Flow throttle valve and delivery device

Abstract

The utility model relates to a flow throttle valve and a delivery device. Methods and systems for providing consistent flow of fluid through a lumen of a delivery device. As one example, a delivery device may include an outer shaft configured to hold a prosthetic implant in a delivery configuration, an inner shaft disposed within the outer shaft and configured to engage an end of the prosthetic implant and move axially relative to the outer shaft, and a cannula shaft disposed within the outer shaft and configured to engage the end of the prosthetic implant and move axially relative to the outer shaft. And configured to cover the prosthetic implant in the delivery configuration. In some examples, the inner shaft may include one or more openings defined therein, the one or more openings extending between an inner surface and an outer surface of the inner shaft, and the one or more openings configured to fluidly couple an inner lumen of the inner shaft with a lumen disposed between the outer surface of the inner shaft and an inner surface of the cannula shaft.

Description

[0001] This application is a divisional application of divisional application 2022224171990 with the title "Percutaneous Leaflet Augmentation" whose filing date is November 12, 2021. Divisional application 2022224171990 is a divisional application of Chinese Patent Application 2021227671448.

[0002] Cross - reference to related applications

[0003] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 113,322, filed on November 13, 2020, which is incorporated herein by reference in its entirety. Technical field

[0004] The present disclosure relates to a delivery device and related flow systems for a docking device configured to fix a prosthetic valve at a native heart valve. Background art

[0005] Prosthetic valves can be used to treat heart valve diseases. The function of native heart valves (e.g., aortic valve, pulmonary valve, tricuspid valve, and mitral valve) is to prevent backward flow or regurgitation while allowing forward flow. Congenital, inflammatory, infectious diseases, etc. may reduce the efficiency of these heart valves. Such diseases may ultimately lead to severe cardiovascular damage or death. In the past, such conditions could be treated with surgical repair or valve replacement during open - heart surgery.

[0006] Transcatheter techniques for introducing and implanting prosthetic heart valves in a less invasive manner than open - heart surgery can reduce the complications associated with open - heart surgery. In this technique, the prosthetic valve can be mounted in a compressed state on the distal portion of a delivery device and advanced through the patient's blood vessels until the valve reaches the implantation site. Then, the valve at the distal portion of the delivery device can be expanded to its functional size at the site of the defective native valve, such as by inflating a balloon on which the valve is mounted. Alternatively, 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. Optionally, the valve can have a balloon - expandable, self - expandable, mechanically expandable frame and / or a frame that can expand in multiple ways or a combination of ways.

[0007] Transcatheter heart valves (THVs) can be appropriately sized to be placed inside many native aortic valves. However, native mitral and tricuspid valves may have different geometries than typical aortic valves, and mitral and tricuspid anatomies may vary from person to person. Thus, it may be difficult to appropriately size and shape a prosthetic valve for many patients. Additionally, when treating valvular insufficiency, the surrounding tissue may not be sufficient to hold certain types of valves in place as needed.

[0008] In some examples, a docking device can be implanted inside a native valve first and can be configured to receive a prosthetic valve and secure (e.g., anchor) the prosthetic valve in a desired position inside the native valve. For example, the docking device can form a more circular and / or stable anchoring site at the native annulus where the prosthetic valve can be expanded and implanted. A transcatheter delivery device can be used to deliver the docking device to the implantation site. The docking device can be disposed inside the delivery device, coaxial with additional components of the delivery device. A plurality of lumens can be provided between the coaxial components of the delivery device, and a flushing fluid can be provided to these lumens during the implantation procedure to reduce or prevent thrombus formation between the components, including around the docking device. However, since these lumens may have different resistances from each other and the resistance of the lumens may change during the implantation procedure, it may be difficult to maintain a constant flow of the flushing fluid in each lumen. Thus, improvements to the transcatheter delivery device that ensure a specified flow of fluid through the respective lumens of the delivery device to prevent thrombus formation are desired. Summary of the Utility Model

[0009] Described herein are docking devices, prosthetic heart valves, delivery devices, and methods for implanting a docking device and a prosthetic heart valve within the docking device. Also described herein are examples of delivery devices, flow mechanisms, and related methods for providing a consistent flow of fluid through the lumens of a flow system. In some examples, the lumens are part of a delivery device configured to deliver a docking device to a target implantation site within a patient. The docking device can be configured to receive a prosthetic valve therein and hold the prosthetic valve firmly in place at the implantation site. By providing a consistent flow of fluid through the lumens of such a delivery device, blood stasis within the delivery device can be reduced or avoided, thereby reducing thrombus formation.

[0010] In a representative example, a delivery device includes an outer shaft configured to hold a prosthetic implant in a delivery configuration; an inner shaft disposed within the outer shaft and configured to engage an end of the prosthetic implant and axially move relative to the outer shaft; and a cannula shaft disposed within the outer shaft, a portion of the cannula shaft being disposed between the outer shaft and the inner shaft, and the cannula shaft being configured to cover the prosthetic implant in the delivery configuration. The inner shaft includes one or more openings defined therein that extend between an inner surface and an outer surface of the inner shaft, and the one or more openings are configured to fluidly couple an inner lumen of the inner shaft with a lumen disposed between an outer surface of the inner shaft and an inner surface of the cannula shaft.

[0011] In another representative example, a delivery device includes an outer shaft configured to hold a prosthetic implant in a delivery configuration; an inner shaft disposed within the outer shaft and configured to engage an end of the prosthetic implant and axially move relative to the outer shaft, the inner shaft including: a rigid main body; and a polymeric distal portion including a flexible polymer and extending distally of the main body. The polymeric distal portion includes one or more holes defined therein that extend between an inner surface and an outer surface of the polymeric distal portion. The delivery device further includes a cannula shaft disposed within the outer shaft, a portion of the cannula shaft being disposed between the outer shaft and the inner shaft, and the cannula shaft being configured to cover the prosthetic implant in the delivery configuration.

[0012] In another representative example, a delivery device includes an outer shaft and an inner shaft, the outer shaft being configured to hold a prosthetic implant in a delivery configuration, the inner shaft being disposed within the outer shaft and configured to engage an end of the prosthetic implant and axially move relative to the outer shaft. The inner shaft includes a rigid main body having a distal portion covered by an outer polymeric layer; a polymeric distal portion including a flexible polymer, disposed distally of the main body, and continuous with the outer polymeric layer; and one or more holes that extend between an outer surface and an inner surface of the inner shaft, through the outer polymeric layer and the main body. The delivery device further includes a cannula shaft disposed within the outer shaft, a portion of the cannula shaft being disposed between the outer shaft and the inner shaft, and the cannula shaft being configured to cover the prosthetic implant in the delivery configuration.

[0013] In a representative example, a flow mechanism includes: a housing that defines at least two flow paths; and at least two paddle gears disposed within the housing and rotatably engaged with each other, each of the at least two paddle gears being fluidly coupled to one of the at least two flow paths and defining a rotation cavity between the housing and an arm of a paddle of the paddle gear, the rotation cavity being configured to meter a predetermined volume of fluid flowing through the flow path to which the paddle gear is fluidly coupled; wherein the flow mechanism is configured to maintain a constant flow rate ratio between the at least two flow paths.

[0014] In another representative example, a flow system includes: a delivery device that includes: a first flow lumen having a first resistance; and a second flow lumen having a second resistance less than the first resistance, wherein the second flow lumen is coaxial with and surrounds the first flow lumen; and a flow mechanism configured to provide fluid to the first flow lumen and the second flow lumen and at a consistent relative flow rate between the first flow lumen and the second flow lumen, the flow mechanism including: a rotatable first paddle gear fluidly coupled to a first flow path defined by a housing of the flow mechanism, the first flow path being fluidly coupled to the first flow lumen; and a rotatable second paddle gear fluidly coupled to a second flow path defined by the housing of the flow mechanism, the second flow path being fluidly coupled to the second flow lumen, wherein rotation of the first paddle gear and rotation of the second paddle gear are associated by engagement between respective gears of the first paddle gear and the second paddle gear.

[0015] The various innovations of the present disclosure may be combined or used individually. This abstract is provided to introduce some concepts in a simplified form that are further described in the specification. This abstract is not intended to identify key features 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 foregoing and other objects, features, and advantages of the present disclosure will be apparent from the following detailed description, claims, and drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 Illustrated schematically is a docking device delivery apparatus implanting a docking device for a prosthetic heart valve at a patient's mitral valve.

[0017] Figure 2A Illustrated schematically is after the docking device delivery apparatus has been removed from the patient Figure 1The docking device is fully implanted at the mitral valve of the patient.

[0018] Figure 2B Illustrated schematically according to an example is the implantation of a prosthetic heart valve in the mitral valve of a patient by a prosthetic heart valve delivery device Figure 2A into the implanted docking device.

[0019] Figure 3 is a side perspective view of a docking device in a helical configuration according to one example.

[0020] Figure 4 is a side view of an exemplary example 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.

[0021] Figure 5 is Figure 4 a side view of the hub assembly of the handle assembly of the delivery device.

[0022] Figure 6 is Figure 5 a first cross-sectional view of the hub assembly, which illustrates the fluid flow through the lumen of the handle assembly.

[0023] Figure 7 is Figure 6 a second cross-sectional view of a more detailed view of the hub assembly, which illustrates the fluid flow through the lumen of the handle assembly.

[0024] Figure 8 is a cross-sectional perspective view of a portion of the delivery device disposed between the distal portion of the delivery device and the hub assembly, which illustrates the flow of fluid through the internal components of the delivery device. Figure 4 through the internal components of the delivery device.

[0025] Fig.9A is Figure 4 a cross-sectional view of the distal portion of the delivery device, which illustrates the flow of fluid through the internal components of the delivery device when the pusher shaft is spaced apart from the docking device.

[0026] Fig. 9B is Figure 4 another cross-sectional view of the distal portion of the delivery device, which illustrates the flow of fluid through the internal components of the delivery device when the pusher shaft is disposed against the docking device.

[0027] Fig.10 is Figure 4 a perspective view of the distal portion of the delivery device, which illustrates an exemplary docking device deployed from the outer shaft of the delivery device and covered by the cannula shaft of the delivery device.

[0028] Fig.11 is Figure 4Perspective view of the distal portion of a delivery device, illustrating the deployment from the outer shaft of the delivery device of Fig.10 an exemplary docking device, where the cannula shaft has been removed from the docking device.

[0029] Fig.12 Top perspective view of an example 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.

[0030] Fig.13 is Fig.12 Side perspective view of the flow mechanism.

[0031] Fig.14 is Fig.12 Top view of the flow mechanism, illustrating the flow of fluid through the flow mechanism.

[0032] Fig.15 Top view of another example of a flow mechanism including paddle gears with different diameter gears.

[0033] Fig.16 Top view of another example of a flow mechanism including paddle gears with paddles having different geometries.

[0034] Fig.17 Perspective view of another example of a flow mechanism including more than two flow paths and two corresponding paddle gears.

[0035] Fig.18 Perspective view of another example 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.

[0036] Fig.19 Perspective view of another example 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.

[0037] Fig. 20 Perspective view of another example of a flow mechanism including two paddle gears with paddles disposed at offset heights.

[0038] Fig.21 is coupled to Fig.12 Top view of an exemplary example of a single fluid supply of the flow mechanism.

[0039] Fig. 22 Top view of another example of a flow mechanism including a drive member configured to drive the rotation of the paddle gears of the flow mechanism at a specified rate.

[0040] Fig.23 illustrates an exemplary arrangement of a flow throttle valve disposed within a hub assembly of Figure 7 configured to control the flow of fluid into two flow lumens of a delivery device.

[0041] Fig.24 is a perspective view of an example of a flow throttle valve configured to control the flow of fluid into at least two separate flow lumens.

[0042] Fig.25 is Fig.24 an end view of the flow throttle valve of

[0043] Fig.26 is a cross-sectional view of the flow throttle valve of Fig.24 disposed within a larger lumen of two flow lumens and sealing around a smaller lumen of the two flow lumens.

[0044] Fig. 27 is an end view of another example of a flow throttle valve configured to control the flow of fluid into at least three separate flow lumens.

[0045] Fig.28 is an end view of another example of a flow throttle valve configured to control the flow of fluid into at least two separate flow lumens.

[0046] Fig.29 is a schematic diagram illustrating four main components of an exemplary pusher shaft of a delivery device for a docking apparatus.

[0047] Fig.30 is a side cross-sectional view of an example of a pusher shaft of a delivery device for a docking apparatus.

[0048] Fig.31 is Fig.30 a side cross-sectional view of an exemplary distal end of the pusher shaft of

[0049] Fig.32 is Fig.30 a proximal view of the pusher shaft of

[0050] Fig.33 is Fig.30 a side view of the main tube of the pusher shaft of

[0051] Fig.34 is a cross-sectional side view of an exemplary arrangement of the pusher shaft of Fig.30 assembled with a cannula shaft and an outer shaft of a delivery device (where the assembly is in a first configuration) during deployment of the docking apparatus from the delivery device.

[0052] Fig.35 is after retracting the cannula shaft from the deployed docking apparatus Fig.34 Cross-sectional side view of the pusher shaft and sleeve shaft assembly (where the assembly is in the second configuration).

[0053] Fig.36 Perspective view of an example of the distal tip of the pusher shaft, which includes a slot provided therein.

[0054] Fig.37 is Fig.36 Side view of the distal tip.

[0055] Fig.38 Perspective view of another example of the distal tip of the pusher shaft, which includes two slots provided therein.

[0056] Fig.39 Perspective view of another example of the distal tip of the pusher shaft, which includes a slot with a varying width provided therein.

[0057] Fig.40 is Fig.39 Side view of the distal tip.

[0058] Fig.41 Side view of an example of the distal portion of the main body of the pusher shaft having one or more holes provided therein, the one or more holes being configured to provide a path for fluid to flow out of the pusher shaft.

[0059] Fig.42 Side view of another example of the distal portion of the main body of the pusher shaft having a plurality of holes provided therein, the plurality of holes being configured to provide a path for fluid to flow out of the pusher shaft.

[0060] Fig.43 Cross-sectional side view of an example of the distal portion of the pusher shaft including a distal tip having one or more holes provided therein, the one or more holes being configured to provide one or more additional flow paths for fluid to flow out of the pusher shaft.

[0061] Fig.44 is Fig.43 Side view of the distal portion of the pusher shaft.

[0062] Fig.45 Cross-sectional side view of another example of the distal portion of the pusher shaft including a polymer tip having one or more holes provided therein, the one or more holes being configured to provide one or more additional flow paths for fluid to flow out of the pusher shaft.

[0063] Fig.46 is Fig.45 Perspective view of the distal portion of the pusher shaft.

[0064] Fig.47 A cross-sectional view of a distal portion of a delivery device, illustrating the flow of fluid through internal components of the delivery device when Fig.45 and 46 the pusher shaft is disposed against the docking device.

[0065] Fig.48 A side cross-sectional view of an exemplary cannula shaft of a delivery device for a docking device.

[0066] Fig.49 Is Fig.48 a perspective view of a proximal section of the cannula shaft.

[0067] Fig.50 A perspective view of an exemplary hemostatic seal configured to seal around a cannula shaft of a delivery device for a docking device.

[0068] Fig.51 Is around Fig.49 the cannula shaft Fig.50 a perspective view of the hemostatic seal positioned at the cut portion.

[0069] Fig.52 A perspective view of a cannula shaft disposed around a pusher shaft of a delivery device for a docking device, wherein a proximal extension of the pusher shaft extends out of an opening in the cut portion of the cannula shaft.

[0070] Fig.53 Is Fig.52 a cross-sectional view of the cut portion of the cannula shaft, illustrating the sharp edge of the cut surface of the cut portion.

[0071] Fig.54A A schematic illustration showing a laser being applied to Fig.53 the cut surface of the cut portion to melt and round the sharp edge of the cut surface.

[0072] Fig.54B A schematic illustration showing Fig.54A the rounded surface achieved by the laser applied in

[0073] Fig.55 A perspective view of an exemplary cut portion of a cannula shaft, showing a first portion of the cut portion before the application of the laser and a second portion of the cannula shaft after the application of the laser, the application of the laser resulting in a rounded edge and / or a rounded surface at the cut surface of the cut portion.

[0074] Fig.56 A schematic illustration showing a finishing machine bit being applied to Fig.53 the cut surface of the cut portion and traveling along the cut surface to finish and / or round the sharp edge of the cut surface. DETAILED DESCRIPTION

[0075] For the purpose of this specification, certain aspects, advantages and novel features of the examples of the present disclosure are described herein. The disclosed methods, devices and systems should not be interpreted as restrictive. On the contrary, the present disclosure relates to all novel and non-obvious features and aspects of the various examples disclosed, which can be individual and various combinations and sub-combinations of each other. The method, device and system are not limited to any particular aspect or feature or combination thereof, and the examples of the present disclosure do not require the existence of any one or more specific advantages or problems to be solved.

[0076] Although the operations of certain disclosed methods are described in a specific, sequential order for ease of expression, it should be understood that this description includes rearrangement unless a specific statement requires a specific order. For example, operations described in order may be rearranged or performed concurrently in some cases. Moreover, for simplicity, the accompanying drawings may not show the various ways in which the disclosed methods can be used in conjunction with other methods. In addition, the description sometimes uses terms like "provide" or "implement" 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 can be easily distinguished by those skilled in the art.

[0077] As used in this application and the claims, the singular forms "a", "an", and "the" include the plural forms unless the context clearly dictates otherwise. In addition, the term "comprising" means "including". Further, the term "coupled" generally means physically, mechanically, chemically, and / or electrically coupled or linked, and does not exclude the presence of intervening elements between coupled or associated items in the absence of specific language to the contrary.

[0078] As used herein, the term "proximal" refers to a position, direction or portion of a device that is closer to a user and further away from an implantation site. As used herein, the term "distal" refers to a position, direction or portion of a device that is further away from a user and closer to an implantation site. Thus, for example, the proximal motion of a device is the motion of the device toward the user, while the distal motion of the device is the motion of the device away from the user. The terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions, unless otherwise clearly defined.

[0079] Examples of the Disclosed Technology

[0080] Various systems, devices, methods, etc. are described herein that can, in some examples, be used in or with a delivery device of a docking device. In some examples, such systems, devices, and / or methods can provide consistent flow of fluid through two or more lumens of a delivery device.

[0081] In some examples, the delivery device can be configured to deliver and implant a docking device at an implantation site, such as a native annulus. The docking device can be configured to more securely hold an expandable prosthetic valve (e.g., a transcatheter heart valve) implanted within the docking device at the native annulus. For example, the docking device can provide or form a more circular and / or stable anchoring site, landing zone, or implantation zone at the implantation site, and the prosthetic valve can be expanded or otherwise implanted within the anchoring site, landing zone, or implantation zone. By providing such an anchoring or docking device, the replacement prosthetic valve can be more securely implanted and held at various annuli, including at the mitral annulus, which does not have a naturally circular cross-section.

[0082] In some examples, the docking device can be disposed within the outer shaft of the delivery device, and a cannula shaft (also referred to herein as a delivery cannula) can be within the delivery device and can cover / surround the docking device during implantation at the target implantation site. A pusher shaft can be disposed proximally to the docking device within the outer shaft and can be configured to push the docking device out of the outer shaft to position the docking device at the target implantation site. The cannula shaft can also be within the outer shaft of the delivery device and around the pusher shaft. After positioning the docking device at the target implantation site, the cannula shaft can be removed from the docking device and retracted into the outer shaft of the delivery device.

[0083] Fluid (e.g., a flushing fluid, such as heparinized saline) can be provided to a pusher shaft lumen defined within the pusher shaft and a delivery shaft lumen defined between the cannula shaft and the outer shaft of the delivery device. Then, fluid from the pusher shaft lumen can flow into a cannula shaft lumen defined between the docking device and the cannula shaft and between the cannula shaft and the pusher shaft. By providing a consistent flow of fluid through these lumens of the delivery device, blood stasis within the delivery device can be reduced or avoided, thereby reducing or preventing thrombus formation.

[0084] In Figure 1-2B the schematic illustration depicts an exemplary transcatheter heart valve replacement procedure in which a docking device is delivered to a native annulus using a first exemplary delivery device and then a transcatheter prosthetic heart valve (THV) is delivered into the docking device using a second exemplary delivery device.

[0085] As described above, a defective native heart valve can be replaced with a transcatheter prosthetic heart valve. However, such a THV may not adequately secure itself to native tissue (e.g., the leaflets and / or annulus of the native heart valve) and may undesirably shift relative to the native tissue, resulting in paravalvular leakage, valve dysfunction, and / or other problems. Thus, a docking device can first be implanted at the native annulus, and then a THV can be implanted within the docking device to help anchor the THV to the native tissue and provide a seal between the native tissue and the THV.

[0086] Figure 1-2B depicts an exemplary transcatheter heart valve replacement procedure utilizing a docking device according to one example. During the procedure, the user first delivers and implants the docking device at the native heart valve of the patient using a docking device delivery device ( Figure 1 ), then removes the docking device delivery device from the patient after implanting the docking device ( Figure 2A ), and finally implants the prosthetic valve within the implanted docking device using a prosthetic valve delivery device ( Figure 2B ).

[0087] Figure 1 depicts a first stage in an exemplary mitral valve replacement procedure, in which the docking device 10 is implanted at the mitral valve 12 of the heart 14 of the patient 16 using a docking device delivery device 18 (which may also be referred to herein as a "catheter" and / or "docking device delivery device").

[0088] Generally, the docking device delivery device 18 includes a delivery shaft 20, a handle 22, and a pusher assembly 24. The delivery shaft 20 is configured to extend into the patient's vasculature and 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 vasculature to the implantation site and may be configured to receive and / or hold the docking device 10 therein. In some examples, the delivery shaft 20 may include an outer sheath or shaft defining a lumen, and the pusher assembly 24 and / or the docking device 10 may be configured to be received within and / or advanced within the lumen.

[0089] The handle 22 is configured to be grasped and / or otherwise held by the user to advance the delivery shaft 20 through the patient's vasculature. Specifically, the handle 22 is coupled 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 vasculature by applying a force on the handle 22 (e.g., pushing the handle 22). In some examples, the delivery shaft 20 may be configured to carry the pusher assembly 24 and / or the docking device 10 as it is advanced through the patient's vasculature. In this way, when the user grasps the handle 22 and pushes the delivery shaft 20 deeper into the patient's vasculature, the docking device 10 and / or the pusher assembly 24 may be advanced through the patient's vasculature synchronously with the delivery shaft 20.

[0090] In some examples, the handle 22 can include one or more articulating members 28 configured to assist in navigating the delivery shaft 20 through a patient's vasculature. Specifically, the articulating members 28 can include one or more of knobs, buttons, wheels, and / or other types of physically adjustable control members configured to be adjusted by a user to flex, bend, twist, rotate, and / or otherwise articulate the distal end 30 of the delivery shaft 20 to assist in navigating the delivery shaft 20 through a patient's vasculature.

[0091] The pusher assembly 24 is configured to deploy and / or implant the docking device 10 at an implantation site (e.g., a native valve). Specifically, the pusher assembly 24 is configured to be adjusted by a user to advance the docking device 10 through the delivery shaft 20 and out of the distal end 30 of the delivery shaft 20. As described above, the pusher assembly 24 can be configured to extend through the delivery shaft 20 within the lumen defined by the outer sheath of the delivery shaft 20. The pusher assembly 24 can also be coupled to the docking device 10 such that when the pusher assembly 24 is advanced through the delivery shaft 20, the pusher assembly 24 pushes the docking device 10 through and / or out of the delivery shaft 20. Stated slightly differently, because the docking device 10 is held, retained, and / or otherwise coupled to the pusher assembly 24, the docking device 10 can be advanced through and / or out of the delivery shaft 20 synchronously with the pusher assembly 24.

[0092] The pusher assembly 24 includes a pusher shaft 32 and, in some examples, can also include a cannula shaft 34. The pusher shaft 32 is configured to advance the docking device 10 through the delivery shaft 20 and out of the distal end 30 of the delivery shaft 20, while the cannula shaft 34 (when included) can be configured to cover the docking device 10 within the delivery shaft 20 and, at the same time, push the docking device 10 out of the delivery shaft 20 and position the docking device 10 at the implantation site. In some examples, the pusher shaft 32 can be covered by the cannula shaft 34 and disposed within the outer shaft or connector of a pusher handle (or hub assembly) 36 (e.g., as Figure 5-7 shown and further described below).

[0093] In some examples, the pusher assembly 24 can include a pusher handle (also referred to herein as a hub assembly) 36 that is coupled to the pusher shaft 32, and the pusher handle 36 is configured to be grasped and pushed by a user to axially translate the pusher shaft 32 relative to the delivery shaft 20 (e.g., to push the pusher shaft 32 into and / or out of the distal end 30 of the delivery shaft 20). The cannula shaft 34 can be configured to retract and / or withdraw from the docking device 10 after the docking device 10 has been positioned at the implantation site. For example, the pusher assembly 24 can include a cannula handle 38 that is coupled to the cannula shaft 34 and is configured to be pulled by a user to retract (e.g., axially move) the cannula shaft 34 relative to the pusher shaft 32.

[0094] The pusher assembly 24 can be removably coupled to the docking device 10 and can thus be configured to release, disengage, separate, and / or otherwise disconnect from the docking device 10 once the docking device 10 has been deployed at the implantation site. By way of example only, the pusher assembly 24 (e.g., the pusher shaft 32) can be removably coupled to the docking device 10 via a line, string, yarn, suture, or other suitable material that is tied or sutured to the docking device 10.

[0095] In some examples, the pusher assembly 24 includes a suture lock assembly 40 that is configured to receive and / or hold a line or other suitable material that is coupled to the docking device 10 via a suture. Thus, the line or other suitable material forming the suture can extend from the docking device 10 through the pusher assembly 24 to the suture lock assembly 40. The suture lock assembly 40 can also be configured to cut the line to release, disengage, separate, and / or otherwise disconnect the docking device 10 from the pusher assembly 24. For example, the suture lock assembly 40 can include a cutting mechanism that is configured to be adjusted by a user to cut the line.

[0096] Further details of the docking device delivery device and its variations are described below with reference to Figure 4-11 and are described in International Application No. PCT / US20 / 36577, which is incorporated herein by reference in its entirety.

[0097] Before inserting the docking device delivery device 18 into the vasculature of the patient 16, the user can first make an incision in the patient's body to access the blood vessel 42. For example, in Figure 1 the example shown, the user can make an incision in the patient's groin to access the femoral vein. Thus, in such an example, the blood vessel 42 can be the femoral vein.

[0098] After making an incision in the blood vessel 42, the user can insert the introducer device 44, the guide wire 46, and / or other devices (e.g., the delivery shaft 20 of the docking device delivery apparatus 18, the pusher shaft 32 and / or the cannula shaft 34, a catheter and / or other delivery devices, the docking device 10, a prosthetic valve, etc.) through the incision into the blood vessel 42. The introducer device 44 (which may include an introducer sheath) is configured to facilitate percutaneous introduction of the guide wire 46 and / or other devices (e.g., the docking device delivery apparatus 18) through the blood vessel 42, and even when it is fully inserted by the user, it may only extend through a portion of the blood vessel 42 (i.e., it may extend through the blood vessel 42 toward the heart 14, but may stop near the heart 14). On the other hand, the guide wire 46 is configured to guide a delivery device (e.g., the docking device delivery apparatus 18, a prosthetic valve delivery device, a catheter, etc.) and its associated devices (e.g., the docking device, a prosthetic heart valve, etc.) to an implantation site within the heart 14, and thus may extend all the way through the blood vessel 42 and into the left atrium 48 of the heart 14. Specifically, the user can advance the guide wire 46 through the blood vessel 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 to allow the guide wire 46 to pass from the right atrium 50 of the heart 14 to the left atrium 48, and then the guide wire 46 can be advanced through the incision in the atrial septum 52 into the left atrium 48. Thus, the guide wire 46 can provide a path that the docking device delivery apparatus 18 can follow as it is advanced through the patient's vasculature to ensure that the docking device delivery apparatus 18 does not perforate the walls of the blood vessel 42 and / or other vascular system tissues.

[0099] After positioning the guide wire 46 within the left atrium 48, the user can insert the docking device delivery apparatus 18 (e.g., the delivery shaft 20) into the patient 16 by advancing the docking device delivery apparatus 18 through the introducer device 44 and over the guide wire 46. Then, the user can continue to advance the docking device delivery apparatus 18 along the guide wire 46 through the patient's vasculature until the docking device delivery apparatus 18 reaches the left atrium 48, as Figure 1 shown. Specifically, the user can advance the delivery shaft 20 of the docking device delivery apparatus 18 by grasping the handle 22 of the docking device delivery apparatus 18 and applying a force to the handle 22 (e.g., pushing the handle 22). When advancing the delivery shaft 20 through the patient's vasculature, the user can adjust one or more articulating members 28 of the handle 22 to navigate around various turns, corners, constrictions, and / or other obstacles in the patient's vasculature.

[0100] Once the delivery shaft 20 reaches the left atrium 48, the user can position the distal end 30 of the delivery shaft 20 at and / or near the posteromedial commissure of the mitral valve 12 using the handle 22 (e.g., the articulating member 28). The user can then deploy and / or implant the docking device 10 at the mitral valve 12 by using the pusher assembly 24 to push the docking device 10 out of the distal end 30 of the delivery shaft 20. For example, the user can actuate the pusher handle 36 to axially translate the pusher shaft 32 relative to the delivery shaft 20 in the distal direction such that the docking device 10 (which may be covered by the cannula shaft 34) is deployed from the delivery shaft 20 and moved to the desired position at the implantation site.

[0101] In some examples, the docking device 10 can be made of, formed of, and / or include a shape memory material and, thus, can return to its original preformed shape when it exits the delivery shaft 20 and is no longer constrained by the delivery shaft 20. As an example, the docking device 10 can be initially formed as a coil and, thus, can wrap around the ventricular side of the leaflets when it exits the delivery shaft 20 and returns to its original coiled configuration (e.g., as Figure 3 shown and further described below).

[0102] After pushing the ventricular portion of the docking device 10 (i.e., the portion of the docking device 10 configured to be positioned / set within the left ventricle 56 and / or on the ventricular side of the mitral valve leaflets), the user can then release the remaining portion of the docking device 10 (the atrial portion of the docking device 10) from the delivery shaft 20 within the left atrium 48. Specifically, the user can retract the delivery shaft 20 away from the posteromedial commissure of the mitral valve 12 relative to the docking device 10. In some examples, the user can maintain the position of the pusher shaft 32 when retracting the delivery shaft 20 (e.g., by applying a holding force and / or a thrust force on the pusher shaft 32) such that the delivery shaft 20 withdraws and / or otherwise retracts 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 when the user retracts the delivery shaft 20, thereby releasing the docking device 10 from the delivery shaft 20. In some examples, the user can also retract the cannula shaft 34 from the docking device 10 to expose the docking device 10 and, in some examples, deploy an expandable cannula of the docking device 10.

[0103] After deploying and / or implanting the docking device 10, the user can separate and / or otherwise disconnect the docking device delivery device 18 from the docking device 10, for example, by cutting a line sutured to the docking device 10. As just one example, the user can utilize the cutting mechanism of the suture lock assembly 40 to cut the line. Once the docking device 10 is disconnected 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, such that the user can deliver and implant the THV at the mitral valve 12. For example, the docking device 10 and the THV can be delivered on two different separate delivery devices, and thus the user may need to remove the docking device delivery device 18 from the patient 16 to make room for the THV delivery device. As another example, the user may need to remove the docking device delivery device 18 from the patient 16 to load the THV onto the delivery device. In either example, the user may need to remove the docking device delivery device 18 from the patient 16 before implanting the THV.

[0104] Figure 2A A second stage in the mitral valve replacement procedure is shown, where the docking device 10 has been fully deployed and implanted at the mitral valve 12, and the docking device delivery device 18 (including the delivery shaft 20) has been removed from the patient 16, such that only the guide wire 46 and the introducer device 44 remain inside the patient 16. The introducer device 44 can remain inside the patient 16 to assist in the percutaneous insertion of the THV and the valve delivery device into the patient 16, while the guide wire 46 can remain within the patient's vasculature to assist in advancing the THV and the valve delivery device through the patient's vasculature. Specifically, the guide wire 46 can ensure that the THV and the valve delivery device do not perforate the walls of the blood vessel 42 and / or other vasculature tissue as they are advanced through the patient's vasculature. In some examples, the user can advance the guide wire 46 through the mitral valve 12 and into the left ventricle 56 to ensure that the guide wire 46 guides the THV and the valve delivery device all the way to the mitral valve 12 and into the docking device 10.

[0105] As Figure 2A shown, the docking device 10 can be configured to wrap around the ventricular side of the leaflets of the mitral valve 12 and radially squeeze the leaflets inward (i.e., radially compress the leaflets) 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 can be configured to reduce the size of the opening of the mitral valve 12 and / or change the shape of the opening to more closely match the cross-sectional shape and / or profile of the THV (e.g., make the opening more circular for a cylindrical THV). By constricting the mitral valve 12 in this manner, the docking device 10 can provide a tighter fit between the THV and the mitral valve 12 and thus a better seal.

[0106] Figure 2BDepicts the third stage in a mitral valve replacement procedure, in which a user delivers and / or implants a prosthetic heart valve 54 (which may also be referred to herein as a "heart valve", "transcatheter prosthetic heart valve", or abbreviated "THV", "replacement heart valve", and / or "prosthetic mitral valve") within a docking device 10 and / or at the mitral valve 12 using a prosthetic heart valve delivery device 58. Thus, the docking device 10 and the prosthetic heart valve 54 can be delivered on different delivery devices at different stages in the mitral valve replacement procedure. Specifically, the docking device 10 can be delivered to the mitral valve 12 using a docking device delivery device 18 during the first stage of the mitral valve replacement procedure, and then the prosthetic heart valve 54 can be delivered using the prosthetic heart valve delivery device 58.

[0107] The prosthetic heart valve delivery device 58 includes a delivery shaft 60 and a handle 62 coupled to the proximal end 64 of the delivery shaft 60. The delivery shaft 60 is configured to extend into a patient's vasculature to deliver, implant, expand, and / or otherwise deploy the prosthetic heart valve 54 within the docking device 10 at the mitral valve 12. The handle 62 can be the same as or similar to the handle 22 of the docking device delivery device 18 and is similarly configured to be grasped and / or otherwise held by a user to advance the delivery shaft 60 through the patient's vasculature.

[0108] In some examples, the handle 62 can include one or more articulating members 66, which are configured to assist in navigating the delivery shaft 60 through the patient's vasculature. Specifically, the articulating members 66 can include one or more of knobs, buttons, wheels, and / or other types of physically adjustable control members configured to be adjusted by a user to flex, bend, twist, turn, and / or otherwise articulate the distal end 68 of the delivery shaft 60 to assist in navigating the delivery shaft 60 through the patient's vasculature.

[0109] In some examples, the prosthetic heart valve delivery device 58 can include an expansion mechanism 70, which is configured to radially expand and deploy the prosthetic heart valve 54. For example, the expansion mechanism 70 can include an inflatable balloon configured to inflate to radially expand the prosthetic heart valve 54 within the docking device 10. The expansion mechanism 70 can be included within and / or coupled to the delivery shaft 60 at and / or near the distal end 68 of the delivery shaft 60. In other examples, the prosthetic heart valve 54 can be self-expanding and can be configured to radially expand on its own without the expansion mechanism 70. In other examples, the prosthetic heart valve 54 can be mechanically expandable, and the prosthetic heart valve delivery device 58 can include one or more mechanical actuators configured to radially expand the prosthetic heart valve 54.

[0110] The prosthetic heart valve 54 may be coupled to the delivery shaft 60 at and / or near the distal end 68 of the delivery shaft 60. In an example where the prosthetic heart valve delivery device 58 includes an expansion mechanism 70, the prosthetic heart valve 54 may be mounted on the expansion mechanism 70 in a radially compressed configuration. In some examples, the prosthetic heart valve 54 may be removably coupled to the delivery shaft 60 such that after the prosthetic heart valve 54 is radially expanded and deployed from the prosthetic heart valve delivery device 58, the prosthetic heart valve delivery device 58 may be retracted away from the implanted prosthetic heart valve 54 and removed from the patient 16.

[0111] The prosthetic heart valve 54 is configured to be received and / or retained within the docking device 10. That is, the docking device 10 is configured to receive the prosthetic heart valve 54 and assist in anchoring the prosthetic heart valve 54 to the mitral valve 12. As will be explained in further detail below, the docking device 10 is also configured to provide a seal between the prosthetic heart valve 54 and the leaflets of the mitral valve to reduce paravalvular leakage around the prosthetic heart valve 54. Specifically, as described above, the docking device 10 may initially contract the leaflets of the mitral valve 12. Then, when the prosthetic heart valve 54 is radially expanded within the docking device 10 (e.g., via inflation of the expansion mechanism 70), the prosthetic heart valve 54 may push the leaflets against the docking device 10. Thus, the docking device 10 and the prosthetic heart valve 54 may be configured to clamp the leaflets of the mitral valve 12 when the prosthetic heart valve 54 is expanded within the docking device 10. In this way, the docking device 10 may provide a seal between the leaflets of the mitral valve 12 and the prosthetic heart valve 54.

[0112] In some examples, one or more of the docking device delivery device 18, the prosthetic heart valve delivery device 58, and / or the introducer device 44 may include one or more flush ports 72 configured to supply a flush fluid to its lumen (e.g., the delivery shaft 20 of the docking device delivery device 18, the delivery shaft 60 of the prosthetic heart valve delivery device 58, and / or the lumen of the introducer device 44) to prevent and / or reduce the likelihood of blood clot (e.g., thrombus) formation. Figure 1 )

[0113] As when delivering the docking device 10, the user may insert the prosthetic heart valve delivery device 58 (e.g., the delivery shaft 60) into the patient 16 by advancing the prosthetic heart valve delivery device 58 through the introducer device 44 and advancing over the guidewire 46. The user may continue to advance the prosthetic heart valve delivery device 58 along the guidewire 46 (through the patient's vasculature) until the prosthetic heart valve delivery device 58 reaches the mitral valve 12, as Figure 2BAs shown. Specifically, a user can advance the delivery shaft 60 of the prosthetic heart valve delivery device 58 by grasping the handle 62 of the prosthetic heart valve delivery device 58 and applying a force on the handle 62 (e.g., pushing the handle 62). When advancing the delivery shaft 60 through the patient's vasculature, the user can adjust one or more articulating members 66 of the handle 62 to navigate various turns, corners, constrictions, and / or other obstacles in the patient's vasculature.

[0114] The user can advance the delivery shaft 60 along the guide wire 46 until the prosthetic heart valve 54 and / or the expansion mechanism 70 is positioned / set within the docking device 10 and / or the mitral valve 12. For example, the user can advance the delivery shaft 60 along the guide wire 46 until the delivery shaft 60 extends through the mitral valve 12 such that the distal end 68 of the delivery shaft 60 is positioned / set within the left ventricle 56. Once the prosthetic heart valve 54 is properly positioned / set within the docking device 10, the user can radially expand the prosthetic heart valve 54 to its fully expanded position or configuration, such as by using the expansion mechanism 70. In some examples, the user can lock the prosthetic heart valve 54 in its fully expanded position (e.g., using a locking mechanism) to prevent the valve from collapsing. After expanding and deploying the prosthetic heart valve 54, the user can separate and / or otherwise disconnect the delivery shaft 60 from the prosthetic heart valve 54 and remove the delivery shaft 60 from the patient.

[0115] Although Figure 1-2B a mitral valve replacement procedure is specifically depicted, 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). Additionally, the same and / or similar delivery devices (e.g., the docking device delivery device 18, the prosthetic heart valve delivery device 58, the introducer device 44, and / or the guide wire 46), docking devices (e.g., the docking device 10), replacement heart valves (e.g., the prosthetic heart valve 54), and / or their components can be used to replace these other heart valves.

[0116] For example, when replacing the native tricuspid valve, the user can also access the right atrium 50 via the femoral vein and may not have to cross the atrial septum 52 to enter the left atrium 48. Alternatively, the user can leave the guidewire 46 in the right atrium 50 and perform the same and / or similar docking device implantation procedure at 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, release the remainder of the docking device 10 from the delivery shaft 20 within 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 prosthetic heart valve implantation procedure at the tricuspid valve within the docking device 10. Specifically, the user can advance the delivery shaft 60 of the prosthetic heart valve delivery device 58 along the guidewire 46 through the patient's vasculature until the prosthetic heart valve 54 is positioned / set within the docking device 10 and the tricuspid valve. Then, the user can expand the prosthetic heart valve 54 within the docking device 10 before removing the prosthetic heart valve delivery device 58 from the patient 16. In another example, the user can perform the same and / or similar procedure to replace the aortic valve, but can access the aortic valve from the outflow side of the aortic valve via the femoral artery.

[0117] In addition, although Figure 1-2B a mitral valve replacement procedure via the left atrium 48 into the mitral valve 12 via the right atrium 50 and femoral vein is depicted, it should be understood that the mitral valve 12 can alternatively be accessed from the left ventricle 56. For example, the user can access the mitral valve 12 from the left ventricle 56 via the aortic valve by advancing one or more delivery devices through an artery to the aortic valve and then through the aortic valve into the left ventricle 56.

[0118] Figure 3 An example of a docking device 100 configured to receive a prosthetic heart valve is shown. For example, the docking device 100 can be implanted within the native annulus, as described above with reference to Figure 1 and 2A . As depicted in Figure 1-2B , the docking device 100 can be configured to receive and fix the prosthetic valve within the docking device, thereby fixing the prosthetic valve at the native annulus.

[0119] Referring to Figure 3, the docking device 100 may include two main components: a coil 102 and a protective member 104 that covers at least a portion of the coil 102. In some examples, the coil 102 may include a shape memory material (e.g., nitinol) such that the docking device 100 (and the coil 102) can move from a substantially straight configuration (also referred to as a "delivery configuration") when disposed within a delivery cannula (e.g., cannula shaft) of a delivery device (as described more fully below) to a helical configuration (also referred to as a "deployment configuration") after being removed from the delivery cannula (e.g., cannula shaft), as Figure 3 shown.

[0120] The coil 102 has a proximal end 102p and a distal end 102d. When disposed within the delivery cannula (e.g., during delivery of the docking device into a patient's vasculature), the body of the coil 102 between the proximal end 102p and the distal end 102d may form a generally straight delivery configuration (e.g., without any coiled or looped portions) to maintain a small radial profile when moving through the patient's vasculature. After being removed from the delivery cannula and deployed at the implant location, the coil 102 may move from the delivery configuration to a helical deployment configuration and wrap around native tissue near the implant location. For example, when implanting the docking device at the location of a native valve, the coil 102 may be configured to surround the native leaflets of the native valve (and the chordae tendineae that connect the native leaflets to adjacent papillary muscles, if present).

[0121] The docking device 100 may be releasably coupled to the delivery device. In some examples, the docking device 100 may be coupled to the delivery device via a release suture that may be configured to be tied to the docking device 100 and cut for removal (as described further below with reference to Figure 4 and 11 ). In one example, the release suture may be tied to the docking device 100 through an eyelet or eyehole located near the proximal end 102p of the coil. In another example, the release suture may be tied around a circumferential recess located near the proximal end 102p of the coil 102.

[0122] In some examples, the docking device 100 in the deployment configuration may be configured to fit in the mitral valve position. In other examples, the docking device may also be shaped and / or adapted to be implanted at other native valve positions, such as at the tricuspid valve. In some examples, the geometry of the docking device 100 may be configured to engage native anatomy, which may, for example, provide increased stability between the docking device 100, a prosthetic valve docked therein, and / or the native anatomy and a reduction in relative movement. This reduction in relative movement may in particular prevent material degradation of components of the docking device 100 and / or a prosthetic valve docked therein and / or prevent damage or trauma to native tissue.

[0123] As Figure 3 shown, the coil 102 in the deployed configuration may include a front turn 106 (or "front coil"), a central region 108, and a stabilizing turn 110 (or "stabilizing coil"). The central region 108 may comprise one or more helical turns having substantially equal inner diameters. The front turn 106 may extend from the distal end of the central region 108 and have a diameter greater than the diameter of the central region 108 (in one or more configurations). The stabilizing turn 110 may extend from the proximal end of the central region 108 and have a diameter greater than the diameter of the central region 108 (in one or more configurations).

[0124] In some examples, the central region 108 may include a plurality of helical turns, such as a proximal turn 108p connected to the stabilizing turn 110, a distal turn 108d connected to the front turn 106, and one or more intermediate turns 108m disposed between the proximal turn 108p and the distal turn 108d. In Figure 3 the example shown, there is only one intermediate turn 108m between the proximal turn 108p and the distal turn 108d. In other examples, there may be more than one intermediate turn 108m between the proximal turn 108p and the distal turn 108d. Some of the helical turns in the central region 108 may be full turns (i.e., rotated 360 degrees). In some examples, the proximal turn 108p and / or the distal turn 108d may be partial turns (e.g., rotated less than 360 degrees, such as 180 degrees, 270 degrees, etc.).

[0125] The size of the docking device 100 may generally be selected based on the size of the desired prosthetic valve to be implanted in a patient. In some examples, the central region 108 may be configured to hold a radially expandable prosthetic valve. For example, the inner diameter of the helical turns in the central region 108 may be configured to be less than the outer diameter of the prosthetic valve when the prosthetic valve is radially expanded, such that additional radial tension may act between the central region 108 and the prosthetic valve to hold the prosthetic valve in place. The helical turns (e.g., 108p, 108m, 108d) in the central region 108 are also referred to herein as "functional turns".

[0126] The stabilizing turn 110 can be configured to help stabilize the docking device 100 in a desired position. For example, the radial dimension of the stabilizing turn 110 can be significantly larger than the radial dimension of the coils in the central region 108 such that the stabilizing turn 110 can fully open or extend outwardly to abut or push against the wall of the circulatory system, thereby improving the ability of the docking device 100 to remain in its desired position prior to implanting a prosthetic valve. In some examples, the diameter of the stabilizing turn 110 is desirably greater than the annulus, the native valve plane, and the atrium for better stabilization. In some examples, the stabilizing turn 110 can be a full turn (i.e., rotating approximately 360 degrees). In some examples, the stabilizing turn 110 can be a partial turn (e.g., rotating between approximately 180 degrees and 270 degrees).

[0127] In one particular example, when the docking device 100 is implanted in the native mitral valve position, the functional turns in the central region 108 can be disposed substantially within the left ventricle, while the stabilizing turn 110 can be disposed substantially within the left atrium. The stabilizing turn 110 can be configured to provide one or more contact points or regions between the docking device 100 and the left atrial wall, such as at least three contact points within the left atrium or full contact on the left atrial wall. In certain examples, the contact points between the docking device 100 and the left atrial wall can form a plane that is generally parallel to the plane of the native mitral valve.

[0128] As described above, the front turn 106 can have a larger radial dimension than the helical turns in the central region 108. The front turn 106 can help more easily guide the coil 102 around and / or through the chordal geometry and fully around all of the native leaflets of the native valve (e.g., native mitral valve, tricuspid valve, etc.). For example, once the front turn 106 is navigated around the desired native anatomy, the remaining coils of the docking device 100 (such as the functional turns) can also be guided around the same features. In some examples, the front turn 106 can be a full turn (i.e., rotating approximately 360 degrees). In some examples, the front turn 106 can be a partial turn (e.g., rotating between approximately 180 degrees and 270 degrees). In some examples, when the prosthetic valve radially expands within the central region 108 of the coil, the functional turns in the central region 108 can further radially expand. Thus, the front turn 106 can be pulled in the proximal direction and become part of the functional turns in the central region 108.

[0129] In some examples, at least a portion of the coil 102 can be surrounded by a first covering. The first covering can be composed of various native and / or synthetic materials. In a particular example, the first covering can include expanded polytetrafluoroethylene (ePTFE). In some examples, the first covering is configured to be fixedly attached to the coil 102 (e.g., by means of textured surface resistance, sutures, glue, heat bonding, or any other means) such that relative axial movement between the first covering and the coil 102 is restricted or prohibited.

[0130] The protective member 104 can form part of a covering assembly for the docking device 100. In some examples, the covering assembly can also include the first covering.

[0131] In a typical example as Figure 3 shown, when the docking device 100 is in a deployed configuration, the protective member 104 can be configured to cover a portion of the stable turns 110 of the coil 102. In some examples, the protective member 104 can be configured to cover at least a portion of the central region 108 of the coil 102, such as a portion of the proximal turns 108p. In some examples, the protective member 104 can extend over the entire coil 102.

[0132] In some examples, the protective member 104 can expand radially to help prevent and / or reduce paravalvular leakage. Specifically, the protective member 104 can be configured to expand radially such that an improved seal is formed closer to and / or against a prosthetic valve deployed within the docking device 100. In some examples, the protective member 104 can be configured to prevent and / or inhibit leakage at a location where the docking device 100 passes between the leaflets of the native valve (e.g., at the commissure of the native leaflets).

[0133] In another example, when the docking device 100 is deployed at a native atrioventricular valve and the protective member 104 primarily covers a portion of the stable turns 110 and / or a portion of the central region 108, the protective member 104 can help cover the atrial side of the atrioventricular valve to prevent and / or inhibit blood leakage through the native leaflets, commissures, and / or around the exterior of the prosthetic valve by preventing blood in the atrium from flowing in the atrium-to-ventricle direction (i.e., antegrade blood flow) rather than through the prosthetic valve.

[0134] In some examples, the protective member 104 can be positioned on the ventricular side of the atrioventricular valve to prevent and / or inhibit blood leakage through the native leaflets, commissures, and / or around the exterior of the prosthetic valve by preventing blood in the ventricle from flowing in the ventricle-to-atrium direction (i.e., retrograde blood flow).

[0135] In some examples, the distal portion 104d of the protective member 104 may be fixedly coupled to the coil 102 (e.g., via a distal suture), and the proximal portion 104p of the protective member 104 may be axially movable relative to the coil 102.

[0136] In certain examples, when the protective member 104 is in a radially expanded state, the proximal portion 104p of the protective member 104 may have a tapered shape as Figure 3 shown, such that the diameter of the proximal portion 104p gradually increases from the proximal end of the protective member 104 to the distally located body portion of the protective member 104. This can, for example, help facilitate loading of the docking device into the delivery cannula (e.g., cannula shaft) of the delivery device and / or retrieving and / or repositioning the docking device into the delivery device during an implantation procedure.

[0137] Figure 4-11 An example of a delivery device (which may also be referred to as a delivery system) 220 is illustrated that is 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 native valve of an animal, human, cadaver, cadaver heart, anthropomorphic phantom, etc.). In some examples, the delivery device 220 may be a transcatheter delivery device that can be used to guide the delivery of the docking device through a patient's vasculature, as explained above with reference to Figure 1 and 2A .

[0138] In Figure 4 an exemplary delivery device 220 is shown, in which the docking device 232 is at least partially deployed from the distal end of the delivery device 220 (e.g., for illustrative purposes). In some examples, 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 that extends distally from the handle assembly 200. The handle assembly 200 may include a handle 222 and a hub assembly 230 that extends proximally from the handle 222. A more detailed view of the hub assembly 230 is shown in Figure 5 , as further described below. Additionally, Figure 6 and 7 are cross-sectional views illustrating examples of the internal components of the hub assembly 230 and the flow of flushing fluid through the internal components of the hub assembly 230. Figure 8 and 9A illustrate the internal components of the delivery device 220 distal to the handle assembly 200 (including the distal portion of the delivery device 220 ( Figures 9A-9B ) and the portion of the delivery device 220 disposed between the distal portion and the hub assembly 230 ( Figure 8) the flow of the flushing fluid.

[0139] As Figure 4 shown, the handle assembly 200 can include a handle 222, and the handle 222 includes one or more knobs, buttons, wheels, etc. For example, as Figure 4 shown, the handle 222 can include knobs 224 and 226, and the knobs 224 and 226 can be configured to control the deflection of the delivery system (e.g., the outer shaft 260). The outer shaft 260 extends distally from the handle 222, and the hub assembly 230 extends proximally from the handle 222. Further details regarding delivery systems and devices (such as the delivery device 220) configured to deliver a docking device to a target implantation site can be found in U.S. Patent Publication Nos. US2018 / 0318079, US2018 / 0263764, and US2018 / 0177594, which are hereby incorporated by reference in their entirety.

[0140] During the delivery of some docking devices at the target implantation site, there is a possibility that the docking device is captured, stuck, and / or blocked by parts of the native anatomy (such as the heart wall, trabeculae, native leaflets, chordae tendineae, etc.). This may be due to various factors, such as the frictional force between the docking device and the native anatomy, the distal end or tip of the docking device being captured in the trabeculae and / or chordae tendineae of the native anatomy, the dimensional difference between the inner diameter of the functional turn of the docking device and the outer diameter of the native leaflet, etc.

[0141] Some docking devices can have a woven or braided texture and / or covering on the outer surface of the docking device to increase friction (e.g., to enhance the holding force between the docking device and the prosthetic valve deployed and implanted therein, as described above with reference to Figure 2B ). However, when advancing the docking device around and / or through the native anatomy, this friction may cause difficulties (e.g., such as increased resistance to the movement of the docking device around the native anatomy and / or the docking device getting stuck or captured on the native anatomy).

[0142] Once the docking device travels into an obstacle (such as a native leaflet, chordae tendineae, and / or trabeculae), a doctor, surgeon, or other medical professional or user may need to retract the docking device into the delivery device (e.g., the delivery device 220) and try to deploy the docking device again. However, due to the texture or fabric on the docking device that frictions and / or captures parts of the tissue and drags it back into the delivery device, this method may cause damage to the native tissue, which may potentially damage or block the delivery device. In addition, this can increase the amount of time for the deployment and implantation procedure.

[0143] To address these challenges, the docking device (e.g., Figure 4The docking device 232) can be configured to have a smooth outer surface during delivery and implantation at the native anatomical structure (e.g., over the entire docking device or at certain portions of the docking device such as functional turns), and to have a higher friction outer surface at least at the functional coil / turns after implantation and during subsequent deployment of the prosthetic valve therein.

[0144] In some examples, this can be achieved using a removable smooth cannula or sheath that can be placed over the docking device during delivery and that can be retracted from the docking device after the docking device is in the desired position / orientation at the implantation site. In some examples, a smooth or low friction cannula / sheath can be incorporated into the delivery device (such as Figure 4 the delivery device 220).

[0145] For example, the delivery device 220 can include a pusher shaft 290 ( Figure 4-11 ) and a cannula shaft 280 ( Figure 5-11 ) that are coaxially located within an outer shaft 260 and each have a portion extending into the handle assembly 200. The pusher shaft 290 can be configured to deploy the docking device 232 from within the distal portion of the outer shaft 260 upon reaching the target implantation site, and the cannula shaft 280 can be configured to cover the docking device 232 ( Fig.11 ) when within the delivery device 220 and when positioned at the target implantation site. Additionally, the delivery device 220 can be configured to adjust the axial position of the cannula shaft 280 to remove the cannula portion (e.g., distal section) of the cannula shaft 280 from the docking device 232 after implantation at the target implantation site, as further explained below. Fig.10 and 11 are perspective views showing an exemplary docking device 232 deployed from the outer shaft 260 of the delivery device 220 and covered by the distal (or cannula) portion 282 of the cannula shaft 280 ( Fig.10 ) and an exemplary docking device 232 after the cannula shaft 280 has been retracted into the outer shaft 260 ( Fig.11 ).

[0146] As Figure 4 and 11 shown, during delivery, the docking device 232 can be coupled to the delivery device 220 via a release suture 236 that can extend through the pusher shaft 290 (or other retrieval lines including string, yarn, or other materials that can be configured to be tied around the docking device and cut for removal). As further explained below with reference to Figure 5 , the release suture 236 can extend through the delivery device 220, through the lumen of the pusher shaft 290, to the suture lock assembly 206 of the delivery device 220.

[0147] As Figure 4 and 5 shown, the hub assembly 230 can include a suture lock assembly (such as a suture lock) 206 and a cannula handle attached thereto. In Figure 4 a first example of the cannula handle 234 is shown, and in Figure 5 a second example of the cannula handle 208 is shown. The hub assembly 230 can be configured to control the pusher shaft 290 and the cannula shaft 280 of the delivery device 220 together (e.g., to move them axially together), while the cannula handle ( Figure 4 the cannula handle 234 in Figure 5 and Figure 4 and 5 the cannula handle 208 in) can control the axial position of the cannula shaft 280 relative to the pusher shaft 290. In this way, the operation of the various components of the handle assembly 200 can actuate and control the operation of the components disposed within the outer shaft 260. In some examples, as

[0148] shown in International Patent Application No. PCT / US20 / 36577, further details regarding the suture lock assembly and the pusher shaft and cannula shaft assemblies of the delivery device for the docking device are described, which are incorporated herein by reference in their entirety. Additionally, further examples of the pusher shaft for a delivery device (such as the delivery device 220) are described below with reference to Figure 29-43 As

[0149] shown Figure 4-7 and further described below, the handle assembly 200 can also include one or more flush ports to supply a flush fluid to one or more lumens disposed within the delivery device 220 (e.g., an annular lumen disposed between coaxial components of the delivery device 220) to reduce potential thrombus formation. In Figure 4 , 6 and 7, an example is shown in which the delivery device 220 includes three flush ports (e.g., flush ports 210, 216, and 218). In an alternative example, the delivery device 220 may not include the flush port 216 (e.g., as Figure 5 and 23 shown and further described below).

[0150] Figure 5 An example of the hub assembly 230 for the delivery device 220 is shown in more detail. In some examples, as Figure 5As shown, the hub assembly 230 may include a Y-shaped connector (e.g., an 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 more than one branch). In some examples, a suture lock assembly (e.g., a suture lock) 206 may be attached to the branch 204, and a cannula handle (e.g., a cannula actuation handle) 208 may be disposed at the proximal end of the straight section 202.

[0151] The hub assembly 230 may be adapted and configured to allow the proximal extension 291 of the pusher shaft 290 (or another similar pusher shaft) to extend into the suture lock assembly 206 disposed at the end of the branch 204, while the cutting portion 288 (which may also be referred to as the proximal portion) of the cannula shaft 280 extends into the cannula handle 208 disposed at the end of the straight section 202. In this configuration, a medical professional may perform the deployment of the docking device (e.g., Figure 4 the docking device 232) by manipulating the position of the handle assembly 200 (e.g., moving it in the axial direction), and may also perform the retraction of the cannula shaft 280 (away from and distal to the implanted docking device) by pulling the cannula handle 208 backward in the axial direction.

[0152] In this way, the cannula shaft 280 and the pusher shaft 290 may be configured to work together such that they can move together simultaneously (e.g., by moving the entire hub assembly 230 forward and / or backward in the axial direction) when the docking device is deployed and positioned at the native valve, but may also move independently, so that the pusher shaft 290 can hold the docking device in place when the cannula shaft 280 is retracted away from the docking device (e.g., by holding the hub assembly 230 in place relative to the outer shaft 260 of the delivery device and / or other parts of the delivery device and / or the docking device when pulling the cannula shaft 280 proximally to withdraw the cannula shaft 280). As described above and as Fig.34 and 35 shown, the cannula shaft 280 and the pusher shaft 290 may be coaxial along some, all, or most of the delivery device 220, as further described below, to facilitate this cooperative interaction.

[0153] As described above and as Figure 4-7 shown, the handle assembly 200 may include one or more irrigation or fluid ports, such as one or more of the irrigation ports 210, 216, and 218, which are configured to receive fluid and provide the received fluid to a selected lumen (e.g., an annular space) between axially extending and coaxial components of the delivery device 220. For example, Figure 4-7The configuration of the irrigation port shown and the various other flow system examples described in detail herein can enable irrigation and / or a constant flow of fluid through a selected lumen of the delivery device 220 during an implantation procedure to reduce or prevent thrombus formation between components, including around the docking device.

[0154] For example, as Fig.9A (which is a schematic illustration of the distal portion of the delivery device 220) shown, the various lumens formed between the docking device 232, the pusher shaft 290, the cannula shaft 280, and the outer shaft 260 are configured to receive fluid during the delivery and implantation procedures.

[0155] A first pusher shaft lumen 201 can be formed inside the pusher shaft (e.g., inside the main tube 292 of the pusher shaft 290). The pusher shaft lumen 201 can receive fluid from a first fluid source that can be fluidly coupled to a portion of the handle assembly (e.g., branch 204, further described below). The irrigation fluid flow 203 through the pusher shaft lumen 201 can travel along the length of the main tube 292 of the pusher shaft 290 to the distal end 293 of the pusher shaft 290. When the distal end 293 of the pusher shaft 290 is spaced from the proximal end of the docking device 232 (as Fig.9A shown), at least a portion of the irrigation fluid flow 203 can flow into a first portion 205 of a second cannula shaft lumen 211 as an irrigation fluid flow 207, the second cannula shaft lumen 211 being disposed between the outer surface of the docking device 232 and the inner surface of the distal section 282 of the cannula shaft 280. Additionally, in some examples, a portion of the irrigation fluid flow 203 can also flow into a second portion 209 of the cannula shaft lumen 211 as an irrigation fluid flow 213, the second portion 209 being disposed between the outer surface of the pusher shaft 290 and the inner surface of the cannula shaft 280. In this way, the same first fluid source can provide irrigation fluid via the pusher shaft lumen 201 to each of the pusher shaft lumen 201, the first portion 205 of the cannula shaft lumen 211, and the second portion 209 of the cannula shaft lumen 211.

[0156] Also as Fig.9A shown, a third delivery shaft lumen 215 can be formed in an annular space formed between the inner surface of the outer shaft 260 and the outer surface of the cannula shaft 280. The delivery shaft lumen 215 can receive fluid from one or more second fluid sources and / or the first fluid source, the one or more second fluid sources being fluidly coupled to a portion of the handle assembly (e.g., branch 204 and / or handle 222, further described below). Fluid from one or more of these sources can cause an irrigation fluid flow 217 to flow through the delivery shaft lumen 215 to the distal end of the outer shaft 260.

[0157] During deployment of the docking device 232 from the delivery device 220 and implantation of the docking device 232 at the target implantation site, providing fluid (e.g., flushing fluid) to the lumen can reduce or prevent thrombus formation on and around the docking device 232 and other concentric parts of the delivery device 220.

[0158] Figure 4-7 Illustrates a possible fluid (e.g., flushing) port arrangement configured to provide flushing fluid to the lumen described above with reference to Fig.9A different examples. Additionally, Figure 8 illustrates the flow of flushing fluid through a portion of the delivery device 220 disposed between the hub assembly 230 ( Figure 4-7 ) and the distal portion of the delivery system ( Fig.9A ).

[0159] In a first example of the flushing port arrangement, the handle assembly 200 can include two flushing ports (which may also be referred to herein as fluid ports) disposed on a branch 204 of the hub assembly 230 (which may be referred to as a suture lock branch), one of the two flushing ports providing a flushing fluid flow 203 to the pusher shaft lumen 201 and the other of the two flushing ports providing a flushing fluid flow 217 to the delivery shaft lumen 215. For example, the two flushing ports on the branch 204 can include a first flushing port 210 and a second flushing port 216, the first flushing port 210 being proximal to the second flushing port 216 disposed on the branch 204 ( Figure 6 and 7 ). In some examples, the position of the second flushing port 216 on the branch 204 can be closer to or farther from the first flushing port 210 than Figure 6 and 7 shown. Additionally or alternatively, in some examples, the first flushing port 210 can be disposed at a more proximal position along the branch 204, such as at the free end of the branch 204 and / or coupled to the suture lock assembly 206.

[0160] As Figure 5-7 shown, the first flushing port 210 has an inner flow lumen fluidly connected to the inner lumen 250 in the branch 204. The open proximal end 252 of the proximal extension 291 of the pusher shaft 290 can be fluidly coupled to the inner lumen 250 and / or disposed within the inner lumen 250 (as Figure 5-7 shown). The proximal extension 291 travels through the branch 204 into the straight section 202 of the hub assembly 230 and connects to the main tube 292 of the pusher shaft 290 ( Figure 6 and 7)。Therefore, the pusher shaft lumen 201 is formed by the main tube 292 and the proximal extension 291 and is within the main tube 292 and the proximal extension 291. Thus, the flushing fluid flow 203 from the first flushing port 210 enters the pusher shaft lumen 201 at the proximal end 252 of the proximal extension 291 and continues to enter and pass through the entire main tube 292 of the pusher shaft 290 to the distal end 293 (as Fig.9A shown).

[0161] The second flushing port 216 has an inner flow lumen that is fluidly connected to the elongated space or cavity 254 (which can be annular along at least a portion of the cavity), and the elongated space or cavity 254 surrounds the outside of the proximal extension 291 within the branch 204 and extends into the straight section 202 in the space between the inner surface of the cut portion 288 of the proximal portion 284 of the cannula shaft 280 and the proximal extension 291 ( Figure 6 and 7 ). Thus, the flushing 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, and into the annular cavity 219 ( Figure 6 and Figure 8 ). The flushing fluid flow 217 can flow through the annular cavity 219 and exit the distal end of the housing 294 of the pusher shaft 290 (as Fig.34 and 35 shown (described further below)) to enter the delivery shaft lumen 215.

[0162] In some examples, as Figure 4 and 6 shown, the delivery shaft lumen 215 can have additional flushing fluid from the third flushing port 218 (in addition to the fluid from the second flushing port 216), and the third flushing port 218 is fluidly coupled to the annular cavity 219 downstream (e.g., distally) of the plug 296 of the pusher shaft 290 (further details regarding the components of the pusher shaft 290, including the plug 296 and the housing 294, will be described below with reference to Figure 29-33 ). In this way, in some examples, the supplementary flushing fluid 221 can be combined with the flushing fluid flow 217 ( Figure 6 ) and supplied to the delivery shaft lumen 215.

[0163] In some examples, as Figure 4 and 6 shown, the third flushing port 218 can be arranged on a part of the handle 222. In alternative examples, the third flushing port 218 can be arranged on the handle at a position Figure 4 and 6At a more distal location as shown. In some examples, the third flush port 218 may not be used during the implantation procedure but may be used only to flush the delivery shaft lumen 215 before the delivery device 220 is inserted into the patient.

[0164] In some examples, the delivery device 220 may not include the third flush port 218.

[0165] Various examples of the hub assembly 230, including the first example of the above-described flush port arrangement, may include a washer 223 within the branch 204 between two flush ports on the branch 204 to create separate and distinct fluid flow lumens supplied by the two flush ports on the branch 204 (e.g., the first flush port 210 and the second flush port 216, as Figure 5-7 shown). For example, the washer 223 may be configured as a disk-shaped member having a single (e.g., in some examples, central) hole configured to closely receive the proximal extension 291 therein. The washer 223 may not include any additional holes and may further be configured to provide a seal between the inner lumen 250 and the chamber 254. Thus, all of the flush fluid flow 203 entering the inner lumen 250 from the first flush port 210 may enter the pusher shaft lumen 201 without entering the chamber 254 and flowing to the delivery shaft lumen 215. Similarly, all of the flush fluid flow 217 entering the chamber 254 from the second flush port 216 may enter the annular chamber 219 and the delivery shaft lumen 215.

[0166] In a second example of the flush port arrangement, the handle assembly 200 may include two flush ports disposed on a branch 204 of the hub assembly 230 (which may be referred to as a suture lock branch), one of the two flush ports providing a flush fluid flow 203 to the pusher shaft lumen 201 and the other of the two flush ports providing a flush fluid flow 217 to the delivery shaft lumen 215. However, in the second example, the flush port providing the flush fluid flow 203 to the pusher shaft lumen 201 may be disposed at the proximal end of the branch 204 at the end of the suture lock assembly 206.

[0167] Examples of flush port arrangements having multiple flush ports, such as the first and second examples described above, may be supplied with flush fluid independently (e.g., using two separate fluid supply sources) or may be supplied with flush fluid together using a common fluid supply source. For example, in some examples, each flush port (e.g., the first flush port 210 and the second flush port 216) may be supplied with flush fluid from two separate infusion pumps (one infusion pump fluidly coupled to each of the flush ports) or another set of fluid sources. In an alternative example, a single infusion device (e.g., a pump) 225 may be connected to multiple flush ports, such as through a Y-connector 227 that connects a single fluid line to the multiple flush ports, as Figure 6 as shown

[0168] In some cases, it may be desirable to provide a constant flow of fluid (e.g., a flushing fluid such as a heparinized saline solution) through each of the pusher shaft lumen 201 and the delivery shaft lumen 215 in order to avoid stagnation of the fluid within the delivery device 220 that may lead to thrombus formation in some cases. In some cases, if a thrombus is displaced during implantation of the docking device, the thrombus may contribute to patient complications. Additionally, the thrombus can increase the force experienced during removal of the distal portion of the cannula shaft 280 from the docking device due to the increased friction between the cannula shaft 280 and the docking device.

[0169] Accordingly, in the case of two dedicated flushing or fluid ports (the flushing port 210 and the flushing port 216 as described above), it may be desirable to separately control the flow of fluid into each of the two fluid ports to ensure a relatively constant or constant flow through the pusher shaft lumen 201 and the delivery shaft lumen 215. As an example, two separate infusion devices (e.g., pumps) can be used to provide a flushing fluid at a specified flow rate to the pusher shaft lumen 201 and the delivery shaft lumen 215. However, such a configuration may be more complex to control and increase the procedural cost and / or setup time compared to controlling only a single device. If only a single flow supply (e.g., an infusion device) is used for the two flushing ports, the amount of fluid entering each flushing port is not controlled but rather depends on the resistance in each flow lumen (e.g., the pusher shaft lumen 201 and the delivery shaft lumen 215). However, the resistance in each of the pusher shaft lumen 201 and the delivery shaft lumen 215 and the resistance ratio between each of the pusher shaft lumen 201 and the delivery shaft lumen 215 may change during the procedure. In some examples, the pusher shaft lumen 201 may have an increased resistance relative to the delivery shaft lumen 215. Thus, the flow from a single fluid source may preferentially flow through the delivery shaft lumen 215, increasing the risk of thrombus formation within the pusher shaft lumen 201 and / or the cannula shaft lumen 211.

[0170] Accordingly, in some examples, it may be desirable to balance or equalize the flow rates of fluid entering each of the two flushing ports (e.g., the first flushing port 210 and the second flushing port 216) and passing through each of the corresponding lumens (e.g., the pusher shaft lumen 201 and the delivery shaft lumen 215) such that a target flow rate that can reduce or prevent thrombus formation is achieved in all of the flow lumens of the delivery device. Referring below to Figure 12-22Discuss examples of flow mechanisms configured to provide a consistent flow rate ratio between two or more flow paths (e.g., a first flush port 210 to a pusher shaft lumen 201 and a second flush port 216 to a delivery shaft lumen 215). Thus, a consistent relative flow rate of fluid between two flush ports can be achieved independent of fluctuating resistances in each of the flow paths (e.g., pusher shaft lumen 201 and delivery shaft lumen 215).

[0171] As used herein, "flow rate ratio" can be defined as the ratio of a first flow rate of fluid through a first flow path to a first flow rate of fluid through a second flow path. Thus, although the individual flow rates can vary, the ratio of the first flow rate to the second flow rate can be maintained at a constant or consistent ratio, as further described herein.

[0172] Now turning to Figure 12-22 , examples of mechanical flow mechanisms are configured to maintain a consistent relative flow rate (or flow rate ratio) between two or more flow paths independent of varying resistances of the two or more flow paths. In some examples, the flow mechanism examples described below with reference to Figure 12-22 can be used to control the flow of fluid into two or more flow lumens (such as the pusher shaft lumen and the delivery shaft lumen of a delivery device 220 (as Figure 5-9A shown)) of a delivery device for an implantable device. In some examples, the flow mechanism examples described below with reference to Figure 12-22 can be used to control the flow of fluid through two or more flow paths (e.g., two or more parallel flow paths such as in an alternative flow system) in an alternative flow system.

[0173] Figure 12-14 FIG. shows an example of a flow mechanism 300 configured to maintain a consistent relative flow rate (e.g., a consistent flow rate ratio) between two or more flow paths. Fig.12 FIG. shows a top perspective view of the flow mechanism 300, Fig.13 FIG. shows a side perspective view of the flow mechanism 300, and Fig.14 FIG. shows a top view of the flow mechanism 300, which also shows the flow of fluid through the flow mechanism 300.

[0174] The flow mechanism 300 includes 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.

[0175] For example, as Figure 12-14As shown, the housing 302 includes a first end portion 320, a second end portion 322, and a center portion 324 disposed between the first end portion 320 and the second end portion 322. In some examples, the first end portion 320 may include two or more conduits (e.g., outlets or outlet conduits) 326 (in Figure 12-14 The example shows two outlet end portions (such as Fig.14 ), the two or more conduits (e.g., outlets or outlet conduits) 326 are configured to direct flow away from the corresponding blade gears and out of the flow mechanism 300. The second end portion 322 may include two or more conduits (e.g., inlet or inlet conduits) 328 (in Figure 12-14 In the example of the embodiment of the present invention, two (two) inlet end portions are shown, and the two or more conduits (e.g., inlet or inlet conduits) 328 are configured to receive flow from a fluid source and direct the flow to corresponding blade gears. However, in alternative examples, conduit 326 can be alternatively configured as an inlet, and conduit 328 can be alternatively configured as an outlet.

[0176] 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 fluidically isolated from each other (e.g., no flow interaction or mixing occurs between the fluid in the first flow path 304 and the fluid in the second flow path 306).

[0177] The first flow path 304 can be fluidly coupled to a first paddle gear 308 disposed within a central portion 324 of the housing 302. The first flow path 304 is defined by a first internal passage 312 formed in the housing 302 between a first flow inlet opening (also referred to as a flow inlet) 314 and a first flow outlet opening (also referred to as a flow outlet) 316. In some examples, the first internal passage 312 can have a relatively constant inner diameter. In some examples, the first internal passage 312 can have a larger diameter (or step) portion 313 within the first end portion 320 that connects to the first flow outlet opening 316. Thus, a flow connector or conduit of a fluid system or a flow connector or conduit coupled to a fluid system can extend into the first flow outlet opening 316 and the larger diameter portion 313 of the first internal passage 312, thereby coupling the flow mechanism 300 to a conduit or flow path of a fluid system that is configured to receive a metered volume of fluid from the first flow path 304.

[0178] Similarly, the second flow path 306 can be fluidly coupled to a second paddle gear 310 disposed within a central portion 324 of the housing 302. The second flow path 306 is defined by a second internal passage 330 formed in the housing 302 between a second flow inlet opening (also referred to as a flow inlet) 332 and a second flow outlet opening (also referred to as a flow outlet) 334. In some examples, the second internal passage 330 can have a relatively constant inner diameter. In some examples, the second internal passage 330 can have a larger diameter (or stepped) portion 331 within a first end portion 320, the larger diameter (or stepped) portion 331 being connected to the second flow outlet opening 334. Thus, a flow connector or pipe of the fluid system or a flow connector or pipe coupled to the fluid system can extend into the second flow outlet opening 334 and the larger diameter portion 331 of the second internal passage 330, thereby coupling the flow mechanism 300 to a pipe or flow path of a fluid system configured to receive a metered volume of fluid from the second flow path 306.

[0179] In some examples, one or both pipes 328 at the second end portion 322 can have a smaller diameter (or stepped) portion 336 configured to receive a flow connector or fluid pipe thereon, thereby coupling the flow mechanism 300 to a flow pipe of a fluid supply or fluid source or to a flow pipe coupled to a fluid supply or fluid source.

[0180] The housing 302 can further define at least two cavities, each cavity being configured to receive a paddle gear. For example, as Figure 12-14 shown, the housing 302 defines a first cavity 338 and a second cavity 340, with the first paddle gear 308 disposed within the first cavity 338 and the second paddle gear 310 disposed within the second cavity 340. The first cavity 338 can be fluidly coupled to the first internal passage 312, and the second cavity 340 can be fluidly coupled to the second internal passage 330. Additionally, as Figure 12-14 shown, the first internal passage 312 (and thus the first flow path 304) can extend on either side of the first cavity 338, and the second internal passage 330 (and thus the second flow path 306) can extend on either side of the second cavity 340. In some examples, the first flow path 304 can extend through the first cavity 338, and the second flow path 306 can extend through the second cavity 340.

[0181] In Figure 12-14 (and for Figure 15-22In other examples shown (similarly), the internal portions of the housing 302 (including the first flow path 304, the second flow path 306, the first chamber 338, and the second chamber 340) are illustrated in dashed lines to indicate their internal orientation relative to the exterior of the housing 302. It should be noted that although the first paddle gear 308 and the second paddle gear 310 are also disposed within the interior of the housing 302, for increased clarity, these components are illustrated in solid lines.

[0182] The first paddle gear 308 includes a first paddle 342 and a first gear 344. The first paddle 342 and the first gear 344 are rotatably coupled to each other and are configured to rotate about a rotational axis 345. In some examples, as Figure 12-14 shown, the first gear 344 includes a plurality of teeth 346 around its circumference. The first paddle 342 may include a plurality of arms 348 that extend radially outward from a central portion 350 of the paddle 342. A chamber 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 the portion of the first chamber 338 where the first paddle 342 is disposed. The volume of the chamber 352 defines a predetermined metered volume of the fluid that the first paddle gear 308 is configured to have flow through the first flow path 304. The volume of the chamber 352 may be defined by the geometry of the first paddle 342. For example, the volume of the chamber 352 may be increased by increasing the length of the arms 348 (e.g., the length defined in the radial direction relative to the rotational axis 345), increasing the height of the arms 348 (and the height of the first paddle 342, e.g., the height defined along a direction parallel to the rotational axis 345), and / or decreasing the width of the arms 348 (e.g., the width defined in the circumferential direction). In this manner, the geometry of the first paddle 342 can be selected based on a specified metered volume of the fluid provided via the first flow path 304 (or a specified flow rate of the fluid, e.g., volume / time). The volume 354 of the fluid in one of the chambers 352 is illustrated in Fig.14 and is further described below.

[0183] Similarly, the second paddle gear 310 includes a second paddle 356 and a second gear 358. The second paddle 356 and the second gear 358 are rotatably coupled to each other and are configured to rotate about a rotational axis 355. In some examples, as Figure 12-14As shown, the second gear 358 includes a plurality of teeth 360 around its circumference. The second blade 356 may include a plurality of arms 362 that extend radially outward from a central portion 364 of the second blade 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 blade 356 and the wall of the portion of the second cavity 340 where the second blade 356 is disposed. The volume of the cavity 366 defines a predetermined metered volume (or flow rate) of the fluid that the second blade gear 310 is configured to have flow through the second flow path 306. The volume of the cavity 366 may be defined by the geometry of the second blade 356, as described above with reference to the first blade 342. Thus, the geometry of the second blade 356 can be selected based on the specified metered volume of the fluid provided via the second flow path 306.

[0184] In some examples, as Figure 12-14 shown, the teeth 346 of the first gear 344 may mesh engage with the teeth 360 of the second gear 358. Thus, the first gear 344 and the second gear 358 can rotate together (e.g., rotation of the first gear 344 can cause rotation of the second gear 358, and vice versa). Thus, as further explained below, the rotation of the first blade gear 308 and the rotation of the second blade gear 310 are related to each other. In some examples, as Fig.14 shown, the first gear 344 may rotate in a first direction 370 (e.g., in Fig.14 this case, counterclockwise), and the second gear 358 may rotate in a second direction 372 (e.g., in Fig.14 this case, clockwise), the second direction 372 being opposite to the first direction 370.

[0185] In other examples, additional gears may be disposed between the first gear 344 and the second gear 358 and mesh engage with each of the first gear 344 and the second gear 358, such that the first gear 344 and the second gear 358 can rotate in the same direction.

[0186] Fig.14 An exemplary flow of fluid through the flow mechanism 300 is illustrated. In Fig.14 this case, the flow of fluid (e.g., a flushing fluid such as heparinized saline and / or another fluid configured to reduce thrombus formation) is shown by arrows 368. As Fig.14As shown, fluid enters the first inner channel 312 and the second inner channel 330 at the first flow inlet opening 314 and the second flow inlet opening 332, respectively. The fluid indicated by arrow 368 then continues through the first flow path 304 and the second flow path to the first chamber 338 and the second chamber 340. Then, the chambers 352 and 366 formed by the respective first paddle 342 and second paddle 356 can capture the incoming flow of fluid from the inflow ends of the respective first flow path 304 and second flow path 306, which causes the first paddle gear 308 and the second paddle gear 310 to rotate.

[0187] As an example, as Fig.14 shown, the flow of fluid can enter one of the chambers 352 formed by the first paddle 342 (e.g., the chamber 352 disposed adjacent to the opening between the first chamber 338 and the inlet end of the first inner channel 312). When the chamber 352 rotates due to the rotation of the first paddle gear 308, the volume 354 of fluid within the chamber 352 then travels towards the outlet end of the first inner channel 312. Thus, the chambers 352 and 366 can be referred to herein as rotating chambers. When the chamber 352 containing the volume 354 of fluid reaches the opening between the first chamber 338 and the outlet end of the first inner channel 312, the volume 354 of fluid is discharged towards the first flow outlet opening 316 into the outlet end of the first inner channel 312. A similar flow of fluid occurs through the second paddle gear 310, as Fig.14 shown.

[0188] The gear ratio between the first gear 344 and the second gear 358 can determine the respective volumes of fluid (and thus the respective flow rates of the fluid) metered into each of the first flow path 304 and the second flow path 306. For example, as Figure 12-14 shown, the gear ratio can be 1:1, and thus, the volume of fluid metered through the first flow path 304 (e.g., the volume 354 of fluid depicted in Fig.14 ) and the volume of fluid metered through the second flow path 306 can be the same. Similarly, the flow rates of the fluid through the first flow path 304 and the second flow path 306 can be the same (and have a flow rate ratio of 1:1).

[0189] In this example, the flow rate of the fluid through the first flow path 304, and the flow rate of the fluid through the second flow path 306 and the flow conduit (e.g., via conduit or outlet 326) coupled to the first and second flow paths 306 and configured to receive the metered flow from the first and second flow paths 306 can be the same or substantially the same. For example, the ratio of the predetermined volume of fluid metered through the first flow path 304 to the predetermined volume of fluid metered through the second flow path 306 (e.g., 1:1 in this case) remains constant during the rotation of the first paddle gear 308 and the second paddle gear 310. Thus, even if the individual flow conduits or flow paths coupled to the flow mechanism 300 and configured to receive fluid via the flow mechanism 300 have different resistances, they can all receive fluid at a constant flow rate via the flow mechanism 300.

[0190] In other examples, if the first gear 344 and the second gear 358 have different diameters, but the geometries of the first paddle 342 and the second paddle 356 remain the same, providing a different gear ratio, then the volumes of fluid metered through the first flow path 304 and the second flow path 306 will be different. In this way, the geometry of the gears of the paddle gears of the flow mechanism 300 can be changed based on the specified metered volume of fluid to be provided to different flow paths or conduits to which the flow mechanism 300 is coupled.

[0191] In Fig.15 an exemplary flow mechanism 400 having paddle gears with gears of different diameters is shown. The flow mechanism 400 can be similar to Figure 12-14 the flow mechanism 300, except that the first paddle gear 402 has a first gear 404 with a diameter larger than that of the second paddle gear 310 and the first paddle gear 308 of the flow mechanism 300.

[0192] For example, as Fig.15 shown, the flow mechanism 400 includes a first paddle gear 402 having a first gear 404 with a first diameter 406 and a second paddle gear 310 having a second gear 358 with a second diameter 408, the first diameter 406 being greater than the second diameter 408. The geometries of the first paddle 342 of the first paddle gear 402 and the second paddle 356 of the second paddle gear 310 can be the same. Thus, 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.). Thus, during one complete rotation of the second paddle gear 310, the first paddle gear 402 does not complete a full rotation (due to its larger diameter). Thus, in Fig.15In the example of , the first paddle gear 402 can provide a smaller metered volume of fluid than the second paddle gear 310 within a set time range. In other words, the first paddle gear 402 can provide a smaller fluid flow rate (e.g., volume / time) than the second paddle gear 310.

[0193] As described above, the volumes of the cavities 352 and 366 respectively formed between the housing 302 and the first and second paddle gears 308 and 310 can also define a predetermined metered volume of the fluid (or the flow rate of the fluid) passing through the first flow path 304 and the second flow path 306. Since the volumes of the cavities 352 and 366 can be defined by the geometries of the first paddle 342 and the second paddle 356 respectively, changing the geometry of the first paddle 342 and / or the second paddle 356 can change the volumes of the cavities 352 and / or 366.

[0194] Fig.16 An exemplary flow mechanism 500 with paddle gears is shown, the paddle gears having paddles with different geometries and thus cavities of different sizes between the housing 302 and the corresponding paddles. The flow mechanism 500 can be similar to Figure 12-14 the flow mechanism 300, except that the second paddle gear 502 has a second paddle 504 with a geometry that defines a cavity 508 having a volume larger than the volume of the cavity 352 defined by the geometry of the first paddle 342 of the first paddle gear 308 (e.g., compared to the flow mechanism 300 where the cavities 352 and 366 can have the same volume).

[0195] For example, as Fig.16 shown, 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, the second length 514 being longer than the first length 510 and the second width 516 being 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. Therefore, the first paddle gear 308 can provide a smaller metered volume of fluid (e.g., fluid with a smaller flow rate) than the second paddle gear 502 within a set time range.

[0196] In this way, the geometries of the paddles and / or gears of two or more paddle gears of the flow mechanism can be selected to provide various specified flow rate ratios between two or more flow paths corresponding to the two or more paddle gears.

[0197] In some examples, as Fig.17As shown, the flow mechanism 600 (which may be similar to the flow mechanism 300) may have more than two flow paths and two corresponding paddle gears, thereby providing a constant flow rate ratio between more than two flow paths.

[0198] For example, as Fig.17 shown, the flow mechanism 600 includes a housing 610 that defines a first flow path 304, a second flow path 306, and a third flow path 602. The flow mechanism 600 may also include three paddle gears, including a first paddle gear 308 fluidly coupled to the first flow path 304, a second paddle gear 310 fluidly coupled to the second flow path 306, and a third paddle gear 604 fluidly coupled to the third flow path 602. Similar to Figure 12-14 the flow mechanism 300, each paddle gear of the flow mechanism 600 may include paddles and gears rotatably coupled to each other.

[0199] As Fig.17 shown, 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. In addition, all of the gears of the first paddle gear 308, the second paddle gear 310, and the third paddle gear 604 may be meshed and engaged with each other. For example, as Fig.17 shown, a second gear 358 is disposed between a first gear 344 and a third gear 606 of the third paddle gear 604 and is meshed and engaged with the first gear 344 and the third gear 606 of the third paddle gear 604.

[0200] In other examples, the flow mechanism 600 and other flow mechanisms described herein may have different numbers of paddle gears and corresponding flow paths, such as four, five, etc.

[0201] In some examples, additional flow paths may be included in the flow mechanism by including paddle gears having paddles disposed on either side of a common gear. For example, Fig.18 an exemplary flow mechanism 700 including four flow paths and four paddle gears is shown, each paddle gear including a paddle rotatably coupled 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 similar to Figure 12-14 the paddles and gears of the first and second paddle gears 308 and 310 of the flow mechanism 300, except that two paddles may share a common gear and be rotatably coupled to the common gear.

[0202] For example, as Fig.18As shown, 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 disposed within the housing 722. Each of the first paddle gear 702, the second paddle gear 704, the third paddle gear 706, and the fourth paddle gear 708 includes paddles 724 (which may be configured to be similar to Figure 12-14 the first paddle 342 and the second paddle 356), and the paddles 724 are rotatably coupled to a common rotatable member shared by two of the paddles 724. In Fig.18 the example of, the common rotatable member is a gear, and the flow mechanism 700 includes a first gear 710 and a second gear 712.

[0203] The paddles 724 of the first paddle gear 702 are fluidly coupled to a first flow path 714 formed in the housing 722, the paddles 724 of the second paddle gear 704 are fluidly coupled to a second flow path 716 formed in the housing 722, the paddles 724 of the third paddle gear 706 are fluidly coupled to a third flow path 718 formed in the housing 722, and the paddles 724 of the fourth paddle gear 708 are fluidly coupled to a fourth flow path 720 formed in the housing 722. Thus, the flow mechanism 700 can be configured to meter the flow rate to four flow paths (e.g., four separate flow paths or lumens of a flow system coupled to the flow mechanism 700).

[0204] As Fig.18 shown, the paddles 724 of the first paddle gear 702 are disposed on a first side of the first gear 710, and the paddles 724 of the second paddle gear 704 are disposed on an opposite second side of the first gear 710. The paddles 724 of both the first paddle gear 702 and the second paddle gear 704 may be rotatably coupled to the first gear 710. Thus, the first gear 710 and the paddles 724 of the first paddle gear 702 and the second paddle gear 704 can all rotate together (e.g., as one), thereby providing the same and constant flow rate of fluid through the first flow path 714 and the second flow path 716.

[0205] Similarly, the paddles 724 of the third paddle gear 706 are disposed on a first side of the second gear 712, and the paddles 724 of the fourth paddle gear 708 are disposed on an opposite second side of the second gear 712. The paddles 724 of both the third paddle gear 706 and the fourth paddle gear 708 may be rotatably coupled to the second gear 712. Thus, the second gear 712 and the paddles 724 of the third paddle gear 706 and the fourth paddle gear 708 can all rotate together (e.g., as one), thereby providing the same and constant flow rate of fluid through the third flow path 718 and the fourth flow path 720.

[0206] In some examples, such as Fig.18 shown, the teeth of the first gear 710 mesh with the teeth of the adjacent second gear 712, thereby correlating the rotation of the first and second blade gears 702 and 704 with the rotation of the third and fourth blade gears 706 and 708 to maintain a consistent flow rate ratio between the four flow paths.

[0207] In other examples, a common rotating member disposed between the blades of two blade gears can be a spacer rather than a gear (e.g., the spacer can be configured as a cylinder or block without teeth), thereby providing fluid at the same flow rate to two flow paths fluidly coupled to the two blade gears (e.g., for blades having the same geometry).

[0208] For example, as Fig.19 shown, the flow mechanism 800 can include a spacer 802 disposed within the housing 812 between a first blade 804 of a first blade gear 806 and a second blade 808 of a second blade gear 810. The first blade 804 can be fluidly coupled to a first flow path 814 formed in the housing 812, and the second blade 808 can be fluidly coupled to a second flow path 816 formed in the housing 812.

[0209] Since both the first blade 804 and the second blade 808 can be rotatably coupled to the spacer 802, the first blade 804 and the second blade 808 can rotate together (e.g., when fluid flows into the first flow path 814 and the second flow path 816), and can provide fluid at the same flow rate through the first flow path 814 and the second flow path 816 (e.g., when the first blade 804 and the second blade 808 have cavities of the same size). In some examples, as described above, the geometry of one of the first blade 804 and the second blade 808 can be changed to increase or decrease the volume of fluid provided to the corresponding flow path and thus the flow rate of the fluid.

[0210] In some examples, additional flow paths and blades separated by additional spacers can be added to the flow mechanism 800, thereby creating additional flow paths for coupling to individual conduits or lumens of a flow system (e.g., additional spacers and blades can be added to the flow mechanism 800 to create three separate flow paths that all rotate together at the same rotational speed).

[0211] In some examples, in order to accommodate a blade having an outer diameter larger than the outer diameter of the gear to which it is coupled, the blades of one blade gear can be disposed at an offset height relative to the blades of an adjacent blade gear. For example, as Fig. 20As shown, the flow mechanism 900 may include a first paddle gear 904, the first paddle gear 904 including a first paddle 906 rotatably coupled to a first gear 908, wherein the first paddle 906 is spaced apart from the first gear 908 in an axial direction relative to the axis of rotation 910 of the first paddle gear 904. In some examples, the first paddle 906 may be rotatably coupled to the first gear 908 via a central shaft 912, the central shaft 912 being elongated relative to the combined height (measured in the axial direction) of the first paddle 906 and the first gear 908.

[0212] The flow mechanism 900 may further include a second paddle gear 914, the second paddle gear 914 including a second paddle 916 rotatably coupled to a second gear 918. As Fig. 20 shown, the first gear 908 and the second gear 918 may be arranged adjacent to each other and engaged with each other. In addition, the first paddle 906 may be offset from the second paddle 916 in the axial direction (e.g., the first paddle 906 and the second paddle 916 are arranged at different heights). Thus, the outer diameter 920 of the first paddle 906 and the second paddle 916 may be greater than the outer diameter 922 of their respective gears (excluding the teeth of the gears), as Fig. 20 shown.

[0213] In this way, the total volume of fluid per unit time or the flow rate of fluid through each flow path of the flow mechanism (such as one of the flow mechanisms described above with reference to Figure 12-20 may be variable, but the ratio of the flow rates between the flow paths of the flow mechanism may remain the same. This may be due to the associated rotation of the paddles of the paddle gears, as described above.

[0214] In some examples, any of the flow mechanisms described herein may be used with a single fluid supply, such as a single infusion pump, configured to provide fluid at a controlled flow rate to all inlets of the flow mechanism, thereby providing fluid at a consistent and predictable flow rate from each outlet of the flow mechanism. For example, Fig.21 an exemplary example of a single infusion pump 1000 fluidly coupled to an inlet conduit 328 of the flow mechanism 300 is shown. For example, as Fig.21 shown, a fitting or flow conduit 1002 may extend from the single infusion pump 1000 to the inlet conduit 328, to the first flow path 304 and the second flow path 306 of the flow mechanism 300.

[0215] Additionally, in some examples, as Fig.21As shown, the first conduit 1006 may be fluidly coupled to the first outlet conduit 1010 of the flow mechanism 300, and the second conduit 1004 may be fluidly coupled 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.

[0216] In some examples, the first conduit 1006 may be the first flush port 210 of the delivery device 220 (or a flow conduit coupled to the first flush port 210), and the second conduit 1004 may be the second flush port 216 of the delivery device 220 (or a flow conduit coupled to the second flush port 216)( Figure 4-7 ).

[0217] In some examples, as Fig. 22 shown, the flow mechanism 1100 (which may be similar to any flow mechanism described herein with reference to Figure 12-21 ) may include a drive member configured to drive the rotation of paddle gears (e.g., the first paddle gear 308 and the second paddle gear 310 shown by way of example in Fig. 22 ) at a specified rate. In some examples, as Fig. 22 shown, the drive member may be a toothed gear (e.g., a toothed drive gear) 1102 configured to engage meshingly with at least one of the paddle gears of the flow mechanism 1100. For example, as Fig. 22 shown, the toothed gear 1102 engages meshingly with the first gear 344 of the first paddle gear 308, and the first gear 344 engages meshingly with the second gear 358 of the second paddle gear 310. Thus, the drive (e.g., rotation) of the toothed gear 1102 drives the rotation of the first gear 344 and the second gear 358.

[0218] In some examples, 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) may drive the rotation of the paddle gears of the flow mechanism 1100 at a set rate. Instead of or in addition to the toothed gear and / or drive mechanism, a fluid pressure differential may be used to drive the rotation of the paddle gears of the flow mechanism 1100 at a set rate.

[0219] In some examples, as Fig. 22As shown, the flow paths of the flow mechanism 1100 (e.g., flow paths 304 and 306) can each be coupled to different fluid sources (e.g., fluid reservoirs), such as a first fluid source 1104 and a second fluid source 1106. In other examples, the flow paths of the flow mechanism 1100 can each be coupled to the same fluid source (e.g., fluid reservoir).

[0220] In this way, the flow mechanism described above with reference to Figure 12-22 can be configured to maintain a consistent relative flow rate between two or more flow paths. Thus, the flow of fluid through two or more parallel flow paths fluidly coupled to two or more flow paths of the flow mechanism can be maintained at a specified flow rate ratio.

[0221] In some examples, such a flow mechanism can be implemented in a delivery device configured to deliver a docking device (such as Figure 4-11 delivery device 220). For example, a flow mechanism (such as flow mechanism 300( Figure 12-14 ), flow mechanism 400( Fig.15 ), flow mechanism 500( Fig.16 ), flow mechanism 800( Fig.19 ), flow mechanism 900( Fig. 20 ) or flow mechanism 1100( Fig. 22 )) can be fluidly coupled to the pusher shaft lumen 201 (e.g., via a first flush port 210) and the delivery shaft lumen 215 (e.g., via a second flush port 216). Thus, regardless of the fluctuating resistance in the pusher shaft lumen 201 and the delivery shaft lumen 215 and the varying resistance between the pusher shaft lumen 201 and the delivery shaft lumen 215, fluid of a consistent relative flow rate can be provided to the pusher shaft lumen 201 and the delivery shaft lumen 215.

[0222] It should be noted that the different flow mechanism examples described above with reference to Figure 12-22 can be combined with each other in any combination to form a flow mechanism configured to provide a consistent and constant relative flow rate between a specified number of flow paths.

[0223] Returning to Figure 4-7 , in a third example of the flush port arrangement for the delivery device 220, the handle assembly 200 can include a single flush port disposed on the branch 204 of the hub assembly 230, the single flush port being configured to provide both a flush fluid flow 203 to the pusher shaft lumen 201 and a flush fluid flow 217 to the delivery shaft lumen 215. For example, certain configurations are capable of flushing all of the lumens described above with reference to Figure 4-9A using only one flush line (such as the first flush port 210).

[0224] In such an example, by incorporating a flow throttle valve including two or more holes in branch 204, a single flush port can supply fluid to two separate lumens (the pusher shaft lumen 201 and the delivery shaft lumen 215), and the two or more holes are configured to supply fluid from the single flush port to the isolated pusher shaft lumen 201 and delivery shaft lumen 215. The following further describes examples of such a flow throttle valve with reference to Figure 23-28 Examples of such a flow throttle valve are further described.

[0225] For example, in some examples, the flow throttle valve can be arranged at Figure 6 and 7 where the washer 223 is shown (e.g., in place of the washer 223 and without the second flush port 216), or further downstream of where the washer 223 is shown (e.g., at the proximal end of the proximal extension 291).

[0226] Fig.24 and Fig.25 show different views of an example of a flow throttle valve 1200 configured to control the flow of fluid from a single fluid source into two separate (e.g., fluidly isolated) flow lumens (or flow paths). Fig.26 An exemplary cross-sectional view shows the flow throttle valve 1200 disposed in a larger flow lumen among two flow lumens and sealing around a smaller flow lumen among the two flow lumens. In Fig.23 an exemplary arrangement of the flow throttle valve 1200 in the hub assembly 230 of the delivery device 220 is shown.

[0227] First, turning to Fig.24 and Fig.25 , a perspective view of the flow throttle valve 1200 ( Fig.24 ) and an end view ( Fig.25 ) are shown. The flow throttle valve 1200 can include a compressible seal member 1202 and a rigid substrate 1204.

[0228] In some examples, as further described below, the rigid substrate 1204 can be at least partially embedded within the compressible seal member 1202. In some examples, the compressible seal member 1202 is overmolded onto a portion of and / or around the rigid substrate 1204.

[0229] As Fig.24 and 25 shown, the portions of the rigid substrate 1204 disposed inside the compressible seal member 1202 (e.g., the second portion 1230 and portions of the first portion 1216) are illustrated in dashed lines to indicate their internal arrangement. In Fig.26Shown (as described further below), is a cross-sectional view of a flow restrictor 1200 disposed within a larger flow lumen taken at the midpoint along the length 1210 of a compressible seal member 1202. Thus, in this view, the rigid substrate 1204 (including the first portion 1216 and the second portion 1230) is illustrated in solid lines.

[0230] The compressible seal member 1202 may include a compressible material configured to compress or change shape under pressure. In some examples, the compressible material of the compressible seal member 1202 is silicone. In other examples, the compressible material of the compressible seal member 1202 is another compressible material, such as another compressible polymeric material (e.g., neoprene, fluorocarbon rubber, etc.).

[0231] The compressible seal 1202 may include a body 1206 defining a first bore 1208 that extends through the length 1210 of the compressible seal 1202 ( Fig.24 ). For example, the first bore 1208 may be configured as an elongated bore that extends through the entire length 1210 of the compressible seal member 1202. The length 1210 may be in a direction parallel to an axial direction that is relative to a first central longitudinal axis 1207 of the first bore 1208.

[0232] In some examples, when the flow restrictor 1200 is implanted in a flow system, the length 1210 may be arranged in a direction parallel to the direction of flow through a parallel flow lumen of the flow system.

[0233] The first bore 1208 of the compressible seal 1202 may have a first diameter 1212 ( Fig.25 ). The first bore 1208 may be spaced from the outer surface 1214 (and outer perimeter) of the compressible seal member 1202. In some examples, the first bore 1208 may be spaced from the outer surface 1214 around its entire circumference.

[0234] In some examples, as Figure 24-26 shown, the compressible seal 1202 is cylindrical and the outer surface 1214 is curved. In other examples, the compressible seal member 1202 may have a different shape, such as oval, square, rectangular, etc. The shape of the compressible seal member 1202 may be selected based on the specified shape of the flow conduit or flow lumen within which the compressible seal member 1202 will be disposed.

[0235] The rigid substrate 1204 may include a relatively rigid material that is more rigid than the material of the compressible seal member 1202. For example, the rigid substrate 1204 may include a biocompatible hard plastic or a metallic material. In other examples, the rigid substrate 1204 may include another incompressible material configured to maintain its shape (e.g., not compress) under pressure. As further described below, in some examples, the rigid substrate 1204 may provide a structure for the compressible seal member 1202.

[0236] As Fig.24 and 25 shown, the rigid substrate 1204 may include a first portion 1216 that is embedded within the compressible seal member 1202 and extends through a length 1210 of the compressible seal member 1202. The first portion 1216 may have a first face 1218 and a second face 1220 disposed on either end of the first portion 1216. The first face 1218 and the second face 1220 may be disposed perpendicular to a direction parallel to the length 1210 and may be disposed outside of the compressible seal member 1202.

[0237] For example, in some examples, the first face 1218 of the first portion 1216 of the rigid substrate 1204 may be disposed at and flush with a first face 1222 of the compressible seal member 1202 ( Fig.24 and 25 ). In other examples, the first face 1218 of the first portion 1216 may extend outwardly from and past the first face 1222 of the compressible seal member 1202.

[0238] Furthermore, in some examples, the second face 1220 of the first portion 1216 of the rigid substrate 1204 may be disposed at and flush with a second face 1224 of the compressible seal member 1202 ( Fig.24 ). In other examples, the second face 1220 of the first portion 1216 may extend outwardly from and past the second face 1224 of the compressible seal member 1202.

[0239] The first portion 1216 of the rigid substrate 1204 may define a second bore 1226 having a second diameter 1228 ( Fig.25 ). The second bore 1226 may extend through the length of the first portion 1216, which in some examples may be the same as the length 1210 of the compressible seal member.

[0240] In some examples, as Fig.25As shown, a second diameter 1228 of the second hole 1226 may be less than a first diameter 1212 of the first hole 1208. In other examples, the first diameter 1212 and the second diameter 1228 may be the same, or the first diameter 1212 may be less than the second diameter 1228.

[0241] In some examples, as Figure 24-26 shown, the first hole 1208 and the second hole 1226 are radially offset from and / or spaced apart from each other. For example, the first hole 1208 may have a first central longitudinal axis 1207, and the second hole 1226 may have a second central longitudinal axis 1225( Fig.24 ). The first central longitudinal axis 1207 and the second central longitudinal axis 1225 may be offset from each other (e.g., not overlapping).

[0242] The rigid substrate 1204 may also include a second portion 1230 embedded within the compressible seal member 1202. The second portion 1230 may extend outwardly from the first portion 1216. As Figure 24-26 shown, the second portion 1230 may extend circumferentially outwardly from the first portion 1216 and surround at least a portion of the first hole 1208.

[0243] In some examples, the second portion 1230 surrounds the first portion 1216 and extends circumferentially outwardly from either side of the first portion 1216. For example, in some examples, the second portion 1230 may include extension portions or wings 1232 that extend from either side of the first portion 1216( Fig.24 and 25 ). As Fig.24 and 25 shown, the wings 1232 extend circumferentially outwardly from the first portion 1216 (e.g., in the Fig.25 shown circumferential direction 1231), and at least partially surround the first hole 1208 (e.g., about 100° to about 170° around the circumference of the first hole 1208).

[0244] In other examples, the second portion 1230 may include extension portions or wings that extend further and surround a greater portion of the first hole 1208 (such as surrounding about 180° to about 360° around the circumference of the first hole 1208). An example of such an arrangement is shown in Fig.28 and is further described below.

[0245] In some examples, each wing 1232 may include a hole 1234 defined therein. The hole 1234 may increase the bond between the compressible seal member 1202 and the rigid substrate 1204. For example, during the formation of the compressible seal member 1202 around the rigid substrate 1204 (e.g., during overmolding), the material of the compressible seal member 1202 may enter the hole 1234, thereby increasing the contact between the compressible seal 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 seal member 1202.

[0246] For example, the geometry of the wing 1232 and / or the hole 1234 may be configured to maintain the rigid substrate 1204 in place within the compressible seal member 1202. In other examples, the wing 1232 may include additional holes 1234 (e.g., in an example where the wing 1232 extends further around the first hole 1208, each wing 1232 may include more than one hole 1234 and / or more elongated or wider holes 1234) in addition to those shown. Fig.24 and 25 In other examples, the rigid substrate 1204 may not have wings 1232 and / or the entire second portion 1230.

[0247] The rigid substrate 1204 may further include a third portion or extension member 1236 that axially extends outward from the first portion 1216 on one side of the compressible seal member 1202. As shown, the extension member 1236 axially extends outward from the first face 1218 of the first portion 1216 and is disposed outside the compressible seal member 1202.

[0248] In some examples, the first portion 1216, the second portion 1230, and the extension member of the rigid substrate 1204 are formed (e.g., molded) as one piece. Fig.24

[0249] The extension member 1236 may be configured to act as a "key" that can be received in a receiving member (e.g., a recess) of a flow system to hold the flow throttle valve 1200 in place (e.g., to hold the flow throttle valve in a specified circumferential orientation). In this way, in some examples, the extension member 1236 may ensure a specified alignment within the flow system during assembly.

[0250]

[0251] Fig.24 25 ​​​​As shown, the extension member 1236 can be elongate and have a trapezoidal cross-section, but with two curved edges. In other examples, the extension member 1236 can have a different shape, such as having a cross-section with a square, triangular, or rectangular shape. In this way, the extension member 1236 can have a specified shape configured to mate with a recess of a corresponding shape in the flow system in which the flow throttle valve 1200 will be disposed.

[0252] In other examples, the rigid substrate 1204 can include a plurality of extension members 1236. In other examples, the rigid substrate 1204 can not include any extension members 1236.

[0253] In some examples, as Figure 24-26 shown, the compressible seal member 1202 can radially extend beyond (e.g., past) the first portion 1216 and the second portion 1230 of the rigid substrate 1204 such that the material of the compressible seal member 1202 forms a continuous outer surface (e.g., outer surface 1214) around the flow throttle valve 1200. Accordingly, radial compression of the flow throttle valve 1200 can be possible (e.g., to increase the seal within and around the components of the flow system in which the flow throttle valve 1200 is disposed). The outer diameter 1242 of the compressible seal member 1202 and / or the radial distance ( Fig.26 ) between the outer surface 1214 of the compressible seal member 1202 and the first portion 1216 and / or the second portion 1230 of the rigid substrate 1204 can be selected or adjusted based on a specified amount of radial compression of the flow throttle valve 1200 when positioned within a flow conduit or component of a flow system.

[0254] In some examples, the compressible seal member 1202 can axially extend past the first face 1218 and the second face 1220 of the first portion 1216 of the rigid substrate 1204, thereby allowing axial compression of the compressible seal member 1202. In this way, in some examples, the length 1210 of the compressible seal member 1202 can be longer than the axial length of the first portion 1216.

[0255] In one exemplary example, as Fig.23 shown, the flow throttle valve 1200 can be disposed on the branch 204 of the hub assembly 230 of the delivery device 220 between two flush ports on the branch 204. As Fig.23 shown, the extension member 1236 can extend into a recess 1238 defined within the branch 204, thereby locking the flow throttle valve 1200 in place.

[0256] Also as Fig.23As shown, the proximal extension 291 of the pusher shaft 290 can extend through the first hole 1208 and be sealed to the first hole 1208, and the cavity 254 can be fluidly coupled to the second hole 1226. For example, as Fig.23 shown, the second hole 1226 can be disposed between the cavity 254 and the inner cavity 250 and fluidly coupled to each of the cavity 254 and the inner cavity 250, thereby throttling the fluid from the first flushing port 210 to the cavity 254 (which can be fluidly coupled to the delivery shaft lumen, as described above).

[0257] In other examples, the flow throttle 1200 can be positioned further downstream in the branch 204, where the outer surface 1214 of the compressible seal member 1202 is disposed against (e.g., in face-to-face contact) the inner surface 1240 of the branch 204 ( Fig.23 ).

[0258] In other examples, the flow throttle 1200 including two or more isolated flow paths can be used in other flow systems.

[0259] Fig.26 Another exemplary example of the flow throttle 1200 disposed within the outer pipe 1250 (e.g., a pipe such as the branch 204 Fig.23 ) is shown. Specifically, Fig.26 is a cross-sectional view taken along the middle portion or midpoint of the flow throttle 1200 of the flow throttle 1200 disposed within the outer lumen (e.g., a lumen such as the cavity 254 Fig.23 ) defined by the inner surface 1254 of the outer pipe 1250. The flow throttle 1200 can be configured to fluidly isolate the outer lumen of the outer pipe 1250 from the inner lumen of the inner pipe 1256, as further described below.

[0260] As Fig.26 shown, the outer surface 1214 of the flow throttle 1200 (and the compressible seal member 1202) can be in face-to-face contact with the inner surface 1254 of the outer pipe 1250. For example, the outer diameter 1242 of the compressible seal member 1202 and the flow throttle 1200 within the outer pipe 1250 can be the same as the inner diameter of the outer pipe 1250 (e.g., which can be the outer diameter of the outer lumen).

[0261] As Fig.26 shown, the inner pipe 1256 (e.g., a proximal extension 291 of the pusher shaft 290 such as Fig.23 ) extends through the first hole 1208 of the compressible seal 1202. The inner diameter 1258 of the inner pipe 1256 defines an inner lumen (e.g., an inner flow lumen or flow path) 1260. When disposed within the first hole 1208 (as Fig.26As shown, the outer diameter of the inner pipe 1256 can be the same as the first diameter 1212 of the first hole 1208. For example, as Fig.26 shown, the outer surface 1262 of the inner pipe 1256 can be in face-to-face contact with the inner surface 1264 of the compressible seal member 1202 that defines the first hole 1208.

[0262] In this way, the outer surface 1214 of the compressible seal member 1202 can seal against the inner surface 1254 of the outer pipe 1250, and the inner surface 1264 of the compressible seal member 1202 that defines the first hole 1208 can seal against the outer surface 1262 of the inner pipe 1256.

[0263] In some examples, the inner lumen 1260 can have a greater resistance (e.g., flow resistance or resistance to flow) than the outer lumen.

[0264] As Fig.26 shown, the second diameter 1228 of the second hole 1226 in the rigid substrate 1204 is smaller than the outer diameter of the outer lumen (formed between the outer pipe 1250 and the inner pipe 1256). Thus, the smaller second hole 1226 can limit the amount of fluid that can enter the larger outer lumen through the flow throttle 1200. In this way, the flow can be throttled into the larger outer lumen, while the flow can enter the inner lumen 1260 without being throttled (e.g., without restriction).

[0265] Since the second hole 1226 is formed within the rigid (non-compressible) substrate 1204, its size (e.g., the second diameter 1228) is not affected by the axial and / or radial compression of the compressible seal member 1202.

[0266] In some examples, the second diameter 1228 of the second hole 1226 can 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 can 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 lumen and the inner lumen 1260. In some examples, the second diameter 1228 can be selected such that a specified relative flow rate between the inner lumen 1260 and the outer lumen is achieved.

[0267] Fig. 27 A end view of another example of a flow throttle 1300 is shown. In some examples, the flow throttle 1300 is similar to Figures 24 - 26 the flow throttle 1200. The flow throttle 1300 can include a compressible seal member 1302 and a rigid substrate 1204. The compressible seal member 1302 can be similar to the compressible seal member 1202 of the flow throttle 1200 ( Figures 24 - 26),Except that the compressible seal member 1302 defines two holes therein, including a first hole 1304 and a second hole 1306, rather than only one hole (e.g., the first hole 1208 of the flow restrictor 1200). Thus, the flow restrictor 1300 can be configured to receive two flow pipes, with one flow pipe passing through each of the first hole 1304 and the second hole 1306, thereby isolating the two flow pipes from each other.

[0268] In some examples, the spacing between the first hole 1304 and the second hole 1306 and / or the spacing between the first hole 1304 and the second hole 1306 within the compressible seal 1302 can be adjusted based on the configuration of the flow system it is intended to house.

[0269] In other examples, the rigid substrate 1204 can have more than one second hole 1226 (e.g., two, three, etc.) for additional flow cavities.

[0270] In other examples, the flow restrictor can include a plurality of rigid substrates 1204 spaced apart from each other within the compressible seal member, thereby accommodating additional flow lumens.

[0271] Figure 28 A end view of another example of a flow restrictor 1400 including a compressible seal member 1202 and a rigid substrate 1402 is shown. In some examples, the flow restrictor 1400 can be similar to Figures 24 - 26 the flow restrictor 1200, except that the rigid substrate 1402 includes a second portion 1404 that surrounds the entire circumference of the first hole 1208 and extends around the entire circumference of the first hole 1208. The second portion 1404 can include one or more holes 1406 (two are shown in Figure 28 , but more or fewer than two holes are also possible). In this way, the second portion 1404 of the rigid substrate 1402 can be configured to completely cover the ring in the compressible material of the compressible seal member 1202.

[0272] Now turning to Figures 29 - 33 , an example of a pusher shaft 1500 of a delivery device configured to deliver a docking device (e.g., one of the docking devices described herein) is shown. For example, the pusher shaft 1500 can be the pusher shaft 290 included in the delivery device 220, as Figures 4 - 11 shown.

[0273] Figure 29 Schematically illustrates four main components of the pusher shaft 1500, while Figure 30 illustrates a more detailed example of the pusher shaft 1500. A side view of an exemplary distal end of the pusher shaft 1500 is shown in Figure 31 , and in Figure 32A proximal end view of pusher shaft 1500 is shown in FIG. Figure 33 Only the main tube (which may be a hypotube in some examples) 1502 of the impeller shaft 1500 is shown. These figures of the impeller shaft 1500 show the central longitudinal axis 1501 of the impeller shaft 1500.

[0274] In some examples, when disposed within a delivery device, the central longitudinal axis 1501 of the pusher shaft 1500 can be coaxial with the central longitudinal axis of a cannula shaft (e.g., cannula shaft 280) and an outer shaft (e.g., outer shaft 260) of a delivery device (e.g., delivery device 220), as described below with reference to Figure 34 and 35 Further explained.

[0275] like Figures 29 - 33 As shown, the exemplary pusher shaft 1500 may include four sections or components, including a main tube (eg, shaft) 1502 ( Figures 29 - 33 )、Shell 1504( Figure 29 , 30 and 32), plug 1506 ( Figure 29 , 30 and 32) and a proximal extension 1510 (such as Figure 29 and 30 As shown, it can be similar to Figures 5 - 7 Proximal extension 291 shown).

[0276] Main tube 1502 can be configured to advance and retract a docking device (such as one of the docking devices described herein) and to accommodate a release suture that secures the docking device to the pusher shaft. Housing 1504 surrounds a portion of main tube 1502, and stopper 1506 connects main tube 1502 to housing 1504 and can be configured as a stop for the cannula shaft. Proximal extension 1510 can be configured to allow pusher shaft 1500 to travel from the interior of the cannula shaft to the exterior of the cannula shaft, thereby allowing the two shafts to be actuated parallel to each other and reducing the overall length of the delivery device (e.g., as Figures 4 - 7 shown).

[0277] The main tube 1502 can be connected to an outer shaft of the delivery device (e.g., Figure 4 The distal end of the outer shaft 260 shown extends to a handle assembly of a delivery device (eg, Figure 4 and 5 In the handle assembly 200). Figure 29 and 30 As shown, pusher shaft 1500 may include a proximal portion 1512 that may include an interface between main tube 1502, housing 1504, plug 1506, and proximal extension 1510. In some examples, such as Figure 6 and 7As shown and as described above, the proximal portion 1512 of the pusher shaft 1500 may be disposed within or near a hub assembly (e.g., hub assembly 230) of a handle assembly of the delivery device. Accordingly, the main tube 1502 may be an elongate tube that extends along a majority of the delivery device.

[0278] In some examples, the main tube 1502 may be a Hypotube. Hypotubes are components that may be used to deploy docking devices and have been previously described in U.S. Patent Publication No. 2018 / 0318079, titled "Deployment systems, tools, and methods for delivery an anchoring device for a prosthetic valve", the disclosure of which is incorporated herein by reference in its entirety. In some examples, the main tube 1502 may comprise a biocompatible metal, such as stainless steel.

[0279] In various examples, the main tube 1502 (shown more particularly in Figure 33 itself) is a relatively rigid tube that provides column strength for actuating (e.g., deploying) the docking device from the delivery device.

[0280] The main tube 1502 may include a distal end 1514 and a proximal end 1516, the distal end 1514 being configured to engage the docking device and the proximal end 1516 being attached to the proximal extension 1510 (as shown in Figure 29 and 30 and 33 and discussed further below).

[0281] In some examples, as shown in Figure 33 the main tube 1502 may have a distal section 1518 that includes a plurality of incisions 1520 therein configured to provide increased flexibility to the main tube 1502 at its distal end. Accordingly, the distal section 1518 may be referred to as the flexible section or portion of the main tube 1502.

[0282] In some examples, the incisions 1520 may be laser incisions formed by laser cutting into the surface (e.g., outer surface) of the main tube 1502. In alternative examples, the incisions 1520 may be another type of incision formed by another cutting process (e.g., via etching, scoring, through-cutting, etc. into the outer surface of the main tube 1502). The width and depth of the incisions 1520 may be configured to add a specified amount of flexibility to the main tube 1502.

[0283] In some examples, each of the incisions 1520 can be a through-incision that penetrates the entire main tube 1502 (e.g., from one side to the other in a direction perpendicular to the central longitudinal axis 1501). In some examples, the width of each incision 1520 can be about 0.05 mm. In some examples, the width of each incision 1520 can be in the range of 0.03 mm to 0.08 mm.

[0284] In some examples, the spacing between adjacent incisions 1520 can vary along the length of the distal section 1518. For example, as Figure 33 shown, the adjacent incisions 1520 can be arranged closest together at the distal end 1514, and then the spacing between the adjacent incisions 1520 can increase from the distal end 1514 of the distal section 1518 to the proximal end.

[0285] In some examples, the incisions 1520 can be formed as helical threads that cut into (and through) the outer surface of the distal section 1518 of the main tube 1502. Thus, in these examples, the spacing or distance between adjacent incisions 1520 can be defined as the pitch of the incision. As Figure 33 shown, the first portion 1522 of the distal section 1518 can have a pitch in the range of 0.4 mm to 0.64 mm, the second portion 1524 of the distal section 1518 can have a pitch in the range of 0.64 to 1.2 mm, the third portion 1526 of the distal section 1518 can have a pitch of 1.2 mm, and the fourth portion 1528 of the distal section 1518 can have a pitch in the range of 1.2 mm to 3.0 mm. In some examples, the pitch of the first portion 1522 can increase from 0.4 mm (at its distal end 1514) to 0.64 mm along its length, the pitch of the second portion 1524 can increase from 0.64 mm to 1.2 mm along its length, the pitch of the third portion 1526 can be about 1.2 mm along its length, and the pitch of the fourth portion 1528 can increase from 1.2 mm to 3.0 mm along its length. It should be noted that the above pitch values for the distal section 1518 are exemplary, and other pitches can be possible, where the pitch values can be selected to provide the main tube 1502 with increased flexibility at its distal end 1514 and a decreasing amount of flexibility along the length of the distal section 1518. In this way, the distal section 1518 can be configured to flex and / or bend along with the outer shaft 2260 of the delivery system as it is navigated through the patient's inner lumen to the target implantation site.

[0286] In some examples, the main tube 1502 may include one or more portions or sections, the one or more portions or sections including an outer flexible polymer layer (e.g., a covering or sheath) configured such that it can be bonded to a plurality of holes 1534 of the inner liner, the inner liner being disposed along the inner surface of the main tube 1502. At the same time, the holes 1534 may be configured to maintain the rigidity of the pusher shaft 1500.

[0287] Figure 33 An example of the main tube 1502 shown includes a first section 1530 and a second section 1532 spaced apart from each other, each section including one or more holes 1534 (e.g., through holes extending through the thickness of the main tube 1502, from the outer surface 1545 of the main tube 1502 and through the outer surface 1545 of the main tube 1502 to the inner surface of the main tube 1502). The holes 1534 may be spaced apart around the circumference of the main tube 1502. In some examples, as Figure 33 shown, each hole 1534 may extend through the entire main tube 1502, resulting in two holes 1534 arranged 180 degrees apart from each other around the circumference of the main tube 1502. Additionally, in some examples, adjacent groups of holes 1534 may be offset from each other by 90 degrees (e.g., as Figure 33 shown, the first section 1530 may include 20 holes).

[0288] The size and / or shape of each hole 1534 and the quantity and spacing between the holes 1534 in each of the first section 1530 and the second section 1532 may be selected to allow the outer flexible polymer layer to bond (e.g., adhere) to the inner liner, with the main tube 1502 disposed therebetween, and still provide rigidity for the pusher shaft 1500. For example, the holes 1534 may be circular with a diameter in the range of 0.4 to 0.6 mm. In some examples, the diameter of the holes 1534 may be approximately 0.5 mm. In some examples, the holes 1534 may have another shape, such as oval, square, rectangular, star-shaped, triangular, etc.

[0289] In some examples, along the length of the first section 1530 and the second section 1532 axially, the holes may be spaced apart from each other at a first (center-to-center) distance 1552, and each group of holes 1534 at the same axial position may be spaced apart from an adjacent group of holes 1534 at a second distance 1554. In some examples, the first distance 1552 is approximately 2 mm, and the second distance 1554 is approximately 1.0 mm. In some examples, 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 examples, the second distance 1554 is half of the first distance 1552. In alternative examples, as Figure 33The number and / or relative spacing between the different apertures 1534 and the arrangement of the apertures 1534 as shown and described above are possible while still providing sufficient bonding between the liner and the outer flexible polymer and providing rigidity for the pusher shaft 1500.

[0290] As Figure 33 shown, the second section 1532 may be disposed at the proximal end 1516 of the main tube 1502 and include fewer apertures 1534 than the first section 1530. However, in alternative examples, the second section 1532 may include more apertures 1534 than Figure 33 shown. In some examples, the first section 1530 may include 20 apertures 1534 and the second section 1532 may include 8 apertures. In other examples, the first section 1530 may include more or fewer than 20 apertures 1534 and the second section 1532 may include more or fewer than 8 apertures 1534.

[0291] As Figure 33 shown, the main tube 1502 may include a third portion 1536 disposed between and extending between the first section 1530 and the second section 1532, and the third portion 1536 does not include any apertures 1534.

[0292] In some examples, as further described below, the main tube 1502 may include an intermediate section 1535 disposed proximal to the distal section 1518 (e.g., which includes the notch 1520) and distal to or as part of the first section 1530. As further described below, the intermediate section 1535 may include one or more apertures 1537 defined in the outer surface 1545, the one or more apertures 1537 may have various sizes, and the one or more apertures 1537 are configured to allow fluid to flow from the interior of the main tube 1502 (e.g., the pusher shaft lumen 1555, as Figure 34 and 35 shown) into the lumen surrounding the pusher shaft 1500 when the pusher shaft 1500 is disposed within the cannula shaft of a delivery device (e.g., delivery device 220). The outer surface 1545 of the main tube 1502 in which the one or more apertures 1537 are disposed may be an outer circumferential surface, where a line perpendicular to the outer surface 1545 intersects the central longitudinal axis 1901.

[0293] Figure 30 Illustrates an exemplary example of components of the pusher shaft 1500. As Figure 30As shown, the pusher shaft 1500 can include a liner 1538 covering the inner surface of the main tube 1502 and forming the inner surface of the proximal extension 1510. In some examples, the liner 1538 can extend along the entire length of the pusher shaft 1500. In some examples, the liner can be relatively thin and include a polymer material such as PTFE. For example, the thickness of the liner 1538 can be in the range of 0.012 mm to 0.064 mm.

[0294] Additionally, in some examples, a portion of the pusher shaft 1500 can include an outer polymer layer (also referred to as an outer covering or sheath) 1540. The outer polymer layer 1540 can be a flexible polymer, as explained further below. In some examples, the outer polymer layer 1540 is disposed on and along a fourth section 1542 of the main tube 1502 (the fourth section 1542 includes 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 ( Figure 30 , Figure 31 and 33 ).

[0295] In some examples, an outer polymer layer 1540 may also be included on the second section 1532 of the main tube 1502 and form an outer layer of the proximal extension 1510. For example, the proximal extension 1510 may include an inner liner 1538 and an outer polymer layer 1540 ( Figure 30 ).

[0296] In some examples, outer polymer layer 1540 may be reflowed over cutouts 1520 and holes 1534 .

[0297] In some examples, the outer polymer layer 1540 may include a polyether-amide block copolymer or a blend of two or more polyether-amide block copolymers. The polymer of the outer polymer layer 1540 may have a Shore D hardness of between about 60 and about 75, between about 65 and about 75, between about 70 and about 75, or about 72 measured according to ISO868:2003. In some examples, the outer polymer layer 1540 may have a flexural modulus of between about 350 MPa and about 550 MPa, between about 450 MPa and about 550 MPa, between about 500 MPa and about 550 MPa, between about 500 MPa and about 525 MPa, between about 510 MPa and about 520 MPa, about 500 MPa, about 505 MPa, about 510 MPa, about 515 MPa, about 520 MPa, or about 525 MPa measured according to ISO178:2010. In some examples, outer polymer layer 1540 may be Grades 7033 and 7233 (Arkema, France) and A blend of one or two or more of grades E62, E72, and EX9200 (Evonik Industries AG, Germany). In some examples, the outer polymer layer 1540 can be 7233. In other examples, the outer polymer layer 1540 can be EX9200.

[0298] In some examples, the main tube 1502 can have a uniform inner diameter ranging from its distal end 1514 to its proximal end 1516 in the range of about 1.0 mm to about 1.34 mm, while the outer diameter can vary from about 1.8 mm to 2.0 mm (e.g., ±0.2 mm) in the proximal and distal sections.

[0299] In Figure 31 an example of the distal tip 1541 of the pusher shaft 1500 is shown. In some examples, the distal tip 1541 includes a more flexible polymer tip or distal portion 1544 that includes a flexible polymer. In some examples, the polymer distal portion 1544 can include the same flexible material as the outer polymer layer 1540 and / or be continuous with the outer polymer layer 1540. Thus, the polymer distal portion 1544 of the distal tip 1541 can flow back onto the distal end 1514 of the main tube 1502 and bond to the inner liner 1538.

[0300] As Figure 29 、 30 and 32 show, the inner diameter 1548 of the housing 1504 is greater than the outer diameter 1550 of the main tube 1502, thereby forming an annular cavity 1546 between the main tube 1502 and the housing 1504 (in the radial direction). Thus, the proximal section 284 of the cannula shaft 280 can slide within the annular cavity (e.g., space) 1546, as further described below with reference to Figure 34 and 35 . Additionally, fluid (e.g., flushing fluid) provided to the lumen on the exterior of the proximal extension 1510 in the hub assembly can flow through the annular cavity 1546 and exit the distal end of the housing (as shown by the arrow 217 in Figure 29 ) to enter the lumen between the cannula shaft 280 and the outer shaft 260 of the delivery device (e.g., the delivery shaft lumen 215 shown in Figure 9A ), as discussed above with reference to Figures 6 - 9A .

[0301] The plug 1506 can be configured to be disposed at the proximal end 1505 of the housing 1504 within the annular cavity 1546 (as shown in Figure 29 、 30 and 32). In some examples, the plug 1506 can have a length 1507 that extends in the direction of the central longitudinal axis 1501 (as shown in Figure 29as shown). In some examples, 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 to 6.5 mm. In some examples, the length 1507 is approximately 6.0 mm.

[0302] The plug 1506 can be configured to "plug" or fill a portion of the annular cavity 1546 at the proximal end 1505 while leaving the remainder of that portion of the annular cavity open to receive the cutting portion of the cannula shaft therein (e.g., Figures 5 - 7 the cutting portion 288 of the cannula shaft 280 shown). For example, as Figure 32 shown, in some examples, the plug 1506 of the pusher shaft 1500 can include an annular portion 1572 and a crescent portion 1574 that extends radially outward from one side of the annular portion 1572. The inner diameter 1576 of the annular portion 1572 can be selected such that the annular portion 1572 surrounds the outer surface 1545 of the main shaft 1502, and the outer diameter 1578 of the crescent portion 1574 can be selected such that the crescent portion 1574 fills the annular space 1546 ( Figure 29 ). For example, the inner diameter 1576 can be selected to be slightly larger than the outer diameter 1550 of the main shaft 1502, and the outer diameter 1578 can be selected to be slightly smaller than the inner diameter 1548 of the housing 1504 (as Figure 29 shown). In some examples, 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 portion 1574 can be in the range of 60 to 140 degrees, 80 to 120 degrees, 90 to 110 degrees, or 95 to 105 degrees.

[0303] In certain examples, the housing 1504 and the plug 1506 can be welded to the main tube 1502 to allow the cutting portion of the cannula shaft to slide between the main tube 1502 and the housing 1504. For example, as Figure 32 shown, a first weld 1580 can secure the annular portion 1572 of the plug 1506 to the main tube 1502, and a second weld 1582 can secure the crescent portion 1572 of the plug 1506 to the housing 1504. In some examples, each of the welds 1580 and 1582 can be a spot weld that does not extend along the entire mating surface between the plug 1506 and the main shaft 1502 and the housing 1504.

[0304] Figure 30Shown is a proximal extension 1510 extending distally from a second section 1932 of the main tube 1502. As described above, the proximal extension 1510 provides flexibility to the pusher shaft 1500 such that it can travel from the interior of the cannula shaft (e.g., cutting portion) to the exterior of the cannula shaft, thereby allowing the two shafts to be actuated in parallel. In many examples, as described above, the proximal extension 1510 may be made of a flexible polymer. In some examples, the flexible polymer is a polyether-amide block copolymer or a blend of two or more polyether-amide block copolymers, such as grades 2533, 3533, 4033, 4533, 5533, 6333, 7033 and 7233 (Arkema, France) and grades E40, E47, E55, E62, E72 and EX9200 (Evonik Industries AG, Germany).

[0305] Turning now to Figure 34 and 35 , an exemplary arrangement of the pusher shaft 1500 assembled with the cannula shaft 280 and the outer shaft 260 of the delivery device 220 (e.g., the pusher shaft and cannula shaft assembly 1600) is shown. As described above, the pusher shaft 1500 and the cannula 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., Figures 4 - 8 the delivery device 220).

[0306] As Figure 34 and 35 shown, the cannula shaft 280 may be configured to cover (e.g., surround) the docking device 232, and the pusher shaft 1500 and the cannula shaft 280 may be configured together to deploy the docking device 232 from the outer shaft 260 of the delivery device after reaching the target implantation site. Figure 34 and 35 Illustrate different stages of the implantation process.

[0307] For example, Figure 34 and 35 illustrate how the proximal section 1604 of the cannula shaft 280 (including the cutting portion 288) passes over the proximal portion 1512 of the pusher shaft 1500 between the main tube 1502 and the housing 1504 within the annular cavity 1546.

[0308] Specifically, Figure 34 illustrates an example of a first configuration of the pusher shaft and cannula shaft assembly 1600 before or during deployment of the docking device 232, wherein the cannula shaft 280 is disposed on the docking device 232 and the end surface 279 of the tube 285 of the cannula shaft 280 is positioned away from the plug 1506.

[0309] During deployment of the docking device 232 from the outer shaft 260 of the delivery device, the pusher shaft 1500 and the cannula shaft 280 can move axially with the docking device 232. For example, actuation of the pusher shaft 1500 that pushes the docking device 232 and moves it out of the outer shaft 260 can also cause the cannula shaft 280 to move along with the pusher shaft 1500 and the docking device 232. Thus, during pushing the docking device 232 via the pusher shaft 1500 to a position at a target implantation site, the docking device 232 can remain covered by the distal section 282 of the cannula shaft 280.

[0310] In some examples, as Figure 34 shown, the outer shaft 260 can have a first inner diameter 1650 at the distal portion of the outer shaft 260 and a second inner diameter 1652 at a more proximal portion of the outer shaft 260. The second inner diameter 1652 can be greater than the first inner diameter 1650 to accommodate a wider housing 1504 therein.

[0311] Additionally, during delivery and implantation of the covered docking device 232 at a target implantation site, the distal tip 1612 of the distal section 282 of the cannula shaft 280 can extend distally (e.g., past) the distal end 1654 of the docking device 232, thereby providing a more atraumatic tip for the distal section 282 of the cannula shaft 280.

[0312] Figure 35 Illustrated is a second configuration of the pusher shaft and cannula shaft assembly 1600 after deploying the docking device 232 from the outer shaft 260 at a target implantation site and retracting the cannula shaft 280 away from the implanted docking device 232. As Figure 35 shown, after implanting the docking device 232 at a target implantation site, in its desired position, the cannula shaft 280 can be pulled away from the docking device 232 and retracted into the outer shaft 260. In some examples, as Figure 35 shown, further retraction of the cannula shaft 280 into the delivery device can be stopped after the end surface 1645 contacts the plug 1506.

[0313] Further details regarding the pusher shaft and cannula shaft assembly (including various material and structural components of the parts) for a delivery device for a docking device are described in International Patent Application No. PCT / US20 / 36577, which is incorporated herein by reference in its entirety.

[0314] As introduced above with reference to Figures 5 - 9A above, spaces or lumens are formed between the various parts of a delivery device including a pusher shaft. Such lumens can include a pusher shaft lumen defined by the inner surface of the main tube of the pusher shaft and a delivery shaft lumen (e.g., Figure 9A the delivery shaft lumen 215 shown),Figure 9A the shown pusher shaft lumen 201 and Figure 34 and 35 the shown pusher shaft lumen 1555). As discussed above with reference to Figure 9A the pusher shaft lumen can supply fluid to a cannula shaft lumen formed between the cannula shaft and the docking device and between the pusher shaft and the cannula shaft (e.g., the cannula shaft lumen 211 shown in FIG. 9 and Figure 34 and 35 the cannula shaft lumen 1557 shown).

[0315] As discussed herein, by maintaining a consistent flow of fluid throughout these lumens of the delivery device, blood stasis can be reduced or avoided, thereby preventing thrombus formation. However, as Figure 34 and 35 shown, the distal end 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 example of Figure 9B where the distal end 293 of the pusher shaft 290 is disposed against the proximal end of the docking device 232 (e.g., adjacent to the proximal end of the docking device 232).

[0316] During various stages of the implantation procedure, the proximal end of the docking device 232 can be compressed against the distal end or tip of the pusher shaft (e.g., the distal tip 1541 of the pusher shaft 1500) with different amounts of force. This inconsistency in the interaction between the distal tip 1541 of the pusher shaft 1500 and the docking device 232 can result in different amounts of fluid flowing out of the pusher shaft lumen 1555 and into the cannula shaft lumen 1557 ( Figure 34 and 35 ).

[0317] In some examples, the docking device 232 can completely occlude the pusher shaft lumen (e.g., due to being pushed up against the distal tip 1541), thereby stopping all flow out of the pusher shaft lumen and preventing fluid from reaching the cannula shaft lumen. For example, as Figure 9B shown, when the distal end 293 of the pusher shaft 290 is pushed up against the docking device 232, it prevents the flush fluid stream 203 from leaving the pusher shaft lumen 201 and reaching the cannula shaft lumen 211. This can lead to an increased risk of thrombus formation.

[0318] Accordingly, it would be desirable to create an additional flow path between the pusher shaft lumen and the cannula shaft lumen, thereby allowing fluid to reach and flow through the cannula shaft and preventing thrombus formation (e.g., even when the distal end of the pusher shaft abuts the proximal end of the docking device and thus the docking device at least partially or completely blocks fluid from leaving the distal end of the pusher shaft).

[0319] Figures 36 - 44 Illustrates the pairFigures 29 - 35 Various modifications and / or Figures 29 - 35 Examples of the pusher shaft 1500 that provide additional flow paths out of the pusher shaft lumen 1555 (e.g., the interior and distal tip 1541 of the main tube 1502), such that fluid communication between the pusher shaft lumen 1555 and the cannula shaft lumen 1557 can be increased.

[0320] In some examples, as described above with reference to Figure 33 and Figure 34 and 35 shown, one or more holes 1537 may be included in the intermediate section 1535 of the main tube 1502. One or more holes 1537 may extend through each of the thicknesses of the main tube 1502, the inner liner 1538, and the outer polymer layer 1540. For example, each hole 1537 may extend between and through 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). Thus, when the pusher shaft 1500 is included in the Figure 34 and 35 pusher shaft and cannula shaft assembly 1600 (or another pusher shaft and cannula shaft assembly of another delivery device), fluid may transfer from the pusher shaft lumen 1555 to the cannula shaft lumen 1557 via one or more holes 1537.

[0321] In some examples, as Figure 33 shown, one or more holes 1537 may be disposed in the pusher shaft 1500 adjacent to the notch 1520 of the distal section 1518.

[0322] In some examples, the intermediate section 1536 may include only one hole 1537, multiple holes 1537 at the same axial location (e.g., two holes 1537 arranged 180° apart from each other, as Figure 34 and 35 shown), multiple holes 1537 axially spaced apart from each other along the intermediate section (as Figure 33 shown), or a combination thereof. In some examples, the intermediate section 1536 may include at least two holes 1537 spaced apart from each other around the circumference of the pusher shaft 1500.

[0323] In some examples, one or more holes 1537 may have various sizes (e.g., diameters), as Figure 33 shown. In some examples, if the pusher shaft 1500 includes multiple holes 1537, all of the holes 1537 may have the same size, or one or more of the multiple holes 1537 may have different sizes.

[0324] In some examples, one or more holes 1537 can have the same dimensions (e.g., diameter) as hole 1534( Figure 33 ). In other examples, one or more holes 1537 can be larger or smaller than hole 1534.

[0325] In some examples, one or more holes 1537 can be circular. In other examples, one or more holes 1537 can have different shapes (or different holes 1537 can have different shapes), such as square, rectangular, oval, rectangular, slit-shaped, etc.

[0326] In some examples, one or more holes 1537 can be cut into the pusher shaft 1500, through the main tube 1502 and the surrounding liner 1538 and outer polymer layer 1540. In some examples, one or more holes 1537 can be produced by laser cutting through the pusher shaft 1500.

[0327] Figures 36 - 40 An example of a distal tip of a pusher shaft 1500 having one or more slots disposed therein is shown, the one or more slots being configured to provide a path for fluid to flow out of the pusher shaft (e.g., out of the pusher shaft lumen and into the cannula shaft lumen 1557, as Figure 34 and 35 shown). Figures 36 - 40 The distal tip shown can be the same as or similar to the distal tip 1541 shown in Figure 31 , except that they include one or more slots that extend through the thickness of the distal tip of the pusher shaft 1500.

[0328] In some examples, the slots described below with reference to Figures 36 - 40 can be cut into the assembled pusher shaft 1500 (e.g., the pusher shaft 1500 shown in Figure 30 and 31 ). In some examples, the slots can be produced by a laser cutting process. As discussed further below, in some examples, if the (one or more) slots extend into the main tube 1502 of the pusher shaft (e.g., past the polymer distal portion 1544), the laser settings for cutting the slots can be set to cut through metal (e.g., stainless steel).

[0329] Figure 36 and 37 show an example of a distal tip 1700 of a pusher shaft 1500, the distal tip 1700 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.

[0330] In some examples, such as Figure 36 and 37 shown, the slot 1702 can extend from the distal end 1704 of the distal tip 1700 to a distance (e.g., an axial distance) away from the distal end 1704 (and into the distal tip 1700), where the distance is the axial length 1706 of the slot 1702.

[0331] In some examples, the axial length 1706 can be selected such that it extends through the polymer distal portion 1544( Figure 31 ) and the distal portion of the main tube 1502. In other examples, the axial length 1706 can be selected such that it only extends through the polymer distal portion 1544 and does not extend through the main tube 1502.

[0332] In some examples, the slot 1702 can have a depth 1708 (in the radial direction) such that it extends through the thickness of the distal tip 1700. For example, the slot 1702 can extend between the inner surface 1714 and the outer surface 1716 of the distal tip 1700 (and the pusher shaft 1500) and through the inner surface 1714 and the outer surface 1716 of the distal tip 1700 (and the pusher shaft 1500).

[0333] In some examples, the slot 1702 can have a width 1710. The width 1710 can be less than the total diameter 1712 of the distal tip 1700 (as Figure 37 shown). In some examples, the width 1710 can be uniform along the axial length 1706. In other examples, the width 1710 can be uniform for most of the axial length 1706.

[0334] The axial length 1706 and the width 1710 can be selected based on the desired flow rate between the pusher shaft lumen and the cannula shaft lumen (e.g., increasing these dimensions can increase the flow path provided between the pusher shaft lumen and the cannula shaft lumen). In some examples, the axial length 1706 and the width 1710 can also be selected to maintain the structural integrity of the distal tip 1700.

[0335] Figure 38 Another example of the distal tip 1800 of the pusher shaft 1500 is shown, the distal tip 1800 including two slots 1702 cut into the distal tip 1800. As Figure 38 shown, in some examples, the two slots 1702 can be arranged 180° apart from each other around the circumference of the distal tip 1800.

[0336] In some examples, the two slots 1702 can have the same axial length 1706 and width 1710. In other examples, the two slots 1702 can have different axial lengths 1706 and / or widths 1710.

[0337] Compared with Figure 36 and 37 the distal tip 1700 of Figure 38 the distal tip 1800 of

[0338] Figure 39 and 40 shows another example of the distal tip 1900 of the pusher shaft 1500, the distal tip 1900 including one or more slots 1902 cut into the distal tip 1900 (one is shown in Figure 39 and 40 ). The slot 1902 can be similar to the slot 1702 described above, but the slot 1902 can have an increasing width from the distal end 1904 of the distal tip 1900 to the proximal end 1906 of the slot 1902. Compared with Figures 36 - 38 the more uniformly wide slot 1702 of

[0339] such a configuration of the slot 1902 can reduce the stress concentration at the distal tip 1900, as well as reduce the risk of opening the distal tip 1900 due to excessive suture tension of the suture extending from the pusher shaft to the docking device. Figure 40 As

[0340] shown, in some examples, the slot 1902 can have one or more customizable dimensions, including an axial length 1908, a first (narrower) width 1910, and a second (wider) width 1912. The second width 1912 (at the proximal end 1906) can be wider than the first width 1910 (at the distal end 1904) and less than the total diameter 1712 of the distal tip 1900. As described above, these dimensions of the slot 1902 can be selected based on the specified (e.g., desired) flow rate between the pusher shaft lumen and the cannula shaft lumen and the maximum dimensions that can maintain the structural integrity of the distal tip 1900 (e.g., and reduce the risk of the distal tip 1900 opening or widening).

[0340] In some examples, as Figure 39 shown, the distal tip 1900 can include a single slot 1902. In other examples, the distal tip 1900 can include two or more slots 1902 spaced circumferentially around the distal tip 1900 (e.g., similar toFigure 38 as shown in the example).

[0341] In some examples, one or more slots 1902 may have a depth 1914 (in the radial direction) such that it extends through the thickness of the distal tip 1900. For example, the slot 1902 may extend between the inner surface 1916 and the outer surface 1918 of the distal tip 1900 (and the pusher shaft 1500) and through the inner surface 1916 and the outer surface 1918 of the distal tip 1900 (and the pusher shaft 1500).

[0342] Figure 41 and Figure 42 An example of a distal portion 2000 of the main tube 1502 of the pusher shaft 1500 having one or more holes 2002 disposed therein is shown, the one or more holes 2002 being configured to provide a path for fluid to flow out of the pusher shaft (e.g., out of the pusher shaft lumen and into the cannula shaft lumen 1557, as Figure 34 and Figure 35 shown). The one or more holes 2002 may extend through each of the thicknesses of the main tube 1502, the inner liner 1538, and the outer polymer layer 1540 ( Figure 31 ). For example, each hole 2002 may extend between and through the inner and outer surfaces of the pusher shaft 1500 (e.g., Figure 34 the inner surface 1563 and the outer surface 1561 shown). Thus, when the pusher shaft 1500 is included in the Figure 34 and 35 pusher shaft and cannula shaft assembly 1600 (or another pusher shaft and cannula shaft assembly of another delivery device), fluid may transfer from the pusher shaft lumen 1555 to the cannula shaft lumen 1557 via one or more holes 1537.

[0343] As Figure 41 and 42 shown, one or more holes 2002 may be disposed at the distal end 1514 of the main tube 1502 distal to the incision 1520. Additionally, one or more holes 2002 may be disposed proximal to the polymer distal portion 1544, as Figure 31 shown.

[0344] In some examples, one or more holes 2002 may include at least two holes 2002 spaced apart from each other about the circumference of the distal portion 2000.

[0345] Figure 41An example is shown in which the distal portion 2000 includes one or two holes 2002 (e.g., one hole 2002 can be cut through the entire pusher shaft, resulting in two holes 2002 arranged 180° apart from each other around the circumference of the distal portion 2000).

[0346] Figure 42 Another example is shown in which the distal portion 2000 includes a plurality of holes 2002 spaced apart around the circumference of the distal portion 2000. In some examples, the diameter or width of the holes 2002 can be less than Figure 41 one or more of the holes 2002.

[0347] The holes 2002 can have various sizes (diameter or width) and / or shapes (e.g., circular (as shown in Figure 41 and 42 ), or square, oval, rectangular, etc.). The size and / or shape of each of the one or more holes 2002 can be selected to achieve a desired flow of fluid out of the pusher shaft lumen and into the cannula shaft lumen.

[0348] Figure 43 and Figure 44 Examples of the distal portion (e.g., tip or tip portion) 2100 of the pusher shaft 1500 are shown, which is 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 and into the cannula shaft lumen 1557, as shown in Figure 34 and 35 ). Figure 43 is a cross-sectional view of the distal portion 2100, and Figure 44 is a side view of the distal portion 2100, the distal portion 2100 including a distal tip 2102 arranged around the distal portion 2104 of the main tube 1502 of the pusher shaft 1500, and an outer polymer layer 1540 that recirculates on a portion of the distal tip 2102 and on a portion of the main tube 1502 that is proximal to the distal tip 2102.

[0349] In some examples, as shown in Figure 43 , the distal tip 2102 can be arranged around and / or coupled to the distal portion 2104 of the main tube 1502. The outer polymer layer 1540 can surround (e.g., cover) a portion (e.g., the proximal portion, which can be most of it) of the main tube 1502 and the distal tip 2102. The tip portion 2106 of the distal tip 2102 can extend distally past the main tube 1502. Additionally, as shown in Figure 43 and 44 , the tip portion 2106 is not covered by the outer polymer layer 1540.

[0350] The distal end portion 2106 of the distal tip 2102 may include one or more holes 2108 disposed therein ( Figure 43 and 44 ). The one or more holes 2108 may extend through the thickness of the distal tip 2102 ( Figure 43 ).

[0351] In some examples, the one or more holes 2108 may be spaced apart from each other around the circumference of the distal end portion 2106 ( Figure 44 ). The one or more holes 2108 may have various sizes and / or shapes (e.g., circular, square, rectangular, etc.).

[0352] In other examples, instead of multiple holes 2108, the distal end portion 2106 may include one or more slots or slits disposed therein that extend through the thickness of the distal tip 2102.

[0353] The distal tip 2102 may be molded or extruded from a polymeric material (such as nylon).

[0354] In some examples, the one or more holes 2108 may be die cut or laser cut into the molded or extruded distal tip 2102.

[0355] In some examples, the assembled pusher shaft 1500 may be modified to include the distal tip 2102. For example, the outer polymeric layer 1540 may be cut away / removed at the distal end 1541 to expose the distal portion 2104 of the main tube 1502. Then, the distal tip 2102 may be attached to the distal portion 2104 of the main tube 1502 and attached around the distal portion 2104 of the main tube 1502. Then, the outer polymeric layer 1540 may be reflowed over the outer surface of the distal tip 2102, but leaving the distal end portion 2106 uncovered, thereby exposing the one or more holes 2108.

[0356] Figures 45 - 47 Another example of the distal portion (e.g., distal tip or distal end portion) 2200 of the pusher shaft 1500 is shown, which is 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 and into the cannula shaft lumen 1557, as Figure 34 and 35 shown).

[0357] The distal portion 2200 may include a more flexible polymeric tip (or distal end) 2202 that includes a flexible polymer (e.g., the same or similar to the polymeric tip 1544 as Figure 31 shown above). In some examples, the polymeric tip 2202 may include the same as (e.g., as referenced above Figure 31The same flexible material as the outer polymer layer 1540 of the pusher shaft 1500 described) and / or continuous with the outer polymer layer 1540 of the pusher shaft 1500. Thus, the polymer tip 2202 can flow back over the distal end 1514 of the main tube 1502 of the pusher shaft 1500 and bond to the inner liner 1538.

[0358] In Figures 45 - 47 In the example shown, one or more holes 2204 may be provided in the polymer tip 2202 distally of the main tube 1502, each of the one or more holes 2204 having a central axis extending in the radial direction. In some examples, each of the one or more holes 2204 may extend from the outer surface 2206 of the polymer tip 2202 to the inner surface 2212 of the inner liner 1538, thus extending through the thickness of each of the polymer tip 2202 and the inner liner 1538.

[0359] In other examples, when the polymer tip 2202 does not include the inner liner 1538, each of the one or more holes 2204 may extend through the thickness of the polymer tip 2202, from the outer surface 2206 of the polymer tip 2202 to the inner surface.

[0360] In some examples, as shown respectively in Figure 45 and 46 In the cross-sectional view and perspective view, one or more holes 2204 may be provided in the polymer tip 2202 around the circumference of the polymer tip 2202. For example, the polymer tip 2202 may include 1-12 holes 2204 (or in some examples, 2-6). The holes 2204 may include various sizes and may be spaced apart from each other around the circumference of the polymer tip 2202. In some examples, the holes may all include a uniform size (e.g., diameter), and / or be uniformly distributed relative to each other (e.g., three holes spaced 120 degrees apart). In other examples, one or more of the holes may include a larger or smaller size than one or more of the other holes, and / or may be non-uniformly distributed relative to each other.

[0361] Now turning to Figure 48 and 49 , a more detailed example of the cannula shaft 280 is shown. In some examples, as shown in Figure 48 The cannula shaft 280 includes three sections: a distal section 282 (or cannula section) including a smooth cannula covering the docking device during deployment, a proximal section 284 for manipulating or actuating the cannula position, and an intermediate section 281 connecting the distal section 282 and the proximal section 284. A portion of the proximal section 284 may be disposed (as referred to above with reference to Figures 5 - 7in the handle assembly discussed). Additionally, at least a portion of the intermediate section 281 and the proximal section 284 can be around the pusher shaft (e.g., Figures 6 - 8 the pusher shaft 290 shown and / or Figure 34 and 35 the pusher shaft 1500 shown).

[0362] The cannula shaft 280 can be formed of multiple components and / or materials. In some examples, the cannula shaft 280 can be formed of a flexible polymer sheath 283 ( Figure 48 ), a more rigid tube 285 ( Figure 48 and 49 ), a liner 287 ( Figure 48 ), and a metal braid 289 ( Figure 48 )(which can be part of or embedded within the polymer sheath 283). As Figure 48 shown, the polymer sheath 283 can be part of the distal section 282 and the intermediate section 281, the liner 287 can extend along the inner surface of the distal section 282 and the intermediate section 281 and form the inner surface of the distal section 282 and the intermediate section 281, and the tube 285 can form the proximal section 284, having a portion extending into the proximal part of the intermediate section 281. In this way, each of the distal section 282, the proximal section 284, and the intermediate section 281 of the cannula shaft 280 can include different layers and material compositions.

[0363] The proximal section 284 of the cannula shaft 280 is designed to be more rigid and provide the column strength to actuate the position of the distal section 282 relative to the docking device by pushing on the intermediate section 281 and the distal section 282 and the docking device (e.g., the docking device 232) and retracting the distal section 282 after the docking device surrounds the native anatomical structure. Since the proximal section 284 of the cannula shaft 280 is around the pusher shaft (e.g., Figure 34 and 35 the pusher shaft 1500 shown or Figures 6 - 9B the pusher shaft 290 shown), this structure can be shaped and configured to be generally tubular and more rigid in structure. For example, the proximal section 284 can be formed of a relatively rigid tube 285 ( Figure 48 and 49 ). In some examples, the tube 285 can be composed of a surgical grade metal such as stainless steel. In some examples, the tube 285 can be a hypodermic tube.

[0364] The tube 285 can include a first section 271 ( Figure 49 )(which can form the entire proximal section 284) and a second section 273 extending into the intermediate section 281 ( Figure 48 and 49)。The first section 271 includes the cutting portion 288 as described above, which has a cross-section (in a plane perpendicular to the central longitudinal axis 275 of the cannula shaft 280) that is not a complete circle (e.g., is open and does not form a closed tube). The remainder of the tube 285 can be tubular (e.g., a closed tube with a relatively circular cross-section). In this way, the tube 285 can be a hollow tube having a complete circular cross-section in its second section 273 and the distal portion of the first section 271 and a partially circular cross-section in the cutting portion 288 (which can also be referred to as the track of the cannula shaft 280).

[0365] As described above with reference to Figures 5 - 7 the cutting portion 288 of the cannula shaft 280 extends into 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 cutting portion 288 (also shown in Figure 52 ). The cutting (e.g., open) profile of the cutting portion 288 can allow the proximal extension 291 of the pusher shaft 290 (or any other pusher shaft described herein) to extend out of the void space 277 (or opening) formed in the cutting portion 288 ( Figure 49 and 52 ) and bifurcate at an angle into the branch 204 of the hub assembly 230. Thus, the pusher shaft 290 and the cannula shaft 280 can operate parallel to each other, as described above.

[0366] In some examples, as shown in Figure 49 and 51 -53, the cutting portion 288 can have a generally U- or C-shaped cross-section, where a portion of the entire tubular structure is removed. For example, the cutting portion 288 can form an open channel or duct having a void space 277 ( Figure 49 , 52 and 53). In various examples, the cutting portion 288 can be cut using a laser, but any other means for removing a portion of the tubular structure can be used.

[0367] The end surface 279 is formed (e.g., exposed) at the interface between the cutting portion 288 and the remainder of the first section 271 on the complete tubular portion of the first section 271 ( Figure 49 ). The end surface 279 can be arranged perpendicular to the central longitudinal axis 275 and can be configured to contact coplanarly with a stop element (e.g., the plug 1506) of the pusher shaft (e.g., as shown in Figure 35 and described above).

[0368] The proximal section 284 of the cannula shaft 280 can be cut to form a partial circular cross-section of the cut portion 288. In some examples, the proximal section 284 can be cut by electrical discharge machining (EDM cutting). However, cutting the tube 285 in this manner can leave relatively flat (planar) cut surfaces 2306 on either side of the void space 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 of the tube 285 and the inner surface 2308 of the cut portion 288) and a second edge 2304 on the inner diameter of the cut portion 288 (e.g., the corner between the cut surface 2306 of the cut portion 288 of the tube 285 and the inner surface 2308 of the cut portion 288), the first edge 2302 and the second edge 2304 being relatively sharp ( Figure 52 and 53 ). For example, the first edge 2302 and the second edge 2304 can be angled and not rounded.

[0369] In some examples, the relatively sharp inner and outer edges (the first edge 2302 and the second edge 2304) on the cut surface 2306 of the cut portion 288 of the cannula shaft 280 can be rounded and / or dressed to eliminate or reduce the sharpness of the first edge 2302 and the second edge 2304.

[0370] Creating a more rounded and smoother edge at the cut surface 2306 can allow for a smoother interface between mating components and the cut portion 288. For example, the first edge 2302 (outer edge) and / or the second edge 2304 can engage various washers, seals, and / or gaskets disposed around the cut portion 288 of the tube 285 surrounding the cannula shaft 280.

[0371] For example, as Figure 50 and 51 shown, a hemostatic seal 2400 can be used to seal around the cut portion 288 of the proximal portion 284 of the cannula shaft 280 adjacent to the cannula actuation handle (e.g., Figure 5 the cannula handle 208 shown). As Figure 50 seen in, the hemostatic seal 2400 can have an opening 2406 shaped as a cross-section of the cut portion 288 of the cannula shaft 280, such as a U-shape or a C-shape or an incomplete (e.g., partial) ring, configured to receive the cut portion 288 therein and seal on all sides of the cannula shaft 280. Figure 51 Illustrates an example of the hemostatic seal 2400 disposed within the straight section 202 of the hub assembly 230. In some examples, as Figure 51As shown, two rigid pads 2402 and 2404 can support each end of the hemostatic seal 2400. The rigid pads 2402, 2404 can have the same profile as the hemostatic seal 2400 to maintain the integrity of the hemostatic seal 2400. The rigid pads 2402, 2404 can place an inward pressure on the hemostatic seal 2400 to ensure a seal between the hemostatic seal 2400 and the cutting portion 288 of the cannula shaft 280.

[0372] Accordingly, 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 cutting portion 288 to produce a smoother edge for engagement with a mating component. In some examples, it may be desirable to form fully rounded edges at the first edge 2302 and second edge 2304 of the cutting portion 288.

[0373] In some examples, the first and second edges 2302 and 2304 can be rounded using a laser. For example, Figure 54A and 54B illustrates an exemplary process for rounding and / or dressing relatively sharp cutting edges on the cutting surface 2306 (first edge 2302 and second edge 2304) of the cutting portion 288 of the cannula shaft 280 to form fully rounded edges or corners or at least dressed edges on the cutting surface 2306 (or a fully rounded and / or dressed cutting surface 2306 without sharp edges).

[0374] For example, a laser 2312 (e.g., a laser beam) can be directed at the cutting surface 2306 and applied for a predetermined amount of time and / or at a predetermined power setting such that the metal at the cutting portion 288 of the cannula shaft 280 melts at the cutting surface 2306 and flows back towards and / or onto the first edge 2302 and second edge 2304 (as shown by the arrow 2320 in Figure 54A until the desired geometry is achieved, such as Figure 54BThe rounded surface 2314 shown. The laser can be applied to the cutting surface one, two, three or more times on the flat edge, the first edge, the second edge, or both edges, more edges to achieve the desired roundness. The rounded surface 2314 can be defined by a first rounded corner 2316 (or edge) at the inner surface 2308 of the cutting portion 288 and a second rounded corner 2318 at the outer surface 2310 of the cutting portion 288. In some examples, the rounded surface 2314 can be a fully rounded surface without sharp corners or edges. For example, the first rounding 2316 and the second rounding 2318 can be continuous with each other and with the inner surface 2308 and the outer surface 2310, such that the rounded surface 2314 is formed as a fully rounded surface along the edge of the cutting portion 288 of the sleeve shaft 280. In some examples, the rounded surface 2314 can curve between the inner surface 2308 and the outer surface 2310.

[0375] Figure 55 An exemplary cutting portion 288 of the sleeve shaft 280 is shown, where a first portion 2326 of the cutting surface 2306 has not been processed (e.g., laser welding or ablation has not been applied), such that the first edge 2302 and the second edge 2304 remain relatively sharp, and a second portion 2328 of the cutting surface 2306 has been processed using a laser (e.g., as described above with reference to Figures 54A - 54B ) As Figure 55 shown, a fully rounded surface 2314 can be achieved using a laser, thereby creating a smoother edge for the cutting portion 288.

[0376] The process described above and shown in Figures 54A - 54B can be referred to as a laser welding reflow process. Although the laser welding reflow process described above can be used to form the rounded surface 2314 (which can be a fully rounded surface or edge in some examples), in other examples, the process can be used to trim the first edge 2302 and the second edge 2304 of the cutting surface 2306 to a selected radius (which may or may not result in a fully rounded edge at the cutting surface 2306). In some examples, such a process can form rounded edges (similar to the first rounded corner 2316 and the second rounded corner 2318), where a flatter surface extends between the rounded edges.

[0377] In other examples, the relatively sharp first edge 2302 and second edge 2304 of the cutting surface 2306 of the cutting portion 288 of the sleeve shaft 280 ( Figure 52 and 53 ) can be rounded and / or trimmed by finishing machining (or finishing bit machining). For example, Figure 56Illustrated is an exemplary finishing process for rounding and / or dressing relatively sharp cutting edges on the cutting surface 2306 (first edge 2302 and second edge 2304) of the cutting portion 288 to form a fully rounded edge or corner or at least a dressed edge on the cutting surface 2306 (or a fully rounded and / or dressed cutting surface 2306 without sharp edges).

[0378] For example, a finishing machine drill bit 2350 can be applied to the cutting surface 2306 and travel along the cutting surface 2306 to dress and / or round the first edge 2302 and the second edge 2304 ( Figure 56 ). In some examples, the finishing machine drill bit 2350 can have a rounding edge 2352 on one or both sides of the finishing machine drill bit 2350 (as Figure 56 shown), and the rounding edge 2352 is sized and shaped to dress and / or produce Figure 54B the rounding edge or surface 2314 (e.g., having a specified radius of curvature) as shown.

[0379] Figure 56 Shown is the finishing machine drill bit 2350 dressing and / or rounding the first (inner) edge 2302 on one side of the cutting portion 288 and the second (outer) edge 2304 on the other opposite side of the cutting portion 288. In this way, in some examples, multiple passes of the finishing machine drill bit 2350 may be required to dress the first edge 2302 and the second edge 2304 on both sides of the cutting portion 288.

[0380] In other examples, the relatively sharp first and second edges 2302 and 2304 of the cutting surface 2306 of the cutting portion 288 of the sleeve shaft 280 ( Figure 52 and 53 ) can be rounded and / or dressed by one or more of shot peening, electropolishing, sinker electrical discharge machining (EDM), electrochemical machining (ECM), and / or burlytic finishing.

[0381] Additional examples of the disclosed technology

[0382] In view of the above-described embodiments of the disclosed subject matter, the present application discloses additional examples listed below. It should be noted that examples having more than one feature obtained by a feature of an example alone or in combination and optionally in combination with one or more features of one or more other examples are also other examples falling within the disclosure of the present application.

[0383] Example 1. A flow mechanism, comprising: a housing that defines at least two flow paths; and at least two paddle gears disposed within the housing and rotatably engaged with each other, each of the at least two paddle gears being fluidly coupled to one of the at least two flow paths and defining a rotation chamber between the housing and an arm of a paddle of the paddle gear, the rotation chamber being configured to meter a predetermined volume of fluid flowing through the flow path to which the paddle gear is fluidly coupled; wherein the flow mechanism is configured to maintain a constant flow rate ratio between the at least two flow paths.

[0384] Example 2. The flow mechanism according to any one of the examples herein (particularly Example 1), wherein the at least two flow paths are fluidly isolated from each other within the flow mechanism.

[0385] Example 3. The flow mechanism according to any one of the examples herein (particularly Example 1 or Example 2), wherein, for each paddle gear, the arm of the paddle of the paddle gear extends radially outward from a central portion of the paddle.

[0386] Example 4. The flow mechanism according to any one of the examples herein (particularly any one of Examples 1-3), wherein, for each paddle gear, each rotation chamber in the rotation chamber is formed between two adjacent arms of the arm of the paddle and a wall of a chamber of the housing in which the paddle gear is disposed.

[0387] Example 5. The flow mechanism according to any one of the examples herein (particularly any one of Examples 1-4), wherein the at least two paddle gears include a first paddle gear and a second paddle gear, the first paddle gear including a first paddle fluidly coupled to a first flow path of the at least two flow paths, and the second paddle gear including a second paddle fluidly coupled to a second flow path of the at least two flow paths.

[0388] Example 6. The flow mechanism according to any one of the examples herein (particularly Example 5), wherein the first paddle gear includes a first gear rotatably coupled to the first paddle, the second paddle gear includes a second gear rotatably coupled to the second paddle, and the teeth of the first gear mesh with the teeth of the second gear.

[0389] Example 7. The flow mechanism according to any one of the examples herein (particularly Example 6), wherein the gear ratio between the first gear and the second gear is 1:1.

[0390] Example 8. The flow mechanism according to any one of the examples herein (particularly Example 6), wherein the gear ratio between the first gear and the second gear is not 1:1, and wherein the diameter of the first gear is different from the diameter of the second gear.

[0391] Example 9. The flow mechanism according to any one of the examples herein (particularly any one of Examples 6-8), wherein the at least two blade gears include a third blade gear, the third blade gear includes a third gear meshingly engaged with one of the first gear and the second gear, and wherein the first blade gear, the second blade gear, and the third blade gear are arranged adjacent to each other within the housing.

[0392] Example 10. The flow mechanism according to any one of the examples herein (particularly any one of Examples 6-9), further comprising a toothed drive gear meshingly engaged with one of the first gear and the second gear, the toothed drive gear being configured to drive the rotation of the at least two blade gears at a selected rate.

[0393] Example 11. The flow mechanism according to any one of the examples herein (particularly Example 5), wherein the first blade and the second blade are rotatably coupled to each other by a common rotatable member of the first blade gear and the second blade gear.

[0394] Example 12. The flow mechanism according to any one of the examples herein (particularly Example 11), wherein the common rotatable member is a first gear having teeth, the teeth of the first gear meshingly engaged with an adjacent second gear, the second gear being rotatably coupled to a third blade and a fourth blade, and wherein the third blade is fluidly coupled to a third flow path of the at least two flow paths, and the fourth blade is fluidly coupled to a fourth flow path of the at least two flow paths.

[0395] Example 13. The flow mechanism according to any one of the examples herein (particularly Example 11), wherein the common rotatable member is a spacer without teeth, the spacer being disposed between the first blade and the second blade.

[0396] Example 14. A system includes: a delivery device including: a first flow lumen having a first resistance; and a second flow lumen having a second resistance less than the first resistance, wherein the second flow lumen is coaxial with and surrounds the first flow lumen; and a flow mechanism configured to provide a fluid having a consistent relative flow rate to the first flow lumen and the second flow lumen and between the first flow lumen and the second flow lumen, the flow mechanism including: a rotatable first paddle gear fluidly coupled to a first flow path defined by a housing of the flow mechanism, the first flow path being fluidly coupled to the first flow lumen; and a rotatable second paddle gear fluidly coupled to a second flow path defined by the housing of the flow mechanism, the second flow path being fluidly coupled to the second flow lumen, wherein rotation of the first paddle gear and rotation of the second paddle gear are correlated by engagement between respective gears of the first paddle gear and the second paddle gear.

[0397] Example 15. The system according to any one of the examples herein (particularly Example 14), wherein the delivery device further includes a first fluid port fluidly coupled to the first flow lumen and a second fluid port fluidly coupled to the second flow lumen, and wherein a first outlet of the first flow path is fluidly coupled to the first fluid port, and a second outlet of the second flow path is fluidly coupled to the second fluid port.

[0398] Example 16. The system according to any one of the examples herein (particularly Example 14 or Example 15), wherein the first flow path and the second flow path of the flow mechanism are fluidly isolated from each other.

[0399] Example 17. The system according to any one of the examples herein (particularly any one of Examples 14 - 16), wherein the first paddle gear includes a first paddle and a first gear rotatably coupled to each other, and wherein the second paddle gear includes a second paddle and a second gear rotatably coupled to each other, each of the first gear and the second gear including teeth that engage with each other.

[0400] Example 18. The system according to any one of the examples herein (particularly Example 17), wherein the first paddle is disposed in a first cavity defined by the housing, and the first flow path extends through the first cavity and extends on each side of the first cavity, and wherein the second paddle is disposed in a second cavity defined by the housing, and the second flow path extends through the second cavity and extends on each side of the second cavity.

[0401] Example 19. A system according to any one of the examples herein (in particular Example 18), wherein a first rotating cavity having a first volume is formed between the arm of the first paddle and the wall of the first cavity, and wherein a second rotating cavity having a second volume is formed between the arm of the second paddle and the wall of the second cavity.

[0402] Example 20. A system according to any one of the examples herein (in particular Example 19), wherein the first volume and the second volume are the same.

[0403] Example 21. A system according to any one of the examples herein (in particular Example 19), wherein the first volume is greater than the second volume.

[0404] Example 22. A system according to any one of the examples herein (in particular any one of Examples 14 - 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.

[0405] Example 23. A system according to any one of the examples herein (in particular any one of Examples 14 - 22), wherein the first flow lumen is defined by the inner surface of the first shaft of the delivery device, and wherein the 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, the first shaft and the second shaft being coaxially arranged within the outer shaft of the delivery device.

[0406] Example 24. A method comprising: flowing a fluid through an inner pusher shaft lumen that extends through the interior of a pusher shaft of a delivery device to a distal end of the pusher shaft, wherein the pusher shaft is coaxially disposed with a cannula shaft of the delivery device and at least partially disposed within the cannula shaft of the delivery device, the cannula shaft and the pusher shaft being disposed within an outer shaft of the delivery device that extends distally from a handle assembly of the delivery device, the cannula shaft including a distal section that surrounds and covers a docking device within the outer shaft; flowing the fluid from the inner pusher shaft lumen into a cannula shaft lumen formed between an outer surface of the docking device and an inner surface of the distal section of the cannula shaft; flowing the fluid through a delivery shaft lumen formed between an outer surface of the cannula shaft and an inner surface of the outer shaft; and maintaining a consistent flow velocity ratio of the fluid to the inner pusher shaft lumen and the delivery shaft lumen and between the inner pusher shaft lumen and the delivery shaft lumen by rotating a first rotatable paddle gear and a second rotatable paddle gear that are meshed with each other together using a single flow mechanism that is fluidly coupled to the inner pusher shaft lumen and the delivery shaft lumen, wherein the first rotatable paddle gear is fluidly coupled to the inner pusher shaft lumen and the second rotatable paddle gear is fluidly coupled to the delivery shaft lumen.

[0407] Example 25. The method according to any one of the examples herein (particularly Example 24), wherein the flow resistance in the inner pusher shaft lumen is greater than the flow resistance in the delivery shaft lumen.

[0408] Example 26. The method according to any one of the examples herein (particularly Example 24 or Example 25), wherein flowing the fluid through the delivery shaft lumen includes flowing the fluid from a first flush port of a conduit coupled to a hub assembly of the delivery device into a first cavity formed between an outer surface of the pusher shaft and an inner surface of the conduit, and flowing the fluid from the first cavity into the delivery shaft lumen.

[0409] Example 27. The method according to any one of the examples herein (particularly Example 26), wherein flowing the fluid through the inner pusher shaft lumen and into the cannula shaft lumen includes flowing the fluid into the inner pusher shaft lumen from a second flush port that is coupled to the conduit proximally of where the first flush port is coupled to the conduit and is in direct fluid communication with the inner pusher shaft lumen.

[0410] Example 28. A method according to any of the examples herein (particularly Example 27), wherein flowing fluid through the pusher shaft lumen comprises providing a fluid at a first flow rate from a first flow path fluidly coupled to the first paddle gear to the second flush port, wherein flowing fluid through the delivery shaft lumen comprises providing a fluid at a second flow rate from a second flow path fluidly coupled to the second paddle gear to the first flush port, and wherein the consistent flow rate ratio of the fluid is the ratio of the first flow rate of the fluid to the second flow rate of the fluid.

[0411] Example 29. A flow throttle valve, comprising: a compressible seal member defining a first hole extending through a length of the compressible seal member, the length being defined in an axial direction relative to a central longitudinal axis of the first hole; and a rigid substrate comprising: a first portion embedded within the compressible seal member, extending through the length of the compressible seal member, and defining a second hole; and a second portion embedded within the compressible seal member and extending outwardly from the first portion and surrounding at least a portion of the first hole.

[0412] Example 30. The flow throttle valve according to any of the examples herein (particularly Example 29), wherein the first hole is radially offset from the second hole such that the central longitudinal axis of the first hole and the central longitudinal axis of the second hole are offset from each other.

[0413] Example 31. The flow throttle valve according to any of the examples herein (particularly Example 29 or Example 30), wherein the first hole has a larger diameter than the second hole.

[0414] Example 32. The flow throttle valve according to any of the examples herein (particularly any one of Examples 29-31), wherein the second portion includes one or more holes defined therein, the one or more holes being configured to increase the bond between the compressible seal member and the rigid substrate.

[0415] Example 33. The flow throttle valve according to any of the examples herein (particularly any one of Examples 29-32), wherein the rigid substrate further includes an extension member that extends axially outwardly from the first portion on one side of the compressible seal member and outside the compressible seal member.

[0416] Example 34. The flow throttle valve according to any of the examples herein (particularly any one of Examples 29-33), wherein the compressible seal member comprises a compressible material and the rigid substrate comprises an incompressible material.

[0417] Example 35. A flow restrictor according to any one of the examples herein (particularly any one of Examples 29 - 34), wherein the compressible seal member comprises silicone.

[0418] Example 36. A flow restrictor according to any one of the examples herein (particularly any one of Examples 29 - 35), wherein the compressible seal member is overmolded onto the first and second portions of the rigid substrate.

[0419] Example 37. A flow restrictor according to any one of the examples herein (particularly any one of Examples 29 - 36), wherein the compressible seal member has a curved outer surface disposed radially outside of the rigid substrate.

[0420] Example 38. A flow restrictor according to any one of the examples herein (particularly any one of Examples 29 - 37), wherein the second portion of the rigid substrate surrounds the entire circumference of the first hole.

[0421] Example 39. A flow restrictor according to any one of the examples herein (particularly any one of Examples 29 - 38), wherein the compressible seal member defines a third hole spaced apart from the first hole.

[0422] Example 40. A flow restrictor according to any one of the examples herein (particularly any one of Examples 29 - 39), wherein the outer surface of the compressible seal member is configured to seal against a first flow conduit of a flow system, and the first hole is configured to seal against a second flow conduit of the flow system.

[0423] Example 41. A delivery device comprising: a first flow conduit defining a first flow lumen having a first resistance; a second flow conduit coaxially disposed with and surrounding the first flow conduit, wherein a second flow lumen is defined between the first flow conduit and the second flow conduit, wherein the second flow lumen has a second resistance less than the first resistance; a fluid port fluidly coupled to the first and second flow lumens and configured to receive fluid; and a flow restrictor disposed downstream of the fluid port and configured to fluidly isolate the first and second flow lumens from each other, the flow restrictor comprising: a compressible seal member defining a first hole that seals around the first flow conduit; and a rigid substrate defining a second hole that fluidly couples the fluid port to the second flow lumen, wherein the compressible seal member is overmolded onto the rigid substrate, and the first hole has a larger diameter than the second hole.

[0424] Example 42. The delivery device according to any one of the examples herein (particularly Example 41), wherein the flow throttle valve is positioned within the second flow lumen, and wherein an outer surface of the compressible seal member is in face-to-face contact with an inner surface of the second flow conduit.

[0425] Example 43. The delivery device according to any one of the examples herein (particularly Example 41 or Example 42), wherein the first flow conduit extends through the first aperture, and wherein an outer surface of the first flow conduit is in face-to-face contact with an inner surface of the compressible seal member defining the first aperture.

[0426] Example 44. The delivery device according to any one of the examples herein (particularly any one of Examples 41-43), wherein the first flow conduit is a proximal extension of a pusher shaft of the delivery device.

[0427] Example 45. The delivery device according to any one of the examples herein (particularly any one of Examples 41-44), wherein the compressible seal member comprises a compressible material, and the rigid substrate comprises an incompressible material.

[0428] Example 46. The delivery device according to any one of the examples herein (particularly any one of Examples 41-45), wherein the rigid substrate comprises an extension member that axially extends outwardly from a side of the compressible seal member and mates with a corresponding recess in the delivery device.

[0429] Example 47. The delivery device according to any one of the examples herein (particularly any one of Examples 41-46), wherein the rigid substrate comprises a first portion and a second portion, the first portion being embedded within the compressible seal member and defining the second aperture, and the second portion being embedded within the compressible seal member and extending circumferentially outwardly from the first portion such that the second portion at least partially surrounds the first aperture.

[0430] Example 48. A delivery device, comprising: an outer shaft configured to hold a prosthetic implant in a delivery configuration; an inner shaft disposed within the outer shaft and configured to engage an end of the prosthetic implant and move axially relative to the outer shaft; and a cannula shaft disposed within the outer shaft, a portion of the cannula shaft being disposed between the outer shaft and the inner shaft, the cannula shaft being configured to cover the prosthetic implant in the delivery configuration; wherein the inner shaft includes one or more openings defined therein, the one or more openings extending between an inner surface and an outer surface of the inner shaft, and the one or more openings being configured to fluidly couple a lumen of the inner shaft with a lumen disposed between an outer surface of the inner shaft and an inner surface of the cannula shaft.

[0431] Example 49. The delivery device according to any one of the examples herein (particularly Example 48), wherein the inner surface and the outer surface of the inner shaft are circumferential surfaces, and a line perpendicular to the inner surface and the outer surface intersects a central longitudinal axis of the delivery device.

[0432] Example 50. The delivery device according to any one of the examples herein (particularly Example 48 or Example 49), wherein the one or more openings are disposed in a distal portion of the inner shaft.

[0433] Example 51. The delivery device according to any one of the examples herein (particularly Example 48 or Example 49), wherein the one or more openings are disposed in a portion of the inner shaft spaced apart from a distal portion of the inner shaft.

[0434] Example 52. The delivery device according to any one of the examples herein (particularly any one of Examples 48 - 51), wherein the one or more openings include at least two openings spaced apart from each other around a circumference of the inner shaft.

[0435] Example 53. The delivery device according to any one of the examples herein (particularly any one of Examples 48 - 52), wherein the inner shaft includes a main tube, a distal section of the main tube including a plurality of incisions spaced apart from each other along a length of the distal section, and wherein the one or more openings are disposed in a portion of the inner shaft disposed adjacent to the distal section.

[0436] Example 54. The delivery device according to any one of the examples herein (particularly Example 53), wherein the one or more openings are configured to extend through the main tube, a liner covering an inner surface of the main tube, and holes in an outer polymer layer covering an outer surface of the main tube.

[0437] Example 55. The delivery device according to any one of the examples herein (particularly Example 53 or Example 54), wherein the main tube of the inner shaft includes an intermediate section adjacent to and disposed proximal to the distal section, and wherein the one or more openings are provided in the intermediate section.

[0438] Example 56. The delivery device according to any one of the examples herein (particularly Example 53 or Example 54), wherein the one or more openings are provided in the distal portion of the inner shaft, the distal portion being adjacent to and disposed distal to the distal section.

[0439] Example 57. The delivery device according to any one of the examples herein (particularly any one of Examples 48 - 50), wherein the one or more openings are one or more slots provided in the distal portion of the inner shaft, and wherein each of the one or more slots extends in a proximal direction from the distal end of the inner shaft to a distance away from the distal end.

[0440] Example 58. The delivery device according to any one of the examples herein (particularly Example 57), wherein the distal portion of the inner shaft includes a polymer distal portion and the distal end of the rigid main tube of the inner shaft, the polymer distal portion including a flexible polymer, the polymer distal portion being disposed distal to the distal end of the main tube, and wherein each slot extends through the polymer distal portion and into the distal end of the main tube.

[0441] Example 59. The delivery device according to any one of the examples herein (particularly Example 57), wherein the distal portion of the inner shaft includes a polymer distal portion and the distal end of the rigid main tube of the inner shaft, the polymer distal portion including a flexible polymer, the polymer distal being disposed distal to the distal end of the main tube, and wherein each slot only extends through the polymer distal portion that is distal to the distal end of the main tube.

[0442] Example 60. The delivery device according to any one of the examples herein (particularly any one of Examples 57 - 59), wherein the one or more slots include a single slot.

[0443] Example 61. The delivery device according to any one of the examples herein (particularly any one of Examples 57 - 59), wherein the one or more slots include two slots spaced apart from each other around the circumference of the distal portion.

[0444] Example 62. The delivery device according to any one of the examples herein (particularly Example 61), wherein the two slots are disposed spaced 180 degrees apart from each other around the circumference of the distal portion.

[0445] Example 63. A delivery device according to any one of the examples herein (in particular any one of Examples 57 - 62), wherein each slot has a uniform width along the axial length of the slot.

[0446] Example 64. A delivery device according to any one of the examples herein (in particular any one of Examples 57 - 62), wherein each slot has a width that increases from the distal end to the proximal end of the slot.

[0447] Example 65. A delivery device according to any one of the examples herein (in particular any one of Examples 48 - 50), wherein the inner shaft includes a distal tip disposed around a distal portion of the main tube of the inner shaft, wherein the distal tip is at least partially covered by a flexible polymer layer that also covers the main tube, the distal tip includes a tip portion that extends distally past the main tube and the flexible polymer layer that includes the one or more openings therein.

[0448] Example 66. A delivery device according to any one of the examples herein (in particular Example 65), wherein the one or more openings are configured as holes spaced apart from each other around the circumference of the tip portion of the distal tip.

[0449] Example 67. A delivery device according to any one of the examples herein (in particular Example 65 or Example 66), wherein the distal tip includes an extruded or molded polymeric material.

[0450] Example 68. A delivery device according to any one of the examples herein (in particular any one of Examples 48 - 50), wherein the one or more openings are provided in a polymeric tip of the inner shaft, the polymeric tip being disposed at the distal end of the inner shaft.

[0451] Example 69. A delivery device according to any one of the examples herein (in particular Example 68), wherein the inner shaft includes a main tube, an outer polymeric layer covering the outer surface of the main tube, and a lining covering the inner surface of the main tube, and wherein the polymeric tip is continuous with the outer polymeric layer and extends distally past the distal end of the main tube.

[0452] Example 70. A delivery device according to any one of the examples herein, further comprising a cannula shaft, the cannula shaft including: a proximal section that includes a rigid material and includes a tubular portion and a cutting portion, the cutting portion extending proximally from the tubular portion and having a cross - section that is an incomplete circle such that the cutting portion forms an open channel with a cutting surface at each end of the cutting portion and defines a void space for the open channel therebetween, wherein the cutting surface has a rounded inner edge and outer edge.

[0453] Example 71. The delivery device according to any example herein (particularly Example 70), wherein the cutting surface is fully rounded such that the rounded inner and outer edges are continuous with each other and with the inner and outer surfaces of the cutting portion.

[0454] Example 72. The delivery device according to any example herein (particularly Example 70 or Example 71), wherein the cutting portion is configured to receive a portion of the pusher shaft, and wherein the void space of the cutting portion of the cannula shaft is configured to receive a flexible proximal extension of the pusher shaft therethrough.

[0455] Example 73. The delivery device according to any example herein (particularly any one of Examples 70 - 72), wherein the proximal section of the cannula shaft comprises metal.

[0456] Example 74. The delivery device according to any example herein (particularly any one of Examples 70 - 73), wherein the cutting surface and the rounded inner and outer edges are trimmed.

[0457] Example 75. A cannula shaft for a delivery device, comprising: a tubular portion having a circular cross - section; and a cutting portion extending proximally from the tubular portion and having a cross - section that is an incomplete circle such that the cutting portion forms an open channel having a cutting surface at each end thereof and defines an opening of the open channel therebetween, wherein the cutting surface has rounded inner and outer edges.

[0458] Example 76. The cannula shaft according to any example herein (particularly Example 75), wherein the cutting surface is fully rounded such that the rounded inner and outer edges are continuous with each other and with the inner and outer surfaces of the cutting portion.

[0459] Example 77. The cannula shaft according to any example herein (particularly Example 75), wherein the inner and outer edges are rounded to a predetermined radius, and wherein a planar portion of the cutting surface extends between the rounded inner and outer edges.

[0460] Example 78. The cannula shaft according to any example herein (particularly any one of Examples 75 - 77), wherein the rounded inner and outer edges are reflow edges formed by laser welding.

[0461] Example 79. The cannula shaft according to any example herein (particularly any one of Examples 75 - 77), wherein the rounded inner and outer edges are formed by finishing machining using a finishing machine drill.

[0462] Example 80. A cannula shaft according to any one of the examples herein (in particular any one of Examples 75 - 78), wherein the cutting portion of the cannula shaft comprises metal.

[0463] Example 81. A method of forming a cannula shaft of a delivery device, comprising: cutting a proximal section of a tube of the cannula shaft to form a cutting portion of the cannula shaft, the cutting portion having a C-shaped cross-section and an opening into the interior of the cutting portion, the cutting portion having cutting surfaces on each side of the opening; and rounding the inner and outer edges of each cutting surface by applying a laser to the cutting surfaces until the metal of the cutting surfaces melts and flows back over the inner and outer edges.

[0464] Example 82. The method according to any one of the examples herein (in particular Example 81), wherein rounding the inner and outer edges of each cutting surface by applying the laser forms a fully rounded surface that curves between the inner and outer surfaces of the cutting portion.

[0465] Example 83. The method according to any one of the examples herein (in particular Example 81), wherein rounding the inner and outer edges of each cutting surface by applying the laser comprises trimming the inner and outer edges to a selected radius.

[0466] Example 84. The method according to any one of the examples herein (in particular any one of Examples 81 - 83), wherein cutting the proximal section of the tube of the cannula shaft comprises cutting the proximal section of the tube by electrical discharge machining, and wherein the inner and outer edges of the cutting surfaces are angled and sharp after the cutting and before the rounding.

[0467] Example 85. A method of forming a cannula shaft of a delivery device, comprising: cutting a proximal section of a tube of the cannula shaft to form a cutting portion of the cannula shaft, the cutting portion having a C-shaped cross-section and an opening into the interior of the cutting portion, the cutting portion having cutting surfaces on either side of the opening; and rounding the inner and outer edges of each cutting surface by applying a finishing drill bit to the cutting surfaces.

[0468] Example 86. A delivery device, comprising: an outer shaft configured to hold a prosthetic implant in a delivery configuration; an inner shaft disposed within the outer shaft and configured to engage an end portion of the prosthetic implant and move axially relative to the outer shaft, the inner shaft including: a rigid main tube; and a polymeric distal portion including a flexible polymer and extending distally of the main tube, wherein the polymeric distal portion includes one or more holes defined therein, the one or more holes extending between an inner surface and an outer surface of the polymeric distal portion; and a cannula shaft disposed within the outer shaft, a portion of the cannula shaft being disposed between the outer shaft and the inner shaft, the cannula shaft being configured to cover the prosthetic implant in the delivery configuration.

[0469] Example 87. The delivery device according to any one of the examples herein (in particular Example 86), wherein the inner shaft further includes an outer polymeric layer covering an outer surface of the main tube and continuous with the polymeric distal portion.

[0470] Example 88. The delivery device according to any one of the examples herein (in particular Example 86 or Example 87), wherein the inner shaft further includes a liner covering an inner surface of the polymeric distal portion and an inner surface of the main tube, and wherein the one or more holes extend through the liner.

[0471] Example 89. The delivery device according to any one of the examples herein (in particular any one of Examples 86-88), wherein the one or more holes include three holes spaced apart from each other circumferentially around the polymeric distal portion.

[0472] Example 90. The delivery device according to any one of the examples herein (in particular any one of Examples 86-89), wherein the one or more holes are configured to fluidly couple an inner lumen of the inner shaft to a lumen disposed between an outer surface of the inner shaft and an inner surface of the cannula shaft.

[0473] Example 91. A delivery device, comprising: an outer shaft configured to hold a prosthetic implant in a delivery configuration; an inner shaft disposed within the outer shaft and configured to engage an end of the prosthetic implant and move axially relative to the outer shaft, the inner shaft comprising: a rigid main tube having a distal portion covered by an outer polymer layer; a polymer distal portion comprising a flexible polymer disposed distally of the main tube and continuous with the outer polymer layer; and one or more holes extending between an outer surface and an inner surface of the inner shaft, through the outer polymer layer and the main tube; and a cannula shaft disposed within the outer shaft, a portion of the cannula shaft disposed between the outer shaft and the inner shaft, the cannula shaft configured to cover the prosthetic implant in the delivery configuration.

[0474] Example 92. The delivery device according to any one of the examples herein (in particular Example 91), wherein the inner shaft further comprises a liner covering an inner surface of the polymer distal portion and an inner surface of the main tube, and wherein the one or more holes extend through the liner.

[0475] Features described in connection with any one example herein can be combined with any one or more of the other features described in any of the other examples, 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. As another example, 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 the delivery device.

[0476] Given the many possible ways in which the principles of the present disclosure can be applied, it should be appreciated that the illustrated configurations depict examples of the disclosed technology and should neither be regarded as limiting the scope of the present disclosure nor as limiting the scope of the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

1. A flow throttle valve, characterized in that, It includes: A compressible seal member that defines a first hole extending through the length of the compressible seal member, with the length defined in the axial direction relative to the central longitudinal axis of the first hole; And A rigid substrate that includes: A first portion that is embedded within the compressible seal member, extends through the length of the compressible seal member, and defines a second hole; And A second portion that is embedded within the compressible seal member and extends outwardly from the first portion and surrounds at least a portion of the first hole.

2. The flow throttle valve according to claim 1, characterized in that, The first hole is radially offset from the second hole such that the central longitudinal axis of the first hole and the central longitudinal axis of the second hole are offset from each other.

3. The flow throttle valve according to claim 1 or claim 2, characterized in that, The first hole has a larger diameter than the second hole.

4. The flow throttle valve according to claim 1, characterized in that, The second portion includes one or more holes defined therein, and the one or more holes are configured to increase the bond between the compressible seal member and the rigid substrate.

5. The flow throttle valve according to claim 1, characterized in that, The rigid substrate further includes an extension member that is on one side of the compressible seal member and extends axially outwardly from the first portion outside the compressible seal member.

6. The flow throttle valve according to claim 1, characterized in that, The compressible seal member is overmolded onto the first portion and the second portion of the rigid substrate.

7. The flow throttle valve according to claim 1, characterized in that, The compressible seal member has a curved outer surface disposed radially outside the rigid substrate.

8. The flow throttle valve according to claim 1, wherein, The second portion of the rigid substrate surrounds the entire circumference of the first hole.

9. The flow throttle valve according to claim 1, characterized in that, The compressible seal member defines a third hole spaced apart from the first hole.

10. The flow throttle valve according to claim 1, characterized in that, The outer surface of the compressible seal member is configured to seal against a first flow conduit of a flow system, and the first hole is configured to seal against a second flow conduit of the flow system.

11. A delivery device, characterized in that, It includes: A first flow conduit that defines a first flow lumen having a first resistance; A second flow conduit that is coaxially arranged with and surrounds the first flow conduit, wherein a second flow lumen is defined between the first flow conduit and the second flow conduit, and wherein the second flow lumen has a second resistance that is less than the first resistance; A fluid port that is in fluid communication with the first flow lumen and the second flow lumen and is configured to receive fluid; and A flow throttle valve that is disposed downstream of the fluid port and is configured to fluidly isolate the first flow lumen and the second flow lumen from each other, the flow throttle valve including: A compressible seal member that defines a first hole that seals around the first flow conduit; and A rigid substrate that defines a second hole that fluidly communicates the fluid port with the second flow lumen, wherein the compressible seal member is overmolded onto the rigid substrate, and the first hole has a larger diameter than the second hole.

12. The delivery device according to claim 11, wherein, The flow throttle valve is positioned within the second flow lumen, wherein the outer surface of the compressible seal member is in face-to-face contact with the inner surface of the second flow conduit.

13. The delivery device according to claim 11 or claim 12, characterized in that, The first flow conduit extends through the first aperture, and wherein an outer surface of the first flow conduit is in face-to-face contact with an inner surface of the compressible seal member that defines the first aperture.

14. The delivery device according to claim 11, wherein, The first flow conduit is a proximal extension of a pusher shaft of the delivery device.

15. The delivery device according to claim 11, wherein, The rigid substrate includes an extension member that axially extends outwardly from a side of the compressible seal member and mates with a corresponding recess in the delivery device.

16. The delivery device according to claim 11, characterized in that, The rigid substrate includes a first portion and a second portion, the first portion being embedded within the compressible seal member and defining the second aperture, the second portion being embedded within the compressible seal member and extending circumferentially outwardly from the first portion such that the second portion at least partially surrounds the first aperture.

Images