Fluid assembly and sealing mechanism

Abstract

The utility model relates to a fluid assembly and a sealing mechanism. Devices and methods for selectively directing fluid flow through a lumen of a catheter for efficient irrigation and / or degassing of a designated lumen of the catheter are disclosed. As one example, an assembly includes a conduit 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 distal to the first shaft, and a cavity disposed within the housing of the sealing mechanism between the first seal and the second seal. The distal end of the first shaft is disposed within the cavity, and the cavity is fluidly sealed by the first seal and the second seal such that fluid from the first lumen of the first shaft cannot exit the cavity.

Description

[0001] This application is a divisional application of Chinese patent application 202321526734.4, entitled “Fluid Components and Sealing Mechanisms,” filed on June 15, 2023.

[0002] Cross-reference to related applications

[0003] This application claims the benefit of U.S. Provisional Application No. 63 / 366,517, filed on June 16, 2022, No. 63 / 368,453, filed on July 14, 2022, and No. 63 / 371,463, filed on August 15, 2022, each of which is incorporated herein by reference in its entirety. Technical Field

[0004] The present disclosure relates to a delivery apparatus for a docking device configured to secure a prosthetic valve at a native heart valve. Background Art

[0005] The human heart may suffer from various valvular diseases. These valvular diseases may cause significant dysfunction of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are many known repair devices (such as stents) and artificial valves, as well as many known methods for implanting these devices and valves into the human body. In various surgeries, percutaneous and minimally invasive surgical methods are used to deliver artificial medical devices to a position in the body that is not easily accessible by surgery or to a position that is desired to be accessible without surgery. In a specific example, an artificial heart valve can be mounted on the distal end of a delivery device in a curled state and advanced through the patient's vascular system (for example, through the femoral artery and aorta) until the artificial valve reaches the implantation site in the heart. Then, for example, by inflating a balloon on which the artificial valve is mounted, actuating a mechanical actuator that applies an expansion force to the artificial valve, or by deploying the artificial valve from the sheath of the delivery device so that the artificial valve can self-expand to its functional size, the artificial valve is expanded to its functional size.

[0006] Artificial heart valves can be appropriately sized to fit inside many native aortic valves. However, the native mitral and tricuspid valves may have different geometries than typical aortic valves. The mitral and tricuspid valve anatomy also varies significantly from patient to patient. Therefore, it can be difficult to appropriately size and shape an artificial heart valve for a variety of patients. Furthermore, when treating valvular regurgitation, the surrounding tissue at the target implantation site (e.g., the native annulus) may not be strong enough to hold certain types of valves in place as desired.

[0007] In some examples, the docking device may be first implanted within the native valve and may be configured to receive the artificial heart valve and secure (e.g., anchor) the artificial heart valve at a desired position within the native valve. For example, the docking device may form a more rounded and / or more stable anchoring site at the native valve annulus into which the artificial heart valve may be expanded and implanted. A transcatheter delivery device may be used to deliver the docking device to the implantation site. The docking device may be arranged within the delivery device, coaxial with additional components of the delivery device. Multiple lumens may be provided between the coaxial components of the delivery device, and flushing fluid may be provided to these lumens before and during the implantation procedure to flush and degas the lumens. For example, the docking device may be covered by a sleeve shaft within the outer shaft of the delivery device, and lumens may be formed between the outer shaft and the sleeve shaft and between the sleeve shaft and the docking device. In some cases, it may be necessary to degas the sleeve shaft lumens in order to remove air around the docking device. Utility Model Content

[0008] Described herein are docking devices, artificial heart valves, delivery devices, and methods for implanting docking devices and artificial heart valves within docking devices. Also described herein are examples of flow mechanisms or assemblies that can be used to selectively direct a fluid flow through the lumen of a catheter so as to effectively flush and / or degas a designated lumen and / or component of a delivery device. 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 sleeve shaft extending through the outer shaft and covering the docking device. The docking device can be configured to receive the artificial heart valve after delivery to an implantation site using the delivery device. The flow mechanism or assembly described herein can be coupled to a distal portion of the delivery device and configured to direct a fluid flow through the lumen of the sleeve shaft, thereby degassing the docking device prior to the implantation procedure.

[0009] The sealing mechanism may include 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.

[0010] In some examples, the sealing mechanism may further include a first seal disposed within the housing adjacent to and proximal to the larger diameter portion of the cavity, and a second seal disposed within the housing adjacent to and distal to the smaller diameter portion of the cavity.

[0011] 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.

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

[0013] In some examples, the first seal is an O-ring and the second seal is an O-ring.

[0014] In some examples, the first seal and the second seal are annular, and the first seal has an inner diameter that is greater than an inner diameter of the second seal.

[0015] In some examples, a sealing mechanism includes a first seal housing and a second seal housing, wherein a first seal is disposed within the first seal housing and a second seal is disposed within the second seal housing. 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 smaller than the first diameter and disposed proximal to the second seal. The sealing mechanism further 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.

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

[0017] In some examples, the sealing mechanism includes: a housing including a cavity and a step disposed within the cavity, the step reducing the diameter of the cavity from a larger diameter portion of the cavity to a smaller diameter portion of the cavity; a first seal disposed within the housing adjacent to and proximal to the larger diameter portion of the cavity; and a second seal disposed within the housing adjacent to and distal to the smaller diameter portion of the cavity.

[0018] In some examples, a sealing mechanism includes a seal housing comprising a main body portion, wherein an inner surface of the main body portion defines a first cavity, and wherein the main body portion includes at least one curved groove extending through the main body portion from an outer surface of the main body portion to the inner surface. The seal housing also includes: a seal disposed within a portion of the first cavity of the seal housing, wherein the seal includes a lumen configured to receive a shaft assembly of an artificial implant delivery device; a locking member comprising an outer wall and an inner wall having a second cavity defined therebetween in a radial direction, wherein the main body portion of the seal housing extends into the second cavity of the locking member and is rotatable within the second cavity; and at least one pin coupled to the inner wall and configured to extend into and slide along the at least one curved groove. 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 the lumen of the seal is reduced in the locked configuration relative to the unlocked configuration.

[0019] In some examples, the sealing mechanism includes one or more components described in Examples 21-23, 70-79, and 98-114 below.

[0020] The assembly may include a catheter or delivery device and a sealing mechanism.

[0021] In some examples, a catheter can include a first shaft and a second shaft extending through the first shaft.

[0022] In some examples, a lumen is defined between an inner surface of the first shaft and an outer surface of the second shaft.

[0023] In some examples, the sealing mechanism may include a first seal disposed around a distal portion of a first shaft, a second seal disposed around a portion of a 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.

[0024] In some examples, the distal end of the first shaft is disposed within a lumen, and the lumen is fluid-sealed by a first seal and a second seal.

[0025] 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.

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

[0027] In some examples, the sealing mechanism may include first and second members that are pivotable relative to each other between an open configuration and a closed configuration, wherein the first and second members are configured to receive a second shaft therebetween and seal around the second shaft when in the closed configuration.

[0028] In some examples, an assembly includes a catheter comprising a first shaft and a second shaft extending through the first shaft. A first lumen is defined between an inner surface of the first shaft and an outer surface of the second shaft. The assembly also includes a sealing mechanism comprising a first seal disposed around a distal portion of the first shaft, a second seal disposed around a portion of the second shaft extending distally of the first shaft, and a lumen 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 fluidically sealed by the first seal and the second seal such that fluid from the first lumen cannot escape the lumen.

[0029] In some examples, the assembly 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 fluidically coupled to each other. The assembly also includes an implantable medical device disposed within a distal portion of the second shaft in a delivery configuration, and a sealing mechanism. The sealing mechanism includes a housing, a first seal disposed within the housing and surrounding the distal portion of the first shaft, a second seal disposed within the housing and surrounding the distal portion of the second shaft, and a cavity disposed within the housing and defined between the first seal and the second seal. The distal end of the first shaft is disposed within the cavity, the distal end of the second shaft extends distally of the distal end of the first shaft and the second seal, and the cavity is fluidically sealed by the first seal and the second seal.

[0030] 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 may extend distally of a distal end of the first shaft. The assembly also includes a sealing mechanism comprising first and second members pivotable relative to each other between an open configuration and a closed configuration, wherein the first and second members are configured to receive the second shaft therebetween and seal around the second shaft when in the closed configuration. The sealing mechanism also includes a tube fluidically 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.

[0031] 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 may extend distally of a distal end of the first shaft; and a sealing mechanism comprising: a first member and a second member pivotable relative to each other between an open configuration and a closed configuration, 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 and second members, and wherein one end of the tube includes an attachment configured to receive a suction tool for drawing fluid through the second shaft.

[0032] 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 may extend distally of a distal end of the first shaft. The assembly also includes a sealing mechanism comprising a seal disposed around the distal portion of the second shaft and a seal housing comprising a cylindrical body portion, wherein an inner surface of the cylindrical body portion defines a first cavity, and wherein the seal is disposed within the first cavity. The sealing mechanism also includes a locking member comprising an annular outer wall and an annular inner wall radially defining a second cavity therebetween, 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. 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 around the second shaft.

[0033] In some examples, an assembly includes one or more components described in Examples 1-20, 54-69, and 80-97 below.

[0034] A method for flushing a catheter may include: positioning a first seal of a sealing mechanism around a distal portion of a first shaft of the catheter; positioning a second seal of the sealing mechanism around a distal portion of a second shaft of the catheter extending through the first shaft; and flowing a fluid through the catheter so that the fluid flows only from a second lumen defined by the second shaft.

[0035] In some examples, the distal portion of the second shaft extends distally of the distal end of the first shaft.

[0036] In some examples, the method includes tightening a first seal around a distal portion of the first shaft and tightening a second seal around a distal portion of the second shaft.

[0037] In some examples, flowing the fluid through the catheter may further include blocking the fluid from flowing out of a second lumen defined between an outer surface of the second shaft and an inner surface of the first shaft.

[0038] In some examples, a method for flushing a catheter includes attaching a first seal of a sealing mechanism to a distal portion of a first shaft of the catheter; attaching a second seal of the 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 to a distal end of the first shaft; and flowing a fluid through the catheter such that the 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.

[0039] In some examples, attaching the first seal to the first shaft includes extending the distal portion of the first shaft into the lumen of the sealing mechanism, through the first seal, and into a cavity of the sealing mechanism, the cavity being defined by a wall of the housing of the sealing mechanism, between the first seal and the second seal.

[0040] In some examples, attaching the second seal to the second shaft includes extending the distal portion of the second shaft through the distal end of the first shaft and distally of the distal end and through the second seal.

[0041] In some examples, attaching the first seal and attaching the second seal include tightening the first seal around the first shaft and tightening the second seal around the second shaft such that the distal end of the first shaft is closed.

[0042] In some examples, flowing the fluid through the catheter such that the fluid exits only from the second lumen defined by the second shaft and is prevented from exiting the first lumen includes flushing the fluid through the catheter using positive pressure applied to the catheter.

[0043] In some examples, flowing the fluid through the catheter such that the fluid flows only from the second lumen defined by the second shaft and is prevented from flowing from the first lumen includes drawing the fluid through the catheter using negative pressure applied to the distal end of the second shaft with a suction tool.

[0044] In some examples, a method for flushing a catheter includes extending a distal portion of a first shaft of the catheter through a first seal disposed in a first seal housing of a sealing mechanism and into a lumen disposed within the first seal housing and a second seal housing of the sealing mechanism, the lumen being defined between the first seal and the second seal of the second seal housing. The method further includes extending a distal portion of a second shaft of the catheter through a distal end of the first shaft and distally therefrom and through a second seal disposed within the second seal housing; securing the first seal around the distal end of the first shaft and securing the second seal around the distal end of the second shaft; and flowing a fluid through the catheter such that the fluid exits only from a first lumen defined by the second shaft and is prevented from exiting from a second lumen defined between an outer surface of the second shaft and an inner surface of the first shaft.

[0045] In some examples, a method includes one or more features described in Examples 33-53 and 115 below.

[0046] The various innovations of this disclosure may be used in combination or individually. This summary is provided to introduce some concepts in a simplified form, which will be further described in the detailed description below. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of this disclosure will become more apparent from the detailed description, claims, and accompanying drawings that follow. BRIEF DESCRIPTION OF THE DRAWINGS

[0047] Figure 1 The first stage in an exemplary mitral valve replacement procedure is schematically illustrated, in which a guide catheter and guidewire are inserted into a patient's blood vessel and guided through the vessel and into the patient's heart toward the heart's native mitral valve.

[0048] Figure 2A The second stage in an exemplary mitral valve replacement procedure is schematically illustrated, in which a docking device delivery apparatus extending through a guide catheter implants a docking device for a prosthetic heart valve at the native mitral valve.

[0049] Figure 2B The third stage in an exemplary mitral valve replacement procedure is schematically shown, wherein Figure 2A The docking device is fully implanted in the patient's native mitral valve and the docking device delivery device is removed from the patient.

[0050] Figure 3A The fourth stage in an exemplary mitral valve replacement procedure is schematically illustrated, wherein a prosthetic heart valve delivery device extended through a guide catheter implants the prosthetic heart valve into an implanted docking device at the native mitral valve.

[0051] Figure 3B The fifth stage in an exemplary mitral valve replacement procedure is schematically illustrated, wherein the prosthetic heart valve is fully implanted within the docking device at the native mitral valve and the prosthetic heart valve delivery device has been removed from the patient.

[0052] Figure 4 A sixth stage in an exemplary mitral valve replacement procedure is schematically illustrated, wherein the guide catheter and guidewire have been removed from the patient.

[0053] Figure 5 is a side perspective view of a docking device in a spiral configuration according to one example.

[0054] Figure 6 is a side view of an exemplary delivery apparatus for a docking device, the delivery apparatus comprising a handle assembly and an outer shaft extending distally from the handle assembly, the outer shaft being configured to receive the docking device therein in a delivery configuration.

[0055] Figure 7 yes Figure 6 A perspective view of a distal portion of a delivery device of FIG. 1 is shown illustrating an exemplary docking device deployed from an outer shaft of the delivery device and covered by a sleeve shaft of the delivery device.

[0056] Figure 8 yes Figure 6 A perspective view of the distal portion of a delivery device showing deployment of the Figure 7 An exemplary docking device wherein the quill is removed from the docking device.

[0057] Figure 9 yes Figure 6 Schematic cross-sectional view of a delivery device of FIG. 1 , showing fluid flow from a first flush port through multiple fluidly connected lumens of the delivery device.

[0058] Figure 10 yes Figure 6 Another schematic cross-sectional view of a delivery device of FIG. 1 , illustrating fluid flow from a second flush port through multiple fluidly connected lumens of the delivery device.

[0059] Figure 11 is a side view of an exemplary sealing mechanism for a catheter, the sealing mechanism configured to regulate fluid flow through two shafts of the catheter, the sealing mechanism shown coupled to Figure 6The outer shaft and quill of the delivery device.

[0060] Figure 12 yes Figure 11 A first end view of the sealing mechanism.

[0061] Figure 13 yes Figure 11 An opposite second end view of the sealing mechanism.

[0062] Figure 14 yes Figure 11 A cross-sectional side view of the sealing mechanism, showing the coupling to Figure 6 A sealing mechanism between the outer shaft and the quill of the delivery device.

[0063] Figure 15 Show Figure 11 A cross-sectional perspective view of the sealing mechanism.

[0064] Figure 16 Show Figure 11 Exploded view of the sealing mechanism.

[0065] Figure 17 is a flow chart of a method for selectively directing fluid flow through a conduit including multiple shafts that are at least partially concentric with each other using a sealing mechanism.

[0066] Figure 18 is a perspective view of an exemplary sealing mechanism for a catheter, the sealing mechanism configured to regulate fluid flow through two shafts of the catheter, the sealing mechanism including a compressible seal and an O-ring seal.

[0067] Figure 19 yes Figure 18 Exploded view of the sealing mechanism.

[0068] Figure 20 yes Figure 18 Cross-sectional side view of the sealing mechanism.

[0069] Figure 21 yes Figure 18 Another sealing mechanism is shown coupled to Figure 6 A sealing mechanism between the outer shaft and the quill of the delivery device.

[0070] Figure 22 is a perspective view of an exemplary sealing mechanism for a catheter, the sealing mechanism configured to regulate fluid flow through two shafts of the catheter, the sealing mechanism including two O-ring seals.

[0071] Figure 23 yes Figure 22 Cross-sectional side view of the sealing mechanism.

[0072] Figure 24 yes Figure 18 A cross-sectional side view of a sealing mechanism further comprising an additional lumen and attachment for the shaft of a suction catheter.

[0073] Figure 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.

[0074] Figure 26 is in a closed configuration Figure 25 A perspective view of the sealing mechanism.

[0075] Figure 27 is a perspective view of a sealing mechanism for sealing to a shaft of a catheter and drawing fluid out of the shaft or flushing fluid through the shaft.

[0076] Figure 28 yes Figure 27 Exploded view of the sealing mechanism.

[0077] Figure 29A yes Figure 27 A first perspective view of the locking cap of the sealing mechanism.

[0078] Figure 29B yes Figure 29A A second perspective view of the locking cap.

[0079] Figure 29C yes Figure 29A Side view of the locking cap.

[0080] Figure 30A yes Figure 27 A side perspective view of the seal housing of the sealing mechanism.

[0081] Figure 30B yes Figure 27 An end perspective view of the seal housing.

[0082] Figure 31 yes Figure 27 A side view of the seal of the sealing mechanism.

[0083] Figure 32A It is in unlocked configuration Figure 27 Side view of the sealing mechanism.

[0084] Figure 32B Is in locked configuration Figure 27 Side view of the sealing mechanism.

[0085] Figure 33A It is in unlocked configuration Figure 32A Cross-sectional side view of the sealing mechanism.

[0086] Figure 33BIs in locked configuration Figure 32B Cross-sectional side view of the sealing mechanism.

[0087] Figure 34 is a perspective view of a sealing mechanism coupled to a suction tool and the shaft of a catheter to be suctioned. DETAILED DESCRIPTION

[0088] General considerations

[0089] For the purposes of this specification, certain aspects, advantages, and novel features of examples of the present 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 non-obvious features and aspects of the various disclosed examples, individually and in various combinations and subcombinations with one another. The methods, apparatus, and systems are not limited to any particular aspect or feature or combination thereof, nor do the disclosed examples require the presence of any one or more specific advantages or problems solved.

[0090] Although the operations of some disclosed examples are described in a particular sequential order for ease of presentation, it should be understood that this description includes rearrangement unless the specific language set forth below requires a particular order. For example, the operations described in sequence may in some cases be rearranged or performed simultaneously. In addition, for the sake of simplicity, the accompanying drawings may not illustrate the various ways in which the disclosed methods can be used in conjunction with other methods. In addition, this specification sometimes uses terms such as "provide" or "implement" to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation and are easily discernible by those of ordinary skill in the art.

[0091] As used in this application and the claims, the singular forms "a," "an," and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the term "comprising" means "including." Furthermore, the term "coupled" generally refers to a physical, mechanical, chemical, magnetic, and / or electrical connection or coupling, and, in the absence of specific language to the contrary, does not exclude the presence of intervening elements between the coupled or associated items.

[0092] As used herein, the term "proximal" refers to a position, direction or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term "distal" refers to a position, direction or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, the proximal motion of a device is the motion of the device away from the implantation site and toward the user (e.g., leaving the patient's body), while the distal motion of the device is the motion of the device away from the user and toward the implantation site (e.g., entering the patient's body). The terms "longitudinal" and "axial" refer to axes extending in proximal and distal directions, unless otherwise expressly defined.

[0093] As used herein, "such as" means "for example," and "ie" means "that is to say."

[0094] Introduction to public technology

[0095] As described above, a delivery device can be used to deliver a docking device for an artificial heart valve to a target implantation site (e.g., a native valve annulus). The docking device can be arranged in a relatively straight (e.g., unwound) delivery configuration within the distal portion of the outer shaft of the delivery device. In some cases, a portion of the docking device may include a retractable and expandable outer protective member. In addition, the sleeve shaft of the delivery device can extend through the outer shaft and be arranged around the docking device (and cover the docking device). Multiple lumens are formed in the delivery device, including a first lumen between the outer shaft and the sleeve shaft and a second lumen within the sleeve shaft (e.g., between the sleeve shaft and the docking device). These lumens can be flushed and degassed before the delivery device is introduced into the patient's body. However, since the first and second lumens are fluidically coupled to each other, the flushing fluid applied to one or more of these lumens may not generate enough flushing pressure to be applied to the second lumen to fully degas the protective member of the docking device. Therefore, there is a need to improve the flushing and degassing procedures of a delivery device having multiple fluidically connected lumens and a catheter. For example, such improvements may enable the sleeve shaft lumen and docking device to be effectively and adequately degassed prior to an implantation procedure.

[0096] Various systems, devices, methods, and the like are described herein that, in some examples, may be used with or in conjunction with delivery devices for prosthetic medical devices (e.g., docking devices for prosthetic heart valves). In some examples, such systems, devices, and / or methods may provide a system and / or method for selectively directing a fluid flow through a catheter (e.g., a delivery device) that includes multiple shafts that are at least partially concentric with each other (or one shaft is at least partially disposed within another shaft) to flush and degas a designated lumen of the catheter.

[0097] In some examples, the docking device delivery apparatus disclosed herein can be used to deliver a docking device to a target implantation site within a patient's body. For example, Figure 1-4 An exemplary transcatheter heart valve replacement procedure is schematically illustrated, wherein a guide catheter is used to guide a docking device delivery apparatus toward a native valve annulus, and then a prosthetic heart valve delivery apparatus is guided toward the native valve annulus. The docking device delivery apparatus is used to deliver the docking device to the native valve annulus, and then the prosthetic heart valve delivery apparatus is used to deliver the transcatheter prosthetic heart valve into the docking device.

[0098] As described above, a defective native heart valve can be replaced with a transcatheter prosthetic heart valve. However, such prosthetic heart valves may not adequately conform to the geometry of the native tissue (e.g., conform to the leaflets and / or annulus of the native heart valve) and may shift undesirably relative to the native tissue, which may result in paravalvular leaks. Therefore, a docking device may first be implanted at the native valve 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. Figure 5 An exemplary docking arrangement is shown in Figure 6 An exemplary delivery apparatus for deploying a docking device at a native heart valve is shown in FIG.

[0099] like Figure 7-10 As shown in , a docking device delivery apparatus may include an outer shaft, a sleeve shaft extending through the outer shaft in a relatively straight delivery configuration and accommodating the docking device therein, and a pusher shaft extending through the outer shaft and disposed adjacent a proximal end of the docking device. A plurality of lumens are formed in the delivery apparatus, including a sleeve shaft lumen extending through the sleeve shaft and an outer shaft lumen formed between the outer shaft and the sleeve shaft. These lumens may be fluidically coupled to one another so that, during a flushing procedure, fluid flow through one lumen may also enter another lumen, such as Figure 9 and 10 As shown schematically in FIG.

[0100] In some examples, such as Figure 11-16 As shown in , a sealing mechanism (or assembly) comprising two seals can be configured to receive the outer shaft and the distal portion of the sleeve shaft passing therethrough. The sealing mechanism can be configured to seal around the outer surface of the outer shaft (e.g., using a first seal) and around the outer surface of the sleeve shaft extending distally of the distal end of the outer shaft (e.g., using a second seal disposed distally of the first seal). Thus, flushing fluid entering the lumen of the delivery device can be prevented from leaving the outer shaft lumen, thereby forcing all or most of the flushing fluid to flow through the sleeve shaft lumen. Thus, the sleeve shaft lumen and the docking device disposed therein can be effectively and fully flushed and degassed. In some cases, the seal can be a compressible seal or a gasket ( Figure 11-16 In some cases, the seal around the outer shaft may be a compressible seal or gasket, and the seal around the sleeve shaft may be an O-ring ( Figure 18-21 In some cases, the two seals can be O-rings of different sizes ( Figure 22-23 ).

[0101] In some examples, instead of flushing the sleeve shaft (or alternative shaft of a catheter) using a sealing mechanism, any of the sealing mechanisms described above can be used to seal around the outer shaft and sleeve shaft (or alternative inner and outer shafts of a catheter), and aspiration of the sleeve shaft (or alternative inner and outer shafts of a catheter) can be performed using an aspiration tool (e.g., a syringe). Figure 24 ).

[0102] In some examples, aspiration or irrigation of a catheter shaft (eg, a sleeve shaft) may be performed using another sealing mechanism including a clamshell mechanism that forms a seal around the sleeve shaft when closed. Figure 25 and 26 ).

[0103] and Figure 27-34 A sealing mechanism configured to seal around a catheter shaft (e.g., a sleeve shaft) and allow irrigation or aspiration of the catheter shaft is depicted. The sealing mechanism includes a seal housing containing a seal therein and a locking cap, the locking cap and seal housing being configured to rotate relative to each other to move the sealing mechanism into a locked configuration in which the seal is radially compressed around the catheter shaft.

[0104] Examples of Publicly Available Technologies

[0105] Figures 1 to 4 An exemplary transcatheter heart valve replacement procedure (e.g., mitral valve replacement procedure) according to one example is depicted, which utilizes a docking device 52 and a prosthetic heart valve 62. During the procedure, the user first uses a guide catheter 30 ( Figure 1 ) creates a passage to the patient's native heart valve. The user then uses the docking device delivery device 50 ( Figure 2A ) delivering and implanting the docking device 52 at the patient's native heart valve, and then removing the docking device delivery apparatus 50 from the patient 10 after implanting the docking device 52 ( Figure 2B The user then uses the artificial valve delivery device 60 ( Figure 3A ) implants the artificial heart valve 62 within the implanted docking device 52. Thereafter, the user removes the artificial valve delivery device 60 from the patient 10 ( Figure 3B ) and the guide catheter 30 ( Figure 4 ).

[0106] Figure 1A first stage in a mitral valve replacement procedure according to one example is depicted in which 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 the heart 14 of the patient 10, and toward the native mitral valve 16. Together, the guide catheter 30 and the guidewire 40 can provide a path for a docking device delivery apparatus 50 and a prosthetic valve delivery apparatus 60 to be guided through and along to the implantation site (either the native mitral valve 16 or the native mitral valve annulus).

[0107] Initially, the user may first make an incision in the patient's body to access the blood vessel 12. For example, Figure 1 In the example shown, a user can make an incision in the patient's groin to access the femoral vein. Therefore, in such an example, the blood vessel 12 can be the femoral vein.

[0108] After forming an incision at the blood vessel 12, the user can insert the guide catheter 30, the guide wire 40 and / or an additional device (such as an introducer device or a transseptal puncture device) into the blood vessel 12 through the incision. The guide catheter 30 (which may also be referred to as an "introducer device", "introducer" or "introducer sheath") is configured to facilitate the percutaneous introduction of various implant delivery devices (e.g., a docking device delivery device 50 and a prosthetic valve delivery device 60) into and through the blood vessel 12, and can extend through the blood vessel 12 and into the heart 14, but can stop before 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 can extend through the blood vessel 12 and into the heart 14, while the handle 32 remains outside the patient 10 and can be operated by the user to manipulate the shaft 34 ( Figure 1 ).

[0109] The guidewire 40 is configured to guide a delivery device (e.g., a guide catheter 30, a docking device delivery device 50, a prosthetic valve delivery device 60, additional catheters, etc.) and its associated devices (e.g., a docking device, a prosthetic heart valve, etc.) to an implantation site within the heart 14 and, thus, may extend 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) ( Figure 1 ).

[0110] In some cases, a transseptal puncture device or catheter can be used to initially access the left atrium 18 prior to inserting the guidewire 40 and guide catheter 30. For example, after making an incision in the blood vessel 12, the user can insert the transseptal puncture device through the incision into the blood vessel 12. The user can guide the transseptal puncture device through the blood vessel 12 and into the heart 14 (e.g., through the femoral vein and into the right atrium 20). The user can then make a small incision in the atrial septum 22 of the heart 14 to allow access to the left atrium 18 from the right atrium 20. The user can then insert and advance the guidewire 40 through the transseptal puncture device in the blood vessel 12 and through the incision in the atrial 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 puncture device can be removed from the patient 10. The user can then insert the guide catheter 30 into the blood vessel 12 and, over the guidewire 40 ( Figure 1 ) Advance the guide catheter 30 into the left atrium 18.

[0111] In some cases, before the guide catheter 30 is inserted into the blood vessel 12, an introducer device can be inserted through the lumen of the guide catheter 30. In some cases, the introducer device can include a tapered end that extends beyond the distal end of the guide catheter 30 and is configured to guide the guide catheter 30 into the left atrium 18 via the guidewire 40. Additionally, in some cases, the introducer device can 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 can remove the introducer device from the guide catheter 30 and the patient 10. Thus, only the guide catheter 30 and the guidewire 40 remain within the patient 10. The guide catheter 30 is then in place to receive the implant delivery device and help guide it to the left atrium 18, as described further below.

[0112] Figure 2A The second stage in an exemplary mitral valve replacement procedure is depicted, 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 a "docking device delivery apparatus").

[0113] Generally, the docking device delivery apparatus 50 includes a delivery shaft 54, a handle 56, and a pusher assembly 58. The delivery shaft 54 is configured to be advanced by a user through the patient's vasculature (blood vessel 12) and to the implantation site (e.g., the native mitral valve 16), and can 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.

[0114] The handle 56 of the docking device delivery apparatus 50 is configured to be grasped and / or otherwise held by a user outside the body of the patient 10 to advance the delivery shaft 54 through the patient's vasculature (eg, blood vessel 12 ).

[0115] In some examples, the handle 56 can include one or more articulating members 57 (or rotatable knobs) configured to facilitate guiding the delivery shaft 54 through the blood vessel 12. For example, the one or more articulating members 57 can 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 cause the distal portion 53 of the delivery shaft 54 to flex, bend, twist, rotate, and / or otherwise articulate to facilitate guiding the delivery shaft 54 through the blood vessel 12 and within the heart 14.

[0116] The pusher assembly 58 can be configured to deploy and / or implant the docking device 52 at an implantation site (e.g., the native mitral valve 16). For example, the pusher assembly 58 is configured to be adjusted by a user to push the docking device 52 out of the distal end portion 53 of the delivery shaft 54. The shaft of the pusher assembly 58 can extend through the delivery shaft 54 and can be positioned adjacent to the docking device 52 within the delivery shaft 54. In some examples, the docking device 52 can be releasably coupled to the shaft of the pusher assembly 58 via a connection mechanism of the docking device delivery apparatus 50, such that the docking device 52 can be released after being deployed at the native mitral valve 16.

[0117] Further details of the docking device delivery apparatus and its variations are described in International Publication No. WO2020 / 247907, which is incorporated herein by reference in its entirety.

[0118] Reference again Figure 2A After positioning the guide catheter 30 within the left atrium 18, the user can insert the docking device delivery device 50 (e.g., delivery shaft 54) into the patient 10 by advancing the delivery shaft 54 of the docking device delivery device 50 through the guide catheter 30 and over the guidewire 40. In some examples, the guidewire 40 can be at least partially retracted away from the left atrium 18 and into the guide catheter 30. The user can then continue to advance the delivery shaft 54 of the docking device delivery device 50 along the guidewire 40 through the blood vessel 12 until the delivery shaft 54 reaches the left atrium 18, as shown. Figure 2A Specifically, a user can advance the delivery shaft 54 of the docking device delivery device 50 toward the patient 10 by grasping the handle 56 of the docking device delivery device 50 and applying force thereon (e.g., pushing the handle). As the delivery shaft 54 is advanced through the blood vessel 12 and the heart 14, the user can adjust one or more hinged members 57 of the handle 56 to navigate various turns, corners, constrictions, and / or other obstacles in the blood vessel 12 and the heart 14.

[0119] Once the delivery shaft 54 reaches the left atrium 18 and extends out of the distal end of the guide catheter 30, the user can use the handle 56 (e.g., hinge member 57) to position the distal portion 53 of the delivery shaft 54 at and / or near the posteromedial commissure of the native mitral valve 16. The user can then use the shaft of the pusher assembly 58 to push the docking device 52 out of the distal portion 53 of the delivery shaft 54 to deploy and / or implant the docking device 52 within the annulus of the native mitral valve 16.

[0120] In some examples, the docking device 52 can be constructed from, formed from, and / or include a shape memory material and, thus, can return to its initial, pre-formed shape when it is free of and no longer constrained by the delivery shaft 54. As one example, the docking device 52 can be initially formed as a coil and, thus, can wrap around the leaflets 24 of the native mitral valve 16 when it is free of the delivery shaft 54 and returns to its initial coiled configuration.

[0121] When pushing the ventricular portion of the docking device 52 (e.g., Figure 2A After deploying the portion of the docking device 52 shown in the figure 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 can then deploy the remaining portion of the docking device 52 (e.g., the atrial portion of the docking device 52) from the delivery shaft 54 within the left atrium 18 by retracting the delivery shaft 54 away from the posteromedial commissure of the native mitral valve 16.

[0122] After deploying and implanting the docking device 52 at the native mitral valve 16, the user can 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 can retract the docking device delivery apparatus 50 from the blood vessel 12 and away from the patient 10, allowing the user to deliver and implant the prosthetic heart valve 62 within the implanted docking device 52 at the native mitral valve 16.

[0123] Figure 2B This third stage in the mitral valve replacement procedure is shown in which 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, so that only the guidewire 40 and the guide catheter 30 remain within the patient 10. In some examples, after the docking device delivery apparatus is removed, the guidewire 40 can 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 ( Figure 2A Thus, the guidewire 40 can 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.

[0124] like Figure 2B As shown, the docking device 52 can include a plurality of turns (or coils) that wrap around the leaflets 24 of the native mitral valve 16 (within the left ventricle 26). The implanted docking device 52 has a more cylindrical shape than the annulus of the native mitral valve 16, thereby providing a geometry that more closely matches the shape or contour of the prosthetic heart valve to be implanted. Thus, the docking device 52 can provide a tighter fit between the prosthetic heart valve and the native mitral valve 16, and thus provide a better seal, as further described below.

[0125] Figure 3A The fourth stage in a mitral valve replacement procedure is depicted, in which a user uses a prosthetic valve delivery device 60 to deliver and / or implant a prosthetic heart valve 62 (which may also be referred to herein as a "transcatheter prosthetic heart valve" or simply "THV," a "replacement heart valve," and / or a "prosthetic mitral valve") within a docking device 52.

[0126] like Figure 3A As shown, the prosthetic valve delivery device 60 may include a delivery shaft 64 and a handle 66, with the delivery shaft 64 extending distally from the handle 66. The delivery shaft 64 is configured to extend into the patient's vasculature to deliver, implant, expand, 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 patient's vasculature.

[0127] In some examples, the handle 66 can include one or more articulating members 68 configured to facilitate guiding the delivery shaft 64 through the blood vessel 12 and the heart 14. Specifically, the articulating member 68 can 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.

[0128] In some instances, the prosthetic valve delivery device 60 can include an expansion mechanism 65 configured to radially expand and deploy the prosthetic heart valve 62 at the implantation site. Figure 3A As shown, the expansion mechanism 65 can include an inflatable balloon configured to be inflated to radially expand the prosthetic heart valve 62 within the docking device 52. The inflatable balloon can be coupled to a distal portion of the delivery shaft 64.

[0129] In some examples, the prosthetic heart valve 62 can be self-expanding and can be configured to radially expand upon removal of a sheath or capsule covering the radially compressed prosthetic heart valve 62 on the distal portion of the delivery shaft 64. In some examples, the prosthetic heart valve 62 can be mechanically expandable, and the prosthetic valve delivery apparatus 60 can include one or more mechanical actuators (e.g., expansion mechanisms) configured to radially expand the prosthetic heart valve 62.

[0130] like Figure 3A As shown, a prosthetic heart valve 62 is mounted in a radially compressed configuration about an expansion mechanism 65 (an inflatable balloon) on a distal portion of a delivery shaft 64 .

[0131] To guide the distal end of the delivery shaft 64 to the implantation site, the user can insert the prosthetic valve delivery device 60 (delivery shaft 64) into the patient 10 through the guide catheter 30 and over the guide wire 40. The user can continue to advance the prosthetic valve delivery device 60 along the guide wire 40 (through the blood vessel 12) until the distal end of the delivery shaft 64 reaches the native mitral valve 16, as shown in FIG. Figure 3A More specifically, a user can advance the delivery shaft 64 of the prosthetic valve delivery device 60 by grasping the handle 66 and applying force thereto (e.g., pushing the handle). As the delivery shaft 64 is advanced through the blood vessel 12 and the heart 14, the user can adjust one or more hinged members 68 of the handle 66 to navigate various turns, corners, constrictions, and / or other obstacles in the blood vessel 12 and the heart 14.

[0132] The user can advance the delivery shaft 64 along the guidewire 40 until the radially compressed prosthetic heart valve 62 mounted around the distal portion of the delivery shaft 64 is positioned within the docking device 52 and the native mitral valve 16. In some embodiments, such as Figure 3A As shown, the distal end of the delivery shaft 64 and at least a portion of the radially compressed prosthetic heart valve 62 can be positioned within the left ventricle 26 .

[0133] Once the radially compressed prosthetic heart valve 62 is properly positioned within the docking device 52 ( Figure 3A ), the user can manipulate one or more actuators of the handle 66 of the artificial valve delivery device 60 to actuate the expansion mechanism 65 (e.g., inflate the inflatable balloon), thereby radially expanding the artificial heart valve 62 within the docking device 52.

[0134] Figure 3B The fifth stage in the mitral valve replacement procedure is shown, 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. Figure 3BAs shown, the 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 docking device 52 can enable 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.

[0135] Also like Figure 3B As shown, after the artificial heart valve 62 has been fully deployed and implanted within the docking device 52 at the native mitral valve 16, the artificial valve delivery device 60 (including the delivery shaft 64) is removed from the patient 10, so that only the guidewire 40 and the guide catheter 30 remain in the patient 10.

[0136] Figure 4 A sixth stage in the mitral valve replacement procedure is depicted, wherein the guidewire 40 and guide catheter 30 have been removed from the patient 10 .

[0137] although Figure 1-4 A mitral valve replacement procedure is specifically shown, but it should be appreciated that the same and / or similar procedures can be used to replace other heart valves (e.g., tricuspid valve, pulmonary valve, and / or aortic valve). 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 can be used to replace these other heart valves.

[0138] For example, when replacing a native tricuspid valve, the user may also enter the right atrium 20 via the femoral vein, but may not need to enter the left atrium 18 through the atrial septum 22. Instead, the user may leave the guidewire 40 in the right atrium 20 and perform the same and / or similar docking device implantation procedure at the tricuspid valve. Specifically, the user may push the docking device 52 out of the delivery shaft 54 around the ventricular side of the tricuspid valve leaflet, release the remaining portion of the docking device 52 from the delivery shaft 54 within the right atrium 20, and then remove the delivery shaft 54 of the docking device delivery device 50 from the patient 10. The user may then advance the guidewire 40 through the tricuspid valve into the right ventricle and perform the same and / or similar artificial heart valve implantation procedure at the tricuspid valve within the docking device 52. Specifically, the user may advance the delivery shaft 64 of the artificial valve delivery device 60 along the guidewire 40 through the patient's vasculature until the artificial heart valve 62 is positioned / set within the docking device 52 and the tricuspid valve. The user can then expand the prosthetic heart valve 62 within the docking device 52 before removing the prosthetic valve delivery apparatus 60 from the patient 10. In some examples, the user can perform the same and / or similar procedure to replace the aortic valve, but can access the aortic valve from the outflow side of the aortic valve via the femoral artery.

[0139] In addition, despite Figure 1-4 A mitral valve replacement procedure is depicted in which the native mitral valve 16 is accessed from the left atrium 18 via the right atrium 20 and the femoral vein, but it should be appreciated that the native mitral valve 16 may alternatively be accessed from the left ventricle 26. For example, a user may advance one or more delivery devices through the arteries to the aortic valve, through the aortic valve into the left ventricle 26, and then from the left ventricle 26 into the native mitral valve 16 via the aortic valve.

[0140] Figure 5 An example of a docking device 100 configured to receive a prosthetic heart valve is shown. For example, the docking device 100 may be implanted within a native valve annulus, as described above with reference to Figure 1-2B As described. Figure 2A-4 In the embodiment of the present invention, the docking device 100 can be used instead of the docking device 52, and thus, the docking device 100 can be configured to receive a prosthetic valve and secure the prosthetic valve within the docking device, thereby securing the prosthetic valve at the native valve annulus.

[0141] refer to Figure 5 , the docking device 100 may include two main components: a coiled tubing 102 and a protective member 104 covering at least a portion of the coiled tubing 102. In some examples, the coiled tubing 102 may comprise a shape memory material (e.g., a nickel-titanium alloy) such that the docking device 100 (and the coiled tubing 102) may be movable from a substantially straight configuration (also referred to as a "delivery configuration") when disposed within a delivery sleeve (e.g., a sleeve shaft) of a delivery device (as described more fully below) to a spiral configuration (also referred to as a "deployed configuration") after removal from the delivery sleeve (e.g., a sleeve shaft). Figure 5 ).

[0142] The 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 patient's vasculature), the body of the coil 102 between the proximal end 102p and the distal end 102d can form a substantially straight delivery configuration (i.e., without any coiled or looped portions) so as to maintain a low radial profile while moving through the patient's vasculature. After being removed from the delivery sleeve and deployed at the implantation site, the coil 102 can be moved from the delivery configuration to a helical deployment configuration and surround native tissue adjacent to the implantation site. For example, when the docking device is implanted at the site of a native valve, the coil 102 can be configured to surround the native leaflets of the native valve (and the chordae tendineae connecting the native leaflets to the adjacent papillary muscles, if present).

[0143] The docking device 100 can be releasably coupled to a delivery device. In some examples, the docking device 100 can be coupled to the delivery device via a release suture that can be configured to be tied to the docking device 100 and cut for removal (as described below with reference to Figure 6 and 8 102p). In one example, the release suture can be tied to the docking device 100 through a small hole or eyelet located near the proximal end 102p of the coil. In some examples, the release suture can be tied around a circumferential recess located near the proximal end 102p of the coil 102.

[0144] In some examples, the docking device 100 in the deployed configuration can be configured to fit at the mitral valve location. In some examples, the docking device can also be shaped and / or adapted for implantation at other native valve locations, such as the tricuspid valve. In some examples, the geometry of the docking device 100 can be configured to engage native anatomical structures, which can, for example, achieve increased stability and reduced relative motion between the docking device 100, the prosthetic valve docked therein, and / or the native anatomical structure.

[0145] like Figure 5 As shown in FIG, the coil 102 in a deployed configuration may include a leading turn 106 (or "leading coil"), a central region 108, and a stabilizing turn 110 (or "stabilizing coil"). The central region 108 may have one or more spiral turns having substantially equal inner diameters. The leading turn 106 may extend from a distal end of the central region 108 and have a diameter that is larger than the diameter of the central region 108 (in one or more configurations). The stabilizing turn 110 may extend from a proximal end of the central region 108 and have a diameter that is larger than the diameter of the central region 108 (in one or more configurations).

[0146] In some examples, the central region 108 may include a plurality of spiral turns, such as a proximal turn 108p connected to the stabilizing turn 110, a distal turn 108d connected to the leading turn 106, and one or more intermediate turns 108m disposed between the proximal turn 108p and the distal turn 108d. Figure 5 In the example shown in FIG, there is only one intermediate turn 108m between the proximal turn 108p and the distal turn 108d.

[0147] In some examples, there may be more than one intermediate turn 108m (e.g., two, three, etc.) between the proximal turn 108p and the distal turn 108d. Some of the spiral turns in the central region 108 may be full turns (i.e., a 360-degree rotation). In some cases, the proximal turn 108p and / or the distal turn 108d may be partial turns (e.g., a rotation less than 360 degrees, such as 180 degrees, 270 degrees, etc.).

[0148] The size of the docking device 100 can 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 can be configured to hold a radially expandable prosthetic valve. For example, when the prosthetic valve is radially expanded, the inner diameter of the helical turns in the central region 108 can be configured to be smaller than the outer diameter of the prosthetic valve so that additional radial tension can act between the central region 108 and the prosthetic valve to hold the prosthetic valve in place. The helical turns (e.g., 108p, 108m, 108d) in the central region 108 are also referred to herein as "functional turns."

[0149] Stabilizing turns 110 can be configured to help stabilize docking device 100 in a desired position within the anatomy surrounding the implant site. For example, the radial dimension of stabilizing turns 110 can be significantly larger than the radial dimension of the coils in central region 108, allowing stabilizing turns 110 to flare or extend sufficiently outward to abut or push against the walls of the heart's atria, thereby improving the ability of docking device 100 to remain in its desired position prior to implantation of a prosthetic valve. In some examples, the diameter of stabilizing turns 110 is larger than the native valve annulus, the plane of the native valve, and the atria to facilitate better stabilization. In some examples, stabilizing turns 110 can be full turns (i.e., rotated approximately 360 degrees). In some examples, stabilizing turns 110 can be partial turns (e.g., rotated between approximately 180 and approximately 270 degrees).

[0150] In one particular example, when the docking device 100 is implanted in the position of the native mitral valve, the functional turns in the central region 108 can be positioned substantially in the left ventricle, and the stabilizing turns 110 can be positioned substantially in the left atrium. The stabilizing turns 110 can be configured to provide one or more contact points or contact areas between the docking device 100 and the left atrial wall, such as at least three contact points in the left atrium or complete contact on the left atrial wall. In some examples, the contact points between the docking device 100 and the left atrial wall can form a plane that is substantially parallel to the plane of the native mitral valve.

[0151] As described above, the leading turn 106 can have a larger radial dimension than the spiral turns in the central region 108. The leading turn 106 can help more easily guide the coil 102 around and / or through the chordae tendineae geometry and fully surround all native leaflets of the native valve (e.g., native mitral valve, tricuspid valve, etc.). For example, once the leading turn 106 is guided around the desired native anatomy, the remaining coils of the docking device 100 (e.g., functional turns) can also be guided around the same feature. In some examples, the leading turn 106 can be a full turn (i.e., rotated approximately 360 degrees). In some examples, the leading turn 106 can be a partial turn (e.g., rotated between approximately 180 degrees and approximately 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 can further expand radially. As a result, the leading turn 106 can be pulled in a proximal direction, can decrease in diameter, and can become a portion of the functional turns in the central region 108.

[0152] In some examples, at least a portion of the coiled tubing 102 may be surrounded by a first cover. The first cover may be constructed from a variety of natural and / or synthetic materials. In one particular example, the first cover may comprise expanded polytetrafluoroethylene (ePTFE). In some examples, the first cover is configured to be fixedly attached to the coiled tubing 102 (e.g., via a textured surface, sutures, glue, thermal bonding, or any other means) such that relative axial movement between the first cover and the coiled tubing 102 is limited or prohibited.

[0153] The protective member 104 may constitute a part of a cover assembly of the docking device 100. In some examples, the cover assembly may further include the first cover.

[0154] In such Figure 5 In the exemplary example shown in , when the docking device 100 is in the deployed configuration, the protective member 104 can be configured to cover a portion of the stable turn 110 of the coiled tubing 102. In some examples, the protective member 104 can be configured to cover at least a portion of the central region 108 of the coiled tubing 102, such as a portion of the proximal turn 108p. In some examples, the protective member 104 can extend over the entirety of the coiled tubing 102.

[0155] In some examples, the guard member 104 can be radially expandable to help prevent and / or reduce paravalvular leakage. Specifically, the guard member 104 can be configured to radially expand so as to form an improved seal closer to and / or against a prosthetic valve deployed within the docking device 100. In some examples, the guard member 104 can be configured to prevent and / or inhibit leakage at a location where the docking device 100 spans between the leaflets of a native valve (e.g., at the junction of the native leaflets).

[0156] In some examples, when the docking device 100 is deployed at a native atrioventricular valve (e.g., the mitral valve or the tricuspid valve) and the protective member 104 substantially covers a portion of the stabilizing turn 110 and / or a portion of the central region 108, the protective member 104 can help cover the atrial side of the atrioventricular valve to prevent and / or inhibit blood leakage through the native valve leaflets, commissures, and / or around the outside of the prosthetic valve by blocking blood in the atria from flowing in the atrial to ventricular direction (i.e., antegrade blood flow) unless through the prosthetic valve.

[0157] In some examples, the protective member 104 may be positioned on the ventricular side of the ventricular valve to prevent and / or inhibit blood leakage through the native leaflets, commissures and / or around the outside of the prosthetic valve by blocking blood in the ventricle from flowing in a ventricular to atrial direction (i.e., retrograde blood flow).

[0158] In some examples, the distal portion 104d of the guard member 104 can be fixedly coupled to the coiled tubing 102 (eg, via a distal suture), and the proximal portion 104p of the guard member 104 can be axially movable relative to the coiled tubing 102 .

[0159] In some cases, when the guard member 104 is in the radially expanded state, the proximal portion 104p of the guard member 104 may have a Figure 5 , such that the diameter of the proximal portion 104p gradually increases from the proximal end of the guard member 104 to the distally located main body portion of the guard member 104. This can, for example, facilitate loading the docking device into a delivery sleeve (e.g., a sleeve shaft) of a delivery device and / or removing and / or repositioning the docking device into the delivery device during an implantation procedure.

[0160] Figure 6-10 A device configured to connect a docking device (e.g., Figure 5 The delivery device 200 is an example of a delivery device (also referred to as a delivery system) 200 for delivering the docking device 100 described above to a target implantation site (e.g., an animal, human, cadaver heart and / or native valve, cadaver heart, anthropomorphic ghost, etc.). In some examples, the delivery device 200 can be a transcatheter delivery device that can be used to guide the docking device installed therein through the patient's vasculature, as described above with reference to Figure 1-2B Explained.

[0161] The exemplary delivery device 200 is Figure 6 , where the docking device 232 is at least partially deployed from the distal end of the delivery device 200 (e.g., for illustrative purposes). In some examples, the docking device 232 can be the docking device described above with reference to FIG. Figure 5 The docking device 100 is described. Figure 7 and8 Shown where the sleeve shaft 280 covers the docking device 232 ( Figure 7 ) and after the quill 280 has been removed from the docking device 232 (but before the docking device 232 is disconnected from the delivery device 200) ( Figure 8 ) of a delivery device 200, wherein a docking device 232 is deployed from an outer shaft 260 of the delivery device. Figure 9 and 10 is a schematic cross-sectional view of the delivery device 200 illustrating the multiple lumens formed between the coaxial components of the delivery device 200.

[0162] Return to Figure 6 , the delivery device 200 may include a handle assembly 220 and an outer shaft (eg, 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. Figure 6 As shown in FIG, the handle assembly 220 may include a handle 222 including one or more knobs, buttons, rollers, etc. For example, as shown in FIG. Figure 6 As shown in , handle 222 can include knobs 224 and 226 that can be configured to control the bending of a delivery device, such as outer shaft 260. Outer shaft 260 extends distally from handle 222, while hub assembly 230 extends proximally from handle 222.

[0163] The delivery device 200 may include a device coaxially positioned within the outer shaft 260 ( Figure 9 and 10 ) and each having a pusher shaft 290 ( Figure 6 and 8 -10) and sleeve shaft 280 ( Figure 7-10 The pusher shaft 290 can be configured to deploy the docking device 232 from within the distal portion of the outer shaft 260 upon reaching the target implantation site, and the sleeve shaft 280 can be configured to deploy the docking device 232 from within the distal portion of the outer shaft 260 upon reaching the target implantation site, and the sleeve shaft 280 can be configured to deploy the docking device 232 from within the delivery device 200 ( Figure 9 and 10 ) and when positioned at the target implantation site ( Figure 7 ) covers the docking device. In addition, the delivery device 200 can be configured to adjust the axial position of the sleeve shaft 280 to remove the sleeve portion (e.g., distal portion) of the sleeve shaft 280 from the docking device after the docking device 232 is implanted at the target implantation site ( Figure 8 ). Figure 7 and 8 FIG. 2 is a diagram showing an exemplary docking device 232 ( FIG. 20 ) deployed from the outer shaft 260 of the delivery device 200 and covered by the distal (or sleeve) portion 282 of the sleeve shaft 280. Figure 7) and the exemplary docking device 232 after the quill 280 has been retracted into the outer shaft 260 ( Figure 8 ) perspective view.

[0164] Thus, the sleeve shaft 270 can be removed from the docking device 232. In some examples, the distal portion 282 of the sleeve shaft 280 can have an outer surface that includes a lubricating or low-friction material that makes it easier to slide the docking device 232 into place over the native anatomy at the implantation site.

[0165] like Figure 6 and 8 As shown in , during delivery, the docking device 232 can be coupled to the delivery apparatus 200 via a release suture 236 (or other retrieval line comprising a string, yarn, or other material that can be configured to be tied around the docking device and sheared for removal) that can extend through the pusher shaft 290. The release suture 236 can extend through the delivery apparatus 200, through the inner lumen of the pusher shaft 290, to the suture lock assembly 206 of the delivery apparatus 200.

[0166] like Figure 6 As shown in FIG, the hub assembly 230 can include a suture lock assembly (e.g., a suture lock) 206 and a sleeve handle 234 attached thereto. The hub assembly 230 can be configured to control the pusher shaft 290 and the sleeve shaft 280 of the delivery device 200 together (e.g., move them axially together), while the sleeve handle 234 can control the axial position of the sleeve shaft 280 relative to the pusher shaft 290. In this way, operation of the various components of the handle assembly 220 can actuate and control the operation of components disposed within the outer shaft 260. In some examples, such as Figure 6 As shown in , hub assembly 230 may be coupled to handle 222 via connector 240 .

[0167] In some examples, the hub assembly 230 may include a Y-shaped connector (e.g., an adapter) having a straight section (e.g., a straight conduit) 202 and at least one branch (e.g., a branch conduit) 204 (although in some examples, it may include more than one branch) ( Figure 6 In some examples, the suture lock assembly 206 can be attached to the branch 204 , and a sleeve handle 234 (eg, a sleeve actuation handle) can be disposed at the proximal end of the straight section 202 .

[0168] Additional details regarding the delivery device 200 and variations thereof, including details regarding a suture lock assembly and a pusher shaft and sleeve shaft assembly for a delivery device for a docking device, are described in International Patent Publication No. WO 2020 / 247907, incorporated herein by reference. Additional details regarding additional delivery systems and devices configured to deliver a docking device to a target implantation site can be found in U.S. Patent Publication Nos. US2018 / 0318079, US2018 / 0263764, and US2018 / 0177594, each of which is incorporated herein by reference in its entirety.

[0169] Return to Figure 6 The handle assembly 220 may also include one or more flushing ports for supplying flushing fluid to one or more lumens disposed within the delivery device 200 (e.g., annular lumens disposed between coaxial components of the delivery device 200) to reduce the likelihood of thrombosis and / or degas components of the delivery device 200 prior to insertion into a patient. Figure 6 An example is depicted in which the delivery device 200 includes three irrigation ports (e.g., irrigation ports 210, 216, and 218). In alternative examples, the delivery device 200 may not include irrigation port 216, or irrigation port 210 may be positioned at one end of the suture lock assembly 206 (e.g., as shown in FIG. Figure 9 and 10 shown).

[0170] For example, as an exemplary simplified schematic diagram of a delivery device 200, Figure 9 and 10 As shown in FIG, a plurality of lumens configured to receive fluids are formed between the docking device 232, the pusher shaft 290, the sleeve shaft 280, and the outer shaft 260. More specifically, a first pusher shaft lumen 201 can 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 lumen 211 is formed within the sleeve shaft 280. Additionally, a third delivery shaft lumen 215 (or outer shaft lumen) can be formed in an annular space formed between the inner surface of the outer shaft 260 and the outer surface of the sleeve shaft 280.

[0171] like Figure 9 As shown, the pusher shaft lumen 201 can receive fluid directly from a first fluid source or flush port 210, which can be fluidically coupled to a portion of the handle assembly, such as one end of the suture lock assembly 206. Figure 9 and 10 Alternatively, Figure 6As shown in FIG, an irrigation port 210 can be coupled to a location along branch 204. An irrigation fluid stream 203 from the irrigation port 210 can travel along the length of the main tube 292 of the pusher shaft 290 through the pusher shaft lumen 201 to the distal end 293 of the pusher shaft 290. A first portion of the irrigation fluid stream 203 can flow as an irrigation fluid stream 207 into the first portion 205 of the sleeve shaft lumen 211 disposed between the outer surface of the docking device 232 and the inner surface of the distal portion 282 of the sleeve shaft 280. In some examples, the irrigation fluid stream 207 can flow through the protective member 231 of the docking device 232 (which can be connected to the distal end 293 of the sleeve shaft 280). Figure 5 104). A second portion of the irrigation fluid stream 203 may also flow as irrigation fluid stream 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 irrigation fluid stream 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 fluidically coupled to the shell portion 294, the irrigation fluid stream 213 may continue into and through the delivery shaft lumen 215 toward the distal end 262 of the outer shaft 260.

[0172] like Figure 10 , the lumen of the delivery device 200 can also receive fluid from a second fluid source, or irrigation port 216, as shown in FIG. The irrigation port 216 can be fluidly coupled to a cavity 254 disposed about the main tube 292 of the pusher shaft 290 in the hub assembly 230. The cavity 254 is fluidly coupled to an annular cavity 219 defined by the shell portion 294, and the annular cavity 219 is fluidly coupled to the delivery shaft lumen 215. Thus, an irrigation fluid stream 221 from the irrigation port 216 can travel through the cavity 254 and into and through the annular cavity 219. The irrigation fluid stream 221 can then be divided into a first irrigation fluid stream 217 that enters and passes through the delivery shaft lumen 215 and a second irrigation fluid stream 223 that enters and passes through the sleeve shaft lumen 211.

[0173] Although fluid flow may be provided to the quill lumen 211 in various circumstances, as described above with reference to Figure 9 and 10 As described above, because the irrigation fluid flow may be split between the sleeve shaft lumen 211 and the delivery shaft lumen 215, a threshold fluid pressure may not be reached to adequately irrigate and degas the docking device (e.g., the guard member 231 of the docking device 232). Therefore, it is desirable to force all or most of the irrigation fluid flow provided by the one or more irrigation ports of the delivery device 200 through the sleeve shaft lumen 211 in order to degas the sleeve shaft lumen 211 and the guard member (or alternative covering) of the docking device.

[0174] Now turn to see Figure 11-16, shows an exemplary sealing mechanism 300 for a catheter configured to regulate fluid flow through two axes of the catheter. For example, the sealing mechanism can be configured to seal around two axes of the catheter that are concentric with each other along at least a distal portion of the catheter (or one axis disposed around the other axis but with a slightly offset central axis) and divert the flow of fluid provided to the catheter through one of the two axes by blocking the flow of fluid from one end of the other axis. In some examples, the catheter is a delivery device for an implantable medical device, such as Figure 6-10 The delivery device 200. For example, Figure 11 (side view) and Figure 14 (Cross-sectional side view) shows sealing mechanism 300 coupled to outer shaft 260 and sleeve shaft 280 of delivery device 200. However, in alternative examples, sealing mechanism 300 can be used with various catheters and delivery devices that include two or more shafts (e.g., an inner shaft and an outer shaft) having fluidically coupled lumens. Figure 12 and 13 showing an alternative end view of the sealing mechanism 300, Figure 15 A cross-sectional perspective view of the sealing mechanism 300 is shown, and Figure 16 An exploded view of the sealing mechanism 300 is shown.

[0175] 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 housing the first seal 302 therein and a second seal housing 308 housing the second seal 304 therein. The first seal 302 and the second seal 304 may be annular in shape having an aperture (e.g., a central aperture) configured to receive a shaft therethrough, such as Figure 14 and 15 As shown in .

[0176] The first seal housing 306 and the second seal housing 308 may be coupled to each other at an interface 310 ( Figure 11 、 14 In some examples, the interface 310 is an overlapping interface where a portion of the first seal housing 306 overlaps a portion of the second seal housing 308 (e.g., Figure 11 and 14 -16). In an alternative example, the interface 310 is an overlapping interface in which a portion of the second seal housing 308 overlaps a portion of the first seal housing 306. In some cases, the first and second seal housings 306, 308 may be coupled together by one or more fasteners extending through one or more holes 312 (or apertures) in the first and second seal housings 306, 308. Figure 11 and 15 ).

[0177] The first seal housing 306 may include a proximal portion 314, a middle portion 316, and a distal portion 318 ( Figure 14-16 The proximal portion 314 has a first inner diameter 320 and includes a plurality of internal threads 322 ( Figure 15 ). In some examples, such as Figure 14 and 15 , the first seal 302 can be disposed within a middle portion 316 of the first seal housing 306. The middle portion 316 can also have a first inner diameter 320. In an alternative example, the first seal 302 can be disposed in a more distal portion of the first seal housing 306.

[0178] The distal portion 318 of the first seal housing 306 may have a second inner diameter 326 ( Figure 15 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 ( Figure 11 and 14 -16). In some cases, the collar portion 328 can have a third inner diameter 330 that is larger than the second inner diameter 326. In some examples, the third inner diameter 330 can be the same as the first inner diameter 320. In alternative examples, the third inner diameter 330 can be larger or smaller than the first inner diameter 320 while still being larger than the second inner diameter 326.

[0179] In some examples, the first seal housing 306 may also include a transition portion 332 including a tapered or angled step 334 that decreases in diameter from the first inner diameter 320 to the second inner diameter 326. Furthermore, in some cases, the angled step 334 may be annular and extend around the circumference of the first seal housing 306. In alternative examples, the step of the transition portion 332 may be a right-angled step rather than an angled step.

[0180] In some cases, the first seal 302 is shaped so that its distal portion tapers to match the taper or inclination of the inclined step 334. Thus, the first seal 302 can be shaped to fit within the intermediate portion 316 and the transition portion 332 against the inclined step 334.

[0181] The sealing mechanism 300 may also include a first threaded member 336 ( Figure 14-16 Specifically, the first threaded member 336 may include external threads 338 configured to mate with the internal threads 322 of the first seal housing 306 ( Figure 14 and 15). A first knob 340 (or alternative rotatable element) may be secured to the first threaded member 336 and configured to rotate ( Figure 11-16 ). In some cases, the first knob can 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 can 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 sealing 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 can contact and push against the proximal end 344 of the first seal 302 ( Figure 14 and 15 ), thereby around an axis disposed therein (e.g., Figure 14 36 ). In this manner, the first seal 302 can be tightened about and sealed against a shaft disposed therein by rotating the first knob 340 (and, therefore, the first threaded member 336). Additionally, compressing the first seal 302 with the first knob 340 can also axially lock the sealing mechanism 300 to the shaft disposed therein, thereby ensuring that the sealing mechanism 300 remains connected to the shaft during flushing under relatively high fluid pressures, as described below.

[0182] The second seal housing 308 may include a proximal portion 346, a middle portion 348, and a distal portion 350 ( Figure 14-16 The proximal portion 346 may have a fourth inner diameter 352 at its proximal end 356 and a fifth inner diameter 354 in a more distal region of the proximal portion 346, wherein the fifth inner diameter 354 is smaller than the fourth inner diameter 352 ( Figure 15 The proximal end 356 of the proximal portion 346 can interface and couple with the first seal housing 306, such as to the collar portion 328 ( Figure 14 and 15 In some cases, fourth inner diameter 352 can be the same as second inner diameter 326 of distal portion 318 of first seal housing 306 .

[0183] In some examples, a step 358 in the proximal portion 346 transitions between the fourth inner diameter 352 and the fifth inner diameter 354. Figure 14 and 15 ). The step 358 may also serve as a stop configured to interface with the distal end of a shaft (eg, outer shaft 260) extending through the first seal housing 306. For example, Figure 14As shown in FIG, 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. Figure 14 , the distal end 262 of the outer shaft 260 can reside in the cavity 360. Furthermore, as explained in more detail below, when the first seal 302 is tightened around the first shaft (e.g., the outer shaft 260) and the second seal 304 is tightened around the second shaft (e.g., the quill 280), the cavity 360 can be fluid-sealed by the walls of the first seal housing 306, the second seal housing 308, the first seal 302, and the second seal 304.

[0184] In some examples, such as Figure 14 and 15 As shown in FIG, the second seal 304 can be disposed within a middle portion 348 of the second seal housing 308. The middle portion 348 can have a sixth inner diameter 362 that is greater than the fifth inner diameter 354.

[0185] In some examples, the second seal housing 308 may also include a transition portion 364 including a tapered or inclined step 366 that increases in diameter from the fifth inner diameter 354 to the sixth inner diameter 362. Furthermore, in some cases, the inclined step 366 may be annular and extend around the circumference of the second seal housing 308. In alternative examples, the step of the transition portion 364 may be a right-angled step rather than an inclined step.

[0186] In some cases, the second seal 304 is shaped so that its proximal portion tapers to match the taper or inclination of the inclined step 366. Thus, the second seal 304 can be shaped to fit within the intermediate portion 348 and the transition portion 364 against the inclined step 366.

[0187] 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. An inclined step 366 may then taper from the larger sixth inner diameter 362 to a diameter that is larger than fifth inner diameter 354.

[0188] The distal portion 350 of the second seal housing 308 has a seventh inner diameter 368 and includes a plurality of internal threads 370 ( Figure 15 ).like Figure 14 and 15 As shown in FIG, threads 370 are provided on the distal side of the second seal 304 in the second seal housing 308 .

[0189] The sealing mechanism may also include a second threaded member 374 ( Figure 14-16 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 ( Figure 11-16 ). In some cases, the second knob 378 can 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 can 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 advances proximally (toward the first seal housing 306), the proximal end 380 of the second threaded member 374 can contact and push against the distal end 382 of the second seal 304 ( Figure 14 and 15 ), thereby around an axis disposed therein (e.g., Figure 14 280) is used to compress the second seal 304. In this manner, the second seal 304 can be tightened around and sealed against a shaft disposed therein by rotating the second knob 378 (and, therefore, the second threaded member 374). Additionally, compressing the second seal 304 with the second knob 378 can also axially lock the sealing mechanism 300 to the shaft disposed therein, thereby ensuring that the sealing mechanism 300 remains connected to the shaft during flushing under relatively high fluid pressures, as described below.

[0190] 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., Figure 14 ). The second threaded member 374 and the inner surface of the second seal 304 can define a second lumen 386 of the sealing mechanism 300 having a second diameter 387 configured (shaped) to receive a second shaft (e.g., Figure 14 ). The second diameter 387 may be smaller than the first diameter 385.

[0191] Figure 17 is a flow chart of an exemplary method 400 for selectively directing a fluid flow through a conduit comprising a plurality of shafts at least partially concentric with one another (or one shaft disposed within another with a slightly offset central longitudinal axis). Specifically, the method 400 may be a flow chart for operating Figure 11-16The method 400 is a method for operating a sealing mechanism 300 to block fluid flow from a first axis of a catheter and direct fluid flow through a second axis of the catheter. However, the method 400 may also be a method for operating other sealing mechanisms such as the sealing mechanism 500 or the sealing mechanism 600 described herein. In some examples, the catheter may be Figure 6-10 In the delivery device 200 , the first shaft may be an outer shaft 260 , and the second shaft may be a sleeve shaft 280 .

[0192] The method 400 begins at 402 and includes attaching the first seal 302 of the sealing mechanism 300 to a first shaft of a catheter (eg, the outer shaft 260, such as Figure 14 Attaching the first seal 302 to the first shaft may include extending the distal portion of the first shaft into the first lumen 384 of the sealing mechanism 300, through the first seal 302, and into the cavity 360 of the sealing mechanism 300 (e.g., as shown in FIG. Figure 14 ). Additionally, in some examples, the distal end of the first shaft can hit or contact a stop (e.g., step 358) in the second seal housing 308. Attaching the first seal 302 to the shaft can also include tightening the first seal 302 around the first shaft, for example, by rotating the first knob 340 and the first threaded member 336.

[0193] At 404, the method includes attaching the second seal 304 of the sealing mechanism 300 to a second shaft of a catheter extending through the first shaft (eg, as shown in FIG. 1 ). Figure 14 Attaching the second seal 304 to the second shaft may include attaching the distal portion of the second shaft to the distal end of 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 the distal portion of the second shaft through the distal end of the first shaft and extending distally of the distal end 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 tightening the second seal 304 around the second shaft, for example, by rotating the second knob 378 and the second threaded member 374. In an alternative example, when the second seal is instead a non-actively compressible seal (e.g., an O-ring in sealing mechanism 500 or sealing mechanism 600), the method may include extending the distal portion of the second shaft through the second seal at 404, wherein the second seal fits tightly around the second shaft and seals against the second shaft.

[0194] After tightening the first seal 302 and the second seal 304 , the lumen 360 can be fluid-tight (eg, no fluid can exit the lumen 360 ), thereby closing the distal end of the first shaft so that fluid from the first lumen of the first shaft cannot exit the lumen 360 .

[0195] Method 400 may continue at 406 by flowing the fluid through the catheter such that the fluid flows only through 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 degassed. For example, when the second shaft is a cannulated shaft 280, flowing the fluid through the catheter and only through the second lumen (and not the first lumen) may effectively and efficiently degas a docking device disposed within the cannulated shaft prior to an implantation procedure.

[0196] Figure 18-21 An exemplary sealing mechanism 500 for a catheter configured to regulate fluid flow through two shafts of the catheter is shown. Figure 18 and 19 is a perspective view of the sealing mechanism 500 . Figure 20 is a cross-sectional side view of the sealing mechanism 500 . Figure 21 is another cross-sectional side view showing sealing mechanism 500 coupled to outer shaft 260 and sleeve shaft 280 of delivery device 200. However, in alternative examples, sealing mechanism 500 may be used with various catheters and delivery devices that include two or more shafts having fluidly coupled lumens.

[0197] Sealing mechanism 500 may be similar to sealing mechanism 300, except that instead of two compressible seals (or gaskets) that are compressible about respective axes via a rotatable element, sealing mechanism 500 may include a compressible seal or gasket that is compressible about a first axis of the conduit and a non-active compressible seal (e.g., an O-ring) disposed about a second axis of the conduit.

[0198] refer to Figure 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 having an aperture (eg, a central aperture) configured to receive a shaft therethrough.

[0199] In some examples, the first seal 502 is a compressible seal or gasket that is configured to be compressed around an outer shaft (e.g., outer shaft 260) via a rotatable element 508 in a manner similar to the first knob 340 and the first threaded member 336 of the sealing mechanism 300. In some examples, the second seal 504 is a non-active compressible seal, such as an O-ring, that is shaped to fit tightly around and seal against an inner shaft (e.g., quill 280). As used herein, the term non-active means "without additional interaction (e.g., rotation, clamping, etc.) provided by a user and / or other mechanisms."

[0200] The rotatable element 508 can also be configured to axially lock the sealing mechanism 500 in place with the system when pressurized. The compressible seal that forms the axial lock can be provided on the outer shaft 260 rather than on the quill 280 because, in at least some cases, the quill 280 can have a hydrophilic coating that can reduce the axial retention of the seal and the rotatable element.

[0201] The rotatable element 508 may include a rotatable knob 510 and a threaded member 512 extending distally from the rotatable knob 510. The threaded member 512 may include one or more external threads 514 (or protrusions) ( Figure 19 ), the one or more external threads being configured to interface with the internal threads 516 on the inner surface 520 of the housing ( Figure 19-21 ). In some examples, such as Figure 19 As shown in FIG, the external threads 514 can 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 can also include one or more locking elements 518 (e.g., tabs or cantilevered protrusions) configured to snap-engage with the internal threads 516 and maintain the rotatable element 508 connected to the housing 506 (e.g., from disengaging from the housing 506 when the rotatable element 508 is fully released).

[0202] The rotatable element 508 can be rotatable relative to the housing 506 such that the threaded member 512 moves distally against the first seal 502, axially pushing the first seal 502 against the curved edge 532 (or beveled edge) of the housing 506, which in turn radially compresses the first seal 502 against a shaft disposed therein, thereby rotating the first seal 502 about the shaft (e.g., Figure 21 The outer shaft 260 shown in FIG. 2 is tightened to the first seal 502. It should be noted that the radial compression of the first seal 502 is comparable to Figure 21 The radial compression shown in FIG5 is more pronounced, and in some examples, the first seal 502 may be pressed further against the curved edge 532 and have a smaller inner diameter when pushed axially against the housing 506 .

[0203] The internal threads 516 of the housing 506 can be disposed at a first end portion 522 of the housing 506 that is proximal to a cavity 524 defined by an inner surface 520 of the housing 506 ( Figure 20 ). The first seal 502 can be disposed within the housing 506 adjacent to and distal to the internal threads 516.

[0204] The inner surface 520 of the housing 506 may further 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 ( Figure 20 and 21 The first seal 502 is disposed within the housing 506 adjacent to and proximal to the larger diameter portion 528 of the cavity 524, and the second seal 504 is disposed within the housing 506 adjacent to and distal to the smaller diameter portion 530 of the cavity 524. Figure 20 and 21 In this manner, a cavity 524 may be defined between the first seal 502 and the second seal 504 .

[0205] 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 ( Figure 21 ). As a result, 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 that seals around the distal portion of the outer shaft 260 (e.g., when the rotatable element 508 is rotated, it axially pushes the first seal 502 (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 sleeve shaft 280 can then extend through the distal end 262 of the outer shaft 260 and extend distally thereto and through the smaller diameter portion 530 of the cavity 524 and the second seal 504. The second seal 504 can be sized to fit tightly around the outer surface of the sleeve shaft 280 so that it is fluid-tight around the sleeve shaft 280. Thus, fluid passing through the delivery device can be prevented from exiting the distal end of the outer shaft 260 and instead forced through the sleeve shaft 280, as Figure 21 As shown in and described above with reference to the sealing mechanism 300 and the method 400 .

[0206] Figure 22 and 23 An exemplary sealing mechanism 600 for a catheter configured to regulate fluid flow through two shafts of the catheter is shown. Sealing mechanism 600 can be similar to sealing mechanism 600, except that instead of one compressible seal or gasket that can be compressed around the outer shaft and one non-compressible seal (e.g., an O-ring) configured to seal around the inner shaft, sealing mechanism 600 can include two non-actively compressible seals (e.g., two O-rings).

[0207] For example, Figure 22 and 23 As shown in FIG, the sealing mechanism 600 may include a housing 602 ( Figure 22), a first seal 604 disposed in a first end portion 608 of the housing 602 and a second seal 606 disposed in a second end portion 610 of the housing 602 ( Figure 23 ). The first seal 604 can be larger than the second seal 606. For example, the first inner diameter 605 of the first seal 604 can be larger than the second inner diameter 607 of the second seal 606, where the first inner diameter 605 is shaped to receive and seal around a first shaft (e.g., outer shaft 260), and the second inner diameter 607 is shaped to receive and seal around a second shaft (e.g., quill shaft 280).

[0208] Similar to the sealing mechanisms described above, the inner surface 612 of the housing 602 may define a cavity 614 ( Figure 23 The housing 602 may further 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 .

[0209] The first seal 604 can be configured to fit tightly around and seal against the outer surface of the outer shaft of the catheter (e.g., outer shaft 260), and the step 616 can form a stop for the distal end of the outer shaft. The second seal 606 can be configured to fit tightly 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 can be fluid-tightly sealed against the respective shafts of the catheter without utilizing a rotatable element or knob, and the distal end of the catheter outer shaft can reside in the cavity 614 disposed between the first seal 604 and the second seal 606. Thus, flow out of the outer shaft can be blocked, thereby forcing all or most of the irrigation fluid introduced into the outer shaft to exit through the lumen of the inner shaft (e.g., the quill lumen of quill 280).

[0210] In some examples, it may be necessary to aspirate fluid from the distal end of the inner shaft of the catheter (e.g., sleeve shaft 280) rather than flushing through the catheter and sealing mechanism as described above. Aspiration of fluid may be referred to herein as applying negative pressure to, for example, one end of the shaft, such that a vacuum is created and the fluid is pulled (rather than pushed) out of the shaft. In contrast, flushing a fluid as used herein may refer to using positive fluid pressure to propel a fluid through the shaft. In some examples, the fluid aspiration and flushing techniques described herein may be used together to direct a fluid through one or more shafts of a catheter.

[0211] In such fluid aspiration 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 both disposed distally of the second seal. Figure 24The sealing mechanism 500 is shown wherein the housing 506 further 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 can act as a stop for the distal end of the inner shaft (quill 280).

[0212] A luer attachment 554 can be attached to the housing 506 distal to the second lumen 550. The luer attachment 554 can be configured to receive a suction tool 556 (e.g., a syringe) for creating a vacuum within the second lumen 550 and aspirating the inner shaft. In some examples, an extension tube 558 can be connected between the luer attachment 554 and the suction tool 556.

[0213] In some examples, a method for withdrawing an inner shaft of a catheter may include: with the inner shaft (sleeve shaft 280) fully retracted within the outer shaft (outer shaft 260), a sealing mechanism (eg, Figure 24 554. The outer shaft is then positioned so that the distal end of the outer shaft abuts the step 526. If a sealing mechanism configuration with a rotatable element is used, the rotatable element 508 can be rotated, causing the first seal 502 to be axially compressed against the housing, thereby radially compressing the first seal 502 and tightening the first seal 502 around the outer shaft. The inner shaft (quill 280) can then be advanced against the step 552 through the second seal 504 and into the second lumen 550. Finally, a suction tool 556 (e.g., a syringe) can be attached to the Luer attachment 554, and the user can use the suction tool 556 to draw a vacuum to aspirate the catheter.

[0214] Figure 25 and 26 An example of a sealing mechanism 700 for sealing to a shaft of a catheter and drawing fluid out of the shaft is shown. The sealing mechanism 700 may include a clamshell member 702 configured to open and receive the shaft of the catheter (e.g., sleeve shaft 280) therein, such as Figure 25 For example, the clamshell member 702 may include a first half shell 704 and a second half shell 706, the second half shell including a slot or lumen 720 for receiving a shaft. In some examples, the second half shell 706 may be pivotable 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, such as Figure 25 ) to receive the shaft therein and then pivot toward and against the first half-shell 704 (into a closed configuration, as shown in Figure 25 ) to seal the shaft between the first half shell 704 and the second half shell 706.

[0215] In some examples, the first and second shell halves 704, 706 can 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 can be defined in the first and second shell halves 704, 706, the lumen configured to receive the catheter shaft therein.

[0216] Tube 714 can 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 can be fluidly connected to lumen 720 through the lumen of housing 712.

[0217] In some examples, the sealing mechanism 700 may include a locking mechanism configured as a sliding knob 718 that moves from a first position ( ) around a portion of the outer surface of the housing 712 to a position ( ). Figure 25 ) is axially slidable to a second position ( Figure 26 In the second position, the sliding knob 718 surrounds the first and second shell halves 704, 706, thereby locking the first and second shell halves in a closed and sealed position about the shaft. In some examples, the first and / or second shell halves 704, 706 may include a stop element 722 configured to prevent the sliding knob 718 from moving further toward the ends of the first and second shell halves 704, 706. Figure 26 Additionally or alternatively, in some examples, the sliding knob 718 can have an ergonomic grip around its outer surface (e.g., Figure 25 and 26 ).

[0218] In alternative examples, the sealing mechanism 700 may include additional or alternative locking mechanisms. For example, in an alternative example, instead of sliding, the knob 718 may be rotatable and have internal threads that interface with threads on the first and second shell halves 704, 706. Thus, the rotatable knob may be rotated and threaded onto the first and second shell halves 704, 706 to hold them together in a closed and sealed position.

[0219] 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 press together for release).

[0220] In some examples, the first and second housing halves 704, 706 can be spring-loaded by springs (e.g., torsion springs). For example, in some cases, the first and second housing halves 704, 706 can be spring-loaded such that the halves are forced open by the springs and can then be closed together under pressure and held closed by a locking mechanism (e.g., a sliding knob 718).

[0221] In some examples, the first and second half shells 704, 706 may be spring loaded such that the half shells are forced closed by the springs and then may be manually opened and moved by a user (thus eliminating the need for a locking mechanism in this instance).

[0222] Once the shaft (e.g., quill 280) is closed and sealed within the clamshell member 702, as shown Figure 26 As shown in , a suction tool can be connected to tube 714 and used to pull a vacuum and draw fluid through and out of the shaft.

[0223] In this way, the sealing mechanism 700 can be easily connected and sealed to the shaft that requires irrigation (sleeve shaft 280).In some examples, the shaft can extend outside and distally of the outer shaft of the catheter (eg, outer shaft 260) during the aspiration process.

[0224] Figure 27-34 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 is shown. The sealing mechanism 800 includes a seal housing 802, a seal 804 disposed within the seal housing 802, and a locking cap 806 (also referred to herein as a locking cap, locking member, or locking member) configured to interface with the seal housing 802 and the seal 804. The locking cap 806 is rotatable relative to the seal housing 802 (or vice versa) about a central longitudinal axis 805 to lock between an unlocked configuration (see, e.g., FIG. 1 ). Figure 32A ) with a locked configuration (see e.g. Figure 32B ) between which the sealing mechanism is moved.

[0225] In some examples, the sealing mechanism 800 may further include a tube 808 extending distally from the locking cap 806. In some cases, the tube 808 is a flexible tube comprising a flexible or compliant material that is configured to receive the shaft of a catheter therethrough (and allow the shaft to move / bend therein). For example, the tube 808 may be configured to take the shape of an inserted catheter shaft (e.g., a curved shape and / or a serpentine shape).

[0226] Figure 27 An assembled view of the sealing mechanism 800 is shown, and Figure 28 An exploded view of the sealing mechanism 800 is shown. Figure 27 and 28The central longitudinal axis 805 of the sealing mechanism 800 is shown in FIG. Figures 29A-29C Seal housing 802 is shown separately in Figure 30A and 30B , and the seal 804 is shown separately in Figure 31 In addition, Figure 32A and 32B depicts a side view of sealing mechanism 800, and Figure 33A and 33B A cross-sectional view of sealing mechanism 800 is depicted.

[0227] In some examples, sealing mechanism 800 can seal a shaft of a delivery device for an implantable medical device, such as Figure 6-10 The delivery device 200. For example, Figure 34 A sealing mechanism 800 is shown coupled to and sealing around the sleeve shaft 280 of the delivery device 200. The sealing mechanism 800 can also be used with (and / or adapted for use in conjunction with) various catheters and delivery devices that include two or more shafts having fluidly coupled lumens.

[0228] The locking cap 806 can be rotated relative to the seal housing 802 (or the locking cap 806 and the seal housing 802 can be rotated relative to each other, or the seal housing 802 can be rotated relative to the locking cap 806) so that the sealing mechanism 800 can be in an unlocked configuration ( Figure 32A and 33A ) and locked configuration ( Figure 32B 、 33B and 34), and in the locked configuration, compresses (and holds) the seal 804 tightly around a shaft disposed within and extending through the sealing mechanism 800. In this manner, the sealing mechanism 800 can be used to flush or draw fluid through the shaft, thereby degassing the shaft (and / or components disposed within the shaft).

[0229] like Figure 27-29C As shown, the locking cap 806 includes an outer wall 810 (or outer portion) and an inner wall 812 (or inner portion) extending proximally from an end wall 814 ( Figure 28 and 29A ), the end wall defines the distal end 816 (or second end) of the locking cap 806. The outer wall 810 and the inner wall 812 can extend to the open proximal end 818 (or first end) of the locking cap 806. The cross-section of the outer wall 810 and the inner wall 812 is annular. Therefore, the outer wall 810 and the inner wall 812 may be referred to herein as circumferentially extending walls and / or annular walls.

[0230] In some cases, the proximal end of the outer wall 810 at the proximal end 818 can include one or more flanges 820 that extend radially outward from the outer wall 810 and circumferentially around at least a portion of the outer wall 810 and the locking cap 806. For example, Figure 27-29C , the locking cap 806 can include two circumferentially extending flanges 820 separated from each other by a gap 822 (or space) in the circumferential direction. In this way, each flange 820 can extend around at least a portion of the circumference of the outer wall 810 (e.g., at least or more than 1 / 3 of the total circumference).

[0231] 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 of the gap 822 (in the circumferential direction) may be greater than or less than Figure 27-29C As shown in .

[0232] In some cases, the locking cap 806 includes one or more extensions 824 (or wings) extending radially outward from the outer wall 810. The one or more extensions 824 are configured to be grasped by a user to rotate the sealing mechanism 800 into a locked configuration and an unlocked configuration. Each extension 824 can intersect with one of the flanges 820. In some cases, such as Figure 27-29C As shown in FIG, the extension 824 extends further radially outward relative to the central longitudinal axis 805 than the flange 820.

[0233] For example, Figure 27-29C , the locking cap 806 can include two extensions 824 that are (circumferentially) spaced apart from each other and disposed on opposite sides of the locking cap 806 (e.g., across the central longitudinal axis 805 from each other). Thus, the extensions 824 can extend radially outward from the outer wall 810 relative to the central longitudinal axis 805 in opposite directions.

[0234] In some cases, locking cap 806 may include more or less than two extensions 824 (eg, one, three, etc.).

[0235] 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). Figure 28 and 29A ). Thus, cavity 826 can be formed by the space separating the outer surface of inner wall 812 and the inner surface of outer wall 810. As described further below, cavity 826 can be configured to receive a portion of seal housing 802 therein.

[0236] The lumen 828 is defined by the inner surface of the inner wall 812. The lumen 828 extends through the locking 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 that extends distally from the proximal end 818 configured to receive a shaft therethrough. Figure 28 and 29A ).

[0237] In some cases, the lumen 828 further includes a second lumen portion 832 extending proximally from the distal end 816 configured to receive the tube 808 therein. The tube 808 is configured to receive the shaft of a catheter therethrough. In this manner, the tube 808 can extend into the second lumen portion 832 and couple to the inner wall 812 of the locking cap 806. Thus, when disposed within the second lumen portion 832, the tube 808 can extend distally outward from the distal end 606 of the locking cap 806 (e.g., Figure 27 ).

[0238] In some cases, the inner surface of the inner wall 812 may define a step or annular protrusion 834 ( 834 ) that separates the first lumen portion 830 and the second lumen portion 832 . Figure 29B , and still Figure 33A and 33B In some cases, the second lumen portion 832 has a second diameter 836 that is smaller than the first diameter 838 of the first lumen portion 830 (e.g., Figure 33A ).

[0239] The inner wall 812 has an axially-facing proximal surface 840 at the proximal end 818 that is configured to interface with the seal 804 (as further described below).

[0240] In some examples, the inner wall 812 further includes one or more radially extending channels 842 (or apertures) extending between the inner surface and the outer surface of the inner wall 812 ( Figure 29A ). One or more channels 842 (e.g., Figure 29A Two are shown) are configured to receive one or more pins 844 ( Figure 28 ), the one or more pins and the seal housing 802 form a locking assembly of the sealing mechanism 800 (described further below). In this way, the pins 844 can extend through the corresponding channels 842 and be coupled to the locking cap 806.

[0241] In some examples, the pin 844 can be an integral part of the locking cap 806. For example, the pin 844 can be mounted within and attached to a corresponding channel 842 in the locking cap 806. In some examples, instead of being positioned within and projecting outwardly from the channel 842, the pin 844 can be attached to and project radially outwardly from the outer surface of the inner wall 812. In this manner, the pin 844 can, in some examples, be an extension of the inner wall 812.

[0242] Go to Figure 30A and 30B (as well as Figure 27 and Figure 28 ), the seal housing 802 includes a proximal end 848 ( Figure 27 and 28 ) and remote 850( Figure 30A and 30B ) between the cylindrical body portion 846. The inner surface of the cylindrical body portion 846 defines a cavity 852 therein. The axially facing proximal wall 854 ( Figure 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 diameter of the opening 856 is smaller than the diameter of the cylindrical body portion 846.

[0243] For example, the inner surface of the cylindrical body portion 846 may further define a lumen 845 extending from the opening 856 into the cylindrical body portion 846. The lumen 845 opens to a wider (larger diameter) lumen 852 at the tapered surface 853 ( Figure 30B 、 33A and 33B), the tapered surface being defined by the inner surface of the cylindrical body portion 846. The tapered surface 853 may be shaped to receive the seal 804 therein, as described below with reference to Figure 33A and 33B Further described, the ramped surface 853 is inclined at a non-zero angle relative to the central longitudinal axis 805 .

[0244] In some cases, such as Figures 27-28 As shown in FIGS. 30A-30B , the proximal wall 854 has a circumferentially extending extension or flange 858 that extends radially outward from the outer surface of the cylindrical body portion 846 and extends around at least a portion of the circumference of the cylindrical body portion 846 .

[0245] 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 when the sealing mechanism 800 is moved between the locked and unlocked configurations. In some examples, the one or more extensions 860 can intersect the flange 858. The extensions 860 extend further radially outward relative to the central longitudinal axis 805 than the flange 858.

[0246] although Figures 27-28 , 30A-30B, and 32A-34, two extensions 860 are depicted, but in alternative examples, the seal housing 802 may include more or less than two extensions 860 (eg, one, three, four, etc.).

[0247] The cylindrical body portion 846 includes one or more slots 862 (or at least one slot 862) extending therethrough between the inner and outer surfaces of the cylindrical body portion 846 (e.g., through the thickness of the cylindrical body portion 846, as defined in a radial direction). For example, Figures 27-28 As shown in FIG. 30A-30B , the cylindrical body portion 846 includes two slots 862 that are circumferentially spaced apart from each other (e.g., in some cases 180 degrees apart from each other). Each slot 862 can be configured to receive one of the pins 844, such as Figure 27 as well as Figure 32A and 32B 862 is equal to the number of pins 844. In alternative examples, more or less than two slots 862 and pins 844 are possible, wherein the number of pins 844 and slots 862 is equal.

[0248] like Figure 28 、 30A As shown in FIG30B and FIG30B , each groove 862 may have a non-straight shape, such as a curve. For example, each groove 862 may have a circumferentially extending portion at the second end 872 of the groove 862 and an axially extending portion at the first end 870 of the groove 862. The first end 870 and the second end 872 of the groove 862 are opposite ends of the groove 862. The first end 870 is closer to the distal end 850 ( FIG30B ) of the cylindrical body portion 846 than the second end 872 of each groove 862. Figure 30A ).

[0249] Thus, when the seal housing 802 and the lock cap 806 are rotated relative to each other between the locked configuration and the unlocked configuration, each pin 844 can slide within the corresponding slot 862 (between the opposing first end 870 and the second end 872) and accordingly cause the seal housing 802 and the lock cap 806 to move axially toward and away from each other, respectively (as further described below). Such relative movement between the seal housing 802 and the lock cap 806 causes the seal 804 to be axially compressed between the seal housing 802 and the lock cap 806 and radially compressed about (and / or radially expanded against) the shaft extending through the sealing mechanism 800.

[0250] The pin 844 and corresponding slot 862 may be configured to allow the seal housing 802 and locking cap 806 to rotate less than 360 degrees, 45-225 degrees, 70-200 degrees, 170-190 degrees, or 80-100 degrees relative to each other between the unlocked and locked configurations.

[0251] exist Figure 31 864 . A side view of the seal 804 is shown in FIG. The seal 804 includes a proximal portion 864 and a distal portion 866. The distal portion 866 is cylindrical (annular). In some examples, the proximal portion 864 is inclined or tapered so that its outer diameter decreases from the distal portion 866 to the proximal end of the proximal portion 864. The diameter of the lumen of the seal 804 can be relatively constant throughout the seal 804 (through the distal portion 866 and the proximal portion 864). In this way, the seal 804 can be configured to fit within the cavity 852 of the seal housing 802, and the inclined outer surface of the proximal portion 864 can be configured to interface with and mate against the tapered surface 853. The axially facing distal side 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 ( Figure 33A and 33B ).

[0252] Figures 32A-33B Describes the operation of the sealing mechanism 800. As described above, the locking component of the sealing mechanism 800 can be in an unlocked configuration (or position) (e.g., Figure 32A and 33A ) and locking configuration (or position) (e.g., Figure 32B and 33B ). For example, the locking assembly can be formed by a pin 844 that extends through (and / or is coupled to) the channel 842 of the locking cap 806 and slides along the slot 862. The seal housing 802 and the locking cap 806 are rotated relative to each other so that the pin 844 moves along the slot 862 at the head end 870 (e.g., Figure 32A , in an unlocked configuration) with the second end 872 of the slot 862 (as shown in FIG. Figure 32BThus, the sealing mechanism 800 provides a discrete binary sealing / unsealing state, which can make the device easy to use.

[0253] In the unlocked configuration, the pin 844 is disposed at the first end 870 of the slot 862 ( Figure 32A ) and the end wall 814 of the locking cap 806 and the distal end 850 of the seal housing 802 are spaced apart from each other by a first gap 874 ( Figure 33A ). In this position, the distal surface 868 of the seal 804 can be in close proximity to or positioned proximal to the proximal surface 840 of the inner wall 812 of the locking cap 806, but the seal 804 is in an uncompressed state (e.g., not compressed between the seal housing 802 and the inner wall 812 of the locking cap 806) or a less compressed state (such that it is not compressed against the catheter shaft extending therethrough). In this state, the tapered surface 853 of the cylindrical body portion 846 has a steeper angle and a larger diameter than the corresponding portion of the seal 804 (and there is a gap between the tapered surface 853 and the seal 804, as shown in FIG. Figure 33A ). Thus, in this configuration, a shaft can be inserted into the sealing mechanism 800 without the seal 804 being compressed and sealed around the shaft.

[0254] As an example, to move the sealing mechanism 800 from the unlocked configuration ( Figure 32A and 33A )Move to locked configuration( Figure 32B and 33B ), the user can hold the locking cap 806 stationary and rotate the seal housing 802 so that the pin 844 moves along the slot 862 to the second end 872 of the slot 862 and the seal housing 802 moves toward (in the axial direction) the locking cap 806.

[0255] In alternative examples, a user may rotate the seal housing 802 and the locking cap 806 relative to each other (in opposite rotational directions), or rotate the locking cap 806 relative to the seal housing 802 , to move the sealing mechanism 800 to the locked configuration.

[0256] As the seal housing 802 moves closer to the locking cap 806, the seal 804 is pressed against the proximal surface 840 of the inner wall 812 of the locking cap 806 (and thereby compressed in the axial direction), and the seal 804 is forced radially outward to fill the space between the tapered surface 853 and the seal 804, and also radially inward toward the central longitudinal axis 805. Thus, when the shaft is disposed within the sealing mechanism 800 (e.g., through the lumen 845 and the lumen of the tube 808), the axially compressed and radially expanded seal 804 is pressed against the outer surface of the shaft, thereby sealing against the shaft (and forming a fluid-tight seal). Figure 33BAs shown in FIG, in the locked configuration, the locking cap 806 and the seal housing 802 are spaced apart from each other by a second gap 876 ( Figure 33B ), the second gap is smaller than the first gap 874. In addition, the second diameter 878 of the lumen of the seal 804 in the locked configuration is smaller than the first diameter 880 of the lumen of the seal 804 in the unlocked configuration.

[0257] In some examples, such as Figure 34 As shown in FIG, the sealing mechanism 800 can be used with the delivery device 200. For example, when the sealing mechanism 800 is in the unlocked configuration, the sleeve shaft 280 (which extends distally of the distal end of the outer shaft 260) is inserted into the seal housing 802, through the seal housing 802, through the locking cap 806, and into the flexible tube 808 ( Figure 34 ). The locking cap 806 and the seal housing 802 are then rotated relative to each other to move the sealing mechanism 800 into the sealed and locked configuration (eg, Figure 34 ). A suction tool 890 can be attached to the distal end of the flexible tube 808 (at an attachment to the tube 808 or to an attachment to an extension tube 892 extending between the flexible tube 808 and the suction tool 890). Suction (or vacuum) is then created with the suction tool 890 (e.g., by pulling back a plunger of a syringe) to pull fluid through the catheter and out of the cannula 280, thereby aspirating the cannula 280.

[0258] In some examples, instead of being used for aspiration (or suction), the aspiration tool 890 can be filled with fluid and then used to push (and flush) the fluid through the sleeve shaft 280 (or another catheter shaft disposed within the sealing mechanism 800).

[0259] Alternatively (or in addition), the end of the flexible tube 808 can be open (not attached to a suction tool), and fluid from a source at the proximal end of the catheter (e.g., Figure 6 、 9 Fluid from the irrigation ports 210 , 216 and / or 218 in the handle assembly 220 shown in FIG. 10 ) is pushed into the catheter, into and through the sleeve shaft 280 .

[0260] Thus, a sleeve shaft or surrogate catheter shaft inserted into the sealing mechanism 800 may be effectively flushed and / or aspirated prior to use of the catheter during a procedure.

[0261] Delivery Technology

[0262] In order to implant the artificial valve in the native aortic valve via the femoral delivery method, the artificial valve is installed along the distal portion of the delivery device in a radially compressed state. The distal portion of the artificial valve and the 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 artificial valve is positioned in the native aortic valve and radially expanded (e.g., by inflating a balloon, actuating one or more actuators of the delivery device or deploying the artificial valve from a sheath to allow the artificial valve to self-expand). Alternatively, the artificial valve can be implanted in the native aortic valve in a transapical surgery, whereby the artificial valve (on the distal portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the artificial valve is positioned in the native aortic valve. Alternatively, in a transaortic procedure, 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 a right parasternal mini-thoracotomy, and is then advanced through the ascending aorta toward the native aortic valve.

[0263] To implant a prosthetic valve within the native mitral valve via a transseptal delivery method, the prosthetic valve is mounted in a radially compressed state along the distal portion of a delivery device. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a perforation created in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, the prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the prosthetic valve is positioned within the native mitral valve.

[0264] To implant the prosthetic valve into the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal portion of the delivery device. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava and into the right atrium, where the prosthetic valve is positioned within the native tricuspid valve. A similar method can be used to implant the prosthetic valve into 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.

[0265] Another delivery method is a transatrial approach, in which the 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 or left atrium) for access to any native heart valve. Atrial delivery can also be performed intravascularly, for example from the pulmonary veins. Yet another delivery method is a transventricular approach, in which the 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 right ventricular wall (usually at or near the base of the heart) for implantation of the prosthetic valve into the native tricuspid valve, native pulmonary valve, or pulmonary artery.

[0266] In all delivery methods, the delivery device can be advanced over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery methods are not intended to be limiting. Any of the artificial valves disclosed herein can be implanted using any of a variety of delivery procedures and delivery devices known in the art.

[0267] Any system, device, equipment etc. herein can be sterilized (for example, with heating / heat, pressure, steam, radiation and / or chemicals etc.) to ensure that they are safe for use for patient, and as one of the steps of method, any method herein can comprise the sterilization of associated system, equipment, device etc. The example of heating / thermal sterilization comprises steam sterilization and autoclave. The example of radiation for sterilization includes but is not limited to gamma radiation, ultraviolet radiation and electron beam. The example of chemical for sterilization includes but is not limited to ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde and glutaraldehyde. For example, hydrogen peroxide plasma can be used to complete with hydrogen peroxide sterilization.

[0268] Additional Examples of the Disclosed Technology

[0269] In view of the above embodiments of the disclosed subject matter, the present application discloses the additional examples listed below. It should be noted that one feature of a separate example or one or more features of an example adopted in combination, and optionally combined with one or more features of one or more other examples, are additional examples that also fall within the disclosure of the present application.

[0270] Example 1. A component 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 comprising: a first seal disposed around a distal portion of the first shaft; a second seal disposed around a portion of the second shaft extending distally of the first shaft, and a lumen disposed within a housing of the sealing mechanism between the first seal and the second seal, wherein the distal end of the first shaft is disposed within the lumen, and wherein the lumen is fluid-sealed by the first seal and the second seal such that fluid from the first lumen cannot leave the lumen.

[0271] Example 2. An assembly according to any of the examples herein, in particular the assembly according to Example 1, wherein the distal end of the first lumen is closed by the cavity, 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.

[0272] Example 3. An assembly according to any of the examples herein, in particular the assembly of Example 1 or Example 2, wherein the sealing mechanism includes a step within the cavity, the step reducing the diameter of the cavity from a larger first diameter adjacent to the first seal to a smaller second diameter adjacent to the second seal, and wherein the distal end of the first shaft is positioned against the step.

[0273] Example 4. An assembly according to any of the examples herein, in particular the assembly according to Example 3, wherein the housing comprises a first seal housing in which the first seal is housed and a second seal housing in which the second seal is housed, and wherein the step is formed on an inner surface of the second seal housing.

[0274] Example 5. A component according to any of the examples described herein, in particular any of the examples 1-4, wherein the first seal is arranged in a first seal housing of the sealing mechanism, and the second seal is arranged in a second seal housing of the sealing mechanism, the first seal housing and the second seal housing are connected to each other, and wherein the cavity is defined by the inner surface of the first seal housing and the inner surface of the second seal housing.

[0275] Example 6. The assembly of any example herein, particularly example 5, wherein the first seal housing and the second seal housing are coupled together via an overlapping interface using one or more fasteners.

[0276] Example 7. An assembly according to any of the examples herein, in particular the assembly according to Example 5 or Example 6, wherein the sealing mechanism further comprises a first threaded member that interfaces with the threads on the inner surface of the first seal housing and is configured to rotate relative to the first seal housing and tighten the first seal around the first axis.

[0277] Example 8. An assembly according to any of the examples herein, in particular the assembly according to Example 7, wherein the sealing mechanism includes a rotatable first knob connected to the first threaded member and configured to rotate the first threaded member so that the first threaded member moves distally against the first seal and tightens the first seal around the first axis.

[0278] Example 9. An assembly according to any of the examples herein, in particular the assembly according to 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 tighten the second seal around the second axis.

[0279] Example 10. An assembly according to any of the examples described herein, in particular the assembly according to Example 9, wherein the sealing mechanism includes a rotatable second knob, the second knob being connected to the second threaded member and being configured to rotate the second threaded member so that the second threaded member moves proximally against the second seal and tightens the second seal around the second axis.

[0280] Example 11. An assembly according to any example herein, particularly example 9 or example 10, wherein the first threaded member has a larger diameter lumen than the second threaded member.

[0281] Example 12. The assembly of any example 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.

[0282] Example 13. An assembly according to any of the examples described herein, in particular the assembly according to Example 12, wherein the sealing mechanism further comprises a threaded member that interfaces with threads on the inner surface of the housing at one end of the housing adjacent to the first seal, and wherein the threaded member is configured to rotate relative to the housing and tighten the first seal around the first axis.

[0283] Example 14. An assembly according to any of the examples described herein, in particular the assembly according to Example 13, wherein the sealing mechanism includes a rotatable knob disposed at one end of the threaded member, and wherein the rotatable knob is configured to rotate the threaded member so that the threaded member moves distally against the first seal and tightens the first seal around the first axis.

[0284] Example 15. The assembly of any example herein, in particular any of Examples 12-14, wherein the first seal is a compressible gasket and the second seal is an O-ring.

[0285] Example 16. The assembly of any example herein, in particular example 12, wherein the first seal is an O-ring and the second seal is an O-ring.

[0286] Example 17. An assembly according to any of the examples herein, in particular the assembly of Example 12, wherein the cavity is a first cavity, wherein the housing further comprises a second cavity disposed distally of the second seal and a second step disposed within the second cavity, the second step reducing the diameter of the second cavity from a larger first diameter adjacent to the second seal to a smaller second diameter, and wherein the distal end of the second shaft is disposed against the second step.

[0287] Example 18. An assembly according to any of the examples herein, in particular the assembly of Example 17, wherein the sealing mechanism further comprises a Luer attachment disposed distally of the second cavity, and wherein the Luer attachment is configured to receive a suction tool for generating a vacuum and to suction the second shaft.

[0288] Example 19. An assembly according to any of the examples herein, in particular any of Examples 1-18, wherein the catheter is a delivery device for a docking device, and wherein the second shaft is configured to accommodate the docking device within a distal portion of the second shaft in a delivery configuration.

[0289] Example 20. The assembly of any example herein, particularly Example 19, wherein the docking device comprises a coil and an expandable guard member disposed around a portion of the coil.

[0290] 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, the step transitioning 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 wherein the step is disposed proximal to the second seal; and 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.

[0291] Example 22. The sealing mechanism of any example herein, in particular the sealing mechanism of Example 21, wherein the first seal and the second seal are annular, and wherein the inner diameter of the first seal is greater than the inner diameter of the second seal.

[0292] Example 23. The sealing mechanism of any example herein, in particular the sealing mechanism of Example 22, wherein the diameter of the cavity proximal to the step is larger than the inner diameter of the first seal.

[0293] Example 24. The sealing mechanism according to any of the examples described herein, in particular the sealing mechanism described in any of Examples 21-23, further includes a first threaded member, the first threaded member including an external thread configured to engage with an internal thread on the inner surface of the proximal portion of the first seal housing, and wherein the first threaded member is configured to rotate and move axially relative to the first housing member.

[0294] Example 25. A sealing mechanism according to any of the examples herein, in particular the sealing mechanism of Example 24, wherein the first seal is disposed within a middle portion of the first seal housing, and wherein the first threaded member is configured to move distally toward the first seal and push the first seal when it is rotated so as to tighten the first seal.

[0295] Example 26. The sealing mechanism according to any of the examples described herein, in particular the sealing mechanism of Example 25, further includes a first rotatable knob connected to the proximal end of the first threaded member, and wherein the first rotatable knob is arranged around the proximal portion of the first seal housing.

[0296] Example 27. The sealing mechanism according to any of the examples described herein, in particular the sealing mechanism of any of Examples 24-26, further includes a second threaded member, the second threaded member including an external thread configured to engage with an internal thread on the inner surface of the distal portion of the second seal housing, and wherein the second threaded member is configured to rotate and move axially relative to the second housing member.

[0297] Example 28. A sealing mechanism according to any of the examples herein, in particular the sealing mechanism of 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 move proximally toward the second seal and push the second seal when it rotates so as to tighten the second seal.

[0298] Example 29. The sealing mechanism of any example herein, in particular the sealing mechanism of 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 arranged around a distal portion of the second seal housing.

[0299] Example 30. A sealing mechanism according to any of the examples described herein, in particular the sealing mechanism of any of Examples 27-29, wherein the inner surface of the first threaded member and the first seal defines a first tubular cavity having a first diameter and configured to receive a first shaft, wherein the inner surface of the second threaded member and the second seal defines a second tubular cavity having a second diameter and configured to receive a second shaft, and wherein the second diameter is smaller than the first diameter.

[0300] Example 31. The sealing mechanism of any example herein, particularly any of Examples 21-30, wherein the first seal housing and the second seal housing are coupled together at an overlapping interface.

[0301] Example 32. The sealing mechanism of any example herein, in particular the sealing mechanism of Example 31, wherein the step is disposed adjacent to the overlapping junction.

[0302] 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 the catheter; attaching a second seal of the 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 to the distal end of the first shaft; and flowing a fluid through the catheter such that the 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.

[0303] Example 34. A method according to any of the examples herein, in particular the method of Example 33, wherein attaching the first seal to the first shaft includes extending the distal portion of the first shaft into the lumen of the sealing mechanism, through the first seal and into the cavity of the sealing mechanism, the cavity being defined by the housing wall of the sealing mechanism and being between the first seal and the second seal.

[0304] Example 35. A method according to any example herein, in particular the method of Example 34, wherein extending the distal portion of the first shaft into the cavity includes extending the distal end of the first shaft into the cavity until the distal end encounters a step defined by the shell.

[0305] Example 36. A method according to any of the examples herein, in particular any of Examples 33-35, wherein attaching the second seal to the second shaft includes extending the distal portion of the second shaft through the distal end of the first shaft and extending distally of the distal end and through the second seal.

[0306] Example 37. A method according to any of the examples herein, in particular any of Examples 33-36, wherein attaching the first seal and attaching the second seal include tightening the first seal around the first axis and tightening the second seal around the second axis such that the distal end of the first axis is closed.

[0307] Example 38. A method according to any of the examples herein, in particular any of Examples 33-37, wherein attaching the first seal to the first shaft includes tightening the first seal around the first shaft by rotating a first knob of the sealing mechanism to move a first threaded member disposed proximal to the first seal axially toward and against the first seal.

[0308] Example 39. A method according to any of the examples herein, in particular any of Examples 33-38, wherein attaching the second seal to the second shaft includes tightening the second seal around the second shaft by rotating a second knob of the sealing mechanism to move a second threaded member distal to the second seal axially toward and against the second seal.

[0309] Example 40. A method according to any of the examples herein, in particular any of Examples 33-39, wherein the catheter is a delivery device for a docking device, and wherein the second shaft is configured to accommodate the docking device within a distal portion of the second shaft in a delivery configuration.

[0310] Example 41. A method according to any of the examples herein, in particular the method of Example 40, wherein the docking device includes a coil and an expandable protective member arranged around a portion of the coil, and wherein flowing the fluid through the catheter so that the fluid flows out only from the second lumen includes flowing the fluid through and around the protective member to degas the protective member.

[0311] Example 42. A method according to any of the examples herein, in particular any of Examples 33-41, wherein causing the fluid to flow through the catheter so that the fluid flows only from the second lumen defined by the second axis and is prevented from flowing from the first lumen includes flushing the fluid through the catheter using positive pressure applied to the catheter.

[0312] Example 43. A method according to any of the examples herein, in particular any of Examples 33-41, wherein causing the fluid to flow through the catheter so that the fluid flows out only from a second lumen defined by the second axis and is prevented from flowing out of the first lumen includes drawing the fluid through the catheter using negative pressure applied to the distal end of the second axis by a suction tool.

[0313] Example 44. A method according to any of the examples herein, in particular any of Examples 33-41, wherein flowing the fluid through the catheter so that the fluid flows only from the second lumen defined by the second axis and is prevented from flowing from the first lumen includes flushing and aspirating the fluid through the catheter using a combination of negative and positive pressures applied to the catheter.

[0314] Example 45. A method for flushing a catheter, comprising: extending a distal portion of a first shaft of the catheter through a first seal disposed in a first seal housing of a sealing mechanism and into a cavity disposed in the first seal housing and a second seal housing of the sealing mechanism, the cavity being defined between the first seal and the second seal of the second seal housing; extending a distal portion of a second shaft of the catheter through the distal end of the first shaft and extending distally of the distal end, and through the second seal disposed in the second seal housing; tightening the first seal around the distal portion of the first shaft and tightening the second seal around the distal portion of the second shaft; and flowing a fluid through the catheter so 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.

[0315] Example 46. A method according to any of the examples herein, in particular the method of Example 45, wherein tightening the first seal around the first axis and tightening the second seal around the second axis includes fluid-sealing the cavity such that fluid from the first lumen cannot leave the cavity and the distal end of the first axis is closed.

[0316] Example 47. A method according to any example herein, in particular the method of Example 45 or Example 46, wherein extending the distal portion of the first shaft into the cavity includes extending the distal end of the first shaft into the cavity until the distal end hits a stop member disposed in the cavity.

[0317] Example 48. The method of any example 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.

[0318] Example 49. A method according to any of the examples herein, in particular any of Examples 45-48, wherein extending the distal portion of the second shaft through the distal end of the first shaft and distal to the distal end and through the second seal includes extending the distal end of the second shaft distal to the distal end of the second seal housing.

[0319] Example 50. A method according to any of the examples herein, in particular any of the examples 45-49, wherein tightening the first seal around the distal portion of the first shaft comprises tightening the first seal around the first shaft by rotating a first knob of the sealing mechanism to rotate a first threaded member threadedly engaged with the first seal housing relative to the first seal housing and move axially toward and against the first seal.

[0320] Example 51. A method according to any of the examples herein, in particular any of Examples 45-50, wherein tightening the second seal around the distal portion of the second shaft comprises tightening the second seal around the second shaft by rotating a second knob of the sealing mechanism to rotate a second threaded member threadedly engaged with the second seal housing relative to the second seal housing and move axially toward and against the second seal.

[0321] Example 52. A method according to any of the examples herein, in particular any of Examples 45-51, wherein the catheter is a delivery device for a docking device, and wherein the second shaft is configured to accommodate the docking device within a distal portion of the second shaft in a delivery configuration.

[0322] Example 53. A method according to any of the examples herein, in particular the method of Example 52, wherein the docking device includes a coil and an expandable protective member arranged around a portion of the coil, and wherein flowing the fluid through the catheter so that the fluid flows out only from the first lumen includes flowing the fluid through and around the protective member to degas the protective member.

[0323] Example 54. A component comprising: a delivery device 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 each other; and a sealing mechanism comprising a housing, a first seal disposed within the housing and surrounding the distal portion of the first shaft, a second seal disposed within the housing and surrounding the distal portion of the second shaft, and a cavity disposed within the housing and defined between the first seal and the second seal, wherein the distal end of the first shaft is disposed within the cavity, wherein the distal end of the second shaft extends 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.

[0324] Example 55. An assembly according to any example herein, particularly Example 54, wherein the first and second lumens are fluidly coupled to each other downstream of the flush port of the delivery device and upstream of the distal end of the first shaft.

[0325] Example 56. An assembly according to any of the examples herein, in particular Example 54 or Example 55, wherein the distal end of the first lumen is closed by the cavity, and wherein the distal end of the second lumen defined at the distal end of the second shaft is open.

[0326] Example 57. An assembly according to any of the examples herein, in particular any of Examples 54-56, wherein the housing includes a step disposed within the cavity, the step reducing the diameter of the cavity from a larger first diameter adjacent to the first seal to a smaller second diameter adjacent to the second seal, and wherein the distal end of the first shaft is disposed against the step.

[0327] Example 58. An assembly according to any of the examples herein, in particular the assembly according to Example 57, wherein the housing comprises a first seal housing in which the first seal is housed and a second seal housing in which the second seal is housed, and wherein the step is formed on an inner surface of the second seal housing.

[0328] Example 59. The assembly of any example herein, particularly Example 58, wherein the first seal housing and the second seal housing are coupled together via an overlapping interface using one or more fasteners.

[0329] Example 60. An assembly according to any of the examples herein, in particular the assembly of 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 tighten the first seal around the first axis.

[0330] Example 61. An assembly according to any of the examples herein, in particular the assembly according to Example 60, wherein the sealing mechanism includes a rotatable first knob connected to the first threaded member and configured to rotate the first threaded member so that the first threaded member moves distally against the first seal and tightens the first seal around the first axis.

[0331] Example 62. An assembly according to any of the examples herein, in particular 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 tighten the second seal around the second axis.

[0332] Example 63. An assembly according to any of the examples herein, in particular the assembly of Example 62, wherein the sealing mechanism includes a rotatable second knob connected to the second threaded member and configured to rotate the second threaded member so that the second threaded member moves proximally against the second seal and tightens the second seal around the second axis.

[0333] Example 64. An assembly according to any example herein, particularly Example 62 or Example 63, wherein the first threaded member has a larger diameter lumen than the second threaded member.

[0334] Example 65. An assembly according to any of the examples described herein, in particular any of Examples 54-57, wherein the sealing mechanism includes a rotatable knob and a threaded member extending distally from the rotatable knob, wherein one or more threads on the threaded member interface with threads disposed proximal to the first seal on an inner surface of the housing, and wherein the rotatable knob is configured to rotate the threaded member relative to the housing so that the threaded member moves distally against the first seal and tightens the first seal around the first axis.

[0335] Example 66. The assembly of any example herein, particularly Example 65, wherein the second seal is an O-ring.

[0336] Example 67. The assembly of any example herein, particularly any of Examples 54-57, wherein the first seal and the second seal are both O-rings.

[0337] Example 68. An assembly according to any of the examples herein, in particular any of Examples 54-67, wherein the implantable medical device is a docking device configured to expand from the delivery configuration to a coiled configuration after deployment from the delivery device, and wherein the docking device in its coiled configuration is configured to receive an artificial heart valve.

[0338] Example 69. An assembly according to any example herein, in particular the assembly of Example 68, wherein the docking device comprises a coil and an expandable protective member disposed around a portion of the coil.

[0339] Example 70. A sealing mechanism comprising: a housing including a cavity and a step disposed within the cavity, the step reducing the diameter of the cavity from a larger diameter portion of the cavity to a smaller diameter portion of the cavity; a first seal disposed within the housing adjacent to and proximal to the larger diameter portion of the cavity; and a second seal disposed within the housing adjacent to and distal to the smaller diameter portion of the cavity.

[0340] Example 71. A sealing mechanism according to any example herein, in particular the sealing mechanism of Example 70, wherein the first seal and the second seal are annular, and wherein the inner diameter of the first seal is greater than the inner diameter of the second seal.

[0341] Example 72. A sealing mechanism according to any of the examples described herein, in particular the sealing mechanism described in Example 70 or Example 71, wherein the sealing mechanism further comprises a threaded member that interfaces with a thread on the inner surface of the shell at one end of the shell adjacent to the first seal, and wherein the threaded member is configured to rotate relative to the shell and to move distally toward the first seal and push the first seal as it rotates so as to tighten the first seal.

[0342] Example 73. A sealing mechanism according to any example described herein, in particular the sealing mechanism described in Example 72, wherein the sealing mechanism includes a rotatable knob arranged at one end of the threaded member, and wherein the rotatable knob is configured to rotate the threaded member.

[0343] Example 74. A sealing mechanism according to any of the examples described herein, in particular the sealing mechanism described in Example 72 or Example 73, wherein the threaded member includes a plurality of external threads that are discontinuous with each other and spaced apart from each other around the outer surface of the threaded member, and the plurality of external threads are configured to interface with and slide along threads on the inner surface of the shell.

[0344] Example 75. A sealing mechanism according to any of the examples herein, in particular any of Examples 72-74, wherein the threaded member includes one or more locking elements, and the one or more locking elements are configured to engage with the threads on the inner surface of the shell and maintain the threaded member connected to the shell.

[0345] Example 76. The sealing mechanism of any example herein, particularly any of Examples 70-75, wherein the first seal is a compressible gasket and the second seal is an O-ring.

[0346] Example 77. The sealing mechanism of any example herein, particularly example 70 or example 71, wherein the first seal is an O-ring and the second seal is an O-ring.

[0347] Example 78. A sealing mechanism according to any of the examples herein, in particular any of 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 distal to the second seal and a second step within the second cavity, the second step reducing the diameter of the second cavity from a larger first diameter adjacent to the second seal to a smaller second diameter.

[0348] Example 79. A sealing mechanism according to any of the examples herein, in particular the sealing mechanism of Example 78, wherein the sealing mechanism further comprises a Luer attachment disposed distally of the second cavity, and wherein the Luer attachment is configured to receive a suction tool for generating a vacuum within the second cavity.

[0349] Example 80. An assembly comprising: 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; and a sealing mechanism comprising: a first member and a second member pivotable relative to each other between an open configuration and a closed configuration, 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 includes an attachment configured to receive a suction tool for drawing fluid through the second shaft.

[0350] Example 81. An assembly according to any of the examples herein, in particular 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.

[0351] Example 82. An assembly according to any of the examples herein, in particular the assembly of Example 81, wherein the sealing mechanism includes a sliding knob that can slide axially from a first position around a portion of the outer surface of the shell to a second position around the first member and the second member when the first member and the second member are in a closed configuration.

[0352] Example 83. An assembly according to any of the examples herein, in particular any of Examples 80-82, wherein the first member and the second member include a compressible filler configured to seal around the second shaft when the first member and the second member are in the closed configuration.

[0353] Example 84. An assembly according to any of the examples herein, in particular any of Examples 80-83, wherein the catheter is a delivery device for a docking device, and wherein the second shaft is configured to accommodate the docking device within a distal portion of the second shaft in a delivery configuration.

[0354] Example 85. An assembly according to any example herein, in particular the assembly of Example 84, wherein the docking device comprises a coil and an expandable protective member disposed around a portion of the coil.

[0355] 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 can extend distally of a distal end of the first shaft; and a sealing mechanism comprising: a seal disposed around the 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 the locking member are rotatable relative to each other between an unlocked configuration and a locked configuration, and wherein in the locked configuration, the seal is compressed axially between the seal housing and the locking member and radially around the second shaft.

[0356] Example 87. An assembly according to any of the examples herein, in particular the assembly of Example 86, wherein in the unlocked configuration, the seal is axially disposed between a portion of the inner surface of the cylindrical body portion defining the first cavity and an axially facing surface of the inner wall of the locking member without being radially compressed around the second axis.

[0357] Example 88. A component according to any of the examples described herein, in particular the component described in Example 87, wherein in the locked configuration, the seal is axially compressed between the portion of the inner surface of the cylindrical main body portion and the axially facing surface of the inner wall of the locking member and radially compressed around the second axis, so that the diameter of the tubular cavity of the seal is smaller in the locked configuration than in the unlocked configuration.

[0358] Example 89. An assembly according to any of the examples herein, in particular the assembly of Example 87 or Example 88, wherein the portion of the inner surface of the cylindrical body portion is a tapered surface inclined at a non-zero angle relative to the central longitudinal axis of the sealing mechanism.

[0359] Example 90. An assembly according to any of the examples herein, in particular any of Examples 86-89, wherein the seal housing includes one or more grooves extending along and through the cylindrical body portion, and further includes one or more pins connected to the inner wall of the locking member, wherein each of the one or more pins is configured to extend through a corresponding groove of the one or more grooves and slide along the groove.

[0360] Example 91. A component according to any of the examples described herein, in particular the component according to 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.

[0361] Example 92. An assembly according to any of the examples herein, in particular any of Examples 86-91, wherein the seal housing and the locking member are arranged to be closer together in the axial direction in the locked configuration than in the unlocked configuration.

[0362] Example 93. A component according to any of the examples herein, in particular any of Examples 86-92, wherein the outer wall and inner wall of the locking member extend proximally from an end wall defining the distal end of the locking member, wherein in the unlocked configuration, there is a first gap in the second cavity between the end wall and the distal end of the cylindrical main portion of the seal housing, and wherein in the locked configuration, there is a second gap in the second cavity between the end wall and the distal end of the cylindrical main portion, the second gap being smaller than the first gap.

[0363] Example 94. An assembly according to any example herein, in particular any of Examples 86-93, further comprising a tube extending distally from the locking member.

[0364] Example 95. An assembly according to any of the examples herein, in particular the assembly of Example 94, wherein the inner surface of the inner wall defines a lumen of the locking member, and wherein the tube is disposed within a first lumen portion of the lumen.

[0365] Example 96. An assembly according to any of the examples herein, in particular the assembly of Example 95, wherein the inner wall includes an annular protrusion that extends radially toward the central longitudinal axis of the sealing mechanism and separates the first lumen portion from a second lumen portion of the lumen configured to receive a second axis therethrough.

[0366] Example 97. An assembly according to any of the examples herein, in particular any of Examples 94-96, wherein the distal end of the tube includes an attachment configured to receive a suction tool for drawing fluid through the second shaft.

[0367] Example 98. A sealing mechanism comprising: a seal housing including a main body portion, wherein an inner surface of the main body portion defines a first cavity, wherein the main body portion includes at least one curved groove extending through the main body portion from an outer surface to an inner surface of the main body portion; a seal disposed within a portion of the first cavity of the seal housing, wherein the seal includes a lumen configured to receive a shaft assembly of an artificial implant delivery device; a locking member including an outer wall and an inner wall defining a second cavity therebetween in a radial direction, wherein the main body portion of the seal housing extends into the second cavity of the locking member and is rotatable within the second cavity; 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 in the locked configuration relative to the unlocked configuration.

[0368] Example 99. A sealing mechanism according to any example herein, in particular the sealing mechanism of Example 98, wherein in the locked configuration, the seal housing and the locking member are spaced closer together than in the unlocked configuration.

[0369] Example 100. A sealing mechanism according to any of the examples described herein, in particular the sealing mechanism described in Example 98 or Example 99, wherein the at least one curved groove has a circumferential extension portion at the second end of the curved groove and an axial extension portion at the first end of the curved groove, wherein the first end of the curved groove is arranged closer to the distal end of the seal housing than the second end of the curved groove, and wherein the distal end of the seal housing is arranged in the second cavity.

[0370] Example 101. A sealing mechanism according to any of the examples herein, in particular the sealing mechanism of any of Examples 98-100, wherein in the unlocked configuration, the seal is axially arranged between a portion of the inner surface of the cylindrical main 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 the proximal end of the locking member.

[0371] Example 102. A sealing mechanism according to any of the examples described herein, in particular the sealing mechanism described in Example 101, wherein in the locked configuration, the seal is axially compressed between the portion of the inner surface of the cylindrical main body portion and the axially facing surface of the inner wall of the locking member, so that the diameter of the tubular cavity of the seal is smaller in the locked configuration than in the unlocked configuration.

[0372] Example 103. A sealing mechanism according to any of the examples described herein, in particular the sealing mechanism described in Example 101 or Example 102, wherein the portion of the inner surface of the cylindrical main body portion is an inclined surface inclined at a non-zero angle relative to the central longitudinal axis of the sealing mechanism, and wherein in the locking configuration, the seal is pressed against the inclined surface.

[0373] Example 104. A sealing mechanism according to any of the examples herein, in particular any of Examples 98-103, wherein the at least one curved groove comprises two curved grooves circumferentially spaced apart from each other around the seal housing, and wherein the at least one pin comprises two pins received in two corresponding channels extending radially through the inner wall of the locking member.

[0374] Example 105. A sealing mechanism according to any of the examples herein, in particular the sealing mechanism of any of Examples 98-104, wherein the inner surface of the cylindrical body portion defines a lumen at the proximal end of the seal housing, the lumen being configured to receive a catheter shaft therethrough, wherein the lumen widens to a first cavity extending from the lumen to the distal end of the seal housing, and wherein in the locked configuration, the diameter of the lumen of the seal is reduced so that the seal seals around the catheter shaft.

[0375] Example 106. The sealing mechanism of any example herein, in particular any of Examples 98-105, further comprising a flexible tube extending distally from the locking member.

[0376] Example 107. A sealing mechanism according to any of the examples herein, in particular the sealing mechanism of Example 106, wherein the inner surface of the inner wall defines a lumen of the locking member, and wherein the flexible tube is disposed within a first lumen portion of the lumen.

[0377] Example 108. A sealing mechanism according to any of the examples described herein, in particular the sealing mechanism of Example 107, wherein the inner wall includes an annular protrusion that extends radially toward the central longitudinal axis of the sealing mechanism and separates the first lumen portion from the second lumen portion of the lumen, and wherein the second lumen portion and the flexible tube are configured to receive a catheter shaft passing therethrough.

[0378] Example 109. A sealing mechanism according to any of the examples herein, in particular any of Examples 106-108, wherein the distal end of the flexible tube includes an attachment configured to receive a suction tool for drawing fluid through a catheter shaft extending through the sealing mechanism.

[0379] Example 110. A sealing mechanism according to any of the examples herein, in particular any of Examples 98-109, wherein the at least one pin and the at least one curved groove of the seal housing are configured such that the seal housing and the locking member rotate less than 360 degrees relative to each other between the unlocked configuration and the locked configuration.

[0380] Example 111. A sealing mechanism according to any of the examples herein, in particular any of Examples 98-109, wherein the at least one pin and the at least one curved groove 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.

[0381] Example 112. A sealing mechanism according to any of the examples herein, in particular any of Examples 98-109, wherein the at least one pin and the at least one curved groove of the seal housing are configured such that the seal housing and the locking member rotate 70-200 degrees relative to each other between the unlocked configuration and the locked configuration.

[0382] Example 113. A sealing mechanism according to any of the examples herein, in particular any of Examples 98-109, wherein the at least one pin and the at least one curved groove 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.

[0383] Example 114. A sealing mechanism according to any of the examples described herein, in particular the sealing mechanism of any of Examples 98-109, wherein the at least one pin and the at least one curved groove of the seal housing are configured such that the seal housing and the locking member rotate 80-100 degrees relative to each other between the unlocked configuration and the locked configuration.

[0384] Example 115. A method comprising sterilizing the sealing mechanism, device, and / or assembly of any example.

[0385] Unless otherwise stated, features described herein with respect to any example may be combined with other features described in any one or more other examples. For example, any one or more features of one delivery device may be combined with any one or more features of another delivery device.

[0386] In view of the many possible ways in which the principles of the present disclosure can 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 present disclosure, nor should they be taken as limiting the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

1. A sealing mechanism, characterized in that: The sealing mechanism includes: 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, the step transitioning 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 wherein the step is disposed proximal to the second seal; and 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.

2. The sealing mechanism according to claim 1, wherein: The first and second seals are annular, and wherein an inner diameter of the first seal is greater than an inner diameter of the second seal.

3. The sealing mechanism according to claim 2, wherein: The diameter of the cavity proximal to the step is larger than the inner diameter of the first seal.

4. The sealing mechanism according to any one of claims 1 to 3, characterized in that: The sealing mechanism additionally includes a first threaded member including external threads configured to engage internal threads on an inner surface of a proximal portion of the first seal housing, and wherein the first threaded member is configured to rotate and travel axially relative to the first housing member.

5. The sealing mechanism according to claim 4, characterized in that: The first seal is disposed within a middle portion of the first seal housing, and wherein the first threaded member is configured to travel distally toward the first seal and urge the first seal upon rotation thereof to tighten the first seal.

6. The sealing mechanism according to claim 5, characterized in that: The sealing mechanism additionally includes a first rotatable knob coupled to a proximal end of the first threaded member, and wherein the first rotatable knob is disposed about a proximal portion of the first seal housing.

7. The sealing mechanism according to claim 4, wherein: The sealing mechanism additionally includes a second threaded member including external threads configured to engage internal threads on an inner surface of a distal portion of the second seal housing, and wherein the second threaded member is configured to rotate and travel axially relative to the second housing member.

8. The sealing mechanism according to claim 7, wherein: The second seal is disposed within a mid-portion of the second seal housing, and wherein the second threaded member is configured to travel proximally toward the second seal and urge the second seal upon rotation thereof to tighten the second seal.

9. The sealing mechanism according to claim 8, characterized in that: The sealing mechanism additionally includes 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.

10. The sealing mechanism according to any one of claims 7 to 9, characterized in that: The inner surface of the first threaded member and the first seal define a first lumen having a first diameter and configured to receive a first shaft, wherein the inner surface of the second threaded member and the second seal define a second lumen having a second diameter and configured to receive a second shaft, and wherein the second diameter is smaller than the first diameter.

11. The sealing mechanism according to any one of claims 1-3 and 5-9, characterized in that: The first seal housing and the second seal housing are coupled together at an overlapping interface.

12. The sealing mechanism according to claim 11, wherein: The step is disposed adjacent to the overlapping junction.

13. A component, characterized in that The assembly includes: a delivery device 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 each other; and a sealing mechanism comprising a housing, a first seal disposed within the housing and surrounding the distal portion of the first shaft, a second seal disposed within the housing and surrounding the distal portion of the second shaft, and a cavity disposed within the housing and defined between the first seal and the second seal, wherein the distal end of the first shaft is disposed within the cavity, wherein the distal end of the second shaft extends 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.

14. The assembly according to claim 13, wherein The first and second lumens are fluidly coupled to each other downstream of the flush port of the delivery device and upstream of the distal end of the first shaft.

15. An assembly according to claim 13 or claim 14, characterised in that The distal end of the first lumen is closed by the cavity, and wherein the distal end of the second lumen defined at the distal end of the second shaft is open.

16. An assembly according to claim 13 or claim 14, characterised in that 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 the distal end of the first shaft is disposed against the step.

17. The assembly according to claim 16, characterized in that The housing includes a first seal housing in which the first seal is accommodated and a second seal housing in which the second seal is accommodated, and wherein the step is formed on an inner surface of the second seal housing.

18. The assembly according to claim 17, characterized in that The first seal housing and the second seal housing are coupled together via an overlapping interface using one or more fasteners.

19. An assembly according to claim 17 or claim 18, characterised in that The sealing mechanism also includes 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 tighten the first seal about the first axis.

20. The assembly according to claim 19, 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 tightens the first seal about the first shaft.

21. The assembly according to claim 19, wherein The sealing mechanism also includes 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 tighten the second seal about the second axis.

22. The assembly according to claim 21, characterized in that 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 tightens the second seal about the second shaft.

23. An assembly according to claim 21 or claim 22, characterised in that The first threaded member has a larger diameter lumen than the second threaded member.

24. An assembly according to claim 13 or claim 14, characterised in that 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 provided 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 so that the threaded member moves distally against the first seal and tightens the first seal around the first axis.

25. The assembly according to claim 24, characterized in that The second seal is an O-ring.

26. An assembly according to claim 13 or claim 14, characterised in that The first sealing member and the second sealing member are both O-rings.

27. The assembly of any one of claims 13-14, 17-18, 20-22 and 25, characterized in that The implantable medical device is a docking device configured to expand from a 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.

28. The assembly according to claim 27, characterized in that The docking device includes a coiled tube and an expandable protective member disposed around a portion of the coiled tube.

29. A sealing mechanism, characterized in that: The sealing mechanism includes: a housing including a cavity and a step arranged in the cavity, the step reducing the diameter of the cavity from a larger diameter portion of the cavity to a smaller diameter portion of the cavity; a first seal adjacent to the larger diameter portion of the cavity and arranged in the housing proximal to the larger diameter portion; and a second seal adjacent to the smaller diameter portion of the cavity and arranged in the housing distal to the smaller diameter portion.

30. The sealing mechanism according to claim 29, wherein: The first seal and the second seal are annular, and wherein the inner diameter of the first seal is greater than the inner diameter of the second seal.

31. The sealing mechanism according to claim 29 or claim 30, wherein: The sealing mechanism also includes a threaded member that interfaces with threads on an inner surface of the housing at one end of the housing adjacent to the first seal, and wherein the threaded member is configured to rotate relative to the housing and to advance distally toward the first seal and push the first seal as it rotates so as to tighten the first seal.

32. The sealing mechanism according to claim 31, wherein: The sealing mechanism includes a rotatable knob disposed at one end of the threaded member, and wherein the rotatable knob is configured to rotate the threaded member.

33. The sealing mechanism according to claim 31, wherein: The threaded member includes a plurality of external threads that are discontinuous with one another and spaced apart from one another around an outer surface of the threaded member, the plurality of external threads being configured to interface with and slide along threads on an inner surface of the housing.

34. The sealing mechanism according to claim 31, wherein: The threaded member includes 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.

35. The sealing mechanism according to any one of claims 29-30 and 32-34, wherein: The first seal is a compressible gasket and the second seal is an O-ring.

36. The sealing mechanism according to claim 29 or claim 30, wherein: The first seal is an O-ring, and the second seal is an O-ring.

37. The sealing mechanism according to any one of claims 29-30 and 32-34, wherein: The cavity is a first cavity and the step is a first step, wherein the housing further comprises a second cavity disposed distally of 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.

38. The sealing mechanism according to claim 37, wherein: The sealing mechanism further includes a luer attachment disposed distally of the second lumen, and wherein the luer attachment is configured to receive a suction tool for creating a vacuum within the second lumen.

39. A component, characterized in that The assembly includes: a catheter, the catheter including a first shaft and a second shaft extending through the first shaft, wherein the distal portion of the second shaft is capable of extending distally of the distal end of the first shaft; and a sealing mechanism, the sealing mechanism including: a seal disposed around the distal portion of the second shaft; a seal housing including a cylindrical body portion, wherein an inner surface of the cylindrical body portion defines a first cavity, and wherein the seal is disposed within the first cavity; and a locking member, the locking member including an annular outer wall and an annular inner wall, the annular outer wall and the 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 capable of rotating 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 the locking member are capable of rotating relative to each other between an unlocked configuration and a locked configuration, and wherein in the locked configuration, the seal is axially compressed between the seal housing and the locking member and radially compressed around the second shaft.

40. The assembly of claim 39, wherein: In the unlocked configuration, the seal is axially disposed between a portion of the inner surface of the cylindrical body portion defining the first cavity and an axially facing surface of the inner wall of the locking member without being radially compressed about the second axis.

41. The assembly according to claim 40, characterized in that 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 and radially compressed around the second axis so that the diameter of the lumen of the seal is smaller in the locked configuration than in the unlocked configuration.

42. An assembly according to claim 40 or claim 41, characterised in that 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.

43. An assembly according to any one of claims 39 to 41, characterized in that The seal housing includes one or more slots extending along and through the cylindrical body portion and further includes 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.

44. The assembly according to claim 43, 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 opposing second end of the corresponding slot.

45. Assembly according to any one of claims 39-41 and 44, characterized in that The seal housing and the locking member are arranged closer together in the axial direction in the locked configuration than in the unlocked configuration.

46. An assembly according to any one of claims 39-41 and 44, characterized in that 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 within the second cavity between the end wall and the distal end of the cylindrical body portion of the seal housing, and wherein in the locked configuration, a second gap exists within the second cavity between the end wall and the distal end of the cylindrical body portion, the second gap being smaller than the first gap.

47. An assembly according to any one of claims 39 to 41 and 44, characterized in that The assembly additionally includes a tube extending distally from the locking member.

48. The assembly according to claim 47, characterized in that 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.

49. The assembly according to claim 48, characterized in that 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.

50. The assembly of claim 47, wherein: The distal end of the tube includes an attachment configured to receive a suction tool for drawing fluid through the second shaft.

Images