Delivery Device for Artificial Implants

Abstract

Apparatus and methods are disclosed for providing a path for fluid to flow around a main lumen of a guide catheter. As an example, a delivery device can include a handle including an outer housing and a flush port coupled to the outer housing, a shaft extending distally from the handle, and a main lumen extending axially through the shaft, the main lumen fluidly coupled to the flush port via a flush lumen extending between the flush port and the main lumen. The delivery device can further include at least one axially extending channel fluidly coupled to the main lumen and radially offset from the main lumen, the channel extending between a first location adjacent the flush lumen and a second location adjacent a distal end of the shaft.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 267,393, filed February 1, 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 [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 are used in a variety of procedures to deliver artificial medical devices to locations within the body that are not easily accessible by surgery or 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 or femoral vein) 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., the native valve area) within the patient and / or to help position the implant delivery device at the target implantation site. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] International Publication No. WO2020 / 247907 [Patent Document 2] U.S. Pat. No. 9,339,384 Summary of the Invention [Means for solving the problem]

[0006] 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 a main lumen of the guide catheter, for example, to introduce the delivery device into the patient's vasculature 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 one or more axially extending channels in fluid communication with the main lumen and providing a path for fluid to flow around the delivery device navigated through the main lumen. Thus, the devices and methods disclosed herein can overcome, among other things, one or more deficiencies of typical guide catheters.

[0007] A delivery device for a prosthetic implant may include a handle and one or more shafts coupled to the handle.

[0008] In some examples, a delivery device can include a shaft with a main lumen including an axially extending channel fluidly connected to and radially offset from the main lumen, the channel extending between a flush lumen of the delivery device and a distal end portion of the shaft.

[0009] In some embodiments, a delivery device can include a handle including an outer housing and a flush port coupled to the outer housing, a shaft extending distally from the handle, a main lumen extending axially through the shaft, the main lumen fluidly coupled to the flush port via a flush lumen extending between the flush port and the main lumen, and at least one axially extending channel fluidly coupled to the main lumen and radially offset from the main lumen, The at least one channel can extend between a first location adjacent the flush lumen and a second location adjacent a distal end of the shaft.

[0010] In some embodiments, the delivery device comprises one or more of the components listed in Examples 1-14 below.

[0011] The delivery assembly can include an implant catheter and a guide catheter, the guide catheter including a handle and a shaft extending distally from the handle and having a main lumen configured to receive a portion of the implant catheter therethrough.

[0012] In some examples, the delivery assembly may include an implant catheter and a guide catheter. The guide catheter may include a handle, a shaft extending distally from the handle and having a main lumen configured to receive a portion of the implant catheter therethrough, and one or more axially extending channels fluidly connected to the main lumen and radially offset from the main lumen. Each of the one or more axially extending channels may have a first end disposed in the handle and an opposing second end disposed at a distal end portion of the shaft such that when the implant catheter is disposed within the main lumen, the first end of the channel is disposed proximal to a prosthetic medical device attached to the distal end portion of the implant catheter and the second end of the channel is disposed distal to the prosthetic medical device.

[0013] In some embodiments, the delivery assembly includes one or more of the components listed in Examples 15-26 below.

[0014] A method for implanting a prosthetic medical device may include inserting a shaft of a guide catheter into a patient's blood vessel, inserting a distal end portion of a first implant catheter into a proximal end of the guide catheter, and pushing the distal end portion of the first implant catheter through a 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.

[0015] In some examples, a method for implanting a prosthetic medical device may include inserting a shaft of a guide catheter into a patient's blood vessel; inserting a distal end portion of a first implant catheter into a proximal end of the guide catheter and pushing the distal end portion of the first implant catheter through a 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; and, during the pushing, flowing fluid through an axially extending channel of the guide catheter that is fluidly connected to the main lumen such that fluid flows around the first implant catheter and between the distal and proximal end portions of the shaft of the guide catheter.

[0016] In some embodiments, the method includes one or more of the features recited in Examples 27-36 and Example 53 below.

[0017] The above methods can be performed on live animals or on simulations (such as on cadavers, cadaver hearts, anthropomorphic ghosts, simulators (e.g., where body parts, hearts, tissues, etc. are simulated), etc.).

[0018] The guide sheath may include a shaft having a main lumen defined by an inner surface of a wall of the shaft.

[0019] In some embodiments, the guide sheath may comprise a shaft having a main lumen defined by an inner surface of a wall of the shaft and one or more axially extending channels extending radially outward from the main lumen, each of the one or more axially extending channels taper into the wall towards an outer surface of the wall of the shaft.

[0020] In some examples, the guide sheath may comprise a shaft having a main lumen defined by an inner surface of a wall of the shaft and an axially extending bypass channel extending through the wall of the shaft and including a first opening to the main lumen disposed adjacent a distal end of the shaft and a second opening to the main lumen disposed adjacent a proximal end of the shaft.

[0021] In some embodiments, the guide sheath includes one or more of the components listed in Examples 37-52 below.

[0022] 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 or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The above and other 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]

[0023] [Figure 1] FIG. 1 illustrates a schematic diagram of a delivery device for a docking device for a prosthetic heart valve, for implanting the docking device into a patient's mitral valve, according to one embodiment. [Figure 2A] FIG. 2A illustrates generally the docking device of FIG. 1 fully implanted in a patient's mitral valve after a delivery device of the docking device has been removed from the patient. [Figure 2B] FIG. 2B illustrates a schematic diagram of a prosthetic heart valve delivery device for implanting the prosthetic heart valve in the implanted docking device of FIG. 2A into a patient's mitral valve, according to one embodiment. [Diagram 3] FIG. 3 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 4] 4 is a cross-sectional side view of the guide catheter of FIG. [Diagram 5] FIG. 5 is a perspective view of an exemplary delivery device for a prosthetic heart valve. [Figure 6] 6 is a side view of a delivery assembly including the guide catheter of FIG. 3 and the delivery device of FIG. [Figure 7]FIG. 7 is a cross-sectional end view of a shaft of a guide catheter that includes multiple axially extending channels extending radially outward from a main lumen of the guide catheter. [Figure 8A] 8A is a first cross-sectional side view of the guide catheter of FIG. 7 showing a portion of the guide catheter having an axially extending channel. [Figure 8B] 8B is a second cross-sectional side view of the guide catheter of FIG. 7 showing a portion of the guide catheter without an axially extending channel. [Figure 9] FIG. 9 is a cross-sectional side view of a guide catheter including a bypass channel extending axially away from the main lumen of the guide catheter. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0024] 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, apparatus, 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, alone and in various combinations and subcombinations. The methods, apparatus, and systems are not limited to any particular aspect or feature, or combination thereof, nor do the disclosed examples require that any one or more particular advantages exist or problems be solved.

[0025] 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.

[0026] 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 link, and does not exclude the presence of intermediate elements between connected or associated members, unless specifically stated to the contrary.

[0027] As used herein, the term "proximal" refers to a position, direction, or portion of a device that is closer to the user and farther away from the implantation site. As used herein, the term "distal" refers to a position, direction, or portion of a device that is farther 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.

[0028] Introduction to the disclosed technology As introduced 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 to guide the delivery device therethrough to the target implantation site of the artificial implant. In some embodiments, the inner diameter of the main lumen of the guide catheter and the outer diameter of the portion of the implant delivery device can be closely matched, thereby resulting in a reduction in the space within the main lumen for air and / or blood to pass around the portion of the implant delivery device, thereby creating friction and / or a vacuum between the main lumen and the delivery device. This can increase the pushing force felt by the user as the user pushes the implant delivery device through the guide catheter. Thus, an improved guide catheter that increases the space for fluid flow and reduces the pushing force when advancing the implant delivery device through the guide catheter is desired.

[0029] Described herein are various systems, devices, methods, etc. that, in some examples, may be used on or with a delivery device for a prosthetic medical device (such as a prosthetic heart valve or a docking device). In some examples, such systems, devices, and / or methods may provide a path for fluid to flow (e.g., passively flow) within the guide catheter as the prosthetic medical device attached to the delivery device is navigated through the lumen of the guide catheter toward an implantation site in the patient's body. The fluid flow path in the guide catheter may reduce the vacuum pressure created within the system, thereby reducing the pushing force felt by the user pushing the delivery device through the guide catheter and increasing the overall efficiency of the system.

[0030] For example, a guide catheter, such as the guide catheters shown in Figures 3 and 4, can be inserted into a patient's blood vessel, and a delivery apparatus (such as that shown in Figure 5) including a prosthetic medical device (e.g., a prosthetic heart valve) mounted thereon can be navigated through the main lumen of the guide catheter toward a target implantation site for the prosthetic medical device, for example, as shown in Figure 6. In some examples, as shown in Figures 7-9, the guide catheter can include one or more axially extending channels fluidly connected to and radially offset from the main lumen. In this manner, the one or more axially extending channels can provide an alternate path for air and / or blood to pass while the delivery apparatus is positioned within the main lumen. As a result, pressure gradients across one or more seals in the handle of the guide catheter can be reduced, thereby maintaining hemostasis and / or reducing pushing forces within the guide catheter.

[0031] In some examples, a guide catheter as 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 1-2B diagrammatically illustrate an exemplary transcatheter heart valve replacement procedure utilizing a guide catheter to guide a delivery device of a docking device toward the native valve annulus and then a delivery device of a prosthetic heart valve toward the native valve annulus. A delivery device of the docking device is used to deliver the docking device to the native valve annulus, and then a delivery device of the prosthetic heart valve is used to deliver a transcatheter prosthetic heart valve (THV) within the docking device.

[0032] A defective native heart valve may be replaced with a transcatheter prosthetic heart valve (THV), as introduced above. However, such a THV may not be able to adequately anchor itself to 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, valve dysfunction, and / or other problems. Thus, a docking device may be first implanted into the native annulus, and then the THV may be implanted within the docking device, which helps to anchor the THV to the native tissue and provide a seal between the native tissue and the THV.

[0033] Examples of the disclosed technology 1-2B illustrate an exemplary transcatheter heart valve replacement procedure utilizing a docking device, according to one embodiment, during which a user first uses a docking device delivery device (FIG. 1) to deliver and implant the docking device into a patient's native heart valve, then removes the docking device delivery device from the patient after implanting the docking device (FIG. 2A), and finally implants a prosthetic valve into the implanted docking device using a prosthetic valve delivery device (FIG. 2B).

[0034] FIG. 1 shows the first step in an exemplary mitral valve replacement procedure in which a docking device 10 is implanted into the mitral valve 12 of a heart 14 of a patient 16 using a docking device delivery device 18 (which may also be referred to as a "catheter" and / or a "docking device delivery device").

[0035] Generally, the docking device delivery device 18 comprises a delivery shaft 20, a handle 22, and a pusher assembly 24. The delivery shaft 20 is configured to extend into the patient's vasculature and provide a passageway for the docking device 10 to reach the implantation site (e.g., the mitral valve 12). Specifically, the delivery shaft 20 may be configured to be advanced by a user through the patient's vasculature to the implantation site and may be configured to receive and / or retain the docking device 10 therein. In some examples, the delivery shaft 20 may comprise an outer sheath or shaft defining an internal lumen, and the pusher assembly 24 and / or the docking device 10 may be configured to be received and / or advanced within the internal lumen.

[0036] The handle 22 is configured to be grasped and / or otherwise held by a user to advance the delivery shaft 20 through the patient's vasculature. Specifically, the handle 22 is coupled to a proximal end 26 of the delivery shaft 20 and is configured to remain accessible to a user (e.g., external to the patient 16) during the implantation procedure of the docking device. In this manner, a user can advance the delivery shaft 20 through the patient's vasculature by exerting a force (e.g., pushing) on ​​the handle 22. In some embodiments, the delivery shaft 20 can be configured to carry the pusher assembly 24 and / or the docking device 10 therewith as it advances through the patient's vasculature. In this manner, the docking device 10 and / or the pusher assembly 24 can advance through the patient's vasculature in the same direction and at the same speed as the delivery shaft 20 as a user grasps the handle 22 and pushes the delivery shaft 20 deeper into the patient's vasculature.

[0037] In some embodiments, the handle 22 may include one or more articulation members 28 configured to aid in navigating the delivery shaft 20 through a patient's vasculature. In particular, the articulation members 28 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 30 of the delivery shaft 20 to aid in navigating the delivery shaft 20 through a patient's vasculature.

[0038] The pusher assembly 24 is configured to deploy and / or implant the docking device 10 at an implantation site (e.g., a native valve). Specifically, the pusher assembly 24 is configured to be adjusted by a user to advance the docking device 10 through the delivery shaft 20 and push the docking device 10 out of the distal end 30 of the delivery shaft 20. As described above, the pusher assembly 24 can be configured to extend through the delivery shaft 20 into a lumen defined by the outer sheath of the delivery shaft 20. The pusher assembly 24 can also be coupled to the docking device 10 such that as the pusher assembly 24 advances through the delivery shaft 20, the pusher assembly 24 pushes the docking device 10 through and / or out of the delivery shaft 20. In other words, the docking device 10 is maintained, held, and / or otherwise coupled to the pusher assembly 24 and therefore may advance through and / or out of the delivery shaft 20 in the same direction and at the same speed as the pusher assembly 24.

[0039] The pusher assembly 24 comprises a pusher shaft 32, and in some embodiments may also include a sleeve shaft 34. The pusher shaft 32 is configured to advance the docking device 10 through the delivery shaft 20 and out the distal end 30 of the delivery shaft 20, while the sleeve shaft 34, if included, may be configured to push the docking device 10 out of the delivery shaft 20 and cover the docking device 10 within the delivery shaft 20 during positioning of the docking device 10 at the implantation site. In some embodiments, the pusher shaft 32 may be covered by the sleeve shaft 34 and disposed within the outer shaft or connector of a pusher handle (or hub assembly) 36.

[0040] In some embodiments, the pusher assembly 24 may include a pusher handle (also referred to as a "hub assembly") 36 coupled to the pusher shaft 32 and configured to be grasped and pushed by a user to move the pusher shaft 32 axially relative to the delivery shaft 20 (e.g., push the pusher shaft 32 into and / or out of the distal end 30 of the delivery shaft 20). The sleeve shaft 34 may be configured to be retracted and / or withdrawn from the docking apparatus 10 after positioning the docking apparatus 10 at the implantation site. For example, the pusher assembly 24 may include a sleeve handle 38 coupled to the sleeve shaft 34 and configured to be withdrawn by a user to retract (e.g., axially move) the sleeve shaft 34 relative to the pusher shaft 32.

[0041] The pusher assembly 24 may be removably coupled to the docking apparatus 10 and thus may be configured to be released, detached, separated, and / or otherwise removed from the docking apparatus 10 once the docking apparatus 10 is deployed at the implantation site. By way of example only, the pusher assembly 24 (e.g., the pusher shaft 32) may be removably coupled to the docking apparatus 10 via thread, string, twine, suture, or other suitable material that is bonded or sutured to the docking apparatus 10.

[0042] In some embodiments, the pusher assembly 24 includes a suture lock assembly 40 configured to receive and / or hold a thread or other suitable material that is coupled to the docking apparatus 10 via a suture. Thus, the thread or other suitable material forming the suture may extend from the docking apparatus 10, through the pusher assembly 24, and to the suture lock assembly 40. The suture lock assembly 40 may also be configured to cut the thread to release, decouple, separate, and / or otherwise remove the docking apparatus 10 from the pusher assembly 24. For example, the suture lock assembly 40 may include a cutting mechanism configured to be adjusted by a user to cut the thread.

[0043] Further details of an exemplary docking device delivery device are described in International Publication No. WO2020 / 247907, the entirety of which is incorporated herein by reference.

[0044] Prior to inserting the delivery device 18 of the docking device into the vascular system of the patient 16, the user may first make an incision in the patient's body to access a blood vessel 42. For example, in the embodiment shown in FIG 1, the user may make an incision in the patient's groin to access the femoral vein. Thus, in such an embodiment, the blood vessel 42 may be the femoral vein.

[0045] After making the incision in the blood vessel 42, the user may insert an introducer apparatus 44 (which may also be referred to herein as a “delivery apparatus,” “guide catheter,” or “guide sheath”), a guidewire 46, and / or other apparatus (such as an introducer apparatus or transseptal puncture apparatus) through the incision and into the blood vessel 42. The introducer apparatus 44 (which may include an introducer or guide sheath) is configured to facilitate percutaneous introduction of various implant delivery devices (e.g., docking apparatus delivery apparatus 18 and prosthetic heart valve delivery apparatus 58) into and through the blood vessel 42 and may extend through the blood vessel 42 and into the heart 14, but in some instances may stop short of the mitral valve 12. The guidewire 46 is configured to guide delivery devices (e.g., introducer device 44, docking device delivery device 18, prosthetic valve delivery device 58, catheters, etc.) and their associated devices (e.g., docking devices, prosthetic heart valves, etc.) to an implantation site within the heart 14, and thus may extend all the way through the blood vessels 42 and into the left atrium 48 of the heart 14 (FIG. 1).

[0046] In some instances, the left atrium 48 may be first accessed using a transseptal puncture device or catheter prior to inserting the guidewire 46 and introducer device 44. For example, after making an incision in the blood vessel 42, the user may insert the transseptal puncture device into the blood vessel 42 through the incision. The user may guide the transseptal puncture device through the blood vessel 42 and into the heart 14 (e.g., through the femoral vein into the right atrium 50). The user may then make a small incision in the atrial septum 52 of the heart 14 to allow access from the right atrium 50 to the left atrium 48. The user may insert and advance the guidewire 46 through the transseptal puncture device in the blood vessel 42 and through the incision in the atrial septum 52 and into the left atrium 48. Once the guidewire 46 is positioned within the left atrium 48 and / or left ventricle 56, the transseptal puncture device may be removed from the patient 16. A user may insert the introducer device 44 into the blood vessel 42 and advance the introducer device 44 over the guidewire 46 into the left atrium 48 (eg, to the position shown in FIG. 1).

[0047] In some examples, prior to inserting the introducer device 44 into the blood vessel 42, an additional introducer or introducer device may be inserted through the lumen of the introducer device 44. In some examples, the additional introducer may include a tapered end extending from the distal tip of the introducer device 44 and configured to guide the introducer device 44 over the guidewire 46 into the left atrium 48. Additionally, in some examples, the additional introducer may include a proximal end portion extending from the proximal end of the introducer device 44. Once the introducer device 44 reaches the left atrium 48, the user may remove the additional introducer from the introducer device 44 and from within the patient 16. Thus, only the introducer device 44 and the guidewire 46 remain within the patient 16. The introducer device 44 is then in place to receive the implant delivery device and help guide it into the left atrium 48, as described further below.

[0048] After positioning the guidewire 46 and introducer device 44 within the left atrium 48, the user may insert the docking device delivery device 18 (e.g., delivery shaft 20) into the patient 16 by advancing the docking device delivery device 18 through the introducer device 44 and over the guidewire 46. The user may continue to advance the docking device delivery device 18 along the guidewire 46 through the patient's vasculature until the docking device delivery device 18 reaches the left atrium 48, as shown in FIG. 1. Specifically, the user may advance the delivery shaft 20 of the docking device delivery device 18 by grasping and exerting a force (e.g., pushing) on ​​the handle 22 of the docking device delivery device 18. The user may adjust one or more articulation members 28 of the handle 22 while advancing the delivery shaft 20 through the patient's vasculature to navigate various turns, angles, stenoses, and / or other obstacles within the patient's vasculature.

[0049] Once the delivery shaft 20 reaches the left atrium 48, the user may use the handle 22 (e.g., articulation member 28) to position the distal end 30 of the delivery shaft 20 at and / or near the posteromedial commissure of the mitral valve 12. The user may then use the pusher assembly 24 to push the docking device 10 out of the distal end 30 of the delivery shaft 20 to deploy and / or implant the docking device 10 into the mitral valve 12. For example, the user may actuate the pusher handle 36 to move the pusher shaft 32 axially in a distal direction relative to the delivery shaft 20 such that the docking device 10 (which may be covered by the sleeve shaft 34) is deployed out of the delivery shaft 20 and moved to a desired location at the implantation site.

[0050] In some examples, the docking device 10 may be constructed from, formed from, and / or include a shape memory material such that it can return to its original preformed shape when it exits the delivery shaft 20 and is no longer constrained by the delivery shaft 20. As an example, the docking device 10 may originally be formed as a coil and thus wrap around the ventricular side of the valve leaflet as it exits the delivery shaft 20 and returns to its original coiled configuration.

[0051] After pushing the ventricular portion of the docking apparatus 10 (i.e., the portion of the docking apparatus 10 configured to be positioned / placed within the left ventricle 56 and / or on the ventricular side of the leaflets of the mitral valve), the user may then release the remaining portion of the docking apparatus 10 (the atrial portion of the docking apparatus 10) from the delivery shaft 20 within the left atrium 48. Specifically, the user may retract the delivery shaft 20 relative to the docking apparatus 10, away from the lateral side of the posteromedial commissure of the mitral valve 12. In some examples, the user may maintain the position of the pusher shaft 32 (e.g., by exerting a holding and / or pushing force on the pusher shaft 32) while retracting the delivery shaft 20 such that the delivery shaft 20 uncoils and / or otherwise retracts relative to the docking apparatus 10 and the pusher shaft 32. In this manner, the pusher shaft 32 may hold the docking apparatus 10 in place while the user retracts the delivery shaft 20, thereby releasing the docking apparatus 10 from the delivery shaft 20. In some embodiments, the user may also retract the sleeve shaft 34 from the docking device 10 , exposing the docking device 10 and, in some embodiments, deploying the expandable sleeve of the docking device 10 .

[0052] After the user deploys and / or implants the docking device 10, the user may separate and / or otherwise remove the docking device delivery device 18 from the docking device 10, for example, by cutting the threads that are sutured to the docking device 10. As just one example, the user may cut the threads using the cutting mechanism of the suture lock assembly 40. Once the docking device 10 is removed from the docking device delivery device 18, the user may stow the entire docking device delivery device 18 (delivery shaft 20, handle 22, and pusher assembly 24) from the patient 16 so that the user can deliver and implant the THV into the mitral valve 12. For example, the docking device 10 and the THV may be delivered with two different and separate delivery devices, and thus the user may need to remove the docking device delivery device 18 from the patient 16 to make room for the THV delivery device. As another example, the user may need to remove the docking device delivery device 18 from the patient 16 to load the THV onto the delivery device. In either embodiment, the user may need to remove the delivery device 18 of the docking device from the patient 16 before implanting the THV.

[0053] 2A illustrates this second stage in the mitral valve replacement procedure, with the docking device 10 fully deployed and implanted into the mitral valve 12 and the delivery device 18 (including the delivery shaft 20) of the docking device removed from the patient 16, so that only the guidewire 46 and the introducer device 44 remain within the patient 16. The introducer device 44 may remain within the patient 16 and aid in percutaneously inserting the THV and valve delivery device into the patient 16, while the guidewire 46 may remain within the patient's vasculature and aid in advancing the THV and valve delivery device through the patient's vasculature. In some examples, the user may advance the guidewire 46 through the mitral valve 12 into the left ventricle 56, where the guidewire 46 consistently and reliably guides the THV and valve delivery device to the docking device 10 up to the mitral valve 12.

[0054] As shown in FIG. 2A, the docking device 10 may be configured to wrap around the ventricular side of the leaflets of the mitral valve 12 and compress the leaflets radially inward (i.e., radially compress the leaflets) to adjust the size and / or shape of the opening between the two leaflets of the mitral valve 12. For example, the docking device 10 may be configured to reduce the size and / or change the shape of the opening in the mitral valve 12 to more closely match the cross-sectional shape and / or profile of the THV (e.g., making the opening more circular for a cylindrical THV). By constricting the mitral valve 12 in this manner, the docking device 10 may provide a tighter fit, i.e., a better seal, between the THV and the mitral valve 12.

[0055] 2B illustrates a third stage in a mitral valve replacement procedure, in which a user delivers and / or implants a prosthetic heart valve 54 (which may also be referred to herein as a "heart valve", "transcatheter prosthetic heart valve", or simply "THV", "replacement heart valve" and / or "prosthetic mitral valve") into the docking device 10 and / or to the mitral valve 12 using a prosthetic heart valve delivery device 58. Thus, the docking device 10 and the prosthetic heart valve 54 may be delivered on different delivery devices at different stages in a mitral valve replacement procedure. Specifically, the docking device 10 may be delivered to the mitral valve 12 by the docking device delivery device 18 during a first stage of the mitral valve replacement procedure, and then the prosthetic heart valve 54 may be delivered by the prosthetic heart valve delivery device 58.

[0056] The prosthetic heart valve delivery device 58 includes a delivery shaft 60 and a handle 62 coupled to a proximal end 64 of the delivery shaft 60. The delivery shaft 60 is configured to extend into a patient's vasculature for delivering, implanting, expanding, and / or otherwise deploying the prosthetic heart valve 54 in the docking apparatus 10 to the mitral valve 12. The handle 62 may be similar to the handle 22 of the docking apparatus delivery device 18 and is similarly configured to be grasped and / or otherwise held by a user to advance the delivery shaft 60 through the patient's vasculature.

[0057] In some embodiments, the handle 62 may include one or more articulation members 66 configured to aid in navigating the delivery shaft 60 through a patient's vasculature. In particular, the articulation members 66 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 68 of the delivery shaft 60 to aid in navigating the delivery shaft 60 through a patient's vasculature.

[0058] In some embodiments, the prosthetic heart valve delivery device 58 may include an expansion mechanism 70 configured to radially expand and deploy the prosthetic heart valve 54. For example, the expansion mechanism 70 may include an inflatable balloon configured to be inflated to radially expand the prosthetic heart valve 54 within the docking device 10. The expansion mechanism 70 may be included within and / or coupled to the delivery shaft 60, at and / or proximate to the distal end 68 of the delivery shaft 60.

[0059] In some embodiments, the prosthetic heart valve 54 may be self-expanding and configured to radially expand by itself without the expansion mechanism 70.

[0060] In some embodiments, the prosthetic heart valve 54 may be mechanically expandable, and the prosthetic heart valve delivery device 58 may include one or more mechanical actuators configured to radially expand the prosthetic heart valve 54.

[0061] The prosthetic heart valve 54 may be coupled to the delivery shaft 60 at and / or proximate to a distal end 68 of the delivery shaft 60. In embodiments in which the prosthetic heart valve delivery device 58 includes an expansion mechanism 70, the prosthetic heart valve 54 may be loaded onto the expansion mechanism 70 in a radially compressed configuration. In some embodiments, the prosthetic heart valve 54 may be removably coupled to the delivery shaft 60 such that after the prosthetic heart valve 54 has been radially expanded and deployed from the prosthetic heart valve delivery device 58, the prosthetic heart valve delivery device 58 may be stowed away from the implanted prosthetic heart valve 54 and removed from the patient 16.

[0062] The prosthetic heart valve 54 is configured to be received and / or held within the docking device 10. That is, the docking device 10 is configured to receive the prosthetic heart valve 54 and help secure the prosthetic heart valve 54 to the mitral valve 12. The docking device 10 may also be configured to provide a seal between the prosthetic heart valve 54 and the leaflets of the mitral valve to reduce paravalvular leakage around the prosthetic heart valve 54. Specifically, as introduced above, the docking device 10 may initially contract the leaflets of the mitral valve 12. The prosthetic heart valve 54 may then press the leaflets against the docking device 10 as it radially expands within the docking device 10 (e.g., by inflation of the expansion mechanism 70). Thus, the docking device 10 and the prosthetic heart valve 54 may be configured to pinch the leaflets of the mitral valve 12 when the prosthetic heart valve 54 is expanded within the docking device 10. In this manner, the docking device 10 may provide a seal between the leaflets of the mitral valve 12 and the prosthetic heart valve 54 .

[0063] In some embodiments, one or more of the docking apparatus delivery devices 18, the prosthetic heart valve delivery device 58, and / or the introducer device 44 may include one or more flushing ports 72 ( FIG. 1 ) configured to supply a flushing fluid to an internal cavity thereof (e.g., the delivery shaft 20 of the docking apparatus delivery device 18, the delivery shaft 60 of the prosthetic heart valve delivery device 58, and / or the internal cavity of the introducer device 44) to prevent and / or reduce the possibility of blood clot (e.g., thrombus) formation and / or remove air from the device or system.

[0064] Similar to delivering the docking apparatus 10, the user may insert the prosthetic heart valve delivery apparatus 58 (e.g., delivery shaft 60) into the patient 16 by advancing the prosthetic heart valve delivery apparatus 58 through the introducer apparatus 44 and over the guidewire 46. The user may continue to advance the prosthetic heart valve delivery apparatus 58 along the guidewire 46 (through the patient's vasculature) until the prosthetic heart valve delivery apparatus 58 reaches the mitral valve 12, as shown in FIG. 2B. Specifically, the user may advance the delivery shaft 60 of the prosthetic heart valve delivery apparatus 58 by grasping the handle 62 of the prosthetic heart valve delivery apparatus 58 and exerting a force (e.g., pushing). The user may adjust one or more articulation members 66 of the handle 62 while advancing the delivery shaft 60 through the patient's vasculature to navigate various turns, angles, stenoses, and / or other obstacles within the patient's vasculature.

[0065] The user may advance the delivery shaft 60 along the guidewire 46 until the prosthetic heart valve 54 and / or the expansion mechanism 70 are positioned / located within the docking device 10 and / or the mitral valve 12. For example, the user may advance the delivery shaft 60 along the guidewire 46 until the delivery shaft 60 extends through the mitral valve 12 such that the distal end 68 of the delivery shaft 60 is positioned / located within the left ventricle 56. Once the prosthetic heart valve 54 is properly positioned / located within the docking device 10, the user may radially expand the prosthetic heart valve 54, such as with the expansion mechanism 70, to its fully expanded position or configuration. In some examples, the user may lock the prosthetic heart valve 54 in its fully expanded position (e.g., with a locking mechanism) to prevent the valve from collapsing. After expanding and deploying the prosthetic heart valve 54, the user may separate and / or otherwise detach the delivery shaft 60 from the prosthetic heart valve 54 and remove the delivery shaft 60 from the patient.

[0066] 1-2B specifically illustrate 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., tricuspid, pulmonary, and / or aortic valves). Additionally, the same and / or similar delivery devices (e.g., docking device delivery device 18, prosthetic heart valve delivery device 58, introducer device 44, and / or guidewire 46), docking devices (e.g., docking device 10), replacement heart valves (e.g., prosthetic heart valve 54), and / or components thereof may be utilized to replace these other heart valves.

[0067] For example, if replacing a native tricuspid valve, the user may also access the right atrium 50 via the femoral vein, but may not need to cross the atrial septum 52 into the left atrium 48. Instead, the user may leave the guidewire 46 in the right atrium 50 and perform the same and / or similar docking device implantation process in the tricuspid valve. Specifically, the user may push the docking device 10 out of the delivery shaft 20 around the ventricular side of the leaflets of the tricuspid valve, release the remaining portion of the docking device 10 from the delivery shaft 20 in the right atrium 50, and then remove the delivery shaft 20 of the docking device delivery device 18 from the patient 16. The user may then advance the guidewire 46 through the tricuspid valve into the right ventricle, and perform the same and / or similar prosthetic heart valve implantation process in the docking device 10 and in the tricuspid valve. Specifically, the user may advance the delivery shaft 60 of the prosthetic heart valve delivery device 58 along the guidewire 46 through the patient's vasculature until the prosthetic heart valve 54 is positioned / placed within the docking device 10 and the tricuspid valve. The user may then expand the prosthetic heart valve 54 within the docking device 10 before removing the prosthetic heart valve delivery device 58 from the patient 16.

[0068] In some examples, a user may perform the same and / or similar process to replace an aortic valve, but access the aortic valve from the outflow side of the aortic valve via the femoral artery.

[0069] 1-2B illustrate the mitral valve replacement procedure in which the mitral valve 12 is accessed from the left atrium 48, via the right atrium 50 and the femoral vein, it should be understood that the mitral valve 12 may alternatively be accessed from the left ventricle 56. For example, a user may access the mitral valve 12 from the left ventricle 56, via the aortic valve, by advancing one or more delivery devices through an artery to the aortic valve, and then through the aortic valve into the left ventricle 56.

[0070] 3 and 4 show an exemplary guide catheter, hereinafter referred to as guide sheath 100 (and may also be referred to herein as a "delivery device" or "introducer device"). In some embodiments, guide sheath 100 may be used in place of introducer device 44 in a docking device and / or prosthetic valve implantation procedure, as described above with reference to FIGS. 1-2B. Guide sheath 100 may be configured to be inserted into a patient's vasculature and receive an implant catheter or delivery device therein to introduce the implant catheter into the patient's vasculature and at least partially guide the implant catheter therein to a target implantation site. An exemplary implant catheter for a prosthetic medical device (hereinafter referred to as "delivery device 200") that may be received within guide sheath 100 is shown in FIGS. 5 and 6, as further described below. Although guide sheath 100 is described herein as being used with delivery apparatus 200, guide sheath 100 may be configured to receive a variety of delivery apparatus or implant catheters, such as a delivery apparatus for alternative prosthetic heart valves, a delivery apparatus for a docking apparatus, and / or a delivery apparatus for other prosthetic medical devices or medical therapies, such as stents.

[0071] The guide sheath 100 of the illustrated embodiment comprises a handle 102, an elongate shaft 104 extending distally from the handle 102, and a central longitudinal axis 112. The shaft 104 has a main (or primary) lumen 122 defined by an inner surface of a wall 130 of the shaft 104 (FIG. 4). The main lumen 122 is configured to receive a delivery device therein (such as any of the delivery devices or implant catheters of the prosthetic devices described herein). In some embodiments, the shaft 104 may extend into the handle 102, as shown in FIG. 4. Additionally, in some embodiments, the main lumen 122 may extend through the handle 102 to an entry port 106 disposed at a proximal end of the handle 102. Thus, in some embodiments, an inner surface of a wall of a portion of the handle (e.g., at the proximal end) may further define the main lumen 122. Thus, the main lumen 122 may extend from the entry port 106 to a distal end 108 of the shaft 104.

[0072] The handle 102 can have an outer housing 105 and can further include a seal housing assembly 110 (which can also be referred to as a "seal stack") with one or more seals 124 housed therein (FIG. 4). The one or more seals 124 of the seal housing assembly 110 can be configured to fluidly seal the main lumen 122 of the guide sheath 100 from the outside environment. For example, the one or more seals 124 of the seal housing assembly 110 can be configured to prevent blood from a patient into which the guide sheath 100 is inserted from exiting the guide sheath 100 and to prevent air from the environment from entering the guide sheath 100 (e.g., through the inlet port 106). The one or more seals 124 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.

[0073] The handle 102, in some examples, may include an adapter spine 114 disposed distally adjacent to the seal housing assembly 110. A flush port 116 may be connected to the outer housing 105 at the adapter spine 114. A flush lumen 126 of the adapter spine 114 is connected to the flush port 116 and further connected to the main lumen 122 (FIG. 4). The flush port 116 may be configured to receive a fluid through its lumen. In this manner, the flush port 116 may be fluidly coupled to the main lumen 122 by the flush lumen 126.

[0074] The handle 102 may include a steering mechanism configured to adjust the curvature of the distal end portion of the shaft 104 (and thus the shaft 104 may be referred to as a steerable shaft). In the illustrated embodiment, the handle 102 includes a body portion 118 disposed adjacent and distal to the adapter spine 114 and an adjustment member, such as the illustrated rotatable knob 120. The body portion 118 may house an internal bending mechanism 128 of the guide sheath 100 operably coupled to the rotatable knob 120 (FIG. 4). In some embodiments, the bending mechanism 128, and thus the knob 120, may be operably coupled to a proximal end portion of a pull wire. The pull wire may extend distally from the handle 102 through the shaft 104 and may have a distal end portion secured to the shaft 104 at or near the distal end 108 of the shaft 104. Rotating the knob 120 may increase or decrease tension in the pull wire, thereby adjusting the curvature of the distal end portion of the shaft 104. Further details regarding steering or bending mechanisms in delivery devices can be found in US Pat. No. 9,339,384, which is incorporated herein by reference.

[0075] 5 illustrates an exemplary prosthetic heart valve delivery device 200 (which may also be referred to herein as an "implant catheter") that may be used to implant an expandable prosthetic heart valve. In some examples, the delivery device 200 is specifically adapted for use in introducing a prosthetic heart valve into the heart. For example, the delivery device 200 may be used in place of the prosthetic heart valve delivery device 58 in a prosthetic valve implantation procedure, as described above with reference to FIG. 2B.

[0076] 5 is a balloon catheter including a handle 202 and a steerable outer shaft 204 extending distally from the handle 202. The delivery device 200 may further include an intermediate shaft 206 (which may also be referred to as a balloon shaft) extending proximally and distally from the handle 202, the portion extending distally from the handle 202 also extending coaxially through the outer shaft 204. In some embodiments, the delivery device 200 may further include an inner shaft extending distally from the handle 202 coaxially through the intermediate shaft 206 and the outer shaft 204, and extending proximally from the handle 202 coaxially through the intermediate shaft.

[0077] The outer shaft 204 and the intermediate shaft 206 can be configured to translate (e.g., move) longitudinally relative to one another along a central longitudinal axis 220 of the delivery device 200 to facilitate delivery and positioning the prosthetic valve at an implantation site within a patient's body.

[0078] The midshaft 206 may include a proximal end portion extending proximally from the proximal end of the handle 202 to an adapter 212. The adapter 212 may include a first port 238 configured to receive a guidewire therethrough and a second port 240 configured to receive fluid (e.g., inflation fluid) from a fluid source. The second port 240 may be fluidly coupled to an inner lumen of the midshaft 206.

[0079] In some embodiments, the midshaft 206 can further include a distal end portion that extends distally beyond the distal end of the outer shaft 204 when the distal end of the outer shaft 204 is positioned away from the inflatable balloon 218 of the delivery device 200. The distal end portion of the inner shaft can extend distally beyond the distal end portion of the midshaft 206 toward or to a nosecone 222 at the distal end of the delivery device 200.

[0080] In some embodiments, the distal end of the balloon 218 can be coupled to the distal end of the delivery device 200, such as a nose cone 222 (as shown in FIG. 5) or to an alternative component at the distal end (e.g., distal shoulder) of the delivery device 200. An intermediate portion of the balloon 218 can cover a valve mounting portion 224 at the distal end portion of the delivery device 200, and a distal end portion of the balloon 218 (as shown in FIG. 4) can cover the distal shoulder of the delivery device 200. As shown in FIG. 5, the prosthetic heart valve 250 can be mounted around the balloon 218 at the valve mounting portion 224 of the delivery device 200 in a radially compressed state. The prosthetic heart valve 250 can be configured to be radially expanded by inflation of the balloon 218 at the native valve annulus, as described above with reference to FIG. 2B.

[0081] The balloon shoulder assembly of the delivery device 200, including the distal shoulder, is configured to maintain the prosthetic heart valve 250 (or other medical device) in a fixed position on the balloon 218 during delivery through the patient's vasculature.

[0082] The outer shaft 204 can include a distal tip portion 228 (best seen in FIG. 6 ) mounted on its distal end. In some embodiments, the outer shaft 204 and the middle shaft 206 can be axially translated relative to one another to position the distal tip portion 228 adjacent a proximal end of the valve mounting portion 224 when the prosthetic valve 250 is mounted in a radially compressed state on the valve mounting portion 224 (as shown in FIG. 5 ) and during delivery of the prosthetic valve to the target implantation site. In this manner, the distal tip portion 228 can be configured to resist axial, proximal movement of the prosthetic valve 250 relative to the balloon 218 when the distal tip portion 228 is disposed adjacent a proximal side of the valve mounting portion 224.

[0083] An annular space can be defined between the outer surface of the inner shaft and the inner surface of the midshaft 206, and the annular space can be configured to receive fluid from a fluid source via the second port 240 of the adapter 212. The annular space can be fluidly connected to a fluid passageway formed between the outer surface of the distal end portion of the inner shaft and the inner surface of the balloon 218. In this manner, fluid from the fluid source can flow from the annular space to the fluid passageway, thereby inflating the balloon 218 to radially expand and deploy the prosthetic valve 250.

[0084] The inner lumen of the inner shaft can be configured to receive a guidewire therethrough for navigating the distal end portion of the delivery device 200 to the target implantation site.

[0085] The handle 202 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery device 200. In the illustrated example, for example, the handle 202 includes an adjustment member, such as the illustrated rotatable knob 260, that is operably coupled to a proximal end portion of a pull wire. The pull wire can extend distally from the handle 202 through the outer shaft 204 and have a distal end portion secured to the outer shaft 204 at or near the distal end of the outer shaft 204. By rotating the knob 260, the tension in the pull wire can be increased or decreased, thereby adjusting the curvature of the distal end portion of the delivery device 200. Further details regarding steering or bending mechanisms for delivery devices can be found in U.S. Pat. No. 9,339,384, previously incorporated by reference above.

[0086] The handle 202 can further include an adjustment mechanism 261 that includes an adjustment member, such as the illustrated rotatable knob 262, and an associated locking mechanism that includes another adjustment member configured as a rotatable knob 278. The adjustment mechanism 261 is configured to adjust the axial position of the middle shaft 206 relative to the outer shaft 204 (e.g., for fine positioning at the implantation site).

[0087] The delivery device 200 may be introduced into the patient's vasculature via a guide catheter, such as the guide sheath 100 of FIGS. 3 and 4. For example, as shown in FIG. 6, to introduce the delivery device 200 (or an alternative implant catheter or delivery device, such as the delivery device 18 of the docking device of FIG. 1) into the patient's vasculature, the shaft 104 of the guide sheath 100 may first be inserted into the patient's vasculature and navigated through the vasculature toward the target implantation site of the medical device or implant. The handle 102 of the guide sheath 100 may remain outside the patient and be accessed by a user (e.g., a physician). The distal end portion of the delivery device 200 (e.g., the nose cone 222 and the radially compressed prosthetic heart valve 250) may then be inserted into the inlet port 106 of the handle 102 of the guide sheath 100, as shown by the arrow 252 in FIG. 6. The distal end portion of the delivery device 200 is then pushed through the seal housing assembly and into the main lumen 122 of the guide sheath 100. The delivery device 200 may then continue to be pushed toward the implantation site through the inner lumen of the shaft 104. The assembly shown in FIG.

[0088] In some embodiments, the inner diameter of the main lumen 122 of the shaft 104 of the guide sheath 100 can be closely matched to the outer diameter of a prosthetic implant attached to the delivery device, such as the radially compressed prosthetic heart valve 250. This can position the prosthetic heart valve (or other prosthetic implant or portion of the delivery device) closer to or against a wall that defines the main lumen 122 of the guide sheath 100 as the delivery device 200 is pushed through the guide sheath 100. In some embodiments, this can increase the force felt by the user as the user pushes the delivery device 200 through the guide sheath 100 (referred to herein as a "pushing force"). This can also result in a reduction in the space within the main lumen 122 of the guide sheath 100 for air and / or another fluid (e.g., blood) to pass around the portion of the delivery device 200, such as the prosthetic heart valve 250.

[0089] Accordingly, the inventors herein have realized that it is advantageous to provide one or more pathways or channels for fluid to flow around the delivery device within the main lumen of the guide sheath as the delivery device is pushed through the guide sheath.

[0090] 7-8B show an example of a shaft 300 for a guide sheath that includes one or more channels configured to allow fluid (e.g., air or blood) to flow around a delivery device or other device disposed within and pushed through a main lumen 302 (or primary lumen) of the shaft 300. The shaft 300 can be used in place of the shaft 104 in the guide sheath 100 of FIG.

[0091] As introduced above, the main lumen 302 of the shaft 300 may be defined by the wall 305 of the shaft 300. In some embodiments, the main lumen 302 may be further defined by the wall of the handle 102. FIG. 7 shows a cross-sectional end view of the shaft 300 (taken along the section of the shaft shown in FIG. 3 when used in place of the shaft 104 in the guide sheath 100 of FIG. 3). The wall 305 of the shaft 300 has an outer surface 304 (e.g., a surface facing radially outward relative to a central longitudinal axis 310 of the shaft 300) and an inner surface 306 (e.g., a surface facing radially inward) that defines the main lumen 302.

[0092] Figures 8A and 8B show cross-sectional side views of a portion of the shaft 300 taken along the section shown in Figure 7. The section shown in Figures 8A and 8B may include a portion of the shaft 300 that extends from within the handle 102 to distally of the handle 102.

[0093] 7, the shaft 300 includes one or more axially extending channels 308 extending radially outward (relative to a central longitudinal axis 310) from a main lumen 302. Each channel 308 can be defined by an inner surface 312, which may be an extension of (e.g., continuous with) the inner surface 306, extending radially outward from the inner surface 306 toward the outer surface 304. In some embodiments, the inner surface 306 that forms the main lumen 302 can be referred to as a first inner surface or an inner surface portion, and the inner surface 306 that forms the channel 308 can be referred to as a second inner surface of the inner surface portion.

[0094] In this manner, each channel 308 can branch off from the main lumen 302 and form a cavity 314 (or space) (radially) between the inner surface 306 and the outer surface 304. In some embodiments, the main lumen 302 can be centered along a central longitudinal axis 310, and one or more of the channels 308 can be radially offset from the central longitudinal axis 310.

[0095] Each channel 308 may dip into the wall 305 toward the exterior surface 304, thereby creating a thinner wall portion in an area of ​​the channel 308 having a first thickness 330 that is less than a second thickness 332 of the portion of the wall 305 disposed between adjacent channels 308. Thus, the wall 305 may have a varying thickness around its circumference.

[0096] It should be noted that while wall 305 is illustrated as being solid wall having a single layer, in some embodiments wall 305 can include additional layers, such as one or more reinforcing layers. Additionally, in some embodiments, pull wires or other bending members can extend through wall 305, thereby allowing the distal end portion of shaft 300 to be maneuvered through the patient's vasculature, as described above.

[0097] In some embodiments, the shaft 300 may include only one channel 308 .

[0098] In some embodiments, the shaft 300 may include multiple channels 308. Although the shaft 300 is illustrated in Figure 7 as having six channels 308, in alternative embodiments, the shaft 300 may have more or less than six channels 308, such as two, three, four, five, eight, etc. The number of channels 308 may be an even or odd number.

[0099] The channels 308 may be circumferentially spaced apart from one another, as shown in FIG. 7. The circumferential distance or spacing 316 between adjacent channels 308 may vary in different embodiments. In some embodiments, the spacing 316 between adjacent channels 308 may be equal for all channels 308 in the shaft 300, as shown in FIG. 7. In alternative embodiments, the spacing 316 between adjacent channels 308 may not be equal for at least two pairs of adjacent channels 308 in the shaft 300. For example, in some embodiments, the shaft 300 may have a first group of channels 308 spaced closer to one another and a second group of channels 308 spaced closer to one another, where the first and second groups are spaced farther apart from one another (e.g., the first group is disposed on a top or first side of the shaft 300 and the second group is disposed on a bottom or second side of the shaft 300, etc.).

[0100] Additionally, the (circumferential) width 318 and / or (radial) depth 320 of each channel 308 may vary. In some embodiments, the width 318 may be selected to be large enough to receive fluid from the main lumen 302, but small enough so that a portion of a delivery device or implant catheter passing through the main lumen 302, such as a portion of the prosthetic heart valve 250, cannot enter and block the cavity 314 of the channel 308. For example, the width 318 may be 10-35% or 15-30% of the diameter of the main lumen 302.

[0101] In some embodiments, all of the channels 308 in the shaft 300 may have the same size (e.g., width 318 and depth 320). In alternative embodiments, at least one channel 308 in the shaft 300 may have a different size than the remaining channels 308 in the shaft 300.

[0102] The channel 308 may be configured to receive a fluid therein, such as air or blood, and allow the fluid to travel axially along the channel 308 while the delivery device 200 (or another implant catheter) is pushed through the main lumen 302. For example, the channel 308 may allow fluid to flow between a first end 322 of the shaft 300 distal to a prosthetic heart valve 250 mounted on the delivery device 200 and a second end 324 of the shaft 300 proximal or upstream of the prosthetic heart valve 250 (FIGS. 8A and 8B).

[0103] As shown in Figure 8A, each channel 308 can extend axially along the shaft 300 for all or a majority of the length of the shaft 300. For example, each channel 308 can extend from a flush lumen 326 of the shaft 300 (Figure 8A) toward or to a first end 322 (e.g., the distal end) of the shaft 300. The flush lumen 326 can fluidly connect the main lumen 302 with a flush lumen and / or flush port of the handle 102 (e.g., flush port 116 of the handle 102 shown in Figures 3 and 4).

[0104] 8A and 8B illustrate the delivery device 200 in the main lumen 302. The prosthetic heart valve 250 can be attached around the distal end portion of the delivery device 200 and pushed through the shaft 300 towards the first end 322. As shown in FIG. 8B, which shows a cross-section of the shaft 300 without the channel 308 (see FIG. 7), the prosthetic heart valve 250 is positioned close to the inner surface 306 of the wall 305 that defines the main lumen 302, and in some embodiments, flush with or skimming the inner surface 306 of the wall 305 that defines the main lumen 302. In contrast, FIG. 8A shows a different cross-section of the shaft 300 in which two channels 308 are positioned directly across each other. As a result, extra space is created for fluid to flow around the prosthetic heart valve 250, as indicated by the arrows 328 (FIG. 8A). Arrows 328 indicate that fluid (e.g., air or blood) may flow in a proximal or distal direction around the prosthetic heart valve 250. In this manner, the channels 308 effectively increase fluid communication within the main lumen 302 of the shaft 300 proximal and distal to the prosthetic heart valve 250 as the prosthetic heart valve 250 passes through the shaft 300 and out its distal end.

[0105] It should be noted that the additional space created by the channel 308 shown in Figure 8A may be exaggerated for illustrative purposes. In some embodiments, the distance between the inner surface of the channel 308 and the delivery device 200 may be less than shown in Figure 8A.

[0106] 9 shows an example of a shaft 400 for a guide sheath that includes one or more channels configured to allow fluid (e.g., air or blood) to flow around a delivery device or other implant catheter that is disposed within and pushed through a main lumen 402 of the shaft 400. The shaft 400 can be used in place of the shaft 104 in the guide sheath 100 of FIG.

[0107] Similar to shaft 300 of FIGS. 7-8B, main lumen 402 of shaft 400 may be defined by an inner surface of a wall 412 of shaft 400 (and in some embodiments also a portion of a wall of handle 102). Shaft 400 includes an outer surface 404 (e.g., a radially outward facing surface) and an inner surface 406 (e.g., a radially inward facing surface) that defines main lumen 402. FIG. 9 shows a cross-sectional side view of a distal portion of shaft 400 and a proximal portion of shaft 400 that may be disposed within a handle of a guide sheath (e.g., handle 102), shaft 400 having a central longitudinal axis 410.

[0108] The shaft 400 includes a flush lumen 426 that can fluidly connect the main lumen 402 with a flush lumen and / or flush port of the handle 102 (e.g., flush port 116 shown in FIGS. 3 and 4). For example, the flush lumen 426 extends through a portion of the wall 412 of the shaft 400.

[0109] The shaft 400 includes at least one axially extending channel 408 disposed within the wall 412 of the shaft 104. The at least one channel 408 can be a bypass channel having a first opening 414 into the main lumen 402 disposed adjacent the flush lumen 426 and a second opening 416 into the main lumen 402 spaced from the first opening 414 and disposed adjacent a distal end 438 of the shaft 400. In some embodiments, the spacing between the distal end 438 and the second opening 416 can be less than or greater than shown in FIG. 9 . However, the spacing can be selected such that the second opening 416 is disposed proximal to the distal end 438 and the second opening 416 remains distal to the prosthetic heart valve 250 until the distal end of the delivery device exits the distal end 438 of the shaft 400.

[0110] The channel 408 may be disposed radially between the inner surface 406 and the outer surface 404 and within the wall 412. It should be noted that the thickness of the wall 412 may be exaggerated in FIG. 9 to facilitate illustration of the channel 408. Thus, in some embodiments, the thickness of the wall 412 may be less than is shown in FIG.

[0111] The channel 408 can have a variety of widths or diameters 418 in different embodiments. In some embodiments, the width or diameter 418 of the channel 408 can be selected to allow fluid to flow through the channel 408, as shown by arrow 420, to reduce the pushing force experienced by a user in pushing the delivery device 200 through the shaft 400 to a desired level. As shown in FIG. 9, the width or diameter 418 of the channel 408 is less than the diameter 428 of the main lumen 402. In some embodiments, the width or diameter 418 of the channel 408 can be 10-35% or 15-30% of the diameter 428 of the main lumen 402.

[0112] A majority of channel 408 (excluding radially extending channel portions directly connected to openings 414 and 416) may be radially spaced away from main lumen 402. As such, channel 408 may be referred to as a bypass or auxiliary lumen, channel, or pathway of guide sheath shaft 400. For example, channel 408 may include a first end portion 415 connected to first opening 414 and a second end portion 417 connected to second opening 416, and channel 408 may extend axially along (and through) wall 412 between first end portion 415 and second end portion 417.

[0113] In some embodiments, the shaft 400 can include more than two channels 408, such as two, three, etc. For example, the shaft 400 can include two channels 408 disposed in the wall 412 and spaced circumferentially from one another.

[0114] In some embodiments, a shaft for a guide catheter, such as guide catheter 100 of Figures 3 and 4, can include both one or more of the axially extending channels 308 and one or more of the bypass channels 408. For example, the shaft can include both the axially extending channel 308 and the bypass channel 408 extending along its length (or at least a portion of its length, as described above).

[0115] In some embodiments, a proximal portion of the shaft can include one or more axially extending bypass channels 408, and a distal portion of the shaft can include one or more axially extending channels 308. Alternatively, a proximal portion of the shaft can include one or more axially extending channels 308, and a distal portion of the shaft can include one or more axially extending bypass channels 408. In this manner, different axially extending segments of the same guide catheter shaft can include different types of axially extending channels.

[0116] The one or more axially extending channels described above with reference to FIGS. 7-9 may provide one or more paths for fluid (e.g., air or blood) to passively flow through the guide catheter and around the delivery device or implant catheter being pushed through the main lumen of the guide catheter. In some embodiments, air may enter one or more axially extending channels of the guide catheter and flow proximally along the one or more axially extending channels toward a flush port in the handle of the guide catheter. The air may then exit the guide catheter via the flush port. As a result of creating additional paths for fluid to flow around the main lumen of the guide catheter, the pressure gradient across one or more fluid seals (e.g., seal 124 shown in FIG. 4) in the handle of the guide catheter may be reduced, thereby increasing the elasticity of the seal housing assembly and maintaining hemostasis within the guide catheter. In addition, the pushing force felt by a user by pushing a delivery device through the main lumen of the guide catheter may be reduced. In some embodiments, this may increase the efficiency of the prosthetic device implantation procedure.

[0117] 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 advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned inside the native aortic valve and radially expanded (e.g., by inflating a balloon, by actuating one or more actuators of the delivery device, or by deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Alternatively, the prosthetic valve can be implanted inside the native aortic valve in a transapical procedure, in which the prosthetic valve (on the distal end portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the prosthetic valve is positioned inside the native aortic valve. Alternatively, in a transaortic procedure, the prosthetic valve (on the distal end portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, such as by a partial J sternotomy or a right parasternal minithoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0118] 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.

[0119] To implant the prosthetic valve inside the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of the delivery device. The prosthetic valve and the distal end portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava into the right atrium, 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 / pulmonary artery.

[0120] 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 inside the native tricuspid valve or inside the native pulmonary valve or inside the pulmonary artery.

[0121] In all delivery approaches, the delivery device may be advanced over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery approaches are not intended to be limiting. Any of the 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.

[0122] Any of the systems, devices, equipment, etc. herein can be sterilized (e.g., using heat / thermal, 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, equipment, etc. as one of the steps of the method. Examples of heat / thermal 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.

[0123] The treatment techniques, methods, steps, etc. described or suggested in this specification, or 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., in which body parts, tissues, etc. are simulated), etc.

[0124] Further Examples of the Disclosed Technology In view of the above implementations of the disclosed subject matter, the present application discloses additional embodiments, as listed below. It should be noted that any feature of an embodiment in isolation, or two or more features of that embodiment taken in combination, and optionally in combination with one or more features of one or more additional embodiments, are also further embodiments that fall within the disclosure of the present application.

[0125] Example 1. A delivery device comprising: a handle including an outer housing and a flush port coupled to the outer housing; a shaft extending distally from the handle; a main lumen extending axially through the shaft, the main lumen fluidly coupled to the flush port via a flush lumen extending between the flush port and the main lumen; and at least one axially extending channel fluidly connected to the main lumen and radially offset from the main lumen, the at least one channel extending between a first location adjacent the flush lumen and a second location adjacent a distal end of the shaft.

[0126] Example 2. A delivery device as described in any of the examples herein, particularly Example 1, wherein the handle comprises one or more fluid seals disposed within the outer housing, and a flush port is coupled to the outer housing distal to the one or more fluid seals.

[0127] Example 3. A delivery device as described in any of the examples herein, particularly any of Example 1 or Example 2, wherein the shaft extends through a portion of the handle to the first position.

[0128] Example 4. A delivery device as described in any of the examples herein, particularly any one of Examples 1-3, wherein at least one channel extends along the entire length of the shaft.

[0129] Example 5. A delivery device as described in any of the examples herein, particularly any one of Examples 1-4, wherein at least one channel is disposed in the wall of the shaft, the inner surface of the wall defining the main lumen.

[0130] Example 6. The delivery device of any embodiment herein, especially example 5, wherein at least one channel extends radially outward from the main lumen into the wall.

[0131] Example 7. A delivery device as described in any of the examples herein, particularly example 6, wherein a first portion of the wall in which the at least one channel is formed has a first thickness, and a second portion of the wall circumferentially disposed away from the at least one channel has a second thickness, the first thickness being less than the second thickness.

[0132] Example 8. A delivery device as described in any of the embodiments herein, particularly any of Example 6 or Example 7, wherein at least one channel includes a plurality of axially extending channels spaced apart from one another in a circumferential direction, and each channel of the plurality of channels extends radially outward from the main lumen.

[0133] Example 9. A delivery device as described in any of the examples herein, especially Example 8, wherein the wall thickness is greater between adjacent ones of the multiple channels than in each channel.

[0134] Example 10. A delivery device as described in any of the examples herein, particularly example 5, wherein at least one channel is disposed within the wall and radially spaced away from the inner surface of the wall, except for a first opening and a second opening of the at least one channel into the main lumen.

[0135] Example 11. A delivery device as described in any of the embodiments herein, particularly example 10, wherein the first opening is disposed at a first location and the second opening is disposed at a second location, the second location being spaced away from the distal end of the shaft.

[0136] Example 12. A delivery device as described in any of the embodiments herein, particularly any one of embodiments 1-11, wherein the main lumen extends from the proximal end of the handle to the distal end of the shaft.

[0137] Example 13. A delivery device described in any of the embodiments herein, particularly any one of Examples 1-12, wherein the handle further comprises a body portion disposed distal to the flush port, the body portion comprising a bending mechanism configured to adjust the curvature of the distal end portion of the shaft.

[0138] Example 14. The delivery device of any embodiment herein, especially example 13, wherein the handle further comprises a rotatable knob operably coupled to the bending mechanism.

[0139] Example 15. A delivery assembly comprising an implant catheter and a guide catheter, the guide catheter comprising a handle, a shaft extending distally from the handle and having a main lumen configured to receive a portion of the implant catheter therethrough, and one or more axially extending channels fluidly connected to the main lumen and radially offset from the main lumen, each of the one or more axially extending channels having a first end disposed in the handle and an opposite second end disposed at the distal end portion of the shaft, such that when the implant catheter is disposed within the main lumen, a first end of the channel is positioned proximal to a prosthetic medical device attached to the distal end portion of the implant catheter and a second end of the channel is positioned distal to the prosthetic medical device.

[0140] Example 16. A delivery assembly as described in any of the examples herein, particularly example 15, wherein the handle comprises one or more fluid seals at a proximal end portion of the handle and a flush port disposed distal to the one or more fluid seals.

[0141] Example 17. A delivery assembly as described in any of the examples herein, particularly Example 16, wherein the handle comprises a flush lumen extending between the flush port and the main lumen, and a first end of each channel is disposed adjacent to the flush port.

[0142] Example 18. The delivery assembly of any embodiment herein, especially example 17, wherein the second end of each channel is disposed adjacent the distal end of the shaft.

[0143] Example 19. A delivery assembly described in any of the examples herein, particularly any one of Examples 15-18, wherein each channel extends radially outward from the main lumen and tapers into the wall of the shaft, a first inner surface of the wall defining the main lumen.

[0144] Example 20. A delivery assembly as described in any of the embodiments herein, particularly Example 19, wherein the second inner surface of the wall defining each channel is continuous with the first inner surface of the wall defining the main lumen.

[0145] Example 21. A delivery assembly as described in any of the examples herein, particularly any of Example 19 or Example 20, wherein the one or more axially extending channels include a plurality of axially extending channels spaced circumferentially from one another around the main lumen, and the wall has a first thickness between adjacent channels of the plurality of axially extending channels and a second thickness in each channel, the first thickness being greater than the second thickness.

[0146] Example 22. A delivery assembly described in any of the examples herein, particularly any one of Examples 15-18, wherein each channel is configured as a bypass channel extending through the wall of the shaft, the inner surface of the wall defining the main lumen.

[0147] Example 23. A delivery assembly as described in any of the examples herein, particularly Example 22, wherein the first end of each channel includes a first opening into the main lumen and the second end of each channel includes a second opening in the main lumen.

[0148] Example 24. A delivery assembly as described in any of the embodiments herein, particularly any one of embodiments 15-23, wherein the implant catheter is configured to deliver a docking device mounted about a distal end portion of the implant catheter.

[0149] Example 25. A delivery assembly described in any of the embodiments herein, particularly any one of embodiments 15-23, wherein the implant catheter is configured to deliver a prosthetic heart valve mounted about a distal end portion of the implant catheter.

[0150] Example 26. A delivery assembly described in any of the embodiments herein, particularly any one of embodiments 15-25, wherein the shaft is a steerable shaft and the handle comprises a bending mechanism configured to adjust the curvature of the distal end portion of the shaft.

[0151] Example 27. A method for implanting a prosthetic medical device comprising: inserting a shaft of a guide catheter into a patient's blood vessel; inserting a distal end portion of a first implant catheter into a proximal end of the guide catheter and pushing the distal end portion of the first implant catheter through a 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; and, during the pushing, flowing fluid through an axially extending channel of the guide catheter that is fluidly connected to the main lumen such that fluid flows around the first implant catheter and between the distal and proximal end portions of the shaft of the guide catheter.

[0152] Example 28. The method of any of the examples herein, particularly Example 27, wherein flowing a fluid through the axially extending channel includes allowing one or more of blood and air to passively flow radially outward of the main lumen through the axially extending channel.

[0153] Example 29. The method of any of the examples herein, particularly any of Example 27 or Example 28, wherein the main lumen is defined by the inner surface of the wall of the shaft of the guide catheter, and the shaft of the guide catheter extends into a handle of the guide catheter that remains outside the patient while a portion of the shaft extending distally from the handle is disposed within the blood vessel.

[0154] Example 30. The method of any of the examples herein, particularly example 29, wherein the handle includes a flush port located distal to one or more fluid seals in the handle that are located adjacent the proximal end of the guide catheter, and the axially extending channel has an end located proximate to the flush port such that air flows through the axially extending channel and out of the flush port.

[0155] Example 31. The method of any of the examples herein, particularly any one of Examples 27-30, further comprising implanting an artificial medical device at the target implantation site, removing the first implant catheter from the guide catheter, and inserting a second implant catheter into the guide catheter and pushing the second implant catheter through the main lumen toward the target implantation site.

[0156] Example 32. The method of any of the examples herein, particularly Example 31, 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.

[0157] Example 33. The method of any of the examples herein, particularly any one of Examples 27-32, wherein the axially extending channels extend radially from and axially along the main lumen.

[0158] Example 34. The method of any of the examples herein, particularly example 33, wherein the axially extending channel is a first axially extending channel, and the method further comprises flowing fluid through a second axially extending channel of the guide catheter extending radially from and axially along the main lumen, and circumferentially spaced from the first axially extending channel.

[0159] Example 35. A method as described in any of the examples herein, particularly any one of Examples 27-32, wherein the axially extending channel is a bypass channel that extends through the wall of the shaft of the guide catheter and around a portion of the main lumen, the inner surface of the wall defining the main lumen.

[0160] Example 36. The method of any of the examples herein, particularly example 35, wherein the portion of the main lumen is a majority of the length of the main lumen, and the axially extending channel includes a first opening into the main lumen disposed at a proximal end portion of the shaft, and a second opening into the main lumen disposed at a distal end portion of the shaft.

[0161] Example 37. A guide sheath comprising a shaft having a main lumen defined by an inner surface of a wall of the shaft, and one or more axially extending channels extending radially outward from the main lumen, each of the one or more axially extending channels recessed into the wall towards an outer surface of the wall of the shaft.

[0162] Example 38. The guide sheath of any of the examples herein, particularly example 37, wherein each channel extends along the entire length of the shaft.

[0163] Example 39. A guide sheath as described in any of the examples herein, particularly example 37 or example 38, wherein the wall thickness varies circumferentially and the wall thickness is smallest at the location where each channel is formed therein.

[0164] Example 40. The guide sheath of any of the embodiments herein, particularly any one of Examples 37-39, wherein each channel is fluidly connected to the main lumen along the entire length of the channel.

[0165] Example 41. A guide sheath as described in any of the examples herein, particularly any one of Examples 37-40, wherein the width of each circumferential channel is 15-30% of the diameter of the main lumen.

[0166] Example 42. A guide sheath described in any of the embodiments herein, particularly any one of embodiments 37-41, wherein the one or more axially extending channels include a plurality of axially extending channels that are circumferentially spaced apart from one another around the main lumen.

[0167] Example 43. A guide sheath as described in any of the examples herein, particularly any one of Examples 37-42, further comprising a handle, the shaft extending distally from the handle.

[0168] Example 44. A guide sheath of any of the embodiments herein, particularly example 43, wherein the shaft extends into the handle toward a flush port in the handle, and each channel has an end disposed adjacent to a flush lumen extending from the main lumen to the flush port.

[0169] Example 45. A guide sheath as described in any of the embodiments herein, particularly example 44, wherein the handle includes a plurality of fluid seals configured to prevent fluid flow through the plurality of fluid seals, and a flush lumen is disposed distal to the plurality of fluid seals.

[0170] Example 46. A guide sheath comprising a shaft having a main lumen defined by an inner surface of a wall of the shaft, and an axially extending bypass channel extending through the wall of the shaft and including a first opening to the main lumen located adjacent the distal end of the shaft, and a second opening to the main lumen located adjacent the proximal end of the shaft.

[0171] Example 47. The guide sheath of any of the embodiments herein, particularly example 46, wherein the bypass channel extends axially along the shaft, parallel to the main lumen.

[0172] Example 48 The guide sheath of any embodiment herein, particularly any of Example 46 or Example 47, wherein the first diameter of the bypass channel is 15-30% of the second diameter of the main lumen.

[0173] Example 49. A guide sheath described in any of the embodiments herein, particularly any one of embodiments 46-48, wherein the bypass channel is radially spaced away from the inner surface of the wall and extends axially through the wall from a first end portion of the bypass channel connected to the first opening and a second end portion of the bypass channel connected to the second opening.

[0174] Example 50. A guide sheath as described in any of the examples herein, particularly any one of examples 46-49, further comprising a handle, the shaft extending distally from the handle.

[0175] Example 51. A guide sheath as described in any of the examples herein, particularly example 50, wherein the shaft extends into the handle toward a flush port in the handle, and the second opening of the bypass channel is positioned adjacent to a flush lumen extending from the main lumen to the flush port.

[0176] Example 52. A guide sheath as described in any of the embodiments herein, particularly example 51, wherein the handle includes a plurality of fluid seals configured to prevent fluid flow through the plurality of fluid seals, and a flush lumen is disposed distal to the plurality of fluid seals.

[0177] Example 53. A method comprising sterilizing the prosthetic heart valve, device, guide sheath, and / or assembly of any of the examples.

[0178] Unless otherwise specified, any feature described herein with respect to any embodiment may be combined with any other feature described in any one or more of the other embodiments. 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.

[0179] In view of the many possible manners to which the principles of the present disclosure may be applied, it will be recognized that the illustrated configurations are illustrative examples of the disclosed technology and should not be taken as limiting the scope of the present disclosure or the claims that follow. 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 including an outer housing and a flush port coupled to the outer housing; a shaft extending distally from the handle; a main lumen extending axially through the shaft, the main lumen fluidly connected to the flush port via a flush lumen extending between the flush port and the main lumen; a delivery device comprising: at least one axially extending channel fluidly connected to and radially offset from the main lumen, the at least one axially extending channel extending between a first location adjacent the flush lumen and a second location adjacent a distal end of the shaft.

2. The delivery device of claim 1 , wherein the handle includes one or more fluid seals disposed within the outer housing, and the flush port is coupled to the outer housing distal to the one or more fluid seals.

3. The delivery device of claim 1 or claim 2, wherein the shaft extends through a portion of the handle to the first position.

4. The delivery device of any one of claims 1 to 3, wherein the at least one channel extends along the entire length of the shaft.

5. The delivery device of any one of claims 1 to 4, wherein the at least one channel is disposed in a wall of the shaft, the inner surface of the wall defining the main lumen.

6. The delivery device of claim 5 , wherein the at least one channel extends radially outward from the main lumen into the wall.

7. 7. The delivery device of claim 5, wherein the at least one channel comprises a plurality of axially extending channels spaced apart circumferentially, each channel of the plurality of channels extending radially outward from the main lumen.

8. The delivery device of claim 7 , wherein the wall thickness is greater between adjacent channels of the plurality of channels than in each channel.

9. 6. The delivery device of claim 5, wherein the at least one channel is disposed within the wall and radially spaced away from the inner surface of the wall, except for a first opening and a second opening of the at least one channel into the main lumen.

10. 10. The delivery device of claim 9, wherein the first opening is disposed at the first location and the second opening is disposed at the second location, the second location being spaced apart from the distal end of the shaft.

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