Fluid Sealing Mechanism for a Catheter

Abstract

An apparatus and method are disclosed for selectively directing fluid flow through the lumen of a catheter to effectively flush and / or degas a specified lumen of the catheter. As an example, the assembly comprises a catheter including a first shaft and a second shaft extending through the first shaft. The assembly further comprises a sealing mechanism including a first seal disposed around a distal end portion of the first shaft, a second seal disposed around 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. The distal end of the first shaft is disposed within the cavity, and the cavity is fluid-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

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims priority to U.S. Provisional Patent Application No. 63 / 366,517, filed on June 16, 2022; U.S. Provisional Patent Application No. 63 / 368,453, filed on July 14, 2022; and U.S. Provisional Patent Application No. 63 / 371,463, filed on August 15, 2022, the entire contents of each of which are incorporated herein by reference.

[0002] The present disclosure relates to a delivery device for a docking device configured to secure an artificial valve to a native heart valve.

Background Art

[0003] The human heart is susceptible to various valvular diseases. These valvular diseases can cause severe heart dysfunction and may ultimately require repair of the native valve or replacement of the native valve with an artificial valve. Numerous repair devices (e.g., stents) and artificial valves are known, and numerous methods for implanting those devices and valves into a human are also known. By using percutaneous and minimally invasive surgical approaches in various procedures, it is possible to deliver artificial medical devices to locations within a patient's body that are not easily accessible surgically and to locations where access without surgery is desirable. In one specific example, an artificial heart valve can be mounted in a crimped state on the distal end of a delivery device and advanced through a patient's vasculature (e.g., through the femoral artery and aorta) to reach an implantation site within the heart. The artificial valve can then be expanded to its functional size, for example, by inflating a balloon on which the artificial valve is mounted, or by driving a mechanical actuator that applies an expansion force to the artificial valve, or by deploying the artificial valve from the sheath of the delivery device such that the artificial valve expands naturally to its functional size.

[0004] An artificial heart valve can be appropriately sized to be disposed within many native aortic valves. However, native mitral valves, and tricuspid valves can have different shapes than typical vena cava valves. The anatomical structures of mitral valves, and tricuspid valves can also vary significantly from person to person. Thus, it can be difficult to appropriately size and shape an artificial heart valve for various patients. Further, when treating valve insufficiency, the surrounding tissue at the target implantation site (e.g., native valve annulus) may not be strong enough to hold a particular type of valve in the desired position.

[0005] In some embodiments, a docking device can be initially implanted within a native valve, configured to receive an artificial heart valve, and to secure (e.g., anchor ring) the artificial heart valve in a desired position within the native valve. For example, the docking device can form a more circular, and / or stable anchor ring site at the native valve annulus where the artificial heart valve can be expanded and implanted. A transcatheter delivery device can be used to deliver the docking device to the implantation site. The docking device can be coaxial with additional components of the delivery device and disposed within the delivery device. A plurality of lumens can be disposed between coaxial components of the delivery device, and flush fluid can be provided to these lumens before and during the implantation procedure to flush and degas the lumens. For example, the docking device can be covered by a sleeve shaft within the outer shaft of the delivery device, and the lumens can be formed between the outer shaft and the sleeve shaft, and between the sleeve shaft and the docking device. In some cases, it may be desirable to degas the sleeve shaft lumen to remove air around the docking device. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEM

[0006] This specification 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 the docking device. Also described herein are examples of flow mechanisms, or assemblies, that can be used to selectively direct fluid flow through the lumen of a catheter to effectively flush and / or degas a particular lumen, and / or component, of the delivery device. In some embodiments, the catheter is part of a delivery device that includes a docking device disposed within an outer shaft of the delivery device and a sleeve shaft that extends through the outer shaft and covers the docking device. The docking device can be configured to receive an artificial heart valve after being delivered at an implantation site using the delivery device. The flow mechanism, or assembly, described herein can be coupled to the distal end portion of the delivery device and is configured to direct fluid flow through the lumen of the sleeve shaft, thereby allowing the docking device to be degassed prior to an implantation procedure.

[0007] The sealing mechanism can include a housing having a cavity and a step disposed within the cavity that reduces the diameter of the cavity from a larger diameter portion of the cavity to a smaller diameter portion of the cavity.

[0008] In some embodiments, the sealing mechanism can further include 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.

[0009] In some embodiments, the housing may include a first seal housing and a second seal housing, with the first seal disposed within the first seal housing and the second seal disposed within the second seal housing.

[0010] In some embodiments, the first seal is a compressible gasket and the second seal is an O-ring.

[0011] In some embodiments, the first seal is an O-ring and the second seal is an O-ring.

[0012] In some embodiments, the first seal and the second seal are annular, and the inner diameter of the first seal is larger than the inner diameter of the second seal.

[0013] In some embodiments, the sealing mechanism comprises a first sealing housing having a first seal disposed within a first sealing housing, and a second sealing housing having a second seal disposed within a second sealing housing. The proximal portion of the second sealing housing includes a step that transitions between a first diameter proximal to the step and a second diameter distal to the step, the second diameter being smaller than the first diameter, and the step is disposed proximal to the second seal. The sealing mechanism further comprises a cavity defined within the distal portion of the first sealing housing and the proximal portion of the second sealing housing between the first seal and the second seal.

[0014] In some embodiments, the sealing mechanism comprises a housing having a cavity and a step disposed within the cavity that decreases the diameter of the cavity from a larger diameter portion of the cavity to a smaller diameter portion of the cavity. The sealing mechanism further comprises 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.

[0015] In some embodiments, the sealing mechanism comprises a housing having a cavity and a step disposed within the cavity that decreases the diameter of the cavity from a larger diameter portion of the cavity to a smaller diameter portion of the cavity, 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 embodiments, the sealing mechanism comprises a sealing housing having a body portion, the inner surface of the body portion defining a first cavity, and the body portion comprising at least one bent slot extending through the body portion from the outer surface to the inner surface. The sealing housing further comprises a seal disposed within a portion of the first cavity of the sealing housing, the seal comprising a lumen configured to receive a shaft assembly of an artificial implant delivery device, an outer wall, an inner wall, and a locking member having a second cavity defined radially therebetween, the body portion of the sealing housing extending into the second cavity of the locking member and being rotatable within the second cavity of the locking member, and comprising at least one pin coupled to the inner wall and extending into and configured to slide along at least one of the bent slots. The sealing housing and the locking member are rotatable relative to each other between an unlocked configuration and a locked configuration. In the unlocked configuration, at least one pin is disposed at a first end of at least one of the bent slots, and in the locked configuration, at least one pin is disposed at a second, opposite end of at least one of the bent slots, and the seal is axially compressed between the sealing housing and the locking member such that the diameter of the lumen of the seal decreases in the locked configuration relative to the unlocked configuration.

[0017] In some embodiments, the sealing mechanism includes one or more of the components recited in Examples 21-23, 70-79, and 98-114 below.

[0018] The assembly can comprise a catheter, or delivery device, and a sealing mechanism.

[0019] In some embodiments, the catheter can include a first shaft and a second shaft extending through the first shaft.

[0020] In some embodiments, the lumen is defined between the inner surface of the first shaft and the outer surface of the second shaft.

[0021] In some embodiments, the sealing mechanism may include a first seal disposed around a distal end portion of the first shaft, a second seal disposed around a portion of a second shaft extending distally from the first shaft, and a cavity disposed within a housing of the sealing mechanism between the first seal and the second seal.

[0022] In some embodiments, the distal end of the first shaft is disposed within the cavity, and the cavity is fluidically sealed by the first seal and the second seal.

[0023] In some embodiments, the assembly may further include a transplantable medical device disposed within a distal end portion of the second shaft in a delivery configuration.

[0024] In some embodiments, the sealing mechanism may include first and second members pivotable relative to each other between an open configuration and a closed configuration, and the first and second members are configured to receive the second shaft therebetween and seal around the second shaft when in the closed configuration.

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

[0026] In some embodiments, the assembly comprises a catheter, the catheter comprising a first shaft and a second shaft extending through the first shaft. A first lumen is defined between the inner surface of the first shaft and the outer surface of the second shaft. The assembly further comprises a first seal disposed around the distal end portion of the first shaft, a second seal disposed around a portion of the second shaft extending distally of the first shaft, and a cavity disposed within a housing of a sealing mechanism between the first seal and the second seal. The distal end of the first shaft is disposed within the cavity, and the cavity is fluid-sealed by the first seal and the second seal such that fluid from the first lumen cannot exit the cavity.

[0027] In some embodiments, the assembly comprises a delivery device. The delivery device comprises a first shaft and a second shaft extending through the first shaft, a first lumen being defined between the inner surface of the first shaft and the outer surface of the second shaft, a second lumen being defined by the second shaft, and the first and second lumens being in fluid communication with each other. The assembly further comprises a transplantable medical device disposed within the distal end portion of the second shaft in a delivery configuration and a sealing mechanism. The sealing mechanism comprises a housing, a first seal disposed within the housing and around the distal end portion of the first shaft, a second seal disposed within the housing and around the distal end 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 distally of the distal ends of the first shaft and the second seal, and the cavity is fluid-sealed by the first seal and the second seal.

[0028] In some embodiments, the assembly comprises a catheter, the catheter comprising a first shaft and a second shaft extending through the first shaft, the distal end portion of the second shaft being extendable distally beyond the distal end of the first shaft. The assembly further comprises a sealing mechanism, the sealing mechanism comprising first and second members pivotable relative to each other between an open configuration and a closed configuration, the first and second members being configured to receive the second shaft therebetween and seal around the second shaft when in the closed configuration. The sealing mechanism further comprises a tube fluidly connected to the lumen defined by the first and second members. The end of the tube comprises a fitting configured to receive a suction tool for suctioning fluid through the second shaft.

[0029] In some embodiments, an assembly comprising a catheter, the catheter comprising a first shaft and a second shaft extending through the first shaft, the distal end portion of the second shaft being extendable distally to the distal end of the first shaft, the second shaft; a sealing mechanism comprising a first member and a second member pivotable relative to each other between an open configuration and a closed configuration, the first and second members being configured to receive the second shaft therebetween and seal around the second shaft when in the closed configuration; and a tube fluidly connected to the lumen defined by the first and second members, the end of the tube comprising a fitting configured to receive a suction tool for suctioning fluid through the second shaft.

[0030] In some embodiments, the assembly comprises a catheter having a first shaft and a second shaft extending through the first shaft, and a distal end portion of the second shaft is extendable distally beyond the distal end of the first shaft. The assembly further comprises a sealing mechanism comprising a seal disposed around the distal end portion of the second shaft and a sealing housing including a cylindrical body portion, an inner surface of the cylindrical body portion defining a first cavity, and the seal being disposed within the first cavity. The sealing mechanism further comprises a locking member having an annular outer wall and an annular inner wall defining a second cavity therebetween, the cylindrical body portion extending into the second cavity and being rotatable within the second cavity, and the sealing housing and the locking member being configured to receive the second shaft therethrough. The sealing 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 sealing housing and the locking member and radially compressed around the second shaft.

[0031] In some embodiments, the delivery device comprises one or more of the components recited in Examples 1-20, 54-69, and 80-97 below.

[0032] A method of flushing a catheter can include positioning a first seal of a sealing mechanism around a distal end portion of a first shaft of the catheter, positioning a second seal of the sealing mechanism around a distal end portion of a second shaft of the catheter extending through the first shaft, and flowing fluid through the catheter such that fluid flows only from a second lumen defined by the second shaft.

[0033] In some embodiments, the distal end portion of the second shaft extends distally to the distal end of the first shaft.

[0034] In some embodiments, the method includes tightening a first seal around the distal end portion of the first shaft and a second seal around the distal end portion of the second shaft.

[0035] In some embodiments, the fluid flowing through the catheter may further include blocking the fluid from flowing from a second lumen defined between the outer surface of the second shaft and the inner surface of the first shaft.

[0036] In some embodiments, a method for flushing a catheter includes attaching a first seal of a sealing mechanism to a distal end portion of a first shaft of the catheter, and attaching a second seal of the sealing mechanism to a distal end portion of a second shaft of the catheter extending through the first shaft, wherein the distal end portion of the second shaft extends distally to the distal end of the first shaft, and flowing fluid through the catheter such that the fluid flows only from a second lumen defined by the second shaft and is blocked from flowing from a first lumen defined between the outer surface of the second shaft and the inner surface of the first shaft.

[0037] In some embodiments, a method for flushing a catheter includes extending a distal end portion of a first shaft of the catheter through a first seal disposed within a first sealing housing of a sealing mechanism and into a cavity defined within the first sealing housing and a second sealing housing, the cavity being defined between the first seal and a second seal of the second sealing housing. The method further includes extending a distal end portion of a second shaft of the catheter through and to the distal end of the first shaft and through a second seal disposed within the second sealing housing, tightening the first seal around the distal end portion of the first shaft, tightening the second seal around the distal end portion of the second shaft, and flowing fluid through the catheter such that the fluid flows only from a first lumen defined by the second shaft and is blocked from flowing from a second lumen defined between the outer surface of the second shaft and the inner surface of the first shaft.

[0038] In some embodiments, the method includes one or more of the features recited in Examples 33 - 53 and 115 below.

[0039] The various innovations in this disclosure can be used in combination or individually. This summary is provided to introduce, in a simplified form, a selection of concepts that are further described in the detailed description below. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The above and other objectives, features, and advantages of the disclosure will become more apparent from the following detailed description, from the claims, and from the accompanying drawings.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0041] General Considerations For the purposes of this specification, specific aspects, advantages, and novel features in the examples of this disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as limiting in any way. Instead, this disclosure is directed to all novel and non-obvious features and aspects, alone and in various combinations and sub-combinations with each other, related to the various disclosed examples. The methods, apparatuses, and systems are not limited to any specific aspect, feature, or combination thereof, and the disclosed examples are not required to have any one or more specific advantages or to solve any problems.

[0042] The operations in some of the disclosed examples are described in a particular sequential order for the sake of presentation, but it should be understood that this mode of description encompasses permutations unless the specific language described below requires a particular order. For example, operations described sequentially may, in some cases, be permuted or may be performed concurrently. Additionally, for simplicity, the accompanying drawings may not show the various ways in which the disclosed methods may be used in combination with other methods. Additionally, in the description, terms such as "provide" or "achieve" are sometimes used to describe the disclosed methods. These terms are high-level abstractions related to the actual operations being performed. The actual operations corresponding to these terms may vary depending on the specific implementation and will be readily recognizable to those of ordinary skill in the art.

[0043] As used in this application, and in the claims, the singular forms "a", "an", and "the" include the plural unless the context clearly dictates otherwise. Additionally, the term "includes" means "comprises". Further, the term "coupled" generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or connecting, and does not exclude the presence of intervening elements between the coupled or associated members, unless a specific contrary language is provided.

[0044] As used herein, the term "proximal" refers to the position, direction, or part of a device that is closer to the user and farther from the implantation site. As used herein, the term "distal" refers to the position, direction, or part of a device that is farther from the user and closer to the implantation site. Thus, for example, proximal movement of a device is movement of the device away from the implantation site and towards the user (e.g., out of the patient's body), while distal movement of a device is movement of the device away from the user and towards the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial" refer to an axis extending in the proximal direction and in the distal direction, unless explicitly defined otherwise.

[0045] As used herein, "e.g." means "for example", and "i.e." means "that is".

[0046] Introduction to the Disclosed Technology As described above, a delivery device can be used to deliver a docking device for an artificial heart valve to a target implantation site (e.g., a native valve annulus). The docking device can be disposed within a distal end portion of an outer shaft of the delivery device in a relatively straight (e.g., non-coiled) delivery configuration. In some cases, a portion of the docking device can include a foldable and expandable outer guard member. Further, a sleeve shaft of the delivery device can extend through the outer shaft and be disposed around (and cover) the docking device. A plurality of 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 prior to introducing the delivery device into the patient. However, since the first and second lumens are fluidly coupled to each other, a flush fluid applied to one or more of these lumens may not provide a sufficient flush pressure to be applied to the second lumen such that the guard member of the docking device is adequately degassed. Thus, an improvement in the flushing and degassing procedures for catheters and delivery devices having a plurality of fluidly connected lumens is desirable. Such improvements can, for example, enable the sleeve shaft lumen and the docking device to be effectively and completely degassed prior to the implantation procedure.

[0047] In this specification, in some embodiments, various systems, devices, methods, etc. are described that can be used with or in a delivery device for an artificial medical device (such as an artificial heart valve or a docking device). In some embodiments, such systems, devices, and / or methods can provide a system and / or method for selectively directing fluid flow through a catheter (e.g., a delivery device) that includes a plurality of shafts that are at least partially concentric with each other (or one shaft disposed at least partially within a separate shaft) for flushing and degassing a specified lumen of the catheter.

[0048] In some embodiments, the docking device delivery device disclosed herein can be used to deliver a docking device to a target implantation site in a patient. For example, FIGS. 1-4 schematically illustrate an exemplary transcatheter heart valve replacement procedure in which a docking device delivery device is guided toward a native valve annulus using a guide catheter and then an artificial heart valve delivery device is guided toward the native valve annulus. The docking device delivery device is used to deliver the docking device to the native valve annulus, and then the artificial heart valve delivery device is used to deliver a transcatheter artificial heart valve inside the docking device.

[0049] As described above, a damaged native heart valve can be replaced with a transcatheter artificial heart valve. However, such artificial heart valves may not be able to conform well to the shape of native tissue (e.g., the leaflets and / or annulus of the native heart valve) and may move in an undesirable manner relative to the native tissue, resulting in paravalvular leakage. Thus, a docking device can be initially implanted in the native valve annulus, and then an artificial heart valve can be implanted within the docking device, helping to anchor the artificial heart valve to the native tissue and provide a seal between the native tissue and the artificial heart valve. An exemplary docking device is shown in FIG. 5, and an exemplary delivery device for deploying the docking device to the native heart valve is shown in FIG. 6.

[0050] As shown in FIGS. 7-10, the docking device delivery device can include an outer shaft, a sleeve shaft that extends through the outer shaft and houses the docking device therein in a relatively straight delivery configuration, and a pusher shaft that extends through the outer shaft and is disposed adjacent to the proximal end of the docking device. A plurality of lumens are formed within the delivery device, including a sleeve shaft lumen that passes through the sleeve shaft and an outer shaft lumen that is formed between the outer shaft and the sleeve shaft. These lumens can be fluidly coupled to each other, such that, as schematically illustrated in FIGS. 9 and 10, fluid flow through one of the lumens can also enter another one of the lumens during a flushing process.

[0051] In some embodiments, as shown in FIGS. 11 - 16, a sealing mechanism (or assembly) with two seals may be configured to receive the distal end portions of an outer shaft and a sleeve shaft therethrough. The sealing mechanism may be configured to seal around the outer surface of the outer shaft (e.g., with a first seal) and around the outer surface of the sleeve shaft that extends distally beyond the distal end of the outer shaft (e.g., with a second seal disposed distally of the first seal). As a result, the flush fluid entering the lumen of the delivery device can be blocked from exiting the outer shaft lumen, thereby forcing all or most of the flush fluid to flow through the sleeve shaft lumen. As a result, the sleeve shaft lumen and the docking device disposed therein can be effectively and completely flushed and degassed. In some cases, both seals may be compressible seals or gaskets (FIGS. 11 - 16). In some cases, the seal around the outer shaft may be a compressible seal or gasket, and the seal around the sleeve shaft may be an O - ring (FIGS. 18 - 21). In some cases, both seals may be O - rings of different sizes (FIGS. 22 - 23).

[0052] In some embodiments, instead of using a sealing mechanism to flush a sleeve shaft (or an alternative shaft of a catheter), any of the sealing mechanisms described above may be used to seal around the outer shaft and the sleeve shaft (or the inner and outer shafts of an alternative catheter), and a suction tool (e.g., a syringe) may be used to suction the sleeve shaft (FIG. 24).

[0053] In some embodiments, the suction or flushing of a catheter shaft (e.g., a sleeve shaft) may be performed using another sealing mechanism comprising a clam - shell mechanism that creates a seal around the sleeve shaft when closed (FIGS. 25 and 26).

[0054] Figures 27-34 further illustrate a sealing mechanism configured to seal around a catheter shaft (e.g., a sleeve shaft) and enable flushing or aspiration of the catheter shaft. The sealing mechanism includes a sealing housing that houses the seal therein, a locking cap, and a sealing housing configured to rotate relative to each other to move the sealing mechanism to a locking configuration in which the seal is radially compressed around the catheter shaft.

[0055] Examples of the disclosed technology Figures 1-4 illustrate an exemplary transcatheter heart valve replacement (e.g., mitral valve replacement) using a docking device 52 and an artificial heart valve 62 according to one embodiment. During the surgery, the user first uses a guide catheter 30 to create a path to the patient's native heart valve (Figure 1). The user then uses a docking device delivery device 50 (Figure 2A) to implant the docking device 52 into the patient's native heart valve and then removes the docking device delivery device 50 from the patient 10 after implanting the docking device 52 (Figure 2B). Thereafter, the user uses an artificial valve delivery device 60 to implant the artificial heart valve 62 into the implanted docking device 52 (Figure 3A). Thereafter, the user removes the artificial valve delivery device 60 (Figure 3B) and the guide catheter 30 (Figure 4) from the patient 10.

[0056] Figure 1 shows the first stage in a mitral valve replacement according to one embodiment, in which a guide catheter 30 and a guide wire 40 are inserted into a blood vessel 12 of a patient 10 and navigated through the blood vessel 12 and into the heart 14 of the patient 10 towards the native mitral valve 16. Together, the guide catheter 30 and the guide wire 40 can provide a path for a docking device delivery device 50 and an artificial valve delivery device 60 to navigate through and along the implantation site (native mitral valve 16 or native mitral valve annulus).

[0057] First, the user can first make an incision in the patient's body to access the blood vessel 12. For example, in the embodiment shown in FIG. 1, the user can make an incision in the patient's groin to access the femoral vein. Thus, in such an embodiment, the blood vessel 12 can be the femoral vein.

[0058] After making an incision in the blood vessel 12, the user can insert a guide catheter 30, a guide wire 40, and / or additional devices (e.g., an introducer device, or a transseptal puncture device) through the incision into the blood vessel 12. The guide catheter 30 (which can also be referred to as an "introducer device", an "introducer", or a "guide sheath") is configured to facilitate the percutaneous introduction of various implant delivery devices (e.g., a docking device delivery device 50, and an artificial valve delivery device 60) into and through the blood vessel 12, and can extend through the blood vessel 12 into the heart 14, but can stop in front of the native mitral valve 16. The guide catheter 30 can include a handle 32 and a shaft 34 extending distally from the handle 32. The shaft 34 can extend through the blood vessel 12 into the heart 14 while the handle 32 remains outside the patient 10's body, and can be operated by the user to manipulate the shaft 34 (FIG. 1).

[0059] The guide wire 40 is configured to guide a delivery device (e.g., the guide catheter 30, the docking device delivery device 50, the artificial valve delivery device 60, an additional catheter, or the like), and their associated devices (e.g., a docking device, an artificial heart valve, or the like) to the implantation site within the heart 14, and thus can consistently extend through the blood vessel 12 into the left atrium 18 of the heart 14 (and in some embodiments, through the native mitral valve 16 into the left ventricle of the heart 14) (FIG. 1).

[0060] In some cases, before inserting the guidewire 40 and the guide catheter 30, the left atrium 18 can be accessed first using a transseptal puncture device or a catheter. For example, after making an incision in the blood vessel 12, the user can insert a transseptal puncture device through the incision into the blood vessel 12. The user can guide the transseptal puncture device through the blood vessel 12 and into the heart 14 (e.g., through the femoral vein and into the right atrium 20). The user can then make a small incision in the atrial septum 22 of the heart 14 to enable access from the right atrium 20 to the left atrium 18. The user can then insert and advance the guidewire 40 through the transseptal puncture device within the blood vessel 12 and through the incision in the atrial septum 22 and into the left atrium 18. When the guidewire 40 is positioned within the left atrium 18 and / or the left ventricle 26, the transseptal puncture device can be removed from the patient 10. The user can then insert the guide catheter 30 into the blood vessel 12 and advance the guide catheter 30 into the left atrium 18 over the guidewire 40 (Figure 1).

[0061] In some cases, the introducer device can 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 introducer device can include a tapered end portion that extends from the distal tip of the guide catheter 30 and is configured to guide the guide catheter 30 into the left atrium 18 over the guidewire 40. Additionally, in some cases, the introducer device can include a proximal end portion that extends from the proximal end of the guide catheter 30. When the guide catheter 30 reaches the left atrium 18, the user can remove the introducer device from the guide catheter 30 and from inside the patient 10. Thus, only the guide catheter 30 and the guidewire 40 remain inside the patient 10. The guide catheter 30 then receives the implant delivery device and assists in guiding it into the left atrium 18 as further described below.

[0062] Figure 2A shows a second stage in an exemplary mitral valve replacement in which a docking device 52 is implanted in the native mitral valve 16 of a patient 10's heart 14 using a docking device delivery apparatus 50 (which may also be referred to as an "implant catheter" and / or "docking device delivery device").

[0063] Generally, the docking device delivery apparatus 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 a patient's vasculature (blood vessel 12) to a implantation site (e.g., the native mitral valve 16) and may be configured to hold the docking device 52 within a distal end portion 53 of the delivery shaft 54. In some embodiments, the distal end portion 53 of the delivery shaft 54 holds the docking device 52 therein in a straight delivery configuration.

[0064] The handle 56 of the docking device delivery apparatus 50 is configured to be grasped and / or otherwise held outside of the patient 10's body by a user to advance the delivery shaft 54 through the patient's vasculature (e.g., blood vessel 12).

[0065] In some embodiments, the handle 56 may include one or more articulating members 57 (or rotatable knobs) configured to assist in navigating the delivery shaft 54 through the patient's blood vessel 12. For example, the one or more articulating members 57 may include one or more of a knob, button, wheel, and / or other types of physically adjustable control members configured to be adjusted by a user to bend, flex, twist, rotate, and / or otherwise articulate the distal end portion 53 of the delivery shaft 54 to assist in navigating the delivery shaft 54 through the patient's blood vessel 12 and into the heart 14.

[0066] The pusher assembly 58 can be configured to deploy and / or implant the docking device 52 at the implantation site (e.g., the native mitral valve 16). For example, the pusher assembly 58 can be configured to be adjusted by a user to push the docking device 52 out from the distal end portion 53 of the delivery shaft 54. The shaft of the pusher assembly 58 can extend through the delivery shaft 54 and can be disposed adjacent to the docking device 52 within the delivery shaft 54. In some embodiments, the docking device 52 can be releasably coupled to the shaft of the pusher assembly 58 via the connection mechanism of the docking device delivery apparatus 50 such that the docking device 52 can be released after being deployed at the native mitral valve 16.

[0067] Further details of the docking device delivery apparatus, and variations thereof, are described in International Publication No. WO2020 / 247907, which is hereby incorporated by reference in its entirety.

[0068] Referring again to FIG. 2A, after the guide catheter 30 is positioned within the left atrium 18, the user can insert the docking device delivery device 50 (e.g., the delivery shaft 54) into the patient 10 by advancing the delivery shaft 54 of the docking device delivery device 50 over the guide wire 40 through the guide catheter 30. In some embodiments, the guide wire 40 can be at least partially stored within the guide catheter 30, spaced apart from the left atrium 18. The user can then continue to advance the delivery shaft 54 of the docking device delivery device 50 along the guide wire 40 through the blood vessel 12 until the delivery shaft 54 reaches the left atrium 18, as shown in FIG. 2A. Specifically, the user can advance the delivery shaft 54 of the docking device delivery device 50 by gripping the handle 56 of the docking device delivery device 50 and applying a force (e.g., pushing) toward the patient 10. While advancing the delivery shaft 54 through the blood vessel 12 and the heart 14, the user can adjust one or more articulating members 57 of the handle 56 to navigate the various turns, corners, stenoses, and / or other obstacles of the blood vessel 12 and the heart 14.

[0069] When the delivery shaft 54 reaches the left atrium 18 and extends outside the distal end of the guide catheter 30, the user can use the handle 56 (e.g., the articulating member 57) to position the distal end portion 53 of the delivery shaft 54 at and / or near the posterior medial commissure of the native mitral valve 16. The user can then use the shaft of the pusher assembly 58 to extrude the docking device 52 out of the distal end portion 53 of the delivery shaft 54 and deploy and / or implant the docking device 52 within the annulus of the native mitral valve 16.

[0070] In some embodiments, the docking device 52 may be constructed from, formed from, and / or include a shape memory material, such that when the docking device exits the delivery shaft 54 and is no longer constrained by the delivery shaft 54, it can return to its original pre-formed shape. As an example, the docking device 52 may originally be formed as a coil, and thus can wrap around the valve tip 24 of the native mitral valve 16 when it exits the delivery shaft 54 and returns to its original coiled configuration.

[0071] After pushing the ventricular portion of the docking device 52 (e.g., the portion of the docking device 52 shown in FIG. 2A configured to be positioned within the left ventricle 26 and / or on the ventricular side of the native mitral valve 16), the user can then 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 withdrawing the delivery shaft 54 away from the posterior medial commissure of the native mitral valve 16 and storing it.

[0072] After deploying and implanting the docking device 52 onto the native mitral valve 16, the user can disconnect the docking device delivery apparatus 50 from the docking device 52. When the docking device 52 is disconnected from the docking device delivery apparatus 50, the user can store the docking device delivery apparatus 50 outside of the blood vessel 12 and away from the patient 10, such that the user can deliver and implant the artificial heart valve 62 into the docking device 52 implanted on the native mitral valve 16.

[0073] Figure 2B shows this third stage in the mitral valve replacement procedure, where the docking device 52 is fully deployed and implanted into the native mitral valve 16, and the docking device delivery apparatus 50 (including the delivery shaft 54) is removed from the patient 10, such that as a result, only the guide wire 40 and the guide catheter 30 remain within the patient 10. In some embodiments, after removing the docking device delivery apparatus, the guide wire 40 can be advanced into the left ventricle 26 outside of the guide catheter 30 and through the docking device 52 implanted in the native mitral valve 16 (Figure 2A). Thus, the guide wire 40 can assist in guiding the artificial valve delivery apparatus 60 at least partially into the left ventricle 26 through the annulus of the native mitral valve 16.

[0074] As shown in Figure 2B, the docking device 52 can comprise a plurality of wraps (or coils) that wrap around the leaflets 24 of the native mitral valve 16 (within the left ventricle 26). The implanted docking device 52 has a more cylindrical shape than the annulus of the native mitral valve 16, thereby providing a geometric shape that more closely matches the shape, or outer profile, of the artificial heart valve to be implanted. As a result, the docking device 52 can provide a tighter fit, and thus a better seal, between the artificial heart valve and the native mitral valve 16, as further described below.

[0075] Figure 3A shows the fourth stage in the mitral valve replacement procedure, where the user is using the artificial valve delivery apparatus 60 to deliver and / or implant an artificial heart valve 62 (which may also be referred to herein as a "transcatheter heart valve", or more simply as a "THV", a "replacement heart valve", and / or an "artificial mitral valve").

[0076] As shown in FIG. 3A, the artificial valve delivery device 60 may include a delivery shaft 64 and a handle 66. The delivery shaft 64 extends distally from the handle 66. The delivery shaft 64 is configured to extend into the patient's vasculature to deliver, implant, expand, and / or otherwise deploy the artificial heart valve 62 within the docking device 52 to the native mitral valve 16. The handle 66 is configured to be held by the user, gripped, and / or otherwise retained to advance the delivery shaft 64 through the patient's vasculature.

[0077] In some embodiments, the handle 66 may include one or more articulating members 68 configured to assist in navigating the delivery shaft 64 through the blood vessel 12 and the heart 14. Specifically, the articulating member 68 may be adjusted by the user to bend, flex, twist, rotate, and / or otherwise join the distal end portion of the delivery shaft 64 to assist in navigating the delivery shaft 64 through the patient's blood vessel 12 to the left atrium 18 and the left ventricle 26 of the heart 14. It may include one or more of a knob, button, wheel, and / or other types of physically adjustable control members.

[0078] In some embodiments, 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, as shown in FIG. 3A, 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 end portion of the delivery shaft 64.

[0079] In some embodiments, the prosthetic heart valve 62 can self-expand and can be configured to radially expand itself upon removal of a sheath or capsule covering the prosthetic heart valve 62 radially compressed on the distal end portion of the delivery shaft 64. In some embodiments, the prosthetic heart valve 62 can be mechanically expandable, and the prosthetic valve delivery device 60 can include one or more mechanical actuators (e.g., an expansion mechanism) configured to radially expand the prosthetic heart valve 62.

[0080] As shown in FIG. 3A, the prosthetic heart valve 62 is attached in a radially compressed configuration around an expansion mechanism 65 (an inflatable balloon) on the distal end portion of the delivery shaft 64.

[0081] To navigate the distal end portion of the delivery shaft 64 to the implantation site, the user can insert the prosthetic valve delivery device 60 (delivery shaft 64) into the patient 10 through the guide catheter 30 and over the guide wire 40. The user can continue to advance the prosthetic valve delivery device 60 along the guide wire 40 (through the blood vessel 12) until the distal end portion of the delivery shaft 64 reaches the native mitral valve 16, as shown in FIG. 3A. More specifically, the user can advance the delivery shaft 64 of the prosthetic valve delivery device 60 by gripping the handle 66 and applying force (e.g., pushing). While advancing the delivery shaft 64 through the blood vessel 12 and the heart 14, the user can adjust one or more articulating members 68 of the handle 66 to navigate various turns, corners, stenoses, and / or other obstacles of the blood vessel 12 and the heart 14.

[0082] The user can advance the delivery shaft 64 along the guide wire 40 until the prosthetic heart valve 62 radially compressed and attached around the distal end portion of the delivery shaft 64 is positioned within the docking device 52 and the native mitral valve 16. In some embodiments, at least a portion of the distal end of the delivery shaft 64 and the prosthetic heart valve 62 radially compressed can be positioned within the left ventricle 26, as shown in FIG. 3A.

[0083] When the radially compressed artificial heart valve 62 is properly positioned within the docking device 52 (FIG. 3A), the user operates one or more actuation mechanisms of the handle 66 of the artificial valve delivery device 60 to activate the expansion mechanism 65 (e.g., inflate an inflatable balloon), thereby radially expanding the artificial heart valve 62 within the docking device 52.

[0084] FIG. 3B shows the fifth stage in mitral valve replacement, in which the artificial heart valve 62 is in its radially expanded configuration and implanted within the docking device 52 within the native mitral valve 16. As shown in FIG. 3B, the artificial heart valve 62 is received and held within the docking device 52. Thus, the docking device 52 assists in anchoring the artificial heart valve 62 within the native mitral valve 16. The docking device 52 allows for a better seal between the artificial heart valve 62 and the valve leaflets 24 of the native mitral valve 16 to reduce paravalvular leakage around the artificial heart valve 62.

[0085] As shown in FIG. 3B, after the artificial heart valve 62 is fully deployed and implanted within the docking device 52 with the native mitral valve 16, the artificial valve delivery device 60 (including the delivery shaft 64) is removed from the patient 10 so that only the guide wire 40 and the guide catheter 30 remain inside the patient 10.

[0086] FIG. 4 shows the sixth stage in mitral valve replacement, in which the guide wire 40 and the guide catheter 30 have been removed from the patient 10.

[0087] Figures 1-4 specifically show mitral valve replacement, but it should be understood that the same and / or similar techniques can be utilized to replace other heart valves (e.g., tricuspid valve, pulmonary valve, and / or aortic valve). Further, the same and / or similar delivery devices (e.g., docking device delivery device 50, artificial valve delivery device 60, guide catheter 30, and / or guide wire 40), docking devices (e.g., docking device 52), replacement heart valves (e.g., artificial heart valve 62), and / or their components can be utilized to replace these other heart valves.

[0088] For example, when replacing the native tricuspid valve, the user can access the right atrium 20 via the femoral vein, but does not need to cross the atrial septum 22 to enter the left atrium 18. Instead, the user can leave the guide wire 40 within the right atrium 20 and perform the same and / or similar docking device implantation process 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 guide wire 40 through the tricuspid valve into the right ventricle and perform the same and / or similar artificial heart valve implantation process within the docking device 52 at the tricuspid valve. Specifically, the user can advance the delivery shaft 64 of the artificial valve delivery device 60 along the guide wire 40 through the patient's vasculature until the artificial heart valve 62 is positioned / located 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 embodiments, the user can perform the same and / or similar process to replace the aortic valve, but can access the aortic valve from the outflow side of the aortic valve via the femoral artery.

[0089] Furthermore, FIGS. 1-4 illustrate a mitral valve replacement that accesses the native mitral valve 16 from the left atrium 18 via the right atrium 20 and the femoral vein, although it should be understood that the native mitral valve 16 can alternatively be accessed from the left ventricle 26. For example, a user can access the native mitral valve 16 from the left ventricle 26 via the aortic valve by advancing one or more delivery devices through an artery to the aortic valve and then through the aortic valve into the left ventricle 26.

[0090] FIG. 5 shows an embodiment of a docking device 100 configured to receive an artificial heart valve. For example, the docking device 100 can be implanted within the native valve annulus as described above with reference to FIGS. 1-2B. As shown in FIGS. 2A-4, the docking device 100 can be used in place of the docking device 52 such that the docking device 100 is configured to receive and fix an artificial valve within the docking device, thereby fixing the artificial valve to the native valve annulus.

[0091] Referring to FIG. 5, the docking device 100 can include two main components: a coil 102 and a guard member 104 that covers at least a portion of the coil 102. In certain embodiments, the coil 102 can include a shape memory material (e.g., nitinol), such that the docking device 100 (and the coil 102) is moveable from a substantially linear configuration (also referred to as a "delivery configuration") when disposed within a delivery sleeve (e.g., a sleeve shaft) of a delivery device (described more fully below) to a helical configuration (also referred to as a "deployed configuration" as shown in FIG. 5) after being removed from the delivery sleeve (e.g., a sleeve shaft).

[0092] Coil 102 has a proximal end 102p and a distal end 102d. When disposed within the delivery sleeve (e.g., during delivery of a docking device to a patient's vasculature), the body of coil 102 between the proximal end 102p and the distal end 102d forms a substantially linear delivery configuration (e.g., without coiled or looped portions) so as to maintain a small radial profile when moving through the patient's vasculature. After being removed from the delivery sleeve and deployed at the implantation site, coil 102 moves from the delivery configuration to a helical deployment configuration and can wrap around the native tissue adjacent to the implantation site. For example, when implanting the docking device at the location of a native valve, coil 102 can be configured to surround the native valve leaflets (and, if present, the chordae tendineae connecting the native valve leaflets to adjacent papillary muscles).

[0093] Docking device 100 can be releasably coupled to a delivery device. In certain embodiments, docking device 100 can be coupled to the delivery device via a release suture configured to be coupled to docking device 100 and cut for removal (as further described below with reference to FIGS. 6 and 8). In one embodiment, the release suture can be coupled to docking device 100 through an eyelet, or eyehole, positioned adjacent to the proximal end 102p of the coil. In some embodiments, the release suture can be coupled around a circumferential recess positioned adjacent to the proximal end 102p of coil 102.

[0094] In some embodiments, docking device 100 in the deployed configuration can be configured to fit at the location of the mitral valve. In other embodiments, the docking device can also be shaped and / or adapted for implantation at the location of other native valves, such as the tricuspid valve. In some embodiments, the geometric shape of docking device 100 can be configured to engage the native anatomical structure, thereby providing, for example, improved stability and reduced relative movement between docking device 100, the prosthetic valve docked therein, and / or the native anatomical structure.

[0095] As shown in FIG. 5, the coil 102 in the deployed configuration may include a leading turn 106 (or "leading coil"), a central region 108, and a stabilizing turn 110 (or "stabilizing coil"). The central region 108 may have one or more helical turns having a substantially equal inner diameter. The leading turn 106 may extend from the distal end of the central region 108 and have a diameter larger than the diameter of the central region 108 (in one or more configurations). The stabilizing turn 110 may extend from the proximal end of the central region 108 and have a diameter larger than the diameter of the central region 108 (in one or more configurations).

[0096] In certain embodiments, the central region 108 can include a plurality of helical turns, such as a proximal turn 108p connected to the stabilizing turn 110, a distal turn 108d connected to the leading turn 106, and one or more intermediate turns 108m disposed between the proximal turn 108p and the distal turn 108d. In the embodiment shown in FIG. 5, there is only one intermediate turn 108m between the proximal turn 108p and the distal turn 108d.

[0097] In some embodiments, there are two or more intermediate turns 108m between the proximal turn 108p and the distal turn 108d. Some of the helical turns in the central region 108 can be full rotations (i.e., 360-degree rotations). In some embodiments, the proximal turn 108p, and / or the distal turn 108d can be partial rotations (e.g., rotations less than 360 degrees such as 180 degrees, 270 degrees, etc.).

[0098] The size of the docking device 100 can generally be selected based on the size of the desired prosthetic valve to be implanted into the patient. In certain embodiments, the central region 108 can be configured to hold a radially expandable prosthetic valve. For example, the inner diameter of the helical turns within the central region 108 can be configured to be smaller than the outer diameter of the prosthetic valve when the prosthetic valve is radially expanded 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 (e.g., 108p, 108m, 108d) in the central region 108 are also referred to herein as "functional turns."

[0099] The stabilization turns 110 can be configured to help stabilize the docking device 100 in a desired position within the surrounding anatomical structures at the implantation site. For example, the radial dimension of the stabilization turns 110 can be significantly larger than the radial dimension of the coils in the central region 108 such that the stabilization turns 110 can be expanded, or extended, sufficiently outwardly to abut, or press against, the wall of the atrium of the heart, thereby improving the ability of the docking device 100 to remain in the desired position prior to implantation of the prosthetic valve. In some embodiments, the diameter of the stabilization turns 110 is larger than the native valve annulus, native valve leaflets, and atrium for good stabilization. In some embodiments, the stabilization turns 110 can be a full rotation (i.e., a rotation of about 360 degrees). In some embodiments, the stabilization turns 110 can be a partial rotation (e.g., a rotation of about 180 degrees to about 270 degrees).

[0100] In one particular embodiment, when implanting the docking device 100 in the location of the native mitral valve, the functional turns within the central region 108 can be disposed substantially within the left ventricle and the stabilization turns 110 can be disposed substantially within the left atrium. The stabilization turns 110 can be configured to provide one or more contact points, or contact regions, between the docking device 100 and the left atrial wall, such as at least three contact points within the left atrium, or complete contact on the left atrial wall. In certain embodiments, the contact points between the docking device 100 and the left atrial wall can form a plane that is substantially parallel to the plane of the native mitral valve.

[0101] As described above, the leading turn 106 can have a larger radial dimension than the helical turns within the central region 108. The leading turn 106 can help to more readily and appropriately guide the coil 102 around and / or through the geometry of the chordae tendineae and around all of the native valve leaflets of a native valve (e.g., native mitral valve, tricuspid valve, etc.). For example, when the leading turn 106 is navigated around the desired native tissue, the remaining coils (e.g., functional turns) of the docking device 100 can also be guided around the same structure. In some embodiments, the leading turn 106 can be a full rotation (i.e., a rotation of about 360 degrees). In some embodiments, the leading turn 106 can be a partial turn (e.g., rotating between about 180 degrees and about 270 degrees). In some embodiments, when the prosthetic valve is radially expanded within the central region 108 of the coil, the functional turns of the central region 108 can be further radially expanded. As a result, the leading turn 106 can be pulled in the proximal direction, its diameter can decrease, and it can become part of the functional turns within the central region 108.

[0102] In certain embodiments, at least a portion of the coil 102 can be surrounded by a first cover. The first cover can be composed of various natural materials and / or synthetic materials. In one particular embodiment, the first cover can include expanded polytetrafluoroethylene (ePTFE). In certain embodiments, the first cover is configured to be fixedly attached to the coil 102 (e.g., by textured surface resistance, suture, glue, heat bonding, or any other means) such that relative axial movement between the first cover and the coil 102 is restricted or prohibited.

[0103] The guard member 104 can form part of a cover assembly for the docking device 100. In some embodiments, the cover assembly can also include a first cover.

[0104] In a typical embodiment as shown in FIG. 5, when the docking device 100 is in the deployed configuration, the guard member 104 may be configured to cover a portion of the stabilizing turns 110 of the coil 102. In certain embodiments, the guard member 104 may be configured to cover at least a portion of the central region 108 of the coil 102, such as a portion of the proximal turn 108p. In particular embodiments, the guard member 104 may extend across the entire coil 102.

[0105] In some embodiments, the guard member 104 may be radially expanded to help prevent and / or reduce perivalvular leakage. Specifically, the guard member 104 may be configured to radially expand such that improved sealing is formed near and / or against an artificial valve deployed within the docking device 100. In some embodiments, the guard member 104 may be configured to prevent and / or impede leakage at locations where the docking device 100 crosses between the leaflets of a native valve (e.g., at the commissures of the native valve leaflets).

[0106] In some embodiments, when the docking device 100 is deployed in a native atrioventricular valve (e.g., mitral or tricuspid valve) and the guard member 104 mainly covers a portion of the stabilizing turns 110 and / or a portion of the central region 108, the guard member 104 may help cover the atrial side of the atrioventricular valve and prevent and / or impede blood from leaking through the native valve leaflets, commissures, and / or around the outside of the artificial valve by preventing blood from flowing in the ventricular-to-atrial direction (i.e., antegrade blood flow) other than through the artificial valve.

[0107] In some embodiments, the guard member 104 may be positioned on the ventricular side of the atrioventricular valve and prevent and / or impede blood from leaking through the native valve leaflets, commissures, and / or around the outside of the artificial valve by preventing blood from flowing in the ventricular-to-atrial direction (i.e., retrograde blood flow).

[0108] In some embodiments, the distal end portion 104d of the guard member 104 may be fixedly coupled to the coil 102 (e.g., via a distal suture), and the proximal end portion 104p of the guard member 104 may be axially movable relative to the coil 102.

[0109] In certain embodiments, when the guard member 104 is in a radially expanded state, the proximal end portion 104p of the guard member 104 may have a tapered shape as shown in FIG. 5, such that the diameter of the proximal end portion 104p gradually increases from the proximal end of the guard member 104 to the body portion located distally of the guard member 104. This may assist, for example, in loading the docking device onto the delivery sleeve (e.g., sleeve shaft) of the delivery device and / or in retrieving and / or repositioning the docking device on the delivery device during the implantation procedure.

[0110] FIGS. 6 - 10 illustrate embodiments of a delivery device (which may also be referred to as a delivery system) 200 configured to deliver a docking device (such as the docking device 100 described above with reference to FIG. 5) to a target implantation site (e.g., the heart and / or native valve of an animal, human, cadaver, cadaver heart, anthropomorphic phantom, and / or the like). In some embodiments, the delivery device 200 may be a transcatheter delivery device that can be used to guide a docking device mounted therein through the vasculature of a patient, as described above with reference to FIGS. 1 - 2B.

[0111] The exemplary delivery device 200 is shown in FIG. 6, and the docking device 232 is at least partially deployed from the distal end of the delivery device 200 (e.g., for illustrative purposes). In some embodiments, the docking device 232 can be the docking device 100 described above with reference to FIG. 5. FIGS. 7 and 8 show a distal end portion of the delivery device 200 having a docking device 232 disposed from the outer shaft 260 of the delivery device, with a sleeve shaft 280 covering the docking device 232 (FIG. 7), and after the sleeve shaft 280 has been removed from the docking device 232 (but before cutting the docking device 232 from the delivery device 200) (FIG. 8). FIGS. 9 and 10 are schematic cross-sectional views of the delivery device 200 showing a plurality of lumens formed between coaxial components of the delivery device 200.

[0112] Referring to FIG. 6, the delivery device 200 can include a handle assembly 220 and an outer shaft (e.g., a delivery catheter) 260 that extends distally from the handle assembly 220. The handle assembly 220 can include a handle 222 and a hub assembly 230 that extends proximally from the proximal end of the handle 222. As shown in FIG. 6, the handle assembly 220 can include a handle 222 that includes one or more knobs, buttons, wheels, etc. For example, as shown in FIG. 6, the handle 222 can include knobs 224 and 226 that can be configured to control the bending of the delivery device (e.g., the outer shaft 260). The outer shaft 260 extends distally from the handle 222, while the hub assembly 230 extends proximally from the handle 222.

[0113] For example, the delivery device 200 can include a pusher shaft 290 (Figs. 6, and 8 - 10) and a sleeve shaft 280 (Figs. 7 - 10) that are coaxially positioned within an outer shaft 260 (Figs. 9 and 10) and each have a portion that extends within a handle assembly 220. The pusher shaft 290 can be configured to deploy a docking device 232 from within a distal end portion of the outer shaft 260 when reaching a target implantation site, and the sleeve shaft 280 can be configured to cover the docking device 232 while positioned at the target implantation site (Fig. 7) within the delivery device 200 (Figs. 9 and 10). Further, the delivery device 200 can be configured to adjust the axial position of the sleeve shaft 280 to remove a sleeve portion (e.g., a distal section) of the sleeve shaft 280 from the docking device 232 after implantation at the target implantation site (Fig. 8). Figs. 7 and 8 show an exemplary docking device 232 deployed from the outer shaft 260 of the delivery device 200 and covered by a distal (or sleeve) portion 282 of the sleeve shaft 280, and are perspective views showing the exemplary docking device 232 after the sleeve shaft 280 has been re - housed within the outer shaft 260 (Fig. 8).

[0114] Accordingly, the sleeve shaft 270 can be removable from the docking device 232. In some embodiments, the distal portion 282 of the sleeve shaft 280 can have an outer surface that includes a lubricious material, or a low - friction material, that facilitates sliding the docking device 232 to a fixed position having a natural anatomical structure at the implantation site.

[0115] As shown in FIGS. 6 and 8, the docking device 232 can be coupled to the delivery device 200 via a release suture (or other retrieval line including a string, yarn, or other material that can be tied around the docking device and configured to be cut for removal) 236 that can extend through the pusher shaft 290. The release suture 236 can extend through the delivery device 200, through the inner lumen of the pusher shaft 290, and to the suture locking assembly 206 of the delivery device 200.

[0116] As shown in FIG. 6, the hub assembly 230 can include a suture lock assembly (e.g., suture lock) 206 and a sleeve handle 234 attached thereto. While the hub assembly 230 can be configured to control (e.g., axially move together) the pusher shaft 290 and the sleeve shaft 280 of the delivery device 200, the sleeve handle 234 can control the axial position of the sleeve shaft 280 relative to the pusher shaft 290. Thus, by operating the various components of the handle assembly 220, the operation of the components disposed within the outer shaft 260 can be actuated and controlled. In some embodiments, as shown in FIG. 6, the hub assembly 230 can be coupled to the handle 222 via a connector 240.

[0117] In some embodiments, the hub assembly 230 can include a Y-shaped connector (e.g., adapter) having a straight section (e.g., straight conduit) 202 and at least one branch (e.g., branch conduit) 204 (although in some cases can include multiple branches) (FIG. 6). In some embodiments, the suture locking assembly 206 can be attached to the branch 204 and the sleeve handle 234 (e.g., sleeve actuating handle) can be disposed at the proximal end of the straight section 202.

[0118] Further details regarding the docking device, and variations thereof, including details regarding the suture locking assembly, and pusher shaft, and sleeve shaft assembly for the delivery device 200 for the docking device, are described in International Patent Application No. WO2020 / 247907, which is hereby incorporated by reference in its entirety. Further details regarding additional delivery systems, and devices configured to deliver the docking device to a target implantation site, can be found in U.S. Patent Publications Nos. US2018 / 0318079, US2018 / 0263764, and US2018 / 0177594, which are hereby incorporated by reference in their entirety.

[0119] As shown in FIG. 6, the handle assembly 220 may further include one or more flushing ports for supplying a flush fluid to one or more lumens disposed within the delivery device 200 (e.g., an annular lumen disposed between coaxial components of the delivery device 200) to reduce potential thrombus formation and / or to degas components of the delivery device 200 prior to insertion into a patient. FIG. 6 shows an example where 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 the flushing port 216, or alternatively, the flushing port 210 may be disposed at the end of the suture locking assembly 206 (e.g., as shown in FIGS. 9 and 10).

[0120] Referring to FIGS. 9 and 10, which are exemplary simplified diagrams of the delivery device 200, various lumens are formed between the docking device 232, the pusher shaft 290, the sleeve shaft 280, and the outer shaft 260 and are configured to receive fluid. More specifically, the first pusher shaft lumen 201 can be formed within the interior of the pusher shaft 290 (e.g., within the main tube 292 of the pusher shaft 290). The second sleeve shaft lumen 211 is formed within the sleeve shaft 280. Additionally, the third delivery shaft lumen 215 (or outer shaft lumen) can be formed within an annular space formed between the inner surface of the outer shaft 260 and the outer surface of the sleeve shaft 280.

[0121] As shown in FIG. 9, the pusher shaft lumen 201 can be fluidly coupled to a first fluid source, such as an end of the suture locking assembly 206, or directly receive fluid from the flushing port 210, as shown in FIGS. 9 and 10, which are part of the handle assembly. Alternatively, as shown in FIG. 6, the flushing port 210 can be coupled at a location along the branch 204. The flush fluid flow 203 from the flushing port 210 can travel through the pusher shaft lumen 201, along the length of the main tube 292 of the pusher shaft 290, to the distal end 293 of the pusher shaft 290. At least a portion of the flush fluid flow 203 can flow as a flush fluid flow 207 into a first portion 205 of the sleeve shaft lumen 211 disposed between the outer surface of the docking device 232 and the inner surface of the distal portion 282 of the sleeve shaft 280. In some embodiments, the flush fluid flow 207 can flow through a guard member 231 of the docking device 232 (which can be identical or similar to the guard member 104 of FIG. 5). A second portion of the flush fluid flow 203 can also flow into a second portion 209 of the sleeve shaft lumen 211, disposed as a flush fluid flow 213, between the outer surface of the pusher shaft 290 and the inner surface of the sleeve shaft 280. The flush fluid flow 213 can continue into the shell portion 294 of the pusher shaft through the second portion 209 of the sleeve shaft lumen 211. Since the delivery shaft lumen 215 is fluidly coupled to the shell portion 294, the flush fluid flow 213 can continue into and through the delivery shaft lumen 215 toward the distal end 262 of the outer shaft 260.

[0122] As shown in FIG. 10, 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 can be fluidly coupled to a cavity 254 disposed around a main tube 292 of a pusher shaft 290 within a hub assembly 230. The cavity 254 is fluidly coupled to an annular cavity 219 defined by a shell portion 294, and the annular cavity 219 is fluidly coupled to the delivery shaft lumen 215. Thus, a flush fluid flow 221 from the flushing port 216 can move through the cavity 254, into the annular cavity 219, and through the annular cavity 219. The flush fluid flow 221 can then be split into a first flush fluid flow 217 within and through the delivery shaft lumen 215 and a second flush fluid flow 223 within and through the sleeve shaft lumen 211.

[0123] Fluid flow can be provided to the sleeve shaft lumen 211 in various cases, but as described above with reference to FIGS. 9 and 10, since the flush fluid flow can be split between the sleeve shaft lumen 211 and the delivery shaft lumen 215, a docking device (e.g., the guard member 231 of the docking device 232) may not reach a threshold fluid pressure for proper flushing and degassing. Thus, to degas the sleeve shaft lumen 211 of the docking device and the guard member (or alternative sheath), it is desirable to force all or most of the flush fluid flow provided by one or more flushing ports of the delivery device 200 through the sleeve shaft lumen 211.

[0124] Referring now to FIGS. 11 - 16, an exemplary sealing mechanism 300 for a catheter is shown that is configured to regulate fluid flow through two shafts of the catheter. For example, the sealing mechanism may be configured to seal around two shafts of the catheter that are concentric with each other (or one is disposed around the other but has a slightly offset central axis) along at least a distal end portion of the catheter, and to block fluid flow from an end of one shaft of the two shafts to the other shaft, thereby redirecting the fluid flow provided to the catheter through one of the two shafts. In some embodiments, the catheter is a delivery device for an implantable medical device, such as the delivery device 200 of FIGS. 6 - 10. For example, FIGS. 11 (side view), and 14 (cross-sectional side view) show the sealing mechanism 300 coupled to the outer shaft 260, and the sleeve shaft 280 of the delivery device 200. However, in alternative embodiments, the sealing mechanism 300 may be used with various catheters and delivery devices that include two or more shafts (e.g., an inner shaft and an outer shaft) having fluidly coupled lumens. FIGS. 12, and 13 show alternative end views of the sealing mechanism 300, FIG. 15 shows a cross-sectional perspective view of the sealing mechanism 300, and FIG. 16 shows an exploded view of the sealing mechanism 300.

[0125] 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 seal housing 306 that houses the first seal 302 therein, and a second seal housing 308 that houses the second seal 304 therein. The first seal 302, and the second seal 304 may be annular and have an opening (e.g., a central opening) configured to receive a shaft therethrough, as shown in FIGS. 14, and 15.

[0126] The first sealing housing 306 and the second sealing housing 308 can be joined to each other at an interface 310 (Figs. 11, 14, and 15). In some embodiments, the interface 310 is an overlapping interface where a portion of the first sealing housing 306 overlaps a portion of the second sealing housing 308 (as shown in Figs. 11 and 14 - 16). In alternative embodiments, the interface 310 is an overlapping interface where a portion of the second sealing housing 308 overlaps a portion of the first sealing housing 306. In some cases, the first sealing housing 306 and the second sealing housing 308 can be joined together by one or more fasteners that extend through one or more holes 312 (or openings) within the first sealing housing 306 and the second sealing housing 308 (Figs. 11 and 15).

[0127] The first sealing housing 306 can include a proximal portion 314, an intermediate portion 316, and a distal portion 318 (Figs. 14 - 16). The proximal portion 314 has a first inner diameter 320 and includes a plurality of internal threads 322 on an inner surface 324 of the first sealing housing 306 (Fig. 15). In some embodiments, as shown in Figs. 14 and 15, the first seal 302 can be disposed within the intermediate portion 316 of the first sealing housing 306. The intermediate portion 316 can also have the first inner diameter 320. In alternative embodiments, the first seal 302 can be disposed in a more distal portion of the first sealing housing 306.

[0128] The distal portion 318 of the first sealing housing 306 can have a second inner diameter 326 that is smaller than the first inner diameter 320 (Fig. 15). In some embodiments, the distal portion 318 can also include an outer collar portion 328 configured at the interface 310 to receive the second sealing housing 308 therein (Figs. 11 and 14 - 16). In some cases, the collar portion 328 can have a third inner diameter 330 that is larger than the second inner diameter 326. In some embodiments, the third inner diameter 330 can be the same as the first inner diameter 320. In alternative embodiments, the third inner diameter 330 can be larger or smaller than the first inner diameter 320, while being larger than the second inner diameter 326.

[0129] In some embodiments, the first sealing housing 306 may also include a transition portion 332 that includes a taper, or angled step 334, of a more gradually decreasing diameter from the first inner diameter 320 to the second inner diameter 326. Further, in some cases, the angled step 334 may be annular and may extend around the perimeter of the first sealing housing 306. In alternative embodiments, instead of being angled, the step of the transition portion 332 may be a right-angled step.

[0130] In some cases, the first seal 302 is shaped such that its distal end portion conforms to the taper, or angle, of the step 334. Thus, the first seal 302 may be shaped to fit within the intermediate portion 316 and the transition portion 332 relative to the angled step 334.

[0131] The sealing mechanism 300 may also include a first threaded member 336 coupled to the proximal portion 314 of the first sealing housing 306 (Figs. 14-16). In particular, the first threaded member 336 may include an external thread 338 configured to mate with an internal thread 322 of the first sealing housing 306 (Figs. 14 and 15). A first knob 340 (or alternative rotatable element) may be fixed to the first threaded member 336 and configured to rotate (Figs. 11-16). In some instances, the first knob may be coupled or fixed 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 rotates the first threaded member 336 relative to the first sealing housing 306, thereby moving the first threaded member 336 axially (relative to the central longitudinal axis 301 of the sealing mechanism 300). When the first threaded member 336 moves distally (toward the second sealing housing 308), the distal end 342 of the first threaded member 336 also contacts and presses against the proximal end 344 of the first seal 302 (Figs. 14 and 15), thereby compressing the first seal 302 around a shaft (e.g., the outer shaft 260 shown in Fig. 14) disposed therein. In this manner, the first seal 302 can be tightened around and sealed against a shaft disposed therein by rotating the first knob 340 (and, as a result, the first threaded member 336). Further, compressing the first seal 302 with the first knob 340 may also axially lock the sealing mechanism 300 to a shaft disposed therein, thereby ensuring that the sealing mechanism 300 remains connected to the shaft during flushing at relatively high fluid pressures, as described below.

[0132] The second sealing housing 308 may include a proximal portion 346, an intermediate portion 348, and a distal portion 350 (Figs. 14-16). 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, and the fifth inner diameter 354 is smaller than the fourth inner diameter 352 (Fig. 15). The proximal end 356 of the proximal portion 346 may be joined to and coupled with the first sealing housing 306, such as a collar portion 328 (Figs. 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.

[0133] In some embodiments, the step 358 of the proximal portion 346 transitions between the fourth inner diameter 352 and the fifth inner diameter 354 (Figs. 14 and 15). The step 358 may also function as a stop configured to engage the distal end of a shaft extending through the first sealing housing 306 (e.g., the outer shaft 260). For example, as shown in Fig. 14, the distal end 262 of the outer shaft 260 may abut against the step 358, thereby preventing the outer shaft 260 from moving further distally through the second sealing housing 308. The cavity 360 may be defined within the first sealing housing 306 and the second sealing housing 308 between the first seal 302 and the second seal 304. As shown in Fig. 14, the distal end 262 of the outer shaft 260 may be present within the cavity 360. Further, as described in more detail below, the cavity 360 may be fluid-sealed by the walls of the first sealing housing 306, the second sealing housing 308, the first seal 302, and the second seal 304 when the first seal 302 is tightened around the first shaft (e.g., the outer shaft 260) and the second seal 304 is tightened around the second shaft (e.g., the sleeve shaft 280).

[0134] In some embodiments, as shown in Figs. 14 and 15, the second seal 304 may be disposed within the intermediate portion 348 of the second sealing housing 308. The intermediate portion 348 may have a sixth inner diameter 362 that is larger than the fifth inner diameter 354.

[0135] In some embodiments, the second sealing housing 308 may also include a transition portion 364 that includes a taper, or angled step 366, with a more gradually increasing diameter from a fifth inner diameter 354 to a sixth inner diameter 362. Further, in some cases, the angled step 366 may be annular and may extend around the perimeter of the second sealing housing 308. In an alternative embodiment, instead of being angled, the step of the transition portion 364 may be a right-angle step.

[0136] In some cases, the second seal 304 is shaped such that its proximal end portion conforms to the taper, or angle, of the angled step 366. In this way, the second seal 304 may be shaped to fit within the intermediate portion 348 and the transition portion 364 with respect to the angled step 366.

[0137] Although step 358 is shown as extending into the transition portion 364, it should be noted that in an alternative embodiment, step 358 may be shorter (axially) and may be formed as a protrusion within the proximal portion 346. Next, the angled step 366 may taper from the larger sixth inner diameter 362 to a diameter larger than the fifth inner diameter 354.

[0138] 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 (FIG. 15). As shown in FIGS. 14 and 15, the threads 370 are disposed distally of the second seal 304 within the second sealing housing 308.

[0139] The sealing mechanism may further include a second threaded member 374 coupled to the distal portion 350 of the second sealing housing 308 (Figs. 14-16). In particular, 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 alternative rotatable element) may be fixed to the second threaded member 374 and configured to rotate (Figs. 11-16). In some instances, the second knob 378 may be coupled or fixed to the distal end of the second threaded member 374 and disposed around the distal portion 350 of the second sealing housing 308. Rotation of the second knob 378 rotates the second threaded member 374 relative to the second sealing housing 308, thereby moving the second threaded member 374 axially (relative to the central longitudinal axis 301). As the second threaded member 374 moves proximally (toward the first sealing housing 306), the proximal end 380 of the second threaded member 374 contacts and presses against the distal end 382 of the second seal 304 (Figs. 14 and 15), thereby compressing the second seal 304 around a shaft (e.g., the sleeve shaft 280 shown in Fig. 14) disposed therein. In this manner, the second seal 304 can be tightened around and sealed against a shaft disposed therein by rotating the second knob 378 (and, as a result, the second threaded member 374). Further, compressing the second seal 304 with the second knob 378 may also axially lock the sealing mechanism 300 to a shaft disposed therein, thereby ensuring that the sealing mechanism 300 remains connected to the shaft during flushing at relatively high fluid pressures, as described below.

[0140] The first threaded member 336 and the inner surface of the first seal 302 may define a first lumen 384 of the sealing mechanism 300 having a first diameter 385 that is configured (shaped) to receive a first shaft (e.g., the outer shaft 260 shown in FIG. 14). The second threaded member 374 and the inner surface of the second seal 304 may define a second lumen 386 of the sealing mechanism 300 having a second diameter 387 that is configured (shaped) to receive a second shaft (e.g., the sleeve shaft 280 shown in FIG. 14). The second diameter 387 may be smaller than the first diameter 385.

[0141] FIG. 17 is a flowchart of an exemplary method 400 for selectively directing fluid flow through a catheter that includes a plurality of shafts that are at least partially concentric with each other (or disposed within the other having a central longitudinal axis that is slightly offset). In particular, method 400 may be a method for operating the sealing mechanism 300 of FIGS. 11 - 16 to block fluid flow exiting a first shaft of the catheter and direct fluid flow through a second shaft of the catheter. However, method 400 may also be a method for operating other sealing mechanisms described herein, such as the sealing mechanism 500 or the sealing mechanism 600. In some embodiments, the catheter may be the delivery device 200 of FIGS. 6 - 10, the first shaft may be the outer shaft 260, and the second shaft may be the sleeve shaft 280.

[0142] Method 400 begins at 402 and includes attaching a first seal 302 of the sealing mechanism 300 to the distal end portion of a first shaft of the catheter (e.g., the outer shaft 260 shown in FIG. 14). Attaching the first seal 302 to the first shaft may include extending the distal end portion of the first shaft through the first seal 302 and into the cavity 360 of the sealing mechanism 300 within the first lumen 384 of the sealing mechanism 300 (e.g., as shown in FIG. 14). Further, in some embodiments, the distal end of the first shaft may abut or contact a stop (e.g., step 358) of the second sealing housing 308. Attaching the first seal 302 to the shaft may further include clamping the first seal 302 around the first shaft, for example, by rotating the first knob 340 and the first threaded member 336.

[0143] At 404, the method includes attaching a second seal 304 of the sealing mechanism 300 to the distal end portion of a second shaft of the catheter that extends through a first shaft (e.g., the sleeve shaft 280 shown in FIG. 14), the distal end portion of the second shaft extending distally of the distal end of the first shaft. For example, attaching the second seal 304 to the second shaft may include extending the distal end portion of the second shaft through and to the distal end of the first shaft and through the second seal. In some embodiments, the distal end of the second shaft may extend outside the distal end of the sealing mechanism 300. Attaching the second seal 304 to the second shaft may further include clamping the second seal 304 around the second shaft, for example, by rotating the second knob 378 and the second threaded member 374. In an alternative embodiment, if the second seal is instead a non-actively compressible seal (such as an O-ring as in sealing mechanism 500 or sealing mechanism 600), method 404 may include extending the distal end portion of the second shaft through the second seal, the second seal fitting snugly around the second shaft and sealing against the second shaft.

[0144] After tightening the first seal 302 and the second seal 304, the cavity 360 can be fluidly sealed (e.g., fluid cannot exit the cavity 360), thereby closing the distal end of the first shaft so that fluid from the first lumen of the first shaft cannot exit the cavity 360.

[0145] Method 400 can continue at 406, including flowing fluid through the catheter such that fluid flows only from the second lumen of the second shaft and blocks fluid from flowing from the first lumen of the first shaft (the first lumen defined between the outer surface of the second shaft and the inner surface of the first shaft). As a result, the second lumen of the second shaft can be fully flushed and degassed. For example, if the second shaft is the sleeve shaft 280 and fluid is flowed through the catheter and only through the second lumen (not the first lumen), the docking device disposed within the sleeve shaft can be effectively and efficiently degassed prior to the implantation procedure.

[0146] Figures 18 - 21 show an exemplary sealing mechanism 500 for a catheter configured to regulate fluid flow through two shafts of the catheter. Figures 18 and 19 are perspective views of the sealing mechanism 500. Figure 20 is a cross-sectional side view of the sealing mechanism 500. Figure 21 is another cross-sectional side view showing the sealing mechanism 500 coupled to the outer shaft 260 and the sleeve shaft 280 of the delivery device 200. However, in alternative embodiments, the sealing mechanism 500 can be used with various catheters and delivery devices including more than two shafts having fluidly coupled lumens.

[0147] The sealing mechanism 500 can be similar to the sealing mechanism 300, except that instead of two compressible seals (or gaskets) that are compressible around each shaft via a rotatable element, the sealing mechanism 500 can include a compressible seal, or gasket, compressible around the first shaft of the catheter and a non-actively compressible seal (such as an O-ring) disposed around the second shaft of the catheter.

[0148] Referring to FIGS. 20-21, the sealing mechanism 500 may include a first seal 502 and a second seal 504 disposed within the housing 506 of the sealing mechanism 300. The first seal 502 and the second seal 504 may be annular with an opening (e.g., a central opening) configured to receive a shaft therethrough.

[0149] In some embodiments, the first seal 502 is a compressible seal or gasket configured to be compressed around an outer shaft (such as 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 embodiments, the second seal 504 is a non-actively compressible seal, such as an O-ring, which fits snugly around and is shaped to seal against an inner shaft (e.g., sleeve shaft 280). As used herein, the term "non-actively" means without additional interaction (e.g., rotation, clamping, etc.) provided by a user and / or other mechanism.

[0150] The rotatable element 508 may also be configured to axially lock the sealing mechanism 500 in a fixed position as a system when pressurized. The compressible seal that generates the axial locking may be disposed 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 can result in a reduction in the axial retention of the seal and the rotatable element.

[0151] The rotatable element 508 can include a rotatable knob 510 and a threaded member 512 that extends distally from the rotatable knob 510. The threaded member 512 can include one or more external threads 514 (or protrusions) (FIG. 19) configured to engage an internal thread 516 on an inner surface 520 of the housing (FIGS. 19-21). In some embodiments, as shown in FIG. 19, the external threads 514 can be discrete protrusions spaced apart from each other around an outer surface of the threaded member 512 that are shaped to interengage and slide along the internal thread 516. In some embodiments, the threaded member 512 can also include one or more locking elements 518 (e.g., tabs, or cantilevered protrusions) configured to snap engage the internal thread 516 and maintain the rotatable element 508 connected to the housing 506 (e.g., without disengaging from the housing 506 when the rotatable element 508 is fully loosened).

[0152] The rotatable element 508 can be rotatable relative to the housing 506 such that the threaded member 512 moves distally relative to the first seal 502 and axially presses the first seal 502 against a bent edge 532 (or beveled edge) of the housing 506, which in turn compresses the first seal 502 radially against a shaft disposed therein, thereby tightening the first seal 502 around the shaft (e.g., outer shaft 260 shown in FIG. 21). The radial compression of the first seal 502 can be more pronounced than that shown in FIG. 21, and it should be noted that in some embodiments, the first seal 502 can be further pressed against the bent edge 532 and can have a smaller inner diameter when axially pressed against the housing 506.

[0153] The internal thread 516 of the housing 506 can be disposed at a first end portion 522 of the housing 506 proximal to a cavity 524 defined by the inner surface 520 of the housing 506 (FIG. 20). The first seal 502 can be disposed within the housing 506 adjacent and distal to the internal thread 516.

[0154] The inner surface 520 of the housing 506 can further define a step 526 within the cavity 524 that decreases the diameter of the cavity 524 from the larger diameter portion 528 of the cavity 524 to the smaller diameter portion 530 of the cavity 524 (Figs. 20 and 21). The first seal 502 is disposed adjacent and proximal to the larger diameter portion 528 of the cavity 524 within the housing 506, and the second seal 504 is disposed adjacent and distal to the smaller diameter portion 530 of the cavity 524 within the housing 506 (Figs. 20 and 21). In this way, the cavity 524 can be defined between the first seal 502 and the second seal 504.

[0155] As described above for the sealing mechanism 300, the step 526 can function as a stop for the distal end 262 of the outer shaft 260 (Fig. 21). In this way, the distal end 262 of the outer shaft 260 can be received within the larger diameter portion 528 of the cavity 524 and can abut against the step 526 having the first seal 502 that seals around the periphery of the distal end portion of the outer shaft 260 (e.g., as the rotatable element 508 rotates, the first seal 502 is axially pushed against the housing (e.g., the bent edge 532). This then compresses the first seal 502 against the outer shaft 260). The inner shaft, or sleeve shaft 280, can then extend distally through the distal end 262 of the outer shaft 260 and through the cavity 524 and the smaller diameter portion 530 of the second seal 504. The second seal 504 can be sized to fit tightly around the outer surface of the sleeve shaft 280, such that the sleeve shaft 280 is fluidly sealed around its periphery. Thus, fluid passing through the delivery device is blocked from exiting at the distal end of the outer shaft 260 as shown in Fig. 21 and as described above with reference to the sealing mechanism 300 and method 400, and instead can pass through the sleeve shaft 280.

[0156] Figures 22 and 23 show an exemplary sealing mechanism 600 for a catheter configured to regulate fluid flow through two shafts of the catheter. The sealing mechanism 600 may be similar to the sealing mechanism 600, except that instead of one compressible seal, or gasket, compressible around the outer shaft and one non-compressible seal (e.g., an O-ring) configured to seal around the inner shaft, the sealing mechanism 600 may comprise two non-actively compressible seals (e.g., two O-rings).

[0157] For example, as shown in FIGS. 22 and 23, the sealing mechanism 600 may include a housing 602 (FIG. 22), a first seal 604 disposed within a first end portion 608 of the housing 602, and a second seal 606 (FIG. 23) disposed within a second end portion 610 of the housing 602. The first seal 604 may be larger than the second seal 606. For example, a first inner diameter 605 of the first seal 604 may be larger than a second inner diameter 607 of the second seal 606, and the first inner diameter 605 is sized to receive and seal around a first shaft (e.g., outer shaft 260), and the second inner diameter 607 is sized to receive and seal around a second shaft (e.g., sleeve shaft 280).

[0158] Similar to the sealing mechanism described above, the inner surface 612 of the housing 602 may define a cavity 614 (FIG. 23) disposed between the first seal 604 and the second seal 606. The housing 602 can further define a step 616 within the cavity 614 that reduces the diameter of the cavity 614 from a larger diameter portion 620 of the cavity 614 to a smaller diameter portion 618.

[0159] The first seal 604 may be configured to fit snugly around the outer surface of the outer shaft of the catheter (e.g., outer shaft 260) and seal against the outer surface, and step 616 may form a stop at the distal end of the outer shaft. The second seal 606 may be configured to slide fit around and seal against the inner shaft of the catheter (e.g., sleeve shaft 280). Thus, the first seal 604 and the second seal 606 can fluidly seal against each shaft of the catheter without using a rotatable element or knob, and the distal end of the outer shaft of the catheter may be located within cavity 614 disposed between the first seal 604 and the second seal 606. As a result, flow from the outer shaft can be blocked, such that all or most of the flush fluid introduced into the outer shaft may be present through the lumen of the inner shaft (e.g., the sleeve shaft lumen of sleeve shaft 280).

[0160] In some embodiments, as described above, it may be desirable to aspirate fluid from the distal end of the inner shaft of the catheter (e.g., sleeve shaft 280) rather than flushing through the catheter and the sealing mechanism. Fluid aspiration is herein sometimes referred to as applying a negative pressure at the end of the shaft such that, for example, a vacuum is created and the fluid is drawn out of (rather than pushed out of) the shaft. In contrast, flush fluid, as used herein, can refer to using a positive fluid pressure to push fluid through the shaft. In some embodiments, the fluid aspiration and flushing techniques described herein may be used together to direct fluid through one or more shafts of the catheter.

[0161] In such an example of fluid aspiration, the housing of any of the above-described sealing mechanisms may extend distally from the second seal and may include a second cavity and a second step both disposed distally of the second seal. For example, FIG. 24 shows a sealing mechanism 500 having a housing 506 further comprising a second cavity 550 disposed distally of a second seal 504 and a step 552 disposed within the second cavity 550. The step 552 decreases 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 function as a stop for the distal end of the inner shaft (sleeve shaft 280).

[0162] A luer attachment 554 may be attached to the distal housing 506 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 suctioning the inner shaft. In some embodiments, an extension tube 558 may be connected between the luer attachment 554 and the suction tool 556.

[0163] In some embodiments, a method for aspirating the inner shaft of a catheter may include positioning a sealing mechanism (e.g., the sealing mechanism 500 shown in FIG. 24) around the outer shaft such that the distal end of the outer shaft abuts the step 526 with the inner shaft (sleeve shaft 280) fully retracted within the outer shaft. When using a sealing mechanism configuration having a rotatable element, the rotatable element 508 may be rotated such that the first seal 502 is axially compressed against the housing, thereby radially compressing the first seal 502 and clamping the first seal 502 around the outer shaft. The inner shaft (sleeve shaft 280) may then advance through the second seal 504 and into the second cavity 550 against the step 552. Finally, a suction tool 556 (e.g., a syringe) may be attached to the luer attachment 554 and the user may draw a vacuum with the suction tool 556 to aspirate the catheter.

[0164] Figures 25 and 26 show an embodiment of a sealing mechanism 700 for sealing a catheter shaft and aspirating fluid from the shaft. The sealing mechanism 700 may include a clam shell member 702 configured to open and receive a catheter therein (e.g., sleeve shaft 280), as shown in FIG. 25. For example, the clam shell member 702 may include a first half shell 704 and a second half shell 706 that include a slot for receiving the shaft or a lumen 720. In some embodiments, 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 pivots away from the first half shell 704 (to an open configuration, as shown in FIG. 25) to receive the shaft therein and then pivots toward and relative to the first half shell 704 (to a closed configuration, as shown in FIG. 25) to seal the shaft between the first half shell 704 and the second half shell 706.

[0165] In some embodiments, the first half shell 704 and the second half shell 706 may include a compressible pad 708 (e.g., a silicone pad or another compressible polymer pad) configured to seal around the shaft when the clam shell member 702 is closed and clamped around the shaft. The lumen 720 may be defined within the first half shell 704 and the second half shell 706 and configured to receive the catheter shaft therein.

[0166] The tube 714 may extend from the housing 712 and may include a luer fitting 716 (or another type of mechanical fitting) configured to receive an aspiration tool (such as a syringe). The lumen of the tube 714 may be fluidly connected to the lumen 720 through the lumen of the housing 712.

[0167] In some embodiments, the sealing mechanism 700 may include a locking mechanism configured as an axially slidable sliding knob 718 from a first position around a portion of the outer surface of the housing 712 (FIG. 25) to a second position around the closed first half shell 704 and the second half shell 706 (FIG. 26). In the second position, the sliding knob 718 surrounds the first half shell 704 and the second half shell 706, thereby locking them in a closed position and a sealing position around the shaft. In some embodiments, the first half shell 704 and / or the second half shell 706 may include a stop element 722 (FIG. 26) configured to stop the sliding knob 718 from further moving towards the ends of the first half shell 704 and the second half shell 706. Additionally or alternatively, in some embodiments, the sliding knob 718 may have an ergonomic grip around its outer surface (as shown in FIGS. 25 and 26).

[0168] In alternative embodiments, the sealing mechanism 700 may include additional or alternative locking mechanisms. For example, in alternative embodiments, instead of sliding, the knob 718 may be rotatable and may have internal threads that engage with threads on the first half shell 704 and the second half shell 706. Thus, the rotatable knob may rotate and be screwed onto the first half shell 704 and the second half shell 706 to hold them together in a closed position and a sealing position.

[0169] In alternative embodiments, instead of or in addition to the sliding knob 718, the first half shell 704 and the second half shell 706 may have complementary locking elements, such as inclined tabs, that allow the first half shell 704 and the second half shell 706 to snap together (and be held together in a closed position until released by a release mechanism, such as a tab, that is pushed together for release).

[0170] In some embodiments, the first half shell 704 and the second half shell 706 can 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 can be spring-loaded by a spring, such that they are forced open by the spring and then closed together under pressure and can remain closed by a locking mechanism (e.g., the sliding knob 718).

[0171] In some embodiments, the first half shell 704 and the second half shell 706 can be spring-loaded by a spring so that they can be forced closed by the spring and then manually opened and separated by the user (thus eliminating the need for a locking mechanism in this case).

[0172] When the shaft (e.g., the sleeve shaft 280) is closed and sealed within the clam shell member 702, a suction tool can be connected to the tube 714, evacuated, and used to draw fluid through and from the shaft, as shown in FIG. 26.

[0173] In this way, the sealing mechanism 700 can be easily connected to and sealed around a shaft (sleeve shaft 280) that requires flushing. In some embodiments, the shaft can extend from and distally of the outer shaft of the catheter (e.g., the outer shaft 260) during the suction process.

[0174] Figures 27-34 show embodiments of a sealing mechanism 800 (or sealing assembly) for sealing to a catheter shaft, aspirating fluid from the shaft, and / or flushing fluid through the shaft. 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, lock member, or locking member) configured to engage the sealing housing 802 and the seal 804. The locking cap 806 is rotatable relative to the sealing housing 802 about a central longitudinal axis 805 (or vice versa) and moves the sealing mechanism between an unlocked configuration (see, e.g., FIG. 32A) and a locked configuration (see, e.g., FIG. 32B).

[0175] In some embodiments, the sealing mechanism 800 may further include a tube 808 that extends distally from the locking cap 806. In some cases, the tube 808 is a flexible tube that includes a flexible or conformable material configured to receive the catheter shaft therethrough (and allow movement / flexure of the shaft therein). For example, the tube 808 may be configured to assume the shape of the inserted catheter shaft (e.g., a bent shape and / or a serpentine shape).

[0176] FIG. 27 shows an assembled view of the sealing mechanism 800, and FIG. 28 shows an exploded view of the sealing mechanism 800. The central longitudinal axis 805 of the sealing mechanism 800 is shown in FIGS. 27 and 28. The locking cap 806 is shown alone in FIGS. 29A-29C, the sealing housing 802 is shown alone in FIGS. 30A and 30B, and the seal 804 is shown alone in FIG. 31. Further, FIGS. 32A and 32B show side views of the sealing mechanism 800, and FIGS. 33A and 33B show cross-sectional views of the sealing mechanism 800.

[0177] In some embodiments, the sealing mechanism 800 can seal the shaft of a delivery device for implantable medical devices, such as the delivery device 200 of FIGS. 6-10. For example, FIG. 34 shows a sealing mechanism 800 coupled to and sealed around the sleeve shaft 280 of the delivery device 200. The sealing mechanism 800 can also be used with (and / or adapted to be used with) various catheters and delivery devices that include two or more shafts with fluidly coupled lumens.

[0178] 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), whereby the sealing mechanism 800 is movable between an unlocked configuration (FIGS. 32A and 33A) and a locked configuration (FIGS. 32B, 33B, and 34) in which the seal 804 is disposed within the sealing mechanism 800 and is tightly compressed (held) around the shaft extending through the sealing mechanism 800. In this way, the sealing mechanism 800 can be used to flush or draw fluid through the shaft, thereby degassing the shaft (and / or components disposed within the shaft).

[0179] As shown in FIGS. 27-29C, the locking cap 806 includes an outer wall 810 (or outer portion) and an inner wall 812 (or inner portion) that extends proximally from an end wall 814 that defines the distal end 816 (or second end) of the locking cap 806 (FIGS. 28 and 29A). The outer wall 810 and the inner wall 812 can extend to the open proximal end 818 (or first end) of the locking cap 806. The cross-sections of the outer wall 810 and the inner wall 812 are annular. Thus, the outer wall 810 and the inner wall 812 can be referred to herein as circumferentially extending walls and / or annular walls.

[0180] In some cases, the proximal end of the outer wall 810 at the proximal end 818 may include one or more flanges 820 that extend radially outward from the outer wall 810 and circumferentially around at least a portion of the outer wall 810 and around the locking cap 806. For example, as shown in FIGS. 27-29C, the locking cap 806 may include two circumferentially extending flanges 820 that are circumferentially separated from each other 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 1 / 3 or more of the entire circumference).

[0181] In some cases, the locking cap 806 may comprise more than two or fewer flanges 820 (e.g., one, three, etc.). In some cases, the width (circumferential) of the gap 822 may be larger or smaller than that shown in FIGS. 27-29C.

[0182] In some cases, the locking cap 806 comprises one or more extensions 824 (or wings) that extend radially outward from the outer wall 810. The one or more extensions 824 are configured to be gripped by a user to rotate the sealing mechanism 800 into a locked and unlocked configuration. Each extension 824 may intersect one of the flanges 820. In some cases, as shown in FIGS. 27-29C, the extension 824 extends further radially outward with respect to the central longitudinal axis 805 than the flange 820.

[0183] For example, as shown in FIGS. 27-29C, the locking cap 806 may include two extensions 824 that are separated from each other (circumferentially) and are disposed on opposite sides of the locking cap 806 (e.g., across the central longitudinal axis 805 from each other). Thus, the extensions 824 may extend in a direction radially outward from the outer wall 810 and opposing the central longitudinal axis 805.

[0184] In some cases, the locking cap 806 may comprise more than three or fewer extensions 824 (e.g., one, three, etc.).

[0185] The cavity 826 is defined in the radial direction (with respect to the central longitudinal axis 805) between the outer wall 810 and the inner wall 812 (FIGS. 28 and 29A). Thus, the cavity 826 can be formed by a space that separates the outer surface of the inner wall 812 and the inner surface of the outer wall 810. As further described below, the cavity 826 can be configured to receive a portion of the sealing housing 802 therein.

[0186] The inner cavity 828 is defined by the inner surface of the inner wall 812. The inner cavity 828 extends through the locking cap 806 and is configured to receive therethrough the shaft of the catheter (to be sealed). For example, the inner cavity 828 can include a first inner cavity portion 830 that extends distally from the proximal end 818 and is configured to receive the shaft therethrough (FIGS. 28 and 29A).

[0187] In some cases, the inner cavity 828 also includes a second inner cavity portion 832 that extends proximally from the distal end 816 and is configured to receive the tube 808 therein. The tube 808 is configured to receive the shaft of the catheter therethrough. In this way, the tube 808 can extend into the second inner cavity portion 832 and be coupled to the inner wall 812 of the locking cap 806. Thus, when disposed within the second inner cavity portion 832, the tube 808 can extend distally outwardly from the distal end 606 of the locking cap 806 (as shown in FIG. 27).

[0188] In some cases, the inner surface of the inner wall 812 can define a step, or annular protrusion 834, that separates the first inner cavity portion 830 and the second inner cavity portion 832 (as also shown in FIGS. 29B, 33A, and 33B). In some cases, the second inner cavity portion 832 has a second diameter 836 that is smaller than a first diameter 838 of the first inner cavity portion 830 (as shown in FIG. 33A).

[0189] The inner wall 812 has a proximal surface 840 that faces axially at the proximal end 818 and is configured to join with the seal 804 (as further described below).

[0190] In some embodiments, the inner wall 812 also includes one or more radially extending channels 842 (or openings) that extend between the inner and outer surfaces of the inner wall 812 (FIG. 29A). One or more channels 842 (e.g., two are shown in FIG. 29A) are configured to receive one or more pins 844 (FIG. 28) that form a locking assembly of the sealing mechanism 800 having the sealing housing 802 (as further described below). In this way, the pins 844 can extend through each channel 842 and be coupled to the locking cap 806.

[0191] In some embodiments, the pins 844 can be an integral part of the locking cap 806. For example, the pins 844 can be mounted and fixed within corresponding channels 842 within the locking cap 806. In some embodiments, instead of being disposed within the channel 842 and protruding outwardly from the channel 842, the pins 844 can be fixed to the outer surface of the inner wall 812 and protrude radially outwardly from the outer surface of the inner wall 812. In this way, the pins 844 can be, in some embodiments, an extension of the inner wall 812.

[0192] Returning to FIGS. 30A and 30B (as well as FIGS. 27 and 28), the sealing housing 802 includes a cylindrical body portion 846 that extends between a proximal end 848 (FIGS. 27 and 28) and a distal end 850 (FIGS. 30A and 30B) of the sealing housing 802. The inner surface of the cylindrical body portion 846 defines a cavity 852 therein. The axially facing proximal wall 854 (FIGS. 27 and 28) is formed at the proximal end 848 of the cylindrical body portion 846 and defines an opening 856 that is configured (e.g., shaped and / or sized) to receive a catheter shaft therethrough. The diameter of the opening 856 is smaller than the diameter of the cylindrical body portion 846 at the distal end 850.

[0193] For example, the inner surface of the cylindrical body portion 846 may further define a lumen 845 that extends from the opening 856 into the cylindrical body portion 846. The lumen 845 opens into a larger (larger diameter) cavity 852 at an inclined surface 853 (Figs. 30B, 33A, and 33B) defined by the inner surface of the cylindrical body portion 846. The inclined surface 853 may be shaped to receive the seal 804 therein, as further described below with reference to Figs. 33A and 33B. The inclined surface 853 is angled at a non-zero angle with respect to the central longitudinal axis 805.

[0194] In some cases, as shown in Figs. 27 - 28, and 30A - 30B, the proximal wall 854 has a circumferentially extending 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.

[0195] In some cases, the seal housing 802 includes one or more radially extending extensions 860 (or flanges) that extend radially outward from the cylindrical body portion 846. The one or more extensions 860 are configured to be gripped by a user to hold and / or rotate the seal housing 802 relative to the locking cap 806 when moving the sealing mechanism 800 between a locked configuration and an unlocked configuration. In some embodiments, the one or more extensions 860 may intersect the flange 858. The extensions 860 extend further radially outward with respect to the central longitudinal axis 805 than the flange 858.

[0196] Two extensions 860 are illustrated in Figs. 27 - 28, Figs. 30A - 30B, and Figs. 32A - 34, but in alternative embodiments, the seal housing 802 may include more than two or less than two extensions 860 (e.g., one, three, four, etc.).

[0197] The cylindrical body portion 846 includes one or more slots 862 (or at least one slot 862) extending therethrough between the inner surface and the outer surface of the cylindrical body portion 846 (e.g., defined radially through the thickness of the cylindrical body portion 846). For example, as shown in FIGS. 27-28 and 30A-30B, the cylindrical body portion 846 includes two slots 862 circumferentially spaced apart from each other (e.g., in some cases, 180 degrees apart). Each slot 862 can be configured to receive one of the pins 844, as shown in FIG. 27 and FIGS. 32A and 32B (described in more detail below). Thus, the number of slots 862 is equal to the number of pins 844. In alternative embodiments, more than three or fewer slots 862 and pins 844 are possible, and the number of pins 844 and slots 862 is equal.

[0198] As shown in FIGS. 28, 30A, and 30B, each slot 862 can have a non-linear shape, such as a bend. For example, each slot 862 can have a portion extending circumferentially at a second end 872 of the slot 862 and a portion extending axially at a first end 870 of the slot 862. The first end 870 and the second end 872 of the slot 862 are opposite ends of the slot 862. The first end 870 is closer to the distal end 850 of the cylindrical body portion 846 than the second end 872 of each slot 862 (FIG. 30A).

[0199] Thus, when the sealing housing 802 and the locking cap 806 rotate relative to each other between the locking configuration and the unlocking configuration, each pin 844 slides within each slot 862 (between the opposing first and second ends 870, 872), and correspondingly, the sealing housing 802 and the locking cap 806 can each be axially moved toward and away from each other (as further described below). Such relative movement between the sealing housing 802 and the locking cap 806 axially compresses the seal 804 between the sealing housing 802 and the locking cap 806 and radially compresses (and / or expands) it around the shaft extending through the sealing mechanism 800.

[0200] The pins 844 and the corresponding slots 862 can be configured such that the sealing housing 802 and the locking cap 806 rotate relative to each other between the unlocking configuration and the locking configuration by 360 degrees, 45 to 225 degrees, 70 to 200 degrees, 170 to 190 degrees, or less than 80 to 100 degrees.

[0201] A side view of the seal 804 is shown in FIG. 31. The seal 804 includes a proximal portion 864 and a distal portion 866. The distal portion 866 is cylindrical (annular). In some embodiments, the proximal portion 864 is angled 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 the seal 804 can be relatively constant through the seal 804 (through the distal portion 866 and the proximal portion 864). In this way, the seal 804 can be configured to fit within the cavity 852 of the sealing housing 802, and the angled outer surface of the proximal portion 864 can be configured to engage and fit against the inclined surface 853. The axially facing distal surface 868 at the distal end of the distal portion 866 is configured to engage (and be in face-to-face contact with) the proximal surface 840 of the locking cap 806 (FIGS. 33A and 33B).

[0202] Figures 32A - 33B illustrate the operation of the sealing mechanism 800. As described above, the locking assembly of the sealing mechanism 800 is movable between an unlocked configuration (or position) (e.g., FIGS. 32A and 33A) and a locked configuration (or position) (e.g., FIGS. 32B and 33B). For example, the locking assembly can be formed by a pin 844 that extends through (and / or is coupled to) a channel 842 of the locking cap 806 and slides along a slot 862. The sealing housing 802 and the locking cap 806 rotate relative to each other to slide the pin 844 along the slot 862 between a first end 870 of the slot 862 (in the unlocked configuration as shown in FIG. 32A) and a second end 872 of the slot 862 (in the locked configuration as shown in FIG. 32B). In this way, the sealing mechanism 800 provides two distinct sealed / unsealed states, which can facilitate the use of the device.

[0203] In the unlocked configuration, the pin 844 is disposed at the first end 870 of the slot 862 (FIG. 32A), and the end wall 814 of the locking cap 806 and the distal end 850 of the sealing housing 802 are spaced apart from each other by a first gap 874 (FIG. 33A). In this position, the distal surface 868 of the seal 804 can abut or be disposed in proximity to the proximal surface 840 of the inner wall 812 of the locking cap 806, but the seal 804 is either in an uncompressed state (e.g., not compressed between the sealing housing 802 and the inner wall 812 of the locking cap 806) or in a state of low compression (not compressed against a catheter shaft extending therethrough). In this state, the inclined 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 inclined surface 853 and the seal 804 as shown in FIG. 33A). Thus, 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.

[0204] As an example, to move the sealing mechanism 800 from the unlocking configuration (Figs. 32A and 33A) to the locking configuration (Figs. 32B and 33B), the user holds the locking cap 806 stationary and rotates the sealing housing 802 such that the pin 844 moves along the slot 862 to the second end 872 of the slot 862 and the sealing housing 802 moves (axially) towards the locking cap 806.

[0205] In an alternative embodiment, the user can move the sealing mechanism 800 to the locking configuration by rotating the sealing housing 802 and the locking cap 806 relative to each other (in opposite rotational directions) or by rotating the locking cap 806 relative to the sealing housing 802.

[0206] When the sealing housing 802 moves near the locking cap 806, the seal 804 is pressed against the proximal surface 840 of the inner wall 812 of the locking cap 806 (thereby being axially compressed), and the seal 804 is forced radially outwards to fill the space between the inclined surface 853 and the seal 804 and also radially inwards towards the central longitudinal axis 805. Thus, when the shaft is disposed inside the sealing mechanism 800 (e.g., through the lumen 845 and the lumen of the tube 808), the axially compressed and radially expanded seal 804 is pressed against the outer surface of the shaft, thereby sealing against the shaft (and creating a fluid tight seal). As shown in Fig. 33B, in the locking configuration, the locking cap 806 and the sealing housing 802 are spaced apart by a second gap 876 (Fig. 33B) that is smaller than the first gap 874. Further, the second diameter 878 of the lumen of the seal 804 in the locking configuration is smaller than the first diameter 880 of the lumen of the seal 804 in the unlocking configuration.

[0207] In some embodiments, as shown in FIG. 34, 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 (extending distally from the distal end of the outer shaft 260) is inserted into the sealing housing 802, through the sealing housing 802, through the locking cap 806, and into the flexible tube 808 (FIG. 34). The locking cap 806 and the sealing housing 802 are then rotated relative to each other to move the sealing mechanism 800 to the sealing configuration and the locking configuration (as shown in FIG. 34). The aspiration tool 890 can be attached to the distal end of the flexible tube 808 (in the attachment of the tube 808 or an extension tube 892 extending between the flexible tube 808 and the aspiration tool 890). Aspiration (or vacuum) is then generated using the aspiration tool 890 (e.g., by pulling back on the plunger of a syringe), drawing fluid out of the sleeve shaft 280 through the catheter, thereby aspirating the sleeve shaft 280.

[0208] In some embodiments, instead of being used for aspiration (or suction), the aspiration tool 890 can be filled with fluid and then used to push (and flush) the fluid through the sleeve shaft 280 (or another catheter shaft disposed within the sealing mechanism 800).

[0209] As another way (or additionally), the end of the flexible tube 808 may be open (not attached to an aspiration tool), and fluid from a fluid source at the proximal end of the catheter (e.g., the flushing ports 210, 216, and / or 218 of the handle assembly 220, as shown in FIGS. 6, 9, and 10) can be pushed through the catheter, into the sleeve shaft 280, and through the sleeve shaft 280.

[0210] As a result, the sleeve shaft or an alternative catheter shaft inserted into the sealing mechanism 800 can be effectively flushed and / or aspirated prior to use of the catheter during a procedure. Delivery Techniques

[0211] To implant the prosthetic valve into the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of the delivery device. The prosthetic valve and the distal end 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 prosthetic valve is positioned inside the native aortic valve and radially expanded (e.g., by inflating a balloon, by actuating one or more actuators of the delivery device, or by deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Alternatively, the prosthetic valve can be implanted inside the native aortic valve in a transapical procedure, in which the prosthetic valve (on the distal end 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 prosthetic valve is positioned inside the native aortic valve. Alternatively, in a transaortic procedure, the prosthetic valve (on the distal end portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, such as by a partial J sternotomy or a right parasternal minithoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0212] To implant the prosthetic valve inside the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of the delivery device. The prosthetic valve and the distal end portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, the prosthetic valve can be implanted inside the native mitral valve in a transapical procedure, in which the prosthetic valve (on the distal end 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 prosthetic valve is positioned inside the native mitral valve.

[0213] To implant an artificial valve inside a native tricuspid valve, the artificial valve is attached in a radially compressed state along the distal end portion of a delivery device. The artificial valve and the distal end portion of the delivery device are inserted into the femoral vein, advanced into the inferior vena cava, and through the inferior vena cava into the right atrium, where the artificial valve is positioned inside the native tricuspid valve. A similar approach can be used to implant an artificial valve inside a native pulmonary valve or the pulmonary artery, except that the artificial valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0214] Another delivery approach is the transatrial approach, where the artificial valve (on the distal end portion of the delivery device) is inserted through a chest incision, which is formed through the atrial wall (the atrial wall of the right or left atrium) to access any of the native heart valves. Atrial delivery can also be performed intravascularly, for example, from a pulmonary vein. Yet another delivery approach is the transventricular approach, where the artificial valve (on the distal end portion of the delivery device) is inserted through a chest incision, which is formed through the wall of the right ventricle (typically at or near the base of the heart) to implant the artificial valve inside the native tricuspid valve or inside the native pulmonary valve or the pulmonary artery.

[0215] In all delivery approaches, the delivery device can be advanced over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery approaches are not intended to be limiting. Any of the artificial valves disclosed herein can be implanted using any of a variety of delivery procedures and any of a variety of delivery devices known in the art.

[0216] All systems, devices, apparatuses, etc. described in this specification can be sterilized (e.g., using heating / heat, pressure, steam, radiation, and / or chemicals, etc.) to ensure their safety for use with patients. All methods described in this specification can include sterilization of the related systems, devices, apparatuses, etc. as one of the steps of the method. Examples of sterilization by heating / heat include sterilization by steam and sterilization by autoclave. Examples of radiation used for sterilization include, but are not limited to, gamma rays, ultraviolet rays, 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 by hydrogen peroxide can be achieved, for example, using hydrogen peroxide plasma.

[0217] Additional examples related to the disclosed technology In view of the above-described implementations of the disclosed subject matter, this application discloses additional examples listed below. It should be noted that one or more features of one isolated example, or a combination thereof, and a combination of two or more features of that example with one or more features of one or more additional examples, are also further examples that fall within the disclosure of this application.

[0218] Example 1. An assembly, comprising: a catheter, 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 end portion of the first shaft, a second seal disposed around 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, wherein a distal end of the first shaft is disposed within the cavity, and the cavity is fluid-sealed by the first seal and the second seal such that fluid from the first lumen cannot exit the cavity.

[0219] Example 2. An assembly according to any of the embodiments described herein, particularly the assembly described in Example 1, wherein the distal end of the first lumen is blocked by a cavity, the second shaft has a second lumen, the distal end of the second lumen is open, and extends distally of the second seal.

[0220] Example 3. An assembly according to any of the embodiments described herein, particularly the assembly described in either Example 1 or Example 2, wherein the sealing mechanism comprises a step within the cavity that reduces the diameter of the cavity from a first larger diameter adjacent the first seal to a second smaller diameter adjacent the second seal, and the distal end of the first shaft is disposed relative to the step.

[0221] Example 4. An assembly according to any of the embodiments described herein, particularly the assembly described in Example 3, wherein the housing comprises a first seal housing that houses the first seal therein and a second seal housing that houses the second seal therein, and the step is formed on the inner surface of the second seal housing.

[0222] Example 5. An assembly according to any of the embodiments described herein, particularly the assembly described in any of Examples 1 to 4, wherein the first seal is disposed within the first seal housing of the sealing mechanism, the second seal is disposed within the second seal housing of the sealing mechanism, the first seal housing and the second seal housing are coupled to each other, and the cavity is defined by the inner surface of the first seal housing and the inner surface of the second seal housing.

[0223] Example 6. An assembly according to any of the embodiments described herein, particularly the assembly described in Example 5, wherein the first and second seal housings are joined together by one or more fasteners at overlapping interfacing surfaces.

[0224] Example 7. An assembly according to any of the embodiments described herein, particularly the assembly according to either Embodiment 5 or Embodiment 6, further comprising a first threaded member configured to engage a thread on an inner surface of a first sealing housing, rotate relative to the first sealing housing, and tighten a first seal around a first shaft.

[0225] Example 8. An assembly according to any of the embodiments described herein, particularly the assembly according to Embodiment 7, further comprising a rotatable first knob coupled to the first threaded member and configured to rotate the first threaded member so that the first threaded member moves distally relative to the first seal and tightens the first seal around the first shaft.

[0226] Example 9. An assembly according to any of the embodiments described herein, particularly the assembly according to either Embodiment 7 or Embodiment 8, further comprising a second threaded member configured to engage a thread on an inner surface of a second sealing housing, rotate relative to the second sealing housing, and tighten a second seal around a second shaft.

[0227] Example 10. An assembly according to any of the embodiments described herein, particularly the assembly according to Embodiment 9, further comprising a rotatable second knob coupled to the second threaded member and configured to rotate the second threaded member so that the second threaded member moves proximally relative to the second seal and tightens the second seal around the second shaft.

[0228] Example 11. An assembly according to any of the embodiments described herein, particularly the assembly according to either Embodiment 9 or Embodiment 10, wherein the first threaded member has a lumen with a diameter larger than that of the second threaded member.

[0229] Example 12. An assembly according to any of the embodiments described herein, particularly the assembly according to any one of Embodiments 1 to 3, wherein the first seal and the second seal are disposed within a housing and a cavity is defined by an inner surface of the housing.

[0230] Example 13. The sealing mechanism further comprises a threaded member that engages a thread on the inner surface of the housing at an end of the housing adjacent to the first seal, the threaded member being configured to rotate relative to the housing and tighten the first seal around the first shaft, of any of the embodiments described herein, particularly the assembly described in Example 12.

[0231] Example 14. The sealing mechanism comprises a rotatable knob disposed at an end of the threaded member, the rotatable knob being configured to move distally relative to the first seal and rotate the threaded member to tighten the first seal around the first shaft, of any of the embodiments described herein, particularly the assembly described in Example 13.

[0232] Example 15. The first seal is a compressible gasket and the second seal is an O-ring, of any of the embodiments described herein, particularly the assembly described in any one of Examples 12 - 14.

[0233] Example 16. The first seal is an O-ring and the second seal is an O-ring, of any of the embodiments described herein, particularly the assembly described in Example 12.

[0234] Example 17. The cavity is a first cavity and the housing further comprises a second cavity disposed distally of the second seal and a second step disposed within the second cavity that decreases the diameter of the second cavity from a larger first diameter adjacent to the second seal to a smaller second diameter, the distal end of the second shaft being disposed relative to the second step, of any of the embodiments described herein, particularly the assembly described in Example 12.

[0235] Example 18. The sealing mechanism further comprises a luer attachment portion disposed distally of the second cavity, the luer attachment portion being configured to receive a suction tool for creating a vacuum and sucking the second shaft, of any of the embodiments described herein, particularly the assembly described in Example 17.

[0236] Example 19. The catheter is a delivery device for a docking device, and the second shaft is configured to accommodate the docking device in a delivery configuration within the distal end portion of the second shaft, of any of the embodiments described herein, particularly the assembly according to any one of Embodiments 1 to 18.

[0237] Example 20. The docking device includes a coil and an expandable guard member disposed around a portion of the coil, of any of the embodiments described herein, particularly the assembly according to Example 19.

[0238] Example 21. A sealing mechanism comprising a first sealing housing having a first seal disposed therein, and a second sealing housing having a second seal disposed therein, wherein the proximal portion of the second sealing housing transitions between a first diameter proximal to the step and a second diameter distal to the step, and includes a second diameter smaller than the first diameter, the step being disposed proximal to the second seal, the second sealing housing, and a cavity defined within the distal portion of the first sealing housing and the proximal portion of the second sealing housing, between the first seal and the second seal.

[0239] Example 22. The first seal and the second seal are annular, and the inner diameter of the first seal is larger than the inner diameter of the second seal, of any of the embodiments described herein, particularly the sealing mechanism according to Example 21.

[0240] Example 23. The diameter of the cavity proximal to the step is larger than the inner diameter of the first seal, of any of the embodiments described herein, particularly the sealing mechanism according to Example 22.

[0241] Example 24. Further comprising a first threaded member having an external thread configured to engage an internal thread on the inner surface of the proximal portion of the first sealing housing, the first threaded member being configured to rotate and move axially relative to the first housing member, of any of the embodiments described herein, particularly the sealing mechanism according to any one of Embodiments 21 to 23.

[0242] Example 25. The first seal is disposed within the intermediate portion of the first sealing housing, and when the first threaded member rotates to tighten the first seal, it moves distally toward the first seal and is configured to press against the first seal, of any of the embodiments described herein, particularly the sealing mechanism according to Example 24.

[0243] Example 26. Further comprising a first rotatable knob coupled to the proximal end of the first threaded member, the first rotatable knob being disposed around the proximal portion of the first sealing housing, of any of the embodiments described herein, particularly the sealing mechanism according to Example 25.

[0244] Example 27. Further comprising a second threaded member having an external thread configured to engage an internal thread on the inner surface of the distal portion of the second sealing housing, the second threaded member being configured to rotate and move axially relative to the second housing member, of any of the embodiments described herein, particularly the sealing mechanism according to any one of Embodiments 24 to 26.

[0245] Example 28. The second seal is disposed within the intermediate portion of the second sealing housing, and when the second threaded member rotates to tighten the second seal, it moves proximally toward the second seal and is configured to press against the second seal, of any of the embodiments described herein, particularly the sealing mechanism according to Example 27.

[0246] Example 29. Further comprising a second rotatable knob coupled to the distal end of the second threaded member, the second rotatable knob being disposed around the distal portion of the second sealing housing, of any of the embodiments described herein, particularly the sealing mechanism according to Example 28.

[0247] Example 30. The first threaded member and the inner surface of the first seal define a first lumen having a first diameter and configured to receive a first shaft, and the second threaded member and the inner surface of the second seal define a second lumen having a second diameter and configured to receive a second shaft, with the second diameter being smaller than the first diameter. The sealing mechanism according to any one of the examples described herein, particularly any one of Examples 27 to 29.

[0248] Example 31. The sealing mechanism according to any one of the examples described herein, particularly any one of Examples 21 to 30, wherein a first sealing housing and a second sealing housing are joined together by an overlapping interface surface.

[0249] Example 32. The sealing mechanism according to any one of the examples described herein, particularly the sealing mechanism according to Example 31, wherein the step is disposed adjacent to the overlapping interface surface.

[0250] Example 33. A method of flushing a catheter, comprising attaching a first seal of a sealing mechanism to a distal end portion of a first shaft of the catheter, and attaching a second seal of the sealing mechanism to a distal end portion of a second shaft of the catheter that extends through the first shaft, wherein the distal end portion of the second shaft extends distally to the distal end of the first shaft, and flowing fluid through the catheter such that fluid flows out only from a second lumen defined by the second shaft and is blocked from flowing out from a first lumen defined between the outer surface of the second shaft and the inner surface of the first shaft.

[0251] Example 34. The method according to any one of the examples described herein, particularly the method according to Example 33, wherein attaching the first seal to the first shaft includes extending a distal end portion of the first shaft into a cavity of the sealing mechanism defined by a wall of the housing of the sealing mechanism between the first seal and the second seal through the first seal within the lumen of the sealing mechanism.

[0252] Example 35. Extending the distal end portion of the first shaft into the cavity until it reaches the step defined by the housing, including extending the distal end of the first shaft into the cavity, any example described herein, particularly the method described in Example 34.

[0253] Example 36. Attaching the second seal to the second shaft, including extending the distal end portion of the second shaft through the distal end of the first shaft and to the distal end and through the second seal, any example described herein, particularly the method described in any one of Examples 33 - 35.

[0254] Example 37. Attaching the first seal and attaching the second seal, including tightening the first seal around the first shaft and the second seal around the second shaft such that the distal end of the first shaft is blocked, any example described herein, particularly the method described in any one of Examples 33 - 36.

[0255] Example 38. Attaching the first seal to the first shaft, including tightening the first seal around the first shaft by rotating the first knob of the sealing mechanism, which causes the first threaded member disposed proximal to the first seal to move axially towards and against the first seal, any example described herein, particularly the method described in any one of Examples 33 - 37.

[0256] Example 39. Attaching the second seal to the second shaft, including tightening the second seal around the second shaft by rotating the second knob of the sealing mechanism, which causes the second threaded member disposed distal to the second seal to move axially towards and against the second seal, any example described herein, particularly the method described in any one of Examples 33 - 38.

[0257] Example 40. The catheter is a delivery device for a docking device, and the second shaft is configured to accommodate the docking device in a delivery configuration within the distal end portion of the second shaft, according to any of the embodiments described herein, particularly the method according to any one of Embodiments 33 to 39.

[0258] Example 41. The docking device comprises a coil and an expandable guard member disposed around a portion of the coil, and flowing fluid through the catheter such that the fluid flows out only from the second lumen and flowing fluid through and around the guard member to degas the guard member, according to any of the embodiments described herein, particularly the method according to Example 40.

[0259] Example 42. Flowing fluid through the catheter such that the fluid flows out only from the second lumen defined by the second shaft and is blocked from flowing out of the first lumen, including flushing the fluid through the catheter using a positive pressure applied to the catheter, according to any of the embodiments described herein, particularly the method according to any one of Embodiments 33 to 41.

[0260] Example 43. Flowing fluid through the catheter such that the fluid flows out only from the second lumen defined by the second shaft and is blocked from flowing out of the first lumen, including sucking the fluid through the catheter using a negative pressure applied to the distal end of the second shaft by a suction tool, according to any of the embodiments described herein, particularly the method according to any one of Embodiments 33 to 41.

[0261] Example 44. Flowing fluid through the catheter such that the fluid flows out only from the second lumen defined by the second shaft and is blocked from flowing out of the first lumen, including flushing and sucking the fluid through the catheter using a combination of negative pressure and positive pressure applied to the catheter, according to any of the embodiments described herein, particularly the method according to any one of Embodiments 33 to 41.

[0262] Example 45. A method of flushing a catheter, comprising extending a distal end portion of a first shaft of the catheter through a first seal disposed within a first sealing housing of a sealing mechanism and into a cavity disposed within the first sealing housing and a second sealing housing; extending a distal end portion of a second shaft of the catheter through the distal end of the first shaft and through a second seal disposed within the second sealing housing; tightening the first seal around the distal end portion of the first shaft and tightening the second seal around the distal end portion of the second shaft; and flowing fluid through the catheter such that fluid flows out only from a first lumen defined by the second shaft and is blocked from flowing out from a second lumen defined between an outer surface of the second shaft and an inner surface of the first shaft.

[0263] Example 46. Tightening the first seal around the first shaft and tightening the second seal around the second shaft, including fluid-sealing the cavity such that fluid from the first lumen cannot exit the cavity and causes occlusion of the distal end of the first shaft, according to any of the examples described herein, particularly the method described in Example 45.

[0264] Example 47. Extending the distal end portion of the first shaft into the cavity, including extending the distal end of the first shaft into the cavity until it contacts a stop disposed within the cavity, according to any of the examples described herein, particularly the method described in either Example 45 or Example 46.

[0265] Example 48. The method according to any of the examples described herein, particularly the method described in Example 47, wherein the stop is defined by an annular step disposed on an inner surface of the second sealing housing proximal to the second seal.

[0266] Example 49. The method according to any one of the embodiments described herein, particularly any one of embodiments 45 to 48, including extending the distal end portion of the second shaft through the distal end portion of the first shaft, distally of the distal end of the first shaft, and through the second seal, such that the distal end portion of the second shaft extends distally of the distal end of the second seal housing.

[0267] Example 50. The method according to any one of the embodiments described herein, particularly any one of embodiments 45 to 49, including tightening the first seal around the distal end portion of the first shaft by rotating a first threaded member engaging the threads of the first seal housing relative to the first seal housing, causing the first threaded member to move axially towards and against the first seal by rotating a first knob of a sealing mechanism.

[0268] Example 51. The method according to any one of the embodiments described herein, particularly any one of embodiments 45 to 50, including tightening the second seal around the distal end portion of the second shaft by rotating a second threaded member engaging the threads of the second seal housing relative to the second seal housing, causing the second threaded member to move axially towards and against the second seal by rotating a second knob of a sealing mechanism.

[0269] Example 52. The method according to any one of the embodiments described herein, particularly any one of embodiments 45 to 51, wherein the catheter is a delivery device for a docking device, and the second shaft is configured to accommodate the docking device in a delivery configuration within the distal end portion of the second shaft.

[0270] Example 53. The docking device comprises a coil and an expandable guard member disposed around a portion of the coil. Flowing fluid through the catheter such that the fluid flows out only from the first lumen includes flowing fluid through and around the guard member to degas the guard member, according to any example described herein, particularly the method described in Example 52.

[0271] Example 54. An assembly comprising a delivery device having 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 second lumen is defined by the second shaft, the second shaft; a transplantable medical device disposed within a distal end portion of the second shaft in a delivery configuration; and a sealing mechanism including a housing, a first seal disposed within the housing and around a distal end portion of the first shaft, a second seal disposed within the housing and around a distal end portion of the second shaft, and a cavity defined within the housing between the first seal and the second seal, wherein a distal end portion of the first shaft is disposed within the cavity, a distal end of the second shaft extends distal to the distal end of the first shaft and the second seal, and the cavity is fluid-sealed by the first seal and the second seal. An assembly comprising a delivery device having a sealing mechanism.

[0272] Example 55. Any example described herein, particularly the assembly of Example 54, wherein the first lumen and the second lumen are fluidly coupled to each other downstream of a flushing port of the delivery device and upstream of a distal end of the first shaft.

[0273] Example 56. Any example described herein, particularly the assembly according to either Example 54 or Example 55, wherein a distal end of the first lumen is blocked by the cavity and a distal end of the second lumen defined at a distal end of the second shaft is open.

[0274] Example 57. An assembly disposed within a cavity, the housing having a step within the cavity that decreases the diameter of the cavity from a larger first diameter adjacent a first seal to a smaller second diameter adjacent a second seal, the distal end of the first shaft being disposed relative to the step, of any of the embodiments described herein, particularly any one of embodiments 54 to 56.

[0275] Example 58. An assembly, the housing comprising a first seal housing that houses a first seal therein and a second seal housing that houses a second seal therein, the step being formed on an inner surface of the second seal housing, of any of the embodiments described herein, particularly the assembly of embodiment 57.

[0276] Example 59. An assembly, the first seal housing and the second seal housing being joined together by overlapping interface surfaces by one or more fasteners, of any of the embodiments described herein, particularly the assembly of embodiment 58.

[0277] Example 60. An assembly described herein, particularly the assembly of either embodiment 58 or embodiment 59, further comprising a first threaded member configured to engage a thread on an inner surface of the first seal housing, rotate relative to the first seal housing, and tighten the first seal around the first shaft.

[0278] Example 61. An assembly described herein, particularly the assembly of embodiment 60, comprising a rotatable first knob coupled to the first threaded member and configured to rotate the first threaded member so that the first threaded member moves distally relative to the first seal and tightens the first seal around the first shaft.

[0279] Example 62. An assembly according to any of the examples described herein, particularly the assembly described in either Example 60 or Example 61, further comprising a second threaded member configured to engage a thread on an inner surface of a second sealing housing, rotate relative to the second sealing housing, and tighten a second seal around a second shaft.

[0280] Example 63. An assembly according to any of the examples described herein, particularly the assembly described in Example 62, further comprising a rotatable second knob coupled to the second threaded member and configured to rotate the second threaded member so that the second threaded member moves proximally relative to the second seal and tightens the second seal around the second shaft.

[0281] Example 64. An assembly according to any of the examples herein, particularly the assembly described in either Example 62 or Example 63, wherein the first threaded member has a lumen with a diameter larger than that of the second threaded member.

[0282] Example 65. An assembly according to any of the examples described herein, particularly the assembly described in any one of Examples 54 - 57, comprising a rotatable knob and a threaded member extending distally from the rotatable knob, wherein one or more threads on the threaded member engage threads on an inner surface of a housing disposed proximally to a first seal, and the rotatable knob is configured to rotate the threaded member relative to the housing so that the threaded member moves distally relative to the first seal and tightens the first seal around a first shaft.

[0283] Example 66. An assembly according to any of the examples described herein, particularly the assembly described in Example 65, wherein the second seal is an O - ring.

[0284] Example 67. An assembly according to any of the examples described herein, particularly the assembly described in any one of Examples 54 - 57, wherein the first seal and the second seal are O - rings.

[0285] Example 68. A transplantable medical device is a docking device configured to expand from a delivery configuration to a coiled configuration after being deployed from a delivery device, and the docking device in the coiled configuration is an assembly according to any of the embodiments described herein, particularly any one of embodiments 54 to 67, configured to receive an artificial heart valve.

[0286] Example 69. A docking device is an assembly according to any of the embodiments described herein, particularly the assembly described in Example 68, comprising a coil and an expandable guard member disposed around a portion of the coil.

[0287] Example 70. A sealing mechanism comprising a housing having a cavity and a step disposed within the cavity that decreases the diameter of the cavity from a larger diameter portion of the cavity to a smaller diameter portion of the cavity, a first seal adjacent to the larger diameter portion of the cavity and disposed proximally within the housing, and a second seal adjacent to the smaller diameter portion of the cavity and disposed distally within the housing.

[0288] Example 71. A sealing mechanism according to any of the embodiments described herein, particularly the sealing mechanism described in Example 70, wherein the first seal and the second seal are annular and the inner diameter of the first seal is larger than the inner diameter of the second seal.

[0289] Example 72. A sealing mechanism according to any of the embodiments described herein, particularly the sealing mechanism described in Example 70 or Example 71, further comprising a threaded member that engages a thread on the inner surface of the housing at an end of the housing adjacent to the first seal, and the threaded member rotates relative to the housing and moves distally towards the first seal and is configured to press against the first seal as it rotates to tighten the first seal.

[0290] Example 73. The sealing mechanism includes a rotatable knob disposed at an end of a threaded member, and the rotatable knob is configured to rotate the threaded member, for any of the embodiments described herein, particularly the sealing mechanism described in Example 72.

[0291] Example 74. The threaded members are discontinuous from each other and include a plurality of external threads spaced apart from each other around the outer surface of the threaded member, and the plurality of external threads are configured to engage and slide along the threads on the inner surface of the front k hour of the housing, for any of the embodiments described herein, particularly the sealing mechanism described in Example 72 or Example 73.

[0292] Example 75. The threaded member includes one or more locking elements configured to snap-engage with the threads on the inner surface of the housing and maintain the threaded member connected to the housing, for any of the embodiments described herein, particularly the sealing mechanism described in any one of Examples 72 to 74.

[0293] Example 76. The first seal is a compressible gasket and the second seal is an O-ring, for any of the embodiments described herein, particularly the sealing mechanism described in any one of Examples 70 to 75.

[0294] Example 77. The first seal is an O-ring and the second seal is an O-ring, for any of the embodiments described herein, particularly the sealing mechanism described in either Example 70 or Example 71.

[0295] Example 78. The cavity is the first cavity, the step is the first step, and the housing further includes a second cavity disposed distally of the second seal and a second step disposed within the second cavity that reduces the diameter of the second cavity from a larger first diameter adjacent to the second seal to a smaller second diameter, for any of the embodiments described herein, particularly the sealing mechanism described in any one of Examples 70 to 77.

[0296] Example 79. The sealing mechanism further comprises a luer attachment portion disposed distally of the second cavity, the luer attachment portion being configured to receive a suction tool for generating a vacuum within the second cavity, any of the embodiments described herein, particularly the sealing mechanism described in Example 78.

[0297] Example 80. An assembly comprising a catheter having a first shaft and a second shaft extending through the first shaft, the distal end portion of the second shaft being extendable distally to the distal end of the first shaft, and a sealing mechanism comprising a first member and a second member pivotable relative to each other between an open configuration and a closed configuration, the first and second members receiving the second shaft therebetween and being configured to seal around the second shaft in the closed configuration, and a tube fluidly connected to the lumen defined by the first and second members, the end of the tube comprising an attachment portion configured to receive a suction tool for aspirating fluid through the second shaft.

[0298] Example 81. The sealing mechanism further comprises a housing, and the first and second members are pivotable relative to each other via a pivot joint connected to the housing, any of the embodiments described herein, particularly the assembly described in Example 80.

[0299] Example 82. The sealing mechanism comprises a slidable knob axially slidable from a first position around a portion of the outer surface of the housing to a second position around the first and second members when the first and second members are in the closed configuration, any of the embodiments described herein, particularly the assembly described in Example 81.

[0300] Example 83. The first and second members comprise a compressible pad configured to seal around the second shaft when the first and second members are in the closed configuration, any of the embodiments described herein, particularly the assembly described in any one of Examples 80 - 82.

[0301] Example 84. The catheter is a delivery device for a docking device, and the second shaft is configured to accommodate the docking device in a delivery configuration within a distal end portion of the second shaft, of any of the embodiments described herein, particularly the assembly according to any one of Examples 80 to 83.

[0302] Example 85. The docking device includes a coil and an expandable guard member disposed around a portion of the coil, of any of the embodiments described herein, particularly the assembly according to Example 84.

[0303] Example 86. An assembly comprising a catheter having a first shaft and a second shaft extending through the first shaft, wherein a distal end portion of the second shaft is extendable distally to the distal end of the first shaft, the catheter; a sealing mechanism having a seal disposed around a distal end portion of the second shaft and a sealing housing having a cylindrical body portion, an inner surface of the cylindrical body portion defining a first cavity, the seal being disposed within the first cavity, the sealing housing; and a locking member having an annular outer wall and an annular inner wall and having a second cavity defined radially therebetween, the cylindrical body portion extending into and being rotatable within the second cavity, the sealing housing and the locking member being configured to receive the second shaft therethrough, the sealing housing and the locking member being rotatable relative to each other between an unlocked configuration and a locked configuration, in the locked configuration, the seal being axially compressed between the sealing housing and the locking member and radially compressed around the second shaft, the locking member.

[0304] Example 87. In the unlocked configuration, the seal is axially disposed between a portion of the inner surface of the cylindrical body portion defining the first cavity and a surface axially facing the inner wall of the locking member without being radially compressed around the second shaft, of any of the embodiments described herein, particularly the assembly according to Example 86.

[0305] Example 88. In the locking configuration, the seal is axially compressed between a portion of the inner surface of the cylindrical body portion and the axially facing surface of the inner wall of the locking member, and the diameter of the inner cavity of the seal is radially compressed around the second shaft so as to be smaller in the locking configuration than in the unlocking configuration, of any of the embodiments described herein, particularly the assembly described in Example 87.

[0306] Example 89. Of any of the embodiments described herein, particularly the assembly described in either Example 87 or Example 88, wherein a portion of the inner surface of the cylindrical body portion is an inclined surface angled at a non-zero angle with respect to the central longitudinal axis of the sealing mechanism.

[0307] Example 90. The sealing housing comprises one or more slots extending along and through the cylindrical body portion, and further comprises one or more pins coupled to the inner wall of the locking member, each pin of the one or more pins being configured to extend through and slide along a corresponding slot of the one or more slots, of any of the embodiments described herein, particularly the assembly described in any one of Examples 86 - 89.

[0308] Example 91. In the unlocking configuration, each pin is disposed at a first end of the corresponding slot, and in the locking configuration, each pin is disposed at a second, opposite end of the corresponding slot, of any of the embodiments described herein, particularly the assembly described in Example 90.

[0309] Example 92. The sealing housing and the base locking member are disposed closer together axially in the locking configuration than in the unlocking configuration, of any of the embodiments described herein, particularly the assembly described in any one of Examples 86 - 91.

[0310] Example 93. The outer wall and the inner wall of the locking member extend proximally from the end wall that defines the distal end of the locking member. In the unlocking configuration, there is a first gap in the second cavity between the end wall and the distal end of the cylindrical body portion of the sealing housing. In the locking configuration, there is a second gap in the second cavity between the end wall and the distal end of the cylindrical body portion. The second gap is smaller than the first gap. An assembly according to any of the examples described herein, particularly any one of Examples 86-92.

[0311] Example 94. An assembly according to any of the examples described herein, particularly any one of Examples 86-93, further comprising a tube extending distally from the locking member.

[0312] Example 95. An assembly according to any of the examples described herein, particularly the assembly according to Example 94, wherein the inner surface of the inner wall defines the inner cavity of the locking member and the tube is disposed within a first inner cavity portion of the inner cavity.

[0313] Example 96. An assembly according to any of the examples described herein, particularly the assembly according to Example 95, wherein the inner wall extends radially towards the central longitudinal axis of the sealing mechanism and comprises an annular protrusion that separates the first inner cavity portion from a second inner cavity portion of the inner cavity configured to receive a second shaft therethrough.

[0314] Example 97. An assembly according to any of the examples described herein, particularly any one of Examples 94-96, wherein the distal end of the tube comprises a mounting portion configured to receive a suction tool for sucking fluid through the second shaft.

[0315] Example 98. A sealing mechanism, comprising a sealing housing having a body portion, an inner surface of the body portion defining a first cavity, the body portion comprising at least one bent slot extending through the body portion from an outer surface to an inner surface thereof, a seal disposed within a portion of the first cavity of the sealing housing, the seal having a lumen configured to receive a shaft assembly of an artificial implant delivery device, a locking member having an outer wall and an inner wall with a second cavity defined radially therebetween, the body portion of the sealing housing extending into the second cavity of the locking member and being rotatable within the second cavity of the locking member, at least one pin coupled to the inner wall and extending into and configured to slide along at least one of the bent slots, the sealing housing and the locking member being rotatable relative to each other between an unlocked configuration and a locked configuration, in the unlocked configuration, at least one pin being disposed at a first end of at least one of the bent slots, and in the locked configuration, at least one pin being disposed at an opposite second end of at least one of the bent slots, the seal being axially compressed between the sealing housing and the locking member such that a diameter of the lumen of the seal decreases in the locked configuration relative to the unlocked configuration.

[0316] Example 99. The sealing mechanism according to any of the examples described herein, particularly Example 98, wherein in the locked configuration, the sealing housing and the locking member are spaced closer to each other than in the unlocked configuration.

[0317] Example 100. The sealing mechanism according to any of the examples described herein, particularly either Example 98 or Example 99, wherein at least one of the bent slots has a circumferentially extending portion at a second end of the bent slot and an axially extending portion at a first end of the bent slot, the first end of the bent slot being disposed closer to a distal end of the sealing housing than the second end of the bent slot, and the distal end of the sealing housing being disposed within the second cavity.

[0318] Example 101. In the unlocking configuration, the seal is axially disposed between a portion of the inner surface of the cylindrical body portion that defines the first cavity and the axially facing surface of the inner wall of the locking member, and the axially facing surface and the portion of the inner surface are not axially compressed, and the axially facing surface of the inner wall defines at least partially the proximal end of the locking member. The sealing mechanism according to any one of the embodiments described herein, particularly any one of embodiments 98 to 100.

[0319] Example 102. In the locking configuration, the seal is axially compressed between a 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. The sealing mechanism according to any one of the embodiments described herein, particularly the sealing mechanism described in Example 101.

[0320] Example 103. A portion of the inner surface of the cylindrical body portion is an inclined surface angled at a non-zero angle with respect to the central longitudinal axis of the sealing mechanism, and in the locking configuration, the seal is pressed against the inclined surface. The sealing mechanism according to any one of the embodiments described herein, particularly the sealing mechanism described in either Example 101 or Example 102.

[0321] Example 104. At least one bent slot comprises two bent slots circumferentially spaced from each other around the sealing housing, and at least one pin is received in each of two channels that extend radially through the inner wall of the locking member. The sealing mechanism according to any one of the embodiments described herein, particularly the sealing mechanism described in any one of embodiments 98 to 103.

[0322] Example 105. The inner surface of the cylindrical body portion at the proximal end of the sealing housing defines a lumen configured to receive a catheter shaft therethrough, the lumen opening into a first cavity that extends distally from the lumen of the sealing housing, and in the locking configuration, the diameter of the lumen of the seal decreases to seal around the catheter shaft. The sealing mechanism according to any one of the embodiments described herein, particularly the sealing mechanism described in any one of embodiments 98 to 104.

[0323] Example 106. A sealing mechanism according to any of the examples described herein, particularly any one of Examples 98 to 105, further comprising a flexible tube extending distally from the locking member.

[0324] Example 107. A sealing mechanism according to any of the examples described herein, particularly the sealing mechanism according to Example 106, wherein the inner surface of the inner wall defines the lumen of the locking member, and the flexible tube is disposed within a first lumen portion of the lumen.

[0325] Example 108. A sealing mechanism according to any of the examples described herein, particularly the sealing mechanism according to Example 107, wherein the inner wall comprises an annular protrusion extending radially toward the central longitudinal axis of the sealing mechanism and separating the first lumen portion from a second lumen portion of the lumen, and the second lumen portion and the flexible tube are configured to receive a catheter shaft therethrough.

[0326] Example 109. A sealing mechanism according to any of the examples described herein, particularly any one of Examples 106 to 108, comprising an attachment portion configured to receive a suction tool for sucking fluid through a catheter shaft extending through the sealing mechanism at the distal end of the flexible tube.

[0327] Example 110. A sealing mechanism according to any of the examples described herein, particularly any one of Examples 98 to 109, wherein at least one pin of the sealing housing and at least one bent slot are configured such that the sealing housing and the locking member rotate less than 360 degrees relative to each other between an unlocked configuration and a locked configuration.

[0328] Example 111. A sealing mechanism according to any of the examples described herein, particularly any one of Examples 98 to 109, wherein at least one pin of the sealing housing and at least one bent slot are configured such that the sealing housing and the locking member rotate between 45 and 225 degrees relative to each other between an unlocked configuration and a locked configuration.

[0329] Example 112. The at least one pin of the sealing housing and the at least one bent slot are configured such that the sealing housing and the locking member rotate relative to each other by 70 to 200 degrees between the unlocking configuration and the locking configuration, according to any of the embodiments described herein, particularly the sealing mechanism according to any one of Embodiments 98 to 109.

[0330] Example 113. The at least one pin of the sealing housing and the at least one bent slot are configured such that the sealing housing and the locking member rotate relative to each other by 170 to 190 degrees between the unlocking configuration and the locking configuration, according to any of the embodiments described herein, particularly the sealing mechanism according to any one of Embodiments 98 to 109.

[0331] Example 114. The at least one pin of the sealing housing and the at least one bent slot are configured such that the sealing housing and the locking member rotate relative to each other by 80 to 100 degrees between the unlocking configuration and the locking configuration, according to any of the embodiments described herein, particularly the sealing mechanism according to any one of Embodiments 98 to 109.

[0332] Example 115. A method comprising sterilizing an artificial heart valve, device, and / or assembly of any embodiment.

[0333] Unless otherwise stated, the features described herein for any example can be combined with the other features described for any one or more other examples. For example, any one or more features of one delivery device can be combined with any one or more features of another delivery device.

[0334] Considering the many possible aspects to which the principles of the present disclosure can be applied, it will be appreciated that the illustrated configurations are illustrative of examples of the disclosed technology and should not be construed as limiting the scope of the present disclosure or the scope of the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

1. It is an assembly, It is a catheter, The first shaft and A catheter comprising: a second shaft extending through the first shaft, the second shaft having a first lumen defined between the inner surface of the first shaft and the outer surface of the second shaft; A sealing mechanism, A first seal is positioned around the distal end portion of the first shaft, A second seal is disposed around a portion of the second shaft that extends distally to the first shaft, An assembly comprising a sealing mechanism, the sealing mechanism comprising a cavity 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 the cavity is fluid-sealed by the first seal and the second seal so that fluid from the first lumen cannot escape the cavity.

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

3. The assembly according to claim 1, wherein the sealing mechanism comprises a step within the cavity, the step reducing the diameter of the cavity from a larger first diameter adjacent to the first sealing to a smaller second diameter adjacent to the second sealing, and the distal end of the first shaft is positioned relative to the step.

4. The assembly according to claim 3, wherein the housing comprises a first sealing housing therein that houses the first sealing and a second sealing housing therein that houses the second sealing, and the step is formed on the inner surface of the second sealing housing.

5. The assembly according to claim 1, wherein the first seal is located within a first sealing housing of the sealing mechanism, the second seal is located within a second sealing housing of the sealing mechanism, the first sealing housing and the second sealing housing are coupled to each other, and the cavity is defined by the inner surface of the first sealing housing and the inner surface of the second sealing housing.

6. The assembly according to claim 5, further comprising a first threaded member configured to engage with threads on the inner surface of the first sealing housing, rotate relative to the first sealing housing, and tighten the first seal around the first shaft.

7. The assembly according to claim 6, wherein the sealing mechanism comprises a rotatable first knob coupled to the first threaded member, the first threaded member being rotated so as to move distally to the first seal and tighten the first seal around the first shaft.

8. The assembly according to claim 6, further comprising a second threaded member configured to engage with threads on the inner surface of the second sealing housing, rotate relative to the second sealing housing, and tighten the second seal around the second shaft.

9. The assembly according to claim 8, wherein the sealing mechanism comprises a rotatable second knob connected to the second threaded member, the second threaded member being rotated so that it moves proximal to the second seal and tightens the second seal around the second shaft.

10. The assembly according to claim 8, wherein the first threaded member has a bore with a larger diameter than the second threaded member.

11. The assembly according to claim 1, wherein the first seal and the second seal are arranged within the housing, and the cavity is defined by the inner surface of the housing.

12. The assembly according to claim 11, wherein the sealing mechanism further comprises a threaded member that engages with threads on the inner surface of the housing at an end of the housing adjacent to the first seal, the threaded member being configured to rotate relative to the housing and tighten the first seal around the first shaft.

13. The assembly according to claim 12, wherein the sealing mechanism comprises a rotatable knob positioned at the end of the threaded member, the rotatable knob is configured to rotate the threaded member so that it moves distally to the first seal and tightens the first seal around the first shaft.

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

15. The assembly according to claim 11, wherein the first seal is an O-ring and the second seal is an O-ring.

16. The assembly according to claim 1, wherein the catheter is a delivery device for a docking device, and the second shaft is configured to house the docking device in a delivery configuration within the distal end portion of the second shaft.

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