Containers, systems and methods for flushing and / or aspirating a prosthetic implant

Abstract

A container configured to receive a dock assembly (200) therein includes a base (104) and a lid (108). The base defines a dock assembly depression (116a), a handle depression (116b), a shaft depression (116e), an aspiration tool depression, and a syringe barrel depression. The dock assembly depression is configured to receive at least a portion of the dock assembly therein. The handle depression is configured to receive at least a portion of a handle of a dock delivery system (300) therein. The shaft depression is configured to receive at least a portion of a shaft of the dock delivery system therein. The aspiration tool depression is configured to receive at least a portion of an aspiration tool therein. The syringe barrel depression is configured to receive at least a portion of a barrel of a syringe therein. The lid (108) is configured to releasably engage with the base (104).

Description

DEVICES AND METHODS FOR FLUSHING AND / OR ASPIRATING A PROSTHETIC IMPLANTCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 715,173, filed on November 1, 2024, which is incorporated by reference herein in its entirety.FIELD

[0002] The present disclosure relates to devices and methods for flushing and / or aspirating a prosthetic implant.BACKGROUND

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can 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 (for example, 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. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery apparatus and advanced through the patient’s vasculature (for example, through a femoral artery and the aorta) until the prosthetic heart valve reaches the implantation site in the heart. The prosthetic heart 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 heart valve, or by deploying the prosthetic heart valve from a sheath of the delivery apparatus so that the prosthetic heart valve can self-expand to its functional size.

[0004] In some examples, prosthetic heart valves can be placed inside native mitral and tricuspid valves. In such examples, dock assemblies (for example, docks or docking devices) can be used to secure the prosthetic heart valves in the proper position within the native mitral or tricuspid annuluses. Furthermore, dock delivery systems can be used to ensure safe and effective delivery of the dock assemblies. The dock assemblies and the dock delivery systems(or other prosthetic implants and their delivery systems) should be properly secured and prepared prior to storage, shipment, or use by medical professionals.SUMMARY

[0005] Described herein are containers and methods for storing prosthetic implants and their delivery systems (for example, dock assemblies and dock delivery systems). The disclosed containers and methods can, for example, facilitate flushing and / or aspiration of the dock assembly and / or the dock delivery system prior to use. As such, the devices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic implants and their delivery apparatus.

[0006] In some examples, a container configured to receive a dock assembly therein can include a base and a lid configured to releasably engage with the base.

[0007] In some examples, the base can define a longitudinal axis extending in a longitudinal direction.

[0008] In some examples, the base can include a dock depression configured to receive at least a portion of the dock assembly therein.

[0009] In some examples, the base can include a handle depression configured to receive at least a portion of a handle of a dock delivery system therein.

[0010] In some examples, the base can include a shaft depression configured to receive at least a portion of a shaft of the dock delivery system therein.

[0011] In some examples, the base can include an aspiration tool depression configured to receive at least a portion of an aspiration tool therein.

[0012] In some examples, the base can include a syringe barrel depression configured to receive at least a portion of a barrel of a syringe therein.

[0013] In some examples, the base can include a syringe thumb rest depression configured to receive at least a portion of a thumb rest of the syringe therein.

[0014] In some examples, the syringe thumb rest depression can be spaced apart in the longitudinal direction from the syringe barrel depression.

[0015] In some examples, the dock depression can be adjacent the aspiration tool depression in the longitudinal direction.

[0016] In some examples, a method can include coupling a shaft of a dock delivery system to an aspiration tool received within an aspiration tool depression of a container base.

[0017] In some examples, the aspiration tool can include a body, a cap coupled to the body, a first seal disposed between the cap and the body, and a second seal disposed between the cap and the body.

[0018] In some examples, a proximal portion of the shaft can be partially received in a shaft depression of the container base.

[0019] In some examples, the method can further include coupling the aspiration tool to a syringe received within a syringe barrel depression of the container base.

[0020] In some examples, coupling the shaft of the dock delivery system to the aspiration tool can include inserting a distal end portion of the shaft through an aperture of the cap, an aperture of the first seal, and an aperture of the second seal into a recess of the body, and tightening the cap against the body.

[0021] In some examples, the method can further include retracting a plunger of the syringe away from a barrel of the syringe to aspirate the shaft of the dock delivery system.

[0022] In some examples, the method can include, after retracting the plunger of the syringe, inserting a thumb rest portion of the syringe at least partially into a syringe thumb rest depression of the container base.

[0023] In some examples, a dock holder configured to releasably secure a dock assembly to a container can include a cylindrical body having a first longitudinal end, a second longitudinal end opposite the first longitudinal end, and an outer surface extending between the first and second longitudinal ends.

[0024] In some examples, the dock holder can include a helical thread extending in a radially outwards-facing direction from the outer surface of the cylindrical body, wherein the helical thread is configured to receive a portion of the dock assembly thereon.

[0025] In some examples, the dock holder can include a first flange extending in the radially outwards -facing direction from the cylindrical body.

[0026] In some examples, the dock holder can include a push to connect fitting coupled to the first flange.

[0027] In some examples, the dock holder can include a tube fitting in fluid connection with the push to connect fitting.

[0028] In some examples, a container configured to receive a dock assembly therein can include a base and a lid configured to releasably engage with the base such that at least a portion of the dock assembly is disposed between the base and the lid. The base can define a longitudinal axis extending in a longitudinal direction, a dock depression configured to receive at least a portion of the dock assembly therein, a handle depression configured to receive at least a portion of a handle of a dock delivery system therein, a shaft depression configured to receive at least a portion of a shaft of the dock delivery system therein, an aspiration tool depression configured to receive at least a portion of an aspiration tool therein; and a syringe barrel depression configured to receive at least a portion of a barrel of a syringe therein.

[0029] In some examples, a method can include coupling a shaft of a dock delivery system to an aspiration tool received within an aspiration tool depression of a container base, wherein a proximal portion of the shaft can be partially received in a shaft depression of the container base, coupling the aspiration tool to a syringe received within a syringe barrel depression of the container base, and retracting a plunger of the syringe away from a barrel of the syringe to aspirate the shaft of the dock delivery system.

[0030] In some examples, a dock holder configured to releasably secure a dock assembly to a container can include: a cylindrical body having a first longitudinal end, a second longitudinal end opposite the first longitudinal end, and an outer surface extending between the first and second longitudinal ends, a helical thread extending in a radially outwards-facing direction from the outer surface of the cylindrical body, wherein the helical thread is configured to receive a portion of the dock assembly thereon, a first flange extending in the radially outwards- facing direction from the cylindrical body, a push to connect fitting coupled to the first flange, and a tube fitting in fluid connection with the push to connect fitting.

[0031] In some examples, a container can include any one or more of the features found in Examples 1-25 below.

[0032] In some examples, a system can include any one or more of the features found in Examples 1-25 below.

[0033] In some examples, a method can include any one or more of the features found in Examples 1-25 below.

[0034] In some examples, a dock holder can include any one or more of the features found in Examples 1-25 below.

[0035] The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (for example, with body parts, heart, tissue, etc. being simulated).

[0036] The various innovations of this disclosure can 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.BRIEF DESCRIPTION OF THE DRAWINGS

[0037] FIG. 1 illustrates a perspective view of a packaging with a dock assembly, a dock holder, and a dock delivery system (DDS) therein, according to an example.

[0038] FIG. 2 illustrates a top perspective view of the packaging of FIG.l in an open configuration showing the base and the lid according to an aspect of the disclosure.

[0039] FIG. 3 illustrates the base of the packaging of FIG. 1.

[0040] FIG. 4 illustrates a top perspective view of the dock holder of FIG. 1.

[0041] FIG. 5 illustrates a bottom perspective view of the dock holder of FIG. 1.

[0042] FIG. 6 illustrates a bottom view of the dock holder of FIG. 1.

[0043] FIG. 7 illustrates a side profile view of the dock holder of FIG. 1.

[0044] FIG. 8 illustrates a side profile view of the dock holder of FIG. 1.

[0045] FIG. 9 illustrates a top-down view of the dock holder of FIG. 1.

[0046] FIG. 10 illustrates a perspective view of the dock assembly of FIG. 1 engaged with the dock holder of FIG. 1.

[0047] FIG. 11 illustrates a top-down view of the dock assembly of FIG. 1 engaged with the dock holder of FIG. 1.

[0048] FIG. 12 illustrates a perspective view of a packaging with a dock delivery system (DDS), an aspiration tool, and a syringe in an advanced configuration therein, according to an example.

[0049] FIG. 13 illustrates a perspective view of the packaging of FIG. 12 with the syringe in a retracted configuration.

[0050] FIG. 14A illustrates a perspective view of the aspiration tool of FIG. 12 connected to the syringe of FIG. 12.

[0051] FIG. 14B illustrates an exploded view of the aspiration tool of FIG. 12.

[0052] FIG. 15A illustrates a perspective view of a syringe holder, according to one example.

[0053] FIG. 15B illustrates a side profile view of the syringe holder of FIG. 15 A.

[0054] FIG. 16A illustrates a perspective view of the syringe holder of FIG. 15A engaged with a syringe.

[0055] FIG. 16A illustrates a side profile view of the syringe holder of FIG. 15A engaged with a syringe.

[0056] FIG. 17 illustrates a side profile view of a dock delivery system (DDS), according to an example.

[0057] FIG. 18 illustrates a side profile view of a dock assembly, according to an example.

[0058] FIG. 19 illustrates a flowchart of a method of aspirating a dock assembly and a dock delivery system, according to an example.

[0059] FIG. 20 illustrates a flowchart of a method of aspirating a dock assembly and a dock delivery system, according to an example.DETAILED DESCRIPTIONGeneral Considerations

[0060] 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.

[0061] 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 can 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.

[0062] 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.

[0063] 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 (for example, 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 (for example, 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.

[0064] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.”Examples of the Disclosed Technology

[0065] Referring to FIGS. 1-3, an exemplary packaging 100 is described. The packaging 100 can be configured to receive a dock assembly 200 therein. The packaging 100 may also be configured to receive a dock delivery system (DDS) 300. An exemplary DDS 300 is shown in greater detail in FIG. 18, as described further below. It should be noted that, although someexamples herein are directed to docks and / or dock delivery devices, devices and methods disclosed herein can used for other prosthetic implants (for example, prosthetic heart valves, stents, etc.).

[0066] Now referring to FIGS. 1 and 2, the packaging 100 can include a dock holder 150 (described below with reference to FIGS. 4-9) configured to receive the dock assembly 200 thereon. The dock assembly 200 can be operatively connected to the DDS 300, such that at least a portion of the dock assembly 200 can be movable by the DDS 300. For example, the DDS 300 can be configured to cause the dock assembly 200 to move into or out of the DDS. In some examples, the DDS 300 can be configured to cause one or more components of the dock assembly 200 (for example, a sleeve 220 and / or a dock 230) to move relative to another portion of the dock assembly 200.

[0067] The packaging 100 can include a base 104 and a lid 108 configured to releasably engage with the base 104. The base 104 and the lid 108 can be collectively referred to herein as a “container.” An interior space 112 (FIG. 1) between the base 104 and the lid 108 can be defined by the base 104 and the lid 108. The interior space 112 can be dimensioned to receive the dock assembly 200 and / or the DDS 300. In some examples, such as the example shown in FIG. 2, both the dock assembly 200 and the DDS 300 can be disposed within the interior space 112 between the base 104 and the lid 108.

[0068] The lid 108 can be configured to securely engage with the base 104 to secure the dock assembly 200 and / or the DDS 300 within the interior space 112. In some examples, the lid 108 can be separate from the base 104, such that the base 104 and the lid 108 are distinct pieces. The lid 108 can be configured to be secured to the base 104 via a snap fit, friction fit, adhesive, fasteners, or via any other suitable mechanism. In some examples, the lid 108 and the base 104 can define a hinged connection therebetween, such that the packaging 100 is a clamshell, wherein the lid 108 can be configured to be attached to the base 104 and can be configured to hingedly move toward and away from the base 104.

[0069] The packaging 100 can include an open configuration and a closed configuration. In the open configuration shown in FIGS. 1 and 2, the lid 108 can be spaced apart from the base 104, such that the interior space 112 can be accessible from an exterior of the packaging 100 via an opening 115 between the base 104 and the lid 108 (FIG. 1). When the packaging 100 is in the open configuration, the dock assembly 200 and / or the DDS 300 can be introduced into the interior space 112. Thus, the interior space 1 12 can be sufficiently large to allow the dockassembly 200 and / or the DDS 300 to be placed therein. In the closed configuration of the packaging 100, the lid 108 can be in contact with, and is affixed to, the base 104.

[0070] As shown in FIGS. 1-3, the base 104 can include a surface 106 configured to receive the one or more components thereon. The surface 106 can define one or more depressions 116 thereon. The depressions 1 16 can be defined in a concave manner on the surface 106. The depressions 116 can be configured to receive components of the dock assembly 200 and / or the DDS 300. For example, as best shown in FIGS. 2-3, the surface 106 of the base 104 can define a dock assembly depression 116a configured to receive at least a portion of the dock assembly 200, a handle depression 116b configured to receive at least a portion of a handle 304 of the DDS 300, a y-connector depression 116c configured to receive at least a portion of a y- connector assembly 308 of the DDS 300, a stopcock depression 116d configured to receive at least a portion of a stopcock assembly 324 of the DDS 300, a shaft depression 116e configured to receive at least a portion of a shaft 330 of the DDS 300, and a suture lock depression 116f configured to receive at least a portion of a suture lock 320 of the DDS 300. The base 104 is not limited to the depressions 116 labeled in FIGS. 1-3. For example, other quantities and arrangements of depressions 116 may be utilized. The depressions 116 can be dimensioned such that they can receive the entirety of the dock assembly 200 and / or the DDS 300 therein. Alternatively, the depressions 116 can be configured to receive portions of the dock assembly 200 and / or the DDS 300.

[0071] Now referring to FIG. 3, when the packaging 100 is in the closed configuration, one or more of the receptacles 124 can be defined between complementary depressions 116 formed on the base 104 and protrusions 120 formed on the lid 108. The receptacle(s) 124 can be configured to receive and secure one or more components of the dock assembly 200 and / or the DDS 300. The receptacle(s) 124 can be dimensioned to at least partly complement the size and shape of the component(s) disposed therein, such that movement of the components is obstructed between the base 104 and the lid 108 (and specifically between the depression 116 and the protrusion 120) when the packaging 100 is in the closed configuration. This can help prevent components from shifting during storage or shipment, and thus can help prevent damage to the components. Preventing the components from moving when the packaging 100 is closed can be further advantageous in that components are arranged and secured in a desired orientation relative to the packaging 100 or to the other components. Retaining the components in the desired orientations when the packaging 100 is closed can help prevent damage to the components, increase effectiveness of flushing, increase effectiveness of aspiration, increaseeffectiveness of sterilization, reduce chance of human error upon unpacking, and simplify conditioning (for example, flushing and / or aspiration) of the components upon unpacking.

[0072] Referring back to FIGS. 1-2, the base 104 and / or the lid 108 can define a plurality of retention members 118 extending therefrom. The base 104 and the lid 108 are not limited to the retention members 1 18 labeled in FIGS. 1-3. For example, other quantities and arrangements of retention members 118 can be utilized. The retention members 118 can extend from the base 104 towards the lid 108 when the packaging is in the closed configuration and / or from the lid 108 toward the base 104. In some examples, the retention members 118 can extend into one or more receptacles 124 defined between the base 104 and the lid 108. The retention members 118 can be configured to contact one or more components disposed on the base 104 or the lid 108, for example the dock assembly 200 and / or the DDS 300. The retention members 118 can be configured to releasably hold a component on the base 104, on the lid 108, or within a receptacle 124. In some examples, the retention members 1 18 can be protrusions that are configured to deflect to allow a component to be moved to the desired place on the base 104 or the lid 108 and to prevent the component from being moved out of the desired location (for example, as shown in FIGS. 1-2). In some examples, the retention members 118 can be fasteners that can be placed on the components to secure the components to the base 104, to the lid 108, or in a receptacle 124.

[0073] Referring back to FIG. 3, one of the receptacles 124 defined between the base 104 and the lid 108 can be a dock receptacle 124a that is configured to receive the dock assembly 200 therein. The dock receptacle 124a can be sized and dimensioned in such a way as to receive the dock assembly 200. In some examples, the dock receptable 124a can be sized and dimensioned in such a way as to also receive a portion of the DDS 300 connected to the dock assembly 200. The dock receptable 124a can be sized and dimensioned to further receive a liquid (for example, a saline solution) therein such that the dock assembly 200 (and, in some examples, the portion of the DDS 300 connected to the dock assembly 200) is at least partly submerged in the liquid in the dock receptacle 124a. The dock receptacle 124a can be configured to retain the liquid for a predetermined time sufficient to condition (for example, flush and / or aspirate) the dock assembly 200, as will be described in further detail below. The dock receptacle 124a can be formed to have various sizes, cross-sectional shapes, and volumes based on the desired quantity of liquid to be introduced therein and / or on the size and shape of the dock assembly 200.

[0074] In some examples, the dock receptacle 124a can be a monolithic unitary component with the rest of the base 104. Alternatively, the dock receptacle 124a can be a separate component from the base 104 that is configured to engage with the base 104. The dock receptacle 124a can be formed from the same material as the rest of the base 104. Alternatively, the dock receptacle 124a can be formed from a different material, so long as the dock receptacle 124a comprises material that permits the desired liquid (for example, saline) to be retained within the dock receptacle 124a for the desired duration. In some examples, the dock receptacle 124a can comprise a coating thereon, the coating being configured to contact the liquid in the dock receptacle 124a and to prevent the liquid from being absorbed into or leaking through the dock receptacle 124a.

[0075] The dock receptacle 124a can be sealed between the base 104 and the lid 108 with the dock assembly 200 therein when the base 104 and the lid 108 are engaged and the packaging 100 is in the closed configuration. In some aspects, the dock assembly 200 can be connected to the DDS 300 when the dock assembly 200 and the DDS 300 are both within their respective receptacles 124 in the packaging 100 (for example, receptacles 124a-124f shown in FIG. 3). As such, the dock receptacle 124a can be configured to communicate, at least in part, with at least one other receptacle 124 that retains one or more components of the DDS 300 (for example, receptacles 124b- 124f). For example, the dock receptacle 124a can be configured to communicate with a receptacle retaining the portion of the DDS 300 that is attached to the dock assembly 200.

[0076] The packaging 100 can define additional receptacles 124b- 124f between the base 104 and the lid 108. For example, as shown in FIG. 3, the packaging 100 can include a handle receptacle 124b configured to receive a handle 304 of the DDS 300. The packaging 100 can include a y-connector assembly receptacle 124c configured to receive a y-connector assembly 308 of the DDS 300, wherein the y-connector assembly 308 can be connected to the handle 304. The packaging 100 can include a stopcock receptacle 124d configured to receive a stopcock assembly 324 of the DDS 300. The packaging 100 can include a shaft receptable 124e configured to receive a shaft 330 of the DDS 300. The packaging 100 can include a suture lock receptacle 124f configured to receive a suture lock 320 of the DDS 300.

[0077] The packaging 100 can comprise various materials, such as plastic, paper, or a combination of plastic and paper. Other materials may be utilized as well, and this disclosure is not limited to any particular material. In some examples, the packaging 100 can include a thermoplastic polymer, such as acrylonitrile butadiene styrene (ABS) or polyethyleneterephthalate, and specifically for example polyethylene terephthalate glycol (PETG). In some examples, it can be advantageous to manufacture the packaging 100 at least partly via vacuum and pressure-forming techniques or by thermoforming. Other suitable materials that can be thermoformed that retain the necessary structural and biocompatibility parameters may also be utilized. The packaging 100 can be formed via injection molding. In some aspects, the packaging 100 can include flashspun high-density polyethylene fibers, such as Tyvek.

[0078] Further details of the packaging 100 can be found in U.S. Patent Application Publication No. 2023 / 0329851, which is incorporated by reference herein in its entirety.

[0079] Now referring back to FIGS. 1-2, a dock holder 150 can be disposed within the packaging 100 to retain the dock assembly 200 within the packaging 100. The dock holder 150 can be configured to receive at least a portion of the dock assembly 200. The dock holder 150 can contact the dock assembly 200 such that the dock assembly 200 can be retained in the desired location within the packaging 100 (for example, within the dock receptacle 124a) and at the desired orientation relative to the packaging 100, another component of the dock assembly 200, and / or the DDS 300. The dock holder 150 can provide a secure way to package and protect the dock assembly 200. The dock holder 150 can be further configured to maintain different portions of the dock assembly 200 in desired locations relative to each other (for example, separating multiple, adjacent coils of the dock assembly 200 to prevent sticking or friction between them). The dock holder 150 can additionally or alternatively facilitate sterilization of the dock assembly 200 when the dock assembly 200 is on the dock holder 150. The dock holder 150 can additionally or alternatively facilitate conditioning (for example, flushing and / or aspiration) of the DDS 300 when the dock assembly 200 is on the dock holder 150 and connected to the DDS 300.

[0080] FIGS. 4-9 illustrate a dock holder 150, according to one example. The dock holder 150 can include a body 154 having a proximal end 158 and a distal end 162 opposite the proximal end 158. A central axis A can extend in a longitudinal direction of the dock holder 150 between the proximal end 158 and the distal end 162, through a center of the dock holder 150. The body 154 can be substantially cylindrical, but it will be appreciated that other shapes can be utilized and can vary based on the type or shape of the dock assembly 200 that the dock holder 150 will be designed to receive and retain. The body 154 can have an exterior surface 166 and an interior surface 170 opposite the exterior surface 166 and spaced from the exterior surface 166 along a radial direction toward the central axis A. The interior surface 170 can define a bore 174 extending through the body 154. The bore 174 can be a through bore thatcan extend along the entirety of the body 154 and can open at both the proximal end 158 and the distal end 162. Alternatively, the bore 174 can be a blind bore that extends along a portion of the body 154 and can open at the proximal end 158 but not at the distal end 162.

[0081] In some examples, it can be advantageous to ensure that the dock holder 150 is affixed to the packaging 100 according to a desired orientation. Accordingly, the dock holder 150 can be designed such that the dock holder 150 can only be affixed to the base 104 and / or the lid 108 of the packaging 100 in a desired orientation. For example, the dock holder 150 can include one or more projections 178 extending from the interior surface 170 in a radially inwards-facing direction towards the central axis A. The projections 178 can define a keyed cross-section (when viewed in a plane perpendicular to the central axis A) that can allow the dock holder 150 to receive a portion of the base 104 and / or the lid 108 (for example, a post extending from the bottom of the depression 116) into the bore 174 only in the desired orientation (for example, a desired rotational orientation).

[0082] Now referring to FIGS. 4-5 and 7, the dock holder 150 can include one or more protrusions extending in a radially outwards-facing direction from the exterior surface 166. The protrusion(s) can be configured to receive the dock assembly thereon. For example, the one or more protrusions of the dock holder 150 can be one or more threads 182 extending from the exterior surface 166 in the radially outwards-facing direction away from the central axis A. The threads 182 can extend circumferentially at least partly around the body 154. The threads 182 can be configured to receive the dock assembly 200 thereon as the dock assembly 200 is wrapped around the body 154.

[0083] In some examples, the threads 182 can have one or more thread breaks, such that a plurality of discontinuous portions of the thread 182 are defined along the thread 182. The presence of breaks along the thread 182 can, for example, allow better access of a sterilization medium to the dock assembly 200 while the dock assembly 200 is contacting the threads 182. Providing discontinuous threads 182 helps increase the surface area of the dock assembly 200 that is not in contact with the dock holder 150. Furthermore, providing discontinuous threads 182 may facilitate formation and manufacturing of the dock holder 150 such that sharp edges are eliminated or sharp edges are spaced away from the dock assembly 200 and not configured to contact the dock assembly 200 when the dock assembly 200 is received onto the dock holder 150. This decreases chances of a sharp edge contacting or catching on the dock assembly 200 and causing damage thereto during introduction of thedock assembly 200 onto the dock holder 150, during storage and shipment, and during retraction of the dock assembly 200 from the dock holder 150.

[0084] As shown, the dock holder 150 can include a first flange 184 extending from the proximal end 158 of the body 154. The first flange 184 can extend in a radially outward-facing direction of the dock holder 150. The first flange 184 can extend partially around the circumference of the body 154. The first flange 184 can contact the base 104 when the dock holder 150 is affixed thereon. As further shown, the dock holder 150 can include a second flange 186 that also extends from the proximal end 158 of the body 154 in the radially outwardfacing direction of the dock holder 150. The second flange 186 can be circumferentially offset from the first flange 184. In some examples, the first flange 184 and / or the second flange 186 can define a cross-section (when viewed in a plane perpendicular to the central axis A) that can match the shape (or a portion thereof) of the depression 116 in which the dock holder 150 is inserted. In this way, the depression 116 and the dock holder 150 can be keyed such that the dock holder 150 fits in the packaging 100 in only in the desired orientation (for example, a desired rotational orientation).

[0085] Now referring to FIGS. 5-8, the dock holder 150 can optionally include one or more feet 188. When the dock holder 150 is seated in the depression 116 of the base 104, the feet 188 can provide spacing between a bottom surface of the first flange 184 and / or the second flange 186 and a bottom surface of the depression 116.

[0086] Referring back to FIGS. 4-9, the dock holder 150 can further include an adapter 190. The adapter 190 can be configured to facilitate the conditioning (for example, flushing and / or aspiration) of the dock assembly 200 and / or the DDS 300, for example, by making it easier to connect of a distal end portion 222 of a sleeve 220 (FIG. 18) with at least one of an aspiration tool (FIGS. 12-14B) and a syringe (FIGS. 12-14A).

[0087] The adapter 190 can include a body 192. As shown, the body 192 can be substantially cylindrical, but it will be appreciated that other shapes can be utilized. The adapter 190 can further include a sleeve fitting 194 at a first end of the body 192. The sleeve fitting 194 can be configured to receive the distal end portion 222 of the sleeve 220. Once the distal end portion 222 of the sleeve 220 has been inserted into the sleeve fitting 194, the sleeve fitting 194 can create and maintain a substantially fluid-tight seal between the sleeve 220 and the adapter 190. The sleeve fitting 194 can be any type of fitting or connector that can connect to the distal endportion 222 of the sleeve 220. For example, the sleeve fitting 194 can be a push-to-connect fitting sized to accept the distal end portion 222 of the sleeve 220.

[0088] Now referring to FIGS. 10-11, the adapter 190 can be positioned such that the opening of the sleeve fitting 194 aligns with the distal end portion of the sleeve 220 when the sleeve 220 is wrapped around the body 154 of the dock holder 150. For example, the opening of the sleeve fitting 194 (located on an end of the body 192) can be oriented in a tangential direction of the dock holder 150, wherein the tangential direction is perpendicular to both the longitudinal and radial directions of the dock holder 150. When the sleeve 220 of the dock assembly 200 is wrapped around the dock assembly 200 in the circumferential direction, the distal end portion 222 of the sleeve 220 will naturally extend in the tangential direction of the dock assembly 150. Thus, orienting the opening of the sleeve fitting 194 in the same direction can facilitate the alignment of the sleeve fitting 194 with the distal end portion 222 of the sleeve 220. Furthermore, the adapter 190 can be positioned on a radially outwards-most periphery of the first flange 184. This can help ensure that there is sufficient clearance between body 154 of the dock holder 150 and the adapter 190 for a clinician or user to wrap and / or unwrap the sleeve 220 from around the dock holder 150.

[0089] The adapter 190 can further include at least one tube fitting that extends from the body 192. For example, as shown, the adapter 190 can include a first tube fitting 196 and a second tube fitting 198. Each tube fitting 196, 198 is shown as a barbed fitting. However, the tube fittings 196, 198 can be any type (or combination of types) of tube fitting. In some examples, it can be advantageous to include multiple tube fittings (for example, tube fittings having different sizes) in order to allow for tubes of different sizes or types to be coupled to the adapter 190. However, it should be understood that some examples of the adapter 190 can include only a single tube fitting, as only one is required for operation.

[0090] Each tube fitting 196, 198 can be configured to fluidly connect to the sleeve fitting 194. For example, the body 192 can define an internal fluid channel that can fluidly connect the sleeve fitting 194 and each tube fitting 196, 198. Each tube fitting 196, 198 can be configured to be connected to a tube that is in turn fluidly connected to an aspiration tool (for example, aspiration tool 500) and / or a syringe (for example, syringe 600). Thus, when the sleeve 220 is connected to the sleeve fitting 194 and the aspiration tool and the syringe are fluidly coupled to at least one of the tube fittings 196, 198, the sleeve 220 can be placed into fluid connection with the aspiration tool and the syringe.

[0091] The sleeve 220 can be conditioned (for example, flushed and / or aspirated) by fluidly connecting the sleeve 220, the aspiration tool, and the syringe via the adapter 190. A proximal end portion of the sleeve 220 can then be filled with a liquid (for example, a saline solution). A plunger of the syringe can then be retracted to create a pressure differential that draws the liquid towards the distal end portion 222 of the sleeve 220. The pressure differential can help counteract the surface tension of the liquid to aspirate the sleeve 220 to draw liquid from the proximal end portion to the distal end portion 222 of the sleeve 220 and better evacuate excess air trapped within the sleeve 220.

[0092] In some examples, the dock assembly 200 and the DDS 300 can be pre-packaged in the packaging 100 such that the dock assembly 200 comes pre -coiled around the dock holder 150 and the distal end portion 222 of the sleeve 220 comes pre-inserted into the sleeve fitting 194. Since it can be easier to connect tubes to the tube fittings 196, 198 than to connect the sleeve 220 to the sleeve fitting 194, pre-packaging the dock holder 150 and the dock assembly 200 in this way can beneficially streamline the conditioning process (for example, flushing and / or aspirating the dock assembly 200 and / or the DDS 300).

[0093] In some examples, the tube fittings 196, 198 can extend upwards in a vertical direction when the dock holder 150 is seated in the base 104 of the packaging 100. Since the vertically oriented tube fittings 196, 198 will extend towards the clinician or user, this vertical orientation can allow the clinician or user to more easily attach tubing to the tube fittings 196, 198. Thus, since the tube fittings 196, 198 are oriented vertically, and the sleeve fitting 194 is oriented horizontally, the tube fittings 196, 198 and the sleeve fitting 194 can be perpendicular to each other.

[0094] FIGS. 12-13 show a portion of a packaging 400, according to one example. In some examples, certain features of the packaging 400 can share similarities with corresponding features of the packaging 100 shown in FIGS. 1-3. Similar features are labeled with similar reference numbers, offset by increments of hundreds.

[0095] The packaging 400 can include a base 404 and a lid (not shown) configured to releasably engage with the base 404, which can be collectively referred to herein as a “container.” The lid can be configured to releasably engage with the base 404 to define an interior space between the base 404 and the lid. The interior space can be dimensioned to receive the dock assembly 200, the DDS 300, an aspiration tool 500, and / or a syringe 600. Insome examples, each of the dock assembly 200, the DDS 300, the aspiration tool 500, and the syringe 600 can be disposed within the interior space between the base 404 and the lid.

[0096] The base 404 can include a surface 406 configured to receive the one or more components thereon. The surface 406 can define one or more depressions 416 thereon. The depressions 416 can be defined in a concave manner on the surface 406. The depressions 416 can be configured to receive at least a portion of any combination of the dock assembly 200, the DDS 300, the aspiration tool 500, and the syringe 600. For example, the illustrated portion of the surface 406 can define a dock assembly depression 416a configured to receive at least a portion of the dock assembly 200, a shaft depression 416e configured to receive at least a portion of a shaft 330 of the DDS 300, and an aspiration tool depression 416g configured to receive at least a portion of the aspiration tool 500, and a syringe barrel depression 416h configured to receive at least a portion of a barrel 602 of the syringe 600. However, it will be appreciated that the base 104 is not limited to exactly those or only those depressions 116 labeled in FTGS. 12-13, and that other quantities and arrangements of depressions 1 16 may be utilized. For example, the non-illustrated portions of the base 404 can include depressions similar to the handle depression 116b, the y-connector depression 116c, the stopcock depression 116d, and the suture lock depression 116f shown in FIGS. 1-3.

[0097] When the base 404 and the lid are in the closed configuration, the aspiration tool depression 416g can define with corresponding protrusions on the lid an aspiration tool receptacle between the base 404 and the lid. Similarly, the syringe barrel depression 416h can define with corresponding protrusions on the lid a syringe receptacle between the base 404 and the lid. Thus, the aspiration tool depression 416g and the syringe barrel depression 416h can allow the packaging 400 to conveniently store the aspiration tool 500 and / or the syringe 600 alongside with the dock assembly 200 and / or the DDS 300.

[0098] As shown, the aspiration tool depression 416g can be arranged longitudinally between the dock assembly depression 416a and the syringe barrel depression 416h. Arranging the dock assembly depression 416a, the aspiration tool depression 416g, and the syringe barrel depression 416h in this order can allow for the sleeve 220 to be pre-inserted into the aspiration tool 500 and / or allow for the aspiration tool 500 to be pre-connected to the syringe 600.

[0099] The syringe 600 can include the barrel 602, a hub 603 at a first end of the barrel 602, and a finger flange 604 at a second end of the barrel. The syringe 600 can include a plunger 606 slidably coupled to the barrel 602 and a thumb rest 607 at the end of the plunger.

[0100] As shown in FIGS. 12-13, the base 404 can further include a syringe thumb rest depression 416i configured to receive at least a portion of the thumb rest 607 of the syringe 600. The syringe thumb rest depression 416i can include a concave indent 417 configured to engage the thumb rest 607 of the syringe 600 when the barrel 602 is inserted into the syringe barrel depression 416h and the plunger 606 is retracted. When the thumb rest 607 is engaged by the indent 417, the movement of the plunger 606 can be restricted.

[0101] The syringe thumb rest depression 416i can be spaced apart in a longitudinal direction (the direction of a longitudinal axis B) from the syringe barrel depression 416h. The spacing between the syringe barrel depression 416h and the syringe thumb rest depression 416i can be such that the thumb rest 607 can be received in the syringe thumb rest depression 416i and the thumb rest 607 can be engaged by the indent 417 when the plunger 606 of the syringe 600 is at least partially retracted (for example, fully retracted), which is best shown in FIG. 13.

[0102] The sleeve 220 of the dock assembly 200 can be conditioned (for example, flushed and / or aspirated) by connecting the distal end portion 222 of the sleeve 220 to the aspiration tool 500. The aspiration tool 500 can then be connected to the hub 603 of the syringe 600 using tubing. A proximal end portion of the sleeve 220 can be filled with a liquid (for example, a saline solution). As shown best in FIG. 13, the plunger 606 of the syringe 600 can be retracted to decrease the pressure within the barrel 602. The decreased pressure within the barrel 602 can result in a pressure differential that draws the liquid from the proximal end portion of the sleeve 220 and through the distal end portion 222 of the sleeve 220 to remove excess air trapped therein. Since the pressure differential may also cause the plunger 606 to advance, the thumb rest 607 can be inserted at least partially into the indent 417 of the syringe thumb rest depression 416i to prevent the movement of the plunger 606 and maintain the pressure differential.

[0103] In some examples, the aspiration tool 500 and the syringe 600 can be pre-connected with tubing. This can reduce the number of steps that the clinician or user needs to perform to aspirate the dock assembly 200 and / or the DDS 300. In such examples, the aspiration tool depression 416g and the syringe barrel depression 416h can be arranged to accommodate the tubing connecting the aspiration tool 500 and the syringe 600, for example, by spacing the aspiration tool depression 416g and the syringe barrel depression 416h apart from each other in the longitudinal direction to provide sufficient clearance for the tubing.

[0104] FIGS. 14A-14B show the aspiration tool 500. The aspiration tool 500 can include a body 510, one or more seals 520, and a cap 530 arranged along a longitudinal axis C.

[0105] The body 510 can be an adapter configured to fluidly connect the sleeve 220 and the syringe 600. As such, the body 510 can include a recess 512 configured to accept the distal end portion 222 of the sleeve 220. The body 510 can include one or more threads 514 extending around the circumference of the recess 512. The threads 514 can be configured to engage corresponding threads 534 on the cap 530. The body 510 can further include a luer connector 516 in fluid connection with the recess 512. As best shown in FIG. 14A, the luer connector 516 can be configured to connect to tubing 550, wherein a first end 552 of the tubing 550 can be engaged with the luer connector 516 and a second end 554 of the tubing 550 can be engaged with the hub 603 of the syringe 600. In some examples, the body 510 can include a shaft 518 (which is also referred to herein as a “stability shaft”) extending opposite the opening of the recess 512 and perpendicular to the luer connector 516. The shaft 518 can be configured to provide a convenient handhold for the clinician or user handling the aspiration tool 500 and / or can be configured to provide stability when the aspiration tool 500 is secured within the packaging 400.

[0106] As best shown in FIG. 14B, the aspiration tool 500 can include one or more seals 520, each of which can be configured to provide a fluid-tight seal between the body 510 and the cap 530. As shown, the aspiration tool 500 includes two seals 520, each of which includes an aperture 522 extending therethrough in the longitudinal direction and sized to receive the distal end portion 222 of the sleeve 220. Although the aspiration tool 500 can be configured to be implemented with any number of seals 520 (for example, one, three, four, five, etc.), it has been found that two seals provides an optimal balance between sealing effectiveness and compactness.

[0107] The cap 530 can include an aperture 532 extending therethrough in the longitudinal direction and sized to receive the distal end portion 222 of the sleeve 220. When the distal end portion 222 of the sleeve 220 is inserted through the aperture 532 of the cap 530, the cap can be tightened to compress the seals 520 around the distal end portion 222 of the sleeve 220, thereby creating a fluid-tight seal.

[0108] As best shown in FIG. 14A, in some examples, the cap 530 can include an annular portion 536 adjacent and surrounding the aperture 532. In some examples, the annular portion 536 can be chamfered to help facilitate the insertion of the distal end portion 222 of the sleeve 220. In some examples, the annular portion 536 can be transparent to help the clinician or user see when the distal end portion 222 of the sleeve 220 has been inserted into the aspiration tool 500.

[0109] FIGS. 15A-16B show a syringe holder 700 for use with the syringe 600, according to one example. The syringe holder 700 can include an elongate body 710, a finger flange portion 720 at a first longitudinal end of the body 710, and a thumb rest portion 730 at a second longitudinal end of the body 710 opposite the first longitudinal end. The finger flange portion 720 can be configured to detachably engage the finger flange 604 of the syringe 600. As shown, the finger flange portion 720 can include one or more first arms 722 and corresponding one or more second arms 724. Each one of the first arms 722 can have a curved shape that conforms to the curvature of the barrel 602 of the syringe 600. As shown, the second arms 724 can have the same curvature. The first arms 722 and the second arms 724 can be spaced apart from each other in the longitudinal direction such that a gap 726 is formed between the first and second arms 722, 724.

[0110] As shown in FIGS. 16A-16B, the finger flange 604 of the syringe 600 can be inserted into the gap 726 between the first and second arms 722, 724 to clip the syringe holder 700 to the syringe 600. This configuration of the first and second arms 722, 724 can help prevent relative movement between the syringe 600 and the syringe holder 700.

[0111] As further shown in FIGS. 16A-16B, the thumb rest portion 730 of the syringe holder 700 can include a flange 732 extending in a direction perpendicular to the elongate body 710. The flange 732 can be configured to engage a surface of the thumb rest 607, thereby preventing the advancement of the plunger 606 of the syringe 600 towards the barrel 602.

[0112] The syringe holder 700 can be used to facilitate the conditioning process (for example, flushing and / or aspirating the dock assembly 200 and / or the DDS 300). For example, the finger flange portion 720 of the syringe holder 700 can be clipped to the finger flange 604 of the syringe 600. The plunger 606 can then be retracted to create a pressure differential. The plunger 606 can be retracted such that the thumb rest 607 rests against the flange 732 of the thumb rest portion 730, thereby preventing the plunger 606 from advancing towards the barrel 602.

[0113] FIG. 17 depicts a non-limiting exemplary DDS 300 that can be connected to the dock assembly 200 and that is configured to deliver the connected dock assembly 200 to a target implantation site. In some examples, the dock assembly 200 can be connected to the DDS 300 by one or more sutures. It will be appreciated that the DDS 300 of FIG. 17 is exemplary and other device delivery systems can be configured to receive and deliver a dock assembly.

[0114] FIG. 17 depicts the DDS 300 as including a handle 304 and a shaft 330 which extends distally from the handle 304 and the dock assembly 200 partially deployed from a distal end of the shaft 330. The shaft 330 can be configured to receive the dock assembly 200 (in an uncoiled or straight configuration) therein during delivery through a patient’s vasculature to a target implantation site.

[0115] The DDS 300 can further include a y-connector assembly 308 (or hub assembly) extending proximally from the handle 304, and a suture lock assembly 320 connected to the y- connector assembly 308. Various flushing ports 334 can be connected to the y-connector assembly 308 and the handle 304 (for example, a flushing port 334 connected to the handle 304 that includes a stopcock assembly 324). The DDS 300 can further include a sleeve handle 234 extending proximally from the y-connector assembly 308. It should be understood that the DDS 300 can include various other components and is not limited only to those described above. Further details of the DDS 300 and its various components are described in PCT Publication No. WO 2020 / 247907, which is incorporated by reference herein in its entirety.

[0116] In some examples where the dock assembly 200 and the DDS 300 are packaged into the same packaging 100, the DDS 300 may be introduced into the packaging 100, as shown in FIGS. 1-3. In some examples where the dock assembly 200, the aspiration tool 500, and the syringe 600 are packaged in the same packaging 400, the DDS 300 may be introduced into the packaging 400, as shown in FIGS. 12-13. The DDS 300 may be oriented and arranged within the packaging 100 based on a desired advantageous placement to protect the various components thereof and to facilitate proper removal of the DDS 300. Some portions of the DDS 300 may be inspected before and after being packaged (for example, into packaging 100 or packaging 400).

[0117] FIG. 18 depicts an exemplary dock assembly 200 that can be delivered to a target implantation site by a suitable DDS (such as the DDS 300 shown in FIG. 17). The dock assembly 200 is shown extending distally out from a distal end of the shaft 330 of the DDS 300. The dock assembly 200 includes the sleeve 220 and a dock 230 within the sleeve 220. The dock 230 is configured to slidably move within the sleeve 220. The sleeve 220 and the dock 230 are configured to be moved relative to a distal end 332 of the shaft 330 of the DDS 300. The dock assembly 200 can be slidably moved within the shaft 330. For reference, this application will refer to a distal movement of the dock assembly 200 when the dock assembly 200 is being moved away from the shaft 330, and will refer to a proximal movement of the dock assembly 200 when the dock assembly 200 is being moved toward the shaft 330. Thesleeve 220 has the distal end portion 222 and a marker band 224 on the distal end portion 222. The dock 230 has a distal end 232.

[0118] The disclosed methods of packaging may also include various additional steps, such as inspecting the different components, cleaning the packaging 100, the DDS 300, and / or the dock assembly 200, or other steps that are commonly performed in medical packaging scenarios.

[0119] After all components of the dock assembly 200 and / or the DDS 300 are properly introduced into the packaging 100 in their respective desired locations and orientations, the packaging 100 may be closed. The closing step may include engaging the lid 108 with the base 104 such that the opening 115 between the base 104 and the lid 108 is closed and the interior space 1 12 is fully enclosed between the base 104 and the lid 108. The packaging 100 can then be sterilized via one or more acceptable sterilization methods suitable for medical device, such as exposure to ethylene oxide gas or gamma radiation. It will be appreciated that other suitable methods of sterilization may be utilized.

[0120] The dock assembly 200 and / or DDS 300 may be stored within the closed and sterilized packaging 100 until they are needed for implementation. Medical use of the dock assembly 200 and the DDS 300 may be conducted under standard medical and surgical conditions under best practices as understood at the time of use. Although various methods of unpackaging and preparing the dock assembly 200 and / or the DDS 300 from the packaging 100 may be utilized, some exemplary processes are described herein. It will be appreciated that deviations from these methods can be made based on intended use, medical conditions, or other aspects that can affect use of the components.

[0121] FIG. 19 illustrates a flowchart 800 of a method of flushing and / or aspirating a dock assembly (for example, dock assembly 200) and a dock delivery system (for example, DDS 300) stored in a packaging (for example, packaging 100), according to an example. At block 802, the packaging 100 can be accessed within a sterile confinement (for example, an operating room). At block 804, the packaging 100 can be opened. At block 806, the dock assembly 200 and the DDS 300 can be visually inspected. At block 808, the sleeve 220 of the dock assembly 200 can be fluidly connected to the dock holder 150. For example, the sleeve 220 can be inserted into the push to connect sleeve fitting 194 as shown in FIGS. 10-11. At block 810, the dock holder 150 can be connected to a syringe (for example, syringe 600), for example, using any combination of the tube fittings 196, 198. At block 812, the sleeve 220 can be flushedand / or aspirated by retracting the plunger of the syringe to draw liquid (for example, saline solution) through the sleeve 220.

[0122] FIG. 20 illustrates a flowchart 900 of a method of flushing and / or aspirating a dock assembly and a dock delivery system stored in a packaging (for example, packaging 400), according to an example. At block 902, the packaging 400 can be accessed within a sterile confinement (for example, an operating room). At block 904, the packaging 400 can be opened. At block 906, the dock assembly 200 and the DDS 300 can be visually inspected. At block 908, the aspiration tool 500 can optionally be removed from the packaging 400. However, it should be understood that this step can be optional in some examples where the aspiration tool 500 can be connected without removing it from the packaging 400. At block 910, the sleeve 220 can be connected to the aspiration tool 500, for example, by inserting the sleeve 220 into the aperture 532 of the aspiration tool 500. At block 912, the syringe 600 can optionally be removed from the packaging 400. However, it should be understood that this step can be optional in some examples where the syringe 600 can be connected without removing it from the packaging 400. At block 914, the aspiration tool 500 can be connected to a syringe (for example, syringe 600), for example, by connecting the luer connection 516 of the aspiration tool to the syringe 600 using tubing. At block 916, the sleeve 220 can be flushed and / or aspirated by retracting the plunger 606 of the syringe to draw liquid (for example, saline solution) through the sleeve 220.

[0123] Sterilization

[0124] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example.

[0125] The treatment techniques, methods, steps, etc. described or suggested herein or in references incorporated herein can be performed on a living animal or on a non-livingsimulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (for example, with the body parts, tissue, etc. being simulated), etc.Additional Examples of the Disclosed Technology

[0126] 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.

[0127] Example 1. A container configured to receive a dock assembly therein can include a base and a lid configured to releasably engage with the base such that at least a portion of the dock assembly is disposed between the base and the lid. The base can define a longitudinal axis extending in a longitudinal direction, a dock depression configured to receive at least a portion of the dock assembly therein, a handle depression configured to receive at least a portion of a handle of a dock delivery system therein, a shaft depression configured to receive at least a portion of a shaft of the dock delivery system therein, an aspiration tool depression configured to receive at least a portion of an aspiration tool therein; and a syringe barrel depression configured to receive at least a portion of a barrel of a syringe therein.

[0128] Example 2. The container of any example herein, particularly Example 1, wherein the base can further include a syringe thumb rest depression configured to receive at least a portion of a thumb rest of the syringe therein, and the syringe thumb rest depression can be spaced apart in the longitudinal direction from the syringe barrel depression.

[0129] Example 3. The container of any example herein, particularly Example 2, wherein the syringe thumb rest depression can include a concave indent, and wherein the concave indent can be configured to engage the syringe thumb rest to prevent movement of a plunger of the syringe.

[0130] Example 4. The container of any example herein, particularly any one of Examples 1-3, wherein the dock depression can be adjacent the aspiration tool depression in the longitudinal direction.

[0131] Example 5. The container of any example herein, particularly any one of Examples 1-4, wherein the aspiration tool depression and the syringe barrel depression can be spaced apart from each other in the longitudinal direction.

[0132] Example 6. A system can include the container of any example herein, particularly any one of Examples 1-4, and an aspiration tool.

[0133] Example 7. The system of any example herein, particularly any one of Examples 6, wherein the aspiration tool can include a body including a luer connection, a cap configured to detachably mate with the body, and first and second seals disposed between the body and the cap.

[0134] Example 8. The system of any example herein, particularly Example 7, wherein each one of the cap, the first seal, and the second seal can include an aperture. The body can include a recess in fluid connection with the luer connection. The aspiration tool can be configured to receive a distal end portion of the shaft of the dock delivery system through the aperture of the cap, through the aperture of the first seal, through the aperture of the second seal, and into the recess of the body.

[0135] Example 9. The system of any example herein, particularly any one of Examples 7-8, wherein the body can include a shaft extending in a direction perpendicular to the luer connection.

[0136] Example 10. The system of any example herein, particularly any one of Examples 7-9, wherein the cap can include a transparent portion adjacent the aperture of the cap.

[0137] Example 11. The system of any example herein, particularly any one of Examples 7-10, wherein the cap can include a chamfered portion adjacent the aperture of the cap.

[0138] Example 12. A method can include coupling a shaft of a dock delivery system to an aspiration tool received within an aspiration tool depression of a container base, wherein a proximal portion of the shaft can be partially received in a shaft depression of the container base, coupling the aspiration tool to a syringe received within a syringe barrel depression of the container base, and retracting a plunger of the syringe away from a barrel of the syringe to aspirate the shaft of the dock delivery system.

[0139] Example 13. The method of any example herein, particularly Example 12, can further include, prior to coupling the shaft of the dock delivery system to the aspiration tool, removing the aspiration tool from the aspiration tool depression.

[0140] Example 14. The method of any example herein, particularly any one of Examples 12-13, can further include, prior to coupling the aspiration tool to the syringe, removing the syringe from the syringe barrel depression.

[0141] Example 15. The method of any example herein, particularly any one of Examples 12-14, wherein the aspiration tool can include a body, a cap coupled to the body, a first seal disposed between the cap and the body, and a second seal disposed between the cap and the body. Coupling the shaft of the dock delivery system to the aspiration tool can include inserting a distal end portion of the shaft through an aperture of the cap, an aperture of the first seal, and an aperture of the second seal into a recess of the body, and tightening the cap against the body.

[0142] Example 16. The method of any example herein, particularly any one of Examples 12-15, can further include, after retracting the plunger of the syringe, inserting a thumb rest portion of the syringe at least partially into a syringe thumb rest depression of the container base.

[0143] Example 17. The method of any example herein, particularly any one of Examples 12-16, can further include, after retracting the plunger of the syringe: engaging a finger flange of the syringe with a first portion of a syringe holder, and engaging a thumb rest of the syringe with a second portion of the syringe holder, wherein the second portion is spaced apart from the first portion.

[0144] Example 18. A dock holder configured to releasably secure a dock assembly to a container can include: a cylindrical body having a first longitudinal end, a second longitudinal end opposite the first longitudinal end, and an outer surface extending between the first and second longitudinal ends, a helical thread extending in a radially outwards-facing direction from the outer surface of the cylindrical body, wherein the helical thread is configured to receive a portion of the dock assembly thereon, a first flange extending in the radially outwards- facing direction from the cylindrical body, a push to connect fitting coupled to the first flange, and a tube fitting in fluid connection with the push to connect fitting.

[0145] Example 19. The dock holder of any example herein, particularly Example 18, wherein the first flange can extend in the radially outwards -facing direction from one of the first longitudinal end and the second longitudinal end of the cylindrical body.

[0146] Example 20. The dock holder of any example herein, particularly any one of Examples 18-19, wherein the push to connect fitting can be coupled to a radially outwards- most periphery of the first flange.

[0147] Example 21. The dock holder of any example herein, particularly any one of Examples 18-20, wherein the push to connect fitting can be oriented in a tangential direction of the dock holder.

[0148] Example 22. The dock holder of any example herein, particularly any one of Examples 18-21, wherein the push to connect fitting can be oriented perpendicular to the tube fitting.

[0149] Example 23. The dock holder of any example herein, particularly any one of Examples 18-22, wherein: the dock holder can further include a second flange extending in the radially outwards-facing direction from the outer surface of the cylindrical body, and the second flange can be offset in a circumferential direction of the dock holder from the first flange.

[0150] Example 24. The container of any example herein, wherein the container is sterilized.

[0151] Example 25. The dock holder of any example herein, wherein the dock holder is sterilized.

[0152] The features described herein with regard to any example can 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 container can be combined with any one or more features of another container. As another example, any one or more features of one method can be combined with any one or more features of another method.

[0153] 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

Claims:

1. A container configured to receive a dock assembly therein, the container comprising: a base defining: a longitudinal axis extending in a longitudinal direction; a dock depression configured to receive at least a portion of the dock assembly therein; a handle depression configured to receive at least a portion of a handle of a dock delivery system therein; a shaft depression configured to receive at least a portion of a shaft of the dock delivery system therein; an aspiration tool depression configured to receive at least a portion of an aspiration tool therein; and a syringe barrel depression configured to receive at least a portion of a barrel of a syringe therein; and a lid configured to releasably engage with the base such that at least a portion of the dock assembly is disposed between the base and the lid.

2. The container of claim 1, wherein: the base further comprises a syringe thumb rest depression configured to receive at least a portion of a thumb rest of the syringe therein, and the syringe thumb rest depression is spaced apart in the longitudinal direction from the syringe barrel depression.

3. The container of claim 2, wherein the syringe thumb rest depression comprises a concave indent, and wherein the concave indent is configured to engage the syringe thumb rest to prevent movement of a plunger of the syringe.

4. The container of any one of claims 1-3, wherein the dock depression is adjacent the aspiration tool depression in the longitudinal direction.

5. The container of any one of claims 1-4, wherein the aspiration tool depression and the syringe barrel depression are spaced apart from each other in the longitudinaldirection.

6. A system comprising: the container of any one of claims 1-4; and an aspiration tool.

7. The system of claim 6, wherein the aspiration tool comprises: a body including a luer connection; a cap configured to detachably mate with the body; and first and second seals disposed between the body and the cap.

8. The system of claim 7, wherein: each one of the cap, the first seal, and the second seal includes an aperture, and the body includes a recess in fluid connection with the luer connection, and the aspiration tool is configured to receive a distal end portion of the shaft of the dock delivery system through the aperture of the cap, through the aperture of the first seal, through the aperture of the second seal, and into the recess of the body.

9. The system of any one of claims 7-8, wherein the body includes a shaft extending in a direction perpendicular to the luer connection.

10. The system of any one of claims 7-9, wherein the cap comprises a transparent portion adjacent the aperture of the cap.

11. The system of any one of claims 7-10, wherein the cap comprises a chamfered portion adjacent the aperture of the cap.

12. A method comprising: coupling a shaft of a dock delivery system to an aspiration tool received within an aspiration tool depression of a container base, wherein a proximal portion of the shaft is partially received in a shaft depression of the container base; coupling the aspiration tool to a syringe received within a syringe barrel depression of the container base; and retracting a plunger of the syringe away from a barrel of the syringe to aspirate theshaft of the dock delivery system.

13. The method of claim 12, further comprising, prior to coupling the shaft of the dock delivery system to the aspiration tool, removing the aspiration tool from the aspiration tool depression.

14. The method of any one of claims 12-13, further comprising, prior to coupling the aspiration tool to the syringe, removing the syringe from the syringe barrel depression.

15. The method of any one of claims 12-14, wherein: the aspiration tool comprises a body, a cap coupled to the body, a first seal disposed between the cap and the body, and a second seal disposed between the cap and the body, and coupling the shaft of the dock delivery system to the aspiration tool comprises: inserting a distal end portion of the shaft through an aperture of the cap, an aperture of the first seal, and an aperture of the second seal into a recess of the body; and tightening the cap against the body.

16. The method of any one of claims 12-15, further comprising, after retracting the plunger of the syringe, inserting a thumb rest portion of the syringe at least partially into a syringe thumb rest depression of the container base.

17. The method of any one of claims 12-16, further comprising, after retracting the plunger of the syringe: engaging a finger flange of the syringe with a first portion of a syringe holder; and engaging a thumb rest of the syringe with a second portion of the syringe holder, wherein the second portion is spaced apart from the first portion.

18. A dock holder configured to releasably secure a dock assembly to a container, the dock assembly comprising: a cylindrical body having a first longitudinal end, a second longitudinal end opposite the first longitudinal end, and an outer surface extending between the first and second longitudinal ends; a helical thread extending in a radially outwards -facing direction from the outersurface of the cylindrical body, wherein the helical thread is configured to receive a portion of the dock assembly thereon; a first flange extending in the radially outwards-facing direction from the cylindrical body; a push to connect fitting coupled to the first flange; and a tube fitting in fluid connection with the push to connect fitting.

19. The dock holder of claim 18, wherein the first flange extends in the radially outwards -facing direction from one of the first longitudinal end and the second longitudinal end of the cylindrical body.

20. The dock holder of any one of claims 18-19, wherein the push to connect fitting is coupled to a radially outwards-most periphery of the first flange.

21. The dock holder of any one of claims 18-20, wherein the push to connect fitting is oriented in a tangential direction of the dock holder.

22. The dock holder of any one of claims 18-21, wherein the push to connect fitting is oriented perpendicular to the tube fitting.

23. The dock holder of any one of claims 18-22, wherein: the dock holder further comprises a second flange extending in the radially outwards- facing direction from the outer surface of the cylindrical body, and the second flange is offset in a circumferential direction of the dock holder from the first flange.

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