Docking holder, package and method of use

Abstract

The present application relates to a container configured to receive a docking assembly therein for packaging. The container can include a base defining an engagement surface and configured to receive the docking assembly, a lid configured to releasably engage with the base such that at least a portion of the docking assembly is disposed between the base and the lid, and a docking retainer attached to the container and configured to receive a first portion of the docking assembly including two or more adjacent coils thereon. The docking retainer can include a protrusion configured to engage the first portion of the docking assembly and space a second portion of the docking assembly apart from the docking retainer.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 123,425, filed December 9, 2020, which is incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure relates to systems and methods associated with systems for treating valvular regurgitation and / or other valvular problems. Background Technology

[0004] Artificial heart valves can be used to treat valvular heart disease. Natural heart valves (aortic, pulmonary, tricuspid, and mitral valves) play a crucial role in ensuring an adequate supply of blood flows forward through the cardiovascular system. These valves can become less effective due to congenital conditions, inflammation, infection, and other factors. These conditions can ultimately lead to serious cardiovascular damage or death.

[0005] Transcatheter techniques can be used to introduce and implant artificial heart valves in a less invasive manner than open-heart surgery using flexible catheters. In this technique, the artificial valve can be mounted in a coiled state on the distal portion of a flexible catheter and advanced through the patient's blood vessels until the valve reaches the implantation site. The valve at the distal end of the catheter is then expanded to its functional size at the site of the defective natural valve, for example, by inflating a balloon with the valve attached. Alternatively, the valve may have a resilient, self-expanding stent or frame that expands the valve to its functional size as the delivery sheath is advanced from the distal end of the catheter. Optionally, the valve may have a mechanically expandable frame, or the valve may have a combination of expansion mechanisms, such as a balloon-expandable portion, a self-expanding portion, and / or a mechanically expandable portion.

[0006] Transcatheter heart valves (THVs) can theoretically be appropriately sized or shaped for placement within the natural mitral and tricuspid valves. However, the anatomy of the mitral and tricuspid valves varies from person to person, and it may be difficult to properly sized and shaped the valve for many patients. Furthermore, when treating valvular insufficiency, the strength of the surrounding tissues may be insufficient to hold certain types of valves in place as needed. Having a docking system and / or device to secure the prosthetic valve in place, along with a suitable delivery system to ensure safe and efficient delivery, would be beneficial. Additionally, the shape of the natural valve may allow paravalvular leakage (i.e., blood flow bypassing the prosthetic valve) around the prosthetic valve. Therefore, solutions to improve prosthetic valve placement efficiency and reduce paravalvular leakage would be beneficial.

[0007] The docking system must be prepared and packaged in a manner that enhances its functionality. Components of the docking and delivery systems should be properly secured and prepared before storage, transport, or use by medical professionals. Summary of the Invention

[0008] The foregoing needs to be satisfied by various aspects of the docking retainer, packaging container, and method of use disclosed herein. According to one aspect of this disclosure, a container configured to receive a docking assembly for packaging includes: a base defining an engagement surface and configured to receive the docking assembly; a lid configured to releasably engage with the base such that at least a portion of the docking assembly is disposed between the base and the lid; and a docking retainer attached to the container and configured to receive a first portion of the docking assembly including two or more adjacent coils thereon. The docking retainer includes a protrusion configured to engage the first portion of the docking assembly and space a second portion of the docking assembly from the docking retainer.

[0009] According to another aspect of this disclosure, a docking retainer configured to releasably secure a docking assembly to a container includes: a body having a proximal end, a distal end opposite the proximal end, and an inner surface defining a central hole extending between the proximal end and the distal end; and a helical thread extending around and radially outward from the outer surface of the body, the helical thread being configured to receive a first portion of the docking assembly thereon.

[0010] According to another aspect of this disclosure, an assembly includes: a container including a base including a first recess and a support extending outwardly from the recess; and a docking retainer disposed within the first recess and mounted around the support. The docking retainer is configured to receive a first portion of a docking assembly around an outer surface of the docking retainer and includes a radial protrusion configured to separate adjacent coils of the first portion of the docking assembly from each other.

[0011] The various innovations disclosed herein can be used in combination or individually. This overview is provided in a simplified form to introduce the selection of concepts further described in the following detailed description. This overview is not intended to identify key or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of this disclosure will become more apparent from the following detailed description, claims, and drawings. Attached Figure Description

[0012] Figure 1 A perspective view of a package of a docking delivery system (DDS) and docking components therein, according to aspects of this disclosure, is shown.

[0013] Figure 2Showing the configuration in open. Figure 1 The top perspective view of the packaging shows the base and lid according to aspects of this disclosure.

[0014] Figure 3 The base of the packaging according to aspects of this disclosure is shown.

[0015] Figure 4 It shows Figure 1 A perspective view of a portion of the packaging, showing the base and lid portions according to aspects of this disclosure.

[0016] Figure 5 It shows Figure 1 A perspective view of a portion of the base of the packaging and showing the docking assembly and docking retainer according to aspects of this disclosure.

[0017] Figure 6 Aspects according to this disclosure are shown Figure 5 Top perspective view of part of the base.

[0018] Figure 7 A perspective view of a docking retainer according to one aspect of this disclosure is shown.

[0019] Figure 8 It shows Figure 7 Another perspective view of the docking retainer.

[0020] Figure 9 It shows Figure 7 Bottom plan view of the docking retainer.

[0021] Figure 10 It shows Figure 7 Front perspective view of the docking retainer.

[0022] Figure 11A A side perspective view of a docking retainer according to another aspect of this disclosure is shown.

[0023] Figure 11B It shows Figure 11A Top plan view of the docking retainer.

[0024] Figure 11C It shows Figure 11A Front sectional view of the docking retainer.

[0025] Figure 11D It shows Figure 11A A front sectional view of a portion of the docking retainer.

[0026] Figure 12 A perspective view of the dock retainer and dock assembly according to aspects of this disclosure is shown.

[0027] Figure 13 A top plan view of the dock retainer and dock assembly according to another aspect of this disclosure is shown.

[0028] Figure 14 It shows Figure 13 A perspective view of the docking retainer and docking components.

[0029] Figure 15 A top plan view of a portion of a package including the proximal end of the DDS, according to aspects of this disclosure, is shown.

[0030] Figure 16 It shows Figure 15 The enlarged top plan view of the package shown.

[0031] Figure 17A A DDS is shown according to aspects of this disclosure.

[0032] Figure 17B The coupling of aspects according to this disclosure is shown. Figure 17A The docking assembly at the distal end of the DDS.

[0033] Figure 18 A flowchart of a method for using packaging according to aspects of this disclosure is shown.

[0034] Figure 19 A perspective view of the sleeve, the first box, and the second box according to aspects of this disclosure is shown.

[0035] Figure 20A A perspective view of a package containing liquid, a DDS, and a docking assembly, according to aspects of this disclosure, is shown.

[0036] Figure 20B It shows Figure 20A Top plan view of the packaging, DDS, and docking components.

[0037] Figure 20C It shows Figure 20A Side perspective view of the packaging, DDS and docking components.

[0038] Figure 21A The docking assembly is shown, which displays a sleeve and a docking piece in a first position relative to the sleeve.

[0039] Figure 21B It shows Figure 21A The docking assembly shows the sleeve and the docking piece in a second position relative to the sleeve.

[0040] Figure 21C It shows Figure 21A The docking assembly shows the sleeve and the docking piece in a third position relative to the sleeve.

[0041] Figure 22 A perspective view of the packaging according to another aspect of this disclosure is shown.

[0042] Figure 23 It shows Figure 22 A close-up of the instruction section on the packaging.

[0043] Figure 24 The diagram shows aspects of this disclosure in a flat configuration. Figure 22 Top plan view of the packaging.

[0044] Figure 25A A top plan view of a docking retainer according to another aspect of this disclosure is shown.

[0045] Figure 25B It shows Figure 25A A side perspective view of the docking retainer.

[0046] Figure 26A A top plan view of a docking retainer according to another aspect of this disclosure is shown.

[0047] Figure 26B It shows Figure 26A A side perspective view of the docking retainer.

[0048] Figure 27A A top plan view of the separate retaining member used with the packaging according to aspects of this disclosure is shown.

[0049] Figure 27B A top plan view of another separate retaining member used with the packaging according to aspects of this disclosure is shown.

[0050] Figure 27C A top plan view of another separate retaining member used with packaging according to aspects of this disclosure is shown.

[0051] Figure 28 A top plan view of the package according to aspects of this disclosure is shown, which shows multiple retaining members.

[0052] Figure 29A A top plan view of a portion of a package according to another aspect of this disclosure is shown, which shows multiple retaining elements on the package.

[0053] Figure 29B It shows Figure 29A A perspective view of another part of the packaging, which shows several other retained components on the packaging.

[0054] Figure 29C It shows Figure 29AA perspective view of another part of the packaging, which shows several other retained components on the packaging.

[0055] Figure 29D It shows Figure 29A A perspective view of another part of the packaging, which shows several other retained components on the packaging.

[0056] Figure 29E It shows Figure 29A A perspective view of another part of the packaging, which shows several other retained components on the packaging.

[0057] Figure 29F It shows Figure 29A A perspective view of another part of the packaging, which shows several other retained components on the packaging.

[0058] Figure 29G It shows Figure 29A A perspective view of another part of the packaging, which shows several other retained components on the packaging.

[0059] Figure 29H It shows Figure 29A A perspective view of another part of the packaging, which shows several other retained components on the packaging.

[0060] Figure 29I It shows Figure 29A A perspective view of another part of the packaging, which shows several other retained components on the packaging.

[0061] Figure 30 A top plan view of the separator in its unfolded configuration, according to aspects of this disclosure, is shown.

[0062] Figure 31 Showing the folded configuration Figure 30 A side perspective view of the separator.

[0063] Figure 32 A perspective view is shown of a dock retainer, dock assembly, and separator joined together according to aspects of this disclosure.

[0064] Figure 33 A portion of a package having a dock receptacle tray is shown according to aspects of this disclosure.

[0065] Aspects of this disclosure will now be described in detail with reference to the accompanying drawings, wherein, unless otherwise stated, the same reference numerals always refer to the same elements. Detailed Implementation

[0066] General Precautions

[0067] For the purposes of this specification, certain aspects, advantages, and novel features of the examples of this disclosure are described herein. The methods, systems, and apparatuses described should not be construed as limiting in any way. Rather, this disclosure is directed toward all novel and non-obvious features and aspects of the various disclosed examples, individually and in various combinations and sub-combinations with each other. The disclosed methods, systems, and apparatuses are not limited to any particular aspect, feature, or combination thereof, nor are they required to possess any one or more particular advantages or solve any one or more particular problems.

[0068] While some of the disclosed examples are described in a specific, sequential order for ease of presentation, it should be understood that this descriptive approach encompasses rearrangement unless the specific language used below requires a particular order. For example, operations described sequentially may be rearranged or performed concurrently in certain situations. Furthermore, for simplicity, the accompanying drawings may not show the various ways in which the disclosed methods can be combined with other methods. Additionally, the specification may sometimes use terms such as "provides" or "implements" to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation and are readily discernible to those skilled in the art.

[0069] As used in this application and claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly indicates otherwise. Furthermore, the term “comprising” means “including.” Additionally, the term “coupled” generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or linked, and does not exclude the existence of intermediate elements between coupled or associated items in the absence of specific contrasting language.

[0070] As used herein, the term "proximal" refers to a location, orientation, or portion of the device that is closer to the user and further away from the implantation site. As used herein, the term "distal" refers to a location, orientation, or portion of the device that is further away from the user and closer to the implantation site. Thus, for example, proximal movement of the device is movement of the device away from the implantation site and toward the user (e.g., away from the patient's body), while distal movement of the device is movement of the device away from the user and toward the implantation site (e.g., into the patient's body). Unless otherwise expressly defined, the terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions, respectively.

[0071] Examples of publicly available technologies

[0072] This document describes examples of docking assemblies configured for deployment at a natural valve of the heart, wherein one or more portions of the docking assembly (e.g., docking element or docking device) are implanted at the natural valve. In some examples, the docking assembly may be included within a docking delivery system (e.g., a delivery device) for navigation toward the implantation site (e.g., the natural valve) via the patient's vascular system and for deployment from the docking delivery system at or near the natural valve.

[0073] This document also describes various examples of packages that include one or more parts and are configured to receive at least a portion of a docking assembly and a docking delivery system. In some examples, the package may be configured to receive or include a docking retainer configured to receive at least a portion of the docking assembly thereon.

[0074] Various heart valve diseases can be mitigated by a docking assembly (or docking device or anchor) introduced within or near the natural heart valve. For example, exemplary docking devices (or “docks”) and their capabilities are disclosed in PCT / 2020 / 036577, which is incorporated herein by reference in its entirety.

[0075] Such docking components (or devices) and / or delivery systems used for such docking components need to be prepared, packaged, stored, transported, and conditioned accordingly to maintain sterility and biocompatibility. The docking components may be configured to undergo sterilization suitable for killing or otherwise inactivating any pathogens on or within the docking components. In some aspects, the docking components may be introduced into a patient via a docking delivery system (DDS) (e.g., the DDS disclosed in the aforementioned PCT / 2020 / 036577). The DDS may be packaged, stored, delivered, and prepared together with the docking components. Therefore, the DDS may also be configured to undergo appropriate sterilization. Finally, to maintain the docking components and DDS in the desired configuration during storage and transport, suitable packaging may be provided in which the docking components and DDS are received. Therefore, the packaging may also undergo adequate sterilization, just like the docking components and DDS.

[0076] In some aspects, the packaging contains the docking components and the DDS, and the packaging, along with the docking components and the DDS, can be sterilized and sealed to prevent exposure to pathogens from an unsterilized external environment. Furthermore, the packaging can serve the functional purpose of protecting the components within and maintaining them in the desired arrangement. Components (e.g., docking components and DDS) can be retained in the desired orientation to prevent damage during transport and storage. This also allows users better access to the components when removing them from the packaging, thereby reducing the chance of user error that could damage the components due to improper removal from the packaging or pre-use adjustment.

[0077] refer to Figures 1-6 An exemplary package 100 (which may also be referred to herein as a container) is described. Package 100 is configured to receive docking assembly 200 therein. Package 100 may also be configured to receive docking delivery system (DDS) 300. As further described below, the exemplary DDS 300 is in Figure 17A More details are shown in the middle.

[0078] Package 100 may include a docking retainer 150 (see below) configured to receive docking assembly 200 thereon. Figures 7-10 (Description). The docking assembly 200 can be operatively connected to the DDS 300 such that at least a portion of the docking assembly 200 is movable by the DDS 300. For example, the DDS 300 can be configured to cause the docking assembly 200 to move in or out of the DDS. In some aspects, the DDS 300 can be configured to cause one or more components of the docking assembly 200 (e.g., sleeve 220 and / or docking member 230) to move relative to another portion of the docking assembly 200.

[0079] refer to Figure 1 and Figure 2 The package 100 may include a base 104 and a lid 108, the lid 108 being configured to releasably engage with the base 104. The internal space 112 between the base 104 and the lid 108 is formed by the base 104 and the lid 108. Figure 1 The internal space 112 may be designed to receive the docking assembly 200 and / or the DDS 300. In some examples, both the docking assembly 200 and the DDS 300 may be disposed within the internal space 112 between the base 104 and the cover 108. Figure 2 ).

[0080] The cover 108 can be configured to securely engage with the base 104 to hold the mating assembly 200 and / or DDS 300 within the interior space 112. In some aspects, the cover 108 can be detachable from the base 104, such that the base 104 and the cover 108 are distinct parts. The cover 108 can be configured to be secured to the base 104 via a snap-fit, friction fit, adhesive, fastener, or other suitable mechanism. In some examples, the cover 108 and the base 104 define a hinged connection between them, such that the package 100 is a flip-top type, wherein the cover 108 is configured to be attached to the base 104 and configured to move hingedly toward and away from the base 104.

[0081] Package 100 includes an open configuration and a closed configuration. In the open configuration ( Figure 1 and Figure 2In the package 100, the lid 108 is spaced apart from the base 104, such that the interior space 112 can be accessed from the outside of the package 100 via the opening 115 between the base 104 and the lid 108. Figure 1 When package 100 is in the open configuration, docking assembly 200 and / or DDS 300 can be introduced into the internal space 112. Therefore, the internal space 112 should be large enough to allow docking assembly 200 and / or DDS 300 to be placed therein. In the closed configuration of package 100, lid 108 contacts and is attached to base 104.

[0082] Continue to refer to Figure 1 and Figure 2 And also refer to Figures 3-6 The base 104 includes a surface 106 configured to receive one or more components thereon. Figure 3 and Figure 4 ). Surface 106 may define one or more recesses 116 thereon (see, for example, see Figure 3 Recess 116 is defined recessedly on surface 106. Recess 116 is configured to receive parts of DDS 300 and / or mating assembly 200. It should be understood that base 104 is not precisely limited to those or only those in Figure 3 The recesses 116 are marked in the middle, and other numbers and arrangements of the recesses 116 can be utilized. The recesses 116 can be designed and sized such that they can receive the entirety of the docking assembly 200 and / or DDS 300 therein. Alternatively, the recesses 116 can be configured to receive portions of the docking assembly 200 and / or DDS 300.

[0083] The cover 108 can define multiple protrusions 120 ( Figure 4 The shape and size of the protrusion 120 on the lid 108 may be complementary to the shape and size of the recess 116 on the base 104. In some aspects, the package 100 may include the recess 116 on the base 104 and have no protrusion 120 on the lid 108. Alternatively, the package 100 may include the protrusion 120 on the lid 108 and have no recess 116 on the base. In a further alternative, the package 100 may include both the recess 116 on the base 104 and the protrusion 120 on the lid 108.

[0084] When the package 100 is in a closed configuration, one or more supports 124 may be defined between a complementary recess 116 on the base 104 and a protrusion 120 on the lid 108. Figure 4The support 124 can be configured to receive and secure one or more components of the docking assembly 200 and / or the DDS 300. The support 124 can be sized to at least partially complement the size and shape of the components disposed therein, such that when the package 100 is in a closed configuration, movement of the components is impeded between the base 104 and the lid 108 (and specifically between the recess 116 and the protrusion 120). This prevents the components from shifting during storage or transport and prevents damage to the components. Preventing component movement when the package 100 is closed can further facilitate the arrangement and securing of specific components relative to the package 100 or other components in a desired orientation. Holding the components in a desired orientation when the package 100 is closed prevents damage to the components, increases the effectiveness of sterilization, reduces the chance of human error during unpacking, and simplifies component adjustment during unpacking.

[0085] The base 104 and / or the cover 108 may define a plurality of retaining members 118 extending therefrom (see, for example, see...). Figure 3 It should be understood that the base 104 and the cover 108 are not precisely limited to those or only to those... Figure 3 The retaining members 118 marked in the diagram, and other numbers and arrangements of retaining members 118 may be utilized. Retaining members 118 may extend from the base 104 toward the lid 108 and / or from the lid 108 toward the base 104 when the package is in a closed configuration. In some aspects, retaining members 118 may extend to one or more of the supports 124 defined between the base 104 and the lid 108. Retaining members 118 are configured to contact one or more components disposed on the base 104 or the lid 108, such as the mating assembly 200 and / or the DDS 300. Retaining members 118 may be configured to releasably retain a component on the base 104, on the lid 108, or within the support 124. In some aspects, retaining members 118 may be protrusions configured to deflect to allow a component to be moved to a desired location on the base 104 or the lid 108 and to prevent the component from being moved out of the desired location (e.g., as shown in the diagram). Figures 1-6 (As shown). In some aspects, the retaining member 118 may be a fastener that can be placed on the component to secure the component to the base 104, the cover 108, or the bracket 124 (e.g., see...). Figures 22 to 29I ).

[0086] In some respects, one of the supports 124 defined between the base 104 and the cover 108 may be a docking support 124a, which is configured to receive the docking assembly 200 therein (see...). Figure 3 , Figure 5 and Figure 6The docking support 124a can be sized and designed to receive the docking assembly 200 and also to receive liquid therein, such that the docking assembly 200 is at least partially immersed in the liquid in the docking support 124a. The docking support 124a can be configured to retain the liquid for a predetermined time sufficient to regulate the docking assembly 200, as will be described in further detail below. It should be understood that the docking support 124a can be formed to have various sizes, cross-sectional shapes, and volumes based on the desired amount of liquid to be introduced therein and / or the size and shape of the docking assembly 200.

[0087] In some aspects, the docking support 124a may be an integral part of the base 104. Alternatively, the docking support 124a may be a separate part of the base 104 configured to engage with it. The docking support 124a may be formed of the same material as the rest of the base 104. Alternatively, the docking support 124a may be formed of a different material, provided that the docking support 124a includes a material that allows a desired liquid (e.g., brine) to remain within the docking support 124a for a desired duration. In some aspects, the docking support 124a may include a coating thereon configured to contact the liquid in the docking support 124a and prevent the liquid from being absorbed into or leaking through the docking support 124a.

[0088] Packaging 100 may comprise a variety of materials, such as plastic, paper, or a combination of plastic and paper. Other materials may also be used, and this disclosure is not limited to any particular material. In some aspects, packaging 100 may comprise thermoplastic polymers, such as acrylonitrile butadiene styrene (ABS) or polyethylene terephthalate, and specifically, for example, polyethylene terephthalate (PETG). In some aspects, it may be advantageous to manufacture packaging 100 at least in part via vacuum and pressure forming techniques or by thermoforming. Other suitable materials may also be used that can be thermoformed and retain the necessary structural and biocompatibility parameters. Packaging 100 may be formed via injection molding. In some aspects, packaging 100 may comprise flash-spun high-density polyethylene fibers, such as Tyvek.

[0089] The docking bracket 124a is configured to receive the docking assembly 200 therein. The docking assembly 200 can be placed and stored in the docking bracket 124a, and in some examples, it is placed and stored in the docking bracket 124a together with a portion of the DDS 300 connected to the docking assembly 200. When the base 104 and the cover 108 are engaged and the package 100 is in a closed configuration, the docking bracket 124a can be sealed between the base 104 and the cover 108, with the docking assembly 200 in the docking bracket 124a. In some aspects, when both the docking assembly 200 and the DDS 300 are in their respective brackets 124 in the package 100 (e.g., ...), Figure 3 When the docking assembly 200 is within the brackets 124a-124f shown and further described below, the docking bracket 124a can be connected to the DDS 300. Therefore, the docking bracket 124a should be configured to communicate at least partially with at least one other bracket 124 (e.g., Figure 3 The brackets 124b-124f in the middle retain one or more parts of the DDS 300 (e.g., the part of the DDS 300 that is attached to the docking assembly 200).

[0090] The docking assembly 200 can be held within the package 100 to prevent movement of the docking assembly 200 during packaging, storage, shipping, or preparation, which reduces the chance of damage to the docking assembly 200. In some aspects, the individual components of the docking assembly 200 can be held relative to each other to better secure the docking assembly 200 and protect the individual components. Furthermore, when the docking assembly 200 and DDS 300 are connected and packaged together, properly securing the docking assembly 200 within the package 100 prevents any movement of the docking assembly 200 (which could cause undesirable movement or twisting of the DDS 300), thereby reducing the risk of damage to the DDS 300 or related components. The DDS 300, including the various components constituting the DDS 300, can also be held within the package 100 to prevent undesirable movement, displacement, or twisting when the package is in a closed configuration. The DDS 300 and its related components can be held relative to each other, the docking assembly 200, and / or the package 100 in a desired orientation.

[0091] To retain the mating assembly 200 within the package 100, the mating retainer 150 can be disposed within the package 100. Figure 1 , Figure 2 and Figure 5 The docking retainer 150 is configured to receive at least a portion of the docking assembly 200. The docking retainer 150 can contact the docking assembly 200 such that the docking assembly 200 is held in a desired position within the package 100 (e.g., within the docking support 124a) and in a desired orientation relative to the package 100, another component of the docking assembly 200, and / or the DDS 300. The docking retainer 150 provides a secure manner for packaging and protecting the docking assembly 200. The docking retainer 150 may be further configured to maintain different portions of the docking assembly 200 relative to each other in desired positions (e.g., separating multiple adjacent coils of the docking assembly 200 to prevent adhesion or friction between them). While the docking assembly 200 is on the docking retainer 150, the docking retainer 150 also facilitates the sterilization of the docking assembly 200. The docking retainer 150 may be positioned and designed such that the docking assembly 200 can be moved from the docking retainer 150 into the DDS 300.

[0092] refer to Figures 7-10 The image shows a docking retainer 150 according to an example. The docking retainer 150 includes a body 154 having a proximal end 158 and a distal end 162 opposite to the proximal end 158. A central axis A extends between the proximal end 158 and the distal end 162, passing through the center of the docking retainer 150. The body 154 may be substantially cylindrical; however, it should be understood that other shapes may be utilized and will depend on the docking assembly 200 to which the docking retainer 150 will be designed to receive and retain. The body 154 has an outer surface 166 and an inner surface 170 opposite to and spaced apart from the outer surface 166 in a radial direction toward the central axis A. The inner surface 170 defines a hole 174 extending through the body 154. The hole 174 may be a through-hole extending integrally along the body 154 and opening at both the proximal end 158 and the distal end 162. Alternatively, the hole 174 may be a blind hole that extends along a portion of the body 154 and opens at the proximal end 158 but not at the distal end 162.

[0093] The mating retainer 150 is configured to be releasably attached to the package 100, such that the mating retainer 150 is secured relative to the package 100. In some aspects, the mating retainer 150 may be attached to a base 104. The base 104 may define a post 148 extending from the base 104 and configured to receive the mating retainer 150 (see [link to product details]). Figure 6 The support 148 may be a continuous, integral portion of the base 104. The mating retainer 150 is configured to slide on the support 148 such that the support 148 is received within the bore 174 of the mating retainer 150. The mating retainer 150 may be configured to be releasably secured to the support 148, or alternatively, the mating retainer 150 may be designed such that once the mating retainer 150 is properly secured to the support 148, the mating retainer 150 will not detach from the support 148.

[0094] In some respects, it may be advantageous to ensure that the docking retainer 150 is attached to the package 100 according to the desired orientation. Therefore, the docking retainer 150 and the support 148 can be designed such that the docking retainer 150 can only be attached to the support 148 in the desired orientation. Figures 7-9 As shown, the docking retainer 150 may include one or more protrusions 178 extending radially from the inner surface 170 toward the central axis A. Figure 9 As seen, for example, protrusion 178 defines a key-shaped cross section (when viewed in a plane perpendicular to the central axis A), which allows the dock retainer 150 to receive the strut 148 into the hole 174 only in a desired orientation (e.g., a desired rotational orientation).

[0095] The support 148 can be sized and shaped to complement the keyed cross-section of the mating retainer 150, such that the support 148 can be received into the bore 174 only when it is correctly oriented and aligned with the keyed cross-section of the bore 174. Figure 6 As shown in the non-limiting example, the strut 148 may have a substantially rectangular cross-section configured to be received into the hole 174 between the protrusions 178. The corners of the strut 148 may be curved, rounded, or beveled to correspond to the cross-sectional shape of the hole 174 of the mating retainer 150. It should be understood that the strut 148 may define other cross-sectional shapes and the hole 174 may define other cross-sectional openings that are complementary to and correspond to the cross-sectional shape of the strut 148.

[0096] In some aspects, the docking retainer 150 may include a proximal end 158 ( Figures 7-10 The adjacent flange 194. The flange 194 may flare radially outward, thereby creating an outwardly flared base at the proximal end 158. The flange 194 may extend circumferentially around the body 154 and may contact the base 104 when the mating retainer 150 is attached to the base 104. In some aspects, the mating retainer 150 may be part of a single integral base 104 (e.g., molded or formed as a single piece) rather than a separate removable component.

[0097] The docking retainer 150 is configured to receive the docking assembly 200 thereon. For example, the docking assembly 200 may be wound around the docking retainer 150 such that at least a portion of the docking assembly 200 is circumferentially surrounding the docking retainer 150 around an outer surface 166. In some aspects, the docking retainer 150 may include features thereon to facilitate the reception and retention of the docking assembly 200 in a desired position and orientation.

[0098] The docking retainer 150 may include a protrusion extending radially outward from an outer surface 166, and the protrusion is configured to receive a docking assembly thereon. (See again) Figure 7 , Figure 8 and Figure 10 In some respects, the protrusion of the mating retainer 150 may be configured as one or more threads 182 extending radially from the outer surface 166 away from the central axis A. The threads 182 extend at least partially circumferentially around the body 154. Each thread 182 has a length measured from the thread lead 183a at the location of the thread 182 and the thread end 183b at the termination of the thread 182. Figure 7 and Figure 8The thread lead 183a is the portion of thread 182 closest to the distal end 162 of the body 154 of the mating retainer 150, and the thread end 183b is the portion of thread 182 closest to the proximal end 158 of the body 154. Thread 182 is configured to receive the mating assembly 200 on thread 182 when the mating assembly 200 is wound around the body 154.

[0099] The mating retainer 150 disclosed herein may have various retention features for receiving and securing the mating assembly 200 thereon. In some aspects, the thread 182 may have various arrangements, dimensions, sizes, and angles, depending on the intended use, the package in which the mating retainer 150 is inserted, and the type of mating assembly 200 received on the thread 182. (See again) Figures 7-10 In some respects, the mating retainer 150 may have a single thread 182 extending helically around the body 154 between the proximal end 158 and the distal end 162. The thread 182 may be continuous in some respects or discontinuous in others.

[0100] like Figure 7 , Figure 8 and Figure 10 As shown, the thread 182 may have a plurality of breaks 186 therein, such that a plurality of discontinuous portions of the thread 182 are defined along the thread 182 between the thread lead 183a and the thread end 183b. As the thread extends helically around the body 154, the breaks 186 are defined along the length of the thread 182 between adjacent portions of the thread 182. In some aspects, at least some of the plurality of breaks 186 may be aligned along the outer surface 166 of the body 154 in a direction parallel to the central axis A.

[0101] For example, the thread lead 183a and thread end 183n of each thread 182 may be spaced apart from each other in the circumferential direction to create a break 186 in the thread 182. The breaks 186 of adjacent threads 182 may be aligned in the axial direction such that a space without threads 182 is formed along the outer surface 166 of the body 154 between the proximal end 158 and the distal end 162.

[0102] The presence of a break 186 along the thread 182 allows for better access of the sterilizing medium to the mating assembly 200 when it contacts the thread 182. Providing a discontinuous thread 182 helps increase the surface area of ​​the mating assembly 200 that does not contact the mating retainer 150. Furthermore, providing a discontinuous thread 182 facilitates the formation and manufacture of the mating retainer 150, eliminating sharp edges or spacing them from the mating assembly 200 when it is received onto the mating retainer 150, and preventing them from contacting the mating assembly 200. This reduces the chance of sharp edges contacting or becoming stuck on the mating assembly 200 and causing damage during the introduction of the mating assembly 200 onto the mating retainer 150, during storage and transport, and during the retraction of the mating assembly 200 from the mating retainer 150.

[0103] In some respects, thread 182 may include a non-helical portion that extends circumferentially around at least a portion of body 154 such that the non-helical portion lies in the same plane (the plane being perpendicular to the central axis A) along its entire length.

[0104] In some respects, thread 182 comprises only one or more helical portions. Thread 182 may have a variety of thread parameters and measurements, including, for example, thread length, pitch, crest, root, major diameter, minor diameter, thread angle, pitch diameter, thread depth, and / or other parameters of the helical thread. It should be understood that the specific dimensions and measurements of thread 182 will depend on the mating assembly 200 intended to be received on the mating retainer 150.

[0105] like Figure 10As shown, the mating retainer 150 may have a pitch 183, which is measured in a direction parallel to the central axis A between identical points of two adjacent portions of the thread 182. In some aspects, the pitch 183 may be between about 0.02 inches and about 1.0 inch (0.05 cm to 2.54 cm), between about 0.1 inches (0.25 cm) and about 0.5 inches (1.27 cm), between about 0.15 inches (0.38 cm) and about 0.2 inches (0.51 cm), in any combination of the above ranges or other suitable ranges. The mating retainer 150 may also define a thread depth 185, which is measured radially outward from the outer surface 166 in a direction away from the central axis A to the edge of the thread 182. Specifically, the thread depth 185 is measured between the base 182a and the tip 182b of the thread 182. The thread 182 may be tapered in a radial direction away from the central axis A, such that the base 182a (the portion closest to the outer surface 166) of the thread 182 is the widest portion of the thread 182 and has a height 187, and the tip 182b (the portion furthest from the outer surface 166) of the thread 182 is the narrowest portion of the thread 182 and has a height 188 less than the height 187 of the base. In some aspects, the thread depth may be in the range of approximately 0.01 inches (0.03 cm) to approximately 1.5 inches (3.81 cm), approximately 0.05 inches (0.13 cm) to approximately 1 inch (2.54 cm), approximately 0.1 inches (0.25 cm) to approximately 0.5 inches (1.27 cm), any combination of the foregoing ranges, or other suitable ranges. The thread 182 may be defined by a specific thread angle 184 measured between adjacent portions of the thread 182 in a direction parallel to the central axis A. In some respects, the thread angle 184 can be between approximately 0 degrees (i.e., non-helical thread) and approximately 90 degrees, between approximately 0 degrees and approximately 60 degrees, between approximately 0 degrees and approximately 45 degrees, between approximately 0 degrees and approximately 30 degrees, or other suitable angles. The attachment of the thread 182 to the body 154 can be a circular attachment, such that the base 182a of the thread 182 and the outer surface 166 define a specific radius of curvature 189.

[0106] The docking retainer 150 can be substantially cylindrical and can have a cross-sectional diameter 151 (measured perpendicular to the central axis A, e.g.) Figure 10(As shown). In some aspects, the cross-sectional diameter 151 may be between about 0.1 inches (0.25 cm) and about 3 inches (7.62 cm), between about 0.2 inches (0.51 cm) and about 2 inches (5.08 cm), between about 0.3 inches (0.76 cm) and about 1.5 inches (3.81 cm), between about 0.4 inches (1.02 cm) and about 1 inch (2.54 cm), or within a combination of the foregoing ranges. The mating retainer 150 may also define a height 152 (measured along the central axis A between the proximal end 158 and the distal end 162). Figure 10 In some respects, a height of 152 can be between approximately 0.1 inches (0.25 cm) and approximately 3 inches (7.62 cm), between approximately 0.2 inches (0.51 cm) and approximately 2 inches (5.08 cm), between approximately 0.3 inches (0.76 cm) and approximately 1.5 inches (3.81 cm), between approximately 0.4 inches (1.02 cm) and approximately 1 inch (2.54 cm), or a combination of the above ranges.

[0107] refer to Figures 11A-11D The figures depict a non-limiting example of a docking retainer 150 with specific measurements and dimensions. It should be understood that the values ​​depicted in these figures are exemplary and are not intended to limit or otherwise restrict the scope of this application. Figures 11A-11D As shown, the exemplary docking retainer 150 may have a thread 182 having a pitch 183 of approximately 0.18 inches (0.46 cm). Figure 11A Thread 182 can have a thread angle of approximately 17 degrees (184). Figure 11C ). Thread 182 can have a thread depth of approximately 0.1 inch (0.25 cm) for 185 ( Figure 11D In some respects, measured in a direction parallel to the central axis A, the base 182a may have a height 187 of approximately 0.057 inches (0.14 cm). Figure 11D ). Measured in the same direction parallel to the central axis A, tip 182b may have a height of approximately 0.033 inches (0.085 cm) 188 ( Figure 11D The attachment of thread 182 to body 154 can be a circular attachment, such that the base of thread 182 and outer surface 166 define a radius of curvature. In some respects, the radius of curvature 189 can be approximately 0.01 inches (0.03 centimeters). Figure 11D In some exemplary aspects (e.g.) Figures 11A-11D (As described in the text), the docking retainer 150 may have a cross-sectional diameter 151 of approximately 0.8 inches (2.03 cm). Figure 11A) and a height of approximately 0.88 inches (2.24 cm) 152 ( Figure 11C ).

[0108] In some aspects, thread 182 may extend less than one turn around the body 154 of the mating retainer 150. In some aspects, thread 182 may extend one or more turns around the body 154. In some aspects, for example in... Figures 11A-11D In the middle, thread 182 can extend around body 154 approximately 3.21 turns.

[0109] In some examples, such as Figure 10 , Figure 11A and Figure 11C As shown, the docking retainer 150 may further include an opening 190 extending through the body 154 between the outer surface 166 and the inner surface 170, such that the outer surface 166 is in fluid communication with the hole 174. Figure 11C The opening 190 may have a central axis defined in the radial direction and perpendicular to the central axis A (extending through the center of the opening 190).

[0110] An opening 190 may be provided between adjacent threads 182 or threaded portions of threads 182 on the body 154. In some aspects, the mating retainer 150 may define a plurality of openings 190 thereon. When the mating assembly 200 is on the mating retainer 150, the opening 190 provides additional passage for the mating assembly 200.

[0111] The docking assembly 200 is configured to be received circumferentially around the body 154 of the docking retainer 150, such that at least a portion of the docking assembly 200 rests on the thread 182. Providing access to an increased surface area of ​​the docking assembly 200 may be advantageous during sterilization, rinsing, and / or other preparation of the docking assembly 200. When the docking device is on the docking retainer 150 and in contact with the thread 182, the opening 190 may be adjacent to the docking assembly 200.

[0112] The opening 190 can be substantially circular, but it should be understood that in other respects, the opening 190 can be a different cross-sectional shape, such as elliptical, triangular, rectangular, or other suitable cross-section. In some respects, each opening 190 is circular and can have a diameter 191 between approximately 0.01 inches (0.03 cm) and approximately 0.2 inches (0.51 cm). In some specific examples (e.g., in...) Figures 11A-11D (As shown in the non-limiting example), the diameter 191 can be approximately 0.063 inches (0.16 cm).

[0113] The docking retainer 150 can be formed of any suitable material that can be contacted by the docking assembly 200, exposed to a liquid (e.g., saline) in which the docking assembly 200 will be conditioned, sterilizable, and will not adversely affect the biocompatibility of the docking assembly 200. In some aspects, the docking retainer 150 may include a plastic material, such as a natural acetal homopolymer (Delrin 500p Nc010). It should be understood that other suitable materials may be used and the docking retainer 150 may include a variety of suitable materials. In some aspects, the docking retainer 150 may include ABS. In some aspects, the docking retainer 150 may include a material suitable for injection molding.

[0114] When the docking assembly 200 is introduced onto the package 100, the docking retainer 150 may be attached to the package 100. Alternatively, in some aspects, the docking retainer 150 may be detached from the rest of the package 100 when the docking assembly 200 is first introduced onto the package 100. Figure 12 An example of a mating assembly 200 placed on a mating retainer 150 is depicted. The mating assembly 200, which may include a helical coil shape, may be oriented about a central axis A such that the mating assembly 200 is axially aligned with the mating retainer 150 along the central axis A. The mating assembly 200 can then be axially moved along the central axis A toward the mating retainer 150. During axial movement, the mating assembly 200 also rotates about the central axis A, such that the mating assembly 200 engages one or more threads 182 on the outer surface 166 of the body 154 of the mating retainer 150. The mating assembly 200 can be moved circumferentially and axially relative to the mating retainer 150 in a helical, screw-like motion, such that the mating assembly 200 follows the threads 182. The mating assembly 200 can coil around the mating retainer 150 such that the threads 182 separate adjacent coils of the mating assembly 200 in a direction parallel to the central axis A. The mating assembly 200 can move continuously along the threads 182 until the mating assembly 200 is in the desired position and orientation relative to the mating retainer 150. It should be understood that similar results can be obtained using the reverse process, wherein the mating assembly 200 remains stationary while the mating retainer 150 is axially and rotationally aligned, oriented, and moved relative to the mating assembly 200. In some aspects, both the mating assembly 200 and the mating retainer 150 can be moved (e.g., rotated) relative to each other, such that engagement between the mating assembly 200 and the mating retainer 150 is achieved to reach the desired position and orientation of the mating assembly 200 on the mating retainer 150.

[0115] In some aspects, the mating assembly 200 includes an extension 204 separating a first portion 208 from a second portion 212 of the mating assembly 200. The second portion 212 of the mating assembly 200 may include an atrial turn or coil of the mating assembly 200 (therefore, the second portion 212 may be referred to as the atrial turn portion). The first portion 208 of the mating assembly 200 may include a plurality of adjacent coils 210 having the same or similar diameter and may be referred to as functional coils of the mating assembly 200. The second portion 212 may have a diameter larger than the diameter of the adjacent coils 210 of the first portion 208 of the mating assembly 200. The first portion 208 may be coiled and configured to contact the thread 182. The first portion 208 may include two or more adjacent coils 210 that are continuous with each other (in a helical or circumferential direction) but axially separated from each other by the thread 182 of the mating retainer 150 when mounted around the mating retainer 150.

[0116] Orienting the mating assembly 200 toward the mating retainer 150 may be advantageous such that, when the mating assembly 200 is fully engaged with the mating retainer 150, the extension 204 is adjacent to the lead 183a of the thread 182 closest to the distal end 162. In these respects, the extension 204 may also be opposite to the mating retainer 150, such that a portion, a majority, or all of the thread 182 is located between the extension 204 and the proximal end 158 of the body 154. Thus, the second portion 212 (or atrial turn portion) of the mating assembly 200 may be spaced apart from the mating retainer 150. Such orientation helps protect the various portions of the mating assembly 200 from damage, for example, by positioning the extension 204 and the atrial turn portion 212 connected to the extension 204, so that it is not under strain when the mating assembly 200 is inserted into the package 100. It should be understood that the accompanying drawings depict non-limiting examples and are not intended to limit the present disclosure to the specific methods shown.

[0117] When the mating assembly 200 is fully engaged with the mating retainer 150, the mating retainer 150 can be attached to the remainder of the package 100. In some aspects, for example Figure 13 and Figure 14 As shown, the docking retainer 150 can be moved into engagement with the post 148 defined on the package 100 as described above. The docking retainer 150 can be fixedly attached to the post 148 such that both the docking retainer 150 and the docking assembly 200 thereon are within the docking support 124a.

[0118] Figure 17AA non-limiting exemplary DDS 300 is depicted, which can be connected to a docking component 200 and configured to deliver the connected docking component 200 to a target implantation site. In some examples, the docking component 200 can be connected to the DDS 300 via one or more sutures. It should be understood that... Figure 17A The DDS 300 is exemplary, and other device delivery systems configured to receive and deliver docking components are also possible.

[0119] Figure 17A A DDS 300 is depicted having a handle 304 and a shaft 330 extending distally from the handle 304, and a docking assembly partially unfolded from the distal end of the shaft 330 (e.g., for illustrative purposes). The shaft 330 can be configured to receive the docking assembly 200 (in an unfolded or straight configuration) during delivery to the target implantation site via the patient's vascular system.

[0120] The DDS 300 may also include a Y-connector assembly 308 (or hub assembly) extending proximally from the handle 304, and a suture locking assembly 320 connected to the Y-connector assembly 308. Various flush ports 334 are connected to the Y-connector assembly 308 and the handle 304 (e.g., flush ports 334 connected to the handle 304 including the valve assembly 324). The DDS 300 may also include a sleeve handle 234 extending proximally from the Y-connector assembly 308. It should be understood that the DDS 300 includes various other components and is not limited to those described above. Further details of the DDS and its various components are described in International Application No. PCT / US2020 / 036577, which is incorporated herein by reference in its entirety.

[0121] In the aspect where docking component 200 and DDS 300 are packaged in the same package 100, DDS 300 can be introduced into package 100, such as Figure 1 , Figure 2 , Figure 15 And / or as shown in Figure 16. Reference Figure 15 and Figure 16 The DDS 300 can be aligned and oriented relative to the features of the package 100 before being inserted into the package 100. The various parts of the DDS 300 can be introduced into their respective holders 124. Figure 3 In the brackets 124b-124f shown, as described above and below. In some aspects, portions of the DDS 300 can be further contacted by the retaining member 118 as described above. The DDS 300 can be oriented and arranged within the package 100 based on a desired advantageous placement to protect the various components of the DDS 300 and facilitate proper removal of the DDS 300. Some exemplary components of the DDS 300 are shown in... Figure 15 and Figure 16 While depicted in the figures, it should be understood that the DDS 300 includes additional components, and the packaging method described herein is not limited to those components shown in the figures. Some portions of the DDS 300 may be inspected before and after being placed in the package 100. The package 100 (e.g., base 104) may be shaped to correspond to various components of the DDS 300 to receive components of the DDS 300 in desired locations and orientations.

[0122] During packaging, it may be advantageous to ensure that certain components of the DDS 300 are arranged in package 100 as needed. For example, refer to Figure 15 The handle 304 of the DDS 300 can be disposed in the handle holder 124b, and the Y-connector assembly 308 connected to the handle 304 can be disposed in the Y-connector assembly holder 124c. The suture locking assembly 320 can be disposed in the suture locking holder 124f, and the stopcock assembly 324 can be disposed in the stopcock holder 124d. Figure 15 Furthermore, the shaft 330 of the DDS 300 can be housed in the shaft support 124e (e.g., Figure 3 (As shown).

[0123] During the packaging process, it may be beneficial to ensure that the suture locking handle 322 (or knob) of the suture locking assembly 320 is facing upward or outward on the inside of the packaging (i.e., in a direction away from the base 104). Figure 15 Furthermore, in some examples of the packaging process, the push button 328 connected to the handle 304 should be screwed in, the outer tube cap 312 connected to the Y-connector assembly 308 should be loose, and the swivel cap connected to the Y-connector assembly 308 should be screwed on but not tightened.

[0124] In the aspect where the packaging 100 includes a lid 108, the lid 108 may also include various protrusions 120 as described above. Figure 4 The cover 108 can be formed such that, like the base 104, the shape of the cover 108, the protrusion 120, and other features on the cover 108 correspond to the desired placement of the DDS 300 and its associated components. For example, as Figure 16 As shown, the lid 108 includes a support 124 configured to receive a stitch lock handle 322 in the support when the lid 108 is engaged with the base 104 and the package 100 is in a closed configuration. This arrangement helps to hold the stitch lock handle 322 in the desired position to prevent the stitch lock handle 322 from twisting or breaking during packaging, storage, or shipping.

[0125] As referenced above Figure 3 and Figure 4The package 100 also includes a plurality of retaining members 118 configured to releasably secure various components (e.g., flush port 334) to or near their respective holders 124. Figure 15 Package 100 may also include a docking bracket 124a configured to receive at least a portion of docking assembly 200, as described herein. Figure 3 ).

[0126] Figure 17B An exemplary docking component 200 is depicted, which can be made of a suitable DDS (e.g., Figure 17A The DDS 300 shown is delivered to the target implantation site. The docking assembly 200 is shown extending distally outward from the distal end of the axis 330 of the DDS 300. The docking assembly 200 includes a cannula 220 and a docking member 230 within the cannula 220. The docking member 230 is configured to be slidably movable within the cannula 220. The cannula 220 and the docking member 230 are configured to move relative to the distal end 332 of the axis 330 of the DDS 300. The docking assembly 200 can be slidably moved within the axis 330. For reference, in this application, movement of the docking assembly 200 away from the axis 330 refers to distal movement of the docking assembly 200, and movement of the docking assembly 200 toward the axis 330 refers to proximal movement of the docking assembly 200. The cannula 220 has a distal end 222 and a marking band 224. The docking member 230 has a distal end 232.

[0127] The disclosed packaging method may also include various additional steps, such as inspecting different components, cleaning the packaging 100, DDS300 and / or docking assembly 200, or other steps typically performed in medical packaging scenarios.

[0128] After all components of docking assembly 200 and / or DDS 300 have been correctly introduced into package 100 in their respective desired positions and orientations, package 100 can be closed. The closing step may include engaging lid 108 with base 104 such that the opening 115 between base 104 and lid 108 is closed and the internal space 112 is completely sealed between base 104 and lid 108. Package 100 can then be sterilized via one or more acceptable sterilization methods suitable for medical devices, such as exposure to ethylene oxide gas or gamma radiation. It should be understood that other suitable sterilization methods may be utilized.

[0129] The docking components 200 and / or DDS 300 may be stored within closed and sterilized packaging 100 until they are needed for implementation. Medical use of the docking components 200 and DDS 300 may be performed under standard medical and surgical conditions, following best practices understood at the time of use. While various methods can be utilized for unpacking and preparing the docking components 200 and / or DDS 300 from packaging 100, some exemplary procedures are described herein. It should be understood that deviations from these methods may be made based on intended use, medical conditions, or other factors that may affect the use of the components.

[0130] refer to Figure 18 The flowchart depicts an exemplary, non-limiting method or process 400 for unpacking, preparing, and conditioning docking components 200 and DDS 300. Some steps in the described process 400 may be omitted or repeated as needed during operation. Furthermore, additional steps may be performed before, during, or after process 400, and this disclosure is not intended to limit process 400 to the steps described only. Additionally, process 400 may be implemented with another docking component and / or DDS that may be similar to docking component 200 and / or DDS 300.

[0131] First, at 404, package 100 is retrieved and accessed from the storage device. Package 100 (which includes docking assembly 200 and / or DDS 300) is in a closed configuration and is sterile. Package 100 may be secured within a housing. In some respects, package 100 may be held within sleeve 101a (see...). Figure 19 For example, sleeve 101a may include a bag or pouch. In some aspects, package 100 may be further held within a first box 101b and optionally within a second box 101c. Figure 19The sleeve 101a and the boxes 101b and 101c can have different levels of sterility. For example, the sleeve 101a can be sealable, such that the interior of the sleeve 101a is sterile. This allows the entire package 100 to also be sterile, wherein both the interior and exterior of the package 100 are sterilized and remain sterile while inside the sleeve 101a. In some aspects, when the sleeve 101a is sealed and sterilized, it is moved to a non-sterile environment, such that the outer surface of the sleeve 101a is no longer sterile, while the sealed interior (which includes the package 100) remains sterile. The sleeve 101a can then be further packaged into an outer container, such as a first box 101b. The first box 101b may not be sterile. In some aspects, the package 100 can be stored or transported while in the first box 101b. Alternatively, the first box 101b can be further packaged into another outer container (e.g., a second box 101c). The second box 101c may also be non-sterile and can be used as additional protection against damage during storage and / or transport. Therefore, at 404, a user can access package 100 from one or more of the sleeve 101a, the first box 101b, the second box 101c, or another container. In some respects, the internally sterile sleeve 101a can be removed from any external container and placed in a sterile environment such that the entire package 100 remains sterile when the sleeve 101a is opened and package 100 is removed from it. The sleeve 101a, boxes 101b and 101c, and any other external container can be disposed of after package 100 has been removed.

[0132] In the method at 408, the user can open the package 100. The package 100 is moved from a closed configuration to an open configuration, wherein in the closed configuration, the internal space 112 is sealed from the external environment by the base 104 and the lid 108, and in the open configuration, the user can access the internal space 112 through the opening 115 defined between the base 104 and the lid 108. Figure 1 and Figure 2 The cover 108 can move away from the base 104. In the case where the cover 108 is separated from the base 104, the cover 108 can be completely removed and spaced apart from the base 104. In the case where the cover 108 and the base 104 are hingedly attached to each other, the cover 108 can rotate or pivot away from the base 104 along the hinged attachment.

[0133] In the method at 412, the user can inspect package 100 and its components. Inspection can reveal any damage to mating assembly 200 and / or DDS 300. In some respects, the user can also verify the correct item identification number. In certain respects, the user can ensure that the stitching locking assembly 320 is undamaged and correctly oriented within package 100. If DDS 300 is damaged while in package 100, stitching locking assembly 320 may be compromised, and it may be advantageous to determine whether any components are damaged before proceeding. The user can also ensure that DDS 300 is completely unbent.

[0134] In some aspects, the docking assembly 200 includes a coating thereon to facilitate insertion into the patient and implementation at the target site. The docking assembly 200 may include a coating, a lubricating coating, and / or a hydrophilic coating (e.g., a hydrogel) thereon (e.g., on the sleeve 220 of the docking assembly 200). In some examples, the docking part 230 of the docking assembly 200 may have a coating. During transport or storage, the environment may change over time, for example, with different weather patterns and / or geographical location. These environmental changes may include humidity variations. Some hydrophilic coatings may absorb moisture from the environment. When the delivery device is transported or stored, the hydrophilic coatings may undergo one or more wet-dry cycles. Due to wet-dry cycles, the hydrophilic coatings on adjacent coils of the docking assembly 200 may stick together. Other coatings may also be prone to sticking together on adjacent coils. Coil sticking of the docking assembly 200 may be problematic when the docking assembly 200 is prepared or loaded into the DDS 300 for use. To improve the use of the docking assembly 200 and ensure its safe transfer into a patient, the docking assembly 200 may be treated before introduction into the patient to mitigate any undesirable changes to its coating. Treatment may include activating the coating on the docking assembly 200. At 416, the coating may be activated by introducing a liquid into the docking assembly 200. The liquid may include saline (e.g., heparinized saline), but it should be understood that other suitable biocompatible liquids may be used. In some aspects, saline may be sprayed onto the docking assembly 200. In some aspects, the docking assembly 200 may be immersed in saline.

[0135] refer to Figures 20A-20CSaline solution 125 can be introduced into the docking holder 124a of package 100. The amount of saline solution 125 should be sufficient to cover the desired portion of docking assembly 200, such as the entire docking assembly 200 or the coil 210 of docking assembly 200. The docking holder 124a can be appropriately sized to allow the necessary amount of saline solution 125 to be received within the docking holder 124a without causing saline solution 125 to overflow from the outside of the docking holder 124a into other parts of package 100. Saline solution 125 can be introduced into the docking holder 124a while the docking assembly 200 remains held within the docking holder 124a, for example, on the docking retainer 150. The docking assembly 200 can be held in the saline solution 125 for a predetermined time. Contacting the docking assembly 200 with the saline solution 125 can activate the coating on the docking assembly 200 and reduce friction between the docking assembly 200 and the patient during insertion into the patient. The saline solution 125 can also degas the docking assembly 200 by diverting air from its contact with the docking assembly 200. This degassing helps reduce the chance of air bubbles being introduced into the patient's body when the docking assembly 200 is inserted.

[0136] Back Figure 18 At 420 of process 400, the DDS 300 and docking assembly 200 are flushed with a liquid (e.g., heparinized saline). The saline may be introduced into one or more of the flushing ports 334 and / or into other flushing ports on the DDS 300. It should be understood that any caps, nuts, or retainers may be loosened, unscrewed, or opened to allow saline to move through the DDS 300. When the DDS 300 is used to introduce the docking assembly 200 into a patient, this flushing helps to degas the DDS 300 to remove air and prevent bubble formation. The user can ensure that the flushing is functioning correctly by observing whether the saline flows from the location where it is introduced at one or more of the flushing ports 334 to and out of the opposite ends of the DDS 300 (e.g., at the location where the DDS 300 receives the docking assembly 200 or at the distal end of the DDS 300). In some respects, the flushing at 420 may be performed prior to activation at 416 of process 400. In this respect, the brine used to rinse the DDS 300 can be collected in the docking support 124a as it leaves the DDS 300 adjacent to the docking assembly 200. Thus, the same brine 125 used to rinse the DDS 300 can then be used to degas and activate the docking assembly 200, as described above with reference to step 416.

[0137] After the inspection, degassing, and rinsing steps, in the aspect where the docking assembly 200 is connected to the DDS 300 and / or at least partially arranged within the DDS 300, the docking assembly 200 can be retracted into the DDS 300 at 424. The DDS 300 can be actuated such that at least a portion of the docking assembly 200 is moved into the DDS 300, for example, by moving into the shaft 330. During this movement, the docking assembly 200 can slide relative to and slide away from the docking retainer 150. This step can be initiated while the docking assembly 200 is still immersed in the brine 125 in the docking support 124a. In some aspects, the docking assembly 200 can be moved into the DDS 300 until a predetermined portion of the docking assembly 200 (e.g., a portion representing a quarter turn of the docking assembly 200, specifically, for example, a quarter turn of the first coiled portion 208 of the docking assembly 200) remains outside the DDS 300.

[0138] Additional steps may be performed after step 420 of process 400, such as DDS 300 and / or further inspection of the mating assembly 200. For example, the user may visually inspect the mating assembly 200 to ensure that its components are correctly aligned. (Reference) Figures 21A-21C An exemplary docking assembly 200 is shown, wherein the sleeve 220 and the docking member 230 are in different positions relative to each other (see [link]). Figure 17B (For reference only). Sleeve 220 includes a distal end 222 and a marking strip 224. Connector 230 includes a distal end 232. If, after 420 in process 400, the distal end 232 of connector 230 is positioned distal to the distal end 222 of sleeve 220 (e.g.) Figure 21C As shown), the sleeve 220 should be moved in the distal direction (away from DDS 300) such that the distal end 222 of the sleeve 220 covers the distal end 232 of the mating member 230. Figure 21A If the distal end 232 of the mating member 230 is positioned proximal to the marking band 224 (i.e., the distal end 232 of the mating member 230 is between the marking band 224 and the DDS 300, such as...) Figure 21B As shown), the sleeve 220 should be moved in the proximal direction (towards DDS 300) opposite to the distal direction until the marking band 224 is between the distal end 232 of the mating member 230 and DDS 300. Figure 21A Ensure that the distal end 232 of the mating member 230 is positioned between the marking strip 224 and the distal end 222 of the sleeve 220. Figure 21A This could be advantageous. Figures 21A-21C In the diagram, a dashed line is included for reference to show the position of the distal end 232 of the mating member 230 relative to the distal end 222 of the sleeve 220.

[0139] The above is for reference only. Figure 18 The described process 400 offers various advantages over the prior art. By providing a docking bracket 124a, the docking assembly 200 can be adjusted in the docking bracket 124a prior to use, allowing the user to hold the docking assembly 200 within the package 100 until it is ready for use. This eliminates the other necessary steps of removing the docking assembly 200 from the package 100, obtaining a suitable container or pallet, placing the docking assembly 200 into the container or pallet, and then adjusting it. By providing the docking bracket 124a, the user can perform the necessary adjustments within the package 100 itself. This reduces the chance of damaging the docking assembly 200 during unintended removal from the package 100. Furthermore, during the adjustment process, the docking assembly 200 can be held on the docking retainer 150, which allows the docking assembly 200 to be oriented in the desired position and the individual coiled portions of the docking assembly 200 can be separated by the threads 182 of the docking retainer 150. This allows the saline solution 125 to better surround, penetrate, and coat the docking assembly 200 compared to removing the docking assembly 200 from the docking holder 150 before performing degassing and rinsing steps. By providing the docking support 124a within the package 100, the need for external tools and trays is eliminated, increasing the workspace in the designated sterile environment (or alternatively reducing the space required for the sterile environment).

[0140] This document also discloses alternative packaging concepts that can be utilized in conjunction with the DDS 300 and / or docking assembly 200 (or similar DDS and docking assemblies) as described above. References Figures 22-24 Package 500 is depicted having a base 504 configured to receive one or both of DDS 300 and docking assembly 200. Package 500 may comprise high-density polyethylene (HDPE) or another suitable polymer. Base 504 is configured such that docking assembly 200 and / or DDS 300 can be releasably secured to base 504 in a desired position and orientation to prevent damage to the components and allow for safe sterilization, packaging, storage, shipping, and preparation for use. Package 500 may provide some or all of the advantages described above with respect to package 100.

[0141] Base 504 defines a base surface 512 configured to receive mating assembly 200 and / or DDS 300 thereon. One or more caps 508 may be configured to releasably contact a portion of base 504. In some aspects, one or more caps 508 may be hingedly attached to base 504 such that one or more caps 508 are configured to rotate toward and away from base 504 along hinge 509. In some aspects, package 500 may include a plurality of caps 508, each of the plurality of caps 508 being individually configured to move toward or away from base 504. Caps 508 may define one or more attachment members 510 configured to releasably secure one or more caps 508 to base 504. Figure 23 and Figure 24 ). Figures 22-23 An example is depicted in which package 500 includes a first lid 508a and a second lid 508b, the second lid 508b including an attachment member 510.

[0142] Multiple retention features 518 (or retention members) are disposed on base surface 512 and configured to releasably engage docking assembly 200 and / or DDS 300. Retention features 518 may comprise deformable, flexible, or otherwise stretchable material, such that retention features 518 can be deflected relative to base 504 in a desired direction to engage corresponding components of docking assembly 200 and DDS 300. Retention features 518 may comprise strips, tabs, notches, protrusions, or other retention mechanisms. In some aspects, retention features 518 are cutouts defined on base 504 that are configured to deflect away from base 504. When retention features 518 are deflected away from base 504, one or more components may be received between retention features 518 and base surface 512, between retention features 518 and one or more caps 508, between retention features 518 and another component, or between separate retention features 518.

[0143] In some respects, additional retaining features separate from base 504 can be introduced into base 504. For example, first strip 520a can be introduced into base 504. Figure 24 The first strip 520a can be secured to the base 504, to one or more recesses 520b defined on the base surface 512. In some aspects, an additional strip (e.g., a second strip 521a) can be introduced into the base 504 and secured with a corresponding recess 521b defined on the base 504. Figure 24 ).exist Figure 27A The first exemplary strip 520a is depicted separately in the image. Figure 27B The second exemplary band 521a is depicted separately, and in Figure 27CThe third exemplary band 522a is depicted separately (in some examples it may be included on the base 504 in place of or attached to it). Figure 24 (The strip shown).

[0144] First, second, and / or third straps 520a, 521a, and 522a may be removably engaged with base 504 to further secure portions of docking assembly 200 and / or DDS 300. In some aspects, the first strap 520a may be used to secure the handle 304 of DDS 300 to base 504. In some aspects, the second strap 521a may be used to secure another portion of DDS 300 extending from handle 304. In some aspects, the third strap 522a may be used to secure one or more tubular components (e.g., various flushing ports 334) to base 504. While the first, second, and third exemplary straps 520a, 521a, and 522a are depicted as components separate from base 504, it should be understood that package 500 may be formed such that the straps are integral with base 504.

[0145] In some aspects, the docking retainer (e.g., the first docking retainer 550a) Figure 25A and Figure 25B ) and / or the second docking retainer 550b ( Figure 26A and Figure 26B The mating assembly 200 or at least a portion thereof may be received in the package 500. The mating retainers 550a, 550b may be components separate from the base 504, configured to be received on and secured to the base 504. The base 504 may include one or more mating retainer supports 548a, 548b configured to receive the mating retainer 550a in the package 500. Figures 22-24 ).

[0146] refer to Figures 25A-26BThe docking retainers 550a and / or 550b may be substantially cylindrical and configured to receive a portion of the docking assembly 200 thereon. Both docking retainers 550a and / or 550b may include a body 554 having a proximal end 558 and a distal end 562 opposite to the proximal end 558. A central axis B extends between the proximal end 558 and the distal end 562. The body 554 may be substantially cylindrical; however, it should be understood that other shapes may be utilized and will depend on the docking assembly 200 that the docking retainers 550a and / or 550b will be designed to receive and retain. The body 554 has an outer surface 566 and an inner surface 570 opposite to the outer surface 566 and spaced radially toward the central axis B from the outer surface 566. The inner surface 570 defines a hole 574 extending through the body 554. Hole 574 may be a through hole that extends integrally along the body 554 and opens at both the proximal end 558 and the distal end 562. Alternatively, hole 574 may be a blind hole that extends along a portion of the body 554 and opens at the proximal end 558 but not at the distal end 562.

[0147] In some aspects, package 500 may include two mating retainers 550a and 550b, both configured to contact mating assembly 200. In some aspects, first mating retainer 550a may be configured to be disposed on base 504 at first mating retainer support 548a, and second mating retainer 550b may be individually configured to be disposed on base 504 at second mating retainer support 548b, spaced apart from first mating retainer support 548a. Figure 23 (The first and second docking retainers 550a and 550b are shown as a phantom image through dashed lines). The first docking retainer 550a may be adjacent to the second docking retainer 550b.

[0148] The first docking retainer 550a can be configured to receive a first portion 208 of the docking assembly 200 thereon, while the second docking retainer 550b can be configured to receive a second portion 212 of the docking assembly 200. Figure 29D The combination of the first docking retainer 550a and the second docking retainer 550b provides additional support for different parts of the docking assembly 200. The second docking retainer 550b may have similar features to the first docking retainer 550a, but is defined relative to the central axis C. Figure 26A and Figure 26BThe central axis C may be parallel to and spaced apart from the central axis B. In some respects, the central axis C may be spaced apart from and not parallel to the central axis B. The second mating retainer 550b may include other features identical to those of the first mating retainer 550a, unless otherwise indicated.

[0149] The first mating retainer 550a and the second mating retainer 550b may have the same shape and size, or alternatively may have different shapes and / or sizes. Each of the first mating retainer 550a and the second mating retainer 550b may be substantially cylindrical and may have cross-sectional diameters 551a and 551b respectively (measured perpendicular to central axis B and central axis C, respectively, e.g., ...). Figure 25A and Figure 26A (As shown). In some aspects, diameters 551a and 551b can be between about 0.1 inches (0.25 cm) and about 3 inches (7.62 cm), between about 0.2 inches (0.51 cm) and about 2 inches (5.08 cm), between about 0.3 inches (0.76 cm) and about 1.5 inches (3.81 cm), between about 0.4 inches (1.02 cm) and about 1 inch (2.54 cm), or within a combination of the above ranges. In some aspects, the diameter 551a of the first mating retainer 550a can be larger than the diameter 551b of the second mating retainer 550b, or vice versa. In some aspects, diameters 551a and 551b can be substantially equal. In some particular aspects (e.g.) Figures 25A-25B (As shown in those aspects), the first docking retainer 550a may have a diameter 551a between approximately 0.7 inches (1.78 cm) and approximately 0.931 inches (2.365 cm). Figures 26A-26B In an exemplary aspect, the second docking retainer 550b may have a diameter 551b between approximately 0.5 inches (1.27 cm) and approximately 0.651 inches (1.654 cm).

[0150] The docking retainers 550a and 550b may also define heights 552a and 552b, respectively, which are measured along central axis B and central axis C between each respective proximal end 558 and distal end 562. Figure 25B and Figure 26BIn some aspects, the height 552a of the first mating retainer 550a may be greater than the height 552b of the second mating retainer 550b. In some aspects, the height 552a may be less than the height 552b. In some aspects, the heights 552a and 552b may be substantially the same. The heights 552a and 552b may be between about 0.1 inches (0.25 cm) and about 3 inches (7.62 cm), between about 0.2 inches (0.51 cm) and about 2.5 inches (6.35 cm), between about 0.3 inches (0.76 cm) and about 2 inches (5.08 cm), between about 0.4 inches (1.02 cm) and about 1.5 inches (3.81 cm), or within a combination of the foregoing ranges. Figures 25A-26B In the specific exemplary aspects depicted, heights 552a and 552b may be approximately 1.5 inches (3.81 cm).

[0151] In some aspects, the aforementioned mating retainer 150 may replace or be attached to one or more mating retainers 550a, 550b for use with package 500. In these aspects, mating retainer supports (or struts) 548a and / or 548b may be configured to engage with mating retainer 150. In some aspects, package 500 may include multiple mating retainers, such as mating retainer 150 and mating retainers 550a or 550b.

[0152] In some respects, the second cover 508b can be defined by one or more attachment members 510 on the second cover 508b. Figure 23 The engagement between the receiving member 511 on the base 504 or on another component within the package 500 and the receiving member 511 is releasably attached to the base 504. Figure 29E and Figure 29G In some aspects, the first docking retainer 550a and / or the second docking retainer 550b may include a receiving member 511 thereon (see...). Figure 29E The receiving member 511 is configured to attach to the attachment member 510 (e.g., the attachment member 510 on the second cover 508b, such as...). Figures 23-24 (As shown) can be releasably engaged.

[0153] Components of docking assembly 200 and DDS 300 can be secured within package 500 by one or more components of package 500. (Reference) Figure 28 and Figures 29A-29I This shows various reserved features 518 that can be configured to engage with components of the DDS 300 and docking assembly 200. Figure 28 and Figures 29A-29INon-limiting examples of various retention features 518 are shown, which are configured to retain various exemplary components of the DDS 300 and / or docking assembly 200 and / or their interfaces.

[0154] As an example, Figure 28 Multiple retention features 518a are shown, which can be configured to retain and / or preserve the shaft 330 (or conduit) of the DDS 300 on the base 504 of the package 500 (e.g., Figure 29C (as shown). In some embodiments, the retaining feature 518a may be configured as a pair of tabs (e.g., a conduit shaft retaining tab) that are configured to extend over a portion of the shaft 330. Figure 28 Also shown is a retaining feature 518b configured as a center handle retaining tab, which is configured to hold part of the handle 304 of the DDS 300 (as shown). Figure 29H (As shown). Package 500 may also include retention feature 518c configured as a stopcock and / or Luer retention tab, configured to retain the stopcock, Luer connector and / or connected stopcock tube (as shown) of DDS 300. Figure 29H and Figure 29I (As shown). The package 500 may also include a retaining feature 518d configured as a pop-out tab, which is configured to retain a portion of the suture locking assembly 320 of the DDS 300 (as shown). Figure 29H and Figure 29I (As shown). Additionally or alternatively, the package 500 may include one or more retention features 518e configured to stop tabs, which are configured to stop or retain another portion of the DDS 300 (as shown). Figure 28 The package 500 may also include one or more retaining features 518f configured to lock tabs, the one or more retaining features 518f being capable of locking together to retain the distal portion of the shaft 330 of the DDS 300, the distal portion of the shaft 330 being configured to receive the docking assembly 200 therein. Figure 28 , Figure 29B , Figure 29E and Figure 29F ).

[0155] As described above, when the docking assembly 200 is secured to one or more docking retainers 150 or 550, it may be advantageous to ensure that the coil 210 of the docking assembly 200 remains separated from the adjacent portion (in the axial direction) of the docking assembly 200. When the docking assembly 200 is introduced onto the docking retainer 550 (e.g., onto the first docking retainer 550a), the separator 582 can be disposed on the docking retainer 550, and when the docking assembly 200 is disposed on the docking retainer 550 (… Figure 32When in contact with the mating assembly 200, the separator 582 can be positioned between adjacent coils (e.g., the first coiled portion 208). Reference Figure 30 An exemplary separator 582 is shown in a flat, unfolded configuration. Separator 582 may comprise the same material as the remainder of package 500, or alternatively, it may comprise a different material. Separator 582 is configured to engage docking retainer 550 such that a portion of separator 582 is arranged axially between at least two adjacent portions of docking assembly 200. Figure 32 The separator 582 includes a body 584 that defines an opening 586 thereon. The opening 586 is configured to receive a docking retainer 550 therein. The body 584 is foldable along a fold 588. Figure 30 A top view of the separator in its unfolded configuration is depicted. Figure 31 A side view of the separator in a folded configuration is depicted. The main body 584 may define multiple openings 586. Figure 32 A docking retainer 550 having a docking assembly 200 thereon and a separator 582 disposed on the docking retainer 550 are depicted such that at least a portion of the separator 582 is between adjacent coils of the first portion 208 of the docking assembly 200.

[0156] In some examples, the base 504 may not include the dedicated docking bracket 124a as described above. In some aspects, and referring to... Figure 33 The detachable docking tray 524a can be introduced into or onto the base 504 to serve substantially the same purpose as the docking tray 124a described throughout this application. The docking tray 524a may comprise the same material as the rest of the package 500, or alternatively, it may comprise a different material. The docking tray 524a can be detached from the package 500 and can be configured for engagement by a user with the package 500. One or more retention features may be provided on the package 500, configured to releasably engage with the docking tray 524a to secure the docking tray 524a to the package 500, for example, to the base 504.

[0157] Utilizing packaging 500 together with docking assembly 200 and / or DDS 300 may have similarities to using packaging 100 as described above. However, there are some differences between the disclosed packaging concepts. Unlike packaging 100 in which various components of docking assembly 200 and / or DDS 300 are secured within multiple supports 124, packaging 500 is configured to secure various components via engagement with multiple retaining features 518.

[0158] In some respects, the package 500 can be manufactured such that the base 504 and / or the caps 508a, 508b need to be modified before the mating assembly 200 or DDS 300 can be introduced therein. The package 500 can be formed as a flat sheet including the base 504 and the caps 508a, 508b (see...). Figure 28 Retention features 518 may be defined on package 508 as cutouts in base 504 and / or caps 508a, 508b. The cutouts may be made by any suitable mechanism (e.g., blade, rotary tool, laser, or other device). Before receiving a component thereon, retention features 518 may need to be modified from a flat configuration (as they are manufactured) to a receiving configuration (where retention features 518 are configured to contact the component and secure the component to package 500). To move retention features 518 from a flat configuration to a receiving configuration, each retention feature 518 used on base 504 may be deflected away from base surface 512. Similarly, any retention feature 518 intended for use on caps 508a and / or 508b may be deflected away from caps 508a and / or 508b.

[0159] After the desired components of the docking assembly 200 and / or DDS 300 are secured to the base 504, the covers 508a, 508b can deflect and hingedly move towards the base 504 along their respective hinges 509 to cover at least a portion of the base 504 and the components thereon. In some aspects, the covers 508a, 508b can be secured to the base via attachment members 510 on the covers 508a, 508b, which are configured to releasably engage with a receiving member 511 on the base 504 or another component of the package 500 (e.g., docking retainer 550). During the packaging process, standard checks can be performed to ensure the quality and safety of all components used. The various components of the DDS 300 and / or docking assembly 200 can then be secured to the base 504 via multiple retaining members (see...). Figure 28 and Figures 29A-29I (Exemplary layout of the directional components and possible parts to be held). After the desired components have been introduced and properly secured within the package 500, the package 500 can undergo the sterilization practices described above. The package 500 may be further introduced into one or more other containers (e.g., sleeve 101a, first box 101b, second box 101c, or other suitable containers) for sterility and protection.

[0160] While systems and methods have been described with reference to various examples in conjunction with the accompanying drawings, those skilled in the art will understand that changes can be made to the examples without departing from their broad inventive concept. Therefore, it should be understood that this disclosure is not limited to the specific examples disclosed and is intended to cover modifications within the spirit and scope of this disclosure as defined by the claims.

[0161] The features of this disclosure described above in the context of individual examples may be provided in combination in a single example. Conversely, the various features of this disclosure described in the context of individual examples may also be provided individually or in any sub-combination. Finally, while examples may be described as part of a series of steps or a more general structure, each of the steps may also be considered an independent example that can be combined with other steps.

[0162] Unless otherwise indicated herein, references to ranges of values ​​herein are intended only as a concise way of referring independently to each individual value falling within that range, and each individual value is incorporated into the specification as if it were referred to independently herein. Unless otherwise indicated herein or clearly contradicted by the context, all methods described herein may be performed in any suitable order.

[0163] Throughout this specification, terms will be given their normal meanings as will be understood by those skilled in the art. However, to avoid misunderstanding, the meanings of certain terms have been specifically defined or clarified.

[0164] Additional examples of publicly available technologies

[0165] In view of the above-described embodiments of the disclosed subject matter, this application discloses the following additional examples. It should be noted that a single feature or combination of features in a single example, as well as more than one feature in an example optionally combined with one or more features of one or more further examples, are also further examples falling within the scope of this application's disclosure.

[0166] Example 1. A container configured to receive a docking assembly for packaging therein, the container comprising: a base defining an engagement surface configured to receive the docking assembly thereon; a lid configured to releasably engage with the base such that at least a portion of the docking assembly is disposed between the base and the lid; and a docking retainer attached to the container and configured to receive a portion of the docking assembly thereon, the container being configured to be sterilized.

[0167] Example 2. The container described in any of the examples in this document, particularly Example 1, is also configured to receive a docking delivery system (DDS) therein.

[0168] Example 3. The container according to any example herein, particularly Example 2, further includes a plurality of supports defined between the base and the lid, each of the plurality of supports being configured to receive at least a portion of the docking assembly and / or the DDS.

[0169] Example 4. The container described in any example herein, particularly Example 2 or 3, also includes a docking support in which a docking retainer is included and the docking support is configured to receive liquid therein.

[0170] Example 5. In any of the examples in this document, particularly Example 4, the container contains at least heparinized saline solution.

[0171] Example 6. According to any of the examples herein, particularly any of Examples 1 through 5, the docking retainer is cylindrical and defines the outer surface configured to contact the docking assembly.

[0172] Example 7. According to any example herein, particularly Example 6, the outer surface defines a protrusion extending radially from the outer surface, the protrusion being configured to receive a docking assembly thereon.

[0173] Example 8. According to any example in this document, particularly Example 7, the protrusion is a helical thread having a length and extending along a helical path from a starting point on the outer surface to an end point on the outer surface axially spaced from the starting point, the length being defined between the starting point and the end point.

[0174] Example 9. According to any example in this document, particularly the container described in Example 7, the thread is a discontinuous thread and defines at least one discontinuity between the start and end points.

[0175] Example 10. According to any example in this document, particularly Example 9, the container has threads defining multiple discontinuities along its length.

[0176] Example 11. According to any example in this document, particularly Example 10, at least some of the multiple discontinuities overlap in the axial direction.

[0177] Example 12. According to any example in this document, especially Example 11, all the multiple discontinuities overlap along the axial direction.

[0178] Example 13. The container described in any of the examples herein, particularly any one of Examples 1 to 12, also includes a support post defined on the base and configured thereon to receive a docking retainer to secure the docking retainer to the base.

[0179] Example 14. According to any example herein, particularly Example 13, a docking retainer defines an extension through which a hole having a first cross-sectional shape extends, a support having a second cross-sectional shape, and the docking retainer is configured to receive the support into the hole when the support is oriented relative to the docking retainer in a desired alignment position, such that the first cross-sectional shape is complementary to the second cross-sectional shape and the support can be inserted into the hole, and if the support is not in the desired alignment position relative to the docking retainer, the support cannot be inserted into the hole.

[0180] Example 15. According to any of the examples herein, particularly any of Examples 1 through 14, the docking retainer defines an opening extending therethrough, which is adjacent to the docking assembly when the docking assembly is received onto the docking retainer.

[0181] Example 16. According to any example in this document, particularly the container described in Example 15, the docking retainer defines a plurality of openings spaced apart from each other.

[0182] Example 17. The container described in any of the examples herein, particularly any one of Examples 1 to 16, further comprises polyethylene terephthalate (PETG).

[0183] Example 18. According to any of the examples in this document, particularly any one of Examples 1 to 17, the lid is hingedly attached to the base and configured to move toward and away from the base.

[0184] Example 19. According to any of the examples herein, particularly any of Examples 1 through 17, the lid is separated from the base and configured to releasably contact the base.

[0185] Example 20. According to any of the examples herein, particularly any of Examples 1 through 17, the base includes one or more retention members configured to contact the docking assembly to releasably secure the docking assembly to the base.

[0186] Example 21. According to any of the examples in this document, particularly any one of Examples 1 to 20, the container includes a plurality of docking retainers, each of which is configured to contact the docking assembly.

[0187] Example 22. A container according to any of the examples herein, particularly any of Examples 1 through 21, further includes a sleeve configured to receive the container therein.

[0188] Example 23. A docking retainer configured to releasably secure a docking assembly to a container, the docking retainer comprising: a body having a proximal end and a distal end opposite to the proximal end, and defining a central axis extending between the proximal end and the distal end; and an outer surface defined on the body and configured thereon to receive the docking assembly.

[0189] Example 24. According to any example herein, particularly Example 23, the outer surface defines a protrusion extending radially from the outer surface, the protrusion being configured to receive a docking assembly thereon.

[0190] Example 25. According to any example herein, particularly Example 24, the protrusion is a helical thread having a length that extends along a helical path from a starting point on the outer surface to an end point on the outer surface axially spaced from the starting point, the length being defined between the starting point and the end point.

[0191] Example 26. According to any example in this document, particularly Example 25, the thread is a discontinuous thread and defines at least one discontinuity between the start and end points.

[0192] Example 27. According to any example in this document, particularly Example 26, the thread defines a plurality of discontinuities along its length.

[0193] Example 28. According to any example in this document, particularly Example 27, at least some of the multiple discontinuities overlap in the axial direction.

[0194] Example 29. According to any example in this document, particularly Example 28, the dock retainer has all the multiple discontinuities overlapping in the axial direction.

[0195] Example 30. The body of the docking retainer described in any of the examples herein, particularly Example 29, is cylindrical.

[0196] Example 31. According to any of the examples herein, particularly any of Examples 23 to 30, the body further includes an inner surface that is radially spaced from the outer surface toward the central axis, the inner surface defining a hole extending through the body.

[0197] Example 32. According to any example herein, particularly Example 31, the hole is a through hole and extends from the proximal end of the body to the distal end.

[0198] Example 33. According to any example herein, particularly Example 31 or 32, the hole has a first cross-sectional shape that is configured to be complementary to a second cross-sectional shape of a post on the container. The docking retainer is configured to be received on the post when the docking retainer is oriented relative to the post in a desired alignment position, such that the first cross-sectional shape corresponds to the second cross-sectional shape and the post can be inserted into the hole of the docking retainer, and if the docking retainer is not in the desired alignment position relative to the post, the docking retainer cannot be received on the post.

[0199] Example 34. According to any of the examples herein, particularly any of Examples 23 to 33, the docking retainer defines an opening extending therethrough, which is adjacent to the docking assembly when the docking assembly is received onto the docking retainer.

[0200] Example 35. According to any example herein, particularly Example 34, the docking retainer defines a plurality of openings spaced apart from each other.

[0201] Example 36. According to any of the examples herein, particularly any of Examples 24 to 35, when the docking assembly is introduced onto the docking retainer, the protrusion is disposed in the axial direction between at least two adjacent portions of the docking assembly.

[0202] Example 37. The mating retainer described in any of the examples in this document, particularly any of Examples 25 to 36, has a thread with a pitch between 0.02 inches and 1.0 inch (0.05 cm to 2.54 cm).

[0203] Example 38. The mating retainer described in any of the examples in this document, particularly any of Examples 25 through 37, has a thread depth between 0.01 inches and 1.5 inches (0.03 cm to 3.81 cm).

[0204] Example 39. According to any of the examples in this article, particularly any one of Examples 25 to 38, the thread has a thread angle between 0 and 60 degrees.

[0205] Example 40. The dock retainer according to any of the examples herein, particularly any of Examples 23 to 39, also includes high-density polyethylene.

[0206] Example 41. A method of assembling a kit including a docking assembly, a docking delivery system (DDS), and a container according to any of the examples herein, particularly any of Examples 1 to 22, the method comprising: placing the docking assembly and / or the DDS within the container; releasably securing the docking assembly and / or the DDS to the container; and supporting the docking assembly on a docking retainer according to any of Examples 23 to 40, the docking assembly being at least partially wound around the docking retainer.

[0207] Example 42. A method for preparing a docking assembly for introduction into a patient, the method comprising: receiving a sterilized docking assembly in a sterile environment within a closed container according to any of the examples herein, particularly Examples 1 to 22; opening the container; using a first liquid to displace air from inside the docking assembly; and using a second liquid to displace air from outside the docking assembly.

[0208] Example 43. The method described according to any example herein, particularly Example 42, further includes preparing a docking delivery system (DDS) to be received in a container having a docking assembly, and further includes using a first liquid to displace air from inside the DDS, wherein using the first liquid to displace air from inside the docking assembly includes introducing the first liquid into the docking assembly through the DDS.

[0209] Example 44. The method described in any of the examples herein, particularly Example 42 or 43, using a second liquid to displace air from outside the docking assembly includes applying the second liquid to the docking assembly.

[0210] Example 45. According to any example in this document, particularly Example 44, applying the second liquid includes spraying the second liquid onto the docking assembly.

[0211] Example 46. According to any example herein, particularly Example 44, applying the second liquid includes immersing the docking assembly in the second liquid within a bracket, the bracket containing the docking assembly and configured to receive and retain the second liquid.

[0212] Example 47. According to any of the examples in this article, particularly any of Examples 43 to 46, the first liquid and the second liquid are the same liquid.

[0213] Example 48. According to any of the examples in this document, particularly any of Examples 42 to 47, the first liquid and the second liquid comprise brine.

[0214] Example 49. A docking tray for use with a container having a docking component therein, the docking tray being configured to receive the docking component and liquid therein.

[0215] Example 50. A docking tray according to any example herein, particularly Example 49, is configured to releasably engage with a container according to any of Examples 1 to 22.

[0216] Example 51. A container configured to receive a docking assembly for packaging therein, the container comprising: a base defining an engagement surface configured to receive the docking assembly; a lid configured to releasably engage with the base such that at least a portion of the docking assembly is disposed between the base and the lid; and a docking retainer attached to the container and configured to receive a first portion of the docking assembly including two or more adjacent coils thereon, the docking retainer including a protrusion configured to engage the first portion of the docking assembly and space a second portion of the docking assembly from the docking retainer.

[0217] Example 52. A container according to any example herein, particularly Example 51, wherein the docking retainer is cylindrical and defines an outer surface configured to contact a first portion of the docking assembly, wherein a protrusion extends radially outward from the outer surface, and wherein the protrusion is configured to separate two or more adjacent coils of the first portion of the docking assembly from each other.

[0218] Example 53. A container according to any example herein, particularly Example 52, wherein the protrusion is a helical thread having a length and extending along a helical path from a starting point on the outer surface of the mating retainer to an ending point on the outer surface, the ending point being axially spaced from the starting point, and the length being defined between the starting point and the ending point.

[0219] Example 54. A container according to any example herein, particularly Example 53, wherein the helical thread is a discontinuous thread and defines at least one discontinuity between the start and end points.

[0220] Example 55. The container described according to any of the examples herein, particularly any of Examples 51 to 54, further includes a support post defined on the base and configured thereon to receive a dock retainer for securing the dock retainer to the base.

[0221] Example 56. A container according to any example herein, particularly Example 55, wherein a docking retainer defines an extension through which a hole having a first cross-sectional shape extends, wherein a post has a second cross-sectional shape, wherein the docking retainer is configured to receive the post into the hole when the post is oriented relative to the docking retainer in a desired alignment position, such that the first cross-sectional shape is complementary to the second cross-sectional shape and the post can be inserted into the hole, and wherein if the post is not in the desired alignment position relative to the docking retainer, the post cannot be inserted into the hole.

[0222] Example 57. A container according to any of the examples herein, particularly any of Examples 51 to 56, wherein a docking retainer defines an opening extending radially therethrough, the opening being adjacent to the first portion of the docking assembly when the first portion of the docking assembly is received onto the docking retainer.

[0223] Example 58. The container described in any of the examples herein, particularly any one of Examples 51 to 57, further includes a plurality of supports defined between the base and the lid, the plurality of supports including a first support including a docking retainer disposed therein and configured to receive liquid therein.

[0224] Example 59. A container according to any example herein, particularly Example 58, wherein a plurality of trays further includes one or more trays configured to receive one or more portions of a docking delivery system (DDS) coupled to a docking assembly.

[0225] Example 60. A container according to any example herein, particularly Example 59, wherein the base includes one or more retention members configured to contact a portion of the DDS to releasably secure a portion of the DDS to the base.

[0226] Example 61. A container according to any of the examples herein, particularly any one of Examples 51 to 60, wherein the lid is hingedly attached to the base and configured to move toward and away from the base.

[0227] Example 62. A docking retainer configured to releasably secure a docking assembly to a container, the docking retainer comprising: a body having a proximal end and a distal end opposite to the proximal end, and an inner surface defining a central hole extending between the proximal end and the distal end; and a helical thread extending around and radially outward from an outer surface of the body, the helical thread being configured to receive a first portion thereon of the docking assembly.

[0228] Example 63. A docking retainer according to any example herein, particularly Example 62, wherein the helical threads are configured to separate adjacent coils of the first portion of the docking assembly from each other along the length of the body of the docking retainer.

[0229] Example 64. A docking retainer according to any example herein, particularly Example 62 or Example 63, wherein the helical thread comprises two or more discontinuous threads spaced apart from each other in an axial direction extending between a proximal end and a distal end of the body of the docking retainer, and wherein the two or more discontinuous threads are configured to separate adjacent coils of a first portion of the docking assembly from each other.

[0230] Example 65. A mating retainer according to any example herein, particularly Example 64, wherein each of two or more discontinuous threads has a thread lead and a thread end spaced apart from each other in a circumferential direction to create a break in the thread, and wherein the breaks of the two or more discontinuous threads are aligned in an axial direction such that a threadless space is formed between the proximal end and the distal end along the outer surface of the body.

[0231] Example 66. A mating retainer according to any example herein, particularly Example 64 or Example 65, wherein the mating retainer defines an opening extending radially through the body between an outer surface and an inner surface, the opening being disposed between adjacent threads of two or more discontinuous threads.

[0232] Example 67. An assembly comprising: a container including a base including a first recess and a support extending outwardly from the recess; and a docking retainer disposed within the first recess and mounted around the support, the docking retainer being configured to receive a first portion of a docking assembly around an outer surface of the docking retainer and including a radial protrusion configured to separate adjacent coils of the first portion of the docking assembly from each other.

[0233] Example 68. The component according to any example herein, particularly Example 67, wherein the base includes a second recess configured to receive part of a docking delivery system coupled to the docking assembly, and wherein the first recess is configured to receive liquid.

[0234] Example 69. An assembly according to any example herein, particularly Example 67 or Example 68, wherein the radial protrusion is a helical thread, the helical thread including a thread lead configured to be adjacent to the distal end of the mating retainer, and wherein the thread lead is configured to space a second portion of the mating assembly from the mating retainer, the second portion having a larger diameter than the first portion of the mating assembly.

[0235] Example 70. The component according to any of the examples herein, particularly any one of Examples 67 to 69, wherein the docking retainer has an inner surface including one or more protrusions extending radially from the inner surface toward the central axis of the docking retainer, and the inner surface defines a central hole having a first cross-sectional shape, and wherein the strut has a second cross-sectional shape complementary to the first cross-sectional shape of the central hole.

[0236] Unless otherwise stated, the features described in any example herein may be combined with other features described in any one or more other examples. For example, any one or more features of a container or package or docking retainer may be combined with any one or more features of another container or package or docking retainer.

[0237] Given the many possible examples to which the principles of the disclosed technology can be applied, it should be understood that the examples shown are merely preferred examples of the disclosed technology and should not be considered as limiting the scope of the claimed subject matter. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

1. A container configured to receive docking components therein for packaging, the container comprising: A base that defines a mating surface and is configured to receive the docking assembly; A cover configured to releasably engage with the base such that at least a portion of the docking assembly is disposed between the base and the cover; as well as A docking retainer, attached to the container and configured to receive a first portion of the docking assembly, the first portion of the docking assembly including two or more adjacent coils thereon, the docking retainer including a protrusion configured to engage the first portion of the docking assembly and space a second portion of the docking assembly from the docking retainer, wherein the docking retainer is cylindrical and defines an outer surface configured to contact the first portion of the docking assembly, wherein the protrusion extends radially outward from the outer surface, and wherein the protrusion is configured to separate the two or more adjacent coils of the first portion of the docking assembly from each other.

2. The container of claim 1, wherein the protrusion is a helical thread having a length and extending along a helical path from a starting point on the outer surface of the docking retainer to an ending point on the outer surface, the ending point being axially spaced from the starting point, and the length being defined between the starting point and the ending point.

3. The container of claim 2, wherein the helical thread is a discontinuous thread and defines at least one discontinuity between the start point and the end point.

4. The container of claim 1 further includes a support post defined on the base and configured to receive the docking retainer thereon to secure the docking retainer to the base.

5. The container of claim 4, wherein the docking retainer defines an extension through a hole having a first cross-sectional shape therein, wherein the support has a second cross-sectional shape, wherein the docking retainer is configured to receive the support into the interior of the hole when the support is oriented relative to the docking retainer in a desired alignment position, such that the first cross-sectional shape is complementary to the second cross-sectional shape and the support can be inserted into the hole, and wherein the support cannot be inserted into the hole if the support is not in the desired alignment position relative to the docking retainer.

6. The container according to any one of claims 1-5, wherein the docking retainer defines an opening extending radially therethrough, the opening being adjacent to the first portion of the docking assembly when the first portion of the docking assembly is received onto the docking retainer.

7. The container according to any one of claims 1-5, further comprising a plurality of supports defined between the base and the lid, the plurality of supports including a first support, the first support including the docking retainer disposed therein and configured to receive liquid therein.

8. The container of claim 7, wherein the plurality of trays further comprises one or more trays configured to receive one or more portions of a docking delivery system coupled to the docking assembly.

9. The container of claim 8, wherein the base includes one or more retention members configured to contact a portion of the docking delivery system to releasably secure the portion of the docking delivery system to the base.

10. The container according to any one of claims 1-5, wherein the lid is hingedly attached to the base and configured to move toward and away from the base.

11. A docking retainer configured to releasably secure a docking assembly to a container, the docking retainer comprising: A body having a proximal end, a distal end opposite the proximal end, and an inner surface defining a central hole extending between the proximal end and the distal end; and A helical thread surrounding and extending radially outward from the outer surface of the body, the helical thread being configured to receive a first portion thereon of the docking assembly.

12. The docking retainer of claim 11, wherein the helical threads are configured to separate adjacent coils of the first portion of the docking assembly from each other along the length of the body of the docking retainer.

13. The docking retainer of claim 11 or claim 12, wherein the helical thread comprises two or more discontinuous threads spaced apart from each other in an axial direction extending between the proximal end and the distal end of the body of the docking retainer, and wherein the two or more discontinuous threads are configured to separate adjacent coils of the first portion of the docking assembly from each other.

14. The mating retainer of claim 13, wherein each of the two or more discontinuous threads has a thread lead and a thread end spaced apart from each other in a circumferential direction to create a break in the thread, and wherein the breaks of the two or more discontinuous threads are aligned in the axial direction such that a threadless space is formed between the proximal end and the distal end along the outer surface of the body.

15. The mating retainer of claim 13, wherein the mating retainer defines an opening extending radially through the body between the outer surface and the inner surface, the opening being disposed between adjacent threads of the two or more discontinuous threads.

16. A docking component, comprising: A container, comprising a base, the base including a first recess and a support extending outward from the first recess; as well as A docking retainer, disposed within the first recess and mounted around the post, is configured to receive a first portion of a docking assembly around its outer surface and includes radial protrusions configured to separate adjacent coils of the first portion of the docking assembly from each other, wherein the radial protrusions are helical threads.

17. The docking assembly of claim 16, wherein the base includes a second recess configured to receive a portion of a docking delivery system coupled to the docking assembly, and wherein the first recess is configured to receive liquid.

18. The docking assembly of claim 16 or claim 17, wherein the helical thread includes a thread lead configured to be adjacent to the distal end of the docking retainer, and wherein the thread lead is configured to space a second portion of the docking assembly from the docking retainer, the second portion having a larger diameter than the first portion of the docking assembly.

19. The docking assembly of claim 16 or claim 17, wherein the docking retainer has an inner surface including one or more protrusions extending radially from the inner surface toward the central axis of the docking retainer and defining a central hole having a first cross-sectional shape, and wherein the strut has a second cross-sectional shape complementary to the first cross-sectional shape of the central hole.

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