Fluid seal mechanism for a catheter

Abstract

The present application is entitled "Fluid Sealing Mechanism for Catheters". Apparatus and methods for selectively directing fluid flow through a lumen of a catheter for effective flushing and / or de-aeration of a designated lumen of the catheter are disclosed. As one example, an assembly includes a catheter including a first shaft and a second shaft extending through the first shaft. The assembly further includes a sealing mechanism including a first seal disposed about a distal portion of the first shaft, a second seal disposed about a portion of the second shaft extending distally of the first shaft, and a cavity disposed within a housing of the sealing mechanism between the first seal and the second seal. A distal end of the first shaft is disposed within the cavity and the cavity is fluidly sealed by the first seal and the second seal such that fluid from a first lumen of the first shaft cannot exit the cavity.

Description

[0001] Cross-referencing related applications

[0002] This application claims the benefits of U.S. Provisional Applications No. 63 / 366,517, filed June 16, 2022; No. 63 / 368,453, filed July 14, 2022; and No. 63 / 371,463, filed August 15, 2022, each of which is incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure relates to a delivery device for a docking apparatus configured to fix an artificial valve at an autologous heart valve. Background Technology

[0004] The human heart can suffer from a variety of valvular diseases. These valvular diseases can lead to significant dysfunction of the heart and ultimately require repair of the original valve or replacement with an artificial valve. There are many known repair devices (such as stents) and artificial valves, as well as many known methods for implanting these devices and valves into the human body. Percutaneous and minimally invasive surgical methods are used in various procedures to deliver artificial medical devices into locations within the body that are not easily accessible surgically or that are desired to be accessible without surgery. In a specific example, an artificial heart valve may be mounted in a coiled state on the distal end of a delivery device and advanced through the patient's vascular system (e.g., through the femoral artery and aorta) until the artificial valve reaches the implantation site in the heart. Then, for example, by inflating a balloon on which the artificial valve is mounted, a mechanical actuator is actuated to apply an expansion force to the artificial valve, or by deploying the artificial valve from the sheath of the delivery device, allowing the artificial valve to self-expand to its functional size.

[0005] Artificial heart valves can be appropriately sized for placement within numerous autologous aortic valves. However, autologous mitral and tricuspid valves may have different geometries than typical aortic valves. The anatomy of the mitral and tricuspid valves also varies significantly from person to person. Therefore, it may be difficult to appropriately size and shape an artificial heart valve for a wide range of patients. Furthermore, when addressing valvular regurgitation, the surrounding tissue at the target implantation site (e.g., the autologous valve annulus) may not be strong enough to hold certain types of valves in place as needed.

[0006] In some examples, the docking device may be implanted first within the autologous valve and can be configured to receive and anchor the artificial heart valve (e.g., anchor) it in the desired location within the autologous valve. For example, the docking device may form a more rounded and / or more stable anchoring site at the autologous valve annulus, where the artificial heart valve can expand and be implanted. A transcatheter delivery device can be used to deliver the docking device to the implantation site. The docking device may be arranged within the delivery device and coaxial with additional components of the delivery device. Multiple lumens may be positioned between the coaxial components of the delivery device, and flushing fluid may be supplied to these lumens before and during the implantation procedure to flush and degas them. For example, the docking device may be covered by a sleeve shaft within the outer shaft of the delivery device, and lumens may be formed between the outer shaft and the sleeve shaft, and between the sleeve shaft and the docking device. In some cases, degassing of the sleeve shaft lumen may be necessary to remove air around the docking device. Summary of the Invention

[0007] This document describes a docking device, an artificial heart valve, a delivery device, and a method for implanting the docking device and the artificial heart valve within it. Examples of flow mechanisms or components are also described, which can be used to selectively guide fluid flow through the lumen of a catheter to effectively flush and / or degas a designated lumen and / or component of the delivery device. In some examples, the catheter is part of the delivery device and includes a docking device disposed within an outer shaft of the delivery device and a sleeve shaft extending through and covering the docking device. The docking device can be configured to receive the artificial heart valve after delivery to the implantation site using the delivery device. The flow mechanisms or components described herein can be coupled to a distal portion of the delivery device and configured to guide fluid flow through the lumen of the sleeve shaft, thereby degassing the docking device prior to the implantation procedure.

[0008] The sealing mechanism may include a housing comprising a cavity and a step disposed within the cavity, the step reducing the diameter of the cavity from a larger diameter portion to a smaller diameter portion.

[0009] In some examples, the sealing mechanism may also include a first seal disposed within the housing at the larger diameter portion of an adjacent cavity and on the proximal side of the larger diameter portion, and a second seal disposed within the housing at the smaller diameter portion of an adjacent cavity and on the distal side of the smaller diameter portion.

[0010] In some examples, the housing may include a first sealing housing and a second sealing housing, wherein the first seal is disposed in the first sealing housing and the second seal is disposed in the second sealing housing.

[0011] In some examples, the first seal is a compressible gasket, and the second seal is an O-ring.

[0012] In some examples, the first seal is an O-ring, and the second seal is an O-ring.

[0013] In some examples, the first and second seals are annular, and the inner diameter of the first seal is larger than the inner diameter of the second seal.

[0014] In some examples, the sealing mechanism includes a first sealing housing and a second sealing housing, wherein a first seal is disposed within the first sealing housing and a second seal is disposed within the second sealing housing. A proximal portion of the second sealing housing includes a step that transitions between a first diameter on a proximal side of the step and a second diameter on a distal side of the step, the second diameter being smaller than the first diameter, and the step being disposed proximal to the second seal. The sealing mechanism also includes a cavity defined within the distal portion of the first sealing housing and the proximal portion of the second sealing housing, located between the first seal and the second seal.

[0015] In some examples, the sealing mechanism includes a housing comprising a cavity and a step disposed within the cavity, the step reducing the diameter of the cavity from a larger diameter portion to a smaller diameter portion. The sealing mechanism also includes a first seal disposed within the housing adjacent to and proximal to the larger diameter portion of the cavity, and a second seal disposed within the housing adjacent to and distal to the smaller diameter portion of the cavity.

[0016] In some examples, the sealing mechanism includes: a housing including a cavity and a step disposed within the cavity, the step reducing the diameter of the cavity from a larger diameter portion to a smaller diameter portion; a first seal disposed within the housing, adjacent to and proximal to the larger diameter portion of the cavity; and a second seal disposed within the housing, adjacent to and distal to the smaller diameter portion of the cavity.

[0017] In some examples, the sealing mechanism includes a sealing housing comprising a body portion, wherein an inner surface of the body portion defines a first cavity, and wherein the body portion includes at least one curved groove extending through the body portion from an outer surface to the inner surface. The sealing housing further includes: a seal disposed within a portion of the first cavity of the sealing housing, wherein the seal includes a lumen configured to receive a shaft assembly of an artificial implant delivery device; a locking member including an outer wall and an inner wall having a second cavity defined therebetween in a radial direction, wherein the body portion of the sealing housing extends into and is rotatable within the second cavity of the locking member; and at least one pin engaged with the inner wall and configured to extend into and slide along the at least one curved groove. The sealing housing and the locking member are rotatable relative to each other between an unlocked configuration and a locked configuration. In the unlocking configuration, the at least one pin is located at a first end of the at least one curved groove, while in the locking configuration, the at least one pin is located at a second opposite end of the at least one curved groove, and the seal is axially compressed between the seal housing and the locking member, such that the diameter of the seal cavity is reduced relative to the unlocking configuration in the locking configuration.

[0018] In some examples, the sealing mechanism includes one or more components as described in Examples 21-23, 70-79 and 98-114 below.

[0019] Components may include conduits or delivery devices and sealing mechanisms.

[0020] In some examples, the conduit may include a first axis and a second axis extending through the first axis.

[0021] In some examples, a lumen is defined between the inner surface of the first shaft and the outer surface of the second shaft.

[0022] In some examples, the sealing mechanism may include a first seal disposed around a distal portion of a first axis, a second seal disposed around a second axis extending distal to the first axis, and a cavity disposed within the housing of the sealing mechanism between the first seal and the second seal.

[0023] In some examples, the distal end of the first shaft is disposed within the cavity, and the cavity is fluid-sealed by a first seal and a second seal.

[0024] In some examples, the component may also include an implantable medical device located in the distal portion of the second axis in the delivery configuration.

[0025] In some examples, the sealing mechanism may include first and second members that are pivotable relative to each other between an open configuration and a closed configuration, wherein the first and second members are configured to receive and seal a second shaft therebetween when in the closed configuration.

[0026] In some examples, the sealing mechanism may include a first member and a second member that are pivotable relative to each other between an open configuration and a closed configuration, wherein the first member and the second member are configured to receive and seal a second shaft therebetween when in the closed configuration.

[0027] In some examples, the component includes a conduit comprising a first shaft and a second shaft extending through the first shaft. A first lumen is defined between an inner surface of the first shaft and an outer surface of the second shaft. The component also includes a sealing mechanism comprising a first seal disposed around a distal portion of the first shaft, a second seal disposed around a distally extending portion of the second shaft, and a cavity disposed within a housing of the sealing mechanism between the first and second seals. The distal end of the first shaft is disposed within the cavity, and the cavity is fluid-sealed by the first and second seals such that fluid from the first lumen cannot exit the cavity.

[0028] In some examples, the component includes a delivery device. The delivery device includes a first shaft, a second shaft extending through the first shaft, wherein a first lumen is defined between an inner surface of the first shaft and an outer surface of the second shaft, and a second lumen is defined by the second shaft, wherein the first lumen and the second lumen are fluidly connected to each other. The component also includes an implantable medical device disposed within a distal portion of the second shaft in the delivery configuration, and a sealing mechanism. The sealing mechanism includes a housing, a first seal disposed within the housing and surrounding a distal portion of the first shaft, a second seal disposed within the housing and surrounding a distal portion of the second shaft, and a cavity disposed within the housing and defined between the first seal and the second seal. The distal end of the first shaft is disposed within the cavity, the distal end of the second shaft extends distal to the distal end of the first shaft and the second seal, and the cavity is fluidly sealed by the first seal and the second seal.

[0029] In some examples, the component includes a conduit comprising a first shaft and a second shaft extending through the first shaft, wherein a distal portion of the second shaft may extend distally to the first shaft. The component also includes a sealing mechanism comprising first and second members pivotable relative to each other between an open configuration and a closed configuration, wherein the first and second members are configured to receive and seal the second shaft therebetween in the closed configuration. The sealing mechanism also includes a tube fluidly connected to a lumen defined by the first and second members. One end of the tube includes an attachment configured to receive a suction tool for aspirating fluid through the second shaft.

[0030] In some examples, a component includes: a conduit including a first shaft and a second shaft extending through the first shaft, wherein a distal portion of the second shaft may extend distally to the first shaft; and a sealing mechanism including: a first member and a second member pivotable relative to each other between an open configuration and a closed configuration, wherein the first member and the second member are configured to receive and seal the second shaft therebetween when in the closed configuration; and a tube fluidly connected to a lumen defined by the first and second members, wherein one end of the tube includes an attachment configured to receive a suction tool for aspirating fluid through the second shaft.

[0031] In some examples, the component includes a conduit comprising a first shaft and a second shaft extending through the first shaft, wherein a distal portion of the second shaft may extend distally to the first shaft. The component also includes a sealing mechanism comprising a seal disposed around the distal portion of the second shaft and a seal housing comprising a cylindrical body portion, wherein an inner surface of the cylindrical body portion defines a first cavity, and wherein the seal is disposed within the first cavity. The sealing mechanism further includes a locking member comprising an annular outer wall and an annular inner wall defining the second cavity therebetween in a radial direction, wherein the cylindrical body portion extends into and is rotatable within the second cavity, and wherein the seal housing and the locking member are configured to receive the second shaft passing therethrough. The seal housing and the locking member are rotatable relative to each other between an unlocked configuration and a locked configuration. In the locked configuration, the seal is axially compressed between the seal housing and the locking member and radially compressed about the second shaft.

[0032] In some examples, the components include one or more parts as described in Examples 1-20, 54-69 and 80-97 below.

[0033] A method for flushing a catheter may include: positioning a first seal of a sealing mechanism around a distal portion of a first shaft of the catheter; positioning a second seal of the sealing mechanism around a distal portion of a second shaft of the catheter extending through the first shaft; and allowing fluid to flow through the catheter such that the fluid flows out only from a second lumen defined by the second shaft.

[0034] In some examples, the distal portion of the second axis extends distally to the distal end of the first axis.

[0035] In some examples, the method includes fastening a first seal around a distal portion of a first axis and fastening a second seal around a distal portion of a second axis.

[0036] In some examples, allowing fluid to flow through the conduit may also include preventing fluid from flowing out of a second lumen defined between the outer surface of the second shaft and the inner surface of the first shaft.

[0037] In some examples, a method for flushing a conduit includes: attaching a first seal of a sealing mechanism to a distal portion of a first shaft of the conduit; attaching a second seal of the sealing mechanism to a distal portion of a second shaft of the conduit extending through the first shaft, wherein the distal portion of the second shaft extends distal to the distal end of the first shaft; and allowing fluid to flow through the conduit such that fluid flows out only from a second lumen defined by the second shaft and is prevented from flowing out from a first lumen defined between an outer surface of the second shaft and an inner surface of the first shaft.

[0038] In some examples, a method for flushing a conduit includes extending a distal portion of a first shaft of the conduit through a first seal disposed in a first seal housing of a sealing mechanism and into a cavity disposed within a first seal housing and a second seal housing of the sealing mechanism, the cavity being defined between the first seal and a second seal housing. The method further includes: extending a distal portion of the second shaft of the conduit through a distal end of the first shaft and extending distal to the distal end of the first shaft and through a second seal disposed within the second seal housing; securing the first seal around the distal portion of the first shaft and securing the second seal around the distal portion of the second shaft; and allowing fluid to flow through the conduit such that fluid flows out only from a first cavity defined by the second shaft and is prevented from flowing out from a second cavity defined between an outer surface of the second shaft and an inner surface of the first shaft.

[0039] In some examples, one approach includes one or more features described in Examples 33-53 and 115 below.

[0040] The various innovations disclosed herein can be used in combination or individually. This summary is provided to introduce some concepts in a simplified form, which will be further described in the detailed description below. This summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of this disclosure will become more apparent from the following detailed description, claims, and drawings. Attached Figure Description

[0041] Figure 1 The illustration schematically depicts the first stage of an exemplary mitral valve replacement surgery, in which a guiding catheter and guidewire are inserted into the patient's blood vessel and guided through the vessel and into the patient's heart, toward the patient's own mitral valve.

[0042] Figure 2A The illustration schematically depicts the second stage of an exemplary mitral valve replacement surgery, in which a docking device delivery device extending through a guiding catheter implants a docking device for an artificial heart valve at the autologous mitral valve.

[0043] Figure 2B The illustration schematically depicts the third stage of an exemplary mitral valve replacement surgery, in which... Figure 2A The docking device was fully implanted into the patient's own mitral valve, and the docking device delivery device was removed from the patient.

[0044] Figure 3A The illustration schematically depicts the fourth stage of an exemplary mitral valve replacement surgery, in which an artificial heart valve is implanted into an implantation docking device located at the autologous mitral valve via an artificial heart valve delivery device extending through a guide catheter.

[0045] Figure 3B The fifth stage of an exemplary mitral valve replacement surgery is illustrated schematically, in which the artificial heart valve is fully implanted into the docking device located at the patient's own mitral valve, and the artificial heart valve delivery device has been removed from the patient.

[0046] Figure 4 The illustration schematically depicts the sixth stage of an exemplary mitral valve replacement procedure, where the guiding catheter and guidewire have been removed from the patient.

[0047] Figure 5 This is a side perspective view of a docking device in a spiral configuration, based on an example.

[0048] Figure 6 This is a side view of an exemplary delivery device for a docking apparatus, the delivery device including a handle assembly and an outer shaft extending distally from the handle assembly, the outer shaft being configured to accommodate the docking apparatus therein in a delivery configuration.

[0049] Figure 7 yes Figure 6 A perspective view of the distal portion of a delivery device, showing an exemplary docking device deployed from the outer shaft of the delivery device and covered by the sleeve shaft of the delivery device.

[0050] Figure 8 yes Figure 6 A perspective view of the distal portion of the delivery device, showing its deployment from the outer axis of the delivery device. Figure 7 An exemplary docking device in which the sleeve shaft is removed from the docking device.

[0051] Figure 9 yes Figure 6 A schematic cross-sectional view of the delivery device shows the fluid flow from the first flushing port through multiple fluid connection cavities of the delivery device.

[0052] Figure 10 yes Figure 6 Another schematic cross-sectional view of the delivery device shows the fluid flow from the second flushing port through multiple fluid connection cavities of the delivery device.

[0053] Figure 11 This is a side view of an exemplary sealing mechanism for a catheter, configured to regulate fluid flow through two axes of the catheter, shown as coupled to... Figure 6 The outer shaft and sleeve shaft of the delivery device.

[0054] Figure 12 yes Figure 11 First end view of the sealing mechanism.

[0055] Figure 13 yes Figure 11 The second end view of the sealing mechanism.

[0056] Figure 14 yes Figure 11 A cross-sectional side view of the sealing mechanism, showing the connection to Figure 6 The sealing mechanism of the outer shaft and sleeve shaft of the delivery device.

[0057] Figure 15 Show Figure 11 A cross-sectional perspective view of the sealing mechanism.

[0058] Figure 16 Show Figure 11 Exploded view of the sealing mechanism.

[0059] Figure 17 It is a flowchart of a method for selectively guiding fluid flow through a conduit comprising multiple shafts that are at least partially concentric with each other, using a sealing mechanism.

[0060] Figure 18This is a perspective view of an exemplary sealing mechanism for a catheter, configured to regulate fluid flow through two axes of the catheter, the sealing mechanism including a compressible seal and an O-ring seal.

[0061] Figure 19 yes Figure 18 Exploded view of the sealing mechanism.

[0062] Figure 20 yes Figure 18 A cross-sectional side view of the sealing mechanism.

[0063] Figure 21 yes Figure 18 Another sealing mechanism is shown connected to Figure 6 The sealing mechanism of the outer shaft and sleeve shaft of the delivery device.

[0064] Figure 22 This is a perspective view of an exemplary sealing mechanism for a catheter, configured to regulate fluid flow through two axes of the catheter, the sealing mechanism comprising two O-ring seals.

[0065] Figure 23 yes Figure 22 A cross-sectional side view of the sealing mechanism.

[0066] Figure 24 yes Figure 18 A cross-sectional side view of the sealing mechanism, which also includes an additional cavity and attachments for the shaft of the aspiration catheter.

[0067] Figure 25 This is a perspective view of an exemplary sealing mechanism used to seal to a shaft of a conduit and draw fluid out of the shaft.

[0068] Figure 26 It is in a closed configuration. Figure 25 A perspective view of the sealing mechanism.

[0069] Figure 27 It is a perspective view of a sealing mechanism used to seal a shaft to a conduit and to draw fluid out of the shaft or flush fluid through the shaft.

[0070] Figure 28 yes Figure 27 Exploded view of the sealing mechanism.

[0071] Figure 29A yes Figure 27 First perspective view of the locking cap of the sealing mechanism.

[0072] Figure 29B yes Figure 29A The second perspective view of the locking cap.

[0073] Figure 29C yes Figure 29A Side view of the locking cap.

[0074] Figure 30A yes Figure 27 A side perspective view of the sealing housing of the sealing mechanism.

[0075] Figure 30B yes Figure 27 Perspective view of the end of the sealing housing.

[0076] Figure 31 yes Figure 27 A side view of the seal of the sealing mechanism.

[0077] Figure 32A It is in unlocked configuration. Figure 27 Side view of the sealing mechanism.

[0078] Figure 32B It is configured as a lock. Figure 27 Side view of the sealing mechanism.

[0079] Figure 33A It is in unlocked configuration. Figure 32A A cross-sectional side view of the sealing mechanism.

[0080] Figure 33B It is configured as a lock. Figure 32B A cross-sectional side view of the sealing mechanism.

[0081] Figure 34 This is a perspective view of the sealing mechanism that connects the shaft to the suction tool and the catheter to be suctioned. Detailed Implementation

[0082] General Considerations

[0083] For the purposes of this specification, certain aspects, advantages, and novel features of embodiments of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Rather, this disclosure relates to all novel and non-obvious features and aspects of various disclosed embodiments, individually and in various combinations and sub-combinations with each other. The methods, apparatus, and systems are not limited to any particular aspect or feature or combination thereof, nor are the disclosed embodiments required to have any one or more particular advantages or problems solved.

[0084] Although the operations of some disclosed instances are described in a specific order for ease of presentation, it should be understood that this description includes rearrangement unless the specific language described below requires a particular order. For example, operations described sequentially may be rearranged or performed concurrently in some cases. Furthermore, for simplicity, the accompanying drawings may not show the various ways in which the disclosed methods can be combined with other methods. Additionally, this specification sometimes uses terms such as "provides" or "implements" 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 are readily discernible to those skilled in the art.

[0085] As used in this application and claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly specifies otherwise. Additionally, the term “comprising” means “including.” Furthermore, the term “link” generally refers to a physical, mechanical, chemical, magnetic, and / or electrical connection or link, and in the absence of specific contrasting language, does not exclude the presence of intermediate elements between linked or associated items.

[0086] As used herein, the term "proximal" refers to a location, orientation, or portion of the device that is closer to the user and further away from the implantation site. As used herein, the term "distal" refers to a location, orientation, or portion of the device that is further away from the user and closer to the implantation site. Thus, for example, proximal movement of the device is movement of the device away from the implantation site and toward the user (e.g., away from the patient's body), while distal movement of the device is movement of the device away from the user and toward the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions, unless otherwise explicitly defined.

[0087] As used in this article, “for example” means “for instance”, and “that is” means “in other words”.

[0088] Introduction to the Disclosed Technology

[0089] As described above, the delivery device can be used to deliver a docking device for an artificial heart valve to a target implantation site (e.g., an autologous valve annulus). The docking device can be arranged in a relatively straight (e.g., unwound) delivery configuration within the distal portion of the outer shaft of the delivery device. In some cases, a portion of the docking device may include a retractable and expandable external protective member. Additionally, a sleeve shaft of the delivery device may extend through the outer shaft and be positioned around (and cover) the docking device. Multiple lumens are formed within the delivery device, including a first lumen between the outer shaft and the sleeve shaft, and a second lumen within the sleeve shaft (e.g., between the sleeve shaft and the docking device). These lumens can be flushed and degassed before the delivery device is introduced into the patient. However, because the first and second lumens are fluidly connected to each other, flushing fluid applied to one or more of these lumens may not generate sufficient flushing pressure to be applied to the second lumen to adequately degassed the protective member of the docking device. Therefore, there is a need for improved flushing and degassed procedures for catheters and delivery devices with multiple fluidly connected lumens. For example, such improvements can enable the sleeve shaft cavity and docking device to be effectively and adequately degassed before the implantation procedure.

[0090] This document describes delivery devices, or various systems, apparatuses, methods, etc., that can be used in conjunction with artificial medical devices (e.g., docking devices for artificial heart valves) in some examples. In some examples, such systems, apparatuses, and / or methods may provide a system and / or method for selectively directing fluid flow through a catheter (e.g., a delivery device) comprising a plurality of shafts (or one shaft at least partially arranged within another) that are at least partially concentric with each other in order to flush and degas a designated lumen of the catheter.

[0091] In some examples, the docking device delivery device disclosed herein can be used to deliver the docking device to a target implantation site within a patient. For example, Figures 1-4 An exemplary transcatheter heart valve replacement procedure is illustrated, which utilizes a guiding catheter to guide a docking device delivery device toward the autologous valve annulus, and then guides an artificial heart valve delivery device toward the autologous valve annulus. The docking device delivery device is used to deliver the docking device to the autologous valve annulus, and then the artificial heart valve delivery device is used to deliver a transcatheter artificial heart valve into the docking device.

[0092] As described above, defective autologous heart valves can be replaced with transcatheter artificial heart valves. However, such artificial heart valves may not adequately conform to the geometry of the autologous tissue (e.g., the leaflets and / or annulus of the autologous heart valve) and may displace undesirably relative to the autologous tissue, potentially leading to paravalvular leaks. Therefore, a docking device can be first implanted at the autologous valve annulus, and then the artificial heart valve can be implanted within the docking device to help anchor the artificial heart valve to the autologous tissue and provide a seal between the autologous tissue and the artificial heart valve. Figure 5 An exemplary docking device is shown in the figure, and in Figure 6 An exemplary delivery device is shown in the figure, which deploys the docking device at an autologous heart valve.

[0093] like Figures 7-10 As shown, the docking device delivery device may include an outer shaft, a sleeve shaft extending through the outer shaft in a relatively straight delivery configuration and housing the docking device therein, and a pusher shaft extending through the outer shaft and disposed proximally to the docking device. A plurality of lumens are formed in the delivery device, including a sleeve shaft lumen passing through the sleeve shaft and an outer shaft lumen formed between the outer shaft and the sleeve shaft. These lumens are fluidly connected to each other, so that during a flushing process, fluid flow through one lumen can also enter another lumen, such as... Figure 9 and 10 As shown schematically in the diagram.

[0094] In some examples, such as Figures 11-16 As shown, a sealing mechanism (or assembly) including two seals can be configured to receive an outer shaft and the distal portion of a sleeve shaft passing through it. The sealing mechanism can be configured to seal around the outer surface of the outer shaft (e.g., using a first seal) and around the outer surface of the sleeve shaft extending distal to the distal end of the outer shaft (e.g., using a second seal disposed distal to the first seal). Therefore, flushing fluid entering the lumen of the delivery device can be prevented from leaving the outer shaft lumen, thereby forcing all or most of the flushing fluid to flow through the sleeve shaft lumen. Thus, the sleeve shaft lumen and the docking device disposed therein can be effectively and adequately flushed and degassed. In some cases, the seals can be compressible seals or gaskets. Figures 11-16 In some cases, the seal around the outer shaft can be a compressible seal or a gasket, and the seal around the sleeve shaft can be an O-ring. Figures 18-21 In some cases, the two seals can be O-rings of different sizes. Figures 22-23 ).

[0095] In some examples, instead of flushing the sleeve shaft (or the alternative shaft of the catheter) using a sealing mechanism, any of the aforementioned sealing mechanisms can be used to seal around the outer shaft and the sleeve shaft (or the inner and outer shafts of the alternative catheter), and the sleeve shaft is aspirated using a suction tool (e.g., a syringe).Figure 24 ).

[0096] In some examples, suction or flushing of the conduit shaft (e.g., sleeve shaft) can be performed using another sealing mechanism including a clamshell mechanism that forms a seal around the sleeve shaft when closed. Figure 25 and 26 ).

[0097] and Figures 27-34 A sealing mechanism is described, configured to seal around a catheter shaft (e.g., a sleeve shaft) and allow flushing or aspiration of the catheter shaft. The sealing mechanism includes a sealing housing in which a seal is received, and a locking cap, the locking cap and the sealing housing being configured to rotate relative to each other to move the sealing mechanism into a locking configuration in which the seal is radially compressed around the catheter shaft.

[0098] Examples of the Disclosed Technology

[0099] Figures 1 through 4 An exemplary transcatheter heart valve replacement procedure (e.g., mitral valve replacement) is depicted according to an example, utilizing a docking device 52 and an artificial heart valve 62. During the procedure, the user first uses a guiding catheter 30 ( Figure 1 This creates a pathway to the patient's own heart valve. The user then uses the docking device to deliver the device 50 ( Figure 2A The docking device 52 is delivered and implanted at the patient's own heart valve, and then the docking device delivery device 50 is removed from the patient 10 after the docking device 52 has been implanted. Figure 2B Then the user uses an artificial valve delivery device 60 ( Figure 3A The artificial heart valve 62 is implanted into the implantation docking device 52. Afterwards, the user removes the artificial valve delivery device 60 from the patient 10. Figure 3B ) and guiding catheter 30 ( Figure 4 ).

[0100] Figure 1 The first stage of a mitral valve replacement surgery according to an example is depicted, wherein a guiding catheter 30 and a guidewire 40 are inserted into a blood vessel 12 of the patient 10 and guided through the blood vessel 12 into the patient 10's heart 14 and toward the autologous mitral valve 16. The guiding catheter 30 and guidewire 40 together provide a path for the docking device delivery device 50 and the artificial valve delivery device 60 to be guided through and along this path to the implantation site (autologous mitral valve 16 or autologous mitral valve annulus).

[0101] Initially, the user can first make an incision inside the patient to access the blood vessel 12. For example, in Figure 1In the example shown, the user can make an incision in the patient's groin to access the femoral vein. Therefore, in such examples, vessel 12 can be the femoral vein.

[0102] After an incision is made at blood vessel 12, the user can insert a guiding catheter 30, guidewire 40, and / or additional devices (such as a guide device or transseptal puncture device) into blood vessel 12 through the incision. The guiding catheter 30 (which may also be referred to as a "guide device," "guide," or "guide sheath") is configured to facilitate the percutaneous introduction and passage of various implant delivery devices (e.g., docking device delivery device 50 and artificial valve delivery device 60) through blood vessel 12 and can extend through blood vessel 12 and into heart 14, but may stop before the autologous mitral valve 16. The guiding catheter 30 may include a handle 32 and a shaft 34 extending distally from the handle 32. The shaft 34 can extend through blood vessel 12 and into heart 14, while the handle 32 remains outside the patient 10 and can be operated by the user to manipulate the shaft 34. Figure 1 ).

[0103] The guidewire 40 is configured to guide the delivery device (e.g., guide catheter 30, docking device delivery device 50, artificial valve delivery device 60, additional catheter, etc.) and its associated devices (e.g., docking device, artificial heart valve, etc.) to the implantation site within the heart 14, and thus can extend through the blood vessel 12 and into the left atrium 18 of the heart 14 (and in some instances, through the autologous mitral valve 16 and into the left ventricle of the heart 14). Figure 1 ).

[0104] In some cases, a transseptal puncture device or catheter can be used for initial access to the left atrium 18 before the insertion of guidewire 40 and guiding catheter 30. For example, after making an incision in vessel 12, the user can insert the transseptal puncture device through the incision into vessel 12. The user can guide the transseptal puncture device through vessel 12 and into heart 14 (e.g., through the femoral vein and into right atrium 20). The user can then make a small incision in the atrioventricular septum 22 of heart 14 to allow access from right atrium 20 to left atrium 18. The user can then insert and advance guidewire 40 through vessel 12 and through the incision in atrioventricular septum 22 into left atrium 18. Once guidewire 40 is positioned within left atrium 18 and / or left ventricle 26, the transseptal puncture device can be removed from patient 10. The user can then insert guiding catheter 30 into vessel 12 and through guidewire 40 ( Figure 1 The guiding catheter 30 is advanced into the left atrium 18.

[0105] In some cases, a guide device may be inserted through the lumen of the guide catheter 30 before the guide catheter 30 is inserted into the blood vessel 12. In some cases, the guide device may include a tapered end extending from the distal end of the guide catheter 30 and configured to guide the guide catheter 30 into the left atrium 18 via a guidewire 40. Additionally, in some cases, the guide device may include a proximal portion extending from the proximal end of the guide catheter 30. Once the guide catheter 30 reaches the left atrium 18, the user can remove the guide device from both the guide catheter 30 and the patient 10. Thus, only the guide catheter 30 and the guidewire 40 remain in the patient 10. The guide catheter 30 is then positioned to receive the implant delivery device and assist in guiding it into the left atrium 18, as further described below.

[0106] Figure 2A A second stage of an exemplary mitral valve replacement surgery is depicted, wherein a docking device 52 is implanted at the autologous mitral valve 16 of the heart 14 of the patient 10 using a docking device delivery device 50 (which may also be referred to as an "implant catheter" and / or a "docking device delivery device").

[0107] Typically, the docking device delivery device 50 includes a delivery shaft 54, a handle 56, and a pusher assembly 58. The delivery shaft 54 ​​is configured to be advanced by a user through the patient's vascular system (vessel 12) and to the implantation site (e.g., autologous mitral valve 16), and can be configured to hold the docking device 52 in the distal portion 53 of the delivery shaft 54. In some instances, the distal portion 53 of the delivery shaft 54 ​​holds the docking device 52 therein in a straightened delivery configuration.

[0108] The handle 56 of the docking device delivery device 50 is configured to be grasped and / or otherwise held by a user outside the patient 10 to advance the delivery shaft 54 ​​through the patient's vascular system (e.g., blood vessel 12).

[0109] In some examples, the handle 56 may include one or more hinge members 57 (or rotatable knobs) configured to facilitate guiding the delivery shaft 54 ​​through the blood vessel 12. For example, the one or more hinge members 57 may 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 hinge the distal portion 53 of the delivery shaft 54 ​​to facilitate guiding the delivery shaft 54 ​​through the blood vessel 12 and within the heart 14.

[0110] The pusher assembly 58 can be configured to deploy and / or implant the docking device 52 at an implantation site (e.g., autologous mitral valve 16). For example, the pusher assembly 58 is configured to be adjusted by a user to push the docking device 52 out of the distal portion 53 of the delivery shaft 54. The shaft of the pusher assembly 58 can extend through the delivery shaft 54 ​​and can be positioned adjacent to the docking device 52 within the delivery shaft 54. In some instances, the docking device 52 can be releasably coupled to the shaft of the pusher assembly 58 via a connection mechanism of the docking device delivery device 50, such that the docking device 52 can be released after deployment at the autologous mitral valve 16.

[0111] Further details of the docking device delivery equipment and its variants are described in International Publication No. WO2020 / 247907, which is incorporated herein by reference in its entirety.

[0112] Refer again Figure 2A After positioning the guiding catheter 30 within the left atrium 18, the user can insert the docking device delivery device 50 (e.g., delivery shaft 54) into the patient 10 by advancing the delivery shaft 54 ​​of the docking device delivery device 50 through the guiding catheter 30 and through the guidewire 40. In some examples, the guidewire 40 may be retracted at least partially away from the left atrium 18 and into the guiding catheter 30. The user can then continue advancing the delivery shaft 54 ​​of the docking device delivery device 50 along the guidewire 40 through the blood vessel 12 until the delivery shaft 54 ​​reaches the left atrium 18, as... Figure 2A As shown. Specifically, the user can advance the delivery shaft 54 ​​of the docking device delivery device 50 toward the patient 10 by grasping the handle 56 of the docking device delivery device 50 and applying force thereon (e.g., pushing the handle). As the delivery shaft 54 ​​is advanced through the blood vessel 12 and the heart 14, the user can adjust one or more hinge members 57 of the handle 56 to guide various turns, corners, constrictions and / or other obstacles in the blood vessel 12 and the heart 14.

[0113] Once the delivery shaft 54 ​​reaches the left atrium 18 and extends distally from the guide catheter 30, the user can use the handle 56 (e.g., articulated member 57) to position the distal portion 53 of the delivery shaft 54 ​​at and / or near the posteromedial commissure of the autologous mitral valve 16. The user can then use the shaft of the pusher assembly 58 to push the docking device 52 out of the distal portion 53 of the delivery shaft 54 ​​to deploy and / or implant the docking device 52 within the annulus of the autologous mitral valve 16.

[0114] In some instances, the docking device 52 may be constituted, formed, and / or include shape memory material, and thus, when it leaves the delivery shaft 54 ​​and is no longer constrained by the delivery shaft 54, it can return to its initial, pre-formed shape. As an example, the docking device 52 may be initially formed as a coil, and thus, when it leaves the delivery shaft 54 ​​and returns to its initial coiled configuration, it may wrap around the leaflet 24 of the autologous mitral valve 16.

[0115] In the ventricular portion that drives the docking device 52 (e.g., Figure 2A After the docking device 52 shown is configured to be positioned within the left ventricle 26 and / or on the ventricular side of the autologous mitral valve 16, the user can deploy the remaining portion of the docking device 52 (e.g., the atrial portion of the docking device 52) from the delivery shaft 54 ​​within the left atrium 18 by retracting the delivery shaft 54 ​​away from the posteromedial junction of the autologous mitral valve 16.

[0116] After deploying and implanting the docking device 52 at the autologous mitral valve 16, the user can disconnect the docking device delivery device 50 from the docking device 52. Once the docking device 52 is disconnected from the docking device delivery device 50, the user can retract the docking device delivery device 50 from the blood vessel 12 and away from the patient 10, so that the user can deliver and implant the artificial heart valve 62 into the implanted docking device 52 at the autologous mitral valve 16.

[0117] Figure 2B This illustrates the third stage of a mitral valve replacement procedure, where the docking device 52 has been fully deployed and implanted at the autologous mitral valve 16, and the docking device delivery device 50 (including the delivery shaft 54) has been removed from the patient 10, leaving only the guidewire 40 and the guiding catheter 30 in the patient 10. In some examples, after removal of the docking device delivery device, the guidewire 40 can be advanced beyond the guiding catheter 30, through the docking device 52 implanted at the autologous mitral valve 16, and into the left ventricle 26 (…). Figure 2A Therefore, the guidewire 40 can help guide the artificial valve delivery device 60 through the annulus of the autologous mitral valve 16 and at least partially into the left ventricle 26.

[0118] like Figure 2B As shown, the docking device 52 may include multiple turns (or coils) surrounding the leaflets 24 of the autologous mitral valve 16 (within the left ventricle 26). The implanted docking device 52 has a more cylindrical shape than the annulus of the autologous mitral valve 16, thereby providing a closer geometric fit to the shape or contour of the artificial heart valve to be implanted. Therefore, the docking device 52 can provide a tighter fit between the artificial heart valve and the autologous mitral valve 16, and thus provide a better seal, as further described below.

[0119] Figure 3A The fourth stage of a mitral valve replacement surgery is described, in which the user delivers and / or implants an artificial heart valve 62 (which may also be referred to herein as a “transcatheter artificial heart valve” or simply “THV”, “replacement heart valve” and / or “artificial mitral valve”) within a docking device 52 using an artificial valve delivery device 60.

[0120] like Figure 3A As shown, the artificial valve delivery device 60 may include a delivery shaft 64 and a handle 66, with the delivery shaft 64 extending distally from the handle 66. The delivery shaft 64 is configured to extend into the patient's vascular system to deliver, implant, expand, and / or otherwise deploy an artificial heart valve 62 within a docking device 52 at the patient's own mitral valve 16. The handle 66 is configured to be grasped and / or otherwise held by a user to advance the delivery shaft 64 through the patient's vascular system.

[0121] In some instances, the handle 66 may include one or more hinge members 68 configured to facilitate guiding the delivery shaft 64 through the blood vessel 12 and the heart 14. Specifically, the hinge member 68 may include one or more of a knob, button, wheel, and / or other type of physically adjustable control member configured to be adjusted by a user to flex, bend, twist, rotate, and / or otherwise hinge the distal portion of the delivery shaft 64 to facilitate guiding the delivery shaft 64 through the blood vessel 12 and into the left atrium 18 and left ventricle 26 of the heart 14.

[0122] In some instances, the artificial valve delivery device 60 may include an expansion mechanism 65 configured to radially expand and deploy the artificial heart valve 62 at the implantation site. In some cases, such as... Figure 3A As shown, the expansion mechanism 65 may include an inflatable balloon configured to inflate to radially expand the artificial heart valve 62 within the docking device 52. The inflatable balloon may be coupled to the distal portion of the delivery shaft 64.

[0123] In some examples, the artificial heart valve 62 may be self-expanding and may be configured to expand radially upon removal of a sheath or capsule of the radially compressed artificial heart valve 62 covering the distal portion of the delivery shaft 64. In some examples, the artificial heart valve 62 may be mechanically expandable, and the artificial valve delivery device 60 may include one or more mechanical actuators (e.g., expansion mechanisms) configured to radially expand the artificial heart valve 62.

[0124] like Figure 3A As shown, the artificial heart valve 62 is mounted in a radially compressed configuration around the expansion mechanism 65 (inflatable balloon) on the distal portion of the delivery axis 64.

[0125] To guide the distal portion of the delivery shaft 64 to the implantation site, the user inserts the artificial valve delivery device 60 (delivery shaft 64) into the patient 10 via the guide catheter 30 and guidewire 40. The user can continue advancing the artificial valve delivery device 60 (through blood vessel 12) along the guidewire 40 until the distal portion of the delivery shaft 64 reaches the autologous mitral valve 16, as shown. Figure 3A As shown. More specifically, the user can advance the delivery shaft 64 of the artificial valve delivery device 60 by gripping the handle 66 and applying force thereon (e.g., pushing the handle). As the delivery shaft 64 is advanced through the blood vessel 12 and the heart 14, the user can adjust one or more hinge members 68 of the handle 66 to guide various turns, corners, constrictions and / or other obstacles in the blood vessel 12 and the heart 14.

[0126] The user can advance the delivery shaft 64 along the guidewire 40 until the radially compressed artificial heart valve 62, mounted around the distal portion of the delivery shaft 64, is positioned within the docking device 52 and the autologous mitral valve 16. In some instances, such as Figure 3A As shown, the distal end of the delivery shaft 64 and at least a portion of the radially compressed artificial heart valve 62 can be positioned within the left ventricle 26.

[0127] Once the radially compressed artificial heart valve 62 is properly positioned within the docking device 52 ( Figure 3A The user can manipulate one or more actuation mechanisms of the handle 66 of the artificial valve delivery device 60 to actuate the expansion mechanism 65 (e.g., to inflate the inflatable balloon), thereby radially expanding the artificial heart valve 62 within the docking device 52.

[0128] Figure 3B The fifth stage of a mitral valve replacement surgery is shown, in which the artificial heart valve 62 is in its radially expanded configuration and is implanted within the docking device 52 of the autologous mitral valve 16. Figure 3B As shown, the artificial heart valve 62 is received and held within the docking device 52. Therefore, the docking device 52 helps to anchor the artificial heart valve 62 within the autologous mitral valve 16. The docking device 52 may enable a better seal between the artificial heart valve 62 and the leaflet 24 of the autologous mitral valve 16 to reduce paravalvular leakage around the artificial heart valve 62.

[0129] For example Figure 3B As shown, after the artificial heart valve 62 has been fully deployed and implanted into the docking device 52 at the autologous mitral valve 16, the artificial valve delivery device 60 (including the delivery shaft 64) is removed from the patient 10, leaving only the guidewire 40 and the guiding catheter 30 in the patient 10.

[0130] Figure 4The sixth stage of the mitral valve replacement surgery is depicted, in which the guidewire 40 and guiding catheter 30 have been removed from patient 10.

[0131] although Figures 1-4 The mitral valve replacement procedure is illustrated, but it should be understood that the same and / or similar procedures can be used to replace other heart valves (e.g., tricuspid, pulmonary, and / or aortic valves). Furthermore, the same and / or similar delivery devices (e.g., docking device delivery device 50, artificial valve delivery device 60, guiding catheter 30, and / or guidewire 40), docking devices (e.g., docking device 52), replacement heart valves (e.g., artificial heart valve 62), and / or components thereof can be used to replace these other heart valves.

[0132] For example, when replacing an autologous tricuspid valve, the user can access the right atrium 20 via the femoral vein, but it is not necessary to cross the interatrial septum 22 to access the left atrium 18. Instead, the user can leave the guidewire 40 in the right atrium 20 and perform the same and / or similar docking device implantation procedure at the tricuspid valve. Specifically, the user can push the docking device 52 out of the delivery shaft 54 ​​around the ventricular side of the tricuspid valve leaflet, release the remaining portion of the docking device 52 from the delivery shaft 54 ​​within the right atrium 20, and then remove the delivery shaft 54 ​​of the docking device delivery device 50 from the patient 10. The user can then advance the guidewire 40 through the tricuspid valve into the right ventricle and perform the same and / or similar artificial heart valve implantation procedure at the tricuspid valve within the docking device 52. Specifically, the user can advance the delivery shaft 64 of the artificial valve delivery device 60 along the guidewire 40 through the patient's vascular system until the artificial heart valve 62 is positioned / placed within the docking device 52 and the tricuspid valve. The user can then expand the artificial heart valve 62 within the docking device 52 before removing the artificial valve delivery device 60 from the patient 10. In some examples, the user can perform the same and / or similar procedures to replace the aortic valve, but can access the aortic valve from the outflow side via the femoral artery.

[0133] Furthermore, despite Figures 1-4 The procedure describes a mitral valve replacement surgery where the autologous mitral valve 16 is accessed from the left atrium 18 via the right atrium 20 and the femoral vein. However, it should be understood that the autologous mitral valve 16 can alternatively be accessed from the left ventricle 26. For example, the user can advance one or more delivery devices through an artery to the aortic valve, and then through the aortic valve to the left ventricle 26, and then from the left ventricle 26 through the aortic valve to the autologous mitral valve 16.

[0134] Figure 5 An example of a docking device 100 configured to receive an artificial heart valve is shown. For example, the docking device 100 may be implanted within an autologous valve annulus, as referenced above. Figures 1-2B As described. InFigures 2A-4 In this process, docking device 100 can be used in place of docking device 52, and therefore, docking device 100 can be configured to receive the artificial valve and fix the artificial valve in the docking device, thereby fixing the artificial valve to the autologous valve annulus.

[0135] refer to Figure 5 The docking device 100 may include two main components: a coil 102 and a protective member 104 covering at least a portion of the coil 102. In some examples, the coil 102 may comprise a shape memory material (e.g., a nickel-titanium alloy) such that the docking device 100 (and the coil 102) can be moved from a substantially straight configuration (also referred to as a “delivery configuration”) (described more fully below) when positioned within a delivery sleeve (e.g., a sleeve shaft) of the delivery device to a helical configuration (also referred to as a “deployment configuration”) after removal from the delivery sleeve (e.g., a sleeve shaft). Figure 5 (as shown in the image).

[0136] The coil 102 has a proximal end 102p and a distal end 102d. When positioned within a delivery sleeve (e.g., during delivery of the docking device to a patient's vascular system), the body of the coil 102 between the proximal end 102p and the distal end 102d can form a generally straight delivery configuration (i.e., without any coiled or looped portions) to maintain a small radial profile as it moves through the patient's vascular system. After removal from the delivery sleeve and deployment at the implantation site, the coil 102 can be moved from the delivery configuration to a helical deployment configuration and surround autologous tissue adjacent to the implantation site. For example, when the docking device is implanted at the location of an autologous valve, the coil 102 can be configured to surround the autologous leaflet of the autologous valve (and chordae tendineae, if present, connecting the autologous leaflet to the adjacent papillary muscle).

[0137] The docking device 100 can be releasably coupled to the delivery device. In some examples, the docking device 100 can be coupled to the delivery device via a release suture, which can be configured to be tied to the docking device 100 and cut to remove (see reference below). Figure 6 and 8 (Further description). In one example, the release suture can be tied to the docking device 100 through a small hole or eyelet located near the proximal end 102p of the coil. In some examples, the release suture can be tied around a circumferential recess located near the proximal end 102p of the coil 102.

[0138] In some examples, the docking device 100 in a deployment configuration may be configured to engage at the mitral valve location. In some examples, the docking device may also be shaped for and / or adapted for implantation at other autologous valve locations, such as the tricuspid valve. In some examples, the geometry of the docking device 100 may be configured to engage autologous anatomical structures, which may, for example, achieve increased stability and reduced relative movement between the docking device 100, the artificial valve docked therein, and / or the autologous anatomical structure.

[0139] like Figure 5 As shown, a coil 102 in a deployment configuration may include a lead coil 106 (or "lead coil"), a central region 108, and a stabilizing coil 110 (or "stabilizing coil"). The central region 108 may have one or more helical coils having substantially equal inner diameters. The lead coil 106 may extend from the distal end of the central region 108 and has a diameter larger than the diameter of the central region 108 (in one or more configurations). The stabilizing coil 110 may extend from the proximal end of the central region 108 and has a diameter larger than the diameter of the central region 108 (in one or more configurations).

[0140] In some examples, the central region 108 may contain multiple spiral turns, such as a proximal turn 108p connected to the stabilizing turn 110, a distal turn 108d connected to the leading turn 106, and one or more intermediate turns 108m disposed between the proximal turn 108p and the distal turn 108d. Figure 5 In the example shown, there is only one intermediate turn 108m between the proximal turn 108p and the distal turn 108d.

[0141] In some examples, there may be more than one intermediate turn 108m between the proximal turn 108p and the distal turn 108d (e.g., two, three, etc.). Some spiral turns in the central region 108 may be complete turns (i.e., rotated 360 degrees). In some cases, 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.).

[0142] The size of the docking device 100 is typically selected based on the size of the desired prosthetic valve to be implanted in the patient. In some examples, the central region 108 may be configured to hold the radially expandable prosthetic valve. For example, when the prosthetic valve expands radially, the inner diameter of the helical turns in the central region 108 may be configured to be smaller than the outer diameter of the prosthetic valve, such that additional radial tension can act between the central region 108 and the prosthetic valve to hold the prosthetic valve in place. The helical turns in the central region 108 (e.g., 108p, 108m, 108d) are also referred to herein as “functional turns”.

[0143] The stabilizing ring 110 can be configured to help stabilize the docking device 100 in its desired position within the anatomical structures surrounding the implantation site. For example, the radial dimension of the stabilizing ring 110 can be significantly larger than the radial dimension of the coil in the central region 108, allowing the stabilizing ring 110 to flare or extend sufficiently to abut or push against the atrial wall of the heart, thereby improving the ability of the docking device 100 to remain in its desired position prior to implantation of the prosthetic valve. In some examples, the diameter of the stabilizing ring 110 is larger than the autologous valve annulus, the autologous valve plane, and the atrium for better stabilization. In some examples, the stabilizing ring 110 can be a full ring (i.e., rotated approximately 360 degrees). In some examples, the stabilizing ring 110 can be a partial ring (e.g., rotated between approximately 180 and approximately 270 degrees).

[0144] In one particular example, when the docking device 100 is implanted at the autologous mitral valve site, the functional turn in the central region 108 may be substantially located in the left ventricle, and the stabilizing turn 110 may be substantially located in the left atrium. The stabilizing turn 110 may be configured to provide one or more contact points or contact areas between the docking device 100 and the left atrial wall, such as at least three contact points in the left atrium or complete contact on the left atrial wall. In some examples, the contact points between the docking device 100 and the left atrial wall may form a plane that is generally parallel to the plane of the autologous mitral valve.

[0145] As described above, the guide coil 106 can have a larger radial dimension than the helical coil in the central region 108. The guide coil 106 helps to more easily guide the disc 102 around and / or through the chordae tendineae geometry and adequately around all the autologous leaflets of the autologous valve (e.g., autologous mitral, tricuspid, etc.). For example, once the guide coil 106 is guided around the desired autologous anatomy, the remaining discs of the docking device 100 (e.g., functional coils) can also be guided around the same features. In some examples, the guide coil 106 can be a full coil (i.e., rotated approximately 360 degrees). In some examples, the guide coil 106 can be a partial coil (e.g., rotated between approximately 180 and approximately 270 degrees). In some examples, the functional coil in the central region 108 can further expand radially as the prosthetic valve expands radially within the central region 108 of the disc. Therefore, the guide coil 106 can be pulled in the proximal direction, its diameter can be reduced, and it can become part of the functional coil in the central region 108.

[0146] In some examples, at least a portion of the coil 102 may be surrounded by a first cover. The first cover may be made of various natural and / or synthetic materials. In a particular example, the first cover may comprise expanded polytetrafluoroethylene (ePTFE). In some examples, the first cover is configured (e.g., by means of textured surface resistance, stitching, adhesive, thermal bonding, or any other means) to be securely attached to the coil 102 such that relative axial movement between the first cover and the coil 102 is restricted or prohibited.

[0147] The protective member 104 may form part of the cover assembly of the docking device 100. In some examples, the cover assembly may also include the first cover.

[0148] In such Figure 5 In the typical example shown, when the docking device 100 is in a deployment configuration, the protective member 104 may be configured to cover a portion of the stabilizing turn 110 of the coil 102. In some examples, the protective member 104 may be configured to cover at least a portion of the central region 108 of the coil 102, such as a portion of the proximal turn 108p. In some examples, the protective member 104 may extend over the entirety of the coil 102.

[0149] In some examples, the protective member 104 may expand radially to help prevent and / or reduce paravalvular leakage. Specifically, the protective member 104 may be configured to expand radially such that a better seal is formed closer to and / or against the artificial valve deployed within the docking device 100. In some examples, the protective member 104 may be configured to prevent and / or suppress leakage at locations where the docking device 100 crosses between the leaflets of the autologous valve (e.g., at the junction of the autologous leaflets).

[0150] In some examples, when the docking device 100 is deployed at the autologous atrioventricular valve (e.g., mitral or tricuspid valve) and the protective member 104 substantially covers a portion of the stabilizing turn 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 autologous leaflet, commissure, and / or the area surrounding the artificial valve by preventing blood in the atrium from flowing in the atrium-to-ventricle direction (i.e., antegrade flow) – except through the artificial valve.

[0151] In some examples, the protective member 104 may be positioned on the ventricular side of the ventricular valve to prevent and / or inhibit blood leakage through the periphery of the autologous leaflet, junction, and / or artificial valve by preventing blood in the ventricle from flowing in the ventricular-to-atrial direction (i.e., retrograde flow).

[0152] 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.

[0153] In some cases, when the protective member 104 is in a radially expanded state, the proximal portion 104p of the protective member 104 may have, for example, Figure 5 The tapered shape shown causes the diameter of the proximal portion 104p to gradually increase from the proximal end of the protective member 104 to the distally positioned body portion of the protective member 104. This can, for example, facilitate loading the docking device into the delivery sleeve (e.g., sleeve shaft) of the delivery device and / or removing and / or repositioning the docking device into the delivery device during the implantation procedure.

[0154] Figures 6-10 The diagram shows a device configured to dock (e.g., referenced above). Figure 5 The described docking device 100 is an example of a delivery device (also referred to as a delivery system) 200 that delivers the docking device 100 to a target implantation site (e.g., the heart and / or autologous valve of an animal, human, or cadaver, cadaveric heart, anthropomorphic ghost, etc.). In some examples, the delivery device 200 may be a transcatheter delivery device that can guide the docking device mounted therein through the patient's vascular system, as referenced above. Figures 1-2B The explanation.

[0155] Exemplary delivery device 200 in Figure 6 As shown, the docking device 232 is deployed at least partially from the remote end of the delivery device 200 (e.g., for illustrative purposes). In some examples, the docking device 232 may be the one referenced above. Figure 5 The docking device 100 is described. Figure 7 and 8 The sleeve shaft 280 covers the docking device 232 (shown in this diagram). Figure 7 And after the sleeve shaft 280 has been removed from the docking device 232 (but before the docking device 232 is disconnected from the delivery device 200) Figure 8 The remote portion of the delivery device 200, wherein the docking device 232 is deployed from the outer shaft 260 of the delivery device. Figure 9 and 10 This is a schematic cross-sectional view of the delivery device 200, showing multiple cavities formed between the coaxial components of the delivery device 200.

[0156] Return to Figure 6The delivery device 200 may include a handle assembly 220 and an outer shaft (e.g., a delivery conduit) 260 extending distally from the handle assembly 220. The handle assembly 220 may include a handle 222 and a hub assembly 230 extending proximally from the handle 222. Figure 6 As shown, the handle assembly 220 may include a handle 222, which includes one or more knobs, buttons, scroll wheels, etc. For example, as Figure 6 As shown, handle 222 may include knobs 224 and 226, which can be configured to control the bending of a delivery device (e.g., outer shaft 260). Outer shaft 260 extends distally from handle 222, while hub assembly 230 extends proximally from handle 222.

[0157] Delivery device 200 may include components coaxially located within outer shaft 260. Figure 9 and 10 And each has a pusher shaft 290 that extends into the handle assembly 220. Figure 6 and 8 -10) and sleeve shaft 280 ( Figures 7-10 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 sleeve shaft 280 can be configured such that the docking device 232 is inside the delivery device 200. Figure 9 and 10 When ) and when positioned at the target implantation site ( Figure 7 The delivery device 200 can also be configured to adjust the axial position of the sleeve shaft 280 to remove the sleeve portion (e.g., the distal portion) of the sleeve shaft 280 from the docking device after the docking device 232 has been implanted into the target implantation site. Figure 8 ). Figure 7 and 8 This illustrates an exemplary docking device 232 deployed from the outer shaft 260 of the delivery device 200 and covered by the distal (or sleeve) portion 282 of the sleeve shaft 280. Figure 7 ) and the exemplary docking device 232 after the sleeve shaft 280 has retracted into the outer shaft 260. Figure 8 A perspective view of ).

[0158] Therefore, the sleeve shaft 270 can be removed from the docking device 232. In some examples, the distal portion 282 of the sleeve shaft 280 may have an outer surface comprising a lubricating or low-friction material, which facilitates the sliding of the docking device 232 onto the autologous anatomical structure at the implantation site.

[0159] like Figure 6 and 8As shown, during delivery, docking device 232 can be coupled to delivery device 200 via a release suture 236 (or other retrieval line including rope, yarn or other material, which can be configured to be tied around docking device and cut off) that extends through pusher shaft 290. Release suture 236 can extend through delivery device 200, through the inner lumen of pusher shaft 290 to suture lock assembly 206 of delivery device 200.

[0160] like Figure 6 As shown, hub assembly 230 may include a suture lock assembly (e.g., a suture lock) 206 and a sleeve handle 234 attached thereto. Hub assembly 230 may be configured to control the pusher shaft 290 and sleeve shaft 280 of delivery device 200 together (e.g., to move them axially together), while sleeve handle 234 controls the axial position of sleeve shaft 280 relative to pusher shaft 290. In this way, operation of various components of handle assembly 220 can actuate and control the operation of components arranged within outer shaft 260. In some examples, such as Figure 6 As shown, hub assembly 230 can be connected to handle 222 via connector 240.

[0161] In some examples, 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 contain more than one branch). Figure 6 In some examples, the suture lock assembly 206 may be attached to the branch 204, and the sleeve handle 234 (e.g., a sleeve actuation handle) may be arranged at the proximal end of the straight section 202.

[0162] Further details regarding the delivery device 200 and its variations are described in International Patent Publication No. WO 2020 / 247907, which is incorporated herein by reference, including details regarding the suture lock assembly and the pusher shaft and sleeve shaft assembly of the delivery device for the docking device. Further details regarding additional delivery systems and devices configured to deliver the docking device to the target implantation site can be found in U.S. Patent Publications Nos. US2018 / 0318079, US2018 / 0263764, and US2018 / 0177594, all of which are incorporated herein by reference in their entirety.

[0163] Return to Figure 6 The handle assembly 220 may also include one or more flushing ports to supply flushing fluid to one or more lumens disposed within the delivery device 200 (e.g., annular lumens disposed between coaxial components of the delivery device 200) to reduce the likelihood of thrombosis and / or to degas the components of the delivery device 200 prior to insertion into a patient.Figure 6 An example is depicted in which the delivery device 200 includes three flushing ports (e.g., flushing ports 210, 216, and 218). In an alternative example, the delivery device 200 may not include flushing port 216, or flushing port 210 may alternatively be located at one end of the suture lock assembly 206 (e.g., as shown in the image). Figure 9 and 10 (As shown).

[0164] For example, as shown in the simplified schematic diagram of the delivery device 200 Figure 9 and 10 As shown, a plurality of cavities configured to receive fluid are formed between the docking device 232, the pusher shaft 290, the sleeve shaft 280, and the outer shaft 260. More specifically, a first pusher shaft cavity 201 may be formed inside the pusher shaft 290 (e.g., inside the main tube 292 of the pusher shaft 290). A second sleeve shaft cavity 211 is formed inside the sleeve shaft 280. Additionally, a third delivery shaft cavity 215 (or outer shaft cavity) may be formed in an annular space formed between the inner surface of the outer shaft 260 and the outer surface of the sleeve shaft 280.

[0165] like Figure 9 As shown, the pusher shaft cavity 201 can directly receive fluid from a first fluid source or flushing port 210, which can be fluidly connected to a part of the handle assembly, for example, fluidly connected to one end of the suture lock assembly 206. Figure 9 and 10 As shown. Or, as... Figure 6 As shown, flushing port 210 can be coupled to a location along branch 204. Flushing fluid flow 203 from flushing port 210 can travel along the length of the main pipe 292 of pusher shaft 290 through pusher shaft cavity 201 to distal end 293 of pusher shaft 290. A first portion of flushing fluid flow 203 can flow as flushing fluid flow 207 into a first portion 205 of sleeve shaft cavity 211 arranged between the outer surface of docking device 232 and the inner surface of the distal portion 282 of sleeve shaft 280. In some examples, flushing fluid flow 207 can flow through protective member 231 of docking device 232 (which can be coupled to...). Figure 5 (The protective member 104 is the same as or similar to the protective member 104). The second portion of the flushing fluid flow 203 may also flow as flushing fluid flow 213 into the second portion 209 of the sleeve shaft cavity 211, which is arranged between the outer surface of the pusher shaft 290 and the inner surface of the sleeve shaft 280. The flushing fluid flow 213 may continue through the second portion 209 of the sleeve shaft cavity 211 and enter the housing portion 294 of the pusher shaft. Since the delivery shaft cavity 215 is fluidly connected to the housing portion 294, the flushing fluid flow 213 may continue to enter and pass through the delivery shaft cavity 215 toward the distal end 262 of the outer shaft 260.

[0166] like Figure 10 As shown, the lumen of the delivery device 200 can also receive fluid from a second fluid source or a flushing port 216. The flushing port 216 is fluidly connected to a cavity 254, which is positioned around the main pipe 292 of the pusher shaft 290 in the hub assembly 230. The cavity 254 is fluidly connected to an annular cavity 219 defined by the housing portion 294, and the annular cavity 219 is fluidly connected to the delivery shaft lumen 215. Therefore, a flushing fluid flow 221 from the flushing port 216 can travel through the cavity 254 and enter and pass through the annular cavity 219. The flushing fluid flow 221 can then be divided into a first flushing fluid flow 217 that enters and passes through the delivery shaft lumen 215 and a second flushing fluid flow 223 that enters and passes through the sleeve shaft lumen 211.

[0167] Although fluid flow can be supplied to the sleeve shaft cavity 211 under various circumstances, as mentioned above... Figures 11-16 and 10 Because the flushing fluid flow can be diverted between the sleeve shaft cavity 211 and the delivery shaft cavity 215, the threshold fluid pressure may not be reached to adequately flush and degas the docking device (e.g., the protective member 231 of the docking device 232). Therefore, it is desirable to force all or most of the flushing fluid flow provided by one or more flushing ports of the delivery device 200 through the sleeve shaft cavity 211 in order to degas the sleeve shaft cavity 211 and the protective member (or alternative cover) of the docking device.

[0168] Now refer to Figures 6-10 An exemplary sealing mechanism 300 for a catheter is shown, configured to regulate fluid flow through two axes of the catheter. For example, the sealing mechanism may be configured to seal around two axes of the catheter (or one axis positioned around the other but with a slightly offset central axis) concentric with each other along at least the distal portion of the catheter, and to divert fluid flow supplied to the catheter through one of the axes by preventing fluid flow from exiting from one end of the other axis. In some examples, the catheter is a delivery device for an implantable medical device, such as… Figure 11 Delivery device 200. For example. Figure 14 (Side view) and Figure 12 (Cross-sectional side view) shows a sealing mechanism 300 coupled to the outer shaft 260 and the sleeve shaft 280 of the delivery device 200. However, in alternative examples, the sealing mechanism 300 can be used with various conduits and delivery devices that include two or more shafts (e.g., inner and outer shafts) with fluid-connected lumens. Figure 15 and 13 An alternative end view of the sealing mechanism 300 is shown. Figure 16 A cross-sectional perspective view of the sealing mechanism 300 is shown, and Figure 14 An exploded view of the sealing mechanism 300 is shown.

[0169] The sealing mechanism 300 may include a first seal 302 and a second seal 304 disposed within a housing of the sealing mechanism 300. The housing may include a first sealing housing 306 in which the first seal 302 is received and a second sealing housing 308 in which the second seal 304 is received. The first seal 302 and the second seal 304 may be annular, such as having orifices (e.g., a central orifice) configured to receive a shaft passing through therethrough. Figure 11 and 15 As shown in the image.

[0170] The first sealing housing 306 and the second sealing housing 308 can be connected to each other at the junction 310. Figure 11 , 14 And 15). In some examples, the junction 310 is an overlapping junction, wherein a portion of the first sealing housing 306 overlaps with a portion of the second sealing housing 308 (e.g. Figure 11 and 14 (As shown in -16). In an alternative example, the junction 310 is an overlapping junction, wherein a portion of the second sealing housing 308 overlaps with a portion of the first sealing housing 306. In some cases, the first sealing housing 306 and the second sealing housing 308 may be joined together by one or more fasteners extending through one or more holes 312 (or orifices) in the first sealing housing 306 and the second sealing housing 308. Figures 14-16 and 15 ).

[0171] The first sealing housing 306 may include a proximal portion 314, a middle portion 316, and a distal portion 318. Figure 15 The proximal portion 314 has a first inner diameter 320 and includes a plurality of internal threads 322 on the inner surface 324 of the first sealing housing 306. Figure 14 In some examples, such as Figure 15 and 15 As shown, the first seal 302 may be disposed within the intermediate portion 316 of the first seal housing 306. The intermediate portion 316 may also have a first inner diameter 320. In an alternative example, the first seal 302 may be disposed in a more distal portion of the first seal housing 306.

[0172] The distal portion 318 of the first sealing housing 306 may have a second inner diameter 326 smaller than the first inner diameter 320. Figure 11 In some examples, the distal portion 318 may also include an outer ring portion 328, which is configured to receive the second sealing housing 308 therein at the junction 310. Figures 14-16 and 14-16). In some cases, the collar portion 328 may have a third inner diameter 330 that is larger than the second inner diameter 326. In some examples, the third inner diameter 330 may be the same as the first inner diameter 320. In alternative examples, the third inner diameter 330 may be larger or smaller than the first inner diameter 320, while still being larger than the second inner diameter 326.

[0173] In some examples, the first seal housing 306 may also include a transition portion 332 comprising a tapering or inclined step 334, the step being progressively smaller in diameter from a first inner diameter 320 to a second inner diameter 326. Furthermore, in some cases, the inclined step 334 may be annular and extend around the circumference of the first seal housing 306. In alternative examples, the step of the transition portion 332 may be a right-angled step rather than an inclined one.

[0174] In some cases, the first seal 302 is configured such that its distal portion tapers to match the taper or inclination of the inclined step 334. Thus, the first seal 302 may be configured to abut against the inclined step 334 within the intermediate portion 316 and the transition portion 332.

[0175] The sealing mechanism 300 may also include a first threaded member 336 coupled to the proximal portion 314 of the first sealing housing 306. Figure 14 Specifically, the first threaded member 336 may include an external thread 338 configured to mate with the internal thread 322 of the first sealing housing 306. Figures 11-16 and 15 The first knob 340 (or alternative rotatable element) can be fixed to the first threaded member 336 and configured to rotate. Figure 14 In some cases, the first knob may be coupled or secured to the proximal end of the first threaded member 336 and disposed around the proximal portion 314 of the first sealing housing 306. Rotation of the first knob 340 causes the first threaded member 336 to rotate relative to the first sealing housing 306, thereby causing the first threaded member 336 to travel in the axial direction (relative to the central longitudinal axis 301 of the sealing mechanism 300). As the first threaded member 336 travels distally (towards the second sealing housing 308), the distal end 342 of the first threaded member 336 may contact and push against the proximal end 344 of the first seal 302. Figure 14 and 15 ), thereby around an axis set therein (e.g., Figures 14-16The outer shaft 260 shown compresses the first seal 302. In this way, the first seal 302 can be fastened around and abut against the shaft by rotating the first knob 340 (and thus the first threaded member 336). In addition, compressing the first seal 302 with the first knob 340 can also axially lock the sealing mechanism 300 to the shaft therein, thereby ensuring that the sealing mechanism 300 remains connected to the shaft during flushing under relatively high fluid pressure, as described below.

[0176] The second sealing housing 308 may include a proximal portion 346, a middle portion 348, and a distal portion 350. Figure 15 The proximal portion 346 may have a fourth inner diameter 352 at its proximal end 356, and a fifth inner diameter 354 in a more distal region of the proximal portion 346, wherein the fifth inner diameter 354 is smaller than the fourth inner diameter 352. Figure 14 The proximal end 356 of the proximal portion 346 may interface with and connect to the first sealing housing 306, for example, to the collar portion 328. Figure 14 and 15 In some cases, the fourth inner diameter 352 may be the same as the second inner diameter 326 of the distal portion 318 of the first sealing housing 306.

[0177] In some examples, the step 358 in the proximal portion 346 transitions between the fourth inner diameter 352 and the fifth inner diameter 354. Figure 14 and 15 Step 358 can also function as a stop, which is configured to interface with the distal end of a shaft (e.g., outer shaft 260) extending through the first sealing housing 306. For example, as Figure 14 As shown, the distal end 262 of the outer shaft 260 can contact a step 358, which prevents further distal movement of the outer shaft 260 through the second seal housing 308. The cavity 360 may be defined within the first seal housing 306 and the second seal housing 308, between the first seal 302 and the second seal 304. Figure 14 As shown, the distal end 262 of the outer shaft 260 may reside in the cavity 360. Furthermore, as explained in more detail below, when the first seal 302 is secured around the first shaft (e.g., the outer shaft 260) and the second seal 304 is secured around the second shaft (e.g., the sleeve shaft 280), the cavity 360 may be fluid-sealed by the walls of the first seal housing 306, the second seal housing 308, the first seal 302, and the second seal 304.

[0178] In some examples, such as Figure 15 and 15As shown, the second seal 304 may be disposed within the intermediate portion 348 of the second seal housing 308. The intermediate portion 348 may have a sixth inner diameter 362 that is greater than the fifth inner diameter 354.

[0179] In some examples, the second seal housing 308 may also include a transition portion 364 comprising a tapered or inclined step 366 that increases in diameter from a fifth inner diameter 354 to a sixth inner diameter 362. Furthermore, in some cases, the inclined step 366 may be annular and extend around the circumference of the second seal housing 308. In alternative examples, the step of the transition portion 364 may be a right-angled step rather than an inclined one.

[0180] In some cases, the second seal 304 is configured such that its proximal portion tapers to match the taper or inclination of the inclined step 366. Thus, the second seal 304 can be configured to abut against the inclined step 366 within the intermediate portion 348 and the transition portion 364.

[0181] It should be noted that although step 358 is shown extending to transition portion 364, in an alternative example, step 358 may be shorter (in the axial direction) and formed as a protrusion within proximal portion 346. The inclined step 366 may then taper from a larger sixth inner diameter 362 to a diameter larger than the fifth inner diameter 354.

[0182] The distal portion 350 of the second sealing housing 308 has a seventh inner diameter 368, and includes a plurality of internal threads 370 on the inner surface 372 of the second sealing housing 308. Figure 14 ).like Figures 14-16 and 15 As shown, thread 370 is disposed on the distal side of the second seal 304 in the second seal housing 308.

[0183] The sealing mechanism may also include a second threaded member 374 coupled to the distal portion 350 of the second sealing housing 308. Figures 11-16 Specifically, the second threaded member 374 may include an external thread 376 configured to mate with the internal thread 370 of the second sealing housing 308. A second knob 378 (or an alternative rotatable element) may be attached to the second threaded member 374 and configured to rotate. Figure 14In some cases, the second knob 378 may be coupled or secured to the distal end of the second threaded member 374 and disposed around the distal portion 350 of the second seal housing 308. Rotation of the second knob 378 causes the second threaded member 374 to rotate relative to the second seal housing 308, thereby causing the second threaded member 374 to travel in the axial direction (relative to the central longitudinal axis 301). As the second threaded member 374 travels proximally (towards the first seal housing 306), the proximal end 380 of the second threaded member 374 may contact and push against the distal end 382 of the second seal 304. Figure 14 and 15 ), thereby around an axis set therein (e.g., Figure 14 The sleeve shaft 280 shown compresses the second seal 304. In this way, the second seal 304 can be fastened around the shaft in which it is disposed and seal against the shaft by rotating the second knob 378 (and thus the second threaded member 374). In addition, compressing the second seal 304 with the second knob 378 can also axially lock the sealing mechanism 300 to the shaft in which it is disposed, thereby ensuring that the sealing mechanism 300 remains connected to the shaft during flushing under relatively high fluid pressure, as described below.

[0184] The inner surfaces of the first threaded member 336 and the first seal 302 may define a first cavity 384 of the sealing mechanism 300, the first cavity having a first diameter 385 configured to receive a first shaft (e.g., Figure 14 The outer shaft 260 shown. The inner surfaces of the second threaded member 374 and the second seal 304 may define a second cavity 386 of the sealing mechanism 300, the second cavity having a second diameter 387 configured to receive a second shaft (e.g., Figure 17 (Sleeve shaft 280 shown). The second diameter 387 may be smaller than the first diameter 385.

[0185] Figures 11-16 This is a flowchart of an exemplary method 400 for selectively guiding fluid flow through a conduit, the conduit comprising a plurality of axes at least partially concentric with each other (or one axis arranged within another with a slightly offset central longitudinal axis). Specifically, method 400 may be for operating Figures 6-10 The sealing mechanism 300 is a method for preventing fluid flow from exiting the first axis of the conduit and guiding fluid flow through the second axis of the conduit. However, method 400 can also be a method for operating other sealing mechanisms such as the sealing mechanism 500 or sealing mechanism 600 described herein. In some examples, the conduit may be... Figure 14 The delivery device 200 may have a first shaft 260 and a second shaft 280.

[0186] Method 400 begins at 402 and includes attaching the first seal 302 of the sealing mechanism 300 to the first shaft of the conduit (e.g., outer shaft 260, as shown). Figure 14 The distal portion of the first seal 302 (as shown in the diagram). Attaching the first seal 302 to the first shaft may include extending the distal portion of the first shaft into a first cavity 384 of the sealing mechanism 300, through the first seal 302, and into a cavity 360 of the sealing mechanism 300 (e.g., as shown in the diagram). Figure 18-21 (as shown in the diagram). Additionally, in some examples, the distal end of the first shaft may touch or contact a stop (e.g., step 358) in the second seal housing 308. Attaching the first seal 302 to the shaft may also include, for example, securing the first seal 302 around the first shaft by rotating the first knob 340 and the first threaded member 336.

[0187] At 404, the method includes attaching a second seal 304 of the sealing mechanism 300 to a second shaft of a conduit extending through the first shaft (e.g., as shown in the image). Figure 18 The distal portion of the sleeve shaft 280 shown, wherein the distal portion of the second shaft extends distally to the distal end of the first shaft. For example, attaching the second seal 304 to the second shaft may include extending the distal portion of the second shaft through the distal end of the first shaft and extending distally to and through the second seal. In some examples, the distal end of the second shaft may extend beyond the distal end of the sealing mechanism 300. Attaching the second seal 304 to the second shaft may also include, for example, securing the second seal 304 around the second shaft by rotating the second knob 378 and the second threaded member 374. In an alternative example, when the second seal is replaced with a non-actively compressible seal (e.g., an O-ring in sealing mechanism 500 or sealing mechanism 600), the method at 404 may include extending the distal portion of the second shaft through the second seal, wherein the second seal fits tightly around the second shaft and seals against the second shaft.

[0188] After the first seal 302 and the second seal 304 are tightened, the cavity 360 can be fluid-sealed (e.g., no fluid can leave the cavity 360), thereby closing the distal end of the first shaft so that fluid from the first cavity of the first shaft cannot leave the cavity 360.

[0189] Method 400 can continue to 406, comprising allowing fluid to flow through a conduit such that the fluid flows out only from the second lumen of the second shaft and is prevented from flowing out from the first lumen of the first shaft (the first lumen defined between the outer surface and the inner surface of the second shaft). Therefore, the second lumen of the second shaft can be completely flushed and degassed. For example, when the second shaft is a sleeve shaft 280, allowing fluid to flow through the conduit and only through the second lumen (instead of the first lumen) allows for effective and efficient degassed placement of the docking device within the sleeve shaft prior to the implantation procedure.

[0190] Figure 20 An exemplary sealing mechanism 500 for a catheter is shown, configured to regulate the flow of fluid through the two axes of the catheter. Figure 21 and 19 This is a perspective view of the sealing mechanism 500. Figures 20-21 This is a cross-sectional side view of the sealing mechanism 500. Figure 19 This is another cross-sectional side view showing the sealing mechanism 500 coupled to the outer shaft 260 and sleeve shaft 280 of the delivery device 200. However, in an alternative example, the sealing mechanism 500 may be used with various conduits and delivery devices that include two or more shafts with fluid-connected lumens.

[0191] The sealing mechanism 500 may be similar to the sealing mechanism 300, except that instead of two compressible seals (or gaskets) that are compressible around a respective axis via a rotatable element, the sealing mechanism 500 may include a compressible seal or gasket that is compressible around a first axis of the conduit and a non-active compressible seal (e.g., an O-ring) disposed around a second axis of the conduit.

[0192] refer to Figures 19-21 The sealing mechanism 500 may include a first seal 502 and a second seal 504 disposed within a housing 506 of the sealing mechanism 300. The first seal 502 and the second seal 504 may be annular having orifices (e.g., a central orifice) configured to receive a shaft passing through therethrough.

[0193] In some examples, the first seal 502 is a compressible seal or gasket configured to be compressed about an outer shaft (e.g., outer shaft 260) via a rotatable element 508 in a manner similar to the first knob 340 and the first threaded member 336 of the sealing mechanism 300. In some examples, the second seal 504 is a non-active compressible seal, such as an O-ring, which is shaped to fit tightly around and abut against an inner shaft (e.g., sleeve shaft 280). As used herein, the term non-active means "without additional interaction provided by the user and / or other mechanisms (e.g., rotation, clamping, etc.)".

[0194] The rotatable element 508 can also be configured to lock the sealing mechanism 500 in place axially with the system under pressure. The compressible seal forming the axial lock can be located on the outer shaft 260 instead of the sleeve shaft 280, because in at least some cases, the sleeve shaft 280 may have a hydrophilic coating that could reduce the axial retention of the seal and the rotatable element.

[0195] The rotatable element 508 may include a rotatable knob 510 and a threaded member 512 extending distally from the rotatable knob 510. The threaded member 512 may include one or more external threads 514 (or protrusions). Figure 19 The one or more external threads are configured to interface with internal threads 516 on the inner surface 520 of the housing. Figure 21 In some examples, such as Figure 21 As shown, the external thread 514 may be a discontinuous protrusion spaced apart from each other around the outer surface of the threaded member 512, which is positioned to interface with and slide along the internal thread 516. In some examples, the threaded member 512 may also include one or more locking elements 518 (e.g., tabs or cantilever protrusions) configured to engage with the internal thread 516 and maintain the rotatable element 508 connected to the housing 506 (e.g., not disengaging from the housing 506 when the rotatable element 508 is fully released).

[0196] The rotatable element 508 is rotatable relative to the housing 506, such that the threaded member 512 moves distally against the first seal 502, axially pushing the first seal 502 against a curved edge 532 (or beveled edge) of the housing 506, which in turn radially compresses the first seal 502 against an axis disposed therein, thereby around the axis (e.g., Figure 20 The outer shaft 260 shown secures the first seal 502. It should be noted that the radial compression of the first seal 502 can be compared to... Figure 20 The radial compression shown is more pronounced, and in some examples, the first seal 502 can be further pressed against the curved edge 532 and has a smaller inner diameter when pushed axially against the housing 506.

[0197] An internal thread 516 may be provided at a first end portion 522 of the housing 506, the first end portion being proximal to a cavity 524 defined by the inner surface 520 of the housing 506. Figure 20 The first seal 502 may be disposed within the housing 506, adjacent to the internal thread 516 and distal to the internal thread.

[0198] The inner surface 520 of the housing 506 may further define a step 526 within the cavity 524, the step causing the diameter of the cavity 524 to decrease from the larger diameter portion 528 of the cavity 524 to the smaller diameter portion 530 of the cavity 524. Figure 21 and 21 A first seal 502 is disposed within the housing 506, adjacent to and proximal to the larger diameter portion 528 of the cavity 524, and a second seal 504 is disposed within the housing 506, adjacent to and distal to the smaller diameter portion 530 of the cavity 524. Figure 21and 21 In this way, cavity 524 can be defined between the first seal 502 and the second seal 504.

[0199] Similar to the description above regarding the sealing mechanism 300, the step 526 can serve as a stop for the distal end 262 of the outer shaft 260. Figure 22 Thus, the distal end 262 of the outer shaft 260 can be received within the larger diameter portion 528 of the cavity 524, and the step 526 is brought into close contact with a first seal 502 that seals around the distal portion of the outer shaft 260 (e.g., when the rotatable element 508 is rotated, it axially pushes the first seal 502 against the housing (e.g., the bent edge 532), which in turn compresses the first seal 502 against the outer shaft 260). The inner shaft or sleeve shaft 280 can then extend through the distal end 262 of the outer shaft 260 and extend distal to the distal end, passing through the smaller diameter portion 530 of the cavity 524 and a second seal 504. The second seal 504 can be sized to fit tightly around the outer surface of the sleeve shaft 280, such that it provides a fluid seal around the sleeve shaft 280. Thus, fluid passing through the delivery device can be prevented from leaving the distal end of the outer shaft 260 and instead forced through the sleeve shaft 280, as... Figure 22 As shown in the diagram and described above with reference to sealing mechanism 300 and method 400.

[0200] Figure 22 and 23 An exemplary sealing mechanism 600 for a catheter is shown, configured to regulate fluid flow through two axes of the catheter. Sealing mechanism 600 may be similar to sealing mechanism 600 except that, instead of a compressible seal or gasket compressible about the outer axis and a non-compressible seal (e.g., an O-ring) configured to seal about the inner axis, sealing mechanism 600 may include two non-active compressible seals (e.g., two O-rings).

[0201] For example, such as Figure 23 and 23 As shown, the sealing mechanism 600 may include a housing 602. Figure 23 A first seal 604 disposed in the first end portion 608 of the housing 602 and a second seal 606 disposed in the second end portion 610 of the housing 602. Figure 24 The first seal 604 may be larger than the second seal 606. For example, the first inner diameter 605 of the first seal 604 may be larger than the second inner diameter 607 of the second seal 606, wherein the first inner diameter 605 is configured to receive a first shaft (e.g., outer shaft 260) and seal around the first shaft, and the second inner diameter 607 is configured to receive a second shaft (e.g., sleeve shaft 280) and seal around the second shaft.

[0202] Similar to the sealing mechanism described above, the inner surface 612 of the housing 602 may define a cavity 614 disposed between the first seal 604 and the second seal 606. Figure 24 The housing 602 may further define a step 616 within the cavity 614, the step reducing the diameter of the cavity 614 from a larger diameter portion 620 to a smaller diameter portion 618.

[0203] The first seal 604 may be configured to fit tightly against and seal the outer surface of the outer shaft of the conduit (e.g., outer shaft 260), and a step 616 may form a stop for the distal end of the outer shaft. The second seal 606 may be configured to fit tightly against and seal the inner shaft of the conduit (e.g., sleeve shaft 280). In this way, the first seal 604 and the second seal 606 can provide fluid sealing against the respective shafts of the conduit without the use of rotatable elements or knobs, and the distal end of the outer shaft of the conduit can reside in a cavity 614 disposed between the first seal 604 and the second seal 606. Thus, flow out of the outer shaft can be blocked, thereby forcing all or most of the flushing fluid introduced into the outer shaft to exist through the lumen of the inner shaft (e.g., the sleeve shaft lumen of the sleeve shaft 280).

[0204] In some examples, it may be necessary to aspirate fluid from the distal end of the inner shaft of the conduit (e.g., sleeve shaft 280), rather than flushing through the conduit and sealing mechanism as described above. Fluid aspiration herein may be referred to as applying a negative pressure at one end of, for example, the shaft, creating a vacuum and pulling (rather than pushing) the fluid out of the shaft. In contrast, flushing fluid, as used herein, may refer to using positive fluid pressure to propel fluid through the shaft. In some examples, the fluid aspiration and flushing techniques described herein may be used together to guide fluid through one or more shafts of the conduit.

[0205] In such fluid aspiration examples, the housing of any of the sealing mechanisms described above may extend distally from the second seal and includes a second cavity and a second step, both disposed distally from the second seal. For example, Figure 25 The sealing mechanism 500 is shown, wherein the housing 506 further includes a second cavity 550 disposed distal to the second seal 504 and a step 552 disposed within the second cavity 550. The step 552 reduces the diameter of the second cavity 550 from a larger first diameter adjacent to the second seal 504 to a smaller second diameter. The step 552 may act as a stop at the distal end of the inner shaft (sleeve shaft 280).

[0206] A Luer attachment 554 may be attached to the housing 506 on the distal side of the second cavity 550. The Luer attachment 554 may be configured to receive a suction tool 556 (e.g., a syringe) for creating a vacuum within the second cavity 550 and aspirating the inner shaft. In some examples, an extension tube 558 may be connected between the Luer attachment 554 and the suction tool 556.

[0207] In some examples, a method for an inner shaft for a suction catheter may include: when the inner shaft (sleeve shaft 280) is fully retracted inside the outer shaft (outer shaft 260), a sealing mechanism (e.g., Figure 25 The sealing mechanism 500 shown can be positioned about an outer shaft such that the distal end of the outer shaft abuts against step 526. If a sealing mechanism configuration with a rotatable element is used, the rotatable element 508 can be rotated, causing the first seal 502 to be axially compressed against the housing, thereby radially compressing the first seal 502 and securing it around the outer shaft. The inner shaft (sleeve shaft 280) can then be advanced against step 552 through the second seal 504 and into the second cavity 550. Finally, a suction tool 556 (e.g., a syringe) can be attached to the Luer attachment 554, and the user can use the suction tool 556 to create a vacuum to aspirate the catheter.

[0208] Figure 25 and 26 An example of a sealing mechanism 700 is shown for sealing a shaft to a conduit and drawing fluid away from the shaft. The sealing mechanism 700 may include a clamshell member 702 configured to open and receive the shaft of the conduit (e.g., a sleeve shaft 280), such as... Figure 25 As shown in the diagram. For example, the clamshell member 702 may include a first half-shell 704 and a second half-shell 706, the second half-shell including a groove or cavity 720 for receiving a shaft. In some examples, the second half-shell 706 may pivot relative to the first half-shell 704 via a pivot joint 710 connected to the housing 712 of the sealing mechanism 700. Thus, the second half-shell 706 may pivot away from the first half-shell 704 (to an open configuration, such as...) Figure 25 (as shown), so as to receive the shaft therein, and then pivot toward and against the first half-shell 704 (to a closed configuration, as shown). Figure 26 (As shown in the diagram) to seal the shaft between the first half-shell 704 and the second half-shell 706.

[0209] In some examples, the first half-shell 704 and the second half-shell 706 may include a compressible filler 708 (e.g., a silicone pad or another compressible polymer filler) configured to seal around the shaft when the clamshell member 702 is closed and clamped around the shaft. A lumen 720 may be defined in the first half-shell 704 and the second half-shell 706, the lumen being configured to receive the conduit shaft therein.

[0210] The tube 714 may extend from the housing 712 and include a Luer attachment 716 (or another type of mechanical attachment) configured to receive a suction tool (e.g., a syringe). The lumen of the tube 714 may be fluidly connected to the lumen 720 through the lumen of the housing 712.

[0211] In some examples, the sealing mechanism 700 may include a locking mechanism configured as a sliding knob 718, the sliding knob being positioned from a first position surrounding a portion of the outer surface of the housing 712. Figure 26 )Axially slidable to a second position surrounding the closed first half-shell 704 and second half-shell 706 ( Figure 25 In the second position, the sliding knob 718 surrounds the first half-shell 704 and the second half-shell 706, thereby locking the first and second half-shells in a closed and sealed position around the axis. In some examples, the first half-shell 704 and / or the second half-shell 706 may include a stop element 722 configured to prevent the sliding knob 718 from traveling further toward the ends of the first half-shell 704 and the second half-shell 706. Figure 26 Alternatively, in some examples, the sliding knob 718 may have an ergonomic grip around its outer surface (e.g., Figures 27-34 and 26 (as shown in the image).

[0212] In alternative examples, the sealing mechanism 700 may include additional or alternative locking mechanisms. For example, instead of sliding, in an alternative example, the knob 718 may be rotatable and have internal threads that engage with the threads on the first half-shell 704 and the second half-shell 706. Thus, the rotatable knob can be rotated and threaded onto the first half-shell 704 and the second half-shell 706 to hold the first and second half-shells together in a closed and sealed position.

[0213] In an alternative example, instead of the sliding knob 718 or in addition to the sliding knob, the first half-shell 704 and the second half-shell 706 may have complementary locking elements, such as a beveled tab, which allows the first half-shell 704 and the second half-shell 706 to snap together (and remain together in the closed position until released by a release mechanism, such as a tab pressed together for release).

[0214] In some examples, the first half-shell 704 and the second half-shell 706 may be spring-loaded by a spring (e.g., a torsion spring). For example, in some cases, the first half-shell 704 and the second half-shell 706 may be spring-loaded such that the half-shells are forcibly opened by the spring and can then be closed together under pressure and held closed by a locking mechanism (e.g., a sliding knob 718).

[0215] In some examples, the first half-shell 704 and the second half-shell 706 may be spring-loaded, such that the half-shells are forcibly closed by the springs and can then be manually opened and moved by the user (therefore, a locking mechanism is not required in this example).

[0216] Once the shaft (e.g., sleeve shaft 280) is closed and sealed within the clamshell member 702, as Figure 32A As shown, the suction tool can be connected to the tube 714 and is used to create a vacuum and draw fluid through the shaft and out of the shaft.

[0217] In this way, the sealing mechanism 700 can be easily connected and sealed to the shaft (sleeve shaft 280) that requires flushing. In some examples, the shaft may extend beyond the outer shaft of the catheter (e.g., outer shaft 260) and extend distal to said outer shaft during the aspiration process.

[0218] Figure 32B An example of a sealing mechanism 800 (or sealing assembly) for sealing a shaft to a conduit and drawing fluid out of the shaft and / or flushing fluid through the shaft is shown. The sealing mechanism 800 includes a sealing housing 802, a seal 804 disposed within the sealing housing 802, and a locking cap 806 (also referred to herein as a locking cap, locking member, or locking element) configured to interface with the sealing housing 802 and the seal 804. The locking cap 806 is rotatable relative to the sealing housing 802 (or vice versa) about a central longitudinal axis 805 to an unlocked configuration (see example...). Figure 27 ) and locking configuration (see example) Figure 28 The sealing mechanism moves between the two.

[0219] In some examples, the sealing mechanism 800 may also include a tube 808 extending distally from the locking cap 806. In some cases, the tube 808 is a flexible tube comprising a flexible or compliant material, the flexible tube being configured to receive the shaft of a conduit passing through it (and allowing the shaft to move / bend therein). For example, the tube 808 may be configured to be shaped like an inserted conduit shaft (e.g., a curved shape and / or a serpentine shape).

[0220] Figure 27 An assembly view of the sealing mechanism 800 is shown, and Figures 29A-29C An exploded view of the sealing mechanism 800 is shown. Figure 30A and 28 The central longitudinal axis 805 of the sealing mechanism 800 is shown. The locking cap 806 is... Figure 31 As shown separately, the sealing housing 802 is in Figure 32A and 30B Shown separately, and seal 804 in Figure 33A It is shown separately. Additionally... Figures 6-10 and 32BDepict a side view of the sealing mechanism 800, and Figure 34 and 33B Depict a cross-sectional view of the sealing mechanism 800.

[0221] In some examples, the sealing mechanism 800 can seal the shaft of a delivery device for an implantable medical device, such as... Figure 32A Delivery device 200. For example. Figure 32B A sealing mechanism 800 is shown, which is coupled to and seals around the sleeve shaft 280 of the delivery device 200. The sealing mechanism 800 can also be used (and / or is adapted for use with) various conduits and delivery devices that include two or more shafts with fluidly connected lumens.

[0222] The locking cap 806 is rotatable relative to the sealing housing 802 (or the locking cap 806 and the sealing housing 802 are rotatable relative to each other, or the sealing housing 802 is rotatable relative to the locking cap 806), so that the sealing mechanism 800 can be in an unlocked configuration. Figures 27-29C and 33A ) and locking configuration ( Figure 28 , 33B The seal 804 moves between 34 and 35, and in the locking configuration, compresses (and retains) the seal 804 tightly around the shaft arranged within and extending through the sealing mechanism 800. In this way, the sealing mechanism 800 can be used to flush or pull fluid through the shaft, thereby degassing the shaft (and / or components arranged within the shaft).

[0223] like Figures 27-29C As shown, the lock cap 806 includes an outer wall 810 (or outer portion) and an inner wall 812 (or inner portion) extending proximally from the end wall 814. Figures 27-29C and 29A The end wall defines the distal end 816 (or second end) of the lock cap 806. The outer wall 810 and inner wall 812 may extend to the open proximal end 818 (or first end) of the lock cap 806. The cross-section of the outer wall 810 and inner wall 812 is annular. Therefore, the outer wall 810 and inner wall 812 may be referred to herein as circumferentially extending walls and / or annular walls.

[0224] In some cases, the proximal end of the outer wall 810 at the proximal end 818 may include one or more flanges 820, which extend radially outward from the outer wall 810 and extend circumferentially around at least a portion of the outer wall 810 and the locking cap 806. For example, as Figures 27-29C As shown, the lock cap 806 may include two circumferentially extending flanges 820 separated from each other in the circumferential direction by a gap 822 (or space). In this way, each flange 820 may extend around at least a portion of the circumference of the outer wall 810 (e.g., at least or more than 1 / 3 of the total circumference).

[0225] In some cases, the lock cap 806 may include more or fewer than two flanges 820 (e.g., one, three, etc.). In some cases, the width of the gap 822 (in the circumferential direction) may be greater than or less than [the specified value]. Figures 27-29C As shown in the image.

[0226] In some cases, the lock cap 806 includes one or more extensions 824 (or wings) extending radially outward from the outer wall 810. The one or more extensions 824 are configured to be gripped by a user for rotating the sealing mechanism 800 into a locking configuration and an unlocking configuration. Each extension 824 may intersect with one of the flanges 820. In some cases, such as Figure 28 As shown, compared to the flange 820, the extension 824 extends further radially outward relative to the central longitudinal axis 805.

[0227] For example, such as Figure 28 As shown, the lock cap 806 may include two extensions 824 that are circumferentially separated from each other and disposed on opposite sides of the lock cap 806 (e.g., across the central longitudinal axis 805). Thus, the extensions 824 may extend radially outward from the outer wall 810 relative to the central longitudinal axis 805 in opposite directions.

[0228] In some cases, the lock cap 806 may include more or fewer than two extensions 824 (e.g., one, three, etc.).

[0229] A cavity 826 is defined between the outer wall 810 and the inner wall 812 in the radial direction (relative to the central longitudinal axis 805). Figure 27 and 29A Therefore, cavity 826 may be formed by a space separating the outer surface of inner wall 812 and the inner surface of outer wall 810. As further described below, cavity 826 may be configured to receive a portion therein of sealing housing 802.

[0230] Lumen 828 is defined by the inner surface of inner wall 812. Lumen 828 extends through cap 806 and is configured to receive a conduit shaft passing through it (abutting against a seal). For example, lumen 828 may include a first lumen portion 830 extending distally from a proximal end 818 configured to receive the shaft passing through it. Figure 29B and 29A ).

[0231] In some cases, the lumen 828 also includes a second lumen portion 832 extending proximally from the distal end 816 of the tube 808 configured to receive therein. The tube 808 is configured to receive the shaft of a conduit passing through it. In this way, the tube 808 can extend into the second lumen portion 832 and is coupled to the inner wall 812 of the cap 806. Thus, when arranged within the second lumen portion 832, the tube 808 can extend distally outward from the distal end 606 of the cap 806 (e.g., Figure 33A (as shown in the image).

[0232] In some cases, the inner surface of the inner wall 812 may define a stepped or annular protrusion 834 separating the first lumen portion 830 and the second lumen portion 832. Figure 33A And still Figure 29A and 33B (As shown in the diagram). In some cases, the second lumen portion 832 has a second diameter 836 that is smaller than the first diameter 838 of the first lumen portion 830 (e.g., Figure 29A (as shown in the image).

[0233] The inner wall 812 has an axially facing proximal surface 840 at the proximal end 818 that is configured to interface with the seal 804 (as further described below).

[0234] In some examples, the inner wall 812 also includes one or more radially extending channels 842 (or orifices) extending between the inner and outer surfaces of the inner wall 812. Figure 28 One or more channels 842 (e.g., Figure 30A Two are shown in the diagram, configured to receive one or more pins 844. Figure 27 The one or more pins and the sealing housing 802 form a locking assembly of the sealing mechanism 800 (as further described below). In this way, the pin 844 can extend through the corresponding channel 842 and be coupled to the lock cap 806.

[0235] In some examples, pin 844 may be a component of lock cap 806. For example, pin 844 may be mounted within and attached to a corresponding channel 842 in lock cap 806. In some examples, instead of being disposed within and protruding outward from channel 842, pin 844 may be attached to and protrude radially outward from the outer surface of inner wall 812. In this way, pin 844 may be an extension of inner wall 812 in some examples.

[0236] Go to Figure 28 and 30B (as well as Figure 27 and Figure 30A The sealing housing 802 includes a proximal end 848 of the sealing housing 802. Figure 27 and 28 ) and remote 850 (Figure 30B and 30B A cylindrical body portion 846 extending between ) . The inner surface of the cylindrical body portion 846 defines a cavity 852 therein. Axially facing proximal sidewall 854 ( Figure 33A and 28 An opening 856 is formed at the proximal end 848 of the cylindrical body portion 846 and defines an opening 856 configured (e.g., shaped and / or sized to) receive a conduit shaft passing through it. At the distal end 850, the diameter of the opening 856 is smaller than the diameter of the cylindrical body portion 846.

[0237] For example, the inner surface of the cylindrical body portion 846 may further define a lumen 845 extending from the opening 856 into the cylindrical body portion 846. The lumen 845 opens at the inclined surface 853 into a wider (larger diameter) cavity 852. Figures 27-28 , 33A (and 33B), the oblique surface is defined by the inner surface of the cylindrical body portion 846. The oblique surface 853 may be positioned therein to receive the seal 804, as described below. Figures 27-28 and 33B Further description: The inclined surface 853 is inclined at a non-zero angle relative to the central longitudinal axis 805.

[0238] In some cases, such as Figures 27-28 As shown in 30A-30B, the proximal sidewall 854 has a circumferential extension or flange 858 that extends radially outward from the outer surface of the cylindrical body portion 846 and extends around at least a portion of the circumference of the cylindrical body portion 846.

[0239] In some cases, the seal housing 802 includes one or more radially extending extensions 860 (or flanges) extending radially outward from the cylindrical body portion 846. The one or more extensions 860 are configured to be gripped by a user to retain and / or rotate relative to the lock cap 806 when the sealing mechanism 800 moves between a locked and unlocked configuration. In some examples, the one or more extensions 860 may intersect with the flange 858. The extensions 860 extend further radially outward relative to the central longitudinal axis 805 than the flange 858.

[0240] although Figure 27 Two extensions 860 are depicted in 30A-30B and 32A-34, but in alternative examples, the seal housing 802 may include more or fewer than two extensions 860 (e.g., one, three, four, etc.).

[0241] The cylindrical body portion 846 includes one or more grooves 862 (or at least one groove 862) extending therethrough between the inner and outer surfaces of the cylindrical body portion 846 (e.g., through the thickness of the cylindrical body portion 846, as defined in the radial direction). For example, as... Figure 32A As shown in 30A-30B, the cylindrical body portion 846 includes two slots 862 that are circumferentially spaced apart from each other (e.g., 180 degrees apart in some cases). Each slot 862 can be configured to receive one of the pins 844, as shown in Figures 30A-30B. Figure 30A as well as Figure 31 and 32B As shown in the diagram (described in more detail below). Therefore, the number of slots 862 is equal to the number of pins 844. In alternative examples, it is possible to have more or fewer than two slots 862 and pins 844, where the number of pins 844 and slots 862 are equal.

[0242] like Figure 33A , 30A As shown in 30B, each groove 862 may have a non-straight shape, such as a curved shape. For example, each groove 862 may have a circumferentially extending portion at a second end 872 of the groove 862 and an axially extending portion at a first end 870 of the groove 862. The first end 870 and the second end 872 of the groove 862 are opposite ends of the groove 862. Compared to the second end 872 of each groove 862, the first end 870 is closer to the distal end 850 of the cylindrical body portion 846. Figures 32A-33B ).

[0243] Thus, as the seal housing 802 and the locking cap 806 rotate relative to each other between a locked configuration and an unlocked configuration, each pin 844 can slide within a corresponding groove 862 (between opposing first and second ends 872), and accordingly cause the seal housing 802 and the locking cap 806 to move axially toward and away from each other, respectively (as further described below). This relative movement between the seal housing 802 and the locking cap 806 causes the seal 804 to be axially compressed between the seal housing 802 and the locking cap 806, and radially compressed (and / or radially expanded against) the axis extending through the sealing mechanism 800.

[0244] Pin 844 and corresponding slot 862 can be configured such that the seal housing 802 and the lock cap 806 can rotate relative to each other between the unlocked and locked configurations by less than 360 degrees, 45-225 degrees, 70-200 degrees, 170-190 degrees, or 80-100 degrees.

[0245] exist Figure 32AThe image shows a side view of seal 804. Seal 804 includes a proximal portion 864 and a distal portion 866. The distal portion 866 is cylindrical (annular). In some examples, the proximal portion 864 is inclined or tapered such that its outer diameter decreases from the distal portion 866 to the proximal end of the proximal portion 864. The diameter of the lumen of seal 804 may be relatively constant throughout seal 804 (through the distal portion 866 and proximal portion 864). In this way, seal 804 can be configured to fit within cavity 852 of seal housing 802, and the inclined outer surface of proximal portion 864 can be configured to interface with and abut against tapered surface 853. The axially facing distal surface 868 at the distal end of distal portion 866 is configured to interface with (and have face-to-face contact with) proximal surface 840 of cap 806. Figure 32B and 33B ).

[0246] Figure 32A The operation of the sealing mechanism 800 is described. As described above, the locking component of the sealing mechanism 800 can be in an unlocked configuration (or position) (e.g., Figure 32B and 33A ) and locking configuration (or location) (e.g., Figure 32A and 33B The locking assembly can move between the two. For example, the locking assembly may be formed by a pin 844 that extends through (and / or is coupled to) a channel 842 in a lock cap 806 and slides along a groove 862. The seal housing 802 and the lock cap 806 rotate relative to each other so that the pin 844 slides along the groove 862 at the head end 870 of the groove 862 (e.g., Figure 33A As shown, in the unlocked configuration) and the second end 872 of slot 862 (as shown) Figure 33A As shown, it slides between the locked configuration. Thus, the sealing mechanism 800 provides discrete binary sealed / unsealed states, which makes the device easy to use.

[0247] In the unlock configuration, pin 844 is located at the first end 870 of slot 862. Figure 32A Furthermore, the end wall 814 of the locking cap 806 and the distal end 850 of the sealing housing 802 are spaced apart by a first gap 874. Figure 32BIn this position, the distal side 868 of the seal 804 may abut or be positioned close to the proximal surface 840 of the inner wall 812 of the cap 806, but the seal 804 is in an uncompressed state (e.g., uncompressed between the seal housing 802 and the inner wall 812 of the cap 806) or a less compressed state (such that it is not compressed against the conduit shaft extending through it). In this state, the tapered surface 853 of the cylindrical body portion 846 has a steeper angle and a larger diameter than the corresponding portion of the seal 804 (and there is a gap between the tapered surface 853 and the seal 804, such as...). Figure 33B (As shown in the diagram). Therefore, in this configuration, the shaft can be inserted into the sealing mechanism 800, and the seal 804 is not compressed and sealed around the shaft.

[0248] As an example, in order to remove the sealing mechanism 800 from the unlock configuration ( Figure 33B and 33A Move to locked configuration () Figure 34 and 33B The user can keep the nut 806 stationary and rotate the seal housing 802, causing the pin 844 to move along the groove 862 to the second end 872 of the groove 862, and the seal housing 802 to move toward (in the axial direction) the nut 806.

[0249] In an alternative example, the user may rotate the seal housing 802 and the locking cap 806 relative to each other (in opposite directions of rotation), or rotate the locking cap 806 relative to the seal housing 802, to move the sealing mechanism 800 into a locking configuration.

[0250] As the seal housing 802 moves closer to the locking cap 806, the seal 804 presses against the proximal surface 840 of the inner wall 812 of the locking cap 806 (and thus compresses axially), and the seal 804 is forced radially outward to fill the space between the tapered surface 853 and the seal 804, and also radially inward toward the central longitudinal axis 805. Therefore, when the shaft is arranged inside the sealing mechanism 800 (e.g., through the lumen of the tube 845 and the tube 808), the axially compressed and radially expanded seal 804 presses against the outer surface of the shaft, thereby sealing the shaft (and forming a fluid-impermeable seal). Figure 34 As shown, in the locking configuration, the lock cap 806 and the sealing housing 802 are spaced apart from each other by a second gap 876. Figure 34 The second gap is smaller than the first gap 874. Additionally, the second diameter 878 of the cavity of the seal 804 in the locked configuration is smaller than the first diameter 880 of the cavity of the seal 804 in the unlocked configuration.

[0251] In some examples, such as Figure 6As shown, the sealing mechanism 800 can be used with the delivery device 200. For example, when the sealing mechanism 800 is in the unlocked configuration, the sleeve shaft 280 (which extends distally at the distal end of the outer shaft 260) is inserted into the seal housing 802, through the seal housing 802, through the locking cap 806, and into the flexible tube 808. ​ Then, the locking cap 806 and the sealing housing 802 rotate relative to each other to move the sealing mechanism 800 into a sealing and locking configuration (e.g., ​ (As depicted in the illustration). The suction tool 890 may be attached to the distal end of the flexible tube 808 (at the attachment of the tube 808 or at the attachment of the extension tube 892 extending between the flexible tube 808 and the suction tool 890). The suction tool 890 is then used (e.g., by pulling back the plunger of the syringe) to create suction (or vacuum) to draw fluid through the conduit and away from the sleeve shaft 280, thereby aspirating the sleeve shaft 280.

[0252] In some examples, instead of aspiration (or suction), the aspiration tool 890 may be filled with fluid and then used to push (and flush) the fluid through the sleeve shaft 280 (or another conduit shaft disposed within the sealing mechanism 800).

[0253] Alternatively (or additionally), the end of the flexible tube 808 may be open (not attached to a suction tool), and the fluid source may be from the proximal end of the tube (e.g., as shown in the image). ​ , 9 Fluid from the flushing ports 210, 216 and / or 218 in the handle assembly 220 shown in 10 is pushed into the conduit, enters and passes through the sleeve shaft 280.

[0254] Therefore, the sleeve shaft or alternative catheter shaft inserted into the sealing mechanism 800 can be effectively flushed and / or aspirated before the catheter is used during surgery.

[0255] Delivery techniques

[0256] To implant an artificial valve into the autologous aortic valve via a transfemoral delivery method, the artificial valve is mounted along the distal portion of the delivery device in a radially compressed state. The artificial valve and the distal portion of the delivery device are inserted into the femoral artery and advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The artificial valve is positioned within the autologous aortic valve and expands radially (e.g., by inflating a balloon, actuating one or more actuators of the delivery device, or deploying the artificial valve from a sheath to allow for self-expansion). Alternatively, the artificial valve can be implanted into the autologous aortic valve during a transapical procedure, whereby the artificial valve (on the distal portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the artificial valve is positioned within the autologous aortic valve. Alternatively, in transaortic surgery, an artificial valve (on the distal portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, for example via a partial J-sternotomy or a right parasternal thoracotomy, and is subsequently advanced through the ascending aorta toward the autologous aortic valve.

[0257] To implant an artificial valve into an autologous mitral valve via transseptal delivery, the artificial valve is mounted radially compressed along the distal portion of the delivery device. The artificial valve and the distal portion of the delivery device are inserted into the femoral vein and advanced through the inferior vena cava into the right atrium, through the atrioventricular septum (via a perforation created in the atrioventricular septum), into the left atrium, and advanced toward the autologous mitral valve. Alternatively, the artificial valve can be implanted into the autologous mitral valve via a transapical procedure, whereby the artificial valve (on the distal portion of the delivery device) is introduced into the left ventricle through a surgical incision in the chest and the apex of the heart, and positioned within the autologous mitral valve.

[0258] To implant an artificial valve into an autologous tricuspid valve, the artificial valve is mounted along the distal portion of the delivery device under radial compression. The artificial valve and the distal portion of the delivery device are inserted into the femoral vein and advanced through the inferior vena cava and into the right atrium, with the artificial valve positioned within the autologous tricuspid valve. A similar method can be used to implant an artificial valve into an autologous pulmonary valve or pulmonary artery, except that the artificial valve is advanced through the autologous tricuspid valve into the right ventricle and towards the pulmonary valve / pulmonary artery.

[0259] Another delivery method is the transatrial approach, in which the artificial valve (on the distal portion of the delivery device) is inserted through an incision in the chest and through an incision made in the atrial wall (of the right or left atrium) to access any autologous heart valve. Atrial delivery can also be performed intravascularly, for example, from the pulmonary vein. Yet another delivery method is the transventricular approach, in which the artificial valve (on the distal portion of the delivery device) is inserted through an incision in the chest and through an incision made in the right ventricular wall (usually at or near the base of the heart) to implant the artificial valve into an autologous tricuspid valve, autologous pulmonary valve, or pulmonary artery.

[0260] In all delivery methods, the delivery device can be advanced over a guidewire previously inserted into the patient's vascular system. Furthermore, the disclosed delivery methods are not intended to be limiting. Any artificial valve disclosed herein can be implanted using any of the various delivery procedures and devices known in the art.

[0261] Any systems, devices, equipment, etc., described herein may be sterilized (e.g., by heating / heat, pressure, steam, radiation, and / or chemicals, etc.) to ensure their safety for patient use, and any method described herein may include the sterilization of associated systems, devices, equipment, etc., as a step in the method. Examples of heating / heat sterilization include steam sterilization and autoclaving. Examples of radiation used for sterilization include, but are not limited to, gamma radiation, ultraviolet radiation, and electron beams. Examples of chemicals used for sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be performed using, for example, hydrogen peroxide plasma.

[0262] Additional examples of the disclosed technology

[0263] In view of the above-described embodiments of the disclosed subject matter, this application discloses the following additional examples. It should be noted that a feature of a single example, or a combination thereof, employing more than one feature of an example, and optionally combined with one or more features of another example, are also additional examples falling within the scope of this application's disclosure.

[0264] Example 1. An assembly comprising: a conduit including a first shaft and a second shaft extending through the first shaft, wherein a first lumen is defined between an inner surface of the first shaft and an outer surface of the second shaft; and a sealing mechanism including: a first seal disposed around a distal portion of the first shaft; a second seal disposed around a distal portion of the second shaft extending from the first shaft; and a cavity disposed within a housing of the sealing mechanism between the first seal and the second seal, wherein the distal end of the first shaft is disposed within the cavity, and wherein the cavity is fluid-sealed by the first seal and the second seal such that fluid from the first lumen cannot exit the cavity.

[0265] Example 2. A component according to any of the examples herein, particularly the component according to Example 1, wherein the distal end of the first lumen is closed by the lumen, wherein the second shaft has a second lumen, and wherein the distal end of the second lumen is open and extends distally to the second seal.

[0266] Example 3. A component according to any example herein, particularly the component of Example 1 or Example 2, wherein the sealing mechanism includes a step within the cavity, the step reducing the diameter of the cavity from a larger first diameter adjacent to the first seal to a smaller second diameter adjacent to the second seal, and wherein the distal end of the first shaft is disposed abutting the step.

[0267] Example 4. The component according to any example herein, particularly the component according to Example 3, wherein the housing includes a first sealing housing in which the first seal is received and a second sealing housing in which the second seal is received, and wherein the step is formed on the inner surface of the second sealing housing.

[0268] Example 5. A component according to any of the examples herein, particularly any of Examples 1-4, wherein the first seal is disposed in a first seal housing of the sealing mechanism, and the second seal is disposed in a second seal housing of the sealing mechanism, the first seal housing and the second seal housing being connected to each other, and wherein the cavity is defined by the inner surface of the first seal housing and the inner surface of the second seal housing.

[0269] Example 6. The component according to any example herein, particularly the component according to Example 5, wherein the first sealing housing and the second sealing housing are joined together by one or more fasteners via an overlapping junction.

[0270] Example 7. A component according to any of the examples herein, particularly the component described in Example 5 or Example 6, wherein the sealing mechanism further includes a first threaded member that threads into the inner surface of the first seal housing and is configured to rotate relative to the first seal housing and secure the first seal about the first axis.

[0271] Example 8. A component according to any example herein, particularly the component of Example 7, wherein the sealing mechanism includes a rotatable first knob coupled to the first threaded member and configured to rotate the first threaded member such that the first threaded member moves distally against the first seal and secures the first seal around the first axis.

[0272] Example 9. The component according to any of the examples herein, particularly the component of Example 7 or Example 8, wherein the sealing mechanism further includes a second threaded member that threads interface with an inner surface of the second seal housing and is configured to rotate relative to the second seal housing and secure the second seal about the second axis.

[0273] Example 10. The component according to any example herein, particularly the component according to Example 9, wherein the sealing mechanism includes a rotatable second knob coupled to the second threaded member and configured to rotate the second threaded member such that the second threaded member moves proximally against the second seal and secures the second seal around the second axis.

[0274] Example 11. A component according to any of the examples herein, particularly the component described in Example 9 or Example 10, wherein the first threaded member has a larger diameter lumen than the second threaded member.

[0275] Example 12. A component according to any of the examples herein, particularly any of Examples 1-3, wherein the first seal and the second seal are disposed in the housing, and wherein the cavity is defined by the inner surface of the housing.

[0276] Example 13. The component according to any example herein, particularly the component according to Example 12, wherein the sealing mechanism further includes a threaded member that engages with a thread on an inner surface of the housing at one end of the housing adjacent to the first seal, and wherein the threaded member is configured to rotate relative to the housing and secure the first seal about the first axis.

[0277] Example 14. The component according to any example herein, particularly the component according to Example 13, wherein the sealing mechanism includes a rotatable knob disposed at one end of the threaded member, and wherein the rotatable knob is configured to rotate the threaded member such that the threaded member moves distally against the first seal and secures the first seal around the first axis.

[0278] Example 15. The component according to any of the examples herein, particularly any of Examples 12-14, wherein the first seal is a compressible gasket and the second seal is an O-ring.

[0279] Example 16. The component according to any example in this document, especially the component according to Example 12, wherein the first seal is an O-ring and the second seal is an O-ring.

[0280] Example 17. A component according to any example herein, particularly the component according to Example 12, wherein the cavity is a first cavity, wherein the housing further includes a second cavity disposed distal to the second seal and a second step disposed within the second cavity, the second step reducing the diameter of the second cavity from a larger first diameter adjacent to the second seal to a smaller second diameter, and wherein the distal end of the second shaft is disposed abutting the second step.

[0281] Example 18. The component according to any of the examples herein, particularly the component according to Example 17, wherein the sealing mechanism further includes a Luer attachment disposed on the distal side of the second cavity, and wherein the Luer attachment is configured to receive a suction tool for generating a vacuum and suction the second shaft.

[0282] Example 19. A component according to any of the examples herein, particularly any of Examples 1-18, wherein the conduit is a delivery device for a docking device, and wherein the second shaft is configured to receive the docking device within a distal portion of the second shaft in a delivery configuration.

[0283] Example 20. A component according to any of the examples herein, particularly the component according to Example 19, wherein the docking device includes a coil and an expandable protective member disposed around a portion of the coil.

[0284] Example 21. A sealing mechanism comprising: a first sealing housing having a first sealing member disposed within the first sealing housing; a second sealing housing having a second sealing member disposed within the second sealing housing, wherein a proximal portion of the second sealing housing includes a step, the step transitioning between a first diameter on a proximal side of the step and a second diameter on a distal side of the step, the second diameter being smaller than the first diameter, and wherein the step is disposed proximal to the second sealing member; and a cavity defined within the distal portion of the first sealing housing and the proximal portion of the second sealing housing, situated between the first sealing member and the second sealing member.

[0285] Example 22. A sealing mechanism according to any example herein, particularly the sealing mechanism of Example 21, wherein the first seal and the second seal are annular, and wherein the inner diameter of the first seal is greater than the inner diameter of the second seal.

[0286] Example 23. A sealing mechanism according to any example herein, particularly the sealing mechanism of Example 22, wherein the diameter of the cavity on the proximal side of the step is greater than the inner diameter of the first seal.

[0287] Example 24. A sealing mechanism according to any of the examples herein, particularly any of Examples 21-23, further includes a first threaded member, the first threaded member including an external thread configured to engage an internal thread on an inner surface of a proximal portion of the first sealing member housing, and wherein the first threaded member is configured to rotate and travel axially relative to the first housing member.

[0288] Example 25. A sealing mechanism according to any example herein, particularly the sealing mechanism of Example 24, wherein the first seal is disposed within a middle portion of the first seal housing, and wherein the first threaded member is configured to travel distally toward the first seal and push the first seal as it rotates, so as to secure the first seal.

[0289] Example 26. A sealing mechanism according to any of the examples herein, particularly the sealing mechanism of Example 25, further includes a first rotatable knob coupled to the proximal end of the first threaded member, wherein the first rotatable knob is disposed around the proximal portion of the first sealing member housing.

[0290] Example 27. A sealing mechanism according to any of the examples herein, particularly any of Examples 24-26, further includes a second threaded member, the second threaded member including an external thread configured to engage an internal thread on an inner surface of a distal portion of the second sealing housing, and wherein the second threaded member is configured to rotate and travel axially relative to the second housing member.

[0291] Example 28. A sealing mechanism according to any example herein, particularly the sealing mechanism of Example 27, wherein the second seal is disposed within the middle portion of the housing of the second seal, and wherein the second threaded member is configured to travel proximally toward the second seal and push the second seal as it rotates, so as to secure the second seal.

[0292] Example 29. A sealing mechanism according to any of the examples herein, particularly the sealing mechanism of Example 28, further includes a second rotatable knob coupled to the distal end of the second threaded member, wherein the second rotatable knob is disposed around the distal portion of the second sealing member housing.

[0293] Example 30. A sealing mechanism according to any example herein, particularly any of Examples 27-29, wherein the inner surfaces of the first threaded member and the first seal define a first cavity having a first diameter and configured to receive a first shaft, wherein the inner surfaces of the second threaded member and the second seal define a second cavity having a second diameter and configured to receive a second shaft, and wherein the second diameter is smaller than the first diameter.

[0294] Example 31. A sealing mechanism according to any of the examples herein, particularly any of Examples 21-30, wherein the first sealing housing and the second sealing housing are joined together at an overlapping junction.

[0295] Example 32. A sealing mechanism according to any example herein, particularly the sealing mechanism of Example 31, wherein the step is disposed adjacent to the overlapping junction.

[0296] Example 33. A method for flushing a conduit, comprising: attaching a first seal of a sealing mechanism to a distal portion of a first shaft of the conduit; attaching a second seal of the sealing mechanism to a distal portion of a second shaft of the conduit extending through the first shaft, wherein the distal portion of the second shaft extends distal to the distal end of the first shaft; and allowing fluid to flow through the conduit such that fluid flows out only from a second lumen defined by the second shaft and is prevented from flowing out from a first lumen defined between an outer surface of the second shaft and an inner surface of the first shaft.

[0297] Example 34. The method according to any example herein, particularly the method of Example 33, wherein attaching the first seal to the first shaft comprises extending a distal portion of the first shaft into a lumen of the sealing mechanism, through the first seal, and into a cavity of the sealing mechanism, the cavity being defined by a housing wall of the sealing mechanism, located between the first seal and the second seal.

[0298] Example 35. The method according to any example herein, particularly the method of Example 34, wherein extending the distal portion of the first shaft into the cavity includes extending the distal end of the first shaft into the cavity until the distal end encounters a step defined by the housing.

[0299] Example 36. The method according to any of the examples herein, particularly any of Examples 33-35, wherein attaching the second seal to the second shaft comprises causing a distal portion of the second shaft to extend through the distal end of the first shaft and extend distal to the distal end and through the second seal.

[0300] Example 37. The method according to any of the examples herein, particularly any of Examples 33-36, wherein attaching the first seal and attaching the second seal comprises securing the first seal around the first shaft and securing the second seal around the second shaft such that the distal end of the first shaft is closed.

[0301] Example 38. The method according to any of the examples herein, particularly any of Examples 33-37, wherein attaching the first seal to the first shaft comprises securing the first seal around the first shaft by rotating a first threaded member disposed near the first seal axially toward and against the first seal.

[0302] Example 39. The method according to any of the examples herein, particularly any of Examples 33-38, wherein attaching the second seal to the second shaft comprises securing the second seal around the second shaft by rotating a second knob of the sealing mechanism to move a second threaded member disposed distal to the second seal axially toward and against the second seal.

[0303] Example 40. The method according to any of the examples herein, particularly any of Examples 33-39, wherein the conduit is a delivery device for a docking device, and wherein the second shaft is configured to receive the docking device within a distal portion of the second shaft in a delivery configuration.

[0304] Example 41. The method according to any example herein, particularly the method of Example 40, wherein the docking device comprises a coil and an expandable protective member disposed around a portion of the coil, and wherein allowing fluid to flow through the conduit such that the fluid flows out only from the second lumen comprises allowing the fluid to flow through and around the protective member to degas the protective member.

[0305] Example 42. The method according to any of the examples herein, particularly any of Examples 33-41, wherein allowing fluid to flow through the conduit such that the fluid flows out only from the second lumen defined by the second axis and is prevented from flowing out from the first lumen comprises flushing the fluid through the conduit using a positive pressure applied to the conduit.

[0306] Example 43. The method according to any of the examples herein, particularly any of Examples 33-41, wherein allowing fluid to flow through the conduit such that the fluid flows out only from the second lumen defined by the second axis and is prevented from flowing out from the first lumen comprises aspirating the fluid through the conduit using a suction tool with negative pressure applied to the distal end of the second axis.

[0307] Example 44. The method according to any of the examples herein, particularly any of Examples 33-41, wherein allowing fluid to flow through the conduit such that the fluid flows out only from the second lumen defined by the second axis and is prevented from flowing out from the first lumen comprises flushing and aspirating the fluid through the conduit using a combination of negative and positive pressure applied to the conduit.

[0308] Example 45. A method for flushing a conduit, comprising: extending a distal portion of a first shaft of the conduit through a first seal disposed in a first seal housing of a sealing mechanism and into a cavity disposed within a first seal housing and a second seal housing of the sealing mechanism, the cavity being defined between the first seal and a second seal of the second seal housing; extending a distal portion of a second shaft of the conduit through a distal end of the first shaft and extending distal to the distal end, and through a second seal disposed within the second seal housing; securing the first seal around the distal portion of the first shaft and securing the second seal around the distal portion of the second shaft; and allowing fluid to flow through the conduit such that fluid flows out only from a first cavity defined by the second shaft and is prevented from flowing out from a second cavity defined between an outer surface of the second shaft and an inner surface of the first shaft.

[0309] Example 46. The method according to any example herein, particularly the method of Example 45, wherein securing the first seal around the first shaft and securing the second seal around the second shaft comprises fluid sealing the cavity such that fluid from the first cavity cannot leave the cavity and the distal end of the first shaft is closed.

[0310] Example 47. The method according to any of the examples herein, particularly Example 45 or Example 46, wherein extending the distal portion of the first shaft into the cavity includes extending the distal end of the first shaft into the cavity until the distal end encounters a stop disposed within the cavity.

[0311] Example 48. The method according to any example herein, especially the method of Example 47, wherein the stop is defined by an annular step disposed on the inner surface of the second seal housing on the proximal side of the second seal.

[0312] Example 49. The method according to any of the examples herein, particularly any of Examples 45-48, wherein extending the distal portion of the second shaft through the distal end of the first shaft and extending distal to the distal end and through the second seal comprises extending the distal end of the second shaft distal to the distal end of the housing of the second seal.

[0313] Example 50. The method according to any of the examples herein, particularly any of Examples 45-49, wherein fastening the first seal around the distal portion of the first shaft comprises fastening the first seal around the first shaft by rotating a first threaded member that is threadedly engaged with the first seal housing relative to the first seal housing and moving axially toward and against the first seal by rotating a first knob of the sealing mechanism.

[0314] Example 51. The method according to any of the examples herein, particularly any of Examples 45-50, wherein fastening the second seal around the distal portion of the second axis comprises fastening the second seal around the second axis by rotating a second threaded member that is threadedly engaged with the housing of the second seal relative to the housing of the second seal and moving it axially toward and against the second seal by rotating a second knob of the sealing mechanism.

[0315] Example 52. The method according to any of the examples herein, particularly any of Examples 45-51, wherein the conduit is a delivery device for a docking device, and wherein the second shaft is configured to receive the docking device within a distal portion of the second shaft in a delivery configuration.

[0316] Example 53. The method according to any example herein, particularly the method of Example 52, wherein the docking device comprises a coil and an expandable protective member disposed around a portion of the coil, and wherein allowing fluid to flow through the conduit such that the fluid flows out only from the first lumen comprises allowing the fluid to flow through and around the protective member to degas the protective member.

[0317] Example 54. An assembly comprising: a delivery device including a first shaft, a second shaft extending through the first shaft, and an implantable medical device disposed in a distal portion of the second shaft in a delivery configuration, wherein a first lumen is defined between an inner surface of the first shaft and an outer surface of the second shaft and a second lumen is defined by the second shaft, wherein the first and second lumens are fluidly connected to each other; and a sealing mechanism including a housing, a first seal disposed within the housing and surrounding a distal portion of the first shaft, a second seal disposed within the housing and surrounding a distal portion of the second shaft, and a cavity disposed within the housing and defined between the first seal and the second seal, wherein the distal end of the first shaft is disposed within the cavity, wherein the distal end of the second shaft extends distal to the distal end of the first shaft and the second seal, and wherein the cavity is fluidly sealed by the first seal and the second seal.

[0318] Example 55. A component according to any of the examples herein, particularly the component according to Example 54, wherein the first lumen and the second lumen are fluidly connected to each other downstream of the flushing port of the delivery device and upstream of the distal end of the first shaft.

[0319] Example 56. A component according to any of the examples herein, particularly the component described in Example 54 or Example 55, wherein the distal end of the first lumen is closed by the lumen, and wherein the distal end of the second lumen defined at the distal end of the second axis is open.

[0320] Example 57. A component according to any of the examples herein, particularly any of Examples 54-56, wherein the housing includes a step disposed within the cavity, the step reducing the diameter of the cavity from a larger first diameter adjacent to the first seal to a smaller second diameter adjacent to the second seal, and wherein the distal end of the first shaft is disposed abutting the step.

[0321] Example 58. The component according to any example herein, particularly the component according to Example 57, wherein the housing includes a first sealing housing in which the first seal is received and a second sealing housing in which the second seal is received, and wherein the step is formed on the inner surface of the second sealing housing.

[0322] Example 59. The component according to any of the examples herein, particularly the component according to Example 58, wherein the first sealing housing and the second sealing housing are joined together by one or more fasteners via an overlapping junction.

[0323] Example 60. The component according to any of the examples herein, particularly the component according to Example 58 or Example 59, wherein the sealing mechanism further includes a first threaded member that threads into an inner surface of the first seal housing and is configured to rotate relative to the first seal housing and secure the first seal about the first axis.

[0324] Example 61. The component according to any example herein, particularly the component according to Example 60, wherein the sealing mechanism includes a rotatable first knob coupled to the first threaded member and configured to rotate the first threaded member such that the first threaded member moves distally against the first seal and secures the first seal around the first axis.

[0325] Example 62. The component according to any of the examples herein, particularly the component according to Example 60 or Example 61, wherein the sealing mechanism further includes a second threaded member that threads intersect with an inner surface of the second seal housing and is configured to rotate relative to the second seal housing and secure the second seal about the second axis.

[0326] Example 63. The component according to any example herein, particularly the component according to Example 62, wherein the sealing mechanism includes a rotatable second knob coupled to the second threaded member and configured to rotate the second threaded member such that the second threaded member moves proximally against the second seal and secures the second seal around the second axis.

[0327] Example 64. A component according to any of the examples herein, particularly the component described in Example 62 or Example 63, wherein the first threaded member has a larger diameter lumen than the second threaded member.

[0328] Example 65. A component according to any of the examples herein, particularly any of Examples 54-57, wherein the sealing mechanism includes a rotatable knob and a threaded member extending distally from the rotatable knob, wherein one or more threads on the threaded member intersect with threads disposed on an inner surface of the housing proximal to the first seal, and wherein the rotatable knob is configured to rotate the threaded member relative to the housing such that the threaded member moves distally against the first seal and secures the first seal about the first axis.

[0329] Example 66. The component according to any of the examples herein, particularly the component according to Example 65, wherein the second seal is an O-ring.

[0330] Example 67. The component according to any of the examples herein, particularly any of Examples 54-57, wherein both the first seal and the second seal are O-rings.

[0331] Example 68. A component according to any of the examples herein, particularly any of Examples 54-67, wherein the implantable medical device is a docking device configured to expand from the delivery configuration to a coiled configuration after deployment from the delivery device, and wherein the docking device in its coiled configuration is configured to receive an artificial heart valve.

[0332] Example 69. A component according to any of the examples herein, particularly the component according to Example 68, wherein the docking device includes a coil and an expandable protective member disposed around a portion of the coil.

[0333] Example 70. A sealing mechanism comprising: a housing including a cavity and a step disposed within the cavity, the step reducing the diameter of the cavity from a larger diameter portion to a smaller diameter portion; a first seal disposed within the housing, adjacent to and proximal to the larger diameter portion of the cavity; and a second seal disposed within the housing, adjacent to and distal to the smaller diameter portion of the cavity.

[0334] Example 71. A sealing mechanism according to any example herein, particularly the sealing mechanism of Example 70, wherein the first seal and the second seal are annular, and wherein the inner diameter of the first seal is greater than the inner diameter of the second seal.

[0335] Example 72. A sealing mechanism according to any example herein, particularly the sealing mechanism of Example 70 or Example 71, wherein the sealing mechanism further includes a threaded member that engages with a thread on an inner surface of the housing adjacent to one end of the housing of the first seal, and wherein the threaded member is configured to rotate relative to the housing and, during its rotation, travel distally toward the first seal and push against the first seal in order to secure the first seal.

[0336] Example 73. A sealing mechanism according to any example herein, particularly the sealing mechanism of Example 72, wherein the sealing mechanism includes a rotatable knob disposed at one end of the threaded member, and wherein the rotatable knob is configured to rotate the threaded member.

[0337] Example 74. A sealing mechanism according to any example herein, particularly the sealing mechanism of Example 72 or Example 73, wherein the threaded member comprises a plurality of external threads that are discontinuous with each other and spaced apart from each other around the outer surface of the threaded member, the plurality of external threads being configured to engage with and slide along threads on the inner surface of the housing.

[0338] Example 75. A sealing mechanism according to any of the examples herein, particularly any of Examples 72-74, wherein the threaded member includes one or more locking elements configured to engage with a threaded snap on an inner surface of the housing and to maintain the threaded member connected to the housing.

[0339] Example 76. A sealing mechanism according to any of the examples herein, particularly any of Examples 70-75, wherein the first seal is a compressible gasket and the second seal is an O-ring.

[0340] Example 77. A sealing mechanism according to any of the examples herein, particularly the sealing mechanism of Example 70 or Example 71, wherein the first seal is an O-ring and the second seal is an O-ring.

[0341] Example 78. A sealing mechanism according to any example herein, particularly any of Examples 70-77, wherein the cavity is a first cavity and the step is a first step, wherein the housing further includes a second cavity disposed distal to the second seal and a second step disposed within the second cavity, the second step reducing the diameter of the second cavity from a larger first diameter adjacent to the second seal to a smaller second diameter.

[0342] Example 79. A sealing mechanism according to any example herein, particularly the sealing mechanism of Example 78, wherein the sealing mechanism further includes a Luer attachment disposed on the distal side of the second cavity, and wherein the Luer attachment is configured to receive a suction tool for generating a vacuum within the second cavity.

[0343] Example 80. An assembly comprising: a conduit including a first shaft and a second shaft extending through the first shaft, wherein a distal portion of the second shaft may extend distally to the first shaft; and a sealing mechanism including: a first member and a second member pivotable relative to each other between an open configuration and a closed configuration, wherein the first member and the second member are configured to receive and seal the second shaft therebetween in the closed configuration; and a tube fluidly connected to a lumen defined by the first member and the second member, wherein one end of the tube includes an attachment configured to receive a suction tool for aspirating fluid through the second shaft.

[0344] Example 81. The component according to any of the examples herein, particularly the component according to Example 80, wherein the sealing mechanism further includes a housing, and wherein the first member and the second member are pivotable relative to each other via a pivot joint connected to the housing.

[0345] Example 82. A component according to any of the examples herein, particularly the component according to Example 81, wherein the sealing mechanism includes a sliding knob that, when the first member and the second member are in a closed configuration, is axially slidable from a first position around a portion of the outer surface of the housing to a second position around the first member and the second member.

[0346] Example 83. A component according to any of the examples herein, particularly any of Examples 80-82, wherein the first member and the second member include a compressible filler configured to seal around the second axis when the first member and the second member are in the closed configuration.

[0347] Example 84. A component according to any of the examples herein, particularly any of Examples 80-83, wherein the conduit is a delivery device for a docking device, and wherein the second shaft is configured to receive the docking device within a distal portion of the second shaft in a delivery configuration.

[0348] Example 85. The component according to any example herein, particularly the component according to Example 84, wherein the docking device includes a coil and an expandable protective member disposed around a portion of the coil.

[0349] Example 86. An assembly comprising: a conduit including a first shaft and a second shaft extending through the first shaft, wherein a distal portion of the second shaft extends distally to the first shaft; and a sealing mechanism including: a seal disposed around the distal portion of the second shaft; a seal housing including a cylindrical body portion, wherein an inner surface of the cylindrical body portion defines a first cavity, and wherein the seal is disposed within the first cavity; and a locking member including an annular outer wall and an annular inner wall having a second cavity defined therebetween in a radial direction, wherein the cylindrical body portion extends into and is rotatable within the second cavity, and wherein the seal housing and the locking member are configured to receive the second shaft passing therethrough, wherein the seal housing and the locking member are rotatable relative to each other between an unlocked configuration and a locked configuration, and wherein in the locked configuration, the seal is axially compressed between the seal housing and the locking member and radially compressed about the second shaft.

[0350] Example 87. The component according to any example herein, particularly the component according to Example 86, wherein in the unlocking configuration, the seal is axially disposed between a portion of the first cavity defined on the inner surface of the cylindrical body portion and the axially facing surface of the inner wall of the locking member without being radially compressed about the second axis.

[0351] Example 88. The component according to any example herein, particularly the component according to Example 87, wherein in the locking configuration, the seal is axially compressed between the portion of the inner surface of the cylindrical body portion and the axially facing surface of the inner wall of the locking member and radially compressed about the second axis, such that the diameter of the lumen of the seal is smaller in the locking configuration than in the unlocking configuration.

[0352] Example 89. The component according to any example herein, particularly the component according to Example 87 or Example 88, wherein the portion of the inner surface of the cylindrical body portion is a variable-angle surface inclined at a non-zero angle relative to the central longitudinal axis of the sealing mechanism.

[0353] Example 90. A component according to any of the examples herein, particularly any of Examples 86-89, wherein the sealing housing includes one or more grooves extending along and through the cylindrical body portion, and additionally includes one or more pins coupled to the inner wall of the locking member, wherein each of the one or more pins is configured to extend through a corresponding groove in the one or more grooves and slide along the groove.

[0354] Example 91. The component according to any example herein, particularly the component according to Example 90, wherein in the unlocking configuration, each pin is disposed at a first end of the corresponding slot, and wherein in the locking configuration, each pin is disposed at an opposite second end of the corresponding slot.

[0355] Example 92. A component according to any of the examples herein, particularly any of Examples 86-91, wherein the sealing housing and the locking member are arranged to be closer together in the axial direction in the locked configuration than in the unlocked configuration.

[0356] Example 93. A component according to any of the examples herein, particularly any of Examples 86-92, wherein the outer and inner walls of the locking member extend proximally from an end wall defining the distal end of the locking member, wherein in the unlocking configuration, a first gap exists within the second cavity between the end wall and the distal end of the cylindrical body portion of the sealing housing, and wherein in the locking configuration, a second gap exists within the second cavity between the end wall and the distal end of the cylindrical body portion, the second gap being smaller than the first gap.

[0357] Example 94. The component according to any of the examples herein, particularly any of Examples 86-93, further includes a tube extending distally from the locking member.

[0358] Example 95. A component according to any of the examples herein, particularly the component according to Example 94, wherein the inner surface of the inner wall defines a lumen of the locking member, and wherein the tube is disposed within a first lumen portion of the lumen.

[0359] Example 96. A component according to any example herein, particularly the component according to Example 95, wherein the inner wall includes an annular protrusion that extends radially toward the central longitudinal axis of the sealing mechanism and separates the first lumen portion from a second lumen portion of the lumen configured to receive a second shaft passing through it.

[0360] Example 97. A component according to any of the examples herein, particularly any of Examples 94-96, wherein the distal end of the tube includes an attachment configured to receive a suction tool for aspirating fluid through the second shaft.

[0361] Example 98. A sealing mechanism comprising: a sealing housing including a body portion, wherein an inner surface of the body portion defines a first cavity, wherein the body portion includes at least one curved groove extending through the body portion from an outer surface to an inner surface; a seal disposed within a portion of the first cavity of the sealing housing, wherein the seal includes a lumen configured to receive a shaft assembly of an artificial implant delivery device; a locking member including an outer wall and an inner wall defining a second cavity therebetween in a radial direction, wherein the body portion of the sealing housing extends into the second cavity of the locking member and is rotatable within the second cavity; and at least one pin, which is coupled to the inner wall and configured to extend into and slide along the at least one curved groove, wherein the seal housing and the locking member are rotatable relative to each other between an unlocked configuration and a locked configuration, wherein in the unlocked configuration, the at least one pin is disposed at a first end of the at least one curved groove, and wherein in the locked configuration, the at least one pin is disposed at an opposite second end of the at least one curved groove, and the seal is axially compressed between the seal housing and the locking member such that the diameter of the lumen of the seal is reduced relative to the unlocked configuration in the locked configuration.

[0362] Example 99. A sealing mechanism according to any example herein, particularly the sealing mechanism of Example 98, wherein in the locking configuration, the sealing housing and the locking member are more closely spaced from each other than in the unlocking configuration.

[0363] Example 100. A sealing mechanism according to any example herein, particularly the sealing mechanism of Example 98 or Example 99, wherein the at least one curved groove has a circumferentially extending portion at a second end of the curved groove and an axially extending portion at a first end of the curved groove, wherein the first end of the curved groove is disposed closer to the distal end of the sealing housing than the second end of the curved groove, and wherein the distal end of the sealing housing is disposed within the second cavity.

[0364] Example 101. A sealing mechanism according to any example herein, particularly any of Examples 98-100, wherein in the unlocking configuration, the seal is axially disposed between a portion of the first cavity defined on the inner surface of the cylindrical body portion and an axially facing surface of the inner wall of the locking member without abutting the axially facing surface and the portion of the inner surface under axial compression, and wherein the axially facing surface of the inner wall at least partially defines the proximal end of the locking member.

[0365] Example 102. A sealing mechanism according to any example herein, particularly the sealing mechanism of Example 101, wherein in the locking configuration, the seal is axially compressed between the portion of the inner surface of the cylindrical body portion and the axially facing surface of the inner wall of the locking member, such that the diameter of the lumen of the seal is smaller in the locking configuration than in the unlocking configuration.

[0366] Example 103. A sealing mechanism according to any example herein, particularly the sealing mechanism of Example 101 or Example 102, wherein the portion of the inner surface of the cylindrical body portion is a variable-angle surface inclined at a non-zero angle relative to the central longitudinal axis of the sealing mechanism, and wherein in the locking configuration, the seal is pressed against the variable-angle surface.

[0367] Example 104. A sealing mechanism according to any of the examples herein, particularly any of Examples 98-103, wherein the at least one curved groove comprises two curved grooves circumferentially spaced apart from each other around the sealing housing, and wherein the at least one pin comprises two pins received in two respective channels extending radially through the inner wall of the locking member.

[0368] Example 105. A sealing mechanism according to any example herein, particularly any of Examples 98-104, wherein the inner surface of the cylindrical body portion defines a lumen at the proximal end of the sealing housing, the lumen being configured to receive a conduit shaft passing through it, wherein the lumen widens to a first cavity extending from the lumen to the distal end of the sealing housing, and wherein, in the locking configuration, the diameter of the lumen of the seal is reduced such that the seal seals around the conduit shaft.

[0369] Example 106. A sealing mechanism according to any of the examples herein, particularly any of Examples 98-105, further comprising a flexible tube extending distally from the locking member.

[0370] Example 107. A sealing mechanism according to any example herein, particularly the sealing mechanism of Example 106, wherein the inner surface of the inner wall defines a lumen of the locking member, and wherein the flexible tube is disposed within a first lumen portion of the lumen.

[0371] Example 108. A sealing mechanism according to any example herein, particularly the sealing mechanism of Example 107, wherein the inner wall includes an annular protrusion that extends radially toward the central longitudinal axis of the sealing mechanism and separates the first lumen portion from a second lumen portion of the lumen, and wherein the second lumen portion and the flexible tube are configured to receive a conduit shaft passing through therethrough.

[0372] Example 109. A sealing mechanism according to any of the examples herein, particularly any of Examples 106-108, wherein the distal end of the flexible tube includes an attachment configured to receive a suction tool for aspirating fluid through a conduit shaft extending through the sealing mechanism.

[0373] Example 110. A sealing mechanism according to any of the examples herein, particularly any of Examples 98-109, wherein the at least one pin and the at least one curved groove of the sealing housing are configured such that the sealing housing and the locking member rotate less than 360 degrees relative to each other between the unlocking configuration and the locking configuration.

[0374] Example 111. A sealing mechanism according to any of the examples herein, particularly any of Examples 98-109, wherein the at least one pin and the at least one curved groove of the sealing housing are configured such that the sealing housing and the locking member rotate relative to each other between the unlocking configuration and the locking configuration by 45-225 degrees.

[0375] Example 112. A sealing mechanism according to any of the examples herein, particularly any of Examples 98-109, wherein the at least one pin and the at least one curved groove of the sealing housing are configured such that the sealing housing and the locking member rotate relative to each other between the unlocking configuration and the locking configuration by 70-200 degrees.

[0376] Example 113. A sealing mechanism according to any of the examples herein, particularly any of Examples 98-109, wherein the at least one pin and the at least one curved groove of the sealing housing are configured such that the sealing housing and the locking member rotate 170-190 degrees relative to each other between the unlocking configuration and the locking configuration.

[0377] Example 114. A sealing mechanism according to any of the examples herein, particularly any of Examples 98-109, wherein the at least one pin and the at least one curved groove of the sealing housing are configured such that the sealing housing and the locking member rotate 80-100 degrees relative to each other between the unlocking configuration and the locking configuration.

[0378] Example 115. A method comprising sterilizing a sealing mechanism, device and / or component of any of the examples.

[0379] Unless otherwise stated, the features described in this document with respect to any instance may be combined with other features described in any one or more other instances. For example, any one or more features of a delivery device may be combined with any one or more features of another delivery device.

[0380] Given the many possible ways in which the principles of this disclosure can be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be construed as limiting the scope of this disclosure or the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

1. A sealing component comprising: The catheter includes: First axis; and A second shaft extending through the first shaft, wherein a first lumen is defined between the inner surface of the first shaft and the outer surface of the second shaft; and A sealing mechanism, comprising: A first seal is disposed around the distal portion of the first shaft; A second seal is disposed around a portion of the second shaft extending distal to the first shaft; and A cavity is disposed within the housing of the sealing mechanism between the first seal and the second seal, wherein the distal end of the first shaft is disposed within the cavity, and wherein the cavity is fluid-sealed by the first seal and the second seal, such that fluid from the first cavity cannot leave the cavity; The housing includes a first sealing housing and a second sealing housing, each of the first and second sealing housings including a proximal portion, a middle portion, a distal portion, and a transition portion, each of the transition portions including an inclined step, and The first seal and the second seal are respectively configured to abut against the inclined step and fit within the middle portion and the transition portion.

2. The assembly of claim 1, wherein the distal end of the first lumen is closed by the lumen, wherein the second shaft has a second lumen, and wherein the distal end of the second lumen is open and extends distally to the second seal.

3. The component of claim 1 or claim 2, wherein the sealing mechanism includes a step within the cavity, the step reducing the diameter of the cavity from a larger first diameter adjacent to the first seal to a smaller second diameter adjacent to the second seal, and wherein the distal portion of the first shaft is disposed abutting the step.

4. The component of claim 3, wherein the first sealing housing houses the first seal, and the second sealing housing houses the second seal, and wherein the step is formed on the inner surface of the second sealing housing.

5. The component according to any one of claims 1 to 2 and 4, wherein the first seal is disposed in the first seal housing of the sealing mechanism, and the second seal is disposed in the second seal housing of the sealing mechanism, the first seal housing and the second seal housing are connected to each other, and wherein the cavity is defined by the inner surface of the first seal housing and the inner surface of the second seal housing.

6. The assembly of claim 5, wherein the sealing mechanism further comprises a first threaded member, the first threaded member being threadedly engaged with the inner surface of the first seal housing and configured to rotate relative to the first seal housing and secure the first seal around the first axis.

7. The assembly of claim 6, wherein the sealing mechanism includes a rotatable first knob coupled to the first threaded member and configured to rotate the first threaded member such that the first threaded member moves distally against the first seal and secures the first seal around the first axis.

8. The assembly of claim 6 or claim 7, wherein the sealing mechanism further comprises a second threaded member, the second threaded member being threadedly engaged with the inner surface of the second seal housing and configured to rotate relative to the second seal housing and secure the second seal around the second axis.

9. The assembly of claim 8, wherein the sealing mechanism includes a rotatable second knob coupled to the second threaded member and configured to rotate the second threaded member such that the second threaded member moves proximally against the second seal and secures the second seal around the second axis.

10. The assembly of claim 8, wherein the first threaded member has a lumen with a larger diameter than the second threaded member.

11. The component according to claim 1 or claim 2, wherein the first seal and the second seal are disposed in the housing, and wherein the cavity is defined by the inner surface of the housing.

12. The assembly of claim 11, wherein the sealing mechanism further comprises a threaded member that is threadedly engaged with an inner surface of the housing at one end of the housing adjacent to the first seal, and wherein the threaded member is configured to rotate relative to the housing and secure the first seal about the first axis.

13. The assembly of claim 12, wherein the sealing mechanism includes a rotatable knob disposed at one end of the threaded member, and wherein the rotatable knob is configured to rotate the threaded member such that the threaded member moves distally against the first seal and secures the first seal around the first axis.

14. The component of claim 11, wherein the first seal is a compressible gasket and the second seal is an O-ring.

15. The component of claim 11, wherein the first seal is an O-ring and the second seal is an O-ring.

16. The component according to any one of claims 1 to 2, 4, 6 to 7, 9 to 10 and 12 to 15, wherein the conduit is a delivery device for a docking device, and wherein the second shaft is configured to receive the docking device within a distal portion of the second shaft in a delivery configuration.

17. A method for flushing the conduit of the component according to any one of claims 1 to 16, comprising: The first seal of the sealing mechanism is attached to the distal portion of the first shaft of the conduit; The second seal of the sealing mechanism is attached to the distal portion of the second shaft of the conduit that extends through the first shaft, wherein the distal portion of the second shaft extends distal to the distal end of the first shaft. as well as Fluid is allowed to flow through the conduit such that the fluid flows out only from the second lumen defined by the second shaft and is prevented from flowing out from the first lumen defined between the outer surface of the second shaft and the inner surface of the first shaft.

18. The method of claim 17, wherein attaching the first seal to the first shaft comprises extending the distal portion of the first shaft into a cavity of the sealing mechanism, through the first seal, and into a cavity of the sealing mechanism, the cavity being defined by the wall of the housing of the sealing mechanism and located between the first seal and the second seal.

19. The method of claim 17 or claim 18, wherein attaching the second seal to the second shaft comprises causing the distal portion of the second shaft to extend through the distal end of the first shaft and extend distal to the distal end and through the second seal.

20. The method of claim 17 or claim 18, wherein attaching the first seal and attaching the second seal comprises securing the first seal around the first shaft and securing the second seal around the second shaft such that the distal portion of the first shaft is closed.

21. The method of claim 17 or claim 18, wherein allowing fluid to flow through the conduit such that the fluid flows out only from the second lumen defined by the second axis and is prevented from flowing out from the first lumen comprises flushing the fluid through the conduit using a positive pressure applied to the conduit.

22. The method of claim 17 or claim 18, wherein allowing fluid to flow through the conduit such that the fluid flows out only from the second lumen defined by the second axis and is prevented from flowing out from the first lumen comprises aspirating the fluid through the conduit using a suction tool with negative pressure applied to the distal end of the second axis.

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