CN220877491U

CN220877491U - Fluid assembly and sealing mechanism

Info

Publication number: CN220877491U
Application number: CN202321526734.4U
Authority: CN
Inventors: K·K·雷德; K·甘茨; D·S·帕特尔
Original assignee: Edwards Lifesciences Corp
Current assignee: Edwards Lifesciences Corp
Priority date: 2022-06-16
Filing date: 2023-06-15
Publication date: 2024-05-03
Anticipated expiration: 2033-06-15
Also published as: CN117244152A

Abstract

The application provides a fluid assembly and a sealing mechanism. Devices and methods for selectively directing fluid flow through a lumen of a catheter for effective flushing and/or degassing of a designated lumen of the catheter are disclosed. As one example, an assembly includes a catheter including a first shaft and a second shaft extending through the first shaft. The assembly also includes a sealing mechanism including a first seal disposed about a distal portion of the first shaft, a second seal disposed about a portion of the second shaft extending distally of the first shaft, and a cavity disposed within a housing of the sealing mechanism between the first seal and the second seal. The distal end of the first shaft is disposed within the lumen, and the lumen is fluidly sealed by the first seal and the second seal such that fluid from the first lumen of the first shaft cannot leave the lumen.

Description

Fluid assembly and sealing mechanism

Cross reference to related applications

The present application claims the benefit of U.S. provisional application Ser. No. 63/366,517, filed on month 16 of 2022, 63/368,453, filed on month 7 of 2022, and 63/371,463, filed on month 8 of 2022, each of which is incorporated herein by reference in its entirety.

Technical Field

The present disclosure relates to a delivery apparatus for a docking device configured to secure a prosthetic valve at a native heart valve.

Background

The human heart may suffer from various valve diseases. These valve diseases can lead to significant dysfunction of the heart and ultimately require repair of the native valve or replacement of the native valve with a prosthetic valve. There are many known prosthetic devices (e.g., stents) and prosthetic valves, and many known methods of implanting these devices and valves into the human body. Percutaneous and minimally invasive surgical methods are used in various procedures to deliver artificial medical devices to locations within the body that are not readily accessible by surgery or where access without surgery is desired. In one particular example, a prosthetic heart valve can be mounted on the distal end of the delivery device in a crimped state and advanced through the vasculature of the patient (e.g., through the femoral artery and aorta) until the prosthetic valve reaches an implantation site in the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies a expanding force to the prosthetic valve, or by deploying the prosthetic valve from a sheath of a delivery device so that the prosthetic valve can self-expand to its functional size.

The prosthetic heart valve may be suitably sized for placement within a number of native aortic valves. However, the native mitral and tricuspid valves may have different geometries than typical aortic valves. Mitral and tricuspid valve anatomy also varies significantly from person to person. Accordingly, it may be difficult to properly size and shape a prosthetic heart valve for various patients. Furthermore, when dealing with valve insufficiency, the surrounding tissue (e.g., the native annulus) at the target implantation site may not be strong enough to hold certain types of valves in place as desired.

In some examples, the docking device may be implanted first within the native valve, and may be configured to receive the prosthetic heart valve and secure (e.g., anchor) the prosthetic heart valve in a desired location within the native valve. For example, the docking device may form a more rounded and/or stable anchoring site at the native annulus, into which the prosthetic heart valve may be expanded and implanted. The transcatheter delivery device may be used to deliver the docking device to the implantation site. The docking means may be arranged within the delivery device coaxially with the additional components of the delivery device. Multiple lumens may be provided between the coaxial components of the delivery device, and irrigation fluid may be provided to the lumens for irrigation and degassing of the lumens prior to and during the implantation procedure. For example, the docking device may be covered by a quill within an outer shaft of the delivery apparatus, and a lumen may be formed between the outer shaft and the quill and between the quill and the docking device. In some cases, it may be desirable to deaerate the sleeve shaft lumen in order to remove air surrounding the docking device.

Disclosure of utility model

Described herein are docking devices, prosthetic heart valves, delivery apparatuses, and methods for implanting a docking device and a prosthetic heart valve within a docking device. Examples of flow mechanisms or assemblies that may be used to selectively direct fluid flow through a lumen of a catheter for efficient flushing and/or deaeration of designated lumens and/or components of a delivery device are also described herein. In some examples, the catheter is part of a delivery device that includes a docking device disposed within an outer shaft of the delivery device and a quill extending through the outer shaft and covering the docking device. The docking device may be configured to receive the prosthetic heart valve after delivery to the implantation site using the delivery apparatus. The flow mechanisms or assemblies described herein may be coupled with a distal portion of a delivery device and configured to direct fluid flow through a lumen of a quill, thereby degassing the docking device prior to an implantation procedure.

The sealing mechanism may include a housing including a cavity and a step disposed within the cavity that reduces a diameter of the cavity from a larger diameter portion of the cavity to a smaller diameter portion of the cavity.

In some examples, the sealing mechanism may further include a first seal disposed within the housing adjacent and proximal to the larger diameter portion of the cavity, and a second seal disposed within the housing adjacent and distal to the smaller diameter portion of the cavity.

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

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

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

In some examples, the first seal and the second seal are annular, and an inner diameter of the first seal is greater than an inner diameter of the second seal.

In some examples, the sealing mechanism includes a first seal housing within which the first seal is disposed and a second seal housing within which the second seal is disposed. The proximal portion of the second seal 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 being disposed proximal to the second seal. The seal mechanism also includes a cavity defined within the distal portion of the first seal housing and the proximal portion of the second seal housing between the first seal and the second seal.

In some examples, the sealing mechanism includes a housing including a cavity and a step disposed within the cavity that reduces a diameter of the cavity from a larger diameter portion of the cavity to a smaller diameter portion of the cavity. The sealing mechanism further includes a first seal disposed within the housing adjacent and proximal to the larger diameter portion of the cavity and a second seal disposed within the housing adjacent and distal to the smaller diameter portion of the cavity.

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

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

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

The assembly may include a catheter or delivery device and a sealing mechanism.

In some examples, the catheter may include a first shaft and a second shaft extending through the first shaft.

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

In some examples, the sealing mechanism may include a first seal disposed about a distal portion of the first shaft, a second seal disposed about a portion of the second shaft extending distally of the first shaft, and a cavity disposed within a housing of the sealing mechanism between the first seal and the second seal.

In some examples, the distal end of the first shaft is disposed within a lumen, and the lumen is fluidly sealed by a first seal and a second seal.

In some examples, the assembly may further include an implantable medical device disposed within the distal portion of the second shaft in the delivery configuration.

In some examples, the sealing mechanism may include first and second members pivotable relative to one another between an open configuration and a closed configuration, wherein the first and second members are configured to receive a second shaft therebetween and seal around the second shaft when in the closed configuration.

In some examples, 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, wherein the first member and the second member are configured to receive a second shaft therebetween and seal around the second shaft when in the closed configuration.

In some examples, an assembly includes a catheter including a first shaft and a second shaft extending through the first shaft. A first lumen is defined between an inner surface of the first shaft and an outer surface of the second shaft. The assembly also includes a sealing mechanism including a first seal disposed about a distal portion of the first shaft, a second seal disposed about a portion of the second shaft extending distally of the first shaft, and a cavity disposed within a housing of the sealing mechanism between the first seal and the second seal. The distal end of the first shaft is disposed within the lumen and the lumen is fluidly sealed by the first seal and the second seal such that fluid from the first lumen cannot leave the lumen.

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

In some examples, an assembly includes a catheter including a first shaft and a second shaft extending through the first shaft, wherein a distal portion of the second shaft may extend distally of a distal end of the first shaft. The assembly also includes a sealing mechanism including first and second members pivotable relative to one another between an open configuration and a closed configuration, wherein the first and second members are configured to receive a second shaft therebetween and seal about the second shaft when in the closed configuration. The sealing mechanism further includes a tube fluidly connected to a lumen defined by the first and second members. One end of the tube includes an attachment configured to receive a suction tool for drawing fluid through the second shaft.

In some examples, an assembly includes: a catheter comprising a first shaft and a second shaft extending through the first shaft, wherein a distal portion of the second shaft is extendable distally of a distal end of the first shaft; and a sealing mechanism, the sealing mechanism comprising: a first member and a second member pivotable relative to each other between an open configuration and a closed configuration, wherein the first member and the second member are configured to receive a second shaft therebetween and seal around the second shaft when in the closed configuration; and a tube fluidly connected to a lumen defined by the first and second members, and wherein one end of the tube includes an attachment configured to receive a suction tool for sucking fluid through the second shaft.

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

In some examples, the assembly includes one or more of the components described in examples 1-20, 54-69, and 80-97 below.

A method for flushing a catheter may include: positioning a first seal of a sealing mechanism around a distal portion of a first shaft of a catheter; positioning a second seal of the sealing mechanism about a distal portion of a second shaft of the catheter extending through the first shaft; and flowing the fluid through the catheter such that the fluid flows only out of the second lumen defined by the second shaft.

In some examples, the distal portion of the second shaft extends distally of the distal end of the first shaft.

In some examples, the method includes securing a first seal about a distal portion of the first shaft and securing a second seal about a distal portion of the second shaft.

In some examples, flowing the fluid through the catheter may further include blocking the outflow of the fluid from a second lumen defined between an outer surface of the second shaft and an inner surface of the first shaft.

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

In some examples, wherein attaching the first seal to the first shaft includes extending the distal portion of the first shaft into a lumen of the sealing mechanism, through the first seal, and into a cavity of the sealing mechanism defined by a wall of a housing of the sealing mechanism, between the first seal and the second seal.

In some examples, wherein attaching the second seal to the second shaft includes extending the distal portion of the second shaft through and distal to the distal end of the first shaft and through the second seal.

In some examples, wherein attaching the first seal and attaching the second seal includes securing the first seal about the first shaft and securing the second seal about the second shaft such that the distal end of the first shaft is closed.

In some examples, wherein flowing fluid through the catheter such that the fluid flows only out of the second lumen defined by the second shaft and is prevented from flowing out of the first lumen includes flushing fluid through the catheter using positive pressure applied to the catheter.

In some examples, wherein flowing fluid through the catheter such that the fluid flows only out of the second lumen defined by the second shaft and is prevented from flowing out of the first lumen includes drawing fluid through the catheter by a suction tool using negative pressure applied to a distal end of the second shaft.

In some examples, a method for flushing a catheter includes extending a distal portion of a first shaft of a catheter through a first seal disposed in a first seal housing of a sealing mechanism and into a cavity disposed within the first seal housing and a second seal housing of the sealing mechanism, the cavity defined between the first seal and the second seal of the second seal housing. The method additionally comprises: extending a distal portion of a second shaft of the catheter through the distal end of the first shaft and distally of the distal end of the first shaft and through a second seal disposed within the second seal housing; securing the first seal about the distal portion of the first shaft and the second seal about the distal portion of the second shaft; and flowing the fluid through the catheter such that the fluid flows only from a first lumen defined by the second shaft and is prevented from flowing from a second lumen defined between an outer surface of the second shaft and an inner surface of the first shaft.

In some examples, a method includes one or more of the features described in examples 33-53 and 115 below.

The various innovations of the present disclosure can be used in combination or alone. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. 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 foregoing and other objects, features, and advantages of the present disclosure will become more apparent from the following detailed description, claims, and drawings.

Drawings

Fig. 1 schematically illustrates a first stage in an exemplary mitral valve replacement procedure in which a guide catheter and guidewire are inserted into a patient's blood vessel and guided through the blood vessel and into a patient's heart, toward the native mitral valve of the heart.

Fig. 2A schematically illustrates a second stage in an exemplary mitral valve replacement procedure in which a docking device delivery apparatus extending through a guide catheter implants a docking device for a prosthetic heart valve at a native mitral valve.

Fig. 2B schematically illustrates a third stage in an exemplary mitral valve replacement procedure, wherein the docking device of fig. 2A is fully implanted at the patient's native mitral valve, and the docking device delivery apparatus has been removed from the patient.

Fig. 3A schematically illustrates a fourth stage in an exemplary mitral valve replacement procedure in which a prosthetic heart valve delivery device extending through a guide catheter implants a prosthetic heart valve into an implanted docking device at a native mitral valve.

Fig. 3B schematically illustrates a fifth stage in an exemplary mitral valve replacement procedure in which the prosthetic heart valve is fully implanted within the docking device at the native mitral valve and the prosthetic heart valve delivery apparatus has been removed from the patient.

Fig. 4 schematically illustrates a sixth stage in an exemplary mitral valve replacement procedure in which the guide catheter and guidewire have been removed from the patient.

Fig. 5 is a side perspective view of a docking device in a spiral configuration according to one example.

Fig. 6 is a side view of an exemplary delivery apparatus for a docking device, the delivery apparatus including a handle assembly and an outer shaft extending distally from the handle assembly, the outer shaft configured to receive the docking device therein in a delivery configuration.

Fig. 7 is a perspective view of a distal portion of the delivery device of fig. 6, showing an exemplary docking mechanism deployed from an outer shaft of the delivery device and covered by a quill of the delivery device.

Fig. 8 is a perspective view of a distal portion of the delivery device of fig. 6, showing the example docking apparatus of fig. 7 deployed from an outer shaft of the delivery device, with the quill removed from the docking apparatus.

Fig. 9 is a schematic cross-sectional view of the delivery device of fig. 6, showing fluid flow from the first flush port through the plurality of fluid connecting lumens of the delivery device.

Fig. 10 is another schematic cross-sectional view of the delivery device of fig. 6, showing fluid flow from the second irrigation port through the plurality of fluid connecting lumens of the delivery device.

Fig. 11 is a side view of an exemplary sealing mechanism for a catheter configured to regulate fluid flow through two shafts of the catheter, the sealing mechanism shown coupled to the outer shaft and sleeve shaft of the delivery device of fig. 6.

Fig. 12 is a first end view of the sealing mechanism of fig. 11.

Fig. 13 is a second, opposite end view of the sealing mechanism of fig. 11.

Fig. 14 is a cross-sectional side view of the sealing mechanism of fig. 11, showing the sealing mechanism coupled to the outer shaft and the quill of the delivery device of fig. 6.

Fig. 15 shows a cross-sectional perspective view of the sealing mechanism of fig. 11.

Fig. 16 shows an exploded view of the sealing mechanism of fig. 11.

FIG. 17 is a flow chart of a method for selectively directing fluid flow through a catheter including a plurality of shafts at least partially concentric with one another using a sealing mechanism.

FIG. 18 is a perspective view of an exemplary sealing mechanism for a catheter configured to regulate fluid flow through two shafts of the catheter, the sealing mechanism including one compressible seal and one O-ring seal.

Fig. 19 is an exploded view of the sealing mechanism of fig. 18.

Fig. 20 is a cross-sectional side view of the sealing mechanism of fig. 18.

Fig. 21 is another of the sealing mechanism of fig. 18, showing the sealing mechanism coupled to the outer shaft and the quill of the delivery device of fig. 6.

FIG. 22 is a perspective view of an exemplary sealing mechanism for a catheter configured to regulate fluid flow through two shafts of the catheter, the sealing mechanism including two O-ring seals.

Fig. 23 is a cross-sectional side view of the sealing mechanism of fig. 22.

FIG. 24 is a cross-sectional side view of the sealing mechanism of FIG. 18, further including an additional lumen and attachment for the shaft of the aspiration catheter.

FIG. 25 is a perspective view of an exemplary sealing mechanism for sealing to a shaft of a catheter and drawing fluid out of the shaft.

Fig. 26 is a perspective view of the sealing mechanism of fig. 25 in a closed configuration.

FIG. 27 is a perspective view of a sealing mechanism for sealing to the shaft of a catheter and drawing fluid out of the shaft or flushing fluid through the shaft.

Fig. 28 is an exploded view of the sealing mechanism of fig. 27.

Fig. 29A is a first perspective view of a locking cap of the sealing mechanism of fig. 27.

Fig. 29B is a second perspective view of the locking cap of fig. 29A.

Fig. 29C is a side view of the locking cap of fig. 29A.

Fig. 30A is a side perspective view of a seal housing of the seal mechanism of fig. 27.

Fig. 30B is an end perspective view of the seal housing of fig. 27.

Fig. 31 is a side view of a seal of the sealing mechanism of fig. 27.

Fig. 32A is a side view of the sealing mechanism of fig. 27 in an unlocked configuration.

Fig. 32B is a side view of the sealing mechanism of fig. 27 in a locked configuration.

Fig. 33A is a cross-sectional side view of the sealing mechanism of fig. 32A in an unlocked configuration.

Fig. 33B is a cross-sectional side view of the sealing mechanism of fig. 32B in a locked configuration.

Fig. 34 is a perspective view of a sealing mechanism coupled to the shaft of the suction tool and catheter to be sucked.

Detailed Description

General considerations

For purposes of this specification, certain aspects, advantages, and novel features of the examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Rather, the present disclosure is directed to all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and subcombinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor does the disclosed examples require that any one or more specific advantages be present or problems be solved.

Although the operations of some of the disclosed examples are described in a particular sequential order for convenience of presentation, it should be understood that this manner of description includes rearrangement, unless a particular order is required by the particular language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. In addition, the present specification sometimes uses terms such as "provide" or "implement" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations corresponding to these terms may vary depending on the particular implementation and are readily discernable to one of ordinary skill in the art.

As used in this specification and the claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. In addition, the term "comprising" means "including. Furthermore, the term "coupled" generally refers to a physical, mechanical, chemical, magnetic, and/or electrical coupling or linkage, and does not exclude the presence of intermediate elements between coupled or associated items in the absence of a particular language of opposite.

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

As used herein, "such as" means "for example," and "i.e." means "that is".

Introduction to the disclosed technology

As described above, the delivery apparatus may be used to deliver a docking device for a prosthetic heart valve to a target implantation site (e.g., an native annulus). The docking device may be disposed within the distal portion of the outer shaft of the delivery apparatus in a relatively straight (e.g., unwound) delivery configuration. In some cases, a portion of the docking device may include a collapsible and expandable outer guard member. In addition, a quill of the delivery apparatus may extend through the outer shaft and be disposed about (and cover) the docking device. A plurality of lumens are formed within the delivery apparatus, including a first lumen between the outer shaft and the quill and a second lumen within the quill (e.g., between the quill and the docking device). These lumens may be flushed and degassed prior to introducing the delivery device into the patient. However, because the first and second lumens are fluidly coupled to one another, the irrigation fluid applied to one or more of these lumens may not generate sufficient irrigation pressure to be applied to the second lumen to sufficiently degas the protective member of the docking device. Thus, there is a need for improved flushing and degassing procedures for catheters and delivery devices having multiple fluidly connected lumens. For example, such improvements may enable the sleeve shaft lumen and the docking device to be effectively and sufficiently deaerated prior to implantation procedures.

Described herein are various systems, apparatuses, methods, etc., that may be used in or with a delivery apparatus for a prosthetic medical device (e.g., a docking device for a prosthetic heart valve) in some examples. In some examples, such systems, devices, and/or methods may provide a system and/or method for selectively directing fluid flow through a catheter (e.g., a delivery device) that includes multiple shafts that are at least partially concentric with one another (or one shaft is at least partially disposed within another shaft) in order to flush and degas a designated lumen of the catheter.

In some examples, the dock delivery apparatus disclosed herein may be used to deliver a dock to a target implantation site within a patient. For example, fig. 1-4 schematically illustrate an exemplary transcatheter heart valve replacement procedure utilizing a guide catheter to guide a docking device delivery apparatus toward a native valve annulus and then guide a prosthetic heart valve delivery apparatus toward the native valve annulus. The dock delivery apparatus is for delivering the dock to the native annulus, and then the prosthetic heart valve delivery apparatus is for delivering the transcatheter prosthetic heart valve into the dock.

As introduced above, the defective native heart valve may be replaced with a transcatheter prosthetic heart valve. However, such prosthetic heart valves may not sufficiently conform to the geometry of the native tissue (e.g., to the leaflets and/or annulus of the native heart valve) and may undesirably shift relative to the native tissue, which may result in paravalvular leakage. Thus, the docking device may be implanted first at the native annulus, and then the prosthetic heart valve may be implanted within the docking device to help anchor the prosthetic heart valve to the native tissue and provide a seal between the native tissue and the prosthetic heart valve. An exemplary docking device is shown in fig. 5, and an exemplary delivery apparatus for deploying the docking device at a native heart valve is shown in fig. 6.

As shown in fig. 7-10, the docking device delivery apparatus may include an outer shaft, a sleeve shaft extending through the outer shaft and receiving the docking device therein in a relatively straight delivery configuration, and a pusher shaft extending through the outer shaft and disposed adjacent to a proximal end of the docking device. A plurality of lumens are formed in the delivery device, including a sleeve shaft lumen through the sleeve shaft and an outer shaft lumen formed between the outer shaft and the sleeve shaft. These lumens may be fluidly coupled to one another, and thus, during the irrigation process, fluid flow through one lumen may also enter the other lumen, as schematically shown in fig. 9 and 10.

In some examples, as shown in fig. 11-16, a sealing mechanism (or assembly) including two seals may be configured to receive the outer shaft and a distal portion of the quill therethrough. The sealing mechanism may be configured to seal around an outer surface of the outer shaft (e.g., with a first seal) and to seal around an outer surface of the quill extending distally of the distal end of the outer shaft (e.g., with a second seal disposed distally of the first seal). Thus, the irrigation fluid entering the lumen of the delivery device may be prevented from exiting the outer lumen, thereby forcing all or most of the irrigation fluid to flow through the sleeve lumen. Thus, the sleeve lumen and the docking device disposed therein can be effectively and adequately flushed and degassed. In some cases, the seal may be a compressible seal or gasket (fig. 11-16). In some cases, the seal around the outer shaft may be a compressible seal or gasket, and the seal around the quill may be an O-ring (fig. 18-21). In some cases, the two seals may be O-rings of different sizes (fig. 22-23).

In some examples, instead of flushing the quill (or an alternative shaft to the catheter) using a sealing mechanism, any of the above sealing mechanisms may be used to seal around the outer shaft and the quill (or the inner shaft and the outer shaft of the alternative catheter) and aspirate the quill using an aspiration tool (e.g., a syringe) (fig. 24).

In some examples, aspiration or irrigation of a catheter shaft (e.g., a quill) may be performed with another sealing mechanism including a clamshell mechanism that forms a seal around the quill when closed (fig. 25 and 26).

While figures 27-34 depict a sealing mechanism configured to seal around a catheter shaft (e.g., a quill) and allow irrigation or aspiration of the catheter shaft. The seal mechanism includes a seal housing in which the seal is received, and a locking cap configured to rotate relative to one another to move the seal mechanism into a locked configuration in which the seal is radially compressed about the catheter shaft.

Examples of the disclosed technology

Fig. 1-4 depict an exemplary transcatheter heart valve replacement procedure (e.g., mitral valve replacement procedure) utilizing a docking device 52 and a prosthetic heart valve 62, according to one example. During surgery, the user first creates a passageway to the patient's native heart valve using guide catheter 30 (fig. 1). The user then delivers and implants the docking device 52 at the patient's native heart valve using the docking device delivery apparatus 50 (fig. 2A), and then removes the docking device delivery apparatus 50 from the patient 10 after implantation of the docking device 52 (fig. 2B). The user then implants a prosthetic heart valve 62 within the implanted docking device 52 using the prosthetic valve delivery apparatus 60 (fig. 3A). Thereafter, the user removes the prosthetic valve delivery device 60 (fig. 3B) and the guide catheter 30 (fig. 4) from the patient 10.

Fig. 1 depicts a first stage in a mitral valve replacement procedure according to one example, wherein a guide catheter 30 and a guidewire 40 are inserted into a blood vessel 12 of a patient 10 and are guided through the blood vessel 12, into a heart 14 of the patient 10, and toward a native mitral valve 16. Together, guide catheter 30 and guidewire 40 may provide a path for docking device delivery apparatus 50 and prosthetic valve delivery apparatus 60 to be guided through and along the path to the implantation site (native mitral valve 16 or native mitral valve annulus).

Initially, a user may first make an incision in a patient to access a blood vessel 12. For example, in the example shown in fig. 1, the user may make an incision in the groin of the patient to access the femoral vein. Thus, in such examples, the blood vessel 12 may be a femoral vein.

After an incision is made at the vessel 12, the user may insert the guide catheter 30, guidewire 40, and/or additional devices (such as an introducer device or a transseptal puncture device) into the vessel 12 through the incision. The guide catheter 30 (which may also be referred to as an "introducer device," "introducer," or "guide sheath") is configured to facilitate percutaneous introduction of various implant delivery devices (e.g., the docking device delivery apparatus 50 and the prosthetic valve delivery apparatus 60) through the blood vessel 12, and may extend through the blood vessel 12 and into the heart 14, but may stop prior to the native mitral valve 16. The guide catheter 30 may include a handle 32 and a shaft 34 extending distally from the handle 32. The shaft 34 may extend through the blood vessel 12 and into the heart 14, while the handle 32 is maintained outside the patient 10 and may be manipulated by a user to manipulate the shaft 34 (fig. 1).

The guidewire 40 is configured to guide the delivery device (e.g., guide catheter 30, docking device delivery device 50, prosthetic valve delivery device 60, additional catheter, etc.) and its associated devices (e.g., docking device, prosthetic heart valve, etc.) to an implantation site within the heart 14, and thus may extend all the way through the blood vessel 12 and into the left atrium 18 of the heart 14 (and in some instances, through the native mitral valve 16 and into the left ventricle of the heart 14) (fig. 1).

In some cases, a transseptal puncturing device or catheter may be used to initially access the left atrium 18 prior to insertion of the guidewire 40 and guide catheter 30. For example, after making an incision in the blood vessel 12, the user may insert a transseptal puncturing device through the incision and into the blood vessel 12. The user may direct the transseptal puncturing 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 may then make a small incision in the septum 22 of the heart 14 to allow access from the right atrium 20 to the left atrium 18. The user may then insert and advance the guidewire 40 through the transseptal puncture device within the blood vessel 12 and through the incision in the septum 22 into the left atrium 18. Once the guidewire 40 is positioned within the left atrium 18 and/or left ventricle 26, the transseptal puncturing device may be removed from the patient 10. The user may then insert the guide catheter 30 into the blood vessel 12 and advance the guide catheter 30 through the guidewire 40 (fig. 1) into the left atrium 18.

In some cases, the introducer device may be inserted through the lumen of the guide catheter 30 prior to inserting the guide catheter 30 into the blood vessel 12. In some cases, the introducer device may include a tapered end extending beyond the distal tip of the guide catheter 30 and configured to guide the guide catheter 30 into the left atrium 18 via the guidewire 40. Additionally, in some cases, the introducer device may include a proximal portion that extends beyond the proximal end of the guide catheter 30. Once the guide catheter 30 reaches the left atrium 18, the user may remove the introducer device from the guide catheter 30 and the interior of the patient 10. Thus, only the guide catheter 30 and guidewire 40 remain within the patient 10. Guide catheter 30 is then positioned to receive the implant delivery device and to help guide it to left atrium 18, as described further below.

Fig. 2A depicts a second stage in an exemplary mitral valve replacement procedure in which a docking device 52 is implanted at the native mitral valve 16 of the heart 14 of the patient 10 using a docking device delivery apparatus 50 (which may also be referred to as an "implantation catheter" and/or "docking device delivery device").

In general, the docking 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 the vasculature of a patient (vessel 12) and to an implantation site (e.g., native mitral valve 16), and may be configured to retain the docking device 52 in the distal portion 53 of the delivery shaft 54. In some examples, the distal portion 53 of the delivery shaft 54 retains the docking device 52 therein in a straightened delivery configuration.

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

In some examples, the handle 56 may include one or more articulation members 57 (or rotatable knobs) configured to help guide the delivery shaft 54 through the vessel 12. For example, the one or more articulation members 57 may include one or more of knobs, buttons, wheels, and/or other types of physically adjustable control members configured to be adjusted by a user to flex, bend, twist, rotate, and/or otherwise articulate the distal portion 53 of the delivery shaft 54 to help guide the delivery shaft 54 through the blood vessel 12 and within the heart 14.

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

Further details of the docking device delivery apparatus and variants thereof are described in international publication No. WO2020/247907, which is incorporated herein by reference in its entirety.

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

Once the delivery shaft 54 reaches the left atrium 18 and extends out of the distal end of the guide catheter 30, the user may use the handle 56 (e.g., the hinge member 57) to position the distal portion 53 of the delivery shaft 54 at and/or near the posterolateral junction of the native mitral valve 16. The user may then push the docking device 52 out of the distal portion 53 of the delivery shaft 54 with the shaft of the pusher assembly 58 to deploy and/or implant the docking device 52 within the annulus of the native mitral valve 16.

In some examples, the interface 52 may be constructed of, formed of, and/or include a shape memory material, and thus, may return to its original, pre-formed shape when it exits the delivery shaft 54 and is no longer constrained by the delivery shaft 54. As one example, the docking device 52 may be initially shaped as a coil, and thus may wrap around the leaflets 24 of the native mitral valve 16 as it exits the delivery shaft 54 and returns to its initial coiled configuration.

After pushing on the ventricular portion of the docking device 52 (e.g., the portion of the docking device 52 shown in fig. 2A that is configured to be positioned within the left ventricle 26 and/or on the ventricular side of the native mitral valve 16), the user may 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 retracting the delivery shaft 54 away from the posterolateral boundary of the native mitral valve 16.

After deploying and implanting the docking device 52 at the native mitral valve 16, the user may disconnect the docking device delivery apparatus 50 from the docking device 52. Once the docking device 52 is disconnected from the docking device delivery apparatus 50, the user may retract the docking device delivery apparatus 50 from the blood vessel 12 and away from the patient 10 so that the user may deliver and implant the prosthetic heart valve 62 within the implanted docking device 52 at the native mitral valve 16.

Fig. 2B illustrates this third stage in the mitral valve replacement procedure, wherein the docking device 52 has been fully deployed and implanted at the native mitral valve 16, and the docking device delivery apparatus 50 (including the delivery shaft 54) has been removed from the patient 10 such that only the guidewire 40 and guide catheter 30 remain within the patient 10. In some examples, after removal of the docking device delivery apparatus, the guidewire 40 may be advanced out of the guide catheter 30, through the implanted docking device 52 at the native mitral valve 16, and into the left ventricle 26 (fig. 2A). Thus, the guidewire 40 may help guide the prosthetic valve delivery device 60 through the annulus of the native mitral valve 16 and at least partially into the left ventricle 26.

As shown in fig. 2B, the interface 52 may include a plurality of turns (or coils) wrapped around the leaflet 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 geometry that more closely matches the shape or contour of the prosthetic heart valve to be implanted. Thus, the docking device 52 may provide a tighter fit between the prosthetic heart valve and the native mitral valve 16, and thus a better seal, as described further below.

Fig. 3A depicts a fourth stage in the mitral valve replacement procedure, wherein a user delivers and/or implants a prosthetic heart valve 62 (which may also be referred to herein as a "transcatheter prosthetic heart valve" or simply "THV," "replacement heart valve," and/or "prosthetic mitral valve") within docking device 52 using prosthetic valve delivery apparatus 60.

As shown in fig. 3A, the prosthetic valve delivery device 60 may include a delivery shaft 64 and a handle 66, the delivery shaft 64 extending distally from the handle 66. The delivery shaft 64 is configured to extend into the vasculature of a patient to deliver, implant, dilate, and/or otherwise deploy the prosthetic heart valve 62 within the docking device 52 at the native mitral valve 16. The handle 66 is configured to be grasped and/or otherwise held by a user to advance the delivery shaft 64 through the vasculature of a patient.

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

In some examples, the prosthetic valve delivery device 60 may include an expansion mechanism 65 configured to radially expand and deploy the prosthetic 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 be inflated to radially expand the prosthetic heart valve 62 within the docking device 52. The inflatable balloon may be coupled to a distal portion of the delivery shaft 64.

In some examples, the prosthetic heart valve 62 may be self-expanding and may be configured to self-radially expand when a sheath or capsule of the radially compressed prosthetic heart valve 62 over the distal portion of the delivery shaft 64 is removable. In some examples, the prosthetic heart valve 62 may be mechanically expandable, and the prosthetic valve delivery device 60 may include one or more mechanical actuators (e.g., expansion mechanisms) configured to radially expand the prosthetic heart valve 62.

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

To guide the distal portion of the delivery shaft 64 to the implantation site, a user may insert the prosthetic valve delivery device 60 (delivery shaft 64) into the patient 10 through the guide catheter 30 and through the guidewire 40. The user may continue to advance the prosthetic valve delivery device 60 (through the vessel 12) along the guidewire 40 until the distal portion of the delivery shaft 64 reaches the native mitral valve 16, as shown in fig. 3A. More specifically, the user may advance the delivery shaft 64 of the prosthetic valve delivery device 60 by grasping the handle 66 and applying a force thereon (e.g., pushing the handle). As delivery shaft 64 is advanced through vessel 12 and heart 14, a user may adjust one or more articulating members 68 of handle 66 to direct various turns, corners, constrictions, and/or other obstructions in vessel 12 and heart 14.

The user may advance the delivery shaft 64 along the guidewire 40 until the radially compressed prosthetic heart valve 62 mounted about the distal portion of the delivery shaft 64 is positioned within the docking device 52 and the native mitral valve 16. In some examples, as shown in fig. 3A, the distal end of the delivery shaft 64 and at least a portion of the radially compressed prosthetic heart valve 62 may be positioned within the left ventricle 26.

Once the radially compressed prosthetic heart valve 62 is properly positioned within the docking device 52 (fig. 3A), the user may manipulate one or more actuation mechanisms of the handle 66 of the prosthetic valve delivery apparatus 60 to actuate the expansion mechanism 65 (e.g., inflate the inflatable balloon) to radially expand the prosthetic heart valve 62 within the docking device 52.

Fig. 3B shows a fifth stage in the mitral valve replacement procedure, wherein the prosthetic heart valve 62 is in its radially expanded configuration and is implanted within the docking device 52 in the native mitral valve 16. As shown in fig. 3B, a prosthetic heart valve 62 is received and retained within the docking device 52. Thus, the docking device 52 helps anchor the prosthetic heart valve 62 within the native mitral valve 16. The interface 52 may be capable of achieving a better seal between the prosthetic heart valve 62 and the leaflets 24 of the native mitral valve 16 to reduce paravalvular leakage around the prosthetic heart valve 62.

As also shown in fig. 3B, after the prosthetic heart valve 62 has been fully deployed and implanted within the docking device 52 at the native mitral valve 16, the prosthetic valve delivery apparatus 60 (including the delivery shaft 64) is removed from the patient 10 such that only the guidewire 40 and guide catheter 30 remain within the patient 10.

Fig. 4 depicts a sixth stage in the mitral valve replacement surgery in which the guidewire 40 and guide catheter 30 have been removed from the patient 10.

Although fig. 1-4 specifically illustrate a mitral valve replacement procedure, it should be appreciated that the same and/or similar procedure can be used to replace other heart valves (e.g., tricuspid valve, pulmonary valve, and/or aortic valve). In addition, the same and/or similar delivery devices (e.g., docking device delivery device 50, prosthetic valve delivery device 60, guide catheter 30, and/or guidewire 40), docking devices (e.g., docking device 52), replacement heart valves (e.g., prosthetic heart valve 62), and/or components thereof may be used to replace these other heart valves.

For example, when replacing an autologous tricuspid valve, the user may also access the right atrium 20 via the femoral vein, but may not need to access the left atrium 18 through the septum 22. Instead, the user may leave the guidewire 40 in the right atrium 20 and perform the same and/or similar procedure of implantation of the docking device at the tricuspid valve. Specifically, the user may push the docking device 52 out of the delivery shaft 54 around the ventricular side of the tricuspid leaflet, release the remainder 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 apparatus 50 from the patient 10. The user may then advance the guidewire 40 through the tricuspid valve into the right ventricle and perform the same and/or similar prosthetic heart valve implantation procedure at the tricuspid valve within the docking device 52. In particular, the user may advance the delivery shaft 64 of the prosthetic valve delivery device 60 along the guidewire 40 through the vasculature of the patient until the prosthetic heart valve 62 is positioned/disposed within the interface 52 and tricuspid valve. The user may then expand the prosthetic heart valve 62 within the docking device 52 prior to removing the prosthetic valve delivery apparatus 60 from the patient 10. In some examples, the user may perform the same and/or similar procedure to replace the aortic valve, but may enter the aortic valve from the outflow side of the aortic valve via the femoral artery.

Furthermore, although fig. 1-4 depict a mitral valve replacement procedure from the left atrium 18 via the right atrium 20 and femoral vein into the native mitral valve 16, it should be appreciated that the native mitral valve 16 may alternatively be accessed from the left ventricle 26. For example, the user may access the native mitral valve 16 by advancing one or more delivery devices through an artery to the aortic valve, through the aortic valve, into the left ventricle 26, and then from the left ventricle 26 through the aortic valve.

Fig. 5 shows an example of a docking device 100 configured to receive a prosthetic heart valve. For example, the docking device 100 may be implanted within an native annulus, as described above with reference to fig. 1-2B. In fig. 2A-4, the docking device 100 may be used in place of the docking device 52, and thus, the docking device 100 may be configured to receive and secure the prosthetic valve within the docking device, thereby securing the prosthetic valve at the native annulus.

Referring to fig. 5, the docking device 100 may include two main components: a coil 102 and a protective member 104 covering at least a portion of the coil 102. In certain examples, coil 102 may comprise a shape memory material (e.g., nickel-titanium alloy) such that docking device 100 (and coil 102) may be moved from a substantially straight configuration (also referred to as a "delivery configuration") disposed within a delivery sleeve (e.g., sleeve shaft) of a delivery apparatus (as described more fully below) to a spiral configuration (also referred to as a "deployment configuration" as shown in fig. 5) after removal from the delivery sleeve (e.g., sleeve shaft).

Coil 102 has a proximal end 102p and a distal end 102d. When disposed within the delivery sleeve (e.g., during delivery of the docking device into the vasculature of a patient), the body of the coiled tubing 102 between the proximal end 102p and the distal end 102d may form a substantially straight delivery configuration (i.e., without any coiled or looped portions) in order to maintain a small radial profile when moved through the vasculature of the patient. Upon removal from the delivery sleeve and deployment at the implantation site, the coiled tubing 102 may be moved from the delivery configuration to the helical deployment configuration and encircle the autologous tissue adjacent the implantation site. For example, when the docking device is implanted at the location of the native valve, the coil 102 may be configured to surround the native valve's native leaflets (and chordae tendineae connecting the native leaflets to adjacent papillary muscles, if present).

Docking device 100 may be releasably coupled to a delivery apparatus. In certain examples, the dock 100 may be coupled to the delivery device via a release suture that may be configured to be tied to the dock 100 and sheared for removal (as described further below with reference to fig. 6 and 8). In one example, the release suture may be tied to the docking device 100 through an aperture or eyelet located near the proximal end 102p of the coil. In some examples, the release suture may be tied around a circumferential recess located near the proximal end 102p of the coil 102.

In some examples, docking device 100 in the deployed configuration may be configured to fit at the mitral valve location. In some examples, the docking device may also be shaped for and/or adapted to be implanted at other native valve locations, such as at the tricuspid valve. In some examples, the geometry of the docking device 100 may be configured to engage a native anatomy, which may, for example, enable an increase in stability and a decrease in relative motion between the docking device 100, a prosthetic valve docked therein, and/or the native anatomy.

As shown in fig. 5, the coil 102 in a deployed configuration may include a lead turn 106 (or "lead coil"), a central region 108, and a stabilizing turn 110 (or "stabilizing coil"). Central region 108 may possess one or more helical turns having substantially equal inner diameters. The lead turn 106 may extend from the distal end of the central region 108 and have a diameter (in one or more configurations) that is greater than the diameter of the central region 108. Stabilizing turns 110 may extend from the proximal end of central region 108 and have a diameter (in one or more configurations) that is greater than the diameter of central region 108.

In some examples, the central region 108 may include a plurality of helical turns, such as a proximal turn 108p connected with the stabilizing turn 110, a distal turn 108d connected with the leading turn 106, and one or more intermediate turns 108m disposed between the proximal turn 108p and the distal turn 108 d. In the example shown in fig. 5, there is only one intermediate turn 108m between the proximal turn 108p and the distal turn 108 d.

In some examples, there may be more than one intermediate turn 108m (e.g., two, three, etc.) between the proximal and distal turns 108p, 108 d. Some of the helical turns in the central region 108 may be complete turns (i.e., 360 degrees of rotation). In some cases, the proximal turns 108p and/or the distal turns 108d may be partial turns (e.g., rotated less than 360 degrees, such as 180 degrees, 270 degrees, etc.).

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

The stabilizing turns 110 may be configured to help stabilize the docking device 100 in a desired position within the anatomy surrounding the implantation site. For example, the radial dimension of the stabilizing turns 110 may be substantially greater than the radial dimension of the coil in the central region 108 such that the stabilizing turns 110 may be sufficiently flared or extended to abut or push against the atrial wall of the heart, thereby improving the ability of the docking device 100 to remain in its desired position prior to implantation of the prosthetic valve. In some examples, the stabilizing turns 110 have a diameter that is larger than the native valve annulus, native valve plane, and atrium for better stabilization. In some examples, the stabilizing turns 110 may be complete turns (i.e., rotated about 360 degrees). In some examples, the stabilizing turns 110 may be partial turns (e.g., rotated between about 180 degrees and about 270 degrees).

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

As described above, the lead turns 106 may have a larger radial dimension than the helical turns in the central region 108. The lead turns 106 may help more easily guide the coil 102 around and/or through the chordae geometry and substantially around all of the native leaflets of the native valve (e.g., native mitral valve, tricuspid valve, etc.). For example, once the lead turns 106 are directed around the desired autologous anatomy, the remaining coils (e.g., functional turns) of the docking device 100 may also be directed around the same features. In some examples, the lead turn 106 may be a complete turn (i.e., rotated about 360 degrees). In some examples, the lead turns 106 may be partial turns (e.g., rotated between about 180 degrees and about 270 degrees). In some examples, as the prosthetic valve radially expands within the central region 108 of the coil, the functional turns in the central region 108 may further radially expand. Thus, the lead turn 106 may be pulled in a proximal direction, may be reduced in diameter, and may become part of a functional turn in the central region 108.

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

The guard member 104 may form part of a cover assembly of the docking device 100. In some examples, the cover assembly may further include the first cover.

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

In some examples, the guard member 104 may be radially expandable to help prevent and/or reduce paravalvular leakage. In particular, the guard member 104 may be configured to radially expand such that an improved seal is formed closer to and/or against a prosthetic valve deployed within the docking device 100. In some examples, the guard member 104 may be configured to prevent and/or inhibit leakage of the docking device 100 at locations spanned between leaflets of the native valve (e.g., at the junctions of the native leaflets).

In some examples, when the docking device 100 is deployed at a native atrioventricular valve (e.g., mitral or tricuspid valve) and the protective member 104 substantially covers a portion of the stabilizing turns 110 and/or a portion of the central region 108, the protective member 104 can help cover the atrial side of the atrioventricular valve to prevent and/or inhibit leakage of blood through the native leaflets, the interface, and/or around the exterior of the prosthetic valve by preventing blood in the atrium from flowing in an atrial-to-ventricular direction (i.e., antegrade blood flow), unless through the prosthetic valve.

In some examples, the guard member 104 may be positioned on the ventricular side of the ventricular valve to prevent and/or inhibit leakage of blood through the native leaflets, the interface, and/or around the exterior of the prosthetic valve by preventing blood in the ventricle from flowing in the ventricular-to-atrial direction (i.e., retrograde blood flow).

In some examples, the distal portion 104d of the guard member 104 may be fixedly coupled to the coiled tubing 102 (e.g., via a distal suture), and the proximal portion 104p of the guard member 104 may be axially movable relative to the coiled tubing 102.

In some cases, the proximal portion 104p of the guard member 104 may have a tapered shape as shown in fig. 5 when the guard member 104 is in a radially expanded state such that the diameter of the proximal portion 104p gradually increases from the proximal end of the guard member 104 to the distally located body portion of the guard member 104. This may, for example, facilitate loading the docking device into a delivery sleeve (e.g., sleeve shaft) of the delivery apparatus and/or removing and/or repositioning the docking device into the delivery apparatus during an implantation procedure.

Fig. 6-10 illustrate examples of a delivery apparatus (which may also be referred to as a delivery system) 200 configured to deliver a docking device (e.g., docking device 100 described above with reference to fig. 5) to a target implantation site (e.g., an animal, a human, a cadaveric heart and/or a native valve, a cadaveric heart, a humanoid prosthesis (anthropomorphic ghost), etc.). In some examples, the delivery device 200 may be a transcatheter delivery device that may be used to guide a docking apparatus mounted therein through a patient's vasculature, as explained above with reference to fig. 1-2B.

An exemplary delivery device 200 is shown in fig. 6, wherein docking mechanism 232 is deployed at least partially from a distal end of delivery device 200 (e.g., for illustrative purposes). In some examples, the docking device 232 may be the docking device 100 described above with reference to fig. 5. Fig. 7 and 8 illustrate a distal portion of delivery device 200 in which sleeve shaft 280 covers docking device 232 (fig. 7) and after sleeve shaft 280 has been removed from docking device 232 (but before docking device 232 is disconnected from delivery device 200) (fig. 8), wherein docking device 232 is deployed from outer shaft 260 of the delivery device. Fig. 9 and 10 are schematic cross-sectional views of delivery device 200, showing a plurality of lumens formed between coaxial components of delivery device 200.

Returning to fig. 6, the delivery device 200 may include a handle assembly 220 and an outer shaft (e.g., a delivery catheter) 260 extending distally from the handle assembly 220. The handle assembly 220 may include a handle 222 and a hub assembly 230 extending from a proximal end of the handle 222. As shown in fig. 6, the handle assembly 220 may include a handle 222 that includes one or more knobs, buttons, rollers, or the like. For example, as shown in fig. 6, the handle 222 may include knobs 224 and 226 that may be configured to control bending of a 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.

The delivery device 200 may include a pusher shaft 290 (fig. 6 and 8-10) and a sleeve shaft 280 (fig. 7-10) coaxially within the outer shaft 260 (fig. 9 and 10) and each having a portion extending into the handle assembly 220. The pusher shaft 290 may be configured to deploy the docking device 232 from within the distal portion of the outer shaft 260 upon reaching the target implantation site, and the sleeve shaft 280 may be configured to cover the docking device 232 when it is within the delivery apparatus 200 (fig. 9 and 10) and positioned at the target implantation site (fig. 7). Further, the delivery apparatus 200 may be configured to adjust the axial position of the sleeve shaft 280 to remove a sleeve portion (e.g., a distal portion) of the sleeve shaft 280 from the docking device 232 after implantation of the docking device at the target implantation site (fig. 8). Fig. 7 and 8 are perspective views showing the example docking device 232 (fig. 7) deployed from the outer shaft 260 of the delivery device 200 covered by the distal (or sleeve) portion 282 of the sleeve shaft 280 and the example docking device 232 (fig. 8) after the sleeve shaft 280 has been retracted into the outer shaft 260.

Thus, the quill 270 may be removed from the docking device 232. In some examples, the distal portion 282 of the sleeve shaft 280 may have an outer surface that includes a lubricating or low friction material that makes it easier to slide the docking device 232 into place in the native anatomy at the implantation site.

As shown in fig. 6 and 8, during delivery, the docking device 232 may be coupled to the delivery apparatus 200 via a release suture 236 (or other retrieval line comprising a string, yarn, or other material that may be configured to be tied around the docking device and shear removed) that may extend through the pusher shaft 290. The release suture 236 may extend through the delivery device 200, through the inner lumen of the pusher shaft 290, to the suture lock assembly 206 of the delivery device 200.

As shown in fig. 6, hub assembly 230 may include a suture lock assembly (e.g., suture lock) 206 and a sleeve handle 234 attached thereto. Hub assembly 230 may be configured to control pusher shaft 290 and sleeve shaft 280 of delivery device 200 together (e.g., axially move them together), while sleeve handle 234 may control the axial position of sleeve shaft 280 relative to pusher shaft 290. In this manner, operation of the various components of the handle assembly 220 may actuate and control operation of components disposed within the outer shaft 260. In some examples, as shown in fig. 6, hub assembly 230 may be coupled to handle 222 via connector 240.

In some examples, the hub assembly 230 may include a Y-connector (e.g., an adapter) having a straight section (e.g., a straight conduit) 202 and at least one branch (e.g., a branched conduit) 204 (although in some examples it may include more than one branch) (fig. 6). In some examples, suture lock assembly 206 may be attached to branch 204 and a sleeve handle 234 (e.g., a sleeve actuation handle) may be disposed at the proximal end of straight section 202.

Further details regarding delivery apparatus 200 and variations thereof, including details regarding suture lock assemblies for delivery apparatuses of docking devices and pusher and sleeve shaft assemblies, are described in international patent publication No. WO 2020/247907, incorporated by reference above. Additional details regarding additional delivery systems and apparatus configured to deliver a docking device to a target implantation site can be found in US2018/0318079, US2018/0263764, and US2018/0177594, all of which are incorporated herein by reference in their entirety.

Returning to fig. 6, the handle assembly 220 may also include one or more irrigation ports to supply irrigation 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) in order to reduce the likelihood of thrombosis and/or to degas components of the delivery device 200 prior to insertion into a patient. Fig. 6 depicts one example in which delivery device 200 includes three irrigation ports (e.g., irrigation ports 210, 216, and 218). In alternative examples, delivery device 200 may not include irrigation port 216, or irrigation port 210 may alternatively be placed at one end of suture lock assembly 206 (e.g., as shown in fig. 9 and 10).

For example, as shown in fig. 9 and 10, which are exemplary simplified schematic illustrations of the delivery device 200, a plurality of lumens configured to receive fluid are formed between the docking device 232, the pusher shaft 290, the sleeve shaft 280, and the outer shaft 260. More specifically, the first pusher shaft lumen 201 may be formed within the interior of the pusher shaft 290 (e.g., within the interior of the main tube 292 of the pusher shaft 290). A second sleeve shaft tube cavity 211 is formed within sleeve shaft 280. Additionally, a third delivery shaft lumen 215 (or outer shaft lumen) may be formed in an annular space formed between an inner surface of the outer shaft 260 and an outer surface of the sleeve shaft 280.

As shown in fig. 9, the pusher shaft lumen 201 may receive fluid directly from a first fluid source or irrigation port 210, which may be fluidly coupled to a portion of the handle assembly, such as to one end of the suture lock assembly 206, as shown in fig. 9 and 10. Alternatively, as shown in fig. 6, the flush port 210 may be coupled to a location along the branch 204. The flow of irrigation fluid 203 from the irrigation port 210 may travel through the pusher shaft lumen 201 to the distal end 293 of the pusher shaft 290 along the length of the main tube 292 of the pusher shaft 290. A first portion of the flow of irrigation fluid 203 may flow as a flow of irrigation fluid 207 into a first portion 205 of the sleeve shaft lumen 211 disposed between an outer surface of the docking device 232 and an inner surface of the distal portion 282 of the sleeve shaft 280. In some examples, the flush fluid stream 207 may flow through a guard member 231 (which may be the same as or similar to the guard member 104 of fig. 5) of the docking device 232. A second portion of the flushing fluid flow 203 can also flow as a flushing fluid flow 213 into the second portion 209 of the sleeve shaft lumen 211 disposed between the outer surface of the pusher shaft 290 and the inner surface of the sleeve shaft 280. The flow of irrigation fluid 213 may continue through the second portion 209 of the sleeve shaft lumen 211 and into the shell portion 294 of the pusher shaft. Because the delivery shaft lumen 215 is fluidly coupled with the housing portion 294, the irrigation fluid flow 213 can continue into and through the delivery shaft lumen 215 toward the distal end 262 of the outer shaft 260.

As shown in fig. 10, the lumen of the delivery device 200 may also receive fluid from a second fluid source or irrigation port 216. The flush port 216 may be fluidly coupled to a cavity 254 disposed about a main tube 292 of the pusher shaft 290 in the hub assembly 230. The lumen 254 is fluidly coupled to the annular lumen 219 defined by the shell portion 294, and the annular lumen 219 is fluidly coupled to the delivery shaft lumen 215. Accordingly, the flow of flushing fluid 221 from the flushing port 216 can travel through the cavity 254 and into and through the annular cavity 219. The flow of irrigation fluid 221 may then be split into a first flow of irrigation fluid 217 into and through the delivery shaft lumen 215 and a second flow of irrigation fluid 223 into and through the sleeve shaft lumen 211.

Although fluid flow may be provided to the sleeve shaft lumen 211 in various circumstances, as described above with reference to fig. 9 and 10, a threshold fluid pressure may not be reached to adequately flush and degas the docking device (e.g., the guard member 231 of the docking device 232) because the flushing fluid flow may be split between the sleeve shaft lumen 211 and the delivery shaft lumen 215. Accordingly, it is desirable to force all or a majority of the irrigation fluid flow provided by the one or more irrigation ports of the delivery apparatus 200 through the sleeve shaft lumen 211 in order to degas the sleeve shaft lumen 211 and the protective member (or alternative covering) of the docking device.

Turning now to fig. 11-16, an exemplary sealing mechanism 300 for a catheter configured to regulate fluid flow through two shafts of the catheter is illustrated. For example, the sealing mechanism may be configured to seal around two shafts of the catheter (or one shaft disposed around the other shaft but having a slightly offset central axis) concentric with each other along at least a distal portion of the catheter, and to divert fluid flow provided to the catheter through one of the two shafts by blocking fluid flow from one end of the other shaft. In some examples, the catheter is a delivery apparatus for an implantable medical device, such as delivery apparatus 200 of fig. 6-10. For example, fig. 11 (side view) and 14 (cross-sectional side view) illustrate a sealing mechanism 300 coupled to the outer shaft 260 and sleeve shaft 280 of the delivery device 200. However, in alternative examples, the sealing mechanism 300 may be used with a variety of catheters and delivery devices that include two or more shafts (e.g., inner and outer shafts) having fluidly coupled lumens. Fig. 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.

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 in which the first seal 302 is received and a second seal housing 308 in which the second seal 304 is received. The first seal 302 and the second seal 304 may be annular with an aperture (e.g., a central aperture) configured to receive a shaft therethrough, as shown in fig. 14 and 15.

The first seal housing 306 and the second seal housing 308 may be coupled to each other at an interface 310 (fig. 11, 14, and 15). In some examples, the interface 310 is an overlapping interface in which a portion of the first seal housing 306 overlaps a portion of the second seal housing 308 (as shown in fig. 11 and 14-16). In an alternative example, the interface 310 is an overlapping interface, where a portion of the second seal housing 308 overlaps a portion of the first seal housing 306. In some cases, the first seal housing 306 and the second seal housing 308 may be coupled together by one or more fasteners extending through one or more holes 312 (or apertures) in the first seal housing 306 and the second seal housing 308 (fig. 11 and 15).

The first seal housing 306 may include a proximal portion 314, a middle portion 316, and a distal portion 318 (fig. 14-16). The proximal portion 314 has a first inner diameter 320 and includes a plurality of internal threads 322 (fig. 15) in an inner surface 324 of the first seal housing 306. In some examples, as shown in fig. 14 and 15, the first seal 302 may be disposed within the intermediate portion 316 of the first seal housing 306. The intermediate portion 316 may also have a first inner diameter 320. In an alternative example, the first seal 302 may be disposed in a more distal portion of the first seal housing 306.

The distal portion 318 of the first seal housing 306 may have a second inner diameter 326 (fig. 15) that is smaller than the first inner diameter 320. In some examples, the distal portion 318 may also include an outer collar portion 328 configured to receive the second seal housing 308 therein at the interface 310 (fig. 11 and 14-16). In some cases, collar portion 328 may have a third inner diameter 330 that is greater than second inner diameter 326. In some examples, the third inner diameter 330 may be the same as the first inner diameter 320. In alternative examples, the third inner diameter 330 may be greater than or less than the first inner diameter 320 while still being greater than the second inner diameter 326.

In some examples, the first seal housing 306 may also include a transition portion 332 that includes a tapered or sloped step 334 that is smaller in diameter from the first inner diameter 320 to the second inner diameter 326. Further, in some cases, the sloped step 334 may be annular and extend around the circumference of the first seal housing 306. In alternative examples, the steps of transition portion 332 may be right-angle steps, rather than slanted.

In some cases, the first seal 302 is shaped such that a distal portion thereof tapers to match the taper or taper of the inclined step 334. Accordingly, the first seal 302 may be shaped to fit within the intermediate portion 316 and the transition portion 332 against the sloped step 334.

The sealing mechanism 300 may also include a first threaded member 336 (fig. 14-16) coupled to the proximal portion 314 of the first seal housing 306. Specifically, the first threaded member 336 may include external threads 338 (fig. 14 and 15) configured to mate with the internal threads 322 of the first seal housing 306. The first knob 340 (or alternative rotatable element) may be fixed to the first threaded member 336 and configured to rotate (fig. 11-16). In some cases, a first knob may be coupled or fixed to the proximal end of the first threaded member 336 and disposed about the proximal portion 314 of the first seal housing 306. Rotation of the first knob 340 may rotate the first threaded member 336 relative to the first seal housing 306, thereby advancing the first threaded member 336 in an axial direction (relative to the central longitudinal axis 301 of the seal mechanism 300). As the first threaded member 336 advances distally (toward the second seal housing 308), the distal end 342 of the first threaded member 336 may contact and push against the proximal end 344 (fig. 14 and 15) of the first seal 302, thereby compressing the first seal 302 about a shaft (e.g., the outer shaft 260 shown in fig. 14) disposed therein. In this way, the first seal 302 may be tightened around and sealed against a shaft disposed therein by rotating the first knob 340 (and thus the first threaded member 336). Additionally, 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.

The second seal housing 308 may include a proximal portion 346, a middle portion 348, and a distal portion 350 (fig. 14-16). The proximal portion 346 may have a fourth inner diameter 352 at a proximal end 356 thereof and a fifth inner diameter 354 in a more distal region of the proximal portion 346, wherein the fifth inner diameter 354 is less than the fourth inner diameter 352 (fig. 15). The proximal end 356 of the proximal portion 346 may interface with and couple to the first seal housing 306, such as to the collar portion 328 (fig. 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 seal housing 306.

In some examples, a step 358 in proximal portion 346 transitions between fourth inner diameter 352 and fifth inner diameter 354 (fig. 14 and 15). The step 358 may also act as a stop configured to interface with a distal end of a shaft (e.g., the outer shaft 260) extending through the first seal housing 306. For example, as shown in fig. 14, the distal end 262 of the outer shaft 260 may encounter a step 358 that prevents the outer shaft 260 from moving further in the distal direction through the second seal housing 308. A cavity 360 may be defined within the first seal housing 306 and the second seal housing 308 between the first seal 302 and the second seal 304. As shown in fig. 14, the distal end 262 of the outer shaft 260 may reside in the lumen 360. Furthermore, as explained in greater detail below, when the first seal 302 is secured about a first shaft (e.g., the outer shaft 260) and the second seal 304 is secured about a second shaft (e.g., the sleeve shaft 280), the cavity 360 may be fluidly sealed by walls of the first seal housing 306, the second seal housing 308, the first seal 302, and the second seal 304.

In some examples, as shown in fig. 14 and 15, the second seal 304 may be disposed within an intermediate portion 348 of the second seal housing 308. Intermediate portion 348 may have a sixth inner diameter 362 that is greater than fifth inner diameter 354.

In some examples, the second seal housing 308 may also include a transition portion 364 that includes a tapered or sloped step 366 that is increasingly larger in diameter from the fifth inner diameter 354 to the sixth inner diameter 362. Further, in some cases, the sloped step 366 may be annular and extend around the circumference of the second seal housing 308. In alternative examples, the steps of the transition portion 364 may be right angle steps, rather than slanted.

In some cases, the second seal 304 is shaped such that a proximal portion thereof tapers to match the taper or slope of the sloped step 366. Thus, the second seal 304 may be shaped to fit within the intermediate portion 348 and the transition portion 364 against the sloped step 366.

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

The distal portion 350 of the second seal housing 308 has a seventh inner diameter 368 and includes a plurality of internal threads 370 (fig. 15) in an inner surface 372 of the second seal housing 308. As shown in fig. 14 and 15, threads 370 are disposed distally of the second seal 304 in the second seal housing 308.

The sealing mechanism may also include a second threaded member 374 (fig. 14-16) coupled to the distal portion 350 of the second seal housing 308. Specifically, the second threaded member 374 may include external threads 376 configured to mate with the internal threads 370 of the second seal housing 308. A second knob 378 (or alternative rotatable element) may be secured to the second threaded member 374 and configured to rotate (fig. 11-16). In some cases, a second knob 378 may be coupled or fixed to the distal end of the second threaded member 374 and disposed about the distal portion 350 of the second seal housing 308. Rotation of the second knob 378 may rotate the second threaded member 374 relative to the second seal housing 308, thereby advancing the second threaded member 374 in an axial direction (relative to the central longitudinal axis 301). As the second threaded member 374 is advanced proximally (toward the first seal housing 306), the proximal end 380 of the second threaded member 374 may contact and push against the distal end 382 (fig. 14 and 15) of the second seal 304, thereby compressing the second seal 304 about a shaft disposed therein (e.g., sleeve shaft 280 shown in fig. 14). In this way, the second seal 304 may be tightened around and sealed against a shaft disposed therein by rotating the second knob 378 (and thus the second threaded member 374). Additionally, 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.

The first threaded member 336 and the inner surface of the first seal 302 can define a first lumen 384 of the sealing mechanism 300 having a first diameter 385 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 configured (shaped) to receive a second shaft (e.g., sleeve shaft 280 shown in fig. 14). The second diameter 387 may be smaller than the first diameter 385.

FIG. 17 is a flow chart of an exemplary method 400 for selectively directing fluid flow through a conduit that includes multiple shafts at least partially concentric with one another (or one shaft disposed within another shaft with a central longitudinal axis slightly offset). In particular, the method 400 may be a method for operating the sealing mechanism 300 of fig. 11-16 to block fluid flow from exiting a first shaft of a catheter and to direct fluid flow through a second shaft of the catheter. However, the method 400 may also be a method for operating the sealing mechanism 500 or other sealing mechanisms 600 described herein. In some examples, the catheter may be the delivery device 200 of fig. 6-10, the first shaft may be the outer shaft 260, and the second shaft may be the sleeve shaft 280.

The method 400 begins at 402 and includes attaching a first seal 302 of the sealing mechanism 300 to a distal portion of a first shaft (e.g., the outer shaft 260, as shown in fig. 14) of a catheter. Attaching the first seal 302 to the first shaft may include extending a distal portion of the first shaft into the first lumen 384 of the sealing mechanism 300, through the first seal 302, and into the lumen 360 of the sealing mechanism 300 (e.g., as shown in fig. 14). Additionally, in some examples, the distal end of the first shaft may hit or contact a stop (e.g., step 358) in the second seal housing 308. Attaching the first seal 302 to the shaft may also include securing the first seal 302 about the first shaft, such as by rotating the first knob 340 and the first threaded member 336.

At 404, the method includes attaching the second seal 304 of the sealing mechanism 300 to a distal portion of a second shaft (e.g., a sleeve shaft 280 as shown in fig. 14) of a catheter extending through the first shaft, wherein the distal portion of the second shaft extends distally of the distal end of the first shaft. For example, attaching the second seal 304 to the second shaft may include extending a distal portion of the second shaft through and distal to the distal end of the first shaft and through the second seal. In some examples, the distal end of the second shaft may extend beyond the distal end of the sealing mechanism 300. Attaching the second seal 304 to the second shaft may also include securing the second seal 304 about the second shaft, such as by rotating the second knob 378 and the second threaded member 374. In an alternative example, when the second seal is instead a non-active compressible seal (e.g., an O-ring in seal mechanism 500 or seal mechanism 600), the method may include, at 404, extending a distal portion of the second shaft through the second seal, wherein the second seal is tightly fitted around and sealed against the second shaft.

After the first seal 302 and the second seal 304 are secured, the lumen 360 may be fluid-tight (e.g., no fluid may leave the lumen 360), thereby closing the distal end of the first shaft such that fluid from the first lumen of the first shaft cannot leave the lumen 360.

The method 400 may continue to 406, including flowing fluid through the catheter such that fluid flows only out of the second lumen of the second shaft and is prevented from flowing out of 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). Thus, the second lumen of the second shaft may be completely flushed and deaerated. For example, when the second shaft is a quill 280, passing fluid through the catheter and through only the second lumen (instead of the first lumen), the docking device disposed within the quill may be effectively and efficiently deaerated prior to the implantation procedure.

Fig. 18-21 illustrate an exemplary sealing mechanism 500 for a catheter configured to regulate fluid flow through two shafts of the catheter. Fig. 18 and 19 are perspective views of the sealing mechanism 500. Fig. 20 is a cross-sectional side view of the sealing mechanism 500. Fig. 21 is another cross-sectional side view illustrating the sealing mechanism 500 coupled to the outer shaft 260 and sleeve shaft 280 of the delivery device 200. However, in alternative examples, the sealing mechanism 500 may be used with a variety of catheters and delivery devices that include two or more shafts with fluidly coupled lumens.

The sealing mechanism 500 may be similar to the sealing mechanism 300, except that instead of two compressible seals (or gaskets) being compressible about respective axes via rotatable elements, the sealing mechanism 500 may include a compressible seal or gasket that is compressible about a first axis of the catheter and a non-active compressible seal (e.g., an O-ring) disposed about a second axis of the catheter.

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

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

The rotatable element 508 may also be configured to lock the sealing mechanism 500 in place axially with the system under pressure. The compressible seal forming the axial lock may be provided on the outer shaft 260 rather than the sleeve shaft 280, as in at least some instances the sleeve shaft 280 may have a hydrophilic coating that may result in reduced axial retention of the seal and rotatable element.

Rotatable element 508 may include a rotatable knob 510 and a threaded member 512 extending distally from rotatable knob 510. The threaded member 512 may include one or more external threads 514 (or protrusions) (fig. 19) configured to interface with internal threads 516 on an inner surface 520 of the housing (fig. 19-21). In some examples, as shown in fig. 19, the external threads 514 may be discrete protrusions spaced apart from one another around the outer surface of the threaded member 512 that are shaped to interface with and slide along the internal threads 516. In some examples, the threaded member 512 may also include one or more locking elements 518 (e.g., tabs or cantilevered protrusions) configured to snap engage the internal threads 516 and maintain the rotatable element 508 connected to the housing 506 (e.g., not disengage from the housing 506 when the rotatable element 508 is fully released).

The rotatable element 508 may be rotatable relative to the housing 506 such that the threaded member 512 moves distally against the first seal 502, pushing the first seal 502 axially against a curved edge 532 (or beveled edge) of the housing 506, which in turn compresses the first seal 502 radially against a shaft disposed therein, thereby securing the first seal 502 about the shaft (e.g., the outer shaft 260 shown in fig. 21). It should be noted that the radial compression of the first seal 502 may be more pronounced than the radial compression shown in fig. 21, and in some examples, the first seal 502 may further press against the curved edge 532 and have a smaller inner diameter when axially pushed against the housing 506.

The internal threads 516 of the housing 506 may be disposed at a first end portion 522 of the housing 506 proximal to a cavity 524 defined by an inner surface 520 of the housing 506 (fig. 20). The first seal 502 may be disposed within the housing 506 adjacent to and distal from the internal threads 516.

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

Similar to that described above for the sealing mechanism 300, the step 526 can act as a stop for the distal end 262 of the outer shaft 260 (fig. 21). Thus, the distal end 262 of the outer shaft 260 can be received within the larger diameter portion 528 of the cavity 524 and abut the step 526 with the first seal 502 sealed about the distal end portion of the outer shaft 260 (e.g., as the rotatable element 508 is rotated, it axially pushes the first seal 502 (e.g., the curved edge 532) against the housing, which in turn compresses the first seal 502 against the outer shaft 260). The inner shaft or quill 280 may then extend through and distally of the distal end 262 of the outer shaft 260 and through the smaller diameter portion 530 of the cavity 524 and the second seal 504. The second seal 504 may be sized to closely fit around the outer surface of the quill 280 such that it is fluid-tight around the quill 280. Thus, fluid passing through the delivery device may be prevented from exiting the distal end of the outer shaft 260, instead being forced through the sleeve shaft 280, as shown in fig. 21 and described above with reference to the sealing mechanism 300 and method 400.

Fig. 22 and 23 illustrate 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 that is compressible about the outer shaft and one non-compressible seal (e.g., O-ring) that is configured to seal about the inner shaft, the sealing mechanism 600 may include two non-active compressible seals (e.g., two O-rings).

For example, as shown in fig. 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 disposed within a second end portion 610 of the housing 602 (fig. 23). The first seal 604 may be larger than the second seal 606. For example, the first inner diameter 605 of the first seal 604 may be greater than the second inner diameter 607 of the second seal 606, wherein the first inner diameter 605 is shaped to receive and seal about a first shaft (e.g., the outer shaft 260) and the second inner diameter 607 is shaped to receive and seal about a second shaft (e.g., the quill 280).

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 may additionally define a step 616 within the cavity 614 that reduces the diameter of the cavity 614 from a larger diameter portion 620 to a smaller diameter portion 618 of the cavity 614.

The first seal 604 may be configured to tightly fit around and seal against an outer surface of an outer shaft of the catheter (e.g., outer shaft 260), and the step 616 may form a stop for a distal end of the outer shaft. The second seal 606 may be configured to tightly fit around and seal against the inner shaft of the catheter (e.g., quill 280). In this way, the first seal 604 and the second seal 606 may be fluidly sealed against the respective shafts of the catheter without utilizing rotatable elements or knobs, and the distal end of the catheter outer shaft may reside in a lumen 614 disposed between the first seal 604 and the second seal 606. Thus, flow out of the outer shaft may be blocked, thereby forcing all or a majority of the irrigation fluid introduced into the outer shaft to exist through the lumen of the inner shaft (e.g., the sleeve shaft lumen of sleeve shaft 280).

In some examples, 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 flush through the catheter and sealing mechanism as described above. Aspiration of fluid may be referred to herein as applying a negative pressure at, for example, one end of a shaft such that a vacuum is created and the fluid is pulled (rather than pushed) out of the shaft. In contrast, flushing fluid as used herein may refer to using positive fluid pressure to push fluid through a shaft. In some examples, the fluid aspiration and irrigation techniques described herein may be used together to direct fluid through one or more shafts of a catheter.

In such fluid-pumping examples, the housing of any of the sealing mechanisms described above may extend distally from the second seal and include a second cavity and a second step, each disposed distally of the second seal. For example, fig. 24 illustrates a sealing mechanism 500 wherein the housing 506 additionally includes a second cavity 550 disposed distally of the second seal 504 and a step 552 disposed within the second cavity 550. The step 552 reduces the diameter of the second cavity 550 from a larger first diameter adjacent the second seal 504 to a smaller second diameter. The step 552 may act as a stop for the distal end of the inner shaft (sleeve shaft 280).

Luer attachment 554 may be attached to housing 506 distally of second cavity 550. Luer (luer) attachment 554 may be configured to receive aspiration tool 556 (e.g., a syringe) for creating a vacuum and aspirating the inner shaft within second lumen 550. In some examples, extension tubing 558 may be connected between luer attachment 554 and aspiration tool 556.

In some examples, a method for aspirating an inner shaft of a catheter may include: with the inner shaft (sleeve shaft 280) fully retracted inside the outer shaft (outer shaft 260), a sealing mechanism (e.g., sealing mechanism 500 shown in fig. 24) may be positioned around the outer shaft such that the distal end of the outer shaft abuts against step 526. If a sealing mechanism configuration with a rotatable element is used, the rotatable element 508 may be rotated such that the first seal 502 is compressed axially against the housing, thereby radially compressing the first seal 502 and securing the first seal 502 about the outer shaft. The inner shaft (sleeve shaft 280) may then be advanced 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 pull a vacuum with the suction tool 556 to aspirate the catheter.

Fig. 25 and 26 illustrate an example of a sealing mechanism 700 for sealing to the shaft of a catheter and drawing fluid out of the shaft. The sealing mechanism 700 may include a clamshell member 702 configured to open and receive a shaft of a catheter (e.g., sleeve shaft 280) therein, as shown in fig. 25. For example, the clamshell member 702 may comprise a first half-shell 704 and a second half-shell 706 that includes a slot or lumen 720 for receiving a shaft. In some examples, the second half-shell 706 may pivot relative to the first half-shell 704 via a pivot joint 710 connected to a housing 712 of the sealing mechanism 700. Thus, the second half-shell 706 may be pivoted away from the first half-shell 704 (into an open configuration, as shown in fig. 25) to receive the shaft therein, and then pivoted toward and against the first half-shell 704 (into a closed configuration, as shown in fig. 25) to seal the shaft between the first half-shell 704 and the second half-shell 706.

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

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

In some examples, the sealing mechanism 700 may include a locking mechanism configured as a sliding knob 718 axially slidable from a first position (fig. 25) around a portion of the outer surface of the housing 712 to a second position (fig. 26) around the closed first half-shell 704 and second half-shell 706. In the second position, sliding knob 718 surrounds first half-shell 704 and second half-shell 706, thereby locking the first and second half-shells in a closed and sealed position about the shaft. In some examples, first half-shell 704 and/or second half-shell 706 may include a stop element 722 configured to prevent sliding knob 718 from traveling further toward the ends of first half-shell 704 and second half-shell 706 (fig. 26). Additionally or alternatively, in some examples, sliding knob 718 may have an ergonomic grip around its outer surface (as shown in fig. 25 and 26).

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

In an alternative example, 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 ramped 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 tabs that are pressed together for release).

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

In some examples, the first half-shell 704 and the second half-shell 706 may be spring loaded such that the half-shells are forced closed by a spring and then may be manually opened and moved by a user (thus eliminating the need for a locking mechanism in this example).

Once the shaft (e.g., sleeve shaft 280) is closed and sealed within the clamshell member 702, as shown in fig. 26, a suction tool may be connected to the tube 714 and used to pull vacuum and suction fluid through the shaft and out of the shaft.

In this manner, the sealing mechanism 700 can be easily connected and sealed to a shaft (quill 280) that requires flushing. In some examples, the shaft may extend beyond and distally of an outer shaft (e.g., outer shaft 260) of the catheter during the aspiration procedure.

27-34 Illustrate an example of a sealing mechanism 800 (or sealing assembly) for sealing to a shaft of a catheter and drawing fluid out of the shaft and/or flushing fluid through the shaft. The seal mechanism 800 includes a seal housing 802, a seal 804 disposed within the seal housing 802, and a lock cap 806 (also referred to herein as a lock cap, lock member, or locking member) configured to interface with the seal housing 802 and the seal 804. The lock cap 806 may be rotated about the central longitudinal axis 805 relative to the seal housing 802 (or vice versa) to move the sealing mechanism between an unlocked configuration (see, e.g., fig. 32A) and a locked configuration (see, e.g., fig. 32B).

In some examples, the sealing mechanism 800 may further include a tube 808 extending distally from the locking cap 806. In some cases, tube 808 is a flexible tube comprising a flexible or compliant material configured to receive the shaft of a catheter therethrough (and allow the shaft to move/bend therein). For example, the tube 808 can be configured to take the shape of an inserted catheter shaft (e.g., a curved shape and/or a serpentine shape).

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 fig. 27 and 28. The lock cap 806 is shown separately in fig. 29A-29C, the seal housing 802 is shown separately in fig. 30A and 30B, and the seal 804 is shown separately in fig. 31. In addition, fig. 32A and 32B depict side views of the sealing mechanism 800, and fig. 33A and 33B depict cross-sectional views of the sealing mechanism 800.

In some examples, the sealing mechanism 800 may seal a shaft of a delivery apparatus for an implantable medical device, such as the delivery apparatus 200 of fig. 6-10. For example, fig. 34 shows a sealing mechanism 800 coupled to and sealed about a quill 280 of a delivery device 200. The sealing mechanism 800 may also be used with (and/or adapted for use in conjunction with) various catheters and delivery devices that contain two or more shafts with fluidly coupled lumens.

The lock cap 806 may be rotated relative to the seal housing 802 (or the lock cap 806 and seal housing 802 may be rotated relative to each other, or the seal housing 802 may be rotated relative to the lock cap 806) such that the seal mechanism 800 may be moved between an unlocked configuration (fig. 32A and 33A) and a locked configuration (fig. 32B, 33B and 34) in which the seal 804 is compressed (and held) tightly about a shaft disposed within and extending through the seal mechanism 800. In this manner, the sealing mechanism 800 may be used to flush or pull fluid through the shaft, thereby degassing the shaft (and/or components disposed within the shaft).

As shown in fig. 27-29C, the locking cap 806 includes an outer wall 810 (or outer portion) and an inner wall 812 (or inner portion) (fig. 28 and 29A) extending proximally from an end wall 814 defining a distal end 816 (or second end) of the locking cap 806. The outer wall 810 and the inner wall 812 may extend to an open proximal end 818 (or first end) of the locking cap 806. The outer wall 810 and the inner wall 812 are annular in cross-section. Accordingly, the outer wall 810 and the inner wall 812 may be referred to herein as circumferentially extending walls and/or annular walls.

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

In some cases, the locking cap 806 may include more or less than two flanges 820 (e.g., one, three, etc.). In some cases, the width (in the circumferential direction) of the gap 822 may be greater or less than that shown in fig. 27-29C.

In some cases, the locking cap 806 includes 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 grasped by a user for rotating the sealing mechanism 800 into a locked configuration and an unlocked configuration. Each extension 824 may intersect one of the flanges 820. In some cases, as shown in fig. 27-29C, extension 824 extends further radially outward relative to central longitudinal axis 805 than flange 820.

For example, as shown in fig. 27-29C, the locking cap 806 may include two extensions 824 that are (circumferentially) separate from one another and disposed on opposite sides of the locking cap 806 (e.g., across the central longitudinal axis 805 from one another). Thus, the extension 824 may extend radially outward from the outer wall 810 in an opposite direction relative to the central longitudinal axis 805.

In some cases, the locking cap 806 may include more or less than two extensions 824 (e.g., one, three, etc.).

A cavity 826 is defined between the outer wall 810 and the inner wall 812 in a radial direction (relative to the central longitudinal axis 805) (fig. 28 and 29A). Thus, the cavity 826 may be formed by a space separating the outer surface of the inner wall 812 and the inner surface of the outer wall 810. As described further below, the cavity 826 may be configured to receive a portion of the seal housing 802 therein.

Lumen 828 is defined by the inner surface of inner wall 812. A lumen 828 extends through the lock cap 806 and is configured to receive a catheter shaft therethrough (to be sealed against). For example, the lumen 828 may include a first lumen portion 830 extending distally from the proximal end 818 configured to receive a shaft therethrough (fig. 28 and 29A).

In some cases, lumen 828 further includes a second lumen portion 832 extending proximally from distal end 816 configured to receive tube 808 therein. Tube 808 is configured to receive the shaft of a catheter therethrough. In this way, the tube 808 may extend into the second lumen portion 832 and be coupled to the inner wall 812 of the locking cap 806. Thus, when disposed within second lumen portion 832, tube 808 may extend distally outward from distal end 606 of locking cap 806 (as shown in fig. 27).

In some cases, the inner surface of the inner wall 812 may define a stepped or annular protrusion 834 (fig. 29B, and also shown in fig. 33A and 33B) separating the first and second lumen portions 830 and 832. In some cases, second lumen portion 832 has a second diameter 836 (as shown in fig. 33A) that is less than first diameter 838 of first lumen portion 830.

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

In some examples, the inner wall 812 also includes one or more radially extending channels 842 (or apertures) extending between the inner and outer surfaces of the inner wall 812 (fig. 29A). One or more channels 842 (e.g., two shown in fig. 29A) are configured to receive one or more pins 844 (fig. 28) that form a locking assembly of seal mechanism 800 with seal housing 802 (as described further below). In this manner, pins 844 may extend through respective channels 842 and be coupled to locking cap 806.

In some examples, pin 844 may be an integral part of locking cap 806. For example, pins 844 may be mounted in corresponding channels 842 in the locking cap 806 and attached to corresponding channels. In some examples, instead of being disposed within and protruding outward from channel 842, pin 844 may be attached to and protrude radially outward from an outer surface of inner wall 812. In this way, pin 844 may be an extension of inner wall 812 in some examples.

Turning to fig. 30A and 30B (and fig. 27 and 28), the seal housing 802 includes a cylindrical body portion 846 extending between a proximal end 848 (fig. 27 and 28) and a distal end 850 (fig. 30A and 30B) of the seal housing 802. The inner surface of the cylindrical body portion 846 defines a cavity 852 therein. An axially facing proximal wall 854 (fig. 27 and 28) is formed at the proximal end 848 of the cylindrical body portion 846 and defines an opening 856 configured (e.g., shaped and/or sized) to receive a catheter shaft therethrough. At the distal end 850, the opening 856 has a diameter smaller than the diameter of the cylindrical body portion 846.

For example, the inner surface of the cylindrical body portion 846 may additionally define a lumen 845 extending into the cylindrical body portion 846 from the opening 856. Lumen 845 opens to a wider (larger diameter) lumen 852 at a ramped surface 853 (fig. 30B, 33A and 33B) defined by the inner surface of cylindrical body portion 846. The ramped surface 853 may be shaped to receive the seal 804 therein, as described further below with reference to fig. 33A and 33B. The ramped surface 853 is inclined at a non-zero angle relative to the central longitudinal axis 805.

In some cases, as shown in fig. 27-28 and 30A-30B, the proximal wall 854 has a circumferentially extending extension or flange 858 extending radially outward from an outer surface of the cylindrical body portion 846 and extending around at least a portion of the circumference of the cylindrical body portion 846.

In some cases, the seal housing 802 includes one or more radially extending extensions 860 (or flanges) extending radially outward from the cylindrical body portion 846. The one or more extensions 860 are configured to be grasped by a user to facilitate holding and/or rotating the seal housing 802 relative to the locking cap 806 as the seal mechanism 800 is moved between the locked and unlocked configurations. In some examples, one or more extensions 860 may intersect flange 858. Extension 860 extends further radially outward relative to central longitudinal axis 805 than flange 858.

Although two extensions 860 are depicted in fig. 27-28, 30A-30B, and 32A-34, in alternative examples, the seal housing 802 may include more or less than two extensions 860 (e.g., one, three, four, etc.).

The cylindrical body portion 846 includes one or more slots 862 (or at least one slot 862) extending therethrough between an inner surface and an outer surface of the cylindrical body portion 846 (e.g., through a thickness of the cylindrical body portion 846, as defined in a radial direction). For example, as shown in fig. 27-28 and 30A-30B, the cylindrical body portion 846 includes two slots 862 circumferentially spaced apart from one another (e.g., 180 degrees apart from one another in some cases). Each slot 862 may be configured to receive one of pins 844, as shown in fig. 27 and in fig. 32A and 32B (as described in more detail below). Thus, the number of slots 862 is equal to the number of pins 844. In alternative examples, more or less than two slots 862 and pins 844 are possible, with the number of pins 844 and slots 862 being equal.

As shown in fig. 28, 30A, and 30B, each slot 862 may have a non-straight shape, such as a curve. For example, each slot 862 may have a circumferential extension at a second end 872 of the slot 862 and an axial extension 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).

Thus, as seal housing 802 and locking cap 806 are rotated relative to one another between the locked and unlocked configurations, each pin 844 is slidable within a respective slot 862 (between opposite first and second ends 870, 872) and, respectively, axially moves seal housing 802 and locking cap 806 toward and away from one another (as further described below). Such relative movement between the seal housing 802 and the lock cap 806 causes the seal 804 to compress axially between the seal housing 802 and the lock cap 806 and radially about (and/or radially expand against) a shaft extending through the seal mechanism 800.

Pin 844 and corresponding slot 862 may be configured to rotate seal housing 802 and locking cap 806 relative to each other between an unlocked configuration and a locked configuration by less than 360 degrees, 45-225 degrees, 70-200 degrees, 170-190 degrees, or 80-100 degrees.

A side view of the seal 804 is shown in fig. 31. Seal 804 includes a proximal portion 864 and a distal portion 866. The distal portion 866 is cylindrical (annular). In some examples, proximal portion 864 is sloped or ramped such that its outer diameter decreases from distal portion 866 to the proximal end of proximal portion 864. The diameter of the lumen of the seal 804 may be relatively constant throughout the seal 804 (through the distal portion 866 and the proximal portion 864). In this way, the seal 804 may be configured to fit within the cavity 852 of the seal housing 802, and the sloped outer surface of the proximal portion 864 may be configured to interface with and fit against the sloped surface 853. An axially facing distal face 868 at the distal end of the distal portion 866 is configured to interface with (and have face-to-face contact with) the proximal surface 840 of the locking cap 806 (fig. 33A and 33B).

Fig. 32A-33B depict the operation of the sealing mechanism 800. As introduced above, the locking assembly of the seal mechanism 800 may be moved between an unlocked configuration (or position) (e.g., fig. 32A and 33A) and a locked configuration (or position) (e.g., fig. 32B and 33B). For example, the locking assembly may be formed from a pin 844 that extends through (and/or is coupled to) a channel 842 of lock cap 806 and slides along slot 862. Seal housing 802 and lock cap 806 are rotated relative to one another to slide pin 844 along slot 862 between a head end 870 of slot 862 (in an unlocked configuration as shown in fig. 32A) and a second end 872 of slot 862 (in a locked configuration as shown in fig. 32B). Thus, the sealing mechanism 800 provides discrete binary sealing/unsealing conditions, which may make the device easy to use.

In the unlocked configuration, pin 844 is disposed at first end 870 of slot 862 (fig. 32A) and end wall 814 of lock cap 806 and distal end 850 of seal housing 802 are spaced apart from each other by a first gap 874 (fig. 33A). In this position, distal face 868 of seal 804 may abut or be disposed proximate proximal surface 840 of inner wall 812 of locking cap 806, but seal 804 is in an uncompressed state (e.g., uncompressed between seal housing 802 and inner wall 812 of locking cap 806) or in an under compressed (less compressed) state (such that it is not compressed against a catheter shaft extending therethrough). In this state, the ramped surface 853 of the cylindrical body portion 846 has a steeper angle and larger diameter than the corresponding portion of the seal 804 (and there is a gap between the ramped surface 853 and the seal 804, as shown in fig. 33A). Thus, in this configuration, the shaft may be inserted into the sealing mechanism 800, and the seal 804 is not compressed and sealed around the shaft.

As one example, to move seal mechanism 800 from the unlocked configuration (fig. 32A and 33A) to the locked configuration (fig. 32B and 33B), a user may hold lock cap 806 stationary and rotate seal housing 802 such that pin 844 moves along slot 862 to second end 872 of slot 862 and seal housing 802 moves toward (in an axial direction) lock cap 806.

In alternative examples, the user may rotate the seal housing 802 and the lock cap 806 relative to each other (in opposite rotational directions), or rotate the lock cap 806 relative to the seal housing 802, to move the seal mechanism 800 to the locked configuration.

As seal housing 802 moves closer to locking cap 806, seal 804 presses against proximal surface 840 of inner wall 812 of locking cap 806 (and thereby compresses in an axial direction), and seal 804 is forced radially outward to fill the space between ramped surface 853 and seal 804, and also radially inward toward 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 presses against the outer surface of the shaft, thereby sealing against the shaft (and forming a fluid-tight seal). As shown in fig. 33B, in the locked configuration, the locking cap 806 and the seal housing 802 are spaced apart from one another by a second gap 876 (fig. 33B) that is less than the first gap 874. In addition, the second diameter 878 of the lumen of the seal 804 in the locked configuration is less than the first diameter 880 of the lumen of the seal 804 in the unlocked configuration.

In some examples, as shown in fig. 34, a sealing mechanism 800 may be used with the delivery device 200. For example, when the sealing mechanism 800 is in the unlocked configuration, the quill 280 (which extends distally of the distal end of the outer shaft 260) is inserted into the seal housing 802, through the lock cap 806, and into the flexible tube 808 (fig. 34). The locking cap 806 and the seal housing 802 are then rotated relative to one another to move the sealing mechanism 800 into the sealing and locking configuration (as depicted in fig. 34). Suction tool 890 may be attached to the distal end of flexible tube 808 (at the attachment of tube 808 or at the attachment of extension tube 892 extending between flexible tube 808 and suction tool 890). Suction (or vacuum) is then created with suction tool 890 (e.g., by retracting the plunger of the syringe) to pull fluid through the catheter and away from sleeve shaft 280, thereby sucking sleeve shaft 280.

In some examples, instead of being used for aspiration (or suction), aspiration tool 890 may be filled with fluid and then used to push (and flush) fluid through sleeve shaft 280 (or another catheter shaft disposed within seal mechanism 800).

Alternatively (or in addition), the end of the flexible tube 808 may be open (unattached to the suction tool) and fluid from a fluid source at the proximal end of the catheter (e.g., irrigation ports 210, 216, and/or 218 in the handle assembly 220 as shown in fig. 6, 9, and 10) is pushed into the catheter, into and through the sleeve shaft 280.

Thus, a quill inserted into the sealing mechanism 800 may be effectively irrigated and/or aspirated or replaced with a catheter shaft prior to use of the catheter during surgery.

Delivery techniques

For implantation of the prosthetic valve within the native aortic valve via a transfemoral delivery method, the prosthetic valve is mounted along a distal portion of the delivery device in a radially compressed state. The distal portion of the prosthetic valve and delivery device is 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 within the native aortic valve and radially expanded (e.g., by inflating a balloon, actuating one or more actuators of a delivery device, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Alternatively, the prosthetic valve may be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal portion of the delivery device) is introduced into the left ventricle through the surgical opening in the chest and the apex, and the prosthetic valve is positioned within the native aortic valve. Alternatively, in trans-aortic surgery, the prosthetic valve (on the distal portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, for example, through a partial J-sternotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

To implant the prosthetic valve within the native mitral valve by transseptal delivery methods, the prosthetic valve is installed along the distal portion of the delivery device in a radially compressed state. The distal portion of the prosthetic valve and delivery device is inserted into the femoral vein and advanced into and through the inferior vena cava, into the right atrium, through the septum (through the perforations made in the septum), into the left atrium, and toward the native mitral valve. Alternatively, the prosthetic valve may be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve is introduced (on the distal portion of the delivery device) into the left ventricle through the surgical opening in the chest and the apex, and the prosthetic valve is positioned within the native mitral valve.

To implant the prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted along the distal portion of the delivery apparatus in a radially compressed state. The distal portion of the prosthetic valve and delivery device is inserted into the femoral vein and advanced into and through the inferior vena cava and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. Similar methods can be used to implant the prosthetic valve within the native pulmonary valve or pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve/pulmonary artery.

Another delivery method is the transatrial method, wherein a prosthetic valve (on the distal portion of the delivery device) is inserted through an incision in the chest and through an incision made through the atrial wall (of the right atrium or left atrium) for accessing any native heart valve. Atrial delivery may also be performed intravascularly, for example from the pulmonary veins. Yet another delivery method is a transventricular method, wherein a prosthetic valve (on the distal portion of the delivery device) is inserted through an incision in the chest and through an incision made in the right ventricular wall (typically at or near the base of the heart) for implantation of the prosthetic valve within the native tricuspid valve, native pulmonary valve, or pulmonary artery.

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

Any of the systems, devices, apparatuses, etc. herein may be sterilized (e.g., with heat/heat, pressure, steam, radiation, and/or chemicals, etc.) to ensure that they are safe for use by a patient, and as one of the steps of the method, any of the methods herein may include sterilization of the associated system, device, apparatus, etc. Examples of heat/heat sterilization include steam sterilization and autoclaving. Examples of radiation for sterilization include, but are not limited to, gamma radiation, ultraviolet radiation, and electron beams. Examples of chemicals for sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using, for example, a hydrogen peroxide plasma.

Additional examples of the disclosed technology

In view of the foregoing embodiments of the disclosed subject matter, additional examples are disclosed below. It should be noted that one feature of an example alone or more features of an example taken in combination, and optionally in combination with one or more features of one or more additional examples, are additional examples that also fall within the disclosure of the present application.

Example 1. An assembly, comprising: a catheter comprising 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, the sealing mechanism comprising: a first seal disposed about a distal portion of the first shaft; a second seal disposed about a portion of the second shaft extending distally of the first shaft, and a lumen 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 lumen, and wherein the lumen is fluidly sealed by the first seal and the second seal such that fluid from the first lumen cannot leave the lumen.

Example 2 the assembly of any of the examples herein, particularly example 1, wherein the distal end of the first lumen is closed by the lumen, wherein the second shaft has a second lumen, and wherein the distal end of the second lumen is open and extends distally of the second seal.

Example 3. The assembly of any of the examples herein, particularly example 1 or example 2, wherein the sealing mechanism comprises a step within the cavity that reduces a diameter of the cavity from a larger first diameter adjacent the first seal to a smaller second diameter adjacent the second seal, and wherein a distal end of the first shaft is disposed against the step.

Example 4. The assembly of any of the examples herein, particularly example 3, wherein the housing comprises a first seal housing in which the first seal is received and a second seal housing in which the second seal is received, and wherein the step is formed on an inner surface of the second seal housing.

Example 5 the assembly of any one of examples herein, particularly examples 1-4, wherein the first seal is disposed in a first seal housing of the sealing mechanism and the second seal is disposed in a second seal housing of the sealing mechanism, the first seal housing and the second seal housing being coupled to one another, and wherein the cavity is defined by an inner surface of the first seal housing and an inner surface of the second seal housing.

Example 6. The assembly of any of the examples herein, particularly example 5, wherein the first seal housing and the second seal housing are coupled together with one or more fasteners through an overlapping interface.

Example 7 the assembly of any of examples herein, particularly example 5 or example 6, wherein the sealing mechanism further comprises a first threaded member interfacing with threads on the inner surface of the first seal housing and configured to rotate relative to the first seal housing and secure the first seal about the first shaft.

Example 8 the assembly of any of the examples herein, particularly example 7, wherein the sealing mechanism includes a rotatable first knob coupled to the first threaded member and configured to rotate the first threaded member such that the first threaded member moves distally against the first seal and secures the first seal about the first shaft.

Example 9 the assembly of any of examples herein, particularly example 7 or example 8, wherein the sealing mechanism further comprises a second threaded member that interfaces with threads on an inner surface of the second seal housing and is configured to rotate relative to the second seal housing and secure the second seal about the second axis.

Example 10 the assembly of any of examples herein, particularly example 9, wherein the sealing mechanism includes a rotatable second knob coupled to the second threaded member and configured to rotate the second threaded member such that the second threaded member moves proximally against the second seal and secures the second seal about the second shaft.

Example 11. The assembly of any of the examples herein, particularly example 9 or example 10, wherein the first threaded member has a larger diameter lumen than the second threaded member.

Example 12. The assembly of any of the examples herein, particularly any of examples 1-3, wherein the first seal and the second seal are disposed in the housing, and wherein the cavity is defined by an inner surface of the housing.

Example 13 the assembly of any of the examples herein, particularly example 12, wherein the sealing mechanism further comprises a threaded member that interfaces with threads on an inner surface of the housing at an end of the housing adjacent the first seal, and wherein the threaded member is configured to rotate relative to the housing and secure the first seal about the first axis.

Example 14. The assembly of any of the examples herein, particularly example 13, wherein the sealing mechanism comprises a rotatable knob disposed at an end of the threaded member, and wherein the rotatable knob is configured to rotate the threaded member such that the threaded member moves distally against the first seal and secures the first seal about the first shaft.

Example 15. The assembly of any of the examples herein, particularly any of examples 12-14, wherein the first seal is a compressible gasket and the second seal is an O-ring.

Example 16. The assembly of any of the examples herein, particularly example 12, wherein the first seal is an O-ring and the second seal is an O-ring.

Example 17. The assembly of any of the examples herein, particularly example 12, wherein the cavity is a first cavity, wherein the housing further comprises a second cavity disposed distal to the second seal and a second step disposed within the second cavity, the second step reducing a diameter of the second cavity from a larger first diameter adjacent the second seal to a smaller second diameter, and wherein a distal end of the second shaft is disposed against the second step.

Example 18 the assembly of any of the examples herein, particularly example 17, wherein the sealing mechanism further comprises a luer attachment disposed distal to the second lumen, and wherein the luer attachment is configured to receive a suction tool for generating a vacuum and to suck the second shaft.

Example 19 the assembly of any of examples herein, particularly any of examples 1-18, wherein the catheter is a delivery device for a docking device, and wherein the second shaft is configured to house the docking device within a distal portion of the second shaft in a delivery configuration.

Example 20. The assembly of any of the examples herein, particularly example 19, wherein the docking device comprises a coiled tube and an expandable guard member disposed about a portion of the coiled tube.

Example 21. A sealing mechanism, comprising: a first seal housing having a first seal disposed within the first seal housing; a second seal housing having a second seal disposed within the second seal housing, wherein a proximal portion of the second seal 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 less than the first diameter, and wherein the step is disposed proximal to the second seal; and a lumen defined within the distal portion of the first seal housing and the proximal portion of the second seal housing, between the first seal and the second seal.

Example 22. The sealing mechanism of any of the examples herein, particularly example 21, wherein the first seal and the second seal are annular, and wherein an inner diameter of the first seal is greater than an inner diameter of the second seal.

Example 23. The sealing mechanism of any of the examples herein, particularly example 22, wherein a diameter of the cavity proximal to the step is greater than an inner diameter of the first seal.

Example 24 the sealing mechanism of any of examples herein, particularly any of examples 21-23, further comprising a first threaded member comprising external threads configured to engage internal threads on an inner surface of the proximal portion of the first seal housing, and wherein the first threaded member is configured to rotate and axially travel relative to the first housing member.

Example 25. The sealing mechanism of any of the examples herein, particularly example 24, wherein the first seal is disposed within a middle portion of the first seal housing, and wherein the first threaded member is configured to travel distally toward and push against the first seal as it rotates in order to secure the first seal.

Example 26. The sealing mechanism of any of the examples herein, particularly example 25, further comprising a first rotatable knob coupled to the proximal end of the first threaded member, and wherein the first rotatable knob is disposed about a proximal portion of the first seal housing.

Example 27. The sealing mechanism of any of the examples herein, particularly any of examples 24-26, further comprising a second threaded member comprising external threads configured to engage internal threads on an inner surface of the distal portion of the second seal housing, and wherein the second threaded member is configured to rotate and axially travel relative to the second housing member.

Example 28. The sealing mechanism of any of the examples herein, particularly example 27, wherein the second seal is disposed within a middle portion of the second seal housing, and wherein the second threaded member is configured to travel proximally toward and push against the second seal as it rotates in order to secure the second seal.

Example 29. The sealing mechanism of any of the examples herein, particularly example 28, further comprising a second rotatable knob coupled to the distal end of the second threaded member, and wherein the second rotatable knob is disposed about a distal portion of the second seal housing.

Example 30. The sealing mechanism of any of the examples herein, particularly any of examples 27-29, wherein 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, wherein 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, and wherein the second diameter is less than the first diameter.

Example 31. The sealing mechanism of any of the examples herein, particularly any of examples 21-30, wherein the first seal housing and the second seal housing are coupled together at an overlapping interface.

Example 32. The sealing mechanism of any of the examples herein, particularly example 31, wherein the step is disposed adjacent to the overlap interface.

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

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

Example 35. The method of any of the examples herein, particularly example 34, wherein extending the distal end portion of the first shaft into the cavity comprises extending the distal end of the first shaft into the cavity until the distal end encounters a step defined by the housing.

Example 36. The method of any of examples herein, particularly any of examples 33-35, wherein attaching the second seal to the second shaft includes extending a distal portion of the second shaft through and distal to a distal end of the first shaft and through the second seal.

Example 37 the method of any one of examples herein, particularly examples 33-36, wherein attaching the first seal and attaching the second seal comprises securing the first seal about the first shaft and securing the second seal about the second shaft such that a distal end of the first shaft is closed.

Example 38. The method of any of the examples herein, particularly any of examples 33-37, wherein attaching the first seal to the first shaft includes securing the first seal about the first shaft by rotating a first knob of the sealing mechanism to axially move a first threaded member disposed proximal to the first seal toward and against the first seal.

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

Example 40. The method of any of the examples herein, particularly any of examples 33-39, wherein the catheter is a delivery apparatus for a docking device, and wherein the second shaft is configured to house the docking device within a distal portion of the second shaft in a delivery configuration.

Example 41. The method of any of the examples herein, particularly example 40, wherein the docking device comprises a coiled tube and an expandable guard member disposed about a portion of the coiled tube, and wherein flowing fluid through the conduit such that the fluid flows only from the second lumen comprises flowing the fluid through and around the guard member to degas the guard member.

Example 42. The method of any of the examples herein, particularly any of examples 33-41, wherein flowing fluid through the catheter such that the fluid flows only from the second lumen defined by the second shaft and is prevented from flowing out of the first lumen comprises flushing fluid through the catheter using positive pressure applied to the catheter.

Example 43. The method of any of the examples herein, particularly any of examples 33-41, wherein flowing fluid through the catheter such that the fluid flows only out of the second lumen defined by the second shaft and is prevented from flowing out of the first lumen comprises drawing fluid through the catheter by a suction tool using negative pressure applied to the distal end of the second shaft.

Example 44. The method of any of the examples herein, particularly any of examples 33-41, wherein flowing fluid through the catheter such that the fluid flows only out of the second lumen defined by the second shaft and is prevented from flowing out of the first lumen comprises flushing and aspirating fluid through the catheter using a combination of negative and positive pressures applied to the catheter.

Example 45. A method for flushing a catheter, comprising: extending a distal portion of a first shaft of a catheter through a first seal disposed in a first seal housing of a seal mechanism and into a cavity disposed within the first and second seal housings of the seal mechanism, the cavity defined between the first seal and a second seal of the second seal housing; extending a distal portion of a second shaft of the catheter through and distal to a distal end of the first shaft and through the second seal disposed within the second seal housing; securing the first seal about the distal portion of the first shaft and securing the second seal about the distal portion of the second shaft; and flowing fluid through the catheter such that fluid flows only from a first lumen defined by the second shaft and is prevented from flowing from a second lumen defined between an outer surface of the second shaft and an inner surface of the first shaft.

Example 46. The method of any of the examples herein, particularly example 45, wherein securing the first seal about the first shaft and the second seal about the second shaft comprises fluidly sealing the lumen such that fluid from the first lumen cannot exit the lumen and close the distal end of the first shaft.

Example 47. The method of any of examples herein, particularly example 45 or example 46, wherein extending the distal end portion of the first shaft into the cavity comprises extending the distal end of the first shaft into the cavity until the distal end encounters a stop disposed within the cavity.

Example 48. The method of any of the examples herein, particularly example 47, wherein the stop is defined by an annular step disposed on an inner surface of the second seal housing proximal to the second seal.

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

Example 50. The method of any of examples herein, particularly examples 45-49, wherein securing the first seal about the distal end portion of the first shaft includes securing the first seal about the first shaft by rotating a first knob of the sealing mechanism to rotate a first threaded member engaged with threads of the first seal housing relative to the first seal housing and axially moving toward and against the first seal.

Example 51. The method of any of the examples herein, particularly any of examples 45-50, wherein securing the second seal about the distal end portion of the second shaft includes securing the second seal about the second shaft by rotating a second threaded member of the seal mechanism in threaded engagement with the second seal housing relative to the second seal housing and moving axially toward and against the second seal.

Example 52. The method of any of the examples herein, particularly any of examples 45-51, wherein the catheter is a delivery device for a docking device, and wherein the second shaft is configured to house the docking device within a distal portion of the second shaft in a delivery configuration.

Example 53. The method of any of the examples herein, particularly example 52, wherein the docking device comprises a coiled tube and an expandable guard member disposed about a portion of the coiled tube, and wherein flowing fluid through the conduit such that the fluid flows only from the first lumen comprises flowing the fluid through and around the guard member to degas the guard member.

Example 54 an assembly, comprising: a delivery apparatus comprising a first shaft, a second shaft extending through the first shaft, and an implantable medical device disposed within a distal portion of the second shaft in a delivery configuration, wherein a first lumen is defined between an inner surface of the first shaft and an outer surface of the second shaft and a second lumen is defined by the second shaft, wherein the first and second lumens are fluidly coupled to one another; and a sealing mechanism comprising a housing, a first seal disposed within the housing and surrounding a distal portion of the first shaft, a second seal disposed within the housing and surrounding a distal portion of the second shaft, and a cavity disposed within the housing and defined between the first seal and the second seal, wherein a distal end of the first shaft is disposed within the cavity, wherein a distal end of the second shaft extends distally of the distal end of the first shaft and the second seal, and wherein the cavity is fluidly sealed by the first seal and the second seal.

Example 55. The assembly of any of the examples herein, particularly example 54, wherein the first lumen and second lumen are fluidly coupled to one another downstream of the irrigation port of the delivery device and upstream of the distal end of the first shaft.

Example 56. The assembly of any of the examples herein, particularly example 54 or example 55, wherein a distal end of the first lumen is closed by the lumen, and wherein a distal end of the second lumen defined at a distal end of the second shaft is open.

Example 57. The assembly of any of the examples herein, particularly examples 54-56, wherein the housing includes a step disposed within the cavity that reduces a diameter of the cavity from a larger first diameter adjacent the first seal to a smaller second diameter adjacent the second seal, and wherein a distal end of the first shaft is disposed against the step.

Example 58 the assembly of any of the examples herein, particularly example 57, wherein the housing comprises a first seal housing in which the first seal is received and a second seal housing in which the second seal is received, and wherein the step is formed on an inner surface of the second seal housing.

Example 59. The assembly of any of the examples herein, particularly example 58, wherein the first seal housing and the second seal housing are coupled together with one or more fasteners through an overlapping interface.

Example 60. The assembly of any of examples herein, particularly example 58 or example 59, wherein the sealing mechanism further comprises a first threaded member that interfaces with threads on an inner surface of the first seal housing and is configured to rotate relative to the first seal housing and secure the first seal about the first shaft.

Example 61. The assembly of any of the examples herein, particularly example 60, wherein the sealing mechanism comprises a rotatable first knob coupled to the first threaded member and configured to rotate the first threaded member such that the first threaded member moves distally against the first seal and secures the first seal about the first shaft.

Example 62. The assembly of any of examples herein, particularly example 60 or example 61, wherein the sealing mechanism further comprises a second threaded member that interfaces with threads on an inner surface of the second seal housing and is configured to rotate relative to the second seal housing and secure the second seal about the second axis.

Example 63. The assembly of any of the examples herein, particularly example 62, wherein the sealing mechanism comprises a rotatable second knob coupled to the second threaded member and configured to rotate the second threaded member such that the second threaded member moves proximally against the second seal and secures the second seal about the second shaft.

Example 64 the assembly of any example herein, particularly example 62 or example 63, wherein the first threaded member has a larger diameter lumen than the second threaded member.

Example 65. The assembly of any of the examples herein, particularly examples 54-57, wherein the sealing mechanism includes a rotatable knob and a threaded member extending distally from the rotatable knob, wherein one or more threads on the threaded member interface with threads disposed on an inner surface of the housing proximal to the first seal, and wherein the rotatable knob is configured to rotate the threaded member relative to the housing such that the threaded member moves distally against the first seal and secures the first seal about the first shaft.

Example 66. The assembly of any of the examples herein, particularly example 65, wherein the second seal is an O-ring.

Example 67. An assembly according to any of the examples herein, particularly any of examples 54-57, wherein the first seal and the second seal are both O-rings.

Example 68 the assembly of any of examples herein, particularly any of examples 54-67, wherein the implantable medical device is a docking device configured to expand from the delivery configuration to a coiled configuration after deployment from the delivery apparatus, and wherein the docking device in its coiled configuration is configured to receive a prosthetic heart valve.

Example 69 the assembly of any example herein, particularly the assembly of example 68, wherein the docking device comprises a coiled tube and an expandable guard member disposed about a portion of the coiled tube.

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

Example 71. The sealing mechanism of any of the examples herein, particularly example 70, wherein the first seal and the second seal are annular, and wherein an inner diameter of the first seal is greater than an inner diameter of the second seal.

Example 72. The sealing mechanism of any of the examples herein, particularly example 70 or example 71, wherein the sealing mechanism further comprises a threaded member that interfaces with threads on an inner surface of the housing adjacent to the housing end of the first seal, and wherein the threaded member is configured to rotate relative to the housing and to travel distally toward the first seal and push against the first seal as it rotates, so as to secure the first seal.

Example 73. The sealing mechanism of any of the examples herein, particularly example 72, wherein the sealing mechanism comprises a rotatable knob disposed at one end of the threaded member, and wherein the rotatable knob is configured to rotate the threaded member.

Example 74. The sealing mechanism of any of examples herein, particularly example 72 or example 73, wherein the threaded member includes a plurality of external threads discontinuous with one another and spaced apart from one another about an outer surface of the threaded member, the plurality of external threads configured to interface with and slide along threads on an inner surface of the housing.

Example 75. The sealing mechanism of any of the examples herein, particularly any of examples 72-74, wherein the threaded member comprises one or more locking elements configured to snap engage threads on an inner surface of the housing and maintain the threaded member connected to the housing.

Example 76. The sealing mechanism of any of the examples herein, particularly any of examples 70-75, wherein the first seal is a compressible gasket and the second seal is an O-ring.

Example 77. The sealing mechanism of any of examples herein, particularly example 70 or example 71, wherein the first seal is an O-ring and the second seal is an O-ring.

Example 78. The sealing mechanism of any of the examples herein, particularly examples 70-77, wherein the cavity is a first cavity and the step is a first step, wherein the housing further comprises a second cavity disposed distal to the second seal and a second step disposed within the second cavity, the second step reducing a diameter of the second cavity from a larger first diameter adjacent the second seal to a smaller second diameter.

Example 79. The sealing mechanism of any of the examples herein, particularly example 78, wherein the sealing mechanism further comprises a luer attachment disposed distal to the second lumen, and wherein the luer attachment is configured to receive a suction tool for creating a vacuum within the second lumen.

Example 80. An assembly, comprising: a catheter comprising a first shaft and a second shaft extending through the first shaft, wherein a distal portion of the second shaft is extendable distally of a distal end of the first shaft; and a sealing mechanism, the sealing mechanism comprising: a first member and a second member pivotable relative to each other between an open configuration and a closed configuration, wherein the first member and the second member are configured to receive a second shaft therebetween and seal around the second shaft when in the closed configuration; and a tube fluidly connected to a lumen defined by the first member and the second member, and wherein one end of the tube includes an attachment configured to receive a suction tool for sucking fluid through the second shaft.

Example 81 the assembly of any example herein, particularly the assembly of example 80, wherein the sealing mechanism further comprises a housing, and wherein the first member and the second member are pivotable relative to each other via a pivot joint connected to the housing.

Example 82. The assembly of any of the examples herein, particularly example 81, wherein the sealing mechanism includes a sliding knob axially slidable from a first position about a portion of the outer surface of the housing to a second position about the first and second members when the first and second members are in a closed configuration.

Example 83 the assembly of any of the examples herein, particularly any of examples 80-82, wherein the first member and the second member comprise a compressible filler configured to seal about the second axis when the first member and the second member are in the closed configuration.

Example 84 the assembly of any of examples herein, particularly any of examples 80-83, wherein the catheter is a delivery device for a docking device, and wherein the second shaft is configured to house the docking device within a distal portion of the second shaft in a delivery configuration.

Example 85 the assembly of any of the examples herein, particularly example 84, wherein the docking device comprises a coiled tube and an expandable guard member disposed about a portion of the coiled tube.

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

Example 87. The assembly of any of the examples herein, particularly example 86, wherein in the unlocked configuration, the seal is disposed axially between a portion of an inner surface of the cylindrical body portion defining the first cavity and an axially facing surface of an inner wall of the locking member without being radially compressed about the second axis.

Example 88 the assembly of any example herein, particularly the assembly of example 87, wherein in the locked configuration, the seal is axially compressed between the portion of the inner surface of the cylindrical body portion and an axially facing surface of an inner wall of the locking member and radially compressed about the second axis such that a diameter of a lumen of the seal is smaller in the locked configuration than in the unlocked configuration.

Example 89 the assembly of any of examples herein, particularly example 87 or example 88, wherein the portion of the inner surface of the cylindrical body portion is a tapered surface that is inclined at a non-zero angle relative to a central longitudinal axis of the sealing mechanism.

Example 90. The assembly of any of the examples herein, particularly any of examples 86-89, wherein the seal housing includes one or more slots extending along and through the cylindrical body portion, and further including one or more pins coupled to an inner wall of the locking member, wherein each of the one or more pins is configured to extend through and slide along a corresponding slot of the one or more slots.

Example 91. The assembly of any of the examples herein, particularly example 90, wherein in the unlocked configuration, each pin is disposed at a first end of the corresponding slot, and wherein in the locked configuration, each pin is disposed at an opposite second end of the corresponding slot.

Example 92. The assembly of any of the examples herein, particularly any of examples 86-91, wherein the seal housing and the locking member are disposed closer together in an axial direction in the locked configuration than in the unlocked configuration.

Example 93 the assembly of any of examples herein, particularly examples 86-92, wherein the outer wall and the inner wall of the locking member extend proximally from an end wall defining a distal end of the locking member, wherein in the unlocked configuration, a first gap exists between the end wall and a distal end of the cylindrical body portion of the seal housing within the second cavity, and wherein in the locked configuration, a second gap exists between the end wall and the distal end of the cylindrical body portion within the second cavity, the second gap being less than the first gap.

Example 94 the assembly of any of examples herein, particularly any of examples 86-93, further comprising a tube extending distally from the locking member.

Example 95 the assembly of any of the examples herein, particularly example 94, wherein an inner surface of the inner wall defines a lumen of the locking member, and wherein the tube is disposed within a first lumen portion of the lumen.

Example 96. The assembly of any of the examples herein, particularly example 95, wherein the inner wall includes an annular protrusion extending radially toward a central longitudinal axis of the sealing mechanism and separating the first lumen portion from a second lumen portion of the lumen configured to receive a second shaft therethrough.

Example 97 the assembly of any of examples herein, particularly any of examples 94-96, wherein the distal end of the tube comprises an attachment configured to receive a suction tool for sucking fluid through the second shaft.

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

Example 99. The sealing mechanism of any of the examples herein, particularly example 98, wherein in the locked configuration the seal housing and the locking member are more closely spaced from one another than in the unlocked configuration.

Example 100. The sealing mechanism of any of the examples herein, particularly example 98 or example 99, wherein the at least one curved groove has a circumferential extension at a second end of the curved groove and an axial extension at a first end of the curved groove, wherein the first end of the curved groove is disposed closer to a distal end of the seal housing than the second end of the curved groove, and wherein the distal end of the seal housing is disposed within the second cavity.

Example 101. The sealing mechanism of any of the examples herein, particularly any of examples 98-100, wherein in the unlocked configuration, the seal is axially disposed between a portion of an inner surface of the cylindrical body portion defining the first cavity and an axially facing surface of an inner wall of the locking member without being axially compressed against the axially facing surface and the portion of the inner surface, and wherein the axially facing surface of the inner wall at least partially defines a proximal end of the locking member.

Example 102. The sealing mechanism of any of the examples herein, particularly example 101, wherein in the locked configuration, the seal is axially compressed between the portion of the inner surface of the cylindrical body portion and an axially facing surface of an inner wall of the locking member such that a diameter of the lumen of the seal is smaller in the locked configuration than in the unlocked configuration.

Example 103. The sealing mechanism of any of examples herein, particularly example 101 or example 102, wherein the portion of the inner surface of the cylindrical body portion is a tapered surface inclined at a non-zero angle relative to a central longitudinal axis of the sealing mechanism, and wherein in the locked configuration the seal presses against the tapered surface.

Example 104. The sealing mechanism of any of examples herein, particularly examples 98-103, wherein the at least one curved groove comprises two curved grooves circumferentially spaced apart from one another about the seal housing, and wherein the at least one pin comprises two pins received within two respective channels extending radially through an inner wall of the locking member.

Example 105. The sealing mechanism of any of the examples herein, particularly examples 98-104, wherein an inner surface of the cylindrical body portion defines a lumen at a proximal end of the seal housing, the lumen configured to receive a catheter shaft therethrough, wherein the lumen widens to a first lumen extending from the lumen to a distal end of the seal housing, and wherein in the locked configuration, a diameter of the lumen of the seal is reduced such that the seal seals around the catheter shaft.

Example 106 the sealing mechanism of any of examples herein, particularly any of examples 98-105, further comprising a flexible tube extending distally from the locking member.

Example 107. The sealing mechanism of any example herein, particularly example 106, wherein an inner surface of the inner wall defines a lumen of the locking member, and wherein the flexible tube is disposed within a first lumen portion of the lumen.

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

Example 109. The sealing mechanism of any of the examples herein, particularly any of examples 106-108, wherein the distal end of the flexible tube comprises an attachment configured to receive a suction tool for sucking fluid through a catheter shaft extending through the sealing mechanism.

Example 110. The sealing mechanism of any of the examples herein, particularly any of examples 98-109, wherein the at least one pin and the at least one curved slot of the seal housing are configured such that the seal housing and the locking member rotate less than 360 degrees relative to one another between the unlocked configuration and the locked configuration.

Example 111 the sealing mechanism of any of examples herein, particularly any of examples 98-109, wherein the at least one pin and the at least one curved slot of the seal housing are configured such that the seal housing and the locking member rotate 45-225 degrees relative to each other between the unlocked configuration and the locked configuration.

Example 112. The sealing mechanism of any of the examples herein, particularly any of examples 98-109, wherein the at least one pin and the at least one curved slot of the seal housing are configured such that the seal housing and the locking member rotate 70-200 degrees relative to one another between the unlocked configuration and the locked configuration.

Example 113. The sealing mechanism of any of the examples herein, particularly any of examples 98-109, wherein the at least one pin and the at least one curved slot of the seal housing are configured such that the seal housing and the locking member rotate 170-190 degrees relative to each other between the unlocked configuration and the locked configuration.

Example 114. The sealing mechanism of any of the examples herein, particularly any of examples 98-109, wherein the at least one pin and the at least one curved slot of the seal housing are configured to rotate the seal housing and the locking member relative to one another between the unlocked configuration and the locked configuration by 80-100 degrees.

Example 115. A method includes sterilizing the sealing mechanism, apparatus, and/or assembly of any of the examples.

Features described herein with respect to any example may be combined with other features described in any one or more other examples, unless otherwise specified. For example, any one or more features of one delivery device may be combined with any one or more features of another delivery device.

In view of the many possible ways in which the principles of the present disclosure may be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology, and should not be taken as limiting the scope of the disclosure, nor as limiting the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

1. A fluid assembly, comprising:

A catheter, the catheter comprising:

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, the sealing mechanism comprising:

A first seal disposed about a distal portion of the first shaft;

A second seal disposed about a portion of the second shaft extending distally of the first shaft; and

A lumen 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 lumen, and wherein the lumen is fluidly sealed by the first seal and the second seal such that fluid from the first lumen cannot exit the lumen.

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

3. The fluid assembly of claim 1 or claim 2, wherein the sealing mechanism comprises a step within the cavity that reduces the diameter of the cavity from a larger first diameter adjacent the first seal to a smaller second diameter adjacent the second seal, and wherein the distal end of the first shaft is disposed against the step.

4. A fluid assembly according to claim 3, wherein the housing comprises a first seal housing in which the first seal is received and a second seal housing in which the second seal is received, and wherein the step is formed on an inner surface of the second seal housing.

5. The fluid assembly of any one of claims 1-4, wherein the first seal is disposed in a first seal housing of the sealing mechanism and the second seal is disposed in a second seal housing of the sealing mechanism, the first seal housing and the second seal housing being coupled to one another, and wherein the cavity is defined by an inner surface of the first seal housing and an inner surface of the second seal housing.

6. The fluid assembly of claim 5, wherein the sealing mechanism further comprises a first threaded member that interfaces with threads on the inner surface of the first seal housing and is configured to rotate relative to the first seal housing and secure the first seal about the first shaft.

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

8. The fluid assembly of claim 6 or claim 7, wherein the sealing mechanism further comprises a second threaded member that interfaces with threads on the inner surface of the second seal housing and is configured to rotate relative to the second seal housing and secure the second seal about the second axis.

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

10. The fluid assembly of claim 8 or claim 9, wherein the first threaded member has a larger diameter lumen than the second threaded member.

11. A fluid assembly according to any one of claims 1 to 3, wherein the first and second seals are disposed in the housing, and wherein the cavity is defined by an inner surface of the housing.

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

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

14. The fluid assembly of any one of claims 11-13, wherein the first seal is a compressible gasket and the second seal is an O-ring.

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

16. The fluid assembly of any one of claims 1-15, wherein the conduit is a delivery device for a docking device, and wherein the second shaft is configured to house the docking device within a distal portion of the second shaft in a delivery configuration.

17. A fluid assembly, comprising:

A catheter, the catheter comprising:

a first shaft; and

A second shaft extending through the first shaft, wherein a distal portion of the second shaft is extendable distally of a distal end of the first shaft; and

A sealing mechanism, the sealing mechanism comprising:

A first member and a second member pivotable relative to each other between an open configuration and a closed configuration, wherein the first member and the second member are configured to receive the second shaft therebetween and seal around the second shaft when in the closed configuration; and

A tube fluidly connected to a lumen defined by the first member and the second member, and

Wherein one end of the tube comprises an attachment configured to receive a suction tool for sucking fluid through the second shaft.

18. The fluid assembly of claim 17, wherein the sealing mechanism further comprises a housing, and wherein the first member and the second member are pivotable relative to each other via a pivot joint connected to the housing.

19. The fluid assembly of claim 17 or claim 18, wherein the first member and the second member comprise a compressible filler configured to seal about the second axis when the first member and the second member are in the closed configuration.

20. A sealing mechanism, comprising:

A seal housing comprising a body portion, wherein an inner surface of the body portion defines a first cavity, wherein the body portion comprises at least one curved slot extending through the body portion from an outer surface of the body portion to the inner surface;

A seal disposed within a portion of the first lumen of the seal housing, wherein the seal comprises a lumen configured to receive a shaft assembly of an artificial implant delivery device;

a locking member including an outer wall and an inner wall defining a second cavity therebetween in a radial direction, wherein the body portion of the seal housing extends into and is rotatable within the second cavity of the locking member; and

At least one pin coupled to the inner wall and configured to extend into and slide along the at least one curved slot,

Wherein the seal housing and locking member are rotatable relative to each other between an unlocked configuration and a locked configuration, wherein in the unlocked configuration the at least one pin is disposed at a first end of the at least one curved slot, and wherein in the locked configuration the at least one pin is disposed at an opposite second end of the at least one curved slot, and the seal is axially compressed between the seal housing and the locking member such that a diameter of the lumen of the seal is reduced relative to the unlocked configuration in the locked configuration.

21. The sealing mechanism of claim 20, wherein in the unlocked configuration, the seal is axially disposed between a portion of an inner surface of a cylindrical body portion defining the first cavity and an axially facing surface of the inner wall of the locking member without being axially compressed against the axially facing surface and the portion of the inner surface, and wherein the axially facing surface of the inner wall at least partially defines a proximal end of the locking member.

22. The sealing mechanism of claim 21, wherein in the locked configuration, the seal is axially compressed between the portion of the inner surface of the cylindrical body portion and the axially facing surface of the inner wall of the locking member such that the diameter of the lumen of the seal is smaller in the locked configuration than in the unlocked configuration.

23. The sealing mechanism of any one of claims 21 to 22, wherein the inner surface of the cylindrical body portion defines a lumen at a proximal end of the seal housing, the lumen configured to receive a catheter shaft therethrough, wherein the lumen widens into the first lumen extending from the lumen to a distal end of the seal housing, and wherein in the locked configuration the diameter of the lumen of the seal is reduced such that the seal seals around the catheter shaft.