Hemostatic valve for catheter applications

Abstract

An example delivery apparatus includes a housing assembly and a seal stack disposed within the housing assembly. The seal stack includes a fluid seal having a first surface, having a circular shape, and a second surface, having a circular shape, disposed opposite to the first surface. The first surface includes first cuts approximately through a center of the first surface and extending partially through the fluid seal toward the second surface. The second surface includes second cuts approximately through a center of the second surface and extending partially through the fluid seal toward the first surface. The second plurality of cuts is angularly offset from the first plurality of cuts.

Description

[0001] GUIDE CATHETER WITH SEAL STACK FOR IMPLANT DELIVERY APPARATUS

[0002] RELATED APPLICATION

[0003] This application claims the benefit of US. Provisional Patent Application No. 63 / 658,679 filed on June 11 , 2024, the entire disclosure of which is incorporated herein by this specific reference.

[0004] FIELD

[0005] The present disclosure relates to guide catheters with seal stacks for delivery apparatuses for prosthetic medical devices.

[0006] BACKGROUND

[0007] The human heart may suffer from various valvular diseases. These valvular diseases may result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (e.g., stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable. Some of the devices used in these procedures include guidewires, catheters, guide sheaths, and the like, which aid in the insertion of a prosthetic heart valve inside the body. In one specific example, a prosthetic heart valve may be mounted in a crimped state on the distal end of a delivery apparatus and advanced through the patient’s vasculature e.g., through a femoral artery or femoral vein) until the prosthetic valve reaches the implantation site in the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic valve, or by deploying the prosthetic valve from a sheath of the delivery apparatus so that the prosthetic valve may self-expand to its functional size.

[0008] A guide catheter (which may also be referred to as a guide sheath) may be used for introducing a delivery apparatus, such as the prosthetic heart valve delivery apparatus described above, into the patient’s vasculature. The guide catheter may include an elongated shaft that is inserted into the vasculature and a handle that remains outside the patient and may be used to manipulate the shaft. The delivery apparatus may be pushed through a main lumen of the guide catheter to help navigate the delivery apparatus to a target implantation site within the patient.

[0009] The guide catheter or sheath may include a hemostatic valve fluid seal through which the delivery apparatus passes to the target implantation site. Pressure gradients between the inside and outside of the guide catheter or sheath may have a tendency to suck air inward through the guide catheter and into the vasculature or to force blood outward from the vasculature and through the guide catheter, e.g., when executing an aspirate and flush step. The purpose of the hemostatic valve fluid seal is to prevent fluid (e.g., air, other gases, blood, or the like) from exiting or entering the patient’s vasculature through the guide catheter. Some typical hemostatic valve fluid seals to do not adequately prevent fluid from exiting or entering the patient’s vasculature through the guide catheter. There is therefore a need for a hemostatic valve seal assembly with a hemostatic valve fluid seal that better prevents fluid (e.g., air or blood) from traveling through the guide sheath.

[0010] SUMMARY

[0011] Described herein are delivery apparatuses and methods including a guide catheter and a hemostatic valve fluid (e.g., blood) seal (hereinafter referred to as the “fluid seal”) within the guide catheter (i.e., guide sheath), for limiting the exit of fluid (e.g., blood) during the implanting of docking stations and / or prosthetic heart valves. The disclosed guide catheters may, for example, be configured to receive a portion of a delivery apparatus within a main lumen of the guide catheter to introduce the delivery apparatus into a patient’s vasculature. As such, the devices and methods disclosed herein may, among other things, overcome one or more of the deficiencies of typical guide catheters.

[0012] In one representative example, a delivery apparatus comprises a housing assembly and a seal stack disposed within the housing assembly. The seal stack comprises a fluid seal having a first surface, having a circular shape, and a second surface, having a circular shape, disposed opposite to the first surface. The first surface comprises a first plurality of cuts approximately through a center of the first surface and extending partially through the fluid seal toward the second surface. The second surface comprises a second plurality of cuts approximately through a center of the second surface and extending partially through the fluid seal toward the first surface. The second plurality of cuts is angularly offset from the first plurality of cuts.

[0013] In another representative example, a delivery apparatus includes a handle and a shaft extending distally from the handle. The handle comprises a housing assembly comprising a seal stack disposed within the housing assembly, the seal stack configured to allow insertion of a device into the handle and prevent fluid flow past the seal stack. The shaft includes a distal end, a proximal end, and a lumen extending between the distal end and the proximal end of the shaft. The proximal end of the shaft is disposed within a distal end of the handle. The seal stack comprises a fluid seal having a distal surface, having a circular shape, and a proximal surface, having a circular shape, disposed opposite to the distal surface. The distal surface comprises a first plurality of cuts approximately through a center of the first surface and extending partially through the fluid seal toward the proximal surface. The proximal surface comprises a second plurality of cuts approximately through a center of the proximal surface and extending partially through the fluid seal toward the distal surface. The second plurality of cuts is angularly offset from the first plurality of cuts.

[0014] In another representative example, a method to implant a prosthetic medical device comprises inserting a shaft of a guide catheter into a vessel of a patient. The method includes inserting a distal end portion of a first implant catheter into a proximal end of a handle of the guide catheter and pushing the distal end portion of the first implant catheter through a seal stack of the handle and then through a main lumen of the shaft of the guide catheter toward a target implantation site for a prosthetic medical device mounted on the distal end portion of the first implant catheter. The seal stack is configured to allow insertion of the first implant catheter into the handle and prevent fluid flow past the seal stack. The seal stack comprises a fluid seal having a distal surface, having a circular shape, and a proximal surface, having a circular shape, disposed opposite to the distal surface. The distal surface comprises a first plurality of cuts approximately through a center of the first surface and extending partially through the fluid seal toward the proximal surface. The proximal surface comprises a second plurality of cuts approximately through a center of the proximal surface and extending partially through the fluid seal toward the distal surface. The second plurality of cuts is angularly offset from the first plurality of cuts.

[0015] In another representative example, a housing assembly for a delivery apparatus comprises a sheath hub, a fluid seal, a spacer, and a cross-slit valve. The fluid seal is disposed within the sheath hub. The spacer is disposed within the sheath hub proximally to the fluid seal. The cross-slit valve is disposed within the sheath hub proximally to the fluid seal. The fluid seal has a distal surface, having a circular shape, and a proximal surface, having a circular shape, disposed opposite to the distal surface. The distal surface comprises a first plurality of cuts approximately through a center of the first surface and extending partially through the fluid seal toward the proximal surface. The proximal surface comprises a second plurality of cuts approximately through a center of the proximal surface angularly offset from the first plurality of cuts and extending partially through the fluid seal toward the distal surface.

[0016] The various innovations of this disclosure may be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures.

[0017] BRIEF DESCRIPTION OF THE DRAWINGS

[0018] FIG. 1 schematically illustrates a first stage in an example aortic valve replacement procedure where a delivery catheter and a guidewire are inserted into a blood vessel of a patient and navigated through the blood vessel and into the aortic arch of the heart of the patient, towards a native aortic valve of the heart.

[0019] FIG. 2A schematically illustrates a second stage in the example aortic valve replacement procedure where the delivery catheter extends through the native aortic valve and arrives at a target or deployment location.

[0020] FIG. 2B schematically illustrates a third stage in the example aortic valve replacement procedure where a docking station is fully implanted at the native aortic valve of the patient.

[0021] FIG. 2C schematically illustrates a fourth stage in the example aortic valve replacement procedure where a prosthetic heart valve delivery apparatus has deployed a prosthetic heart valve in the implanted docking station at the native aortic valve. FIG. 2D schematically illustrates a fifth stage in the example aortic valve replacement procedure where the delivery catheter and the guidewire have been removed from the patient.

[0022] FIG. 3 is an elevation view of a guide catheter having a shaft or sheath and a housing assembly, together with a delivery apparatus for implanting a prosthetic implant.

[0023] FIG. 4 is an elevation view of the guide catheter of FIG. 3 along with an introducer locking hub and an introducer.

[0024] FIG. 5 is an elevation view of the guide catheter of FIG. 3 along with a portion of the delivery apparatus of FIG. 3.

[0025] FIG. 6 is an elevation view of the housing assembly of FIG. 3.

[0026] FIGS. 7A and 7B include cross sectional views of the guide catheter, introducer, and introducer locking hub of FIG. 4 from orthogonal cutting planes.

[0027] FIG. 8 is a cross sectional view of the guide catheter and introducer locking hub of FIG. 4.

[0028] FIG. 9 is a distal end view of a sheath locking sleeve and proximal fluid seal (and a portion of a sheath hub) of the housing assembly of FIG. 3.

[0029] FIGS. 10A-10F respectively include a first elevation view of the introducer locking hub coupled to the introducer of FIG. 4, a second elevation view of the introducer locking hub coupled to the introducer, a distal end view of the introducer locking hub coupled to the introducer, a partial side view of the introducer locking hub coupled to the introducer, a partial perspective view of the introducer locking hub coupled to the introducer, and another partial perspective view of the introducer locking hub coupled to the introducer.

[0030] FIGS. 11A-11F respectively include a distal end view of the introducer locking hub of FIG. 4, a first elevation view of the introducer locking hub, a proximal end view of the introducer locking hub, a first perspective view of the introducer locking hub, a second elevation view of the introducer locking hub, and a second perspective view of the introducer locking hub.

[0031] FIGS. 12A-12F respectively include a distal end view of the sheath locking sleeve of FIG. 3, a first elevation view of the sheath locking sleeve, a proximal end view of the sheath locking sleeve, a first perspective view of the sheath locking sleeve, a second elevation view of the sheath locking sleeve, and a second perspective view of the sheath locking sleeve. FIGS. 13 A-l 3G illustrate another embodiment of a housing assembly that may be implemented in the guide catheter of FIG. 3 or in other sheaths, catheters, or apparatuses herein and respectively include a first perspective view of the housing assembly, a second perspective view of the housing assembly, an elevation view of the housing assembly, a third perspective view of the housing assembly, and a cross-sectional view of the housing assembly.

[0032] FIG. 14 is a perspective view of a sheath hub of the housing assembly of FIGS. 13A-13G.

[0033] FIGS. 15A-15B include perspective views of a retainer of the housing assembly of FIGS. 13A-13E.

[0034] FIGS. 16A-16E illustrate another embodiment of a housing assembly that may be implemented in the guide catheter of FIG. 3 or in other sheaths, catheters, or apparatuses herein and respectively include an elevation view of the housing assembly, a first perspective view of the housing assembly, a second perspective view of the housing assembly, a cross-sectional view of the housing assembly, and a partially exploded perspective view of the housing assembly.

[0035] FIGS. 17A-17H illustrate another embodiment of a housing assembly that may be implemented in the guide catheter of FIG. 3 or in other sheaths, catheters, or apparatuses herein and respectively include an elevation view of the housing assembly, a first perspective view of the housing assembly, a second perspective view of the housing assembly, a third perspective view of the housing assembly with a portion of a retainer of the housing assembly removed, a detailed view of a portion of the third perspective view, a first cross-sectional view of the housing assembly in a plane perpendicular to an axis of the housing assembly, a second cross-sectional view of the housing assembly in a plane parallel to and including the axis of the housing assembly, and an exploded perspective view of the housing assembly.

[0036] FIG. 18 A illustrates a front view of an example docking station configured to dock and / or support one or more prosthetic valves and / or valve components.

[0037] FIG. 18B illustrates a top view of the docking station of FIG. 18 A.

[0038] FIG. 18C illustrates a cutaway side view of the docking station of FIG. 18A with a valve disposed therein and implanted in a patient to replace a native aortic valve.

[0039] FIGS. 19A-19D include various views of an example seal stack for any of the guide catheters herein, and respectively include a perspective view of the seal stack, a cross- sectional view of the seal stack, a first exploded perspective view of the seal stack, and a second exploded perspective of the seal stack.

[0040] FIG. 20A includes a front view and a cross-sectional view of a fluid seal of the seal stack of FIGS. 19A-19D.

[0041] FIG. 20B includes a transparent perspective view of the fluid seal of the seal stack of FIGS. 19A-19D.

[0042] FIGS. 21A-21D include various views of another example seal stack for any of the guide catheters herein, and respectively include a perspective view of the seal stack, a cross-sectional view of the seal stack, a first exploded perspective view of the seal stack, and a second exploded perspective of the seal stack.

[0043] FIG. 22A includes a front view and a cross-sectional view of a fluid seal of the seal stack of FIGS. 21A-21D.

[0044] FIG. 22B includes a transparent perspective view of the fluid seal of the seal stack of FIGS. 21A-21D.

[0045] FIGS. 23A-23D include various views of an example seal stack for any of the guide catheters herein, and respectively include a perspective view of the seal stack, a cross- sectional view of the seal stack, a first exploded perspective view of the seal stack, and a second exploded perspective of the seal stack.

[0046] FIG. 24A includes a front view, a cross-sectional view, and a right side view of a fluid seal of the seal stack of FIGS. 23A-23D.

[0047] FIG. 24B includes a transparent perspective view of the fluid seal of the seal stack of FIGS. 23A-23D.

[0048] DETAILED DESCRIPTION

[0049] General Considerations

[0050] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved. Tt should be understood that the disclosed embodiments may be adapted for delivery and implantation in any of the native annuluses and blood vessels of the heart (e.g., the pulmonary, mitral, and tricuspid annuluses, the inferior and superior vena cava, etc.), and may be used with any of various delivery approaches (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0051] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods may be used in conjunction with other methods. Additionally, the description sometimes uses terms like “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 one of ordinary skill in the art.

[0052] All features described herein are independent of one another and, except where structurally impossible, may be used in combination with any other feature described herein.

[0053] As used in this application and in 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.” Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language. As used herein, the term “and / or” used between the last two of a list of elements means any one or more of the listed elements. For example, the phrase “A, B, and / or C” means “A”, “B,”, “C”, “A and B”, “A and C”, “B and C”, or “A, B, and C.”

[0054] In the context of the present application, the terms “lower” and “upper” are used interchangeably with the terms “inflow” and “outflow,” respectively. Thus, for example, typically the lower end of a valve or docking station as depicted in the figures is its inflow end and the upper end of the valve or docking station is its outflow end unless explicitly described otherwise. As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (e.g., out of the patient’s body), while distal motion of the device is motion 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 an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0055] Although there are alternatives for various components, features, parameters, operating conditions, etc., set forth herein, that does not mean that those alternatives are necessarily equivalent and / or perform equally well. Nor does it mean that the alternatives are listed in a preferred order unless stated otherwise.

[0056] Directions and other relative references (e.g., inner, outer, upper, lower, etc.) may be used to facilitate discussion of the drawings and principles herein, but are not intended to be limiting. For example, certain terms may be used such as “inside,” “outside,”, “top,” “down,” “interior,” “exterior,” and the like. Such terms are used, where applicable, to provide some clarity of description when dealing with relative relationships, particularly with respect to the illustrated embodiments. Such terms are not, however, intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, an “upper” part may become a “lower” part simply by turning the object over. Nevertheless, it is still the same part and the object remains the same. As used herein, “and / or” means “and” or "or", as well as “and” and “or”.

[0057] As used herein, the terms “integrally formed” and “unitary construction” refer to a construction that does not require any sutures, fasteners, or other securing means to attach two portions of the construction together.

[0058] Assembly and / or use of the systems and apparatuses herein may involve movement of the systems or apparatuses as a whole and / or of components thereof. When movement (e.g., translational and / or rotational movement) between a first component and a second component of a system or apparatus is described as relative, it may involve movement of the first component relative to a reference frame (e.g., an environment) while the second component remains fixed relative to the reference frame, movement of the second component relative to the reference frame while the first component remains fixed relative to the reference frame, or movement of the first and second components relative to the reference frame and relative to each other. Thus, if the first component is described as being moved relative to the second component, this may include the first component being moved while the second component remains fixed relative to the environment, the second component being moved while the first component remains fixed relative to the environment, or the first component and the second component both being moved relative to the environment and to each other.

[0059] Introduction to the Disclosed Technology

[0060] This disclosure is related to seal stacks that are intended to help address the problem of hemostasis in transcatheter access sheaths. For technologies in the transcatheter space that are minimally invasive, access sheaths may help to deliver a variety of catheter types to perform an array of different procedures and functions. Access sheaths require hemostatic seals to prevent loss of blood from the patient for the duration of the procedure while also preventing anything from the outside environment from getting into the patient, such as air emboli.

[0061] This disclosure relates to a seal stack for use in a guide sheath or guide catheter for use in delivery apparatuses for prosthetic devices, such as in delivery apparatuses, described here. For example, the seal stack may be seal stack 82 in guide catheter or guide sheath 30 depicted in FIGS. 7A-7B, seal stack 1310 in a guide catheter or guide sheath that includes housing assembly 1300 depicted in FIG. 13E, seal stack 1610 in a guide catheter or guide sheath that includes housing assembly 1600 depicted in FIG. 16D, or seal stack 1710 in a guide catheter or guide sheath that includes housing assembly 1700 depicted in FIGS. 17G-17H,

[0062] Described herein are various systems, apparatuses, methods, or the like, that, in some examples, may be used in or with delivery apparatuses for prosthetic medical devices (such as prosthetic heart valves or docking devices). In some examples, such systems, apparatuses, and / or methods include a hemostatic valve fluid seal disposed within the delivery apparatus that prevents fluid (e.g., air, blood) from entering into or exiting from the human body upon insertion into and / or use of the delivery apparatus in the human body. In some examples, the fluid seal includes a circular polyisoprene material or elastomeric silicone or other material with a double crosshair configuration. The fluid seal thus reduces the risk of air entering into and / or blood exiting from the patient’ s vasculature. Generally, the seal stack includes a fluid seal with a double cross-hair configuration. The fluid seal may have a disc or cylindrical shape. See, for example, FIGS. 23A-24B. In some embodiments, the fluid seal may have a thickness of about 1 / 16-1 / 4 inches, or about 0.05-0.2 inches, such as about 1 / 8 inch or about 0.125 inches, and a diameter of about 0.5-1 inches, such as about 0.75 inches. The disc shaped fluid seal may have four slits, with two slits on each face of the fluid seal and the two slits on one face angularly offset from the two slits on the other face. For example, the two slits on each surface may form a cross-hair (e.g., the two slits on a given surface arranged orthogonally to each other) with the cross-hair on one surface angularly offset from the cross-hair on the other surface by 45 degrees or some other angle. In some examples, the two slits on one surface may be described as a vertical slit and a horizontal slit while the two slits on the opposite surface may be described as oblique slits. FIGS. 23A-24B depict some examples of such a disc shaped fluid seal with four slits (i.e., a double cross-hair configuration).

[0063] The two slits on each face may intersect approximately in a center of the corresponding face. Each slit penetrates partially through the fluid seal, such as greater than 50% to about 80%, or about 55% through the fluid seal, so that each slit extends from a corresponding one of the two faces into the fluid seal toward the opposite face. As a result, the two intersecting slits on one face meet the two intersecting slits on the other face in a center of the fluid seal to create a pinhole in the center of the disc where all four slits intersect. In some embodiments, the two slits on each surface are roughly perpendicular to one another, e.g., having an angle of about 80-100 degrees or about 90 degrees between the two slits as viewed when looking at a face or surface of the fluid seal. The two slits on one face may be angularly offset from the two slits on the other face, e.g., by an angle of about 35-55 degrees or about 45 degrees. The pinhole in the center of the fluid seal may only be visible when the material is stretched out. In another example, the double crosshair slits (e.g., the angularly offset cross-hair slits on opposing surfaces) create a central opening that enables catheter entry and removal without creating an open pin-hole clear of material during entry or removal or while the catheter is positioned therethrough.

[0064] The fluid seal may be composed of any suitable material, such as polyisoprene rubber, styrene polyisoprene rubber, styrene ethylene butylene rubber, vulcanized natural rubber, high consistency rubber (HCR), liquid silicone rubber (LSR), elastomeric silicone, or an enhanced tear resistant (ETR) silicone elastomer. In some embodiments, the material of the fluid seal has a Shore hardness of about 25-50 A, e.g., about 25-45 A, about 25-30A, about 30-35 A, about 30-40 A, about 40-50 A, about 25-27 A, about 27 -78a, about 29-31 A, about 31-35 A, about 35-40 A, about 40-45 A, or about 45-50 A. In some embodiments, the material of the fluid seal may have 500-1500% elongation, such as about 500-800% elongation, about 800-1100% elongation, or about 1100-1500% elongation. One example of a suitable LSR for the fluid seal is ELKEM LSR 4325, which is characterized by a 26 A Shore hardness and 1035% elongation after four hours of cure at a temperature of 200 degrees Celsius. This and other materials herein may be versatile for the application of hemostatic seals on an access sheath device that may need to allow various catheter diameter sizes to go through the fluid seal. In one example, the fluid seal comprises an enhanced tear resistant (ETR) silicone elastomer. In another example, the fluid seal may comprise an LSR. In another example, the fluid seal may specifically comprise LSR 4325. In another example, the fluid seal may comprise an HCR. In another example, the fluid seal may have a clear appearance.

[0065] A fluid seal may be incorporated into a seal stack as shown in FIGS. 7A-7B, 13E, 16D, 17G-17H, 19A-19D, 21A-21D, and 23A-23D. Such a fluid seal is incorporated, for example into seal stack 82 in guide catheter or guide sheath 30 depicted in FIGS. 7A-7B; into seal stack 1310 in housing assembly 1300 in FIG. 13E; into seal stack 1610 in housing assembly 1600 in FIG. 16D; into seal stack 1710 in housing assembly 1700 in FIGS. 17G- 17H; into seal stack 1900 in FIGS. 19A-19D; into seal stack 2100 in FIGS. 21A-21D; and into seal stack 2300 in FIGS. 23A-23D. In some embodiments, the fluid seal may be part of a seal stack comprising the fluid seal and a spacer and / or a cross-slit valve. For example, FIGS. 7A-7B illustrate the seal stack 82 that includes fluid seal 82c, spacer 82b, and crossslit valve 82a; FIG. 13E illustrates the seal stack 1310 that includes fluid seal 1310C, spacer 1310B, and cross-slit valve 1310A; FIG. 16D illustrates the seal stack 1610 that includes fluid seal 1610C, spacer 1610B, and cross-slit valve 1610A; FIGS. 17G-17H illustrate the seal stack 1710 that includes fluid seal 1710C, spacer 1710B, and cross-slit valve 1710A; FIGS. 19A-19D illustrate the seal stack 1900 that includes fluid seal 1902, spacer 1904, and cross-slit valve 1906; FIGS. 21A-21D illustrate the seal stack 2100 that includes fluid seal 2102, spacer 2104, and cross-slit valve 2106; and FIGS. 23A-23D illustrate the seal stack 2300 that includes fluid seal 2302, spacer 2304, and cross-slit valve 2306. Referring to, e.g., FIGS. 23A-23D, in some embodiments, the spacer 2304 may be a rigid plastic component comprising black ABS material. The spacer 2304 may be an injection-molded component used to provide structural support and fitment for the other elastomeric silicone (or other) materials retained inside the guide sheath seal housing assembly and serve as a compression force for retention of the seal stack. The spacer 2304 may fit the cross-slit valve 2306 and provide peripheral structural integrity for the seal stack components that reside inside the housing assembly, which may be comprised of polycarbonate. The spacer 2304 may include a rigid circular component with a hollow central diameter.

[0066] In some embodiments, the spacer 2304 may have an outer diameter that is the same as, or similar to, that of the fluid seal 2302, e.g., a diameter of about 0.5-1 inches, such as about 0.75 inches. In some embodiments, the spacer 2304 may have an inner diameter that is about 50-95%, about 70-90%, or about 80%, of the outer diameter of the spacer 2304, such as about 0.4-0.9 inches or about 0.6 inches. The inner diameter of the spacer 2304 may be sized to the exterior of a minor outer diameter portion 2308 of the cross-slit valve 2306 so that the exterior of the minor outer diameter portion 2308 of the cross-slit valve 2306 fits snugly against the inner diameter of the spacer 2304. The minor outer diameter portion 2308 of the cross-slit valve 2306 may be shaped to fit snugly into the interior of the spacer 2304 so that the minor outer diameter portion 2308 of the cross-slit valve 2306 fits snugly against a proximal surface of the spacer 2304. For example, the minor outer diameter portion 2308 of the cross-slit valve 2306 may have an outer diameter of about 0.4-0.9 inches or about 0.6 inches, and a thickness of about 0.2-0.4 inches, or about 0.3 inches. The spacer 2304 may have a thickness that accommodates the minor outer diameter portion 2308 of the cross-slit valve 2306, so that the distal end of the cross-slit valve 2306 fits snugly against the proximal surface of the spacer 2304. In some embodiments, the spacer 2304 has a thickness of about 0.2-0.4 inches, or about 0.3 inches. In some embodiments, the cross-slit valve 2306 is included, and helps to hold fluid seal 2302 in place. The cross-slit valve 2306 may be composed of polyisoprene material. Thus, in summary and as depicted in FIGS. 23A-23D, the seal stack 2300 comprises the cross-slit valve 2306, and particularly the minor outer diameter portion 2308 of cross-slit valve 2306, fitting snugly inside the inner diameter of spacer 2304, and the fluid seal 2302 fitting snugly against a distal end of the spacer 2304. Tn certain embodiments, the cross-slit valve 2304 may be comprised of polyisoprene or platinum-cured silicone material, and is thus compliant and possesses built-in retention features. The proximal side of the cross-slit valve 2306 may possess a generally concave shape which enables catheters entering a human body to converge towards a center of an entry point of the seal stack 2300. Functionally, the fluid seal 2302, which contains double cross-hair slits (i.e., one set of cross-hair slits on its proximal surface and another set on its distal surface) directly within its center in certain embodiments, allows entering catheter systems to converge and be inserted into the center of the access sheath and thereby into the human body. During use of the guide sheath or catheter in a medical procedure, the cross-slit valve 2306 also helps maintain entering catheter systems generally centered throughout the entirety of the procedure. The fluid seal 2302 may mold around, conform to, and / or seal around devices of a variety of diameters, including guide wires, introducers, delivery devices, and the like.

[0067] In some examples, the delivery apparatuses disclosed herein may be used to introduce one or more delivery apparatuses (or implant catheters) into the vasculature of a patient and guide the one or more delivery apparatuses at least partially through the vasculature toward a target implantation site. For example, FIGS. 1-2D schematically illustrate an example transcatheter heart valve replacement procedure which utilizes a guide catheter to guide a docking device delivery apparatus toward a native valve annulus and then a prosthetic heart valve delivery apparatus toward the native valve annulus. The docking device delivery apparatus is used to deliver a docking device to the native valve annulus and then the prosthetic heart valve delivery apparatus is used to deliver a transcatheter prosthetic heart valve inside the docking device.

[0068] As introduced above, defective native heart valves may be replaced with transcatheter prosthetic heart valves. However, such prosthetic heart valves may not be able to sufficiently conform to the geometry of the native tissue (e.g., to the leaflets and / or annulus of the native heart valve) and may undesirably shift around relative to the native tissue, which may lead to paravalvular leakage. Thus, a docking device may be implanted first at the native valve annulus and then the prosthetic heart valve may be implanted within the docking device to help anchor the prosthetic heart valve to the native tissue and provide a seal between the native tissue and the prosthetic heart valve. An example delivery apparatus for delivering a docking device at a native heart valve is shown in FIG. 2A, and an example docking device is shown in FIGS. 18A-18C. An example delivery apparatus for delivering a prosthetic heart valve within a docking device at a native heart valve is shown in FIG. 2B, and an example prosthetic heart valve is shown in FIGS. 18A-18C.

[0069] Example guide catheters are shown in more detail in, e.g., FIGS. 3-7B. Example housing assemblies included in such guide catheters are shown in more detail in, e.g., FIGS. 8, 13A-13E, 16A-16E, and 17A-17H. Example seal stacks that may be implemented in any of the guide catheters and / or housing assemblies herein are shown in more detail in, e.g., FIGS. 19A-I9D, 21A-21D, and 23A-23D.

[0070] Example Delivery Techniques

[0071] FIGS. 1-2D depict an example transcatheter heart valve replacement procedure (e.g., an aortic valve replacement procedure) which utilizes a docking device or station 50 and a prosthetic heart valve 29, according to one example. During the procedure, a clinician first creates a pathway to a patient’s native heart valve using a guide wire 40 (FIG. 1). The clinician then positions a guide catheter 30 to the target position (e.g., aortic valve 16) (FIG. 2A) and, using a docking device delivery apparatus 22 (FIG. 2A), delivers and implants the docking station 50 at the patient’s native aortic valve 16 (FIG. 2B), after which the docking device delivery apparatus 22 is removed from the patient 10. The clinician then, using a prosthetic valve delivery apparatus 60 (FIG. 2B), implants the prosthetic heart valve 29 (FIG. 2C) within the implanted docking station 50, after which the prosthetic valve delivery apparatus 60 is removed from the patient 10 (FIG. 2C). Thereafter, the clinician removes the guide catheter 30 from the patient 10 (FIG. 2D).

[0072] FIG. 1 depicts a first stage in an aortic valve replacement procedure, according to one example, where the guide catheter 30 and the guidewire 40 are inserted into a blood vessel 12 of a patient 10 and navigated through the blood vessel 12, into an aortic arch 18 of the patient 10, and toward the native aortic valve 16. Together, the guide catheter 30 and the guidewire 40 may provide a path for the docking station 50, and for the prosthetic valve delivery apparatus 60, to be navigated past the aortic arch 18 and to the target or implantation site, the native aortic valve 16 or native aortic valve annulus.

[0073] Initially, the clinician may make an incision in the patient’s body to access the blood vessel 12. For example, the clinician may make an incision in the patient’s groin to access a femoral artery. Thus, in some examples, the blood vessel 12 may be a femoral artery.

[0074] After making the incision at the blood vessel 12, the clinician may insert the guide catheter 30, the guidewire 40, and / or additional devices (such as an introducer device) through the incision and into the blood vessel 12. The guide catheter 30 (which may also be referred to as an “introducer device,” “introducer,” or “guide sheath”) is configured to facilitate the percutaneous introduction of various implant delivery devices (e.g., the docking device delivery apparatus 22 and the prosthetic valve delivery apparatus 60) into and through the blood vessel 12 and may extend through the blood vessel 12, into the aortic arch 18, and to the native aortic valve 16.

[0075] The guide catheter 30 may comprise a handle 32 and a shaft 34 extending distally from the handle 32. The shaft 34 may extend through the blood vessel 12 and into the heart 14 while the handle 32 remains outside the body of the patient 10 and may be operated by the clinician to manipulate the shaft 34 (FIG. 1).

[0076] The guidewire 40 is configured to guide the delivery apparatuses (e.g., the guide catheter 30, the docking device delivery apparatus 22, the prosthetic valve delivery apparatus 60, additional catheters, or the like) and their associated devices (e.g., docking station 50, prosthetic heart valve 29, and the like) to the implantation site within the heart 14, and thus may extend all the way through the blood vessel 12, into the aortic arch 18, and into the native aortic valve 16 of the heart 14 (FIG. 1).

[0077] In some instances, an introducer device may be inserted through a lumen of the guide catheter 30 prior to inserting the guide catheter 30 into the blood vessel 12. In some instances, the introducer device may include a tapered end that extends out a distal tip of the guide catheter 30 and that is configured to guide the guide catheter 30 into the aortic valve 16 annulus over the guidewire 40. Additionally, in some instances the introducer device may include a proximal end portion that extends out a proximal end of the guide catheter 30. Once the guide catheter 30 reaches the aortic valve 16 annulus, the clinician may remove the introducer device from inside the guide catheter 30 and the patient 10. Thus, only the guide catheter 30 and the guidewire 40 remain inside the patient 10. The guide catheter 30 is then in position to receive an implant delivery apparatus and help guide it to the aortic valve 16, as described further below.

[0078] FIG. 2A depicts a second stage in the example aortic valve replacement procedure where the guide catheter 30 has reached the target or implantation site. For example, the guide catheter 30 may reach the aortic valve 16 and / or an annulus associated therewith. The docking device 50 is implanted at the native aortic valve 16 of the heart 14 of the patient 10 using the docking device delivery apparatus 22 (which may also be referred to as an “implant catheter” and / or a “docking device delivery device”). Tn general, the docking device delivery apparatus 22 comprises a delivery shaft 24, a handle 26, and a pusher assembly 28. The delivery shaft 24 is configured to be advanced through the patient’s vasculature (blood vessel 12) and to the implantation site (e.g., native aortic valve 16) by the clinician and may be configured to retain the docking device 50 in a distal end portion of the delivery shaft 24. In some examples, the distal end portion of the delivery shaft 24 retains the docking device 50 therein in a compressed delivery configuration.

[0079] The handle 26 of the docking device delivery apparatus 22 is configured to be gripped and / or otherwise held by the clinician, outside the body of the patient 10, to advance the delivery shaft 24 through the patient’s vasculature (e.g., blood vessel 12).

[0080] In some examples, the handle 26 may comprise one or more articulation members 27 (or rotatable knobs) that are configured to aid in navigating the delivery shaft 24 through the blood vessel 12. For example, the one or more articulation members 27 may comprise one or more of knobs, buttons, wheels, and / or other types of physically adjustable control members that are configured to be adjusted by the clinician to flex, bend, twist, turn, and / or otherwise articulate a distal end portion of the delivery shaft 24 to aid in navigating the delivery shaft 24 through the blood vessel 12 and within the heart 14.

[0081] The pusher assembly 28 may be configured to deploy and / or implant the docking device 50 at the implantation site (e.g., the native aortic valve 16). For example, the pusher assembly 28 is configured to be adjusted by the clinician to push the docking device 50 out of the distal end portion of the delivery shaft 24. A shaft of the pusher assembly 28 may extend through the delivery shaft 24 and may be disposed adjacent to the docking device 50 within the delivery shaft 24. In some examples, the docking device 50 may be releasably coupled to the shaft of the pusher assembly 28 via a connection mechanism of the docking device delivery apparatus 22 such that the docking device 50 may be released after being deployed at the native aortic valve 16.

[0082] In some examples, the docking station 50 may be constructed from, formed of, and / or comprise a shape memory material, and as such, may return to its original, preformed shape when it exits the delivery shaft 24 and is no longer constrained by the delivery shaft 24. Additionally or alternatively, a balloon (not illustrated) may be included radially inward from the docking station 50 within the delivery shaft 24 and after exposing the docking station 50, the balloon may be inflated (by liquid or air) to cause the docking station 50 to expand from its compressed state to the expanded state. After deploying and implanting the docking station 50 at the native aortic valve 16, the clinician may disconnect the docking station 50 from the docking device delivery apparatus 22. Once the docking station 50 is disconnected from the docking device delivery apparatus 22, the clinician may retract the docking device delivery apparatus 22 out of the blood vessel 12 and away from the patient 10 so that the clinician may deliver and implant the prosthetic heart valve 29 within the implanted docking device 50 at the native aortic valve 16.

[0083] FIG. 2B depicts a third stage in the aortic valve replacement procedure, where the docking station 50 has been fully deployed and implanted at the native aortic valve 16 and the docking device delivery apparatus 22 (including the delivery shaft 24) has been removed from the patient 10. In this stage, the prosthetic valve delivery apparatus 60 is inserted into the patient through the guide catheter 30 to implant the prosthetic heart valve 29.

[0084] As shown in FIG. 2B, the prosthetic valve delivery apparatus 60 may include a delivery shaft 64 and a handle 66, the delivery shaft 64 extending distally from the handle 66. The delivery shaft 64 is configured to extend into the patient’ s vasculature to deliver, implant, expand, and / or otherwise deploy the prosthetic heart valve 29 within the docking station 50 at the native aortic valve 16. The handle 66 is configured to be gripped and / or otherwise held by the clinician to advance the delivery shaft 64 through the patient’s vasculature.

[0085] In some examples, the handle 66 may comprise one or more articulation members 68 that are configured to aid in navigating the delivery shaft 64 through the blood vessel 12 and the heart 14. Specifically, the articulation member(s) 68 may comprise one or more of knobs, buttons, wheels, and / or other types of physically adjustable control members that are configured to be adjusted by the clinician to flex, bend, twist, turn, and / or otherwise articulate a distal end portion of the delivery shaft 64 to aid in navigating the delivery shaft 64 through the blood vessel 12 and to the docking station 50 at the aortic valve 16.

[0086] In some examples, the prosthetic valve delivery apparatus 60 may include an expansion mechanism that is configured to radially expand and deploy the prosthetic heart valve 78at the implantation site. In some instances, the expansion mechanism may include an inflatable balloon that is configured to be inflated to radially expand the prosthetic heart valve 29 within the docking device 50. The inflatable balloon may be coupled to the distal end portion of the delivery shaft 64. Tn other examples, the prosthetic heart valve 29 may be self-expanding and may be configured to radially expand on its own upon removal of a sheath or capsule covering the radially compressed prosthetic heart valve 29 on the distal end portion of the delivery shaft 64. In still other examples, the prosthetic heart valve 29 may be mechanically expandable and the prosthetic valve delivery apparatus 60 may include one or more mechanical actuators (e.g., the expansion mechanism) configured to radially expand the prosthetic heart valve 29.

[0087] To navigate the distal end portion of the delivery shaft 64 to the implantation site, the clinician may insert the prosthetic valve delivery apparatus 60 (the delivery shaft 64) into the patient 10 through the guide catheter 30 and over the guidewire 40. The clinician may continue to advance the prosthetic valve delivery apparatus 60 along the guidewire 40 (through the blood vessel 12) until the distal end portion of the delivery shaft 64 reaches the native aortic valve 16. More specifically, the clinician may advance the delivery shaft 64 of the prosthetic valve delivery apparatus 60 by gripping and exerting a force on (e.g., pushing) the handle 66. While advancing the delivery shaft 64 through the blood vessel 12 and the heart 14, the clinician may adjust the one or more articulation members 68 of the handle 66 to navigate the various turns, corners, constrictions, and / or other obstacles in the blood vessel 12 and heart 14.

[0088] The clinician may advance the delivery shaft 64 along the guidewire 40 until the radially compressed prosthetic heart valve 29 mounted around the distal end portion of the delivery shaft 64 is positioned within the docking device 50 and the native aortic valve 16.

[0089] Once the radially compressed prosthetic heart valve 29 is appropriately positioned within the docking device 50, the user may manipulate one or more actuation mechanisms of the handle 66 of the prosthetic valve delivery apparatus 60 to actuate the expansion mechanism (e.g., inflate the inflatable balloon), thereby radially expanding the prosthetic heart valve 29 within the docking device 50.

[0090] FIG. 2C depicts a fourth stage in the aortic valve replacement procedure where the prosthetic heart valve 29 (which may also be referred to herein as a “transcatheter heart valve” or “THV” for short, “replacement heart valve,” and / or “prosthetic aortic valve”) has been deployed within the docking station 50.

[0091] FIG. 2D shows a fifth stage in the aortic valve replacement procedure where the prosthetic heart valve 29 is in its radially expanded configuration and implanted within the docking station 50 in the native aortic valve 16. As shown in FIG. 2D, the prosthetic heart valve 29 is received and retained within the docking station 50. Thus, the docking station 50 aids in anchoring the prosthetic heart valve 29 within the native aortic valve 16. Additionally, the guidewire 40 and the guide catheter 30 have been removed from the patient 10.

[0092] Although FIGS. 1-2D specifically depict an aortic valve replacement procedure, it should be appreciated that the same and / or similar procedure may be utilized to replace other heart valves (e.g., tricuspid, pulmonary, and / or mitral valves). Further, the same and / or similar delivery apparatuses (e.g., docking device delivery apparatus 22, prosthetic valve delivery apparatus 60, guide catheter 30, and / or guidewire 40), docking devices (e.g., docking device 50), replacement heart valves (e.g., prosthetic heart valve 29), and / or components thereof may be utilized for replacing these other heart valves.

[0093] For example, when replacing a native tricuspid valve, the user may access the right atrium via a femoral vein without crossing the atrial septum into the left atrium. Instead, the user may leave the guidewire 40 in the right atrium and perform the same and / or similar docking device implantation process at the tricuspid valve. Specifically, the user may push the docking device 50 out of the delivery shaft 24 around the ventricular side of the tricuspid valve leaflets, release the remaining portion of the docking device 50 from the delivery shaft 24 within the right atrium, and then remove the delivery shaft 24 of the docking device delivery apparatus 22 from the patient 10. The user may then advance the guidewire 40 through the tricuspid valve into the right ventricle and perform the same and / or similar prosthetic heart valve implantation process at the tricuspid valve, within the docking device 50. Specifically, the user may advance the delivery shaft 64 of the prosthetic valve delivery apparatus 60 through the patient’s vasculature along the guidewire 40 until the prosthetic heart valve 29 is positioned / disposed within the docking device 50 and the tricuspid valve. The user may then expand the prosthetic heart valve 29 within the docking device 50 before removing the prosthetic valve delivery apparatus 60 from the patient 10. In another example, the user may perform the same and / or similar process to replace the mitral valve via the femoral artery, the aortic valve, and the left ventricle or via the femoral vein, across the atrial septum, and into the left atrium. Example Guide Catheter With First Example Housing Assembly

[0094] FIG. 3 illustrates an embodiment of the guide catheter 30 that includes the shaft or sheath 34 and a housing assembly 36 in use with a representative delivery apparatus 38, for delivering an implant 42, or other type of implantable, to a patient. The housing assembly 36 may be, include, be included in, or correspond to the handle 32 of FIGS. 1 - 2D. The delivery apparatus 38 may be, include, be included in, or correspond to the docking device delivery apparatus 22, the prosthetic valve delivery apparatus 60, or other delivery apparatuses herein. The implant 42 may be, include, be included in, or correspond to the docking device 50 or prosthetic heart valve 29 or other implantable devices herein. The sheath 34 is depicted in FIG. 3 in an exploded form relative to the housing assembly 36 to view elements therein.

[0095] The delivery apparatus 38 may include a delivery shaft 44 that extends from a handle 46 and a balloon catheter 48 extending through the handle 46 and the delivery shaft 44. The delivery shaft 44 and / or the ballon catheter 48 may be, include, be included in, or correspond to the delivery shaft 24 of the docking device delivery apparatus 22, the delivery shaft 64 of the prosthetic valve delivery apparatus 60, or other delivery shafts herein. The handle 46 may be, include, be included in, or otherwise correspond to the handle 26 of the docking device delivery apparatus 22, the handle 66 of the prosthetic valve delivery apparatus 60, or other handles herein. The delivery shaft 44 and the balloon catheter 48 in the illustrated embodiment are adapted to slide longitudinally relative to each other to facilitate delivery and positioning of the implant 42 at an implantation site in a patient's body. The sheath 34 is an elongate tube that may be expandable and / or may include a hemostasis valve at the proximal end of the sheath 34 to, e.g., stop blood leakage.

[0096] FIG. 4 illustrates the guide catheter 30 of FIG. 3 including a sheath locking system 52 which prevents axial and rotational translation of an introducer 56 with respect to the sheath 34. The sheath 34 includes a main lumen through which the introducer 56, an implant catheter, or other device may be inserted, e.g., to access a target implantation site. The sheath locking system 52 keeps the introducer 56 fixed with respect to the sheath 34 during insertion without requiring a physician or technician to hold the introducer 56 and the sheath 34 in place at the distal end. The sheath locking system 52 includes a sheath locking sleeve 58, which is part of the housing assembly 36, coupled to the sheath 34 via a sheath hub 70 of the housing assembly 36, and an introducer locking hub 72 coupled to the introducer 56. The sheath locking sleeve 58 engages the introducer locking hub 72 and is moveable between a locked and unlocked position, thereby fixing the relative positions of the introducer 56 and the sheath 34 and preventing movement therebetween during insertion. As will be described in more detail below, the sheath locking system 52 may keep the introducer 56 from separating from the sheath 34 and may prevent gaps from forming that may cause patient abrasions and unintended fluid flow between the introducer 56 and the sheath 34 during insertion.

[0097] FIGS. 4 and 6-8 illustrate the sheath locking sleeve 58 coupling the introducer locking hub 72 to the sheath hub 70. As will be described in more detail below, the sheath locking sleeve 58 includes one or more posts or protrusions 74 that engage one or more corresponding locking channels 76 provided on the introducer locking hub 72. The post 74 moves within the locking channel 76 between an unlocked position, where the sheath locking sleeve 58 is rotationally and axially movable with respect to the introducer locking hub 72, and a locked position (FIG. 4), where the sheath locking sleeve 58 is axially fixed with respect to the introducer locking hub 72.

[0098] The sheath locking sleeve 58 is illustrated, for example, in FIGS. 12A-12F. The sheath locking sleeve 58 includes an elongated sleeve body 78 with a central lumen 80a extending longitudinally between a proximal end 78a and distal end 78b of the sleeve body 78. As provided in FIG. 8, the central lumen 80a defines a generally cylindrical inner surface 78c of the sheath locking sleeve 58. The central lumen 80a has a diameter of at least 0.3". In some examples, the diameter ranges between 0.3" and 0.6" or is about 0.40". The distal end 78b of the sleeve body 78 may also have a frustoconical outer surface 78d that tapers about the distal end 78b to help with positioning the sheath locking sleeve 58 within the sheath hub 70 and abutting a seal stack 82 (FIGS. 7A and 7B). The sheath locking sleeve 58 may also have one or more interface tabs 78e that extend radially from the outer surface 78d of the sleeve body 78 around (all or a portion of) the circumference of the sheath locking sleeve 58. As illustrated in FIG. 7A, these interface tabs 78e may be sized and configured to engage corresponding recesses and / or slots 84 provided in the sheath hub 70 for securing the sheath locking sleeve 58 to the sheath hub 70.

[0099] The sheath locking sleeve 58 includes the post(s) 74 projecting from the outer surface 78f of the sheath locking sleeve 58. The post 74 engages a corresponding shaped locking channel 76 in the introducer locking hub 72. The post 74 extends radially from the outer surface 78f and at least partially around the circumference of the outer surface 78f. As illustrated in FIG. 8, in some embodiments, the radially outer surface of the post 74 does not extend beyond the outer surface of the introducer locking hub 72 when the sheath locking sleeve 58 and the introducer locking hub 72 are coupled. For example, the radial height of the post 74 from the outer surface 78f in FIG. 8 corresponds to the radial wall thickness of the introducer locking hub 72 proximate the post 74 when the sheath locking sleeve 58 and the introducer locking hub 72 are coupled. Tn another example, the radially outer surface of the post 74 may be recessed with respect to the outer surface of the introducer locking hub 72. That is, the radial height of the post 74 from the outer surface 78f may be less than the wall thickness of the introducer locking hub 72. In other examples, the radial height of the post 74 may be greater than a wall thickness of the introducer locking hub 72 such that the post 74 may extend beyond the outer surface of the introducer locking hub 72 when the sheath locking sleeve 58 and the introducer locking hub 72 are coupled. In some examples, the radial height of the post 74 is between about 0.050" and about 0.10." In some examples the radial height of the post 74 is about 0.075".

[0100] As illustrated in FIGS. 12B-12F, the post 74 may include a cylindrically shaped projection. However, it is contemplated that the post 74 may have any other regular or irregular shape that would facilitate movement of the post 74 within the locking channel 76 of the introducer locking hub 72. For example, the post 74 may have an elongated hexagon shape. The post 74 may have a diameter / width ranging from about 0.05" to about 0.20". In some embodiments, the post 74 has a diameter / width of about 0.100".

[0101] In some examples, the sheath locking sleeve 58 may be formed from polycarbonate, but in other examples the sheath locking sleeve 58 may be formed from rigid plastic, or any other material suitable for providing a strong locking connector for an introducer 56 (metal, composite, etc.)

[0102] FIGS. 10A-10F illustrate the introducer locking hub 72 with the introducer 56 coupled thereto. Example introducer sheaths are described, for example in U.S. Pat. Nos. 8,690,936 and 8,790,387, the disclosures of which are incorporated herein by reference. As illustrated in the cross-section views of FIGS. 7A and 7B, the introducer 56 may be coupled to the introducer locking hub 72 and may extend beyond the distal end of the introducer locking hub 72 body. When coupled to the sheath hub 70, the introducer 56 extends through the central lumen 80a of the sheath locking sleeve 58, the sheath hub 70 and the central lumen of the sheath 34.

[0103] In some examples, the sheath 34 may include a radially expandable tubular structure. Passage of the introducer 56 through the sheath 34 and into a patient's vessel may cause the vessel to radially expand to about the diameter of the sheath 34. That is, the diameter of the central lumen of the sheath 34 may generally be about the outer diameter of the introducer 56 such that the introducer 56 provides a mechanism to expand a patient's vessel to accept the sheath 34. As illustrated in FIGS. 7A-7B and 10A-10F, the introducer 56 may be formed as an elongate body with a central lumen extending therethrough. As illustrated in FIGS. 7 A and 7B, the central lumen of the introducer 56 may be aligned with central lumens of the introducer locking hub 72, the sheath hub 70 and the sheath 34. The introducer 56 may be received within a recessed opening 86 (FIGS. 7A-8) provided on an interior surface of the introducer locking hub 72, the recessed opening 86 axially aligned with a central lumen 88 (FIGS. 7A-8, 11 A, 11C) of the introducer locking hub 72. The introducer 56 is coupled to the introducer locking hub 72 at the recessed opening 86. In an example system, the introducer 56 has a diameter corresponding to or less than the diameter of the recessed opening 86. In some examples, the introducer 56 is fixedly coupled to the introducer locking hub 72 at the recessed opening 86. For example, the introducer 56 may be coupled to the recessed opening 86 of the introducer locking hub 72 by at least one of a press fit, an interference fit, a snap fit, a mechanical fastener, a chemical fastener (e.g., an adhesive), a weld, a thermal process, and / or any other suitable coupling process known in the art.

[0104] As described above, the introducer 56 has a central lumen that aligns with the central lumen 88 of the introducer locking hub 72. This joined lumen allows for the passage of surgical equipment and / or medical devices to the treatment site. In an example system, and as provided in FIGS. 7A and 7B, the central lumen of the introducer 56 has a diameter corresponding to at least a portion of the diameter of the central lumen 88 of the introducer locking hub 72. In general, the corresponding diameter portion is adjacent the distal end of the central lumen 88. In other examples, the diameter of the central lumen 88 at the distal end of the introducer locking hub 72 is slightly larger than the diameter of the central lumen passing through the introducer 56. The central lumen 88 may also have a decreasing tapered portion 90 between the proximal end and the distal end of the introducer locking hub 72 (see FIG. 8). The corresponding diameter portion and decreasing tapered portion 90 may allow for smooth transition and delivery of surgical equipment and / or medical devices through the introducer locking hub 72 and into the central lumen of the introducer 56.

[0105] FIGS. 4 and 6 illustrate the introducer locking hub 72 coupled to the sheath locking sleeve 58. FIGS. 10A-10F illustrate the introducer locking hub 72 coupled to the introducer 56. FIGS. 11A-1 IF illustrate multiple views of the introducer locking hub 72. As described above, the introducer 56 may be fixedly coupled to the introducer locking hub 72, and the introducer locking hub 72 may couple with the sheath locking sleeve 58 to fix the position of the introducer 56 (axially and rotationally) with respect to the sheath locking sleeve 58 and the sheath 34.

[0106] Referring to FIGS. 10C-10F, the introducer locking hub 72 includes a hub body 91 having a proximal end 91a and a distal end 91b and defining a central lumen 88 (FIGS. 7A-8, HA, 11C) extending therethrough. The introducer locking hub body 91 has a first (middle) portion 92, a second (distal) portion 93 which extends distally from the first portion 92 and a third (proximal) portion 94 which extends proximally from the first portion 92. The first portion 92 includes the cylindrically-shaped recessed opening 86 (FIGS. 7A-8) for receiving and retaining the introducer 56 and an outer surface 92b. In some examples, the recessed opening 86 has a diameter ranging between 0.15" and about 0.25". In some examples, the recessed opening 86 has a diameter ranging between 0.17" and about 0.20". In some examples, the recessed opening has a diameter of about 0.194".

[0107] The third (proximal) portion 94 of the introducer locking hub 72 includes the decreasing tapered portion 90 (FIGS. 7A-8) of the central lumen 88 (FIGS. 7A-8, 11 A, 11C). The decreasing tapered portion 90 defining a frustoconical shape with decreasing taper / diameter from the proximal to the distal end of the decreasing tapered portion 90. It is contemplated that the tapered portion 90 has a minimum diameter of about 0.007" and a maximum diameter of about 0.194" in some embodiments.

[0108] As illustrated in FIG. 7 A- 8, when coupled the central lumen 80a of the sheath locking sleeve 58 is aligned with the central lumen 88 of the introducer locking hub 72. In some examples, the central lumen 80a of the sheath locking sleeve 58 is coaxial with the central lumen 88 of the introducer locking hub 72. When coupled, the proximal end of the sheath locking sleeve 58 is received within the central lumen 88 of the introducer locking hub 72. The proximal end surface of the sheath locking sleeve 58 is adjacent a shoulder 95 provided on an inner surface of the central lumen 88 of the introducer locking hub 72. As illustrated in FIG. 7 A, the central lumen 88 of the introducer locking hub 72 includes a first portion 96 having a first diameter adjacent the proximal end of the introducer locking hub 72, and a second portion 97 having a second, larger, diameter adjacent the distal end of the introducer locking hub 72. The recessed opening 86 may be consider either a component of the first portion 96 of the central lumen 88, or a separate component of the central lumen 88 located between the first (proximal) portion 96 and the second (distal) portion 97. When the sheath locking sleeve 58 and introducer locking hub 72 are coupled, at least a portion of the sleeve body 78 of the sheath locking sleeve 58 is received within the second portion 97 (larger diameter portion) of the central lumen 88 of the introducer locking hub 72. The central lumen 80a of the sheath locking sleeve 58 is aligned with the central lumen 88 of the introducer locking hub 72 such that they are co-axial.

[0109] As described generally above, the sheath locking sleeve 58 couples to the introducer locking hub 72 via engagement between the post 74 on the sheath locking sleeve 58 and the locking channel 76 provided in the introducer locking hub 72. As illustrated in FIGS. 11A-11F, the introducer locking hub 72 includes two locking channels 76. However, it is contemplated that the introducer locking hub 72 may include one locking channel 76 or more than two locking channels 76. The locking channel 76 may be formed as a recess or groove in a surface of the introducer locking hub 72, as a slotted opening, a clip, or as any other feature capable of receiving and securing the post 74 projecting from the outer surface of the sheath locking sleeve 58 with the introducer locking hub 72. Illustrated in FIG. 9 B, the locking channels 76 provide an interface to secure the sheath locking sleeve 58 to the introducer locking hub 72 and ensure a fixed axial position between the introducer 56 and the sheath 34.

[0110] The locking channel 76 is formed on the distal end of the introducer locking hub 72. Referring to, e.g., FIGS. 11B and 1 ID, the locking channel 76 includes an opening on the distal end of the introducer locking hub 72 that leads to an angled guide portion 98 that transitions to a locking portion 99. The guide portion 98 is configured to direct the post 74 of the sheath locking sleeve 58 in an axial and circumferential direction along the side wall of the guide portion 98 towards the locking portion 99 upon rotation of the introducer locking hub 72 and / or the sheath locking sleeve 58. The locking portion 99 is configured to securely engage the post 74, fixing the axial position of the introducer locking hub 72 with respect to the sheath locking sleeve 58. As illustrated in FIG. 11B, the guide portion

[0111] 98 of the locking channel 76 extends from the distal end of the introducer locking hub 72 axially towards the proximal end of the introducer locking hub 72 and circumferentially around the introducer locking hub 72. For example, the guide portion 98 of the locking channel 76 may be described as extending helically around / along a length of the introducer locking hub 72 or on an angle from the distal end of the introducer locking hub 72.

[0112] As illustrated in FIGS. 1 IB and 1 ID, the locking portion 99 of the locking channel 76 extends at an angle from the end of the guide portion 98. As provided in FIG. 1 IB, the angle between a centerline of the guide portion 98 and a centerline of the locking portion

[0113] 99 is greater than 90-degrees. In another example, the angle between the centerline of the guide portion 98 and the centerline of the locking portion 99 is about 120-degrees. In an example system, the locking portion 99 extends around a portion of the circumference of the introducer locking hub 72. The locking portion 99 may extend parallel or substantially parallel to the distal end of the introducer locking hub 72. In an example system, the length of the guide portion 98 (measured along its centerline) is greater than a length of the locking portion 99 (measured along its centerline). In another example, the length of the guide portion 98 equals or is less than a length of the locking portion 99.

[0114] The locking portion 99 may include a catch 100 (FIG. 1 IB) for securing the post 74 within the locking portion 99 of the locking channel 76 and forming a partial barrier for the post 74 within the locking portion 99. As illustrated in FIG. 1 IB, the catch 100 includes a projection that extends from a side wall 99a of the locking portion 99 and releasably secures the post 74 within the locking channel 76. The catch 100 extends from the side wall 99a of the locking portion 99 in a proximal direction towards the center line of the locking portion 99 and has a height sufficient to retain the post 74 between the catch 100 and the end of the locking portion 99.

[0115] The distal surface of the distal end 91b of the introducer locking hub 72 may include features for biasing the post 74 towards the locking channel 76. For example, the distal end of the introducer locking hub 72 may include a sloped surface angled toward an opening of the locking channel 76. As illustrated in FIG. 11B, the distal end 91b of the introducer locking hub 72 includes a first sloped surface 101 angled towards a leading edge of the opening of the locking channel 76 and a second sloped surface 102 angled towards the trailing edge of the opening of the locking channel 76.

[0116] In use, engagement between the post 74 and the guide portion 98 of the locking channel 76 is configured to bias the sheath locking sleeve 58 in a proximal axial direction toward the proximal end of the introducer locking hub 72 (towards a locked position) when the sheath locking sleeve 58 is rotated in a first axial direction. In this direction the post 74 advances toward the locking portion 99 of the locking channel 76 into the locked position. Alternatively, engagement between the post 74 and the locking portion 99 of the locking channel 76 is configured to bias the sheath locking sleeve 58 in a distal axial direction toward the distal end of the introducer locking hub 72 (towards an unlocked position) when the sheath locking sleeve 58 is rotated in a second (opposite) axial direction. In the second direction, the post 74 advances away from the locking portion 99 of the locking channel 76, to the unlocked position. When the post 74 is in the locked position and retained within the locking portion 99 by catch 100, rotation in the second direction causes the post 74 to bias against the catch 100 and eventually overcome oppositional forces of the catch 100, and move the post 74 from the locked to the unlocked position.

[0117] As illustrated in FIGS. 10A-1 IF, the outer surface 92b of the introducer locking hub body 91 may include gripping features and / or surfaces for a physician or technician to use when manipulating the introducer locking hub 72. As illustrated in FIGS. 11B and 11E-11F for example, the introducer locking hub body 91 may include two recessed gripping surfaces 103 on opposite sides of the longitudinal axis of the introducer locking hub 72. When the introducer locking hub 72 is viewed from the side, the gripping surfaces 103 define a dog-bone / barbell shape to the introducer locking hub body 91, i.e., a shape having a smaller diameter / width center portion and larger diameter / width end portions. In an example system, the gripping surfaces 103 are provided along at least 40% of the length of the introducer locking hub body 91. In another example, the gripping surfaces 103 are provided along at least 50% of the length of the introducer locking hub body 91.

[0118] In general, the introducer locking hub 72 may be formed from polycarbonate, but in other examples the introducer locking hub 72 may be formed from rigid plastic, or any other material suitable for providing a locking mechanism for an introducer 56 (metal, composite, etc.).

[0119] FIGS. 4-8 illustrate an example sheath hub 70. As described above, the sheath 34 is coupled to the sheath hub 70 which in turn is removably coupled to the sheath locking sleeve 58. The sheath hub 70 provides a housing for a seal stack and / or seal assemblies and an access point for a secondary lumen (e.g., fluid lumen) in fluid communication with the central lumen of the sheath hub 70.

[0120] Referring to FIGS. 6, 7A, and 8, the sheath hub 70 further has receiving slots 84. The receiving slots 84 are openings which extend around a portion of the circumference of the sheath hub 70 and are sized and configured to accept the interface tabs 78e. Coupling between the receiving slots 84 and the interface tabs 78e of the sheath locking sleeve 58 may axially and rotationally fix the sheath locking sleeve 58 and the sheath hub 70 relative to each other.

[0121] The distal end of the sheath hub 70 includes threads 104 for coupling to a threaded sheath hub cap or retainer 105. The sheath 34 is provided between the sheath hub 70 and the retainer 105 such that coupling the retainer 105 to the sheath hub 70 fixes the sheath 34 to the sheath hub 70. The retainer 105 is a cylindrical cap having a cap body having a proximal end and a distal end and defining a central lumen extending longitudinally between the proximal end and the distal end. The retainer 105 has a larger diameter at its proximal end than at its distal end.

[0122] The seal stack 82 as described above and as shown in FIGS. 7 A and 7B is included in the sheath hub 70. The seal stack 82 includes proximal seal 82a, intermediate seal 82b, and distal seal 82c. When assembled, the introducer 56 passes through the seal assembly and extends distal of the sheath 34. The proximal seal 82a, the intermediate seal 82b, and the distal seal 82c are each formed to prevent unwanted fluid from advancing in the proximal direction through the sheath hub 70 and proximal of the seal stack 82. They are each openable and closable to provide pressure variation to affect the desired fluid flow from a physician or technician. In some embodiments, the proximal seal 82a comprises a cross-slit valve, the intermediate seal 82b is or is substituted for a spacer, and / or the proximal seal comprises a fluid seal with a cross-hair configuration, a double cross-hair configuration, a “duck fin” configuration, or other suitable configuration. Examples and details of some of the foregoing are provided elsewhere herein.

[0123] Although not required, the sheath hub 70 or other component of the housing assembly 36 may include a flush port 85 (FIGS. 3-5, 7B). The flush port 85 may include a flush lumen coupled to a lumen of the sheath hub 70 and / or may be used in an aspirate and / or flush step of a procedure.

[0124] As illustrated in, e.g., FIGS. 4-7B, the sheath 34 may include a seal tube or strain relief portion 106. The seal tube 106 is coupled to the distal end of the sheath hub 70 and creates a smooth transition surface between the sheath 34 and the sheath hub 70. The frustoconical seal tube 106 body has a proximal end and a distal end and a central lumen extending longitudinally therethrough. The seal tube 106 tapers from the proximal end to the distal end such that the diameter of the seal tube 106 at the proximal end is greater than the diameter of the seal tube 106 at the distal end of the seal tube 106.

[0125] A method for delivering a prosthetic device to a procedure site such that axial movement between the introducer 56 and the sheath 34 is eliminated is described below. Preventing gapping between the introducer 56 and the sheath 34 during insertion reduces the risk of trauma to the patient's vasculature. FIG. 4 shows the example device for delivering the prosthetic device. The method includes providing an introducer locking huh 72 having an elongated introducer 56 coupled to the introducer locking hub body 91 of the introducer locking hub 72. As described above the introducer locking hub 72 includes a locking channel 76 disposed in the introducer locking hub body 91. The sheath locking sleeve 58 is advanced to a position adjacent a distal end of the introducer locking hub 72 such that a post 74 projecting from an outer surface of the sheath locking sleeve 58 is received within the opening to the locking channel 76. Advancing the sheath locking sleeve 58 to a position adjacent the distal end of the introducer locking hub 72 also includes advancing the introducer 56 axially within the central lumen of the expandable delivery sheath 34.

[0126] The introducer locking hub 72 is then rotated in a first direction with respect to the sheath locking sleeve 58 to move the post 74 along the locking channel 76 into a locked position. In particular, moving the post 74 into the locked position includes rotating the introducer locking hub 72 to move the post 74 along a guide portion 98 of the locking channel 76 toward a locking portion 99. Further rotation of the introducer locking hub 72 directs the post 74 into the locking portion 99 of the locking channel 76, the locking portion 99 configured to securely engage the post 74 and fix the axial position of the introducer locking hub 72 with respect to the sheath locking sleeve 58. Where the locking channel 76 includes a catch 100, rotation of the introducer locking hub 72 in the first direction causes the post 74 to overcome the bias force of the catch 100 and advance the post 74 beyond the catch 100 into the locking portion 99, where the catch 100 secures the post 74 within the locking portion 99 thereby fixing the axial location of the sheath 34 with respect to the introducer 56.

[0127] The coupled sheath 34 and introducer 56 are then inserted, at least partially, into the vasculature of the patient.

[0128] Once positioned, the introducer locking hub 72 is rotated in a second, opposite, direction with respect to the sheath locking sleeve 58. Rotating the introducer locking hub 72 in the second direction causes the post 74 to slide along the locking channel 76, from the locking portion 99 toward the guide portion 98. In particular, rotating of the introducer locking hub 72 in the second direction directs the post 74 out of the locking portion 99 of the locking channel 76 and through the guide portion 98 and releases the introducer locking hub 72 from the sheath locking sleeve 58. Where the locking channel 76 includes a catch 100, rotation of the introducer locking hub 72 in the second direction causes the post 74 to overcome the bias force of the catch 100 and advance from the locking portion 99 to the guide portion 98 of the locking channel 76. As a result, the post 74 slides out of the locking channel 76 into the unlocked position.

[0129] The introducer locking hub 72 is then disengaged from the sheath locking sleeve 58 and the introducer 56 is withdrawn from the central lumen of the sheath 34. With the central lumen of the sheath 34 clear, the medical device (e.g., implant 42) is advanced through the central lumen of the sheath 34. The medical device (implant 42) is delivered to the procedure site via the central lumen of the sheath 34.

[0130] A method of securing a delivery sheath to an introducer in a device for prosthetic heart valve delivery device is disclosed herein. The method comprises providing an introducer locking hub 72 having an elongated introducer 56 coupled thereto and including a locking channel 76 disposed in the introducer locking hub body 91. The sheath locking sleeve 58 is advanced to a position adjacent a distal end of the introducer locking hub 72 such that a post 74 projecting from an outer surface of the sheath locking sleeve 58 is received within an opening of the locking channel 76. Advancing the sheath locking sleeve 58 to a position adjacent the distal end of the introducer locking hub 72 also includes advancing the introducer 56 axially within the central lumen of the expandable delivery sheath 34.

[0131] The introducer locking hub 72 is then rotated in a first direction with respect to the sheath locking sleeve 58 to move the post 74 along the locking channel 76 into the locked position. In particular, moving the post 74 into the locked position includes rotating the introducer locking hub 72 to move the post 74 along a guide portion 98 of the locking channel 76 toward a locking portion 99. Further rotation of the introducer locking hub 72 directs the post 74 into the locking portion 99 of the locking channel 76, the locking portion 99 configured to securely engage the post 74 and fix the axial position of the introducer locking hub 72 with respect to the sheath locking sleeve 58. Where the locking channel 76 includes a catch 100, rotation of the introducer locking hub 72 in the first direction causes the post 74 to overcome the bias force of the catch 100 and advance the post 74 beyond the catch 100 into the locking portion 99, where the catch 100 secures the post 74 within the locking portion 99 thereby fixing the axial location of the sheath 34 with respect to the introducer 56.

[0132] To unlock the introducer locking hub 72 from the sheath locking sleeve 58, the introducer locking hub 72 is rotated in a second, opposite, direction with respect to the sheath locking sleeve 58. Rotating the introducer locking hub 72 in the second direction causes the post 74 to side along the locking channel 76, from the locking portion 99 toward the guide portion 98. In particular, rotating of the introducer locking hub 72 in the second direction directs the post 74 out of the locking portion 99 of the locking channel 76 and through the guide portion 98 to release the introducer locking hub 72 from the sheath locking sleeve 58. Where the locking channel 76 includes a catch 100, rotation of the introducer locking hub 72 in the second direction causes the post 74 to overcome the bias force of the catch 100 and advance from the locking portion 99 to the guide portion 98 of the locking channel 76. As a result, the post 74 slides out of the locking channel 76 into the unlocked position.

[0133] The introducer locking hub 72 is then disengaged from the sheath locking sleeve 58 and the introducer 56 may be withdrawn from the central lumen of the sheath 34. Second Example Housing Assembly

[0134] FIGS. 13A-13G illustrate another embodiment of a housing assembly 1300 that may be implemented in the guide catheter 30 or other sheaths, catheters, or apparatuses herein. For example, the housing assembly 1300 may be implemented in the guide catheter 30 of, e.g., FIGS. 3-5, in place of the housing assembly 36. As illustrated, the housing assembly 1300 includes a retainer 1302, a sheath hub 1304, and a sheath locking sleeve 1306. FIG. 13E additionally depicts a seal tube or strain relief portion 1308 that may be part of a shaft or sheath (such as the shaft or sheath 34 of FIGS. 3-5 and 7A-7B) and which may be, include, be included in, or correspond to the seal tube 106 of FIGS. 4-7B. The shaft or sheath that includes the seal tube 1308 may further include a main lumen through which an introducer (such as the introducer 56), an implant catheter, or other device may be inserted, e.g., to access a target implantation site. FIG. 13E further depicts a seal stack 1310 within the sheath hub 1304 as well as an o-ring 1312 positioned to form a seal between the sheath hub 1304 and the seal tube 1308.

[0135] Each of the retainer 1302, the sheath hub 1304, the sheath locking sleeve 1306, and the seal stack 1310 may have a similar configuration and / or function as the corresponding retainer 105, sheath hub 70, sheath locking sleeve 58 and seal stack 82. In some embodiments, one or more of the foregoing components of the housing assembly 1300 may have one or more differences compared to the corresponding components of the housing assembly 36, as described elsewhere herein.

[0136] In an example, the sheath locking sleeve 1306 may include a proximal end 1314 with an outer surface 1316 and one or more posts or other protrusions 1318 extending therefrom that are similar or identical to the proximal end 78a, the proximal end outer surface78f, and the posts 74 of the sheath locking sleeve 58 of, e.g., FIGS. 12A-12F. In some embodiments, the foregoing portions of the sheath locking sleeve 1306 may be substantially identical to the corresponding portions of the sheath locking sleeve 58 as part of a common interface that may be complementary to a corresponding interface of an introducer locking hub (such as the introducer locking hub 72 of FIGS. 11 A-l IF). In this manner, any introducer locking hub with the corresponding interface may be couplable to any sheath locking sleeve with the complementary interface, such as the sheath locking sleeve 1306 or the sheath locking sleeve 58.

[0137] FIG. 13F is a cross-sectional perspective view of the housing assembly 1300 taken along cutting plane A-A in FIG. 13C. With reference to, e.g., FIGS. 13B, 13C, and 13F, the sheath locking sleeve 1306 may further include one or more features to engage with corresponding features of the sheath hub 1304 to prevent axial and / or rotational movement, similar or analogous to the interface tabs 78e of the sheath locking sleeve 58 and the recesses and / or slots 84 of the sheath hub 70. In this example, the sheath locking sleeve 1306 includes two interface tabs 1320, similar or analogous to the interface tabs 78e of the sheath locking sleeve 58. The two interface tabs 1320 may be on opposite sides of the sheath locking sleeve 1306, e.g., 180 degrees angularly offset from one another. The sheath locking sleeve 1306 may have a first diameter from an outermost surface of one of the interface tabs 1320 to an outermost surface of the other interface tab 1320. The sheath locking sleeve 1306 may additionally include a circumferential flange 1321 that may have an outer diameter greater than the first diameter through the interface tabs 1320.

[0138] The sheath hub 1304 includes a body 1304A that defines two corresponding slots 1322 that each forms a cantilevered tab 1324. Each of the slots 1322 includes a portion that extends circumferentially. In particular, each slot 1322 has a generally U-shaped configuration where the bottom of the “U” shape extends circumferentially, while the two sides of the “U” shape extend axially. A distal end of each cantilevered tab 1324 may include a protrusion 1324A that protrudes radially inward. An inner diameter of the sheath hub 1304 between innermost surfaces of the protrusions 1324A of the tabs 1324 may be a second diameter when the tabs 1324 are in an unflexed state. The second diameter of the sheath hub 1304 may be smaller than the first diameter of the sheath locking sleeve 1306. A proximal surface of the protrusions 1324 may be ramped to facilitate smooth insertion of the sheath locking sleeve 1306 proximally past the interface tabs 1320 while a distal surface of the protrusions 1324 may be parallel to a proximal surface of the interface tabs 1320 for engagement between the protrusions 1324 and the interface tabs 1320 to inhibit relative axial movement between the sheath locking sleeve 1306 and the sheath hub 1304.

[0139] During assembly of the sheath locking sleeve 1306 to the sheath hub 1304, the interface tab 1320 of the sheath locking sleeve 1306 may be circumferentially aligned to the cantilevered tab 1324 of the sheath hub 1304. The sheath locking sleeve 1306 may then be inserted into a proximal end 1326 of the sheath hub 1304. As the interface tabs 1320 pass under the tabs 1324, the greater first diameter through the interface tabs 1320 compared to the second diameter between the protrusions 1324A of the tabs 1324 in the unflexed state may cause the tabs 1324 to flex outward. When the interface tabs 1320 clear the protrusions 1324A of the tabs 1324, i.e., when the interface tabs 1320 reach the circumferentially extending portion of the slots 1322 such that they are distally disposed relative to the protrusions 1324A of the tabs 1324 and extend partially into the circumferentially extending portions of the slots 1322, the tabs 1324 may return to their unflexed state. In this relative arrangement of the sheath locking sleeve 1306 and the sheath hub 1304, a distal surface 1321 A (FIG. 13E) of the flange 1321 of the sheath locking sleeve 1306 may abut a proximal surface 1326A (FIG. 13E) of the proximal end 1326 of the sheath hub 1304 to inhibit further axial movement of the sheath locking sleeve 1306 relative to the sheath hub 1304 in the insertion direction. In their unflexed state, the distal surfaces of the inwardly extending protrusions 1324A at distal ends of the tabs 1324 urge against or at least abut or are proximate to the proximal surfaces of the interface tabs 1320 to retain the sheath locking sleeve 1306 coupled to the sheath hub 1304 and inhibit axial movement of the sheath locking sleeve 1306 relative to the sheath hub 1304 in a removal direction. In addition, the circumferential extent of the circumferentially extending portions of the slots 1322 may be complementary to (e.g., slightly bigger than) the circumferential extent of the interface tabs 1320 to inhibit rotational movement between the sheath hub 1304 and the sheath locking sleeve 1306. To remove the sheath locking sleeve 1306 from the sheath hub 1304, a removal force may be applied to the sheath locking sleeve 1306 (in the proximal direction) and / or to the sheath hub 1304 (in the distal direction), optionally while prying distal ends of the tabs 1324 of the sheath hub 1304 outward. With a sufficiently large removal force, a bias of the tabs 1324 may be overcome to the point that they flex outward to disengage the interface tabs 1324 and thereby permit removal of the sheath locking sleeve 1306 from the sheath hub 1304. FIG. 14 illustrates the sheath hub 1304 and FIGS. 15A-15B illustrate the retainer 1302. Referring to FIGS. 13A-15B, the retainer 1302 may be configured to mate with the sheath hub 1304 to secure therebetween the seal tube 1308. The o-ring 1312 may be positioned between the seal tube 1308 and the sheath hub 1304 to form a seal between the seal tube 1308 and the sheath hub 1304. While the retainer 1302 and the sheath hub 1304 are configured to be coupled together, similar to the retainer 105 and the sheath hub 70 of, e.g., FIG. 8, the coupling between the retainer 1302 and the sheath hub 1304 is different than that between the retainer 105 and the sheath hub 70. In particular, while the retainer 105 and the sheath hub 70 are threadably coupled, the retainer 1302 and the sheath hub 1304 have a twist lock coupling configuration, similar or analogous to the twist lock coupling configuration between the sheath locking sleeve 58, 1306 and the introducer locking hub 72 or other introducer locking hub.

[0140] Referring to FIGS. 13E and 14, the sheath hub 1304 includes, moving in a distal direction, a circumferential flange 1328, one or more posts or protrusions 1330, a shoulder 1332, and a frustoconical distal end 1334. Referring to FIGS. 13E and 15A-15B, the retainer 1302 includes a frustoconical distal end 1336, an intermediate segment 1338, a circumferential flange 1340, and a collar 1342 that extends proximally from the flange 1340. The retainer 1302 defines one or more locking channels 1344 that cooperate with the one or more posts 1330 of the sheath hub 1304 to couple the retainer 1302 and the sheath hub 1304 together in a twist lock configuration.

[0141] In more detail, each locking channel 1344 passes at least partially through the flange 1340 and the intermediate segment 1338 of the retainer 1302. Each locking channel

[0142] 1344 includes an opening that leads to an angled guide portion 1345 that transitions to a locking portion 1346. The guide portion 1345 is configured to direct the post 1330 of the sheath hub 1304 in an axial and circumferential direction along a side wall of the guide portion 1345 towards the locking portion 1346 upon rotation of the retainer 1302 and / or the sheath hub 1304 relative to one another in a locking direction. The locking portion 1346 is configured to securely engage the post 1330, fixing the axial position of the retainer 1302 with respect to the sheath hub 1304. As illustrated in FIG. 15 A, the guide portion

[0143] 1345 of the locking channel 1344 extends from the proximal end of the intermediate segment 1338 of the retainer 1302 primarily axially towards the distal end 1336 of the retainer 1302, although the guide portion 1345 may also extend circumferentially. The locking portion 1346 extends from the guide portion 1345 primarily circumferentially around a portion of the intermediate segment 1338 of the retainer 1302, although the locking portion 1346 may also extend axially towards the distal end 1336 of the retainer 1302. In this and other embodiments, the guide portion 1345 and / or the locking portion 1346 of the locking channel 1344 may be described as extending helically around / along a length of the retainer 1302 or on an angle from the proximal end of the intermediate segment 1338 of the retainer 1302. The locking channel 1344 may terminate at a detent 1348 (e.g., an indent, depression, recess, or the like) that, in some examples, extends proximally from the locking portion 1346.

[0144] As illustrated in FIGS. 13 A, 13C, 13D, and 15 A, the locking portion 1346 of the locking channel 1344 extends at an angle from the end of the guide portion 1345. In some examples, the angle between a centerline of the guide portion 1345 and a centerline of the locking portion 1346 is 90 degrees or greater. In an example system, the locking portion 1346 extends around a portion of the circumference of the retainer 1302. The locking portion 1346 may extend parallel to or angled relative to the flange 1340. In an example system, the length of the guide portion 1345 (measured along its centerline) is less than a length of the locking portion 1346 (measured along its centerline). In another example, the length of the guide portion 1345 equals or is greater than a length of the locking portion 1346.

[0145] With reference again to FIGS. 13E and 14, the o-ring 1312 may be positioned against the shoulder 1332 of the sheath hub 1304 which may inhibit axial movement of the o-ring 1312 when the seal tube 1308 is assembled to the housing assembly 1300. For example, the o-ring 1312 may be advanced over the distal end 1334 of the sheath hub 1304 to the shoulder 1332. The seal tube 1308 may then be advanced proximally over the distal end 1334 of the sheath hub 1304 and the o-ring 1312. The seal tube 1308 may be somewhat tight around the o-ring 1312 which may have a tendency to push the o-ring 1312 proximally as the seal tube 1308 advances. However, the shoulder 1332 may prevent, or at least inhibit, the o-ring 1312 from advancing proximally beyond the shoulder 1332 as the seal tube 1308 is advanced proximally.

[0146] As illustrated in FIG. 14, the sheath hub 1304 may include one or more longitudinal channels 1350 between the flange 1328 and the distal end 1334. One or more of the longitudinal channels 1350 may be configured to receive therein one or more inwardly directed tabs or other protrusions (not illustrated in FIG. 14) of the seal tube 1308. The presence of the one or more inwardly directed tabs or other protrusions of the seal tube 1308 within the one or more longitudinal channels 1350 of the sheath hub 1304 may inhibit rotational movement of the seal tube 1308 relative to the sheath hub 1304 when the seal tube 1308 is assembled together with the housing assembly 1300.

[0147] As further illustrated in FIG. 14, the flange 1328 may include one or more cantilevered beams 1352 that extend circumferentially from a base connection 1354 to the flange 1328. FIG. 13G includes a cross-sectional view of the housing assembly 1300 along a plane that passes through one of the cantilevered beams 1352. The cantilever configuration of the cantilevered beam 1352 may permit the cantilevered beam 1352 to flex, e.g., distally and / or proximally, relative to the rest of the flange 1328. Referring to at least FIGS. 13G-14, an end of each cantilevered beam 1352 may include a distally-directed protrusion 1356 configured to engage a corresponding opening 1358 in the retainer 1302 to inhibit rotational movement of the retainer 1302 relative to the sheath hub 1304 when the two are assembled together. The opening 1358 may generally be or include any negative space feature, such as a hole (e.g., a snap lock hole), a cavity, a recess, a dimple, a depression, an indent, or the like.

[0148] In more detail, the retainer 1302 may include one or more openings 1358 defined in the flange 1340. At least one of the openings 1358 may be angularly offset from at least one of the detents 1348 of the retainer 1302 by a same (or approximately same) amount as the angular offset between at least one of the posts 1330 and at least one of the protrusions 1356 of the sheath hub 1304. In this manner, when the post 1330 is seated in the detent 1348, the protrusion 1356 at the end of the cantilevered beam 1352 may be rotationally aligned to and extend distally into the opening 1358.

[0149] A method of securing a retainer to a sheath hub is disclosed herein. The method may include providing the sheath hub 1304 with, e.g., flange 1328, cantilevered beams 1352 with distally-directed protrusions 1356, posts 1330, shoulder 1332, and frustoconical distal end 1334; providing the retainer 1302 with frustoconical distal end 1336, intermediate segment 1338 and flange 1340 with locking channels 1344 and openings 1358 formed therein, and collar 1342; and providing the o-ring 1312 and the seal tube 1308. The o-ring 1312 may be seated on the frustoconical distal end 1334 of the sheath hub 1304 against the shoulder 1332 and the seal tube 1308 may be advanced proximally over the frustoconical distal end 1334 of the sheath hub and the o-ring 1312 generally until a frustoconical portion 1360 of the seal tube 1308 (which is complementary to the frustoconical distal end 1334 of the sheath hub 1304) abuts the frustoconical distal end 1334 of the sheath huh 1304. The retainer 1302 is then advanced proximally along the seal tube 1308 and the sheath hub 1304 and rotated relative to the sheath hub 1304 until the posts 1330 are rotationally aligned to openings of the locking channels 1344 (if not already rotationally aligned).

[0150] With rotational alignment of the openings of the locking channels 1344 of the retainer 1302 relative to the posts 1330 of the sheath hub 1304, the retainer 1302 may continue its generally proximal advancement relative to the seal tube 1308 and the sheath hub 1304 as the posts 1330 pass into and through the guide portion 1345 of the locking channels 1344 to a beginning of the locking portions 1346. With the posts 1330 at the beginning of the locking portions 1346, the retainer 1302 may then be rotated relative to the sheath hub 1304 until the posts 1330 are seated in the detents 1348 and the flange 1328 of the sheath hub 1304 is encircled by the collar 1342 of the retainer 1302. An angle of the locking portions 1346 of the retainer 1302 in cooperation with the posts 1330 may urge the retainer 1302 proximally relative to the sheath hub 1304 as the retainer 1302 is rotated in a locking direction around the sheath hub 1304.

[0151] Advancing the retainer 1302 until the posts 1330 are at the beginning of the locking portions 1346 may alternatively or additionally position the cantilevered beams 1352 (FIG. 14) of the sheath hub 1304 against or at least proximate to the flange 1340 of the retainer 1302. For example, the protrusions 1356 of the cantilevered beams 1352 may abut the proximal surface of the flange 1340 of the retainer 1302. As already described, the rotation of the retainer 1302 in the locking direction around the sheath hub 1304 may cause the retainer 1302 to be urged proximally relative to the sheath hub 1304 due to the angle of the locking portions 1346 of the retainer 1302. As the retainer 1302 advances proximally relative to the sheath hub 1304 while being rotated in the locking direction, the protrusions 1356 may also be urged proximally by the proximal surface of the flange 1340 of the retainer 1302, with the cantilever nature of the cantilevered beams 1352 permitting the cantilevered beams 1352 to flex proximally as the retainer 1302 advances proximally. Rotation of the retainer 1302 in the locking direction continues until the distally-directed protrusions 1356 reach the openings 1358 (the posts 1330 also reaching the detents 1348 at this point where the angular offset between the posts and the protrusions 1356 matches the angular offset between the detents 1348 and the openings 1358). The openings 1358 remove (or at least reduce) the proximal urging of the proximal surface of the flange 1340 of the retainer 1302 against the protrusions 1356, permitting the cantilevered beams 1352 to return to (or at least towards) their unflexed state with the protrusions 1356 extending distally into the openings 1358. The protrusions 1356 may engage the openings 1358 to inhibit rotational movement of the retainer 1302 relative to the sheath hub 1304 as any attempt to “unlock” the retainer 1302 from the sheath hub 1304 (i.e., rotate the retainer 1302 relative to the sheath hub 1304 in the opposite direction from the locking direction) will have to be sufficient to flex the cantilevered beams 1352 sufficiently to force the protrusions 1356 out of the openings 1358.

[0152] In some embodiments, the frustoconical distal end 1336 of the retainer 1302 may have an inner diameter that is complementary to an outer diameter of the frustoconical portion 1360 of the seal tube 1308. The relative sizes of two or more of the frustoconical distal end 1334 of the sheath hub 1304, the frustoconical portion 1360 of the seal tube 1308, and / or the frustoconical distal end 1336 of the retainer 1302 may be arranged such that the frustoconical distal end 1336 of the retainer 1302 abuts and is already at least somewhat tight to the frustoconical portion 1360 of the seal tube 1308 before the retainer 1302 is fully rotated to seat the posts 1330 in the detents 1348 and / or such that the frustoconical portion 1360 of the seal tube 1308 is already somewhat tight to the frustoconical distal end 1334 of the sheath hub 1304 before the retainer 1302 is fully rotated to seat the posts 1330 in the detents 1348. In this manner, rotating the retainer 1302 such that the posts 1330 travel from the beginning of the locking portion 1346 to the detents 1348 while the slope of the locking portion 1346 interacting with the posts 1330 urges the retainer 1302 proximally relative to the sheath hub 1304 may further tighten the frustoconical distal end 1336 of the retainer 1302 against the frustoconical portion 1360 of the seal tube 1308 and / or the frustoconical portion 1360 of the seal tube 1308 against the frustoconical distal end 1334 of the sheath hub 1304. Alternatively or additionally, positioning the posts 1330 in the detents 1348 may inhibit axial movement of the retainer 1302 relative to the sheath hub 1304 and the seal tube 1308.

[0153] To unlock the retainer 1302 from the sheath hub 1304, the retainer 1302 is rotated relative to the sheath hub 1304 in an unlocking direction that is opposite to the locking direction. Rotating the retainer 1302 in the second direction forces the posts 1330 out of the detents 1348 and along the locking channels 1344. In particular, rotating the retainer 1302 in the unlocking direction directs the posts 1330 out of the detents 1348 ofthe locking channels 1344 and through the locking portions 1346 and the guide portions 1345 to release the retainer 1302 from the sheath hub 1304. Where the locking channels 1344 include detents 1348, rotation of the retainer 1302 in the unlocking direction causes the posts 1330 to overcome the bias force of the detents 1348 and advance from the detents 1348 through the locking portions 1346 and the guide portions 1345 of the locking channels 1344. As a result, the posts 1330 slide out of the locking channels 1344 and the retainer 1302 may be removed from the sheath hub 1304. The retainer 1302 may then be removed from the seal tube 1308 and / or the seal tube 1308 may be removed from the sheath hub 1304.

[0154] Referring to FIG. 13E, the seal stack 1310 may include a cross-slit valve 1310A, a spacer 1310B, and a fluid seal 1310C. Additional details regarding example aspects of the seal stack 1310 are provided elsewhere herein.

[0155] Although not required, the sheath hub 1304 or other component of the housing assembly 1300 may include a flush port 1362 (FIGS. 13A-14). The flush port 1362 may include a flush lumen coupled to a lumen of the sheath hub 1304 and / or may be used in an aspirate and / or flush step of a procedure.

[0156] Third Example Housing Assembly

[0157] FIGS. 16A-16E illustrate another embodiment of a housing assembly 1600 that may be implemented in the guide catheter 30 or other sheaths, catheters, or apparatuses herein. For example, the housing assembly 1600 may be implemented in the guide catheter 30 of, e.g., FIGS. 3-5, in place of the housing assembly 36 and / or the housing assembly 1300. As illustrated, the housing assembly 1600 includes a retainer 1602, a sheath hub 1604, and a sheath locking sleeve 1606. FIGS. 16A-16E additionally depict a proximal sleeve 1608, a seal stack 1610 (FIG. 16D), an o-ring 1612 (FIGS. 16D-16E), and an introducer locking hub 1614.

[0158] The proximal sleeve 1608 may be part of a shaft or sheath (such as the shaft or sheath 34 of FIGS. 3-5 and 7A-7B) and may be, include, be included in, or correspond to the seal tube 106 of FIGS. 4-7B or other component of a shaft or sheath. The shaft or sheath that includes the proximal sleeve 1608 may further include a main lumen through which an introducer (such as the introducer 56), an implant catheter, or other device may be inserted, e.g., to access a target implantation site.

[0159] The seal stack 1610 may be, include, be included in, or correspond to other seal stacks herein and may include a cross-slit valve 1610A, a spacer 1610B, and a fluid seal 1610C. Additional details regarding example aspects of the seal stack 1610 are provided elsewhere herein. The o-ring 1612 may be, include, be included in, or correspond to other seals herein, such as the o-ring 1312 of FIG. 13E.

[0160] The introducer locking hub 1614 may be, include, be included in, or correspond to other introducer locking hubs herein, such as the introducer locking hub 72 of, e.g., FIGS. 4 and 6-8.

[0161] Each of the retainer 1602, the sheath hub 1604, the sheath locking sleeve 1606, and the seal stack 1610 may have a similar configuration and / or function as the corresponding retainer 105, 1302, sheath hub 70, 1304, sheath locking sleeve 58, 1306, and seal stack 82, 1310 described elsewhere herein. In some embodiments, one or more of the foregoing components of the housing assembly 1600 may have one or more differences compared to the corresponding components of the housing assembly 36, 1300 as described below.

[0162] In an example, the sheath locking sleeve 1606 may have a same or similar configuration as the sheath locking sleeve 1306 of FIGS. 13A-13G. For example, and referring to FIG. 16D, the sheath locking sleeve 1606 may include a proximal end 1616 having an outer surface 1606 A with one or more posts or protrusions 1618 extending radially outward therefrom. The posts 1618 may engage corresponding locking channels 1620 formed in the introducer locking hub 1614 to couple the sheath locking sleeve 1606 to the introducer locking hub 1614 in a twist lock configuration, as described with respect to the sheath locking sleeve 1306 of FIGS. 13A-13G. Alternatively or additionally, the sheath locking sleeve 1606 may mate with the sheath hub 1604 in a same, similar, or different configuration compared to other sheath locking sleeves and sheath hubs described herein, such as the sheath locking sleeves 58, 1306 and sheath hubs 70, 1304.

[0163] Referring to FIGS. 16D- 16E, the retainer 1602 may be configured to mate with the sheath hub 1604 to secure therebetween the proximal sleeve 1608 (which in turn may be coupled to and / or included as part of a sheath or shaft). The o-ring 1612 may be positioned between the proximal sleeve 1608 and the sheath hub 1604 to form a seal between the proximal sleeve 1608 and the sheath hub 1604. While the retainer 1602 and the sheath hub 1604 are configured to be coupled together, similar to the retainer 105 and the sheath hub 70 of FIG. 8 and the retainer 1302 and sheath hub 1304 of FIGS. 13A-15B, the coupling between the retainer 1602 and the sheath hub 1604 is different than that between the retainer 105 and the sheath hub 70 or between the retainer 1302 and the sheath hub 1304. In particular, while the retainer 105 and the sheath hub 70 are threadably coupled and the retainer 1302 and the sheath hub 1304 have a twist lock coupling configuration, the retainer 1602 and the sheath hub 1604 have a clamshell coupling configuration.

[0164] With continued reference to FIGS. 16D-16E, the sheath hub 1604 includes, generally moving in a distal direction, a segment 1624, one or more alignment ribs 1626, an axial retention flange 1628, a circumferential channel 1630, and a frustoconical distal end 1632. The alignment ribs 1626 extend radially outward from the segment 1624 and in an axial direction and are configured to mate with corresponding features in the retainer 1602 to inhibit rotational movement between the sheath hub 1604 and the retainer 1602. The flange 1628 extends radially outward from and circumferentially around the segment 1624 while channel 1630 is formed radially inward in the segment 1624.

[0165] Although not required, the sheath hub 1604 or other component of the housing assembly 1600 may include a flush port 1633. The flush port 1633 may include a flush lumen coupled to a lumen of the sheath hub 1604 and / or may be used in an aspirate and / or flush step of a procedure.

[0166] The proximal sleeve 1608 includes a proximal skirt 1634 with one or more alignment ribs 1636 extending radially outward therefrom. The alignment ribs 1636 also extend in an axial direction and are configured to mate with corresponding features in the retainer 1602 to prevent rotational movement between the proximal sleeve 1608 and the retainer 1602.

[0167] The retainer 1602 includes two or more clamshell portions 1638 A, 1638 A (collectively or generically clamshell portion(s) 1638) selectively couplable to each other to couple the proximal sleeve 1608 (and more generally a sheath) to the sheath hub 1604. Each clamshell portion 1638 may include two or more energy directors and / or energy acceptors 1640A, 1640B (collectively or generically energy director(s) / acceptor(s) 1640), a semi-circumferential channel 1642, a shoulder 1644, and one or more longitudinal channels 1646.

[0168] While interior features (such as energy directors / acceptors 1640, semi- circumferential channel 1642, shoulder 1644, and longitudinal channel 1646) of the clamshell portion 1638A are not visible in FIG. 16E, in some embodiments, the clamshell portion 1638 A (including its interior features) may be identical or similar to the clamshell portion 1638B. If the two clamshell portions 1638 are identical to each other (within manufacturing tolerances), this may simplify manufacturing by using two instances of the same component (rather than two different components) to form the retainer 1602. The energy directors / acceptors 1640 may alternatively or additionally be referred to as shell engagement features and may include energy directors 1640 A and energy acceptors 1640B. In particular, the energy directors 1640A each includes a protrusion that extends from the corresponding clamshell portion 1638 while the energy acceptors 1640B each includes an opening defined in the corresponding clamshell portion 1638. Each energy director 1640A of the clamshell portion 1638B may be configured to be received in a corresponding energy acceptor 1640B of the clamshell portion 1638 A, while each energy acceptor 1640B of the clamshell portion 1638B may be configured to receive therein a corresponding energy director 1640A of the clamshell portion 1638 A. Each energy director 1640 A may have an interference fit or other fit with the corresponding energy acceptor 1640B. FIG. 16E depicts the clamshell portion 1638B having both energy directors 1640 A and energy acceptors 1640B, in which case the clamshell portion 1638 A may have complementary energy acceptors 1640B and energy directors 1640 A so the two clamshell portions 1638 may be coupled together. In another example, one of the clamshell portions 1638 may have only energy directors 1640A while the other clamshell portion 1638 has only energy acceptors 1640B. Moreover, while FIG. 16E depicts the clamshell portion 1638B as having one row of only energy directors 1640 A and another row on an opposite side of the clamshell portion 1638B of only energy acceptors 1640B, in another example, each row may include a mix of one or more energy directors 1640A and one or more energy acceptors 1640B provided the clamshell portion 1638 A has complementary rows of energy directors 1640A and energy acceptors 1640B.

[0169] When the two clamshell portions 1638 are coupled together, the two semi- circumferential channels 1642 (one in each clamshell portion 1638) align with each other and form a single circumferential channel. Similarly, when the two clamshell portions 1638 are coupled together, the two shoulders 1644 (one in each clamshell portion 1638) align with each other and form a single circumferential shoulder.

[0170] As depicted in FIG. 16D, when the retainer 1602 is coupled to the sheath hub 1604, the flange 1628 extending from the segment 1624 of the sheath hub 1604 extends into and is seated within the circumferential channel formed by the combination of the two semi- circumferential channels 1642 of the clamshell portions 1638. The flange 1628 of the sheath hub 1604 engages the circumferential channel (made up of semi-circumferential channels 1642) of the retainer 1602 to prevent, or at least inhibit, relative axial movement between the retainer 1602 and the sheath hub 1604. Tn addition, and referring to FTG. 16E, when the retainer 1602 is coupled to the sheath hub 1604, the alignment ribs 1626 extend into and / or are seated within the corresponding longitudinal channels 1646. The alignment ribs 1626 of the sheath hub 1604 engage the longitudinal channels 1646 of the retainer 1602 to prevent, or at least inhibit, relative rotational or angular movement between the retainer 1602 and the sheath hub 1604.

[0171] During assembly and / or coupling of the proximal sleeve 1608 to the housing assembly 1600, the o-ring 1612 may be positioned in the channel 1630 formed in the segment 1624 of the sheath hub 1604 which may inhibit axial movement of the o-ring 1612 when the proximal sleeve 1608 is assembled to the housing assembly 1600. For example, the o-ring 1612 may be advanced over the distal end 1632 and a distal end of the segment 1624 into the channel 1630. The o-ring 1612 may include an elastic or resilient material so as to expand when advanced over the distal end of the segment 1624 (which may have a larger diameter to the distal and proximal sides of the channel 1630 than at the channel 1630 itself) before contracting back towards an unexpanded size when seated within the channel 1630. The proximal sleeve 1608 may then be advanced proximally over the distal end 1632 of the sheath hub 1604 and the o-ring 1612 until a proximal end of the skirt 1634 of the proximal sleeve 1608 reaches the flange 1628 of the sheath hub 1604. The skirt 1634 of the proximal sleeve 1608 may be somewhat tight around the o-ring 1612 which may have a tendency to push the o-ring 1612 proximally as the proximal sleeve 1608 advances proximally relative to the sheath hub 1604. However, the channel 1630 may prevent, or at least inhibit, the o-ring 1612 from advancing proximally beyond the channel 1630 as the proximal sleeve 1608 is advanced proximally to the flange 1628.

[0172] A method of securing a retainer to a sheath hub is disclosed herein. The method may include providing the sheath hub 1604 with, e.g., alignment ribs 1626, flange 1628, channel 1630, and frustoconical distal end 1632; providing the retainer 1602 with clamshell portions 1638 having energy directors / acceptors 1640, semi-circumferential channels 1642, shoulders 1644, and longitudinal channels 1646; and providing the o-ring 1612 and the proximal sleeve 1608. The o-ring 1612 may be placed on the frustoconical distal end 1632 of the sheath hub 1604 and advanced proximally to the channel 1630 and the proximal sleeve 1608 may be advanced proximally over the frustoconical distal end 1632 of the sheath hub 1604 and the o-ring 1612 generally until a frustoconical portion 1648 of the proximal sleeve 1608 (FIG. 16D) (which is complementary to the frustoconical distal end 1632 of the sheath hub 1604) abuts the frustoconical distal end 1632 of the sheath hub 1604. The proximal sleeve 1608 may be rotated relative to the sheath hub 1604 to align the alignment ribs 1636 of the proximal sleeve 1608 to the alignment ribs 1626 of the sheath hub 1604, if not already aligned. The two clamshell portions 1638 of the retainer 1602 may then each be positioned on opposite sides of the sheath hub 1604 to receive one of the alignment ribs 1626 and a portion of the flange 1628 of the sheath hub 1604 respectively into the longitudinal channel 1646 and the semi-circumferential channel 1642. With the alignment ribs 1636 of the proximal sleeve 1608 aligned to the alignment ribs 1626 of the sheath hub 1604, the foregoing positioning of the clamshell portions 1638 of the retainer 1602 relative to the sheath hub 1604 also results in the alignment ribs 1636 of the proximal sleeve 1608 being received into a proximal portion of the longitudinal channels 1646 (e.g., a portion of the longitudinal channels 1646 that is proximal to the semi-circumferential channels 1642) of the clamshell portions 1638. The foregoing positioning of the clamshell portions 1638 may also align the energy directors 1640A of the clamshell portion 1638B to the energy acceptors 1640B of the clamshell portion 1638 A and the energy acceptors 1640B of the clamshell portion 1638B to the energy directors 1640A of the clamshell portion 1638 A. The two clamshell portions 1638 may then be squeezed together around the sheath hub 1604 and the proximal sleeve 1608 until the energy directors 1640 A of each clamshell portion 1638 are received into the energy acceptors 1640B of the corresponding clamshell portion 1638 to couple the two clamshell portions 1638 together. The two clamshell portions 1638 may also be ultrasonically welded together after being coupled together by the energy directors / acceptors 1640. For example, in some embodiments, the two clamshell portions 1638 may be ultrasonically welded together specifically at coupled pairs of one energy director 1640A and one energy acceptor 1640B. After the two clamshell portions 1638 are coupled together (before or after being ultrasonically welded together), and as illustrated in FIG. 16D, the single circumferential shoulder (made up of the two shoulders 1644 of the two clamshell portions 1638) of the retainer 1602 abuts a distal end of the skirt 1634 of the proximal sleeve 1608 to prevent, or at least inhibit, axial movement of the proximal sleeve 1608 relative to the housing assembly 1600.

[0173] Fourth Example Housing Assembly

[0174] FIGS. 17A-17H illustrate another embodiment of a housing assembly 1700 that may be implemented in the guide catheter 30 or other sheaths, catheters, or apparatuses herein. For example, the housing assembly 1700 may be implemented in the guide catheter 30 of, e.g., FIGS. 3-5, in place of the housing assembly 36, the housing assembly 1300, and / or the housing assembly 1600. As illustrated, the housing assembly 1700 includes a retainer 1702, a sheath hub 1704, and a sheath locking sleeve 1706. FIGS. 17A-17E additionally depict a proximal sleeve 1708, a seal stack 1710 (FIGS. 17G-17H), and an o- ring 1712 (FIGS. 17G-17H).

[0175] The proximal sleeve 1708 may be part of a shaft or sheath (such as the shaft or sheath 34 of FIGS. 3-5 and 7A-7B) and may be, include, be included in, or correspond to the seal tube 106 of FIGS. 4-7B or other component of a shaft or sheath. The shaft or sheath that includes the proximal sleeve 1708 may further include a main lumen through which an introducer (such as the introducer 56), an implant catheter, or other device may be inserted, e.g., to access a target implantation site.

[0176] The seal stack 1710 may be, include, be included in, or correspond to other seal stacks herein and may include a cross-slit valve 1710A, a spacer 1710B, and a fluid seal 1710C. Additional details regarding example aspects of the seal stack 1710 are provided elsewhere herein.

[0177] The o-ring 1712 may be, include, be included in, or correspond to other seals herein, such as the o-ring 1312 of FIG. 13E.

[0178] Each of the retainer 1702, the sheath hub 1704, the sheath locking sleeve 1706, and the seal stack 1710 may have a similar configuration and / or function as the corresponding retainer 105, 1302, 1602 sheath hub 70, 1304, 1604 sheath locking sleeve 58, 1306, 1606 and seal stack 82, 1310, 1610 described elsewhere herein. In some embodiments, one or more of the foregoing components of the housing assembly 1700 may have one or more differences compared to the corresponding components of the housing assembly 36, 1300, 1600 as described below.

[0179] In an example, the sheath locking sleeve 1706 may have a same or similar configuration as the sheath locking sleeve 1306 of FIGS. 13A-13G. For example, and referring to FIGS. 17G-17H, the sheath locking sleeve 1706 may include a proximal end 1716 having an outer surface 1706 A with one or more posts or protrusions 1718 extending radially outward therefrom. The posts 1718 may engage corresponding locking channels (such as locking channels 1620 of FIG. 16D) formed in an introducer locking hub (such as the introducer locking hub 1614 of FIGS. 16A-16E) to couple the sheath locking sleeve 1706 to the introducer locking hub in a twist lock configuration, e.g., as described with respect to the sheath locking sleeve 1306 of FIGS. 13A-13G.

[0180] Referring to FIGS. 17F-17H, the sheath locking sleeve 1706 may include a distal end 1750 having an outer surface 1706B with one or more interference ridges 1752 extending radially outward therefrom. Only some of the interference ridges 1752 are labeled in FIGS. 17F-17H for simplicity. Each of the interference ridges 1752 may extend axially along the outer surface 1706B of the distal end 1750. When the distal end 1750 of the sheath locking sleeve 1706 is fully inserted into a proximal end 1754 of the sheath hub 1704, the interference ridges 1752 may form an interference fit with an inner surface 1704A of the proximal end 1754 of the sheath hub 1704.

[0181] In some embodiments, and referring to FIGS. 17G-17H, the sheath locking sleeve 1706 may include a circumferential flange 1756 extending radially outward from the sheath locking sleeve 1706 between the proximal end 1716 and the distal end 1750. The circumferential flange 1756 may act as a stop to prevent, or at least inhibit, the distal end 1750 of the sheath locking sleeve 1706 from being inserted beyond a desired depth into the proximal end 1754 of the sheath hub 1704.

[0182] With continued reference to FIGS. 17G-17H, in some embodiments, a cylindrical ridge 1758 may extend distally from the circumferential flange 1756 of the sheath locking sleeve 1706. The proximal end 1754 of the sheath hub 1704 may define a cylindrical channel 1760 (FIG. 17G) having a complementary shape to that of the cylindrical ridge 1758 and may be configured to receive therein the cylindrical ridge 1758. In some embodiments, the locations of the cylindrical ridge 1758 and the cylindrical channel 1760 may be reversed, e.g., the cylindrical ridge 1758 may extend from the sheath hub 1704 while the cylindrical channel 1760 may be formed in the sheath locking sleeve 1706. The cylindrical ridge 1758 of the sheath locking sleeve 1706 and the cylindrical channel 1760 of the sheath hub 1704 may cooperate to prevent or inhibit relative movement between the sheath locking sleeve 1706 and the sheath hub 1704 in a plane perpendicular to an axis 1762 (FIG. 17G) of the housing assembly 1700.

[0183] Alternatively or additionally, the sheath locking sleeve 1706 and / or the sheath hub 1704 may include one or more features to prevent or inhibit relative rotational movement between the sheath locking sleeve 1706 and the sheath hub 1704. For example, and referring to FIGS. 17D and 17H, the sheath locking sleeve 1706 may include one or more alignment tabs 1764 that each extends radially outward from the cylindrical ridge 1758 and / or proximally from the circumferential flange 1756, while the proximal end 1754 of the sheath hub 1704 may define one or more complementary alignment channels 1766. Each alignment tab 1764 of the sheath locking sleeve 1706 may be configured to be received within a corresponding one of the alignment channels 1766 of the sheath hub 1704. The one or more alignment tabs 1764 of the sheath locking sleeve 1706 and the one or more complementary alignment channels 1766 of the sheath hub 1704 may cooperate to prevent or inhibit relative rotational movement between the sheath locking sleeve 1706 and the sheath hub 1704.

[0184] In some embodiments, the cylindrical ridge 1758 of the sheath locking sleeve 1706 is an energy director and the cylindrical channel 1760 of the sheath hub 1704 is an energy acceptor. In this and other embodiments, the sheath locking sleeve 1706 and the sheath hub 1704 may be pressed together with the cylindrical ridge 1758 being inserted into the cylindrical channel 1760, i.e., such that the energy director is received into the energy acceptor, followed by ultrasonically welding the sheath locking sleeve 1706 and the sheath hub 1704 together.

[0185] The retainer 1702 may be configured to mate with the sheath hub 1704 to secure therebetween the proximal sleeve 1708 (which in turn may be coupled to and / or included as part of a sheath or shaft) in the same or similar manner as in FIGS. 16A-16E, or in some other manner. For example, the o-ring 1712 may be positioned between the proximal sleeve 1708 and the sheath hub 1704 to form a seal between the proximal sleeve 1708 and the sheath hub 1704. The retainer 1702 and the sheath hub 1704 have a clamshell coupling configuration, similar to the retainer 1602 and the sheath hub 1604 of FIGS. 16A-16E.

[0186] Referring to FIGS. 17G-17H, the sheath hub 1704 includes, generally moving in a distal direction, a segment 1724, one or more alignment ribs 1726, an axial retention flange 1728, a circumferential channel 1730, and a frustoconical distal end 1732. The alignment ribs 1726 extend radially outward from the segment 1724 and in an axial direction and are configured to mate with corresponding features in the retainer 1702 to inhibit rotational movement between the sheath hub 1704 and the retainer 1702. The flange 1728 extends radially outward from and circumferentially around the segment 1724 while channel 1730 is formed radially inward in the segment 1724.

[0187] Although not required, the sheath hub 1704 or other component of the housing assembly 1700 may include a flush port 1733. The flush port 1733 may include a flush lumen coupled to a lumen of the sheath hub 1704 and / or may be used in an aspirate and / or flush step of a procedure.

[0188] The proximal sleeve 1708 includes a proximal skirt 1734 with one or more alignment ribs 1736 extending radially outward therefrom. The alignment ribs 1736 also extend in an axial direction and are configured to mate with corresponding features in the retainer 1702 to prevent rotational movement between the proximal sleeve 1708 and the retainer 1702.

[0189] The retainer 1702 includes two or more clamshell portions 1738 A, 1738 A (collectively or generically clamshell portion(s) 1738) selectively couplable to each other to couple the proximal sleeve 1708 (and more generally a sheath) to the sheath hub 1704. The clamshell portion 1738B has been omitted from FIGS. 17D and 17E. Each clamshell portion 1738 may include two or more energy directors and / or energy acceptors 1740A, 1740B (collectively or generically energy director(s) / acceptor(s) 1740), a semi- circumferential channel 1742, a shoulder 1744, and one or more longitudinal channels 1746.

[0190] While interior features (such as energy directors / acceptors 1740, semi- circumferential channel 1742, shoulder 1744, and longitudinal channel 1746) of the clamshell portion 1738A are not visible in FIG. 17G or 17H, in some embodiments, the clamshell portion 1738A (including its interior features) may be identical or similar to the clamshell portion 1738B. If the two clamshell portions 1738 are identical to each other (within manufacturing tolerances), this may simplify manufacturing by using two instances of the same component (rather than two different components) to form the retainer 1702.

[0191] The energy directors / acceptors 1740 may alternatively or additionally be referred to as shell engagement features and may include energy directors 1740A and energy acceptors 1740B. In particular, the energy directors 1740A each includes a protrusion that extends from the corresponding clamshell portion 1738 while the energy acceptors 1740B each includes an opening defined in the corresponding clamshell portion 1738. Each energy director 1740A of the clamshell portion 1738B may be configured to be received in a corresponding energy acceptor 1740B of the clamshell portion 1738A, while each energy acceptor 1740B of the clamshell portion 1738B may be configured to receive therein a corresponding energy director 1740A of the clamshell portion 1738 A. Each energy director 1740 A may have an interference fit or other fit with the corresponding energy acceptor 1740B. FIG. 17E depicts the clamshell portion 1738B having both energy directors 1740A and energy acceptors 1740B, in which case the clamshell portion 1738A may have complementary energy acceptors 1740B and energy directors 1740 A so the two clamshell portions 1738 may be coupled together. In another example, one of the clamshell portions 1738 may have only energy directors 1740A while the other clamshell portion 1738 has only energy acceptors 1740B. Moreover, while FIG. 17H depicts the clamshell portion 1738B as having one row of only energy directors 1740 A and another row on an opposite side of the clamshell portion 1738B of only energy acceptors 1740B, in another example, each row may include a mix of one or more energy directors 1740A and one or more energy acceptors 1740B provided the clamshell portion 1738A has complementary rows of energy directors 1740 A and energy acceptors 1740B.

[0192] When the two clamshell portions 1738 are coupled together, the two semi- circumferential channels 1742 (one in each clamshell portion 1738) align with each other and form a single circumferential channel. Similarly, when the two clamshell portions 1738 are coupled together, the two shoulders 1744 (one in each clamshell portion 1738) align with each other and form a single circumferential shoulder.

[0193] As depicted in FIG. 17G, when the retainer 1702 is coupled to the sheath hub 1704, the flange 1728 extending from the segment 1724 of the sheath hub 1704 extends into and is seated within the circumferential channel formed by the combination of the two semi- circumferential channels 1742 of the clamshell portions 1738. The flange 1728 of the sheath hub 1704 engages the single circumferential channel (made up of semi- circumferential channels 1742) of the retainer 1702 to prevent, or at least inhibit, relative axial movement between the retainer 1702 and the sheath hub 1704.

[0194] In addition, and referring to FIG. 17H, when the retainer 1702 is coupled to the sheath hub 1704, the alignment ribs 1726 extend into and / or are seated within the corresponding longitudinal channels 1746. The alignment ribs 1726 of the sheath hub 1704 engage the longitudinal channels 1746 of the retainer 1702 to prevent, or at least inhibit, relative rotational or angular movement between the retainer 1702 and the sheath hub 1704.

[0195] During assembly and / or coupling of the proximal sleeve 1708 to the housing assembly 1700, the o-ring 1712 may be positioned in the channel 1730 formed in the segment 1724 of the sheath hub 1704 which may inhibit axial movement of the o-ring 1712 when the proximal sleeve 1708 is assembled to the housing assembly 1700. For example, the o-ring 1712 may be advanced over the distal end 1732 and a distal end of the segment 1724 into the channel 1730. The o-ring 1712 may include an elastic or resilient material so as to expand when advanced over the distal end of the segment 1724 (which may have a larger diameter to the distal and proximal sides of the channel 1730 than at the channel 1730 itself) before contracting back towards an unexpanded size when seated within the channel 1730. The proximal sleeve 1708 may then be advanced proximally over the distal end 1732 of the sheath hub 1704 and the o-ring 1712 until a proximal end of the skirt 1734 of the proximal sleeve 1708 reaches the flange 1728 of the sheath hub 1704. The skirt 1734 of the proximal sleeve 1708 may be somewhat tight around the o-ring 1712 which may have a tendency to push the o-ring 1712 proximally as the proximal sleeve 1708 advances proximally relative to the sheath hub 1704. However, the channel 1730 may prevent, or at least inhibit, the o-ring 1712 from advancing proximally beyond the channel 1730 as the proximal sleeve 1708 is advanced proximally to the flange 1728.

[0196] The clamshell configuration of FIGS. 17A-17H is different in some respects from that of FIGS. 16A-16E. For example, and referring to FIGS. 17D-17E and 17H, the flange 1728 of the sheath hub 1704 may include one or more dimples 1768 or other depressions or openings, while the proximal sleeve 1708 may include one or more complementary alignment posts 1770 that extend proximally from the alignment ribs 1736. During assembly, the alignment posts 1770 of the proximal sleeve 1708 may be aligned to the dimples 1768 of the sheath hub 1704 and positioned therein. The alignments posts 1770 and the dimples 1768 may cooperate to inhibit relative rotational movement between the proximal sleeve 1708 and the sheath hub 1704. Alternatively or additionally, positioning the alignments posts 1770 in the dimples 1768 may ensure the alignment ribs 1726 of the sheath hub 1704 and the alignment ribs 1736 of the proximal sleeve 1708 are aligned to the longitudinal channels 1746 of the retainer 1702 during assembly.

[0197] A method of securing a retainer to a sheath hub is disclosed herein. The method may include providing the sheath hub 1704 with, e.g., alignment ribs 1726, flange 1728, channel 1730, and frustoconical distal end 1732; providing the retainer 1702 with clamshell portions 1738 having energy directors / receivers 1740, semi-circumferential channels 1742, shoulders 1744, and longitudinal channels 1746; and providing the o-ring 1712 and the proximal sleeve 1708. The o-ring 1712 may be placed on the frustoconical distal end 1732 of the sheath hub 1704 and advanced proximally to the channel 1730 and the proximal sleeve 1708 may be advanced proximally over the frustoconical distal end 1732 of the sheath hub 1704 and the o-ring 1712 generally until a frustoconical portion 1748 of the proximal sleeve 1708 (FIG. 17D) (which is complementary to the frustoconical distal end 1732 of the sheath hub 1704) abuts the frustoconical distal end 1732 of the sheath hub 1704. The proximal sleeve 1708 may be rotated relative to the sheath hub 1704 to align and insert the alignment posts 1770 of the proximal sleeve 1708 into the dimples 1768 of the sheath hub 1704, which may serve to align the alignment ribs 1736 of the proximal sleeve 1708 to the alignment ribs 1726 of the sheath hub 1704. The two clamshell portions 1738 of the retainer 1702 may then each be positioned on opposite sides of the sheath hub 1704 to receive one of the alignment ribs 1726 and a portion of the flange 1728 of the sheath hub 1704 respectively into the longitudinal channel 1746 and the semi- circumferential channel 1742. With the alignment posts 1770 positioned in the dimples 1768 such that the alignment ribs 1736 of the proximal sleeve 1708 are aligned to the alignment ribs 1726 of the sheath hub 1704, the foregoing positioning of the clamshell portions 1738 of the retainer 1702 relative to the sheath hub 1704 also results in the alignment ribs 1736 of the proximal sleeve 1708 being received into a proximal portion of the longitudinal channels 1746 (e.g., a portion of the longitudinal channels 1746 that is proximal to the semi-circumferential channels 1742) of the clamshell portions 1738. The foregoing positioning of the clamshell portions 1738 may also align the energy directors 1740A of the clamshell portion 1738B to the energy acceptors 1740B of the clamshell portion 1738A and the energy acceptors 1740B of the clamshell portion 1738B to the energy directors 1740A of the clamshell portion 1738A. The two clamshell portions 1738 may then be squeezed together around the sheath hub 1704 and the proximal sleeve 1708 until the energy directors 1740A of each clamshell portion 1738 are received into the energy acceptors 1740B of the corresponding clamshell portion 1738 to couple the two clamshell portions 1738 together. The two clamshell portions 1738 may also be ultrasonically welded together after being coupled together by the energy directors / receivers 1740. For example, in some embodiments, the two clamshell portions 1738 may be ultrasonically welded together specifically at coupled pairs of one energy director 1740A and one energy acceptor 1740B. After the two clamshell portions 1738 are coupled together (before or after being ultrasonically welded together), and as illustrated in FIG. 17G, the single circumferential shoulder (made up of the shoulders 1744 of the two clamshell portions 1738) of the retainer 1702 abuts a distal end of the skirt 1734 of the proximal sleeve 1708 to prevent, or at least inhibit, axial movement of the proximal sleeve 1708 relative to the housing assembly 1700.

[0198] Representative Docking Station and Valve

[0199] FIG. 18A illustrates a side view of another example docking station 1810 that has a self-expandable outer frame 1811 and an inner frame 1813. FIG. 18B illustrates a top view of the docking station 1810 of FIG. 18A. FIG. 18C depicts the docking station 1810 implanted in the aortic arch of a patient’s heart. FIG. 18C also depicts a sealing skirt 1812 which is not shown in FIGS. 18A and 18B for convenience.

[0200] Referring to FIG. 18 A, the docking station 1810 may include an inner wire frame 1813 (“inner frame”) and an outer wire frame 1811 (“outer frame”) concentrically joined at an upstream junction 1814. The outer frame 1811 may include an open mesh which can include a series of cells 1815 around the circumference of the outer frame 1811, each single cell 1815 may extend the length 1818 of the outer frame 1811. The inner frame 1813 may be joined to the outer frame 1811 at apices 1816 of the cells 1815 of the outer frame 181 1 and extend toward the inside of the outer frame 1811. In some embodiments, the inner frame 1813 may include single wires extending inside the outer frame 1811 from the apex 1816 to a region 1817 inside the outer frame 1811. In these and other embodiments, the inner frame 1813 may extend along a same length or less as the outer frame 1811. Stated another way, the inner frame 1813 may not extend past the downstream end of the outer frame 1811. In some embodiments, the inner frame 1813 may include connections between the struts of the inner frame 1813. For example, a reinforcing strut or other material may connect the inner frame 1813. The cross section of the outer frame 1811 / inner frame 1813 junction 1814 may be “V-shaped” or “U-shaped.”

[0201] In some embodiments, the apices 1816 may be rounded, bulged, bulbous, or any other shape which may reduce or minimize trauma caused by the apices 1816 when interfacing with the anatomy of the patient. While such apices 1816 may not be completely atraumatic, such an embodiment may reduce the amount of damage or penetration into the tissue.

[0202] In some embodiments, the sealing skirt 1812 (FIG. 18B) may be attached to a proximal / upstream end of the docking station 1810. For example, the sealing skirt 1812 may be coupled to the docking station 1810 at the joined outer frame 1811 / inner frame 1813 and may extend from the inside end of the inner frame 1813 (e.g., the valve seat 1820) to the apices 1816, and then turn upward along the outside of the outer frame 1811. In some embodiments, the distance the sealing skirt 1812 covers the outer frame 1811 may extend a predetermined distance as desired by the user or clinician, and may typically include a short distance. For example, the distance may be selected to avoid sealing against the aortic ostia 1823a and 1823b as illustrated in FIG. 18C, and in this manner, ostium blockage may be eliminated or reduced. For example, the distance may include 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, or any range bounded by any of the foregoing values. In some embodiments, the distance may be one tenth of the length 1818 of the docking station 1810, one fifth of the length 1818, one fourth of the length 1818, one third of the length 1818, or any other distance, or any range bounded by any of the foregoing values.

[0203] In some embodiments, the docking station 1810 may be wider (e.g., have a larger diameter) than the length 1818 of the docking station 1810. In some embodiments, the relative dimensions may be described as the width relative to the length 1818. For example, in some embodiments, a ratio of the width to the length 1818 may include 1 : 1, 1.25: 1, 1.5:1, 1.75:1, 2:1, 2.5:1, 3: 1, 4:1, or any other ratio bounded by any of the foregoing values, such as between 1.25: 1 and 1.75:1.

[0204] In some embodiments, the docking station 1810 may be crimpable and may be selfexpanding. For example, the docking station 1810 may be crimped or otherwise compressed to be loaded onto a delivery catheter. When deploying the docking station 1810, the docking station 1810 may expand from its compressed state to an expanded state (e.g., self-expansion when made of nitinol or other shape-memory alloy). Additionally or alternatively, the docking station 1810 may be balloon-expandable. In some embodiments, the inner frame 1813 and / or the outer frame 1811 of the docking station 1810 may include a single cell that spans along the length 1818 of the docking station 1810, which may or may not be repeated about the entire circumference of the docking station 1810. Additionally or alternatively, the inner frame 1813 and / or the outer frame 1811 may include multiple cells along the length 1818 of the docking station 1810. In some embodiments, cells of the inner frame 181 and / or the cells 1815 of the outer frame 1811 may include reinforcing components (e.g., struts, bridges, wires, etc.) to strengthen one or more of the cells. In some embodiments, the reinforcing components may divide a given cell into multiple cells. In these and other embodiments, less than all of the cells may include the reinforcing components. For example, every other cell, every third cell, or any other configuration of cells may include the reinforcing components. Tn some embodiments, the length 1818 of the docking station 1810 may be variable. For example, a set or series of lengths may be manufactured or designed such that a clinician may select an appropriately sized docking station 1810 based on the anatomy of a given patient. In some embodiments, the length may be selected based upon a length that a clinician determines would facilitate anchoring or adequately support anchoring. Additionally or alternatively, the length may be selected based on a size and / or location of coronary ostium. For example, the length may be selected such that there may be a space within the inner frame 1813 to hold at least a section of a prosthetic valve (e.g., prosthetic valve 1808) while leaving a gap 1821 between the inner frame 1813 and the outer frame 1811 to allow for adequate blood flow into the coronary ostium.

[0205] In some embodiments, the gap 1821 between the outer frame 1811 and the inner frame 1813 may be sized to provide adequate blood flow into the coronary ostium and / or to permit subsequent procedures to be performed associated with the coronary ostium without disturbing the deployed docking station 1810. For example, the gap 1821 may be sized to allow a coronary procedure catheter to be inserted, to allow for the performance of coronary procedures without, for example, moving, removing, or otherwise disturbing the docking station 1810. For example, a coronary ablation may be performed, all or portions of a coronary bypass may be performed, or any other procedure involving the ostium may be performed.

[0206] In some embodiments, the docking station 1810 may include a sealing skirt 1812 that extends from the distal tip 1819 of the docking station 1810, rather than covering a portion along the outer frame 1811. In these and other embodiments, the sealing skirt 1812 follows and traverses the inner frame 1813 and creates a seal from the distal tip 1819 of the docking station 1810 against the anatomy of a patient. Such an embodiment may permit greater access to the ostia, which is beneficial for certain aortic procedures, while posing a potential increase in risk of failing to create an adequate seal against the anatomy.

[0207] Because there is a narrow, shorter landing zone when implanting to replace the aortic valve as compared to docking stations deployed in other locations, such as the interior vena cava, the sealing skirt 1812 may be designed to include a majority of the material of the sealing skirt 1812 along the inner frame 1813 rather than the outer frame 1811, which may keep the outer regions of the docking station 1810 accessible. The docking station 1810 with the sealing skirt 1812 may allow for both improved and facilitated anchoring of a prosthetic valve, and improved accessibility for coronary intervention.

[0208] In some embodiments, the docking station 1810 may include a flange 1825. The flange 1825 may be used to create a better seal against the anatomy of a patient. For example, the flange 1825 proximate the distal tip 1819 may contribute to creating a seal against the surrounding anatomy as well as keeping the docking station 1810 in its place. In another embodiment, the flange 1825 proximate the distal tip 1819 is used to create the proper desired seal.

[0209] In some embodiments, a foam lining (not shown) may be associated with the flange 1825. For example, between the apices 1816 and the sealing skirt 1812 the foam lining may provide protection for the docking station 1810 and / or protection for the native anatomy of the patient. Additionally or alternatively, the foam lining may facilitate forming a seal between the docking station 1810 and the anatomy of the patient.

[0210] In some embodiments, the docking station 1810 may vary in length to change the anchoring strength of the docking station 1810. For example, the docking station 1810 may extend further along the aorta to facilitate anchoring of the docking station 1810 into place. In some embodiments, the longer length may be accomplished with additional cells and / or with longer individual cells.

[0211] As illustrated in FIG. 18C, the prosthetic valve 1808 may be deployed within the docking station 1810 when the docking station 1810 is deployed to replace an aortic valve. The docking station 1810 may seat the prosthetic valve 1808 to reduce backflow or regurgitation while also reducing or eliminating blockage of coronary ostia 1823 a and / or 1823b.

[0212] In some embodiments, the docking station 1810 may include one or more radiopaque markers 1826 (such as the radiopaque markers 1826a-c) that may facilitate understanding the position of the docking station 1810 relative to a valve to be disposed within the docking station 1810. For example, the radiopaque markers 1826 may facilitate guidance, orientation, and otherwise facilitate a procedure of guiding the valve through the body of the patient into the docking station 1810, and / or otherwise positioning or verifying the position of the docking station 1810 when seating the valve 1808 into the docking station 1810. For example, the radiopaque markers 1826 may facilitate a view into an axial or radial orientation, state of deployment, or other information for the clinician when performing a procedure involving the docking station 1810 and / or the valve. The radiopaque markers 1826 may be made of any radiopaque material, such as tantalum, bismuth, iodine, barium, or gold.

[0213] First Example Seal Stack

[0214] FIGS 19A-19D include various views of an example seal stack 1900 for a guide catheter, according to one example. FIG. 19A is a perspective view, FIG. 19B is a cross- sectional view, and FIGS. 19C-19D are exploded perspective views of the seal stack 1900. The seal stack 1900 may be, include, be included in, or correspond to other seal stacks described herein, such as the seal stacks 82, 1310, 1610, and 1710. As illustrated, the seal stack 1900 includes a fluid seal 1902, a spacer 1904, and a cross-slit valve 1906. In some embodiments, the spacer 1904 may be a rigid plastic component comprising black ABS material. The spacer 1904 may be an injection-molded component used to provide structural support and fitment for the other components (e.g., fluid seal 1902 and cross-slit valve 1906) retained inside a housing assembly (and specifically a sheath hub in some embodiments) and serve as a compression force for retention of the seal stack 1900. The spacer 1904 may fit the cross-slit valve 1906 and provide peripheral structural integrity for the seal stack 1900 components that reside inside the housing assembly, which may include polycarbonate. The spacer 1904 is typically a rigid cylindrical component with a hollow central diameter.

[0215] In some embodiments, the spacer 1904 may have an outer diameter that is the same as, or similar to, that of the fluid seal 1902, e.g., a diameter of about 0.5-1 inches, such as about 0.75 inches. In some embodiments, the spacer 1904 may have an inner diameter that is about 50-95%, about 70-90%, or about 80%, of the outer diameter of the spacer 1904, such as about 0.4-0.9 inches or about 0.6 inches. The inner diameter of the spacer 1904 may be sized to house a minor outer diameter portion 1908 of the cross-slit valve 1906 so that the minor outer diameter portion 1908 of the cross-slit valve 1906 fits snugly inside the inner diameter of the spacer 1904. The minor outer diameter portion 1908 of the crossslit valve 1906 may be shaped to fit snugly into the interior of the spacer 1904. For example, the minor outer diameter portion 1908 of the cross-slit valve 1906 may have an outer diameter of about 0.4-0.9 inches or about 0.6 inches, and a thickness of about 0.2- 0.4 inches, or about 0.3 inches. The spacer 1904 may have an axial thickness or length that accommodates the minor outer diameter portion 1908 of the cross-slit valve 1906, so that the distal end of the cross-slit valve 1906 fits snugly against a proximal surface of the spacer 1904. In some embodiments, the spacer 1904 has an axial thickness or length of about 0.2-0.4 inches, or about 0.3 inches.

[0216] FIG. 20A includes a front view (left side of FIG. 20A) and a cross-sectional view of the fluid seal 1902 of FIGS. 19A-19D, according to one example. FIG. 20B includes a transparent perspective view of the fluid seal 1902, according to one example.

[0217] In general, the fluid seal 1902 may have a disc or cylinder shape. In some embodiments, the fluid seal 1902 may have a thickness of about 1 / 16-1 / 4 inches, or about 0.05-0.2 inches, such as about 1 / 8 inch or about 0. 125 inches, and a diameter of about 0.5- I inches, such as about 0.75 inches. The fluid seal 1902 may have two slits 2002, 2004 on opposite surfaces of the fluid seal 1902. The two slits 2002, 2004 may be arranged in a cross-hair configuration.

[0218] Each slit 2002, 2004 may penetrate partially through the fluid seal 1902, such as greater than 50%, or about 60-90%, or about 75% through the fluid seal 1902, so that each slit 2002, 2004 extends from the corresponding surface into the fluid seal 1902 toward the opposite surface. As a result, the two slits 2002, 2004 meet one another to create a pinhole in the center of the fluid seal 1902. In some embodiments, the two slits 2002, 2004 are roughly perpendicular to one another, e.g., having an angle of about 80-100 degrees or about 90 degrees between the two slits 2002, 2004 as viewed when looking at a face or surface of the disc. The pinhole in the center of the fluid seal 1902 may only be visible when the material is stretched out.

[0219] In another example, the cross-hair slits of the fluid seal 1902 may be formed in a cross-slit-through (CST) configuration. In another example, the cross-hair slits can be formed by creating a midpoint vertical slit and a midpoint horizontal slit. In another example, the cross-hair slits create a central opening that enables catheter entry and removal without creating an open pin-hole clear of material.

[0220] Further details on fluid seals that have a cross-hair configuration (as in FIGS. 19A- 20B) may be found in International Application No. PCT / US2024 / 017801, which is incorporated by reference herein in its entirety.

[0221] Second Example Seal Stack

[0222] FIGS 21A-21D include various views of an example seal stack 2100 for a guide catheter, according to one example. FIG. 21A is a perspective view, FIG. 21B is a cross- sectional view, and FIGS. 21C-21D are exploded perspective views of the seal stack 2100. The seal stack 2100 may be, include, be included in, or correspond to other seal stacks described herein, such as the seal stacks 82, 1310, 1610, and 1710. As illustrated, the seal stack 2100 includes a fluid seal 2102, a spacer 2104, and a cross-slit valve 2106. In some embodiments, the spacer 2104 may be a rigid plastic component comprising black ABS material. The spacer 2104 may be an injection-molded component used to provide structural support and fitment for the other components (e.g., fluid seal 2102 and cross-slit valve 2106) retained inside a housing assembly (and specifically a sheath hub in some embodiments) and serve as a compression force for retention of the seal stack 2100. The spacer 2104 may fit the cross-slit valve 2106 and provide peripheral structural integrity for the seal stack 2100 components that reside inside the housing assembly, which may include polycarbonate. The spacer 2104 is typically a rigid cylindrical component with a hollow central diameter.

[0223] In some embodiments, the spacer 2104 may have an outer diameter that is the same as, or similar to, that of the fluid seal 2102, e.g., a diameter of about 0.5-1 inches, such as about 0.75 inches. In some embodiments, the spacer 2104 may have an inner diameter that is about 50-95%, about 70-90%, or about 80%, of the outer diameter of the spacer 2104, such as about 0.4-0.9 inches or about 0.6 inches. The inner diameter of the spacer 2104 may be sized to house a minor outer diameter portion 2108 of the cross-slit valve 2106 so that the minor outer diameter portion 2108 of the cross-slit valve 2106 fits snugly inside the inner diameter of the spacer 2104. The minor outer diameter portion 2108 of the crossslit valve 2106 may be shaped to fit snugly into the interior of the spacer 2104. For example, the minor outer diameter portion 2108 of the cross-slit valve 2106 may have an outer diameter of about 0.4-0.9 inches or about 0.6 inches, and a thickness of about 0.2- 0.4 inches, or about 0.3 inches. The spacer 2104 may have an axial thickness or length that accommodates the minor outer diameter portion 2108 of the cross-slit valve 2106, so that the distal end of the cross-slit valve 2106 fits snugly against a proximal surface of the spacer 2104. In some embodiments, the spacer 2104 has an axial thickness or length of about 0.2-0.4 inches, or about 0.3 inches.

[0224] FIG. 22A includes a front view (left side of FIG. 22A) and a cross-sectional view of the fluid seal 2102 of FIGS. 21A-21D, according to one example. FIG. 22B includes a transparent perspective view of the fluid seal 2102, according to one example.

[0225] In general, the fluid seal 2102 may have a disc or cylinder shape. In some embodiments, the fluid seal 2102 may have a thickness of about 1 / 16-1 / 4 inches, or about 0.05-0.2 inches, such as about 1 / 8 inch or about 0. 125 inches, and a diameter of about 0.5- 1 inches, such as about 0.75 inches. The fluid seal 2102 may have a plurality of slits 2202, 2204, 2206, 2208, and all of the slits 2202, 2204, 2206, 2208 are on the same face of the disc. In some embodiments, the slits 2202, 2204, 2206, 2208 may be referred to as a vertical slit 2202, a horizontal slit 2204, a first oblique slit 2206, and a second oblique slit 2208.

[0226] Each slit 2202, 2204, 2206, 2208 penetrates partially through the fluid seal 2102, such as about 40-60%, about 60-90%, about 50%, or about 75% through the fluid seal 2102, so that each slit 2202, 2204, 2206, 2208 extends from the face with the slits 2202, 2204, 2206, 2208 (e.g., the first face or first surface) into the fluid seal 2102 toward the opposite face (e.g., the second face or the second surface). The four slits 2202, 2204, 2206, 2208 meet one another to create a pinhole in the center of the fluid seal 2102. In some embodiments, the four slits 2202, 2204, 2206, 2208 are roughly equidistant to one another, e.g., having an angle of about 35-55 degrees or about 45 degrees between the four slits 2202, 2204, 2206, 2208 as viewed when looking at a face or surface of the fluid seal 2102. The pinhole in the center of the fluid seal 2102 may only be visible when the material is stretched out.

[0227] On the second surface, opposite to the first surface having the slits 2202, 2204, 2206, 2208, one or more tapered holes or openings 2210, 2212 may extend toward the first surface. Opposite sides of the tapered hole 2210 may have an angle of about 10° therebetween. Opposite sides of the tapered opening 2212 may have an angle of about 156° therebetween. The tapered hole 2210 may include a meet point where the slits 2202, 2204, 2206, 2208 intersect that may be used to guide a guide catheter, wire, or device to that point and to decrease the force needed to bring the guide catheter, wire, or device through the fluid seal 2102. Together, the tapered opening 2212 and the tapered hole 2210 penetrate partially through the fluid seal 2102, such as about 20-40%, 40-60%, or about 50% through the fluid seal 2102. The tapered opening 2212 may have a diameter, at the second surface, of about 0.25-0.45 inches, about 0.30-0.40 inches, or about 0.35 inches. The tapered hole 2210 may have a diameter, where it intersects the tapered opening 2212, of about 0.01-0.35 inches, about 0.01-0.1 inches, about 0.1-0.2 inches, or about 0.2-0.35 inches.

[0228] Further details on fluid seals that have two sets of orthogonal slits on the same surface (as in FIGS. 21A-22B) may be found in US Provisional Application No. 63 / 613,369, which is incorporated by reference herein in its entirety. Third Example Seal Stack

[0229] FIGS 23A-23D include various views of an example seal stack 2300 for a guide catheter, according to one example. FIG. 23A is a perspective view, FIG. 23B is a cross- sectional view, and FIGS. 23C-23D are exploded perspective views of the seal stack 2300. The seal stack 2300 may be, include, be included in, or correspond to other seal stacks described herein, such as the seal stacks 82, 1310, 1610, and 1710. As illustrated, the seal stack 2300 includes a fluid seal 2302, a spacer 2304, and a cross-slit valve 2306. In some embodiments, the spacer 2304 may be a rigid plastic component comprising black ABS material. The spacer 2304 may be an injection-molded component used to provide structural support and fitment for the other components (e.g., fluid seal 2302 and cross-slit valve 2306) retained inside a housing assembly (and specifically a sheath hub in some embodiments) and serve as a compression force for retention of the seal stack 2300. The spacer 2304 may fit the cross-slit valve 2306 and provide peripheral structural integrity for the seal stack 2300 components that reside inside the housing assembly, which may include polycarbonate. The spacer 2304 is typically a rigid cylindrical component with a hollow central diameter.

[0230] In some embodiments, the spacer 2304 may have an outer diameter that is the same as, or similar to, that of the fluid seal 2302, e.g., a diameter of about 0.5-1 inches, such as about 0.75 inches. In some embodiments, the spacer 2304 may have an inner diameter that is about 50-95%, about 70-90%, or about 80%, of the outer diameter of the spacer 2304, such as about 0.4-0.9 inches or about 0.6 inches. The inner diameter of the spacer 2304 may be sized to house a minor outer diameter portion 2308 of the cross-slit valve 2306 so that the minor outer diameter portion 2308 of the cross-slit valve 2306 fits snugly inside the inner diameter of the spacer 2304. The minor outer diameter portion 2308 of the crossslit valve 2306 may be shaped to fit snugly into the interior of the spacer 2304. For example, the minor outer diameter portion 2308 of the cross-slit valve 2306 may have an outer diameter of about 0.4-0.9 inches or about 0.6 inches, and a thickness of about 0.2- 0.4 inches, or about 0.3 inches. The spacer 2304 may have an axial thickness or length that accommodates the minor outer diameter portion 2308 of the cross-slit valve 2306, so that the distal end of the cross-slit valve 2306 fits snugly against a proximal surface of the spacer 2304. In some embodiments, the spacer 2304 has an axial thickness or length of about 0.2-0.4 inches, or about 0.3 inches. FIG. 24A includes a front view (left side of FIG. 24A), a cross-sectional view (middle of FIG. 24A), and a right side view (right side of FIG. 24A) of the fluid seal 2302 of FIGS. 23A-23D, according to one example. FIG. 24B includes a transparent perspective view of the fluid seal 2302, according to one example.

[0231] In general, the fluid seal 2302 may have a disc or cylinder shape with a double cross-hair configuration. In some embodiments, the fluid seal 2302 may have a thickness of about 1 / 16-1 / 4 inches, or about 0.05-0.2 inches, such as about 1 / 8 inch or about 0.125 inches, and a diameter of about 0.5-1 inches, such as about 0.75 inches. The fluid seal 2302 may have a plurality of slits 2402, 2404, 2406, 2408, with two slits 2402, 2404 on one face of the fluid seal 2302 and two slits 2406, 2408 on an opposite face of the fluid seal 2302 and angularly offset from the two slits 2402, 2404 on the other face. For example, the two slits 2402, 2404 and 2406, 2408 on each surface may form a cross-hair (e.g., the two slits on a given surface arranged orthogonally to each other) with the cross-hair on one surface angularly offset from the cross-hair on the other surface by 45 degrees or some other angle. In some embodiments, the slits 2402, 2404, 2406, 2408 may be referred to as a vertical slit 2402, a horizontal slit 2404, a first oblique slit 2406, and a second oblique slit 2408.

[0232] The two slits 2402, 2404 or 2406, 2408 on each face may intersect approximately in a center of the corresponding face. Each slit 2402, 2404, 2406, 2408 penetrates partially through the fluid seal, such as greater than 50% to about 80%, or about 55% through the fluid seal, so that each slit 2402, 2404, 2406, 2408 extends from a corresponding one of the two faces into the fluid seal 2302 toward the opposite face. As a result, the two intersecting slits 2402, 2404 or 2406, 2408 on one face meet the two intersecting slits 2406, 2408 or 2402, 2404 on the other face in a center of the fluid seal 2302 to create a pinhole in the center of the fluid seal 2302 where all four slits 2402, 2404, 2406, 2408 intersect. In some embodiments, the two slits 2402, 2404 or 2406, 2408 on each surface are roughly perpendicular to one another, e.g., having an angle of about 80-100 degrees or about 90 degrees between the two slits 2402, 2404 or 2406, 2408 as viewed when looking at a face or surface of the fluid seal 2302. The two slits 2402, 2404 or 2406, 2408 on one face may be angularly offset from the two slits 2406, 2408 or 2402, 2404 on the other face, e.g., by an angle of about 35-55 degrees or about 45 degrees. The pinhole in the center of the fluid seal 2302 may only be visible when the material is stretched out. In another example, the double cross-hair slits 2402, 2404, 2406, 2408 (e.g., the angularly offset cross-hair slits on opposing surfaces) create a central opening that enables catheter entry and removal without creating an open pin-hole clear of material during entry or removal or while the catheter is positioned therethrough.

[0233] Various embodiments herein include guide catheter seal stacks that include a fluid seal, a spacer, and a cross-slit valve, such as described with respect to, e.g., FIGS. 19A- 19D, 21A-21D, and 23A-23D. In other embodiments, a guide catheter seal stack may include two or more fluid seals in series, optionally separated by a spacer or other structure. For example, another embodiment of the seal stack 2300 of FIGS. 23A-23D may include, moving in a proximal to distal direction, the cross-slit valve 2306, the spacer 2304, the fluid seal 2302 (e.g., a first fluid seal 2302), another spacer (similar to or different from the spacer 2304), and another fluid seal 2302 (e.g., a second fluid seal 2302).

[0234] Additional Examples of the Disclosed Technology

[0235] In view of the above-described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.

[0236] Example 1. A delivery apparatus comprising: a seal housing assembly and a seal stack disposed within the seal housing assembly, wherein the seal stack comprises a fluid seal having a first surface, having a circular shape, and a second surface, having a circular shape, disposed opposite to the first surface, wherein the first surface comprises a first plurality of cuts approximately through a center of the first surface and extending partially through the fluid seal toward the second surface; wherein the second surface comprises a second plurality of cuts approximately through a center of the second surface and extending partially through the fluid seal toward the first surface; and wherein the second plurality of cuts is angularly offset from the first plurality of cuts.

[0237] Example 2. The delivery apparatus of any example herein, wherein the seal stack further comprises a spacer disposed proximately to the fluid seal and in contact with the first surface of the fluid seal or the second surface of the fluid seal.

[0238] Example 3. The delivery apparatus of any example herein, wherein the seal stack further comprises a cross-slit valve, wherein at least a portion of the cross-slit valve is disposed proximately to the spacer and in contact with the spacer. Example 4. The delivery apparatus of any example herein, wherein the first plurality of cuts comprises a horizontal cut and a vertical cut that intersect perpendicularly at the center of the first surface.

[0239] Example 5. The delivery apparatus of any example herein, wherein the second plurality of cuts comprises a first oblique cut and a second oblique cut that intersect perpendicularly at the center of the second surface.

[0240] Example 6. The delivery apparatus of any example herein, particularly example 5, wherein each of the first and second oblique cuts intersects each of the horizontal and vertical cuts at a 45 -degree angle.

[0241] Example 7. The delivery apparatus of any example herein, wherein each of the first plurality of cuts extends from the first surface more than halfway toward the second surface and each of the second plurality of cuts extends from the second surface more than halfway toward the first surface.

[0242] Example 8. The delivery apparatus of any example herein, wherein the delivery apparatus is a guide catheter.

[0243] Example 9. The delivery apparatus of any example herein, wherein the fluid seal comprises one or more of polyisoprene rubber, styrene polyisoprene rubber, styrene ethylene butylene rubber, vulcanized natural rubber, high consistency rubber, liquid silicone rubber, elastomeric silicone, or an enhanced tear resistant silicone elastomer.

[0244] Example 10. The delivery apparatus of any example herein, wherein the fluid seal has a Shore hardness in a range from 25 A to 50 A, or in a range from 25 A to 30 A, or in a range from 30 A to 35 A.

[0245] Example 11. The delivery apparatus of any example herein, wherein the first plurality of cuts and the second plurality of cuts are configured to prevent entry of fluid through the fluid seal.

[0246] Example 12. The delivery apparatus of any example herein, further comprising a shaft extending distally from the housing assembly, wherein the housing assembly includes: a sheath hub within which the seal stack is disposed; a retainer coupled to the sheath hub, the retainer cooperating with the sheath hub to couple the shaft to the housing assembly; and a sheath locking sleeve coupled to a proximal end of the sheath hub.

[0247] Example 13. The delivery apparatus of any example herein, particularly example 12, wherein the retainer comprises internal threads and a distal end of the sheath hub comprises external threads that are complementary to the internal threads of the retainer to threadably couple the distal end of the sheath hub to the retainer.

[0248] Example 14. The delivery apparatus of any example herein, particularly example 12 or 13, wherein: the seal stack is configured to accommodate passage of and seal around an introducer, the introducer having a proximal end coupled to an introducer locking hub; the sheath locking sleeve is configured to couple to the introducer locking hub to axially and rotationally fix the introducer with respect to the housing assembly; the sheath locking sleeve includes an outer surface having one or more posts that extend radially outward from the outer surface; and the introducer locking hub includes one or more locking channels configured to receive therein the one or more posts of the sheath locking sleeve.

[0249] Example 15. The delivery apparatus of any example herein, particularly example 14, wherein: each of the one or more locking channels of the introducer locking hub includes a guide portion and a locking portion; the guide portion is configured to direct the post in an axial and circumferential direction along a side wall of the guide portion towards the locking portion upon rotation of at least one of the introducer locking hub or the sheath locking sleeve; and the locking portion of the locking channel is configured to securely engage the post to fix an axial position of the introducer locking hub with respect to the sheath locking sleeve.

[0250] Example 16. The delivery apparatus of any example herein, particularly example 14 or 15, wherein each locking channel includes a catch that extends proximally from an end of the locking channel to releasably secure a corresponding post within a corresponding locking channel.

[0251] Example 17. The delivery apparatus of any example herein, particularly any one of examples 12-16, wherein the shaft includes a seal tube or a strain relief portion that is coupled to the housing assembly.

[0252] Example 18. The delivery apparatus of any example herein, particularly any one of examples 12-17, wherein the sheath hub includes a flush port, the flush port including a flush lumen coupled to a lumen of the sheath hub.

[0253] Example 19. A delivery apparatus comprising: a handle comprising a housing assembly comprising a seal stack disposed within the housing assembly, the seal stack configured to allow insertion of a device into the handle and prevent fluid flow past the seal stack; and a shaft extending distally from the handle, the shaft including a distal end, a proximal end, and a lumen extending between the distal end and the proximal end of the shaft, wherein the proximal end of the shaft is disposed within a distal end of the handle; wherein: the seal stack comprises a fluid seal having a distal surface, having a circular shape, and a proximal surface, having a circular shape, disposed opposite to the distal surface; the distal surface comprises a first plurality of cuts approximately through a center of the first surface and extending partially through the fluid seal toward the proximal surface; the proximal surface comprises a second plurality of cuts approximately through a center of the proximal surface and extending partially through the fluid seal toward the distal surface; and the second plurality of cuts is angularly offset from the first plurality of cuts.

[0254] Example 20. The delivery apparatus of any example herein, wherein the seal stack further comprises a spacer disposed proximately to the fluid seal and in contact with the proximal surface of the fluid seal.

[0255] Example 21. The delivery apparatus of any example herein, wherein the seal stack further comprises a cross-slit valve, wherein at least a portion of the cross-slit valve is disposed proximately to the spacer and in contact with the spacer.

[0256] Example 22. The delivery apparatus of any example herein, wherein the first plurality of cuts or the second plurality of cuts comprises a horizontal cut and a vertical cut that intersect perpendicularly at the center of the first surface or the second surface.

[0257] Example 23. The delivery apparatus of any example herein, wherein the second plurality of cuts or the first plurality of cuts comprises a first oblique cut and a second oblique cut that intersect perpendicularly at the center of the second surface or the first surface.

[0258] Example 24. The delivery apparatus of any example herein, particularly example 23, wherein each of the first and second oblique cuts intersects each of the horizontal and vertical cuts at a 45 -degree angle.

[0259] Example 25. The delivery apparatus of any example herein, wherein each of the first plurality of cuts extends from the first surface more than halfway toward the second surface and each of the second plurality of cuts extends from the second surface more than halfway toward the first surface.

[0260] Example 26. The delivery apparatus of any example herein, wherein the delivery apparatus is a guide catheter.

[0261] Example 27. The delivery apparatus of any example herein, wherein the fluid seal comprises one or more of polyisoprene rubber, styrene polyisoprene rubber, styrene ethylene butylene rubber, vulcanized natural rubber, high consistency rubber, liquid silicone rubber, elastomeric silicone, or an enhanced tear resistant silicone elastomer.

[0262] Example 28. The delivery apparatus of any example herein, wherein the fluid seal has a Shore hardness in a range from 25 A to 50 A, or in a range from 25 A to 30 A, or in a range from 30 A to 35 A.

[0263] Example 29. The delivery apparatus of any example herein, wherein the first plurality of cuts and the second plurality of cuts are configured to prevent entry of fluid through the fluid seal.

[0264] Example 30. The delivery apparatus of any example herein, wherein the housing assembly includes: a sheath hub within which the seal stack is disposed; a retainer coupled to the sheath hub, the retainer cooperating with the sheath hub to couple the shaft to the housing assembly; and a sheath locking sleeve coupled to a proximal end of the sheath hub.

[0265] Example 31. The delivery apparatus of any example herein, particularly example 30, wherein the retainer comprises internal threads and a distal end of the sheath hub comprises external threads that are complementary to the internal threads of the retainer to threadably couple the distal end of the sheath hub to the retainer.

[0266] Example 32. The delivery apparatus of any example herein, wherein: the seal stack is configured to accommodate passage of and seal around an introducer, the introducer having a proximal end coupled to an introducer locking hub; the sheath locking sleeve is configured to couple to the introducer locking hub to axially and rotationally fix the introducer with respect to the housing assembly; the sheath locking sleeve includes an outer surface having one or more posts that extend radially outward from the outer surface; and the introducer locking hub includes one or more locking channels configured to receive therein the one or more posts of the sheath locking sleeve.

[0267] Example 33. The delivery apparatus of any example herein, particularly example 32, wherein: each of the one or more locking channels of the introducer locking hub includes a guide portion and a locking portion; the guide portion is configured to direct the post in an axial and circumferential direction along a side wall of the guide portion towards the locking portion upon rotation of at least one of the introducer locking hub or the sheath locking sleeve; and the locking portion of the locking channel is configured to securely engage the post to fix an axial position of the introducer locking hub with respect to the sheath locking sleeve. Example 34. The delivery apparatus of any example herein, particularly example 32 or 33, wherein each locking channel includes a catch that extends proximally from an end of the locking channel to releasably secure a corresponding post within a corresponding locking channel.

[0268] Example 35. The delivery apparatus of any example herein, wherein the shaft includes a seal tube or a strain relief portion that is coupled to the housing assembly.

[0269] Example 36. The delivery apparatus of any example herein, wherein the sheath hub includes a flush port, the flush port including a flush lumen coupled to a lumen of the sheath hub.

[0270] Example 37. A method to implant a prosthetic medical device, comprising: inserting a shaft of a guide catheter into a vessel of a patient; and inserting a distal end portion of a first implant catheter into a proximal end of a handle of the guide catheter and pushing the distal end portion of the first implant catheter through a seal stack of the handle and then through a main lumen of the shaft of the guide catheter toward a target implantation site for a prosthetic medical device mounted on the distal end portion of the first implant catheter; wherein: the seal stack is configured to allow insertion of the first implant catheter into the handle and prevent fluid flow past the seal stack; the seal stack comprises a fluid seal having a distal surface, having a circular shape, and a proximal surface, having a circular shape, disposed opposite to the distal surface; the distal surface comprises a first plurality of cuts approximately through a center of the first surface and extending partially through the fluid seal toward the proximal surface; the proximal surface comprises a second plurality of cuts approximately through a center of the proximal surface and extending partially through the fluid seal toward the distal surface; and the second plurality of cuts is angularly offset from the first plurality of cuts.

[0271] Example 38. The method of any example herein, wherein the shaft of the guide catheter extends into the handle of the guide catheter which remains exterior to the patient while a portion of the shaft extending distally from the handle is disposed within the vessel.

[0272] Example 39. The method of any example herein, wherein a flush port is disposed distal to one or more fluid seals of the handle between the one or more fluid seals and a proximal end of the shaft.

[0273] Example 40. The method of any example herein, further comprising implanting the prosthetic 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 seal stack and through the main lumen toward the target implantation site.

[0274] Example 41. The method of any example herein, particularly example 40, further comprising after inserting the second implant catheter, aspirating fluid and / or air out of the guide catheter through a flush port having a flush lumen coupled to the main lumen.

[0275] Example 42. The method of any example herein, particularly example 40 or 41, wherein the first implant catheter is a docking device delivery apparatus and the prosthetic medical device is a docking device, and wherein the second implant catheter is a prosthetic heart valve delivery apparatus configured to deliver a prosthetic heart valve within the implanted docking device.

[0276] Example 43. A housing assembly for a delivery apparatus, the housing assembly comprising: a sheath hub; a fluid seal disposed within the sheath hub; a spacer disposed within the sheath hub proximally to the fluid seal; and a cross-slit valve disposed within the sheath hub proximally to the fluid seal; wherein: the fluid seal has a distal surface, having a circular shape, and a proximal surface, having a circular shape, disposed opposite to the distal surface; the distal surface comprises a first plurality of cuts approximately through a center of the first surface and extending partially through the fluid seal toward the proximal surface; and the proximal surface comprises a second plurality of cuts approximately through a center of the proximal surface angularly offset from the first plurality of cuts and extending partially through the fluid seal toward the distal surface.

[0277] Example 44. The housing assembly of any example herein, wherein the cross-slit valve comprises a distal portion having a first outer diameter equal to or less than an inner diameter of the spacer, the distal portion of the cross-slit valve is received within the spacer, and a distal surface of the distal portion of the cross-slit valve fits snugly against a proximal surface of the spacer.

[0278] Example 45. The housing assembly of any example herein, wherein the cross-slit valve comprises a proximally-facing concave surface configured to direct a catheter being inserted through the housing assembly toward a center of the cross-slit valve.

[0279] Example 46. The housing assembly of any example herein, wherein the fluid seal comprises one or more of polyisoprene rubber, styrene polyisoprene rubber, styrene ethylene butylene rubber, vulcanized natural rubber, high consistency rubber, liquid silicone rubber, elastomeric silicone, or an enhanced tear resistant silicone elastomer. Example 47. The housing assembly of any example herein, wherein the fluid seal has a Shore hardness in a range from 25 A to 50 A, or in a range from 25 A to 30 A, or in a range from 30 A to 35 A.

[0280] Example 48. The housing assembly of any example herein, wherein the first plurality of cuts and the second plurality of cuts are configured to prevent entry of fluid through the fluid seal.

[0281] The features described herein with regard to any example may be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more of the 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 apparatus may be combined with any one or more features of another delivery apparatus.

[0282] In view of the many possible ways in which the principles of the disclosure may be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure nor the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

CLAIMSWhat is claimed is:

1. A delivery apparatus comprising: a housing assembly and a seal stack disposed within the housing assembly, wherein the seal stack comprises a fluid seal having a first surface, having a circular shape, and a second surface, having a circular shape, disposed opposite to the first surface, wherein the first surface comprises a first plurality of cuts approximately through a center of the first surface and extending partially through the fluid seal toward the second surface; wherein the second surface comprises a second plurality of cuts approximately through a center of the second surface and extending partially through the fluid seal toward the first surface; and wherein the second plurality of cuts is angularly offset from the first plurality of cuts.

2. The delivery apparatus of claim 1 , wherein the seal stack further comprises a spacer disposed proximately to the fluid seal and in contact with the first surface of the fluid seal or the second surface of the fluid seal.

3. The delivery apparatus of claim 1 or 2, wherein the seal stack further comprises a cross-slit valve, wherein at least a portion of the cross-slit valve is disposed proximately to the spacer and in contact with the spacer.

4. The delivery apparatus of any one of claims 1-3, wherein the first plurality of cuts comprises a horizontal cut and a vertical cut that intersect perpendicularly at the center of the first surface.

5. The delivery apparatus of any one of claims 1-4, wherein the second plurality of cuts comprises a first oblique cut and a second oblique cut that intersect perpendicularly at the center of the second surface.

6. The delivery apparatus of claim 5, wherein each of the first and second oblique cuts intersects each of the horizontal and vertical cuts at a 45 -degree angle.

7. The delivery apparatus of any one of claims 1-6, wherein each of the first plurality of cuts extends from the first surface more than halfway toward the second surface and each of the second plurality of cuts extends from the second surface more than halfway toward the first surface.

8. The delivery apparatus of any one of claims 1-7, wherein the delivery apparatus is a guide catheter.

9. The delivery apparatus of any one of claims 1-8, wherein the fluid seal comprises one or more of polyisoprene rubber, styrene polyisoprene rubber, styrene ethylene butylene rubber, vulcanized natural rubber, high consistency rubber, liquid silicone rubber, elastomeric silicone, or an enhanced tear resistant silicone elastomer.

10. The delivery apparatus of any one of claims 1-9, wherein the fluid seal has a Shore hardness in a range from 25 A to 50 A, or in a range from 25 A to 30 A, or in a range from 30 A to 35 A.

11. The delivery apparatus of any one of claims 1-10, wherein the first plurality of cuts and the second plurality of cuts are configured to prevent entry of fluid through the fluid seal.

12. The delivery apparatus of any preceding claim, further comprising a shaft extending distally from the housing assembly, wherein the housing assembly includes: a sheath hub within which the seal stack is disposed; a retainer coupled to the sheath hub, the retainer cooperating with the sheath hub to couple the shaft to the housing assembly; and a sheath locking sleeve coupled to a proximal end of the sheath hub.

13. The delivery apparatus of claim 12, wherein the retainer comprises internal threads and a distal end of the sheath hub comprises external threads that are complementary tothe internal threads of the retainer to threadably couple the distal end of the sheath hub to the retainer.

14. The delivery apparatus of claim 12 or 13, wherein: the seal stack is configured to accommodate passage of and seal around an introducer, the introducer having a proximal end coupled to an introducer locking hub; the sheath locking sleeve is configured to couple to the introducer locking hub to axially and rotationally fix the introducer with respect to the housing assembly; the sheath locking sleeve includes an outer surface having one or more posts that extend radially outward from the outer surface; and the introducer locking hub includes one or more locking channels configured to receive therein the one or more posts of the sheath locking sleeve.

15. The delivery apparatus of claim 14, wherein: each of the one or more locking channels of the introducer locking hub includes a guide portion and a locking portion; the guide portion is configured to direct the post in an axial and circumferential direction along a side wall of the guide portion towards the locking portion upon rotation of at least one of the introducer locking hub or the sheath locking sleeve; and the locking portion of the locking channel is configured to securely engage the post to fix an axial position of the introducer locking hub with respect to the sheath locking sleeve.

16. The delivery apparatus of claim 14 or 15, wherein each locking channel includes a catch that extends proximally from an end of the locking channel to releasably secure a corresponding post within a corresponding locking channel.

17. The delivery apparatus of any one of claims 12-16, wherein the shaft includes a seal tube or a strain relief portion that is coupled to the housing assembly.

18. The delivery apparatus of any one of claims 12- 17, wherein the sheath hub includes a flush port, the flush port including a flush lumen coupled to a lumen of the sheath hub.

19. A delivery apparatus comprising: a handle comprising a housing assembly comprising a seal stack disposed within the housing assembly, the seal stack configured to allow insertion of a device into the handle and prevent fluid flow past the seal stack; and a shaft extending distally from the handle, the shaft including a distal end, a proximal end, and a lumen extending between the distal end and the proximal end of the shaft, wherein the proximal end of the shaft is disposed within a distal end of the handle; wherein: the seal stack comprises a fluid seal having a distal surface, having a circular shape, and a proximal surface, having a circular shape, disposed opposite to the distal surface; the distal surface comprises a first plurality of cuts approximately through a center of the first surface and extending partially through the fluid seal toward the proximal surface; the proximal surface comprises a second plurality of cuts approximately through a center of the proximal surface and extending partially through the fluid seal toward the distal surface; and the second plurality of cuts is angularly offset from the first plurality of cuts.

20. The delivery apparatus of claim 19, wherein the seal stack further comprises a spacer disposed proximately to the fluid seal and in contact with the proximal surface of the fluid seal.

21. The delivery apparatus of claim 19 or 20, wherein the seal stack further comprises a cross-slit valve, wherein at least a portion of the cross-slit valve is disposed proximately to the spacer and in contact with the spacer.

22. The delivery apparatus of any one of claims 19-21, wherein the first plurality of cuts or the second plurality of cuts comprises a horizontal cut and a vertical cut that intersect perpendicularly at the center of the first surface or the second surface.

23. The delivery apparatus of any one of claims 19-22, wherein the second plurality of cuts or the first plurality of cuts comprises a first oblique cut and a second oblique cut that intersect perpendicularly at the center of the second surface or the first surface.

24. The delivery apparatus of claim 23, wherein each of the first and second oblique cuts intersects each of the horizontal and vertical cuts at a 45 -degree angle.

25. The delivery apparatus of any one of claims 19-24, wherein each of the first plurality of cuts extends from the first surface more than halfway toward the second surface and each of the second plurality of cuts extends from the second surface more than halfway toward the first surface.

26. The delivery apparatus of any one of claims 19-25, wherein the delivery apparatus is a guide catheter.

27. The delivery apparatus of any one of claims 19-26, wherein the fluid seal comprises one or more of polyisoprene rubber, styrene polyisoprene rubber, styrene ethylene butylene rubber, vulcanized natural rubber, high consistency rubber, liquid silicone rubber, elastomeric silicone, or an enhanced tear resistant silicone elastomer.

28. The delivery apparatus of any one of claims 19-27, wherein the fluid seal has a Shore hardness in a range from 25 A to 50 A, or in a range from 25 A to 30 A, or in a range from 30 A to 35 A.

29. The delivery apparatus of any one of claims 19-28, wherein the first plurality of cuts and the second plurality of cuts are configured to prevent entry of fluid through the fluid seal.

30. The delivery apparatus of any one of claims 19-29, wherein the housing assembly includes: a sheath hub within which the seal stack is disposed; a retainer coupled to the sheath hub, the retainer cooperating with the sheath hub to couple the shaft to the housing assembly; anda sheath locking sleeve coupled to a proximal end of the sheath hub.

31. The delivery apparatus of claim 30, wherein the retainer comprises internal threads and a distal end of the sheath hub comprises external threads that are complementary to the internal threads of the retainer to threadably couple the distal end of the sheath hub to the retainer.

32. The delivery apparatus of any one of claims 19-31 , wherein: the seal stack is configured to accommodate passage of and seal around an introducer, the introducer having a proximal end coupled to an introducer locking hub; the sheath locking sleeve is configured to couple to the introducer locking hub to axially and rotationally fix the introducer with respect to the housing assembly; the sheath locking sleeve includes an outer surface having one or more posts that extend radially outward from the outer surface; and the introducer locking hub includes one or more locking channels configured to receive therein the one or more posts of the sheath locking sleeve.

33. The delivery apparatus of claim 32, wherein: each of the one or more locking channels of the introducer locking hub includes a guide portion and a locking portion; the guide portion is configured to direct the post in an axial and circumferential direction along a side wall of the guide portion towards the locking portion upon rotation of at least one of the introducer locking hub or the sheath locking sleeve; and the locking portion of the locking channel is configured to securely engage the post to fix an axial position of the introducer locking hub with respect to the sheath locking sleeve.

34. The delivery apparatus of claim 32 or 33, wherein each locking channel includes a catch that extends proximally from an end of the locking channel to releasably secure a corresponding post within a corresponding locking channel.

35. The delivery apparatus of any one of claims 19-34, wherein the shaft includes a seal tube or a strain relief portion that is coupled to the housing assembly.

36. The delivery apparatus of any one of claims 19-35, wherein the sheath hub includes a flush port, the flush port including a flush lumen coupled to a lumen of the sheath hub.

37. A method to implant a prosthetic medical device, comprising: inserting a shaft of a guide catheter into a vessel of a patient; and inserting a distal end portion of a first implant catheter into a proximal end of a handle of the guide catheter and pushing the distal end portion of the first implant catheter through a seal stack of the handle and then through a main lumen of the shaft of the guide catheter toward a target implantation site for a prosthetic medical device mounted on the distal end portion of the first implant catheter; wherein: the seal stack is configured to allow insertion of the first implant catheter into the handle and prevent fluid flow past the seal stack; the seal stack comprises a fluid seal having a distal surface, having a circular shape, and a proximal surface, having a circular shape, disposed opposite to the distal surface; the distal surface comprises a first plurality of cuts approximately through a center of the first surface and extending partially through the fluid seal toward the proximal surface; the proximal surface comprises a second plurality of cuts approximately through a center of the proximal surface and extending partially through the fluid seal toward the distal surface; and the second plurality of cuts is angularly offset from the first plurality of cuts.

38. The method of claim 37, wherein the shaft of the guide catheter extends into the handle of the guide catheter which remains exterior to the patient while a portion of the shaft extending distally from the handle is disposed within the vessel.

39. The method of claim 37 or 38, wherein a flush port is disposed distal to one or more fluid seals of the handle between the one or more fluid seals and a proximal end of the shaft.

40. The method of any one of claims 37-39, further comprising implanting the prosthetic 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 seal stack and through the main lumen toward the target implantation site.

41. The method of claim 40, further comprising after inserting the second implant catheter, aspirating fluid and / or air out of the guide catheter through a flush port having a flush lumen coupled to the main lumen.

42. The method of claim 40 or 41 , wherein the first implant catheter is a docking device delivery apparatus and the prosthetic medical device is a docking device, and wherein the second implant catheter is a prosthetic heart valve delivery apparatus configured to deliver a prosthetic heart valve within the implanted docking device.

43. A housing assembly for a delivery apparatus, the housing assembly comprising: a sheath hub; a fluid seal disposed within the sheath hub; a spacer disposed within the sheath hub proximally to the fluid seal; and a cross-slit valve disposed within the sheath hub proximally to the fluid seal; wherein: the fluid seal has a distal surface, having a circular shape, and a proximal surface, having a circular shape, disposed opposite to the distal surface; the distal surface comprises a first plurality of cuts approximately through a center of the first surface and extending partially through the fluid seal toward the proximal surface; and the proximal surface comprises a second plurality of cuts approximately through a center of the proximal surface angularly offset from the first plurality of cuts and extending partially through the fluid seal toward the distal surface.

44. The housing assembly of claim 43, wherein the cross-slit valve comprises a distal portion having a first outer diameter equal to or less than an inner diameter of the spacer,the distal portion of the cross-slit valve is received within the spacer, and a distal surface of the distal portion of the cross-slit valve fits snugly against a proximal surface of the spacer.

45. The housing assembly of claim 43 or 44, wherein the cross-slit valve comprises a proximally-facing concave surface configured to direct a catheter being inserted through the housing assembly toward a center of the cross-slit valve.

46. The housing assembly of any one of claims 43-45, wherein the fluid seal comprises one or more of polyisoprene rubber, styrene polyisoprene rubber, styrene ethylene butylene rubber, vulcanized natural rubber, high consistency rubber, liquid silicone rubber, elastomeric silicone, or an enhanced tear resistant silicone elastomer.

47. The housing assembly of any one of claims 43-46, wherein the fluid seal has a Shore hardness in a range from 25 A to 50 A, or in a range from 25 A to 30 A, or in a range from 30 A to 35 A.

48. The housing assembly of any one of claims 43-47, wherein the first plurality of cuts and the second plurality of cuts are configured to prevent entry of fluid through the fluid seal.

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