one side of a compressible sealing member, which fits into a corresponding recess in the delivery device, as described in any embodiment of this specification, particularly any one of Examples 41 to 45.

[0366] Example 47. A delivery device according to any embodiment of this specification, particularly any one of Examples 41 to 46, comprising a rigid substrate, a first portion embedded within a compressible sealing member defining a second opening, and a second portion embedded within the compressible sealing member extending circumferentially outward from the first portion, wherein the second portion at least partially surrounds the first opening.

[0367] Example 48. A delivery device comprising: an outer shaft configured to hold an artificial implant in a delivery configuration; an inner shaft disposed within the outer shaft, coupled to the end of the artificial implant, and configured to move axially relative to the outer shaft; and a sleeve shaft disposed within the outer shaft, wherein a portion of the sleeve shaft is disposed between the outer shaft and the inner shaft, the sleeve shaft is configured to cover the artificial implant in a delivery configuration, and the inner shaft extends between the inner and outer surfaces of the inner shaft, and includes one or more defined openings therein, the inner lumen of the inner shaft being configured to fluidly connect with a lumen disposed between the outer surface of the inner shaft and the inner surface of the sleeve shaft.

[0368] Example 49. The inner and outer surfaces of the inner shaft are circumferential surfaces, and lines perpendicular to the inner and outer surfaces intersect the central longitudinal axis of the delivery device, as described in any embodiment of this specification, particularly the delivery device described in Embodiment 48.

[0369] Example 50. One or more openings are located at the distal end portion of the inner shaft, in the delivery device according to any embodiment of this specification, particularly Example 48 or Example 49.

[0370] Example 51. One or more openings are located in a portion of the inner shaft that is spaced away from the distal end portion of the inner shaft, as described in any embodiment of this specification, particularly Example 48 or Example 49 of the delivery device.

[0371] Example 52. A delivery device according to any embodiment of this specification, in particular any one of Examples 48 to 51, wherein one or more openings include at least two openings spaced apart from each other around the periphery of an inner shaft.

[0372] Example 53. The delivery device according to any embodiment of this specification, in particular any one of embodiments 48 to 52, wherein the inner shaft comprises a main tube, and the distal section of the main tube includes a plurality of cuts therein, spaced apart from one another along the length of the distal section, and one or more openings are located in a portion of the inner shaft adjacent to the distal section.

[0373] Example 54. A delivery device according to any embodiment of this specification, particularly Example 53, wherein one or more openings are configured as openings extending through a main tube, an inner liner covering the inner surface of the main tube, and an outer polymer layer covering the outer surface of the main tube.

[0374] Example 55. The main tube of the inner shaft includes an intermediate section adjacent to and proximal to the distal section, and one or more openings are located in the intermediate section, as described in any embodiment of this specification, particularly Example 53 or Example 54 of the delivery device.

[0375] Example 56. One or more openings are located in the distal end portion of an inner shaft that is positioned distally adjacent to the distal section, as described in any embodiment of this specification, particularly Embodiment 53 or Embodiment 54 of the delivery device.

[0376] Example 57. The delivery device according to any embodiment of this specification, in particular any one of Examples 48 to 50, wherein one or more openings are one or more slots located at the distal end of the inner shaft, and each of the one or more slots extends from the distal end of the inner shaft in the proximal direction to a certain distance away from the distal end.

[0377] Example 58. The delivery device according to any embodiment of this specification, particularly Example 57, comprises a polymer distal end portion containing a flexible polymer and a rigid main tube distal end of the inner shaft, wherein the polymer distal end portion is distally positioned to the distal end of the main tube, and each slot extends through the polymer distal end portion to the distal end of the main tube.

[0378] Example 59. The delivery device according to any embodiment of this specification, particularly Example 57, wherein the distal end portion of the inner shaft comprises a polymer distal end portion containing a flexible polymer and the distal end of a rigid main tube of the inner shaft, the polymer distal end being distally positioned to the distal end of the main tube, and each slot extending to the distal end of the main tube only through the distal polymer distal end portion.

[0379] Example 60. One or more slots include a single slot, as described in any embodiment of this specification, in particular any one of Examples 57 to 59.

[0380] Example 61. A delivery device according to any embodiment of this specification, in particular any one of Examples 57 to 59, wherein one or more slots include two slots spaced apart from each other around the circumference of the distal end portion.

[0381] Example 62. The two slots are arranged 180 degrees apart from each other around the periphery of the distal end portion of the delivery device according to any embodiment of this specification, in particular Example 61.

[0382] Example 63. Each slot has a uniform width along the axial length of the slot, as described in any embodiment of this specification, particularly any one of Examples 57 to 62.

[0383] Example 64. A delivery device according to any embodiment of this specification, particularly any one of Examples 57 to 62, wherein each slot has a width that increases from the distal end to the proximal end of the slot.

[0384] Example 65. The delivery device according to any embodiment of this specification, particularly any one of Examples 48 to 50, wherein the inner shaft includes a distal tip positioned around the distal end portion of the main tube of the inner shaft, the distal tip being at least partially covered by a flexible polymer layer that also covers the main tube, and the distal tip including a tip portion extending distally beyond the flexible polymer layer containing the main tube and one or more openings therein.

[0385] Example 66. A delivery device according to any embodiment of this specification, particularly the one described in Embodiment 65, wherein one or more openings are configured as openings spaced apart from one another around the circumference of the tip portion of the distal tip.

[0386] Example 67. The distal tip comprises an extruded or molded polymer material, as described in any of the embodiments of this specification, particularly Example 65 or Example 66 of the delivery device.

[0387] Example 68. A delivery device according to any embodiment of this specification, particularly any one of Examples 48 to 50, wherein one or more openings are located at the polymer tip of the inner shaft, and the polymer tip is located at the distal end of the inner shaft.

[0388] Example 69. The delivery device according to any embodiment of this specification, particularly Example 68, comprises an inner shaft comprising a main tube, an outer polymer layer covering the outer surface of the main tube, and an inner liner covering the inner surface of the main tube, wherein the polymer tip is continuous with the outer polymer layer and extends distally beyond the distal end of the main tube.

[0389] Example 70. A delivery device according to any embodiment herein, further comprising a sleeve shaft, the sleeve shaft comprising a rigid material and comprising a proximal section comprising a tubular portion and a cut portion, the cut portion extending proximal to the tubular portion and having a cross-section that is an imperfect circle, so that the cut portion forms an open channel with a cut surface at either end of the cut portion, defining a void in the open channel between them, and the cut surface has rounded inner and outer edges.

[0390] Example 71. The delivery device according to any embodiment of this specification, particularly Example 70, wherein the cut surface is completely rounded so that the rounded inner and outer edges are continuous with each other and with the inner and outer surfaces of the cut portion.

[0391] Example 72. The delivery device according to any embodiment of this specification, particularly Example 70 or Example 71, wherein the cut portion is configured to receive a portion of the pusher shaft, and the gap in the cut portion of the sleeve shaft is configured to receive the flexible proximal extension of the pusher shaft through it.

[0392] Example 73. The proximal section of the sleeve shaft is made of metal, as described in any of the embodiments of this specification, particularly any one of Examples 70 to 72.

[0393] Example 74. The cut surface and the rounded inner and outer edges are deburred, as in any embodiment of this specification, particularly any one of Examples 70-73 of the delivery device.

[0394] Example 75. A sleeve shaft for a delivery device, comprising a tubular portion having a circular cross-section and a cut portion extending proximal to the tubular portion and having an incomplete circular cut surface, wherein the cut portion forms an open channel with a cut surface at either end of the cut portion, defining an opening of the open channel between them, and the cut surface has rounded inner and outer edges.

[0395] Example 76. The cut surface is a sleeve shaft according to any embodiment of this specification, particularly Embodiment 75, in which the rounded inner and outer edges are completely rounded so that they are continuous with each other and with the inner and outer surfaces of the cut portion.

[0396] Example 77. The inner and outer edges are rounded to a predetermined radius, and the planar portion of the cut surface extends between the rounded inner and outer edges, as described in any embodiment of this specification, particularly Embodiment 75, of the sleeve shaft.

[0397] Example 78. The rounded inner and outer edges are reflowed edges formed by laser welding, as described in any embodiment of this specification, particularly any one of Examples 75-77, of the sleeve shaft.

[0398] Example 79. The rounded inner and outer edges are formed by deburring using a deburring machine bit, as described in any embodiment of this specification, particularly any one of Examples 75 to 77, of the sleeve shaft.

[0399] Example 80. The cut portion of the sleeve shaft is a sleeve shaft according to any embodiment of this specification, in particular any one of Examples 75 to 78, which includes metal.

[0400] Example 81. A method for forming a sleeve shaft of a delivery device, comprising the steps of: cutting a proximal section of a tube of a sleeve shaft into a cut portion having a C-shaped cross-section and an opening, wherein the cut portion has cut surfaces on both sides of the opening; and rounding the inner and outer edges of each cut surface by irradiating the cut surface with a laser until the metal of the cut surface melts and reflows over the inner and outer edges.

[0401] Example 82. The step of rounding the inner and outer edges of each cut surface by irradiating it with a laser forms a perfectly rounded surface that curves between the inner and outer surfaces of the cut portion, as described in any embodiment of this specification, particularly the method of Example 81.

[0402] Example 83. The step of rounding the inner and outer edges of each cut surface by irradiating them with a laser includes the step of deburring the inner and outer edges to a selected radius, as described in any embodiment of this specification, particularly the method of Example 81.

[0403] Example 84. The step of cutting the proximal section of the sleeve shaft tube comprises cutting the proximal section of the tube by electrical discharge machining, wherein the inner and outer edges of the cut surface are angled and sharp after cutting and before rounding, according to any embodiment of this specification, in particular the method of any one of Examples 81 to 83.

[0404] Example 85. A method for forming a sleeve shaft of a delivery device, comprising the steps of: cutting a proximal section of a tube of a sleeve shaft into a cut portion having a C-shaped cross-section and an opening, wherein the cut portion has cut surfaces on both sides of the opening; and rounding the inner and outer edges of each cut surface by applying a deburring machine bit to the cut surface.

[0405] Example 86. A delivery device comprising: an outer shaft configured to hold an artificial implant in a delivery configuration; an inner shaft disposed within the outer shaft, joined to the end of the artificial implant, and configured to move axially relative to the outer shaft, the inner shaft comprising a rigid main tube and a polymer distal end portion comprising a flexible polymer and extending distally to the main tube, the polymer distal end portion having one or more openings defined therein, extending between the inner and outer surfaces of the polymer distal end portion; and a sleeve shaft disposed within the outer shaft, a portion of which the sleeve shaft is disposed between the outer shaft and the inner shaft, and the sleeve shaft is configured to cover the artificial implant in a delivery configuration.

[0406] Example 87. The delivery device according to any embodiment of this specification, particularly Example 86, further comprising an inner shaft covering the outer surface of the main tube and an outer polymer layer continuous with the polymer distal end portion.

[0407] Example 88. The inner shaft further includes an inner liner covering the inner surface of the polymer distal end portion and the inner surface of the main tube, and one or more openings extending through the inner liner, as described in any embodiment of this specification, particularly Example 86 or Example 87 of the delivery device.

[0408] Example 89. A delivery device according to any embodiment of this specification, particularly any one of Examples 86 to 88, wherein one or more openings include three openings spaced apart from each other around the periphery of the distal end portion of the polymer.

[0409] Example 90. A delivery device according to any embodiment of this specification, particularly any one of Examples 86 to 89, wherein one or more openings are configured to fluidly connect the inner lumen of the inner shaft to a lumen located between the outer surface of the inner shaft and the inner surface of the sleeve shaft.

[0410] Example 91. A delivery device comprising: an outer shaft configured to hold an artificial implant in a delivery configuration; an inner shaft disposed within the outer shaft, joined to the end of the artificial implant, and configured to move axially relative to the outer shaft, the inner shaft comprising a rigid main tube including a distal end portion covered by an outer polymer layer; a polymer distal end portion comprising a flexible polymer, disposed distal to the main tube and continuous with the outer polymer layer; and one or more openings between the outer surface and the inner surface of the inner shaft, extending through the outer polymer layer and the main tube; and a sleeve shaft disposed within the outer shaft, wherein a portion of the sleeve shaft is disposed between the outer shaft and the inner shaft, and the sleeve shaft is configured to cover the artificial implant in a delivery configuration.

[0411] Example 92. The delivery device according to any embodiment of this specification, particularly Example 91, further comprises an inner liner covering the inner surface of the polymer distal end portion and the inner surface of the main tube, with one or more openings extending through the inner liner.

[0412] Features described herein in relation to any embodiment can be combined with other features described in any one or more other embodiments, unless otherwise stated. For example, any one or more features of one flow mechanism can be combined with any one or more features of another flow mechanism. In another embodiment, any one or more features of one pusher shaft of a delivery device can be combined with any one or more features of another pusher shaft of a delivery device.

[0413] Given the many possible embodiments to which the principles of this disclosure may apply, it should be recognized that the illustrated configurations illustrate embodiments of the disclosed technology and should not be construed as limiting the scope of this disclosure or the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents. [Explanation of symbols]

[0414] 18 Delivery device, 34 Sleeve shaft, 58 Delivery device, 220 Delivery device, 260 Outer shaft, 280 Sleeve shaft, 282 Distal section, 292 Main tube, 1260 Inner lumen, 1502 Main tube, 1518 Distal section, 1520 Cut section, 1535 Intermediate section, 1538 Inner liner, 1540 Outer polymer layer, 1544 Polymer distal end portion, 2202 Polymer tip, 2406 Opening

Claims

[Claim 1] Delivery device as described in the specification and drawings.

Images