Guide Catheter for Implant Delivery Device - Patent application

Abstract

Apparatus and methods are disclosed for providing fluid to a lumen of a guide catheter having a fluid reservoir fluidly connected to the lumen such that pressure within the lumen is maintained at a desired level. As an example, a delivery device may include a handle, a shaft extending within and distally therefrom and having a main lumen, and a reservoir fluidly connected to the main lumen. The reservoir is filled with fluid and has an adjustable fluid volume, and the reservoir is configured to passively supply fluid to the main lumen based on fluid pressure within the main lumen.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 268,322, filed February 22, 2022, which is incorporated by reference in its entirety herein.

[0002] The present disclosure relates to a guide catheter for a delivery apparatus for an artificial medical device. [Background technology]

[0003] The human heart can suffer from a variety of valvular diseases. These valvular diseases can cause serious malfunctions of the heart, eventually requiring repair of the native valve or replacement of the native valve with an artificial valve. Numerous repair devices (e.g., stents) and artificial valves are known, as are numerous methods for implanting the devices and valves in humans. Percutaneous and minimally invasive surgical approaches can be used in a variety of procedures to deliver artificial medical devices to locations within a patient's body that are not easily accessible by surgery and where access without surgery is desirable. In one embodiment, an artificial heart valve can be mounted in a crimped state on the distal end of a delivery device and advanced through the patient's vasculature (e.g., through the femoral artery and aorta) to reach the implantation site within the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon in which the prosthetic valve is mounted, or by activating a mechanical actuator that applies an expansive force to the prosthetic valve, or by deploying the prosthetic valve from a sheath of a delivery device and allowing the prosthetic valve to self-expand to its functional size.

[0004] A guide catheter (which may also be referred to as a guide sheath) can be used to introduce an implant delivery device, such as the prosthetic heart valve delivery device described above, into the patient's vasculature. The guide catheter may include an elongate shaft that is inserted into the vasculature and a handle that remains outside the patient and can be used to manipulate the shaft. An implant delivery device may be inserted through the lumen of the guide catheter to help direct the implant delivery device to a target implantation site (e.g., a region of the native valve) within the patient and / or to help position the implant delivery device at the target implantation site. Summary of the Invention [Means for solving the problem]

[0005] Described herein are prosthetic heart valves, docking devices, delivery devices, guide catheters, and methods for implanting the docking devices and prosthetic heart valves. The disclosed guide catheters can be configured to receive a portion of the delivery device within the main lumen of the guide catheter, for example, to introduce the delivery device into the vasculature of a patient and guide the delivery device toward a target implantation site of a prosthetic medical device attached to the delivery device. In some embodiments, the guide catheter can include a reservoir disposed within or external to the handle of the guide catheter and configured to passively supply fluid to the main lumen of the guide catheter such that a volume and pressure within the main lumen is maintained. Thus, the devices and methods disclosed herein can overcome, among other things, one or more deficiencies of typical guide catheters.

[0006] The delivery device may include a handle and one or more shafts coupled to the handle.

[0007] In some examples, the handle may include a housing and a compressible reservoir disposed within the housing.

[0008] In some embodiments, the handle may include a housing and a reservoir disposed externally of the housing.

[0009] In some embodiments, the reservoir may be filled with a fluid and may have an adjustable fluid volume.

[0010] In some examples, the shaft may extend into and distally from the handle and have a main lumen, the main lumen fluidly connected to the reservoir by a first channel disposed in the handle.

[0011] In some examples, the one or more shafts can include a shaft extending into and distally from the handle and having a main lumen, and the delivery device comprises a bladder containing a fluid volume fluidly connected to the main lumen.

[0012] In some embodiments, the bladder may comprise flexible walls configured to conform to a fluid volume and contract inwardly as the fluid volume decreases.

[0013] In some embodiments, a delivery device comprises a handle, the handle comprising a housing and a compressible reservoir disposed within the housing, the reservoir is filled with a fluid and has an adjustable fluid volume, the delivery device further comprises a shaft extending within and distal to the handle and having a main lumen, the main lumen fluidly coupled to the reservoir by a first channel disposed within the handle.

[0014] In some embodiments, the delivery device comprises a handle, a shaft extending within and distal to the handle and having a main lumen, and a bladder containing a fluid volume fluidly connected to the main lumen, the bladder comprising a flexible wall configured to conform to the fluid volume and contract inwardly as the fluid volume decreases.

[0015] In some examples, the delivery device comprises a handle, a shaft extending within and distal to the handle and having a main lumen, and a reservoir fluidly coupled to the main lumen, the reservoir being filled with fluid and having an adjustable fluid volume, the reservoir being configured to passively supply fluid to the main lumen based on fluid pressure within the main lumen.

[0016] In some embodiments, the delivery device comprises one or more of the components listed in Examples 1-12, 34-42, and 57-73 below.

[0017] The delivery assembly may include an implant catheter and a guide catheter.

[0018] In some examples, the guide catheter may include a handle and a shaft extending distally from within the handle, the shaft having a main lumen configured to receive a portion of the implant catheter therethrough.

[0019] In some embodiments, the handle can include a housing and a flushing port coupled to the housing.

[0020] In some embodiments, the guide catheter may include a compressible reservoir disposed within the housing, the reservoir being filled with a fluid and having an adjustable fluid volume, and the irrigation port being fluidly connected to the reservoir.

[0021] In some examples, the main lumen of the shaft can be fluidly connected to a reservoir.

[0022] In some examples, the reservoir may be disposed about and radially outward of the shaft, and the main lumen may be fluidly connected to the reservoir by a first channel extending between the main lumen and the reservoir.

[0023] In some examples, the delivery assembly comprises an implant catheter and a guide catheter. The guide catheter comprises a handle, the handle comprising a housing and an irrigation port coupled to the housing. The guide catheter further comprises a compressible reservoir disposed within the housing, the reservoir filled with a fluid and having an adjustable fluid volume, and the irrigation port is fluidly coupled to the reservoir. The guide catheter further comprises a handle and a shaft extending distally from within the handle, having a main lumen configured to receive a portion of the implant catheter therethrough, the main lumen being fluidly coupled to the reservoir.

[0024] In some embodiments, the delivery assembly includes one or more of the components listed in Examples 13-23 below.

[0025] The guide sheath may include a handle and a shaft extending within and distally from the handle.

[0026] In some embodiments, the handle may include a housing, a irrigation port coupled to the housing, and a seal housing assembly including one or more fluid seals.

[0027] In some embodiments, the handle may include a compressible reservoir disposed within the housing, distal to the seal housing assembly.

[0028] In some embodiments, the reservoir may be filled with a fluid and may have an adjustable volume, and the flush port may be fluidly connected to the reservoir.

[0029] In some embodiments, the shaft may have a main lumen extending within the housing and through the seal housing assembly, the main lumen fluidly connected to the reservoir.

[0030] In some embodiments, the guide sheath comprises a handle comprising a housing, an irrigation port coupled to the housing, a seal housing assembly including one or more fluid seals, and a compressible reservoir disposed within the housing distal to the seal housing assembly. The reservoir is filled with a fluid and has an adjustable volume, and the irrigation port is fluidly coupled to the reservoir. The guide sheath further comprises a shaft extending within and distal to the handle and having a main lumen extending within the housing and through the seal housing assembly, the main lumen being fluidly coupled to the reservoir.

[0031] In some embodiments, the guide sheath comprises a handle comprising a housing and an irrigation port coupled to the housing. The guide sheath further comprises a reservoir fluidly coupled to the irrigation port and disposed external to the housing, the reservoir being filled with a fluid and having an adjustable volume. The guide sheath further comprises a shaft extending into and distal to the handle and having a main lumen extending into the housing, the main lumen being fluidly coupled to the reservoir by the irrigation port, the reservoir being configured to passively supply fluid to the main lumen based on fluid pressure in the main lumen.

[0032] In some embodiments, the guide sheath includes one or more of the components listed in Examples 24-33 and 74-82 below.

[0033] The method may include inserting a shaft of a guide catheter into a patient's blood vessel, inserting a distal end portion of an implant catheter into a proximal end of the guide catheter, and advancing the distal end portion of the implant catheter through the guide catheter toward a target implantation site of a prosthetic medical device attached to the distal end portion of a first implant catheter.

[0034] In some examples, the method may include advancing a distal end portion of the implant catheter through a main lumen of a shaft of a guide catheter toward the target implantation site, the shaft extending within and distal to a handle of the guide catheter.

[0035] In some examples, the method can include passively drawing fluid from the fluid reservoir into the main lumen such that a volume of the fluid reservoir decreases as the distal end portion of the implant catheter advances through the main lumen.

[0036] In some embodiments, the fluid reservoir is external to the handle and fluidly connected to the main lumen.

[0037] In some embodiments, the fluid reservoir is internal to the housing of the handle.

[0038] In some embodiments, a method of implanting a prosthetic medical device includes inserting a shaft of a guide catheter into a patient's blood vessel, the shaft having a main lumen and extending into and distal to a handle of the guide catheter, inserting a distal end portion of a first implant catheter into a proximal end of the guide catheter, and advancing the distal end portion of the first implant catheter through the main lumen of the guide catheter toward a target implantation site of a prosthetic medical device attached to the distal end portion of the first implant catheter. As the distal end portion of the first implant catheter advances through the main lumen, fluid is passively drawn from the fluid reservoir into the main lumen such that a volume of the fluid reservoir is reduced.

[0039] In some embodiments, a method for implanting a prosthetic medical device includes inserting a shaft of a guide catheter into a patient's blood vessel, the shaft having a main lumen and extending into and distal to a handle of the guide catheter. The method further includes inserting a distal end portion of a first implant catheter into a proximal end of the guide catheter and advancing the distal end portion of the first implant catheter through the main lumen of the guide catheter toward a target implantation site of a prosthetic medical device attached to the distal end portion of the first implant catheter. The method further includes compressing a fluid reservoir disposed within a housing of the handle and flowing fluid from within the fluid reservoir into the main lumen such that a volume of the fluid reservoir is reduced.

[0040] In some embodiments, a method for implanting a prosthetic medical device includes inserting a shaft of a guide catheter into a patient's blood vessel, the shaft having a main lumen and extending into and distal to a handle of the guide catheter, the method further includes inserting a distal end portion of a first implant catheter into a proximal end of the guide catheter, and advancing the distal end portion of the first implant catheter through the main lumen of the guide catheter toward a target implantation site of a prosthetic medical device attached to the distal end portion of the first implant catheter, wherein as the distal end portion of the first implant catheter is advanced through the main lumen, fluid is drawn from the fluid reservoir into the main lumen such that a volume of the fluid reservoir is reduced, the fluid reservoir being disposed within the handle.

[0041] In some embodiments, the method includes one or more of the features recited in Examples 43-56 and 83-92 below.

[0042] The above methods can be performed on live animals or can be performed on simulations such as cadavers, cadaver hearts, anthropomorphic ghosts, simulators (e.g., where body parts, hearts, tissues, etc. are simulated), etc.

[0043] The various innovations in this disclosure can be used in combination or separately. This Summary is provided to introduce in a simplified form a selection of concepts that are further described in the Detailed Description below. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. These and other objects, features, and advantages of the present disclosure will become more apparent from the following Detailed Description, from the claims, and from the accompanying drawings. [Brief description of the drawings]

[0044] [Figure 1] FIG. 1 illustrates generally the first step in an exemplary mitral valve replacement procedure, in which a guide catheter and guidewire are inserted into a patient's blood vessels and navigated through the vessels into the patient's heart toward the heart's native mitral valve. [Figure 2A] FIG. 2A illustrates a schematic diagram of a second step in an exemplary mitral valve replacement procedure, in which a docking device delivery device extending through a guide catheter implants a docking device for a prosthetic heart valve into the native mitral valve. [Figure 2B] FIG. 2B illustrates generally a third stage in an exemplary mitral valve replacement procedure in which the docking device of FIG. 2A has been fully implanted with the patient's native mitral valve and the docking device delivery device has been removed from the patient. [Figure 3A] FIG. 3A illustrates a schematic diagram of a fourth stage in an exemplary mitral valve replacement procedure, in which a prosthetic heart valve delivery device extending through a guide catheter implants a prosthetic heart valve within a docking device implanted with the native mitral valve. [Figure 3B] FIG. 3B illustrates a schematic diagram of a fifth stage in an exemplary mitral valve replacement procedure, in which the prosthetic heart valve is fully implanted within the docking device with the native mitral valve and the prosthetic heart valve delivery device is removed from the patient. [Figure 4] FIG. 4 illustrates generally a sixth stage in an exemplary mitral valve replacement procedure, in which the guide catheter and guidewire have been removed from the patient. [Diagram 5] FIG. 5 is a perspective view of an exemplary delivery device for a prosthetic heart valve. [Figure 6] FIG. 6 is a side view of an exemplary guide catheter configured to receive a delivery device and guide the delivery device through a portion of a patient's vasculature. [Figure 7A] FIG. 7A is a cross-sectional side view of the guide catheter of FIG. 6, according to one embodiment. [Figure 7B] 7B is a cross-sectional side view of the guide catheter of FIG. 6, according to one embodiment. [Figure 8] 8 is a side view of a delivery assembly including the guide catheter of FIG. 6 and the delivery device of FIG. [Figure 9A] 9A is another cross-sectional side view of the guide catheter of FIG. 6 showing a compressible reservoir disposed within the handle of the guide catheter in an expanded configuration as a delivery device is directed through the main lumen of the guide catheter. [Figure 9B] FIG. 9B is another cross-sectional side view of the guide catheter of FIG. 9A showing the compressible reservoir in a compressed configuration as the delivery device is directed further along the main lumen of the guide catheter. [Figure 10A] FIG. 10A is a cross-sectional side view of an exemplary guide catheter showing an adjustable reservoir external to the handle of the guide catheter in an expanded configuration as a delivery device is directed through the main lumen of the guide catheter. [Figure 10B] FIG. 10B is a cross-sectional side view of the guide catheter of FIG. 10A showing the external reservoir in a compressed configuration as the delivery device is directed further along the main lumen of the guide catheter. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0045] General Considerations For purposes of this specification, certain aspects, advantages, and novel features of the examples of the disclosure are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any way. Instead, the disclosure is directed to all novel and non-obvious features and aspects of the various disclosed examples, both alone and in various combinations and subcombinations. The methods, devices, and systems are not limited to any particular aspect, feature, or combination thereof, nor do the methods, devices, and systems require that any one or more particular advantages be present or problems be solved.

[0046] Although operations in some disclosed examples are described in a particular sequential order for convenience of presentation, it should be understood that aspects of the description encompass reordering unless a particular order is required by specific language set forth below. For example, operations described sequentially may be reordered or performed simultaneously in some cases. Furthermore, for simplicity, the accompanying drawings may not show various ways in which the disclosed methods may be used in combination with other methods. In addition, the description sometimes uses terms such as "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by those skilled in the art.

[0047] 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 "includes" means "comprises." Furthermore, the term "coupled" generally means to physically, mechanically, chemically, magnetically, and / or electrically connect or join together, and does not exclude the presence of intermediate elements between connected or associated members, unless specifically stated to the contrary.

[0048] As used herein, the term "proximal" refers to a position, orientation, or portion of a device that is closer to the user and away from the implantation site. As used herein, the term "distal" refers to a position, orientation, or portion of a device that is away from the user and closer to the implantation site. Thus, for example, proximal movement of a device is the movement of the device away from the implantation site and toward the user (e.g., out of the patient's body), while distal movement of a device is the movement of the device away from the user and toward the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial" refer to axes extending proximally and distally, unless expressly defined otherwise.

[0049] Introduction to the disclosed technology As described above, a guide catheter can be inserted into the patient's vasculature and then receive an implant delivery device within the main lumen of the guide catheter for guiding the delivery device therethrough to a target implantation site of the prosthetic implant. In some embodiments, the inner diameter of the main lumen of the guide catheter and the outer diameter of a portion of the implant delivery device can be closely matched. Thus, in some embodiments, as the delivery device is pushed distally through the main lumen of the guide catheter, a negative pressure (or vacuum) can be created within the main lumen, proximal to the implant, thereby creating an increasing pressure gradient across one or more fluid seals in the handle of the guide catheter. This results in an increase in the force felt by the user as the user pushes the delivery device through the guide catheter (referred to herein as a "pushing force"). Thus, improvements to guide catheters that reduce or prevent negative pressure from being created within the main lumen are desirable. Such improvements can help, for example, to maintain hemostasis and / or reduce pushing forces when advancing a delivery device through the guide catheter.

[0050] Described herein are various systems, devices, methods, etc. that, in some examples, may be used in or with a delivery device for an artificial medical device (such as an artificial heart valve or a docking device). In some examples, such systems, devices, and / or methods may provide a fluid reservoir fluidly coupled to the handle of the guide catheter configured to provide fluid to (and reduce volume in) the lumen of the guide catheter and maintain pressure within the lumen as the delivery device is navigated through the lumen of the guide catheter toward an implantation site within the patient's body. The fluid reservoir can reduce the negative pressure generated within the system, thereby reducing the pressure gradient across the fluid seal of the handle of the guide catheter and reducing the pushing force experienced by the user by pushing the delivery device through the guide catheter. As a result, hemostasis can be maintained, the system can be easy to operate, and in some cases, the likelihood of air being drawn into the guide catheter can be reduced.

[0051] In some examples, a guide catheter disclosed herein can be used to introduce one or more delivery devices (or implant catheters) into the patient's vasculature and guide the one or more delivery devices at least partially through the vasculature toward a target implantation site. For example, Figures 1-4 diagrammatically illustrate an exemplary transcatheter heart valve replacement procedure utilizing a guide catheter to guide a docking device delivery device toward the native valve annulus and then a prosthetic heart valve delivery device toward the native valve annulus. The docking device delivery device is used to deliver the docking device to the native valve annulus. The prosthetic heart valve delivery device is used to deliver the transcatheter prosthetic heart valve within the docking device.

[0052] As mentioned above, a defective native heart valve may be replaced with a transcatheter prosthetic heart valve. However, such a prosthetic heart valve may not be able to adequately conform itself to the shape of the native tissue (e.g., to the leaflets and / or annulus of the native heart valve) and may move undesirably relative to the native tissue, resulting in paravalvular leakage. Therefore, a docking device may be first implanted on the native annulus, and then the prosthetic heart valve may be implanted within the docking device, which helps to fix the prosthetic heart valve to the native tissue and provide a seal between the native tissue and the prosthetic heart valve. An exemplary delivery device for delivering a prosthetic heart valve into the docking device with a native heart valve is shown in FIG. 5.

[0053] Exemplary guide catheters are shown in more detail in Figures 6-8. In some embodiments, as shown in Figures 7A, 7B, and 9A-10B, the guide catheter may include a reservoir filled with fluid and fluidly connected to the main lumen of the guide catheter. In this manner, the reservoir may compress or reduce volume and provide fluid to the main lumen as the delivery device moves through the main lumen. As a result, the pressure gradient across one or more seals in the handle of the guide catheter may be reduced, thereby maintaining hemostasis within the guide catheter, reducing the likelihood that air will be introduced into the system (in some cases), and reducing pushing forces felt by a user manipulating the delivery device.

[0054] In some embodiments, the reservoir may be within the handle of the guide catheter (FIGS. 7A-7B and 9A-9B).

[0055] In some embodiments, the reservoir may be external to the handle of the guide catheter (FIGS. 10A-10B).

[0056] Examples of the disclosed technology 1-4 illustrate an exemplary transcatheter heart valve replacement procedure (e.g., mitral valve replacement) utilizing a docking device 52 and a prosthetic heart valve 62, according to one embodiment. During the procedure, a user first creates a pathway to the patient's native heart valve using a guide catheter 30 (FIG. 1). The user implants the docking device 52 with the patient's native heart valve using a docking device delivery device 50 (FIG. 2A), and then removes the docking device delivery device 50 from the patient 10 after implanting the docking device 52 (FIG. 2B). The user implants the prosthetic heart valve 62 within the implanted docking device 52 using a prosthetic valve delivery device 60 (FIG. 3A). The user then removes the prosthetic valve delivery device 60 (FIG. 3B), as well as the guide catheter 30 (FIG. 4), from the patient 10.

[0057] 1 illustrates a first step in a mitral valve replacement procedure in which a guide catheter 30 and guidewire 40 are inserted into a blood vessel 12 of a patient 10 and navigated through the blood vessel 12 into the heart 14 of the patient 10 toward the native mitral valve 16, according to one embodiment. Together, the guide catheter 30 and guidewire 40 can provide a pathway for a docking device delivery device 50 and a prosthetic valve delivery device 60 to navigate through and along the implantation site (the native mitral valve 16 or the native mitral valve annulus).

[0058] First, a user may first make an incision in the patient's body to access blood vessel 12. For example, in the embodiment shown in Figure 1, a user may make an incision in the patient's groin to access the femoral vein. Thus, in such an embodiment, blood vessel 12 may be the femoral vein.

[0059] After making the incision in the blood vessel 12, the user may insert the guide catheter 30, guidewire 40, and / or additional devices (e.g., an introducer device or a transseptal puncture device) into the blood vessel 12 through the incision. The in-guide catheter 30 (which may also be referred to as an "introducer device," "introducer," or "guide sheath") is configured to facilitate percutaneous introduction of various implant delivery devices (e.g., a docking device delivery device 50 and a prosthetic valve delivery device 60) into and through the blood vessel 12 and may extend through the blood vessel 12 and into the heart 14, but may stop short of the native mitral valve 16. The guide catheter 30 may include a handle 32 and a shaft 34 extending distally from the handle 32. The shaft 34 may extend through the blood vessel 12 into the heart 14 while the handle 32 remains outside the body of the patient 10 and may be manipulated by a user to manipulate the shaft 34 (FIG. 1).

[0060] 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, or the like) and their associated devices (e.g., a docking device, a prosthetic heart valve, or the like) to an implantation site within the heart 14, and thus may extend all the way through the blood vessels 12 to the left atrium 18 of the heart 14 (and, in some embodiments, through the native mitral valve 16 to the left ventricle of the heart 14) (FIG. 1).

[0061] In some cases, the left atrium 18 may be first accessed using a transseptal puncture device or catheter prior to inserting the guidewire 40 and guide catheter 20. For example, after making an incision in the blood vessel 12, the user may insert the transseptal puncture device into the blood vessel 12 through the incision. The user may guide the transseptal puncture device through the blood vessel 12 and into the heart 14 (e.g., through the femoral vein into the right atrium 20). The user may make a small incision in the atrial septum 22 of the heart 14 to allow access from the right atrium 20 to the left atrium 18. The user may 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 and 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 may be removed from the patient 10. A user may insert guide catheter 30 into blood vessel 12 and advance guide catheter 30 over guidewire 40 into left atrium 18 (FIG. 1).

[0062] In some cases, the introducer device may be inserted through the lumen of the guide catheter 30 prior to inserting the guide catheter 30 into the blood vessel 12. In some cases, the introducer device may include a tapered end extending from the distal tip of the guide catheter 30 and configured to guide the guide catheter 30 over the guidewire 40 into the left atrium 18. Additionally, in some cases, the introducer device may include a proximal end portion extending from the proximal end of the guide catheter 30. Once the guide catheter 30 reaches the left atrium 18, the user may remove the introducer device from the guide catheter 30 and from inside the patient 10. Thus, only the guide catheter 30 and the guidewire 40 remain inside the patient 10. The guide catheter 30 is then in a position to receive the implant delivery device and help guide it into the left atrium 18 as further described below.

[0063] FIG. 2A shows a second step in an exemplary mitral valve replacement procedure in which a docking device 52 is implanted into the native mitral valve 16 of the patient's 10's heart 14 using a docking device delivery device 50 (which may also be referred to as an "implant catheter" and / or a "docking device delivery device").

[0064] Generally, docking device delivery device 50 comprises 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) to an implantation site (e.g., native mitral valve 16) and may be configured to retain the docking device 52 within a distal end portion 53 of the delivery shaft 54. In some embodiments, the distal end portion 53 of the delivery shaft 54 ​​retains the docking device 52 therein in a straight delivery configuration.

[0065] The handle 56 of the docking device delivery device 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 (e.g., blood vessel 12).

[0066] In some examples, the handle 56 may include one or more articulation members 57 (or rotatable knobs) configured to aid in navigating the delivery shaft 54 ​​through the patient's blood vessel 12. For example, the one or more articulation members 57 may include one or more of knobs, buttons, wheels, and / or other types of physically adjustable control members configured to be adjusted by a user to flex, bend, twist, rotate, and / or otherwise articulate the distal end portion 53 of the delivery shaft 54 ​​to aid in navigating the delivery shaft 54 ​​through the patient's blood vessel 12 and into the heart 14.

[0067] 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 disposed adjacent to the docking device 52 within the delivery shaft 54. In some examples, the docking device 52 can be removably 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 it has been deployed at the native mitral valve 16.

[0068] Further details of the docking device delivery device and variations thereof are described in International Publication No. WO2020 / 247907, the entire contents of which are incorporated herein by reference.

[0069] 2A , after the guide catheter 30 is positioned within the left atrium 18, the user may 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 may be at least partially stored within the guide catheter 30, away from the left atrium 18. The user may 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 in FIG. 2A . Specifically, the user may advance the delivery shaft 54 ​​of the docking device delivery device 50 by grasping the handle 56 of the docking device delivery device 50 and exerting a force (e.g., pushing) toward the patient 10. The user may adjust one or more articulation members 57 of the handle 56 while advancing the delivery shaft 54 ​​through the blood vessel 12 and the heart 14 to navigate various turns, angles, stenoses, and / or other obstacles in the blood vessel 12 and the heart 14.

[0070] Once the delivery shaft 54 ​​reaches the left atrium 18 and extends out of the distal end of the guide catheter 30, the user may use the handle 56 (e.g., articulation member 57) to position the distal end portion 53 of the delivery shaft 54 ​​at and / or near the posteromedial commissure of the native mitral valve 16. The user may use the shaft of the pusher assembly 58 to push the docking device 52 out of the distal end 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.

[0071] In some examples, the docking device 52 may be constructed from, formed from, and / or include a shape memory material such that the docking device can return to its original preformed shape when it exits the delivery shaft 54 ​​and is no longer constrained by the delivery shaft 54. As an example, the docking device 52 may originally be formed as a coil and thus wrap around the leaflets 24 of the native mitral valve 16 upon exiting the delivery shaft 54 ​​and returning to its original coiled configuration.

[0072] The user may press the ventricular portion of the docking device 52 (e.g., the portion of the docking device 52 shown in FIG. 2A that is configured to be positioned within the left ventricle 26 and / or on the ventricular side of the native mitral valve 16) and then retract the delivery shaft 54 ​​away from the posterior medial commissure of the native mitral valve 16, thereby deploying 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.

[0073] After deploying and implanting the docking device 52 on the native mitral valve 16, the user may disconnect the docking device delivery device 50 from the docking device 52. Once the docking device 52 is disconnected from the docking device delivery device 50, the user may store the docking device delivery device 50 out of the blood vessel 12 and away from the patient 10 so that the user can deliver and implant a prosthetic heart valve 62 within the docking device 52 implanted with the native mitral valve 16.

[0074] 2B illustrates this third stage in the mitral valve replacement procedure, where the docking device 52 is fully deployed and implanted in the native mitral valve 16 and the docking device delivery device 50 (including the delivery shaft 54) is removed from the patient 10, so that only the guidewire 40 and the guide catheter 30 remain inside the patient 10. In some embodiments, after removal of the docking device delivery device, the guidewire 40 can be advanced out of the guide catheter 30, through the docking device 52 implanted in the native mitral valve 16, and into the left ventricle 26 (FIG. 2A). In this manner, 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.

[0075] 2B, the docking device 52 can include multiple 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 implanted prosthetic heart valve. As a result, the docking device 52 can provide a tighter fit, and therefore a better seal, between the prosthetic heart valve and the native mitral valve 16, as described further below.

[0076] FIG. 3A shows a fourth stage in the mitral valve replacement procedure, in which a user is using 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 a “THV,” a “replacement heart valve,” and / or a “prosthetic mitral valve”) into a docking device 52.

[0077] 3A , the prosthetic valve delivery device 60 can 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 to 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.

[0078] In some examples, the handle 66 may include one or more articulation members 68 configured to aid in navigating the delivery shaft 64 through the blood vessel 12 and the heart 14. In particular, the articulation members 68 may include one or more of knobs, buttons, wheels, and / or other types of physically adjustable control members configured to be adjusted by a user to flex, bend, twist, rotate, and / or otherwise articulate a distal end portion of the delivery shaft 64 to aid in navigating the delivery shaft 64 through the patient's blood vessel 12 and into the left atrium 18 and left ventricle 26 of the heart 14.

[0079] In some embodiments, the prosthetic valve delivery device 60 may include an expansion mechanism 65 configured to radially expand and deploy the prosthetic heart valve 62 at the implantation site. In some cases, as shown in FIG. 3A , the expansion mechanism 65 may include an inflatable balloon configured to inflate to radially expand the prosthetic heart valve 62 within the docking device 52. The inflatable balloon may be coupled to a distal end portion of the delivery shaft 64.

[0080] In some embodiments, the prosthetic heart valve 62 may be self-expanding and configured to radially expand on its own upon removal of a sheath or capsule covering the radially compressed prosthetic heart valve 62 on the distal end portion of the delivery shaft 64.

[0081] In some embodiments, the prosthetic heart valve 62 may be mechanically expandable, and the prosthetic valve delivery device 60 may include one or more mechanical actuators (e.g., expansion mechanisms) configured to radially expand the prosthetic heart valve 62.

[0082] As shown in FIG. 3A, the prosthetic heart valve 62 is mounted in a radially compressed configuration about an expansion mechanism 65 (an inflatable balloon) on the distal end portion of a delivery shaft 64 .

[0083] To navigate the distal end portion of the delivery shaft 64 to the implantation site, the user can insert the prosthetic valve delivery device 60 (delivery shaft 64) through the guide catheter 30 and over the guidewire 40 into the patient 10. The user can continue to advance the prosthetic valve delivery device 60 along the guidewire 40 (through the blood vessel 12) until the distal end portion of the delivery shaft 64 reaches the native mitral valve 16, as shown in FIG. 3A. More specifically, the user can advance the delivery shaft 64 of the prosthetic valve delivery device 60 by grasping the handle 66 and exerting a force (e.g., pushing). The user can adjust one or more articulation members 68 of the handle 66 while advancing the delivery shaft 64 through the blood vessel 12 and the heart 14 to navigate various turns, angles, stenoses, and / or other obstacles within the blood vessel 12 and the heart 14.

[0084] The user can advance the delivery shaft 64 along the guidewire 40 until the radially compressed prosthetic heart valve 62 mounted about a distal end portion of the delivery shaft 64 is positioned within the docking device 52 and the native mitral valve 16. In some examples, as shown in FIG. 3A, the distal end of the delivery shaft 64 and at least a portion of the radially compressed prosthetic heart valve 62 can be positioned within the left ventricle 26.

[0085] Once the radially compressed prosthetic heart valve 62 is properly positioned within the docking device 52 (FIG. 3A), a user can manipulate one or more actuation mechanisms on the handle 66 of the prosthetic valve delivery device 60 to actuate the expansion mechanism 65 (e.g., inflate an inflatable balloon), thereby radially expanding the prosthetic heart valve 62 within the docking device 52.

[0086] 3B shows a fifth stage in the mitral valve replacement procedure, in which the prosthetic heart valve 62 is in its radially expanded configuration and is implanted within the docking device 52 of the native mitral valve 16. As shown in FIG. 3B, the prosthetic heart valve 62 is received and held within the docking device 52. Thus, the docking device 52 helps to secure the prosthetic heart valve 62 within the native mitral valve 16. The docking device 52 allows for 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.

[0087] As shown in FIG. 3B , after the prosthetic heart valve 62 is fully deployed and implanted within the docking device 52 with the native mitral valve 16, the prosthetic valve delivery device 60 (including the delivery shaft 64) is removed from the patient 10 so that only the guidewire 40 and guide catheter 30 remain inside the patient 10.

[0088] FIG. 4 illustrates a sixth stage in the mitral valve replacement procedure, in which guidewire 40 and guide catheter 30 have been removed from patient 10.

[0089] 1-4 specifically depict a mitral valve replacement procedure, it should be understood that the same and / or similar procedures may be utilized to replace other heart valves (e.g., the tricuspid, pulmonary, and / or aortic valves). Additionally, the same and / or similar delivery devices (e.g., docking device 50, prosthetic valve delivery device 60, guide catheter 30, and / or guidewire 40), docking devices (e.g., docking device 52), replacement heart valves (e.g., prosthetic heart valve 62), and / or components thereof may be utilized to replace these other heart valves.

[0090] For example, if a user is replacing a native tricuspid valve, the user may also access the right atrium 20 via the femoral vein, but without having to cross the atrial septum 22 into the left atrium 18. Instead, the user may leave the guidewire 40 in the right atrium 20 and perform the same and / or similar docking device implantation process in the tricuspid valve. Specifically, the user may push the docking device 52 out of the delivery shaft 54 ​​around the ventricular side of the leaflets of the tricuspid valve, release the remaining portion of the docking device 52 from the delivery shaft 54 ​​in the right atrium 20, and remove the delivery shaft 54 ​​of the docking device delivery device 50 from the patient 10. The user may advance the guidewire 40 through the tricuspid valve into the right ventricle, and perform the same and / or similar prosthetic heart valve implantation process in the docking device 52 and in the tricuspid valve. Specifically, the user may advance the delivery shaft 64 of the prosthetic valve delivery device 60 along the guidewire 40 through the patient's vasculature until the prosthetic heart valve 62 is positioned / placed within the docking device 52 and the tricuspid valve. The user may expand the prosthetic heart valve 62 within the docking device 52 before removing the prosthetic valve delivery device 60 from the patient 10. In some examples, the user may perform the same and / or similar process to replace the aortic valve, but access the aortic valve from the outflow side of the aortic valve via the femoral artery.

[0091] 1-4 illustrate the mitral valve replacement procedure in which the native mitral valve 16 is accessed from the left atrium 18 via the right atrium 20 and femoral vein, it should be understood that the native mitral valve 16 may alternatively be accessed from the left ventricle 26. For example, a user may access the native mitral valve 16 from the left ventricle 26, through the aortic valve, by advancing one or more delivery devices up an artery to the aortic valve, through the aortic valve, and into the left ventricle 26.

[0092] Figure 5 illustrates an exemplary prosthetic heart valve delivery device 100 (which may also be referred to herein as an "implant catheter") that may be used to implant an expandable prosthetic heart valve in place of the prosthetic valve delivery device 60 of Figure 3 A. In some embodiments, the delivery device 100 is specifically adapted for use in introducing a prosthetic heart valve into the heart.

[0093] 5 is a balloon catheter that includes a handle 102 and a steerable outer shaft 104 extending distally from the handle 102. The delivery device 100 can further include an intermediate shaft 106 (which may also be referred to as a balloon shaft) that extends proximally and distally from the handle 102, with the portion that extends distally from the handle 102 also extending coaxially through the outer shaft 104. In some embodiments, the delivery device 100 can further include an inner shaft that extends distally from the handle 102 coaxially through the intermediate shaft 106 and the outer shaft 104, and that extends proximally from the handle 102 coaxially through the intermediate shaft.

[0094] The outer shaft 104 and the intermediate shaft 106 can be configured to translate (e.g., move) longitudinally relative to one another along a central longitudinal axis 120 of the delivery device 100 to facilitate delivery and positioning of the prosthetic valve to an implantation site within a patient's body.

[0095] The midshaft 106 can include a proximal end portion extending proximally from the proximal end of the handle 102 to an adapter 112. The adapter 112 can include a first port 138 configured to receive a guidewire therethrough and a second port 140 configured to receive fluid (e.g., inflation fluid) from a fluid source. The second port 140 can be fluidly coupled to the lumen of the midshaft 106.

[0096] In some embodiments, the midshaft 106 can further include a distal end portion that extends distally beyond the distal end of the outer shaft 104 when the distal end of the outer shaft 104 is positioned away from the inflatable balloon 118 of the delivery device 100. The distal end portion of the inner shaft can extend distally beyond the distal end portion of the midshaft 106 toward or to a nosecone 122 at the distal end of the delivery device 100.

[0097] In some embodiments, the distal end of the balloon 118 can be coupled to the distal end of the delivery device 100, such as a nose cone 122 (as shown in FIG. 5) or to an alternative component at the distal end of the delivery device 100 (e.g., a distal shoulder). An intermediate portion of the balloon 118 can cover a valve mounting portion 124 at the distal end portion of the delivery device 100, and a distal end portion of the balloon 118 (as shown in FIG. 5) can cover the distal shoulder of the delivery device 100. As shown in FIG. 5, the prosthetic heart valve 150 can be mounted around the balloon 118 at the valve mounting portion 124 of the delivery device 100 in a radially compressed state. The prosthetic heart valve 150 can be configured to be radially expanded by inflation of the balloon 118 at the native annulus, as described above with reference to FIGS. 3A and 3B.

[0098] The balloon shoulder assembly of the delivery device 100, including the distal shoulder, is configured to maintain the prosthetic heart valve 150 (or other medical device) in a fixed position on the balloon 118 during delivery through the patient's vasculature.

[0099] The outer shaft 104 can include a distal tip portion 128 (best seen in FIG. 8 ) mounted on its distal end. In some embodiments, the outer shaft 104 and the intermediate shaft 106 can be axially translated relative to one another to position the distal tip portion 128 adjacent a proximal end of the valve mounting portion 124 when the prosthetic valve 150 is mounted in a radially compressed state on the valve mounting portion 124 (e.g., as shown in FIG. 5 ) and during delivery of the prosthetic valve to the target implantation site. In this manner, the distal tip portion 128 can be configured to resist movement of the prosthetic valve 150 axially proximally relative to the balloon 118 when the distal tip portion 128 is positioned adjacent the proximal side of the valve mounting portion 124.

[0100] An annular space can be defined between an outer surface of the inner shaft and an inner surface of the midshaft 106, and the annular space can be configured to receive fluid from a fluid source via the second port 140 of the adapter 112. The annular space can be fluidly connected to a fluid passageway formed between an outer surface of the distal end portion of the inner shaft and an inner surface of the balloon 118. In this manner, fluid from the fluid source can flow from the annular space to the fluid passageway, thereby inflating the balloon 118 to radially expand and deploy the prosthetic valve 150.

[0101] The lumen of the inner shaft can be configured to receive a guidewire therethrough for steering the distal end portion of the delivery device 100 to the target implantation site.

[0102] The handle 102 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery device 100. In the illustrated example, for example, the handle 102 includes an adjustment member, such as the illustrated rotatable knob 160, that is operably coupled to a proximal end portion of a pull wire. The pull wire can extend distally from the handle 102 through the outer shaft 104 and have a distal end portion fixed relative to the outer shaft 104 at or near the distal end of the outer shaft 104. By rotating the knob 160, the tension in the pull wire can be increased or decreased, thereby adjusting the curvature of the distal end portion of the delivery device 100. Further details regarding steering or bending mechanisms in delivery devices can be found in U.S. Pat. No. 9,339,384, which is incorporated herein by reference.

[0103] The handle 102 can further include an adjustment mechanism 161 that includes an adjustment member, such as the illustrated rotatable knob 162, and an associated locking mechanism that includes another adjustment member configured as a rotatable knob 178. The adjustment mechanism 161 is configured to adjust the axial position of the intermediate shaft 106 relative to the outer shaft 104 (e.g., for fine positioning at the implantation site).

[0104] Attention is now directed to FIGS. 6-7B, which show an exemplary guide catheter, hereinafter referred to as guide sheath 200 (and which may also be referred to herein as a "delivery device" or "introducer device" or "introducer"). In some embodiments, guide sheath 200 may be used in place of guide catheter 30 in a docking device and / or prosthetic valve implantation procedure, as described above with reference to FIGS. 1-4. Guide sheath 200 may be configured to be inserted into a patient's vasculature and receive an implant catheter or delivery device therein (e.g., delivery device 100 of FIG. 5, as shown in FIG. 8) to introduce the implant catheter into the patient's vasculature and at least partially guide the implant catheter therein to a target implantation site. Although guide sheath 200 is described herein as being used with delivery device 100, guide sheath 200 may be configured to receive a variety of delivery devices or implant catheters, such as delivery devices for alternative prosthetic heart valves, docking device delivery devices, and / or delivery devices for other prosthetic medical devices or medical therapies, such as stents.

[0105] The guide sheath 200 of the illustrated embodiment comprises a handle 202, an elongate shaft 204 extending distally from the handle 202, and a central longitudinal axis 212 (FIGS. 7A and 7B). The shaft 204 has a main (or primary) lumen 222 defined by an inner surface of a wall 230 of the shaft 204 (FIGS. 7A and 7B). The main lumen 222 is configured to receive a delivery device therein (such as any of the prosthetic device delivery devices or implant catheters described herein). In some embodiments, the shaft 204 may extend into the handle 202, as shown in FIGS. 7A and 7B. Additionally, in some embodiments, the main lumen 222 may extend through the handle 202 to an entry port 206 disposed at a proximal end of the handle 202. Thus, in some embodiments, an inner surface of a wall of a portion of the handle (e.g., at a proximal end) may further define the main lumen 222. Thus, the main lumen 222 may extend from the inlet port 206 to the distal end 208 of the shaft 204 .

[0106] The handle 202 can have a housing 205 (also referred to as an "outer housing 205") with a body portion 218, and a seal housing assembly 210 (also referred to as a "seal stack") with one or more seals 224 contained therein (FIGS. 7A and 7B). The one or more seals 224 of the seal housing assembly 210 can be configured to fluidly seal the main lumen 222 of the guide sheath 200 from the outside environment (e.g., from blood, air, and the like). For example, the one or more seals 224 of the seal housing assembly 210 can be configured to prevent blood from a patient into which the guide sheath 200 is inserted from exiting the guide sheath 200 and to prevent air from the environment from entering the guide sheath 200 (e.g., through the inlet port 206). The one or more seals 224 can include various types of seals, such as a duckbill seal, a flapper seal, an umbrella valve, a cross slit valve, a dome valve, and the like.

[0107] The body portion 218 is disposed adjacent and distal to the seal housing assembly 210. The handle 202 may include a steering mechanism configured to adjust the curvature of a distal end portion of the shaft 204 (and thus the shaft 204 may be referred to as a steerable shaft). In the illustrated embodiment, the handle 202 includes an adjustment member, such as the illustrated rotatable knob 220 (FIGS. 6-7B). The body portion 218 may house the bending mechanism 228 of the guide sheath 200 operably coupled to the rotatable knob 220 (FIGS. 7A-7B). In some embodiments, the bending mechanism 228, and thus the knob 220, may be operably coupled to a proximal end portion of a pull wire. The pull wire may extend distally from the handle 202 through the shaft 204 and have a distal end portion secured to the shaft 204 at or near the distal end 208 of the shaft 204. Rotating knob 220 increases or decreases the tension in the pull wire, thereby adjusting the curvature of the distal end portion of shaft 204. Further details regarding steering or bending mechanisms in delivery devices can be found in U.S. Patent No. 9,339,384, already incorporated by reference above.

[0108] 7A and 7B show two alternative exemplary positions of the bending mechanism 228 within the housing 205, including a first position (FIG. 7A) in which the bending mechanism 228 is positioned radially closer to the shaft 204, and a second position (FIG. 7B) in which the bending mechanism 228 is positioned radially closer to the housing 205 (and can be spaced from the shaft 204 by another component), as described further below.

[0109] The handle 202 may include a flushing port 216 connected to the housing 205 distal to the seal housing assembly 210. In some embodiments, the flushing port 216 is connected to a body portion 218 of the housing 205.

[0110] The handle 202 further includes a compressible reservoir 240. As shown in FIGS. 7A and 7B, the reservoir 240 is disposed within the housing 205. The reservoir 240 is filled with a fluid 242 and has an adjustable fluid volume. For example, the reservoir 240 can include a wall 244 that defines an internal cavity 246 that contains the fluid 242 therein. The wall 244 can include a flexible material configured to expand (or stretch) with an increase in fluid volume (of the fluid 242) within the reservoir 240 and compress (or collapse or contract) with a decrease in fluid volume within the reservoir 240. In some cases, the wall 244 can be configured to conform to the volume of the fluid 242 as the volume of the fluid 242 changes, thereby changing the size of the cavity 246. In this manner, the reservoir 240 can be configured as an expandable and compressible reservoir, bladder, or balloon with an adjustable (or reducible) fluid volume. As described further below with reference to Figures 9A and 9B, the walls 244 of the reservoir 240 can compress as the interior volume of the fluid 242 decreases, thereby reducing the overall volume of the cavity 246.

[0111] The reservoir 240 may be fluidly coupled to the flushing port 216 by a first channel 254 (or flushing lumen). For example, the first channel 254 may extend from the flushing port 216 through the housing 205 into the interior of the reservoir 240 such that an end of the first channel 254 is disposed within the fluid 242 in the cavity 246. The cavity 246 may be configured to receive fluid from the flushing port 216 through the first channel 254 (e.g., during preparation or cleaning of the guide sheath 200), as described further below with reference to FIGS. 9A and 9B. Thus, the first channel 254 serves as a fluid inlet for the reservoir 240 and may be referred to as a fluid inlet.

[0112] In some cases, as shown in FIGS. 7A and 7B, the first channel 254 can be disposed at a proximal end 256 of the reservoir 240 distal to and adjacent to the seal housing assembly 210.

[0113] In some cases, the first channel 254 may be located at another location along the reservoir 240, such as at its distal end or at a location between its proximal end 256 and the distal end.

[0114] The reservoir 240 may be fluidly coupled to the main lumen 222 via a second channel 258 (or flow lumen). The second channel 258 may extend radially between the cavity 246 of the reservoir 240 and the main lumen 222. During use of the guide sheath 200, the fluid 242 may flow through the second channel 258 into the main lumen 222 based on the fluid pressure within the main lumen 222. Thus, the second channel 258 serves as a fluid outlet for the reservoir 240 and may be referred to as a fluid outlet. In some cases, the second channel 258 may be disposed at a proximal end 256 of the reservoir 240 (FIGS. 7A and 7B).

[0115] In some cases, the second channel 258 may be a radially extending channel disposed on one side of the reservoir 240 or extending circumferentially around only a portion of the reservoir 240 .

[0116] In some cases, the second channel 258 may be annular and may extend around the entire circumference of the reservoir.

[0117] For example, in some cases, the reservoir 240 may be annular and extend circumferentially around the shaft 204 (as shown in FIGS. 7A and 7B ). In such examples, the wall 244 of the reservoir 240 may have a portion that faces radially inward on one side of the cavity 246 (the side closest to the shaft 204) and a portion that faces radially outward on the opposite side of the cavity 246 (the side closest to the housing 205).

[0118] In some embodiments, the reservoir 240 may be disposed radially outside of the flexion mechanism 228 (e.g., radially between the housing 205 and the flexion mechanism 228), as shown in Figure 7A. In alternative embodiments, the reservoir 240 may be disposed radially inside of the flexion mechanism 228 (e.g., radially between the shaft 204 and the flexion mechanism 228), as shown in Figure 7B. In both embodiments, the second channel 258 may be disposed proximal and adjacent to the proximal end of the flexion mechanism 228.

[0119] 7A and 7B and disposed within the housing 205 of the handle 202, in alternative embodiments, the reservoir 240 may be disposed outside the housing 205 and fluidly connected to the main lumen 222 via a second channel 258 extending between the external reservoir 240 and the main lumen 222. The irrigation port 216 may be attached directly to the reservoir 240.

[0120] As described above, the guide sheath 200 can be configured to receive a delivery device, such as the delivery device 100 of FIG. 5, within the main lumen 222 of the guide sheath 200. Prior to inserting the delivery device 100 into the guide sheath (and / or prior to inserting the guide sheath into the patient's vasculature), the main lumen 222 and the reservoir 240 can be primed or flushed through the flushing port 216. For example, a fluid (e.g., fluid 242) can flow through the flushing port 216 and into the cavity 246 of the reservoir 240 via the first channel 254. In some cases, the cavity 246 can be filled with the fluid 242 until the wall 244 of the reservoir 240 expands as far as it can and hits the wall of the housing 205 (FIGS. 7A and 9A) or the wall of the bending mechanism 228 (FIG. 7B). Once the reservoir 240 is full (and in its expanded configuration, as shown in FIG. 9A ), fluid entering the reservoir 240 from the flushing port 215 can continue to flow into the main lumen 222 via the second channel 258. In some cases, this process can continue until the main lumen 222 is filled to a desired level. In some examples, the fluid 242 used to fill the reservoir 240 and main lumen 222 is saline or an alternative biocompatible flushing fluid.

[0121] After positioning the shaft 204 of the guide sheath 200 within the patient's vasculature, the distal end portion of the delivery apparatus 100 (e.g., the nose cone 122 and radially compressed prosthetic heart valve 150) may be inserted into the inlet port 206 of the handle 202 of the guide sheath 200, as shown by arrow 152 in FIG. 8. The distal end portion of the delivery apparatus 100 may then be navigated through the seal housing assembly 210 and into the main lumen 222 of the guide sheath 200. The delivery apparatus 100 continues to be navigated through the main lumen 222 of the shaft 204 toward the implantation site. The assembly shown in FIG. 8 may be referred to as a delivery assembly 130.

[0122] 9A and 9B depict different exemplary states of the reservoir 240 as the delivery device 100 is navigated through the main lumen 222 of the guide sheath 200. As noted above, in FIG. 9A, the reservoir 240 is in an expanded state or configuration. The distal end portion of the delivery device 100, including the prosthetic heart valve 150, has just been inserted into the main lumen 222 and is disposed within the handle 202.

[0123] As the distal end portion of the delivery device 100 is navigated further through the main lumen 222, the pressure (fluid pressure) in the proximal portion of the main lumen 222 (e.g., the portion within the handle 202, shown in FIG. 9A ) may decrease due to the prosthetic heart valve 150 (or an alternative portion of the delivery device 100) sliding against the inner surface of the wall 230 of the shaft 204. As the pressure in the main lumen 222 decreases, the fluid 242 in the reservoir 240 may be pulled from the reservoir cavity 246 into the main lumen 222, and at the same time, the wall 244 of the reservoir 240 is compressed radially inward, thereby decreasing the interior volume of the reservoir cavity 246 (as shown in FIG. 9A ). As a result, the pressure in the main lumen 222 may equalize, which in some cases may reduce the negative pressure (or vacuum) created by advancing the distal end portion of the delivery device 100 through the main lumen 222.

[0124] It should be noted that during this process, fluid does not enter the reservoir via first channel 254 (eg, the fluid inlet to reservoir 240 may be closed).

[0125] In the expanded state of the reservoir 240 (FIG. 9A), the cavity 246 has a first fluid volume. In the compressed state or configuration of the reservoir 240 (FIG. 9B), the cavity 246 has a second fluid volume that is smaller than the first fluid volume. Furthermore, in the compressed state, a radially outwardly facing portion of the wall 244 of the reservoir 240 is spaced from the inner surface of the wall of the housing 205. Thus, as fluid flows out of the cavity 246 and into the main lumen 222 of the guide sheath 200, the total volume of the cavity 246 decreases with the decrease in fluid volume.

[0126] In some cases, the size (e.g., diameter, width, and / or length) of second channel 258 may be specified based on a transfer rate of a selected fluid volume that maintains the pressure in main lumen 222 at a desired level (e.g., non-negative pressure) and maintains hemostasis within the guide sheath. For example, by increasing the volume of second channel 258, the transfer rate of fluid between reservoir 240 and main lumen 222 may be increased, thereby better maintaining the pressure in main lumen 222 at a non-negative pressure value as the delivery device is navigated therethrough.

[0127] In some examples, the use of a compressible reservoir can also reduce the pushing force felt by a user navigating a delivery device through the main lumen of a guide catheter by maintaining the pressure within the main lumen of the guide sheath or catheter at a non-negative level.

[0128] 10A and 10B illustrate an exemplary guide catheter or guide sheath 300 (which may also be referred to herein as a "delivery device", or an "introducer device", or an "introducer"). In some embodiments, the guide sheath 300 may be used in place of the guide catheter 30 in a docking device and / or prosthetic valve implantation procedure, as described above with reference to FIGS. 1-4. The guide sheath 300 may be configured to be inserted into a patient's vasculature and receive an implant catheter or delivery device therein (e.g., the delivery device 100 of FIG. 5) to introduce the implant catheter into the patient's vasculature and at least partially guide the implant catheter therein to a target implantation site. For example, in some cases, the guide sheath 300 may be used in place of the guide sheath 200 of FIG. 8.

[0129] Although guide sheath 300 is described herein as being used with delivery apparatus 100, guide sheath 300 may be configured to receive a variety of delivery apparatus or implant catheters, such as alternative prosthetic heart valve delivery apparatus, docking apparatus delivery apparatus, and / or delivery apparatus for other prosthetic medical devices or medical therapies, such as stents.

[0130] Guide sheath 300 may be similar to guide sheath 200, except that guide sheath 300 includes a reservoir 340 disposed external to guide sheath handle 302 (and thus may also be referred to herein as "external reservoir 340").

[0131] For example, the guide sheath 300 may include a handle 302, an elongate shaft 304 extending distally from the handle 302, and a central longitudinal axis 312. The shaft 304 has a main (or primary) lumen 322 defined by an inner surface of a wall 330 of the shaft 304. The main lumen 322 is configured to receive a delivery device therein (such as any of the prosthetic device delivery devices or implant catheters described herein). In some embodiments, the shaft 304 may extend into the handle 302, as shown in FIGS. 10A and 10B. Additionally, in some embodiments, the main lumen 322 may extend through the handle 302 to an entry port 306 disposed at a proximal end of the handle 302. Thus, in some embodiments, an inner surface of a wall of a portion of the handle (e.g., at a proximal end) may further define the main lumen 322. Thus, the main lumen 322 can extend from the inlet port 306 to the distal end of the shaft 304 (eg, the distal end 208 shown in FIG. 6).

[0132] The handle 302 can have a housing 305 (which can also be referred to as an “outer housing 305”) that includes a seal housing assembly 310 (which can also be referred to as a “seal stack”) that includes a main body portion 318 and one or more seals 324 housed therein. The one or more seals 324 of the seal housing assembly 310 can be configured to fluidly seal the main lumen 322 of the guide sheath 300 from the outside environment. For example, the one or more seals 324 of the seal housing assembly 310 can be configured to prevent blood from a patient into which the guide sheath 300 is inserted from exiting the guide sheath 300 and to prevent air from the environment from entering the guide sheath 300 (e.g., through the inlet port 306). The one or more seals 324 can include various types of seals, such as a duckbill seal, a flapper seal, an umbrella valve, a cross slit valve, a dome valve, etc.

[0133] The flush port 316 may be connected to the outer housing 305 .

[0134] The handle 302 may, in some cases, include an adapter spine 314 disposed distally adjacent to the seal housing assembly 310. In some embodiments, an irrigation port 316 is connected to the outer housing 305 at the adapter spine 314. An irrigation lumen 326 (or fluid channel) of the adapter spine 314 is connected to the irrigation port 316, which is further connected to the main lumen 322. The irrigation port 316 may be configured to receive a fluid through its lumen. In this manner, the irrigation port 316 may be fluidly coupled to the main lumen 322 by the irrigation lumen 326.

[0135] The handle 302 may include a steering mechanism configured to adjust the curvature of the distal end portion of the shaft 304 (and thus the shaft 304 may be referred to as a steerable shaft). In the illustrated embodiment, the handle 302 includes an adjustment member, such as the illustrated rotatable knob 320. The body portion 318 may house a bending mechanism 328 of the guide sheath 300 operably coupled to the rotatable knob 320. In some embodiments, the bending mechanism 328, and thus the knob 320, may be operably coupled to a proximal end portion of a pull wire. The pull wire may extend distally from the handle 302 through the shaft 304 and have a distal end portion secured to the shaft 304 at or near the distal end of the shaft 304. Rotating the knob 320 may increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the shaft 304. Further details regarding steering or bending mechanisms in delivery devices can be found in US Pat. No. 9,339,384, already incorporated by reference above.

[0136] The guide sheath 300 further includes a reservoir 340 having an adjustable volume. As shown in Figures 10A and 10B, the reservoir 340 is disposed external to the housing 305 of the handle 302. The reservoir 340 may be fluidly connected to the irrigation port 316 and thus the irrigation lumen 326 and the main lumen 322.

[0137] For example, in some cases, the reservoir 340 may be directly connected to the flush port 316 .

[0138] In some cases, the reservoir 340 may be connected to the flushing port 316 with a stopcock 332, or may be connected to another type of connector or adapter that can open and close the fluid connection between the reservoir 340 and the flushing port 316. For example, as shown in Figures 10A and 10B, when the stopcock 332 is in the open position, fluid can be transferred (and flow) from the reservoir 340 to the flushing port 316, the flushing lumen 326, and the main lumen 322.

[0139] Reservoir 340 is filled with fluid 342 and has an adjustable fluid volume. For example, reservoir 340 may include a barrel 345 and a movable wall 344 (also referred to as a plunger) disposed within barrel 345. Barrel 345 and movable wall 344 define an interior cavity 346 that contains fluid 342 therein.

[0140] In some embodiments, reservoir 340 is a syringe.

[0141] In some cases, when the movable wall 344 is forced into the barrel 345, fluid exits the reservoir 340, decreasing the fluid volume of the fluid 342. In some cases, when the fluid 342 is drawn into the wash port 316 (e.g., from negative pressure inside the main lumen 322, as described further below), the movable wall 344 is drawn with the fluid 342, and the fluid volume of the fluid 342 in the reservoir 340 (and the volume of the cavity 346) decreases.

[0142] In this manner, reservoir 340 may be configured (via movement of movable wall 344) as an expandable and contractible (or reducible) reservoir having an adjustable (or reducible) fluid volume.

[0143] During use of the guide sheath 300, the reservoir 340 may be opened and fluidly connected to the main lumen 322 via the irrigation lumen 326 (e.g., by opening the stopcock 332). As a result, the fluid 342 inside the reservoir 340 may freely and passively flow through the irrigation lumen 326 into the main lumen 322 based on the fluid pressure within the main lumen 322. As used herein, "passively" or "passive" with respect to the flow of fluid from the various reservoirs into the main lumen of the guide sheath may refer to the flow of fluid without user intervention. For example, fluid may be drawn (passively) from the reservoir into the main lumen due to a vacuum or negative pressure within the main lumen and not due to a user actively pushing fluid from the reservoir.

[0144] As mentioned above, the guide sheath 300 can be configured to receive a delivery device, such as the delivery device 100 of Figure 5, within the main lumen 322 of the guide sheath 300. Prior to inserting the delivery device 100 into the guide sheath 300 (and / or prior to inserting the guide sheath into the patient's vasculature), the reservoir 340 can be filled with fluid 342.

[0145] In some cases, the irrigation lumen 326 and the main lumen 322 may be primed or flushed with a reservoir 340 or another flushing device through the irrigation port 316. For example, a fluid (e.g., fluid 342) may flow through the irrigation port 316 and the irrigation lumen 326 into the main lumen 322. The reservoir 340 may be relatively full and in its expanded configuration, as shown in FIG.

[0146] After positioning the shaft 304 of the guide sheath 300 within the patient's vasculature, the distal end portion of the delivery device 100 (e.g., the nosecone 122 and radially compressed prosthetic heart valve 150) may be inserted into the entry port 306 of the handle 302 of the guide sheath 300. The distal end portion of the delivery device 100 may then be navigated through the seal housing assembly 310 and into the main lumen 322 of the guide sheath 300.

[0147] In some examples, after the delivery device 100 is inserted into the guide sheath 300 (e.g., after the distal end of the delivery device 100 is inserted through or distal to the seal housing assembly 310), the reservoir 340 can be attached to the irrigation port 316. The reservoir 340 can then be opened to the irrigation port 316 such that fluid can be passively drawn from the reservoir 340 into the irrigation lumen 326 and main lumen 322.

[0148] The delivery device 100 can continue to be navigated through the main lumen 322 of the shaft 304 toward the implantation site.

[0149] 10A and 10B depict different exemplary states of the reservoir 340 as the delivery device 100 is navigated through the main lumen 322 of the guide sheath 300. As noted above, in FIG. 10A, the reservoir 340 is in an expanded state or configuration. The distal end portion of the delivery device 100, including the prosthetic heart valve 150, has just been inserted into the main lumen 322 and is disposed within the handle 302.

[0150] As the distal end portion of the delivery device 100 is navigated further through the main lumen 322, the pressure (fluid pressure) in the proximal portion of the main lumen 322 (e.g., the portion within the handle 302, shown in FIG. 10A ) may be reduced by the prosthetic heart valve 150 (or an alternative portion of the delivery device 100) sliding against the inner surface of the wall 330 of the shaft 304 (e.g., the valve 150 sliding against the inner surface of the wall 330 prevents fluid from flowing distal to the valve 150). As the pressure in the proximal portion of the main lumen 322 is reduced, the fluid 342 in the reservoir 340 is drawn from the cavity 346 of the reservoir 340 into the main lumen 322. The wall 344 of the reservoir 340 may move inward toward the fluid 342 and the flushing port 316, thereby reducing the interior volume of the cavity 346 of the reservoir 340 (as shown in FIG. 10B ). As a result, the pressure within the main lumen 322 may equalize, and in some cases may reduce the negative pressure (or vacuum) created by advancing the distal end portion of the delivery device 100 through the main lumen 322.

[0151] In the expanded state of the reservoir 340 (FIG. 10A), the cavity 346 has a first fluid volume. In the compressed state or configuration of the reservoir 340 (FIG. 10B), the cavity 346 has a second fluid volume that is smaller than the first fluid volume. Furthermore, in the compressed or reduced state, the movable wall 344 of the reservoir 340 is forced inward toward the outlet of the reservoir 340 (where the reservoir 340 connects to the flushing port 316). In this manner, as fluid flows out of the cavity 346 and into the main lumen 322 of the guide sheath 300, the total volume of the cavity 346 may decrease with the decrease in fluid volume.

[0152] It should be noted that the fluids in the main lumen 322 (and the main lumen shown in other figures, such as Figures 9A and 9B) and various reservoirs are illustrated with general cross-hatching. However, the fluid downstream or distal to the prosthetic heart valve of the delivery device within the guide sheath may be a combination of priming fluid (e.g., saline) and blood, while the fluid upstream of the prosthetic heart valve of the delivery device may be a fluid provided from a reservoir (e.g., saline).

[0153] delivery technology To implant the prosthetic valve into the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of the delivery device. The prosthetic valve and the distal end portion of the delivery device are inserted into the femoral artery and driven forward into and through the descending aorta, around the aortic arch and through the ascending aorta. The prosthetic valve is positioned inside the native aortic valve and radially expanded (e.g., by inflating a balloon, by actuating one or more actuators of the delivery device, or by deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Alternatively, the prosthetic valve can be implanted inside the native aortic valve in a transapical procedure, in which the prosthetic valve (on the distal end portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the prosthetic valve is positioned inside the native aortic valve. Alternatively, in a transaortic procedure, the prosthetic valve (on the distal end portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, such as by a partial J sternotomy or a right parasternal minithoracotomy, and then driven forward through the ascending aorta toward the native aortic valve.

[0154] To implant the prosthetic valve inside the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of the delivery device. The prosthetic valve and the distal end portion of the delivery device are inserted into the femoral vein, advanced into the inferior vena cava and through the inferior aorta into the right atrium, across the atrial septum (through a puncture hole created in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, the prosthetic valve may be implanted inside the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the prosthetic valve is positioned inside the native mitral valve.

[0155] To implant the prosthetic valve inside the native tricuspid valve, the prosthetic valve is mounted in radial compression along the distal end portion of the delivery device. The prosthetic valve and the distal end portion of the delivery device are inserted into the femoral vein and driven forward into and through the inferior vena cava into the right atrium, where the prosthetic valve is positioned inside the native tricuspid valve. A similar approach can be used to implant the prosthetic valve inside 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 / artery.

[0156] Another delivery approach is the transatrial approach, where the prosthetic valve (on the distal end portion of the delivery device) is inserted through an incision in the chest and an incision is made through the atrial wall (of the right or left atrium) to access either of the native heart valves. Atrial delivery can also be performed intravascularly, such as from a pulmonary vein. Yet another delivery approach is the transventricular approach, where the prosthetic valve (on the distal end portion of the delivery device) is inserted through an incision in the chest and an incision is made through the wall of the right ventricle (typically at or near the base of the heart) to implant the prosthetic valve into the native tricuspid valve or into the native pulmonary valve or into the pulmonary artery.

[0157] In all delivery approaches, the delivery device may be driven forward over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery approaches are not intended to be limiting. Any of the prosthetic valves disclosed herein can be implanted using any of a variety of delivery procedures and any of a variety of delivery devices known in the art.

[0158] Any of the systems, devices, apparatus, etc. herein can be sterilized (e.g., using heat / heat, pressure, steam, radiation, and / or chemicals, etc.) to ensure that they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / high temperature sterilization include steam sterilization and autoclave sterilization. Examples of radiation used for sterilization include, but are not limited to, gamma radiation, ultraviolet light, and electron beam. Examples of chemicals for use in sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Hydrogen peroxide sterilization may be performed, for example, using hydrogen peroxide plasma.

[0159] Treatment techniques, methods, steps, etc., as described or suggested herein, or as described or suggested in the references incorporated herein, may be performed on live animals or may be performed on non-biological simulations, such as cadavers, cadaver hearts, anthropomorphic ghosts, simulators (e.g., where a body part, heart, tissue, etc. is simulated), etc.

[0160] Further Examples of the Disclosed Technology In view of the above implementations of the disclosed subject matter, the present application discloses additional embodiments, which are listed below. It should be noted that a feature in isolation from an embodiment or two or more features taken in combination, and optionally in combination with one or more features from one or more additional embodiments, are also further embodiments that fall within the disclosure of the present application.

[0161] Example 1. A delivery device comprising: a handle comprising a housing and a compressible reservoir disposed within the housing, the reservoir being filled with a fluid and having an adjustable fluid volume; and a shaft extending within and distally therefrom and having a main lumen, the main lumen being fluidly connected to the reservoir by a first channel disposed within the handle.

[0162] Example 2. A delivery device as described in any example herein, particularly example 1, wherein the wall of the reservoir comprises a flexible material and the reservoir is configured to compress as its fluid volume decreases.

[0163] Example 3. A delivery device as described in any of the examples herein, particularly any one of Example 1 or Example 2, wherein the handle further comprises an irrigation port connected to the housing, the irrigation port being fluidly connected to the reservoir by a second channel.

[0164] Example 4. A delivery device as described in any of the embodiments herein, particularly Example 3, wherein the handle further comprises a seal housing assembly including one or more fluid seals, and the first channel is disposed at a proximal end of the reservoir disposed adjacent to the seal housing assembly.

[0165] Example 5. The delivery device of any example herein, especially example 4, wherein the irrigation port and second channel are disposed at a proximal end of the reservoir that is disposed adjacent to the seal housing assembly.

[0166] Example 6. The delivery device of any embodiment herein, particularly any one of embodiments 3-5, wherein the second channel extends radially inwardly from the irrigation port into the internal cavity of the reservoir.

[0167] Example 7. A delivery device as described in any of the embodiments herein, particularly any one of embodiments 1-6, wherein the reservoir is annular and extends axially along a portion of the handle, and the reservoir is disposed radially outward of the shaft relative to a central longitudinal axis of the delivery device.

[0168] Example 8. A delivery device described in any of the embodiments herein, particularly any one of embodiments 1-7, wherein the reservoir is radially disposed between the housing and the bending mechanism of the handle, and the bending mechanism is configured to adjust the curvature of the distal end portion of the shaft.

[0169] Example 9. A delivery device as described in any of the embodiments herein, particularly any one of embodiments 1-7, wherein the reservoir is radially disposed between the shaft of the handle and the bending mechanism, and the bending mechanism is disposed within the housing and configured to adjust the curvature of the distal end portion of the shaft.

[0170] Example 10. A delivery device as described in any embodiment herein, any embodiment herein, particularly any of Example 8 or Example 9, wherein the handle further comprises a rotatable knob operably coupled to the bending mechanism.

[0171] Example 11. A delivery device according to any of the embodiments described herein, particularly any one of embodiments 1-10, wherein the fluid in the reservoir is saline.

[0172] Example 12. A delivery device described in any of the embodiments herein, particularly any one of embodiments 1-11, wherein the reservoir is configured to compress radially inward toward the main lumen and reduce in volume when fluid in the reservoir is transferred to the main lumen via the first channel.

[0173] Example 13. A delivery assembly comprising an implant catheter; a handle comprising a housing and an irrigation port coupled to the housing; a compressible reservoir disposed within the housing, the reservoir filled with fluid and having an adjustable fluid volume, the irrigation port fluidly connected to the reservoir; and a shaft extending distally from within the handle and having a main lumen configured to receive a portion of the implant catheter therethrough, the main lumen fluidly connected to the reservoir.

[0174] Example 14. A delivery assembly as described in any of the examples herein, particularly example 13, wherein the reservoir is disposed about and radially outward of the shaft, and the main lumen is fluidly connected to the reservoir by a first channel extending between the main lumen and the reservoir.

[0175] Example 15 The delivery assembly of any embodiment herein, particularly any of Example 13 or Example 14, wherein the reservoir is annular and disposed between the main lumen and the housing.

[0176] Example 16. The delivery assembly of any one of the embodiments herein, particularly Example 14 or Example 15, wherein the handle further comprises a seal housing assembly including one or more fluid seals, the seal housing assembly being disposed at the proximal end of the handle.

[0177] Example 17. A delivery assembly as described in any of the examples herein, particularly example 16, wherein the reservoir is disposed adjacent and distal to the seal housing assembly in the handle, and the first channel is disposed at a proximal end of the reservoir, adjacent to the seal housing assembly.

[0178] Example 18. The delivery assembly of any of the examples herein, particularly any of Example 16 or Example 17, wherein the irrigation port is fluidly connected to the reservoir by a second channel extending from the irrigation port into an internal cavity of the reservoir filled with fluid.

[0179] Example 19 The delivery assembly of any embodiment herein, especially example 18, wherein the second channel is disposed at the proximal end of the reservoir, adjacent the seal housing assembly.

[0180] Example 20. A delivery assembly described in any of the embodiments herein, particularly any one of embodiments 16-19, wherein the handle further comprises a bending mechanism arranged within the housing and around a portion of the shaft, the bending mechanism configured to adjust the curvature of the distal end portion of the shaft.

[0181] Example 21. A delivery assembly as described in any of the embodiments herein, particularly example 20, wherein the handle further comprises a rotatable knob operably coupled to the bending mechanism, and the reservoir is axially disposed between the knob and the seal housing assembly.

[0182] Example 22 The delivery assembly of any embodiment herein, particularly example 21, wherein the reservoir is further disposed about the bending mechanism.

[0183] Example 23. A delivery assembly described in any of the embodiments herein, particularly any one of embodiments 13-22, wherein the reservoir is configured to compress radially inward toward the main lumen and reduce in volume when fluid in the reservoir is transferred to the main lumen.

[0184] Example 24. A guide sheath comprising: a handle comprising a housing and an irrigation port coupled to the housing; a seal housing assembly including one or more fluid seals; a compressible reservoir disposed within the housing and distal to the seal housing assembly, the reservoir being filled with fluid and having an adjustable volume, the irrigation port being fluidly connected to the reservoir; and a shaft extending within and distal to the handle, the shaft having a main lumen extending within the housing and through the seal housing assembly, the main lumen being fluidly connected to the reservoir.

[0185] Example 25. A guide sheath as described in any of the embodiments herein, particularly example 24, wherein the reservoir comprises a flexible wall and a cavity defined by the wall, the cavity being filled with fluid, and the wall being configured to move away from the housing and towards the shaft when fluid from the cavity flows into the main lumen.

[0186] Example 26. A guide sheath as described in any of the embodiments herein, particularly example 25, wherein the reservoir has a fluid inlet configured as a first channel extending between the flushing port and the cavity, and the reservoir has a fluid outlet configured as a second channel extending between the cavity and the main lumen.

[0187] Example 27 The guide sheath of any embodiment herein, particularly example 26, wherein the first channel is disposed at a proximal end of the reservoir disposed adjacent the seal housing assembly.

[0188] Example 28 The guide sheath of any embodiment herein, particularly any of Example 26 or Example 27, wherein the second channel is disposed at a proximal end of the reservoir disposed adjacent to the seal housing assembly.

[0189] Example 29. A guide sheath described in any embodiment herein, particularly any one of embodiments 24 to 28, wherein the handle further comprises a bending mechanism configured to adjust the curvature of the distal end portion of the shaft and be disposed within the housing, the bending mechanism being disposed distal to the seal housing assembly.

[0190] Example 30. The guide sheath of any of the embodiments herein, particularly example 29, wherein the reservoir is disposed radially outward of the bending mechanism.

[0191] Example 31 The guide sheath of any of the embodiments herein, particularly example 29, wherein the reservoir is disposed radially inward of the bending mechanism.

[0192] Example 32. A guide sheath described in any of the embodiments herein, particularly any one of embodiments 29 to 31, wherein the handle further comprises a rotatable knob operably coupled to the bending mechanism, the rotatable knob being positioned distal to the storage portion.

[0193] Example 33. A guide sheath described in any of the embodiments herein, particularly any one of embodiments 24-32, wherein the reservoir is annular and extends axially along a portion of the handle, and the reservoir is disposed radially outward of the shaft relative to a central longitudinal axis of the guide sheath.

[0194] Example 34. A delivery device comprising a handle, a shaft extending within and distal to the handle and having a main lumen, and a bladder containing a fluid volume fluidly connected to the main lumen, the bladder having a flexible wall configured to conform to the fluid volume and contract inwardly as the fluid volume decreases.

[0195] Example 35. A delivery device as described in any of the embodiments herein, particularly example 34, wherein the bladder is annular and a radially outwardly facing portion of the wall extending around the circumference of the shaft is configured to contract inwardly when the fluid volume decreases.

[0196] Example 36 A delivery device as described in any of the embodiments herein, particularly any of Example 34 or Example 35, wherein the bladder has an expanded state and a compressed state, and the fluid volume is greater in the expanded state than in the compressed state.

[0197] Example 37 The delivery device of any embodiment herein, particularly any of embodiments 34-36, wherein the bladder is disposed within the housing of the handle.

[0198] Example 38. A delivery device as described in any of the embodiments herein, particularly example 37, wherein the bladder has an expanded state and a compressed state, and in the expanded state the walls of the bladder are positioned closer to the housing than in the compressed state, and in the compressed state the walls of the bladder are positioned away from the housing and toward the shaft.

[0199] Example 39 A delivery device as described in any embodiment herein, particularly any of embodiment 37 or embodiment 38, wherein the bladder is annular and disposed about the shaft.

[0200] Example 40. A delivery device described in any of the embodiments herein, particularly any one of embodiments 34-36, wherein the bladder is disposed external to the housing of the handle.

[0201] Example 41. A delivery device as described in any of the embodiments herein, particularly any one of embodiments 34-40, wherein the bladder comprises a fluid outlet fluidly connected to the main lumen, and the bladder comprises a fluid inlet.

[0202] Example 42. A delivery device described in any of the embodiments herein, particularly any one of embodiments 34-41, wherein the handle comprises one or more fluid seals disposed at a proximal end of the handle, the main lumen extends through the one or more fluid seals, and the bladder is fluidly connected to the main lumen at a location distal to the one or more fluid seals.

[0203] Example 43. A method of implanting a prosthetic medical device comprising: inserting a shaft of a guide catheter into a patient's blood vessel, the shaft having a main lumen and extending into and distal to a handle of the guide catheter; inserting a distal end portion of a first implant catheter into a proximal end of the guide catheter and navigating the distal end portion of the first implant catheter through the main lumen of the guide catheter toward a target implantation site of a prosthetic medical device attached to the distal end portion of the first implant catheter; compressing a fluid reservoir in a housing of the handle and causing fluid in the fluid reservoir to flow into the main lumen as the volume of the fluid reservoir decreases.

[0204] Example 44. The method of any of the examples herein, particularly example 43, wherein compressing the fluid reservoir occurs passively as fluid is drawn from within the fluid reservoir into the main lumen by reducing fluid pressure within the main lumen as the distal end portion of the first implant catheter advances further along the main lumen.

[0205] Example 45 The method of any of the embodiments herein, particularly any of Example 43 or Example 44, wherein compressing the fluid reservoir comprises contracting a wall of the fluid reservoir inwardly, such that an interior cavity of the fluid reservoir containing the fluid decreases as the fluid flows into the main lumen.

[0206] Example 46. The method of any of the embodiments herein, particularly any one of Examples 43-45, wherein flowing fluid from within the reservoir into the main lumen includes flowing fluid from within the reservoir through a fluid channel extending between the interior of the fluid reservoir and the main lumen inside the housing.

[0207] Example 47. A method as described in any of the embodiments herein, particularly any one of embodiments 43-46, wherein the handle is coupled to the housing and includes an irrigation port positioned distal to one or more fluid seals in the handle positioned adjacent the proximal end of the guide catheter, and the fluid reservoir is fluidly connected to the irrigation port.

[0208] Example 48. The method of any of the examples herein, particularly any one of Examples 43-47, further comprising implanting an artificial medical device at the target implantation site, removing the first implant catheter from the guide catheter, inserting a second implant catheter into the guide catheter, and advancing the second implant catheter through the main lumen toward the target implantation site.

[0209] Example 49. The method of any of the examples herein, particularly example 48, wherein the first implant catheter is a docking device delivery device, the prosthetic medical device is a docking device, and the second implant catheter is a prosthetic heart valve delivery device configured to deliver a prosthetic heart valve within the implanted docking device.

[0210] Example 50. A method of implanting a prosthetic medical device comprising: inserting a shaft of a guide catheter into a patient's blood vessel, the shaft having a main lumen and extending into and distal to a handle of the guide catheter; and inserting a distal end portion of a first implant catheter into a proximal end of the guide catheter and advancing the distal end portion of the first implant catheter through the main lumen of the guide catheter toward a target implantation site of a prosthetic medical device attached to the distal end portion of the first implant catheter, wherein as the distal end portion of the first implant catheter is advanced through the main lumen, fluid is drawn from a fluid reservoir into the main lumen, thereby reducing the volume of the fluid reservoir and disposing the fluid reservoir within the handle.

[0211] Example 51 The method of any of the embodiments herein, particularly example 50, wherein the fluid reservoir is disposed about the shaft.

[0212] Example 52. The method of any of the embodiments herein, particularly example 51, wherein as fluid is drawn from the fluid reservoir into the main lumen, the walls of the fluid reservoir contract inwardly toward the main lumen of the shaft, reducing the size of the fluid cavity defined by the walls of the fluid reservoir.

[0213] Example 53 The method of any embodiment herein, particularly any of Example 51 or Example 52, wherein the fluid reservoir is fluidly connected to the main lumen by a first channel disposed in the handle.

[0214] Example 54. A method as described in any of the embodiments herein, particularly any one of embodiments 50-53, wherein the handle includes an irrigation port disposed distal to one or more fluid seals in the handle coupled to a housing of the handle and disposed adjacent the proximal end of the guide catheter, and a fluid reservoir is fluidly connected to the irrigation port.

[0215] Example 55. The method of any of the embodiments herein, particularly any one of Examples 50-54, further comprising implanting an artificial medical device at the target implantation site, removing the first implant catheter from the guide catheter, inserting a second implant catheter into the guide catheter, and advancing the second implant catheter through the main lumen toward the target implantation site.

[0216] Example 56. The method described in any of the examples herein, particularly example 55, wherein the first implant catheter is a docking device delivery device, the prosthetic medical device is a docking device, and the second implant catheter is a prosthetic heart valve delivery device configured to deliver a prosthetic heart valve within the implanted docking device.

[0217] Example 57. A delivery device comprising a handle, a shaft extending within and distal to the handle and having a main lumen, and a reservoir fluidly connected to the main lumen, the reservoir being filled with fluid and having an adjustable fluid volume, the reservoir being configured to passively supply fluid to the main lumen based on fluid pressure within the main lumen.

[0218] Example 58. A delivery device as described in any of the embodiments herein, particularly example 57, wherein the handle further comprises an irrigation port connected to the housing, the irrigation port being fluidly connected to the reservoir.

[0219] Example 59. A delivery device as described in any embodiment herein, particularly example 58, wherein the handle further comprises a seal housing assembly including one or more fluid seals, and the cleaning port is located distally and adjacent to the seal housing assembly.

[0220] Example 60. A delivery device described in any of the embodiments herein, particularly any one of embodiments 57-59, wherein the main lumen is fluidly connected to the reservoir by a first channel disposed in the handle.

[0221] Example 61. The delivery device of any of the embodiments herein, particularly example 60, wherein the reservoir includes a movable wall configured to conform to the adjustable fluid volume and move inward when fluid in the reservoir is transferred via the first channel to the main lumen and the fluid volume decreases.

[0222] Example 62. A delivery device as described in any of the embodiments herein, particularly any one of embodiments 57-61, wherein the handle comprises a housing and the reservoir is disposed within the housing.

[0223] Example 63 A delivery device as described in any embodiment herein, particularly embodiment 62, wherein the wall of the reservoir comprises a flexible material and the reservoir is configured to compress as its fluid volume decreases.

[0224] Example 64. A delivery device described in any of the embodiments herein, particularly any of embodiments 62 or 63, wherein the handle further comprises an irrigation port connected to the housing of the handle, and the second channel extends radially inward from the irrigation port into the internal cavity of the reservoir.

[0225] Example 65. A delivery device described in any of the embodiments herein, particularly any one of embodiments 62-64, wherein the reservoir is annular and extends axially along a portion of the handle, and the reservoir is disposed radially outward of the shaft relative to a central longitudinal axis of the delivery device.

[0226] Example 66. A delivery device described in any of the embodiments herein, particularly any one of embodiments 62 to 65, wherein the storage portion is radially disposed between the housing and the bending mechanism of the handle, and the bending mechanism is configured to adjust the curvature of the distal end portion of the shaft.

[0227] Example 67. A delivery device described in any of the embodiments herein, particularly any one of embodiments 62 to 65, wherein the reservoir is radially disposed between the shaft of the handle and the bending mechanism, and the bending mechanism is disposed within the housing and configured to adjust the curvature of the distal end portion of the shaft.

[0228] Example 68. A delivery device as described in any of the embodiments herein, particularly any of embodiments 66 or 67, wherein the handle further comprises a rotatable knob operably connected to the bending mechanism.

[0229] Example 69. A delivery device described in any of the embodiments herein, particularly any one of embodiments 62-68, wherein the reservoir is configured to compress radially inward toward the main lumen and reduce in volume when fluid in the reservoir is transferred to the main lumen via the first channel.

[0230] Example 70. A delivery device described in any of the embodiments herein, particularly any one of embodiments 57-61, wherein the handle comprises a housing and the reservoir is disposed outside the housing.

[0231] Example 71. A delivery device as described in any of the examples herein, particularly example 70, wherein the reservoir is fluidly connected to an irrigation port coupled to the housing, and the irrigation port is fluidly connected to the main lumen by an irrigation lumen extending through the adapter spine of the handle.

[0232] Example 72. A delivery device as described in any of the embodiments herein, particularly any of embodiments 70 or 71, wherein the reservoir comprises a barrel and a movable wall disposed within the barrel, the barrel and the movable wall defining an internal cavity containing a fluid therein, and the movable wall is configured to move inwardly as fluid in the reservoir is transferred to the main lumen and the fluid volume decreases in response to the fluid pressure in the main lumen being negative.

[0233] Example 73. A delivery device according to any of the embodiments described herein, particularly any one of embodiments 57-72, wherein the fluid in the reservoir is saline.

[0234] Example 74. A guide sheath comprising a handle comprising a housing, an irrigation port connected to the housing, and a reservoir fluidly connected to the irrigation port and positioned outside the housing, the reservoir filled with a fluid and having an adjustable volume, and a shaft extending within the handle and distal therefrom and having a main lumen extending into the housing, the main lumen fluidly connected to the reservoir by the irrigation port, the reservoir configured to passively supply fluid to the main lumen based on fluid pressure within the main lumen.

[0235] Example 75. The guide sheath described in any of the embodiments herein, particularly example 74, wherein the handle further comprises a seal housing assembly including one or more fluid seals.

[0236] Example 76. The guide sheath of any of the embodiments herein, particularly example 75, wherein the shaft extends through the seal housing assembly.

[0237] Example 77. The guide sheath described in any of the embodiments herein, particularly any of embodiments 75 or 76, wherein the flushing port is coupled to the housing distal to the seal housing assembly.

[0238] Example 78. A guide sheath as described in any of the embodiments herein, particularly any one of embodiments 74-77, wherein the reservoir comprises a barrel and a movable wall disposed within the barrel, the barrel and the movable wall defining an internal cavity for containing a fluid therein.

[0239] Example 79. A guide sheath as described in any of the embodiments herein, particularly example 78, wherein the movable wall is configured to move inwardly toward the irrigation port as fluid is passively drawn from the reservoir into the main lumen and the volume of fluid in the reservoir decreases in response to negative pressure in the main lumen.

[0240] Example 80. The guide sheath of any embodiment herein, particularly any one of embodiments 74-79, wherein the reservoir is a syringe.

[0241] Example 81. A guide sheath as described in any of the embodiments herein, particularly any one of embodiments 74-80, further comprising a stopcock disposed between the flushing port and the reservoir, the stopcock being movable between a closed position and an open position in which the reservoir is fluidly connected to the main lumen and fluid can flow freely from the reservoir to the flushing port and into the main lumen.

[0242] Example 82. The guide sheath of any of the embodiments herein, particularly any one of embodiments 74-81, wherein the fluid inside the reservoir is saline.

[0243] Example 83. A method of implanting a prosthetic medical device comprising: inserting a shaft of a guide catheter into a patient's blood vessel, the shaft having a main lumen and extending into and distal to a handle of the guide catheter; and inserting a distal end portion of a first implant catheter into a proximal end of the guide catheter and advancing the distal end portion of the first implant catheter through the main lumen of the guide catheter toward a target implantation site of a prosthetic medical device attached to the distal end portion of the first implant catheter, wherein as the distal end portion of the first implant catheter is advanced through the main lumen, fluid is passively drawn from a fluid reservoir into the main lumen, thereby decreasing the volume of the fluid reservoir.

[0244] Example 84. The method of any of the embodiments described herein, particularly example 83, wherein fluid is passively drawn from within the fluid reservoir into the main lumen by reducing fluid pressure within the main lumen as the distal end portion of the first implant catheter advances further along the main lumen.

[0245] Example 85. A method as described in any of the embodiments herein, particularly any of embodiments 83 or 84, wherein the handle of the guide catheter includes an irrigation port disposed distal to one or more fluid seals in the handle coupled to the housing of the handle and disposed adjacent the proximal end of the guide catheter, and a fluid reservoir is fluidly connected to the irrigation port.

[0246] Example 86 The method of any of the examples herein, especially example 85, wherein the fluid reservoir is disposed external to the handle and connected to an irrigation port, the irrigation port being fluidly connected to the main lumen by an irrigation lumen extending through the handle.

[0247] Example 87. The method of any one of the embodiments herein, particularly any one of embodiments 83-85, wherein the fluid reservoir is disposed within the handle, and the fluid reservoir is fluidly connected to the main lumen by a channel disposed within the handle.

[0248] Example 88. The method of any of the embodiments herein, particularly example 87, wherein a fluid reservoir is disposed about the shaft, and as fluid is drawn from the fluid reservoir into the main lumen, the walls of the fluid reservoir contract inwardly toward the main lumen of the shaft, reducing the size of the fluid cavity defined by the walls of the fluid reservoir.

[0249] Example 89. The method of any of the examples herein, particularly any one of Examples 83-88, further comprising implanting an artificial medical device at the target implantation site, removing the first implant catheter from the guide catheter, inserting a second implant catheter into the guide catheter, and advancing the second implant catheter through the main lumen toward the target implantation site.

[0250] Example 90. The method of any of the examples herein, particularly example 89, wherein the first implant catheter is a docking device delivery device, the prosthetic medical device is a docking device, and the second implant catheter is a prosthetic heart valve delivery device configured to deliver a prosthetic heart valve within the implanted docking device.

[0251] Example 91. The method according to any of the examples herein, particularly any one of Examples 43-56 or 83-90, wherein the method is performed in a living animal or a non-living simulation.

[0252] Example 92. A method comprising sterilizing the prosthetic heart valve, device, and / or assembly of any of the examples.

[0253] Example 93. The prosthetic heart valve of any one of Examples 1 to 92, wherein the prosthetic heart valve is sterilized.

[0254] Various features described herein with respect to any example may be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more features of one guide catheter may be combined with any one or more features of another guide catheter. As another example, any one or more features of one delivery device may be combined with any one or more features of another delivery device.

[0255] In view of the many possible examples to which the principles of the present disclosure may be applied, it will be recognized that the illustrated configurations illustrate examples of the disclosed technology and should not be taken as limiting the scope of the claims of the present disclosure. Rather, the scope of claimed subject matter is defined by the following claims, and equivalents thereof.

Claims

1. 1. A delivery device comprising: A handle (202; 302), a shaft (204; 304) extending within and distally from the handle (202; 302) and having a main lumen (222; 322); a reservoir (240; 340) fluidly connected to the main lumen (222; 322), the reservoir (240; 340) being filled with a fluid (242; 342) and having an adjustable fluid (242; 342) volume, the reservoir (240; 340) passively providing fluid (242; 342) to the main lumen (222; 322) based on fluid (242; 342) pressure within the main lumen (222; 322); a reservoir (240; 340) configured to dispense fluid (242; 342) into the main lumen (222; 322) due to a vacuum or negative pressure within the reservoir (240; 340) and not due to a user actively forcing fluid (242; 342) from the reservoir (240; 340).

2. 2. The delivery device of claim 1, wherein the handle (202; 302) further comprises an irrigation port (216; 316) coupled to a housing (205; 305) of the handle (202; 302), the irrigation port (205; 305) being fluidly connected to the reservoir (240; 340).

3. 3. The delivery device of claim 2, wherein the handle (202; 302) further comprises a seal housing assembly (210; 310) including one or more fluid seals (224; 324), and the flushing port (216; 316) is located distal to and adjacent to the seal housing assembly (210; 310).

4. 4. The delivery device of claim 1, wherein the main lumen (222; 322) is fluidly connected to the reservoir (240; 340) by a first channel (254) disposed in the handle (202; 302), the reservoir (240; 340) conforming to the adjustable fluid (242; 342) volume, and wherein fluid (242; 342) in the reservoir (240; 340) is transferred to the main lumen (222; 322) via the first channel (254), and the delivery device comprises a movable wall (344) configured to move inward as the fluid (242; 342) volume decreases.

5. A delivery device according to any one of claims 1 to 4, wherein the handle (202; 302) comprises a housing (205; 305), and the reservoir (240; 340) is located inside the housing (205; 305).

6. 6. The delivery device of claim 5, wherein the walls (244) of the reservoir (240; 340) comprise a flexible material, and the reservoir (240; 340) is configured to compress as its fluid (242; 342) volume decreases.

7. 7. The delivery device of claim 5, wherein the handle (202; 302) further comprises an irrigation port (216; 316) connected to a housing (205; 305) of the handle (202; 302), and wherein a second channel (258) extends radially inward from the irrigation port (216; 316) into an internal cavity of the reservoir (240; 340).

8. 8. A delivery device according to any one of claims 5 to 7, wherein the reservoir (240; 340) is annular and extends axially along a portion of the handle (202; 302), the reservoir (240; 340) being disposed radially outward of the shaft (204; 304) relative to a central longitudinal axis of the delivery device.

9. A delivery device according to any one of claims 1 to 4, wherein the handle (202; 302) comprises a housing (205; 305), and the reservoir (240; 340) is arranged externally of the housing (205; 305).

10. 10. The delivery device of claim 9, wherein the reservoir (240; 340) is fluidly connected to an irrigation port (216; 316) coupled to the housing (205; 305), and the irrigation port (216; 316) is fluidly connected to the main lumen (222; 322) by an irrigation lumen extending through an adapter spine of the handle (202; 302).

11. 11. The delivery device of claim 9 or claim 10, wherein the reservoir (240; 340) comprises a barrel (345) and a movable wall (344) disposed within the barrel (345), the barrel (345) and the movable wall (344) defining an internal cavity (346) containing the fluid (242; 342) therein, the movable wall (344) configured to move inward as the fluid (242; 342) volume decreases in response to fluid (242; 342) in the reservoir (240; 340) being transferred to the main lumen (222; 322) and the fluid (242; 342) pressure in the main lumen (222; 322) being negative.

12. A delivery device as described in any one of claims 1 to 11, wherein the delivery device is a guide catheter (200; 300).

13. A delivery assembly comprising: A guide catheter (200; 300) as specified in claim 12, an implant catheter (100); and a delivery assembly comprising:

14. A delivery assembly as described in claim 13, wherein the main lumen (222; 322) of the guide catheter (200; 300) is configured to receive a portion of the implant catheter (100) therethrough.

15. A delivery assembly as described in claim 13 or claim 14, wherein the implant catheter (100) is adapted for use in introducing an artificial heart valve into the heart.

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