Systems and methods for pre-filling medical delivery assemblies

Abstract

A pre-filled medical delivery assembly that is assembled and configured to allow delivery of a single dose of a therapeutic agent (e.g., a vaccine, a drug, a medicament, etc.) from a blow-fill-seal (BFS) vial to a patient. The delivery assembly generally includes a modular design that is comprised of individually constructed components that are arranged and connected in cooperation with one another.

Description

[0001] Cross-reference to related applications

[0002] This application claims interest and priority under 35 USC §119(e) and is a non-provisional patent application filed on July 30, 2020, entitled “PRE-FILLED MEDICAL DELIVERY ASSEMBLIES”, which is incorporated herein by reference in its entirety. Background Technology

[0003] Millions of people are infected with and die each year from various diseases, some of which are preventable by vaccines. Although vaccination has led to a dramatic decrease in cases of several infectious diseases, some remain prevalent.

[0004] Some implementations of immunization programs typically involve vaccination via reusable syringes. However, in many cases, vaccine administration occurs outside of hospitals and may be provided by non-professionals, resulting in injections to patients without careful control over syringe use. The use of reusable syringes in these situations increases the risk of infection and transmission of bloodborne diseases, especially when previously used and no longer sterile syringes are used for subsequent injections. For example, the World Health Organization (WHO) estimates that bloodborne diseases such as hepatitis and human immunodeficiency virus (HIV) are spreading due to the reuse of such syringes, causing more than one million deaths annually.

[0005] Previous attempts to address these issues by offering single-use or disposable injection units in the industry have had measurable success, but have failed to adequately resolve the existing problems. Prefilled disposable injection units manufactured via injection molding or mold-fill-seal (FFS) processes, such as the Uniject™ unit available from Becton, Dickinson, and the Company of Franklin Lakes, New Jersey, offer precise manufacturing tolerances in the range of 0.002 inches (0.002 inch; 50.8 µm) to 0.4 inches (0.004 inch; 101.6 µm) for orifice diameters in molded parts. These prefilled disposable injection units require separate sterilization processes incompatible with certain fluids (e.g., gamma irradiation) for orifice diameters in molded parts, limiting productivity to approximately 9,000 non-sterile units per hour, and are available to end users at approximately one dollar and forty cents ($1.40) per dose / unit. Attached Figure Description

[0006] When considered in conjunction with the accompanying drawings, the embodiments described herein and their many accompanying advantages can be readily understood by referring to the following detailed description, wherein:

[0007] Figures 1A, 1B, 1C, 1D, 1E and 1F are various views of a prefilled medical delivery assembly according to some embodiments;

[0008] Figures 2A, 2B, 2C, 2D, 2E, 2F and 2G are various views of pre-filled medical delivery assembly connectors according to some embodiments;

[0009] Figures 3A, 3B, 3C, 3D, 3E, 3F and 3G are various views of a pre-filled medical delivery assembly according to some embodiments;

[0010] Figures 4A, 4B, 4C, 4D, 4E, 4F and 4G are various views of prefilled medical delivery assembly connectors according to some embodiments;

[0011] Figures 5A, 5B, 5C, 5D, 5E, 5F and 5G are various views of the needle interface of a prefilled medical delivery assembly according to some embodiments;

[0012] Figures 6A, 6B, 6C, 6D, 6E, and 6F are various views of a pre-filled medical delivery assembly cap according to some embodiments; and

[0013] Figures 7A, 7B, 7C, 7D, 7E, and 7F are various views of a pre-filled medical delivery assembly safety shield according to some embodiments. Detailed Implementation

[0014] I. Introduction

[0015] Embodiments of the present invention provide systems and methods for prefilled medical delivery assemblies that overcome the drawbacks of current delivery devices and methods. For example, some embodiments of the prefilled medical delivery assembly may include a blow-fill-seal (BFS) vial or bottle connected to a dedicated collar that facilitates the attachment of a drug delivery component (e.g., a needle) to the BFS vial. In some embodiments, such a prefilled medical delivery assembly can be selectively actuated by applying a rotational force to a cap covering the application component, resulting in axial advancement of the application component and puncture of the fluid reservoir of the BFS vial. Using such a system employing a BFS vial can be advantageous and can address various drawbacks of prior systems.

[0016] For example, BFS vials can provide a cheaper alternative to typical vials or devices manufactured using other manufacturing techniques. In some embodiments, BFS vials (e.g., due to the nature of the BFS manufacturing process) may not require separate sterilization (e.g., and therefore may be compatible with a wider range of fluids), can provide increased hourly productivity of sterile / preservative units, and / or can be offered to end users at a significantly reduced cost per dose / unit. In some embodiments, these advantages may be accompanied by the incidental disadvantages of reduced manufacturing tolerances and other disadvantages of using “soft” plastics (e.g., having a Shore / hardness tester “D” hardness between 60 and 70). For example, the BFS process may offer lower manufacturing tolerances, ranging from five-hundredths of an inch (0.05 inch; 1.27 mm) to fifteen-hundredths of an inch (0.15 inch; 3.81 mm) – for linear dimensions, for example, according to ISO 2768-1 "General tolerances for linear and angular dimensions without individual tolerance indications" published by the International Organization for Standardization (ISO) in Geneva, Switzerland on November 15, 1989, and / or may not be easily adapted to form certain mating features (e.g., standardized threads). In some embodiments, these disadvantages and / or deficiencies of existing systems can be advantageously addressed by specific features, configurations, and / or components described below.

[0017] II. Prefilled Medical Delivery Components - External Threaded Connections

[0018] Referring first to Figures 1A, 1B, 1C, 1D, 1E, and 1F, various views of a pre-filled medical delivery assembly 100 according to some embodiments are shown. In some embodiments, the pre-filled medical delivery assembly 100 may include various interconnected and / or modular components, such as a BFS vial 110, which includes and / or defines a neck 112, a fluid seal 114, a mounting flange 116, a bottle flange 118, a retractable reservoir 120, a dispensing reservoir 122, and / or an identification region 124. According to some embodiments, the pre-filled medical delivery assembly 100 may include an application (e.g., injection) module or component 130 manufactured, assembled, and / or supplied as a separate unit from the BFS vial 110. In some embodiments, the application component 130 may include a mounting collar 132, which itself includes, connects to, and / or defines various features and / or elements. The mounting collar 132 and / or application component 130 may be maintained as closed and / or sterile components, for example, by a seal 134 (e.g., foil, wax, paper, and / or other thin, puncture-resistant, tearable, and / or removable object or layer attached to the mounting collar 132 and / or application component 130), the seal 134 sealing the internal volume or support (not separately labeled) of the mounting collar 132 disposed at its first end. According to some embodiments, the mounting collar 132 may include one or more connection or mounting features 136, an internal seat 138 (e.g., configured to receive the mounting flange 116 of the BFS vial 110 when the neck 112 of the BFS vial 110 is inserted into the mounting collar 132 and / or application component 130), a puncture seal 140, and / or external threads 142. In some embodiments, the mounting collar 132 may include and / or define an external flange 144 (e.g., a radial flange) operable to receive, engage, and / or otherwise engage the needle interface 150. In some embodiments, the needle interface 150 may be coupled to the mounting collar 132 via its threads 152 corresponding to and / or engaging the threads 142 of the mounting collar 132. According to some embodiments, the needle interface 150 may include, connect to, and / or accommodate a needle, cannula, and / or other application member 170 and / or a cap 180 (e.g., selectively engaging and / or connecting to the needle interface 150 to cover, position, and / or protect the application member 170). According to some embodiments, the pre-filled medical delivery assembly 100 may include a modular design comprising individually constructed components 110, 130, 132, 150, 170, 180 that are cooperatively arranged and coupled to each other.

[0019] In some embodiments, the shrinkable reservoir 120 may be (fully or partially) filled with fluid or other reagents (not shown separately) for delivery to, for example, a patient (not shown). According to some embodiments, fluid may be injected into the BFS vial 110 in a sterile environment during manufacturing via a BFS process and sealed within the BFS vial 110 by a fluid seal 114. The fluid seal 114 may include a portion molded from the BFS vial 110, for example, a portion configured to be punctured to expel fluid, for example by providing a flat or smooth puncture surface and / or by an axis perpendicular to the BFS vial 110 (and / or the pre-filled medical delivery assembly 100). In some embodiments, the fluid seal 114 may include foil, wax, paper, and / or other thin, punctureable objects or layers attached to the BFS vial 110. In some embodiments, the neck 112 of the BFS vial 110 may include a mounting flange 116, such as the “annular” shaped outer flange shown. For example, mounting flange 116 may provide a radially resilient mating surface that is operable to provide selective engagement or mating within the bracket of application assembly 130.

[0020] According to some embodiments, fluid can generally pass between the retractable reservoir 120 and the connected dispensing reservoir 122. In some embodiments, the junction, valve, and / or passage (not separately labeled) between the dispensing reservoir 122 and the retractable reservoir 120 may restrict flow, allowing fluid to easily enter one of the dispensing reservoir 122 and the retractable reservoir 120, but not easily return to the other reservoir 120, 122. In some embodiments, such retraction can provide the advantages described herein. In some embodiments, retraction may not be necessary or desirable, for example, when the retractable reservoir 120 and the dispensing reservoir 122 are formed and / or combined into a single unobstructed reservoir, such as a single fluid reservoir (not shown).

[0021] In some embodiments, the prefilled medical delivery assembly 100 may include a modular design comprising separately constructed components 110, 130 arranged and connected in a cooperative manner. As shown in FIG1A, for example, the BFS vial 110 and the application assembly 130 may be manufactured, packaged, transported, stored, and / or supplied as separate components. In this way, the application assembly 130 may not need to be stored or transported according to the often restrictive requirements for drug administration, and the amount of space required for such dedicated storage and / or transport can be reduced accordingly. The application assembly 130 may also or alternatively be manufactured, stored, and / or transported in advance (e.g., at a first time), while the prefilled fluid-filled BFS vial 110 may be manufactured, stored, and / or transported at a later time (e.g., at a second time). In some embodiments, the delay between the first and second times may be long without having a decisive impact, as in some embodiments the application assembly 130 may be stored indefinitely. In this way, units of the application assembly 130 can be supplied to be on hand before the BFS vial 110 becomes available and / or arrives, reducing supply chain constraints in the case of proactive procurement of the application assembly 130.

[0022] According to some embodiments, components 110 and 130 can be connected, for example, in the field and / or in situ, to provide an active pre-filled (e.g., injectable) medical delivery device. As shown in FIG1B, for example, the seal 134 can be removed from the application component 130 (at “A”), and the application component 130 (and / or its support) can be aligned with the neck 112 of the BFS vial 110. According to some embodiments, the application component 130 (and / or its mounting collar 132) can be axially engaged with the BFS vial 110 by applying a mating axial force, as shown in FIG1C (at “B”). The application component 130 (and / or its mounting collar 132) can be pushed onto the neck 112 of the BFS vial 110, for example, such that a cooperatingly shaped inner seat 138 (e.g., an internal groove or channel) receives a mounting flange 116, thereby detachably connecting the BFS vial 110 and the application component 130 (and / or its mounting collar 132). In some embodiments, the inner seat 138 (and / or other internal features) and / or mounting flange 116 may be shaped such that separation of the BFS vial 110 and the application member 130 (and / or its mounting ring 132) is mechanically prohibited. In some embodiments, the mounting flange 116 may be shaped as an axially elongated circular outer flange (e.g., the depicted “ring” shape) and / or the inner seat 138 may include cooperating and / or mirrored axially elongated circular inner grooves or tracks. According to some embodiments, one or more mounting features 136 (e.g., the mirrored axial slit shown) may engage with the vial flange 118 (and / or a portion of the BFS vial 110) such that the application member 130 (and / or its mounting ring 132) is restricted relative to the BFS vial 110 when they are engaged. In some embodiments, the connection between the BFS vial 110 and the application member 130 (and / or its mounting collar 132) may explicitly allow free rotation of the BFS vial 110 relative to the application member 130 (and / or its mounting collar 132) (e.g., free rotation about a common axis). For example, in some embodiments, the mounting feature 136 may not engage with the BFS vial 110 (and / or its mounting flange 116), for example, to allow rotation between them.

[0023] As shown in Figure 1D, in some embodiments, the neck 112 of the BFS vial 110 can be pushed and / or forced into the socket of the mounting collar 132 until the mounting flange 116 falls into (and / or engages or mates with) the inner seat 138 (e.g., seat position). In this way, the fluid seal 114 can be advantageously positioned adjacent to the perforated seal 140. According to some embodiments, the mounting flange 116 can be configured as annular (as shown) to provide various advantages for the pre-filled medical delivery assembly 100. For example, axial elongation of the mounting flange 116 can provide a smooth, uniform, and / or less forceful mating process that is less likely to deform the soft plastic neck 112 of the BFS vial 110, and / or provide an extended mating surface that is more likely to prevent fluid leakage. In some embodiments, the mounting flange 116 and the shape- and size-matched inner seat 138 can allow the application component 130 to be attached to the BFS vial 110 simply, effectively, and / or economically.

[0024] In some embodiments, the needle interface 150 may be coupled to the mounting collar 132 via engagement of the external thread 142 of the mounting collar 132 with the internal thread 152 of the needle interface 150. The internal thread 152 corresponds to and engages with the external thread 142, such that they are rotatably and / or detachably connected. According to some embodiments, the application member 130 may be provided with a partially engaged mounting collar 132 and needle interface 150 (e.g., partially connected threads 142, 152), as depicted in, for example, FIG. 1D. In some embodiments, partial engagement (or a first engagement state) may result in the application member 170 (e.g., its second end or proximal end) being positioned adjacent to (and / or in contact with) the puncture seal 140 of the mounting collar 132. In such a first engagement state, the application member 130 may be connected to the BFS vial 110, but the BFS vial 110 (and / or the puncture seal 140) has not yet been punctured and / or destroyed by the application member 170.

[0025] According to some embodiments, the needle interface 150 may be connected to and / or retain the application member 170. The application member 170 may be inserted into and / or pass through the needle interface 150, for example, such that it includes a first end or application end extending axially distally from the BFS vial 110 and a second end or puncture end disposed within the needle interface 150. In some embodiments, the application end and / or distal portion of the application member 170 may be received, covered, and / or concealed by a cap 180. According to some embodiments, the cap 180 may be configured to receive the application member 170 and removably connected to the housing 150 (e.g., by fitting it externally and / or by engaging with an external flange 144).

[0026] According to some embodiments, the combination of the mounting collar 132 and the needle interface 150 can be used to connect and / or mate the application member 170 with the BFS vial 110 to provide a mechanism via which the application member 170 can be reliably connected to the soft plastic BFS vial 110. Due to the nature of the BFS plastic and / or the processing and / or the small shape factor of the BFS vial 110, for example, providing a standard external thread (not shown) directly on the neck 112 would not be a viable option because this would result in an imprecise, unreliable, and / or non-watertight connection between the BFS vial 110 and, for example, the needle interface 150 (i.e., even if the thread can be correctly manufactured within the required tolerances, the thread will deform, which is not the intended result). The applicant has recognized, for example, that the “soft” plastic required for the BFS process is not susceptible to the effects of machining due to thermal deformation of machining features during molding attempts, and deformation due to mechanical stress during use. Therefore, the standardized screw-in needle interface (not shown; although similar to needle interface 150 in some embodiments) is not readily compatible for attachment to BFS vial 110 (e.g., without the collar 132 installed).

[0027] In some embodiments, the application member 170 may include a needle shaped and / or sized to administer a liquid medication to a patient via at least one of subcutaneous, intramuscular, intradermal, and intravenous administration. For ease of explanation and description, the application member 170 is generally referred to as a needle or cannula in the accompanying drawings and description. However, it should be noted that in other embodiments, the medication delivery member 170 may include a nozzle (not shown) configured to control the administration of a fluid medication to a patient. The nozzle may include a spray nozzle, for example, configured to facilitate the dispersion of the fluid medication into a spray. Thus, a needle interface 150 equipped with a spray nozzle may be particularly useful for administering a fluid medication to, for example, the nasal passages or other parts of the body that benefit from spray application (e.g., ear canals, other orifices). In other embodiments, the nozzle may be configured to facilitate the formation of fluid medication droplets. Thus, a needle interface 150 including a droplet nozzle may be used for administering a fluid medication by droplets, such as for application to the eyes, topical application, etc.

[0028] As commonly understood, a fluid or pharmaceutical agent (e.g., stored in BFS vial 110 and / or one or more of its reservoirs 120, 122) may include an agent intended to be injected into a patient (e.g., an animal, such as a mammal, human, or non-human) and capable of producing an effect (alone or in combination with an active ingredient). Therefore, the agent may include, but is not limited to, vaccines, drugs, therapeutic agents, pharmaceutical preparations, diluents, etc. According to some embodiments, one or both of the fluid agent and the active ingredient (i.e., the pharmaceutical preparation and / or its components) may be tracked, monitored, and their compatibility checked, for example, by utilizing electronic data storage devices (not shown) connected to various modules or components such as BFS vial 110 (e.g., at, on, or in identification area 124) and / or application component 130.

[0029] According to some embodiments, the mounting collar 132, needle interface 150, and / or cap 180 may be made of medical-grade materials. In some embodiments, the mounting collar 132, needle interface 150, and / or cap 180 may be composed of thermoplastic polymers or other “hard” plastics (e.g., greater than 80 on the Rockwell “R” scale), including, but not limited to, polybenzimidazole, acrylonitrile butadiene styrene (ABS), polystyrene, polyvinyl chloride, etc. In some embodiments, the prefilled medical delivery assembly 100 may advantageously be manufactured (in large quantities) as separate parts or portions, namely at least a “soft” plastic BFS vial 110 portion (e.g., a “first” portion) and a “hard” plastic drug delivery component 130 (e.g., a “second” portion), these different plastic parts / portions being selectively connected for drug delivery to a patient.

[0030] According to some embodiments, the pre-filled medical delivery assembly 100 can be advanced from a first engaged state to a second engaged state, in which the application member 170 has pierced the BFS vial 110 and fluid therein can be readily expelled through the application member 170 (e.g., into the patient's body). As shown in FIG1D, by applying a rotational force to the cap 180, the partial engagement of the mounting collar 132 and the needle interface 150 (e.g., via partially connected threads 142, 152) can, for example, be transformed into a more advanced, fully advanced, or fully advanced state, as shown, for example, in FIG1D (“C”). In some embodiments, a more advanced and / or fully engaged (or the second engaged state; as shown in FIG1E) can cause the application member 170 (e.g., its second or proximal end) to advance through the puncture seal 140 of the mounting collar 132 and through the seal 114 of the BFS vial 110. In this way, for example, the continuous rotational engagement of threads 142, 152 can cause the application member 170 (e.g., its second or proximal end) to open a fluid passage between the BFS vial 110 (e.g., and / or neck 112 and / or its reservoirs 120, 122) and the first or distal end of the application member 170. In some embodiments, the cap 180 can be used as a rotational force actuator to transmit rotational force to the needle interface 150 to induce engagement of threads 142, 152 (and, for example, puncture the puncture seal 140 and the seal 114 of the BFS vial 110).

[0031] In some embodiments, fewer or more components 110, 112, 114, 116, 118, 120, 122, 124, 130, 132, 134, 136, 138, 140, 142, 144, 150, 152, 170, 180 and / or the depicted components 110, 112, 114, 116, 118, 120, 122, 124, 130, 132, 134, 136, 138, 140, 142, 144, 150, 152, 170, 180 may be included in various configurations of the prefilled medical delivery assembly 100 without departing from the scope of the embodiments described herein. In some embodiments, for components with similar names and / or numbers described herein, the configuration and / or function of parts 110, 112, 114, 116, 118, 120, 122, 124, 130, 132, 134, 136, 138, 140, 142, 144, 150, 152, 170, and 180 may be similar. According to some embodiments, the pre-filled medical delivery assembly 100 may include a mounting flange 116 but not a retractable reservoir 120. In some embodiments, the pre-filled medical delivery assembly 100 may include a mounting flange 116 but not a dispensing reservoir 122. According to some embodiments, the administration component 130 may be provided without (and / or separately from) the BFS vial 110.

[0032] Referring now to Figures 2A, 2B, 2C, 2D, 2E, 2F, and 2G, several views are shown of a pre-filled medical delivery assembly connector 232 (e.g., a connector made of “hard” plastic and configured to securely mate with a “soft” plastic BFS object / container) according to some of the illustrated embodiments. Connector 232 may include similar features and / or construction and / or may resemble the mounting collar 132 of Figures 1A, 1B, 1C, 1D, 1E, and / or 1F. Connector 232 may include and / or define, for example, chambers, voids, volumes, and / or mounting holes 232-1, top surfaces 232-2, and / or one or more mounting features 236. In some embodiments, the mounting hole 232-1 may be shaped to receive and / or retain the neck of the BFS vial (not shown; e.g., neck 112 of Figures 1A, 1B, 1C, 1D, 1E, and / or 1F), for example, by defining various internal dimensions and / or features. The mounting hole 232-1 may include and / or define, for example, various internal diameters, each defined at a different portion of the mounting hole 232-1. According to some embodiments, the mounting hole 232-1 may include and / or define an inner seat 238 whose position, size, and / or shape are particularly suited to receiving a mounting flange (not shown; e.g., the “annular” mounting flange 116 of Figures 1A, 1B, 1C, 1D, 1E, and / or 1F). In some embodiments, the inner seat 238 may include an internal recess, channel, and / or seat that includes and / or defines various physical dimensions and / or features, such as mating length, seat depth, and / or rounding radius. According to some embodiments, mounting hole 232-1 may include an outflow channel arranged, formed and / or cut into its second end but blocked by seal 240.

[0033] According to some embodiments, by applying an axial engaging force, connector 232 can axially engage with a BFS vial (not shown; e.g., BFS vials of Figures 1A, 1B, 1C, 1D, 1E and / or 1F herein). A seal covering mounting hole 232-1 (not shown; e.g., seal 134 of Figures 1A, 1B, 1C, 1D, 1E and / or 1F) can be removed, for example, and connector 232 can be pushed onto the neck of the BFS vial such that a co-formed inner seat 238 receives the mounting flange of the BFS vial, thereby selectively and / or removably connecting the BFS vial to connector 232. In some embodiments (not shown), inner seat 238 (and / or other internal features) and / or mounting flange can be shaped such that mechanical disengagement of the BFS vial and connector 232 is mechanically prevented. According to some embodiments, the neck of the BFS vial can be advanced into a mounting hole 232-1 at a first portion having a first inner diameter. In some embodiments, the neck can continue to advance into a second portion of the mounting hole 232-1 at a second portion having a second inner diameter. As shown, the second inner diameter may be smaller than the first inner diameter. According to some embodiments, the second inner diameter can be sized to accept the outer diameter of the neck of the BFS vial, which can continue to be inserted into the mounting hole 232-1.

[0034] In some embodiments, once the mounting flange of the BFS vial (e.g., an outer circular and / or axially elongated flange) reaches the second portion having a second inner diameter, the mounting flange may engage with the sidewall at a junction / transition between the first and second inner diameters. The first inner diameter may be larger than the radial extent of the mounting flange, but the second inner diameter may be smaller than the radial extent, resulting in engagement. In some embodiments, such as those depicted (but not separately labeled), an internal taper may be provided between the first and second inner diameters, such that the mounting flange may engage along the taper before reaching the second portion having a second inner diameter.

[0035] According to some embodiments, the BFS vial may be made of a softer material than the connector 232 (e.g., having a lower hardness rating and / or being resilient), which may cause the mounting flange to deflect radially inward (and continue to apply axial force) when engaging the inner wall / surface of the mounting hole 232-1. The mounting flange may deform, compress, and / or flatten to pass through, for example, a second portion having a second inner diameter, and may be advanced into the inner seat 238.

[0036] According to some embodiments, once the mounting flange of the BFS vial enters the inner seat 238, the mounting flange may expand radially outward to (or near) its original axial range (e.g., releasing elastic potential energy stored therein by elastic deformation). In some embodiments, such as when the inner seat 238 is designed to be slightly smaller than the mounting flange (e.g., 0.5% to 2% (0.5%-2.0%)), the mounting flange may be able to reform only to near its original range, resulting in the mounting flange retaining some of the stored elastic energy due to its continued (albeit small) deformation. For example, this retained deformation can result in an interference pressure between the mounting flange and the inner wall of the inner seat 238, keeping the fit between the materials tight and substantially leak-proof. In some embodiments, the configuration of the inner seat 238 and / or mounting hole 232-1 may be defined to mate with BFS vials or bottles of a specific size (e.g., BFS vials 110 of Figures 1A, 1B, 1C, 1D, 1E and / or 1F) such that their mating can be achieved by applying mating forces in a stable and uniform manner, which reduces strain on the components and provides a successful and repeatable user experience.

[0037] According to some embodiments, the first inner diameter may be between 7.45 mm and 9 mm (7.45 mm to 9 mm). In some embodiments, the second inner diameter may be between 6.5 mm and 7 mm (6.5 mm to 7 mm). According to some embodiments, the third inner diameter may be equal to or smaller than the second inner diameter. The third inner diameter may, for example, be between 6 mm and 6.5 mm (6 mm to 6.5 mm). In some embodiments, the dimensions of the mating length, base depth, and / or fillet radius may mate with the mounting flange of the BFS vial. According to some embodiments, the mating length may be between 3 and 4 mm (3 mm to 4 mm), the base depth may be between 65 mm and 9 / 10 mm (0.65 mm to 0.8 mm), and / or the fillet radius may be between 4 and 5 mm (4 mm to 5 mm).

[0038] In some embodiments, connector 232 may include and / or define external threads 242 disposed on and / or around its second end. According to some embodiments, connector 232 may include one or more thread breaks 242-1 that provide areas of increased wall thickness to reduce the likelihood of structural failure when the threads 242 receive rotational forces (e.g., torque) when mating with a corresponding object (not shown; e.g., the needle interface 150 of Figures 1A, 1B, 1C, 1D, 1E, and / or 1F herein). In some embodiments, the path through mounting hole 232-1 and into inner seat 238 may be adjusted from a simple circular cross-section to facilitate easier access of the inserted mounting flange. In some embodiments, for example, the inner channel may include a plurality of radially spaced undercuts that locally increase the inner diameter of the channel to provide less friction against the mounting flange, which is pushed inward toward inner seat 238.

[0039] According to some embodiments, connector 232 may include and / or define one or more external flanges 244. For example, the depicted external flanges 244 may define a stop surface that limits the axial engagement range of connector 232 with other objects and / or components (not shown; e.g., needle interfaces 150 of Figures 1A, 1B, 1C, 1D, 1E, and / or 1F). For example, in the case where the needle interface is threaded onto connector 232, the external flanges 244 may engage with a portion of the needle interface to prevent axial advance and / or threaded engagement beyond the external flanges 244.

[0040] In some embodiments, fewer or more components 232-1, 232-2, 236, 238, 240, 242, 242-1, 244 and / or various configurations of the illustrated components 232-1, 232-2, 236, 238, 240, 242, 242-1, 244 may be included in the pre-filled medical delivery assembly connector 232 without departing from the scope of the embodiments described herein. In some embodiments, components 232-1, 232-2, 236, 238, 240, 242, 242-1, 244 may be similar in configuration and / or function to components with similar naming and / or numbering described herein.

[0041] III. Prefilled Medical Delivery Assembly - Internal Threaded Connections and Safety Shield

[0042] Turning to Figures 3A, 3B, 3C, 3D, 3E, 3F, and 3G, various views of a pre-filled medical delivery assembly 300 according to some embodiments are shown. In some embodiments, the pre-filled medical delivery assembly 300 may include various interconnected and / or modular components, such as a BFS vial 310, which includes and / or defines a neck 312, a fluid seal 314, a mounting flange 316, a vial flange 318, a retractable reservoir 320, a dispensing reservoir 322, and / or an identification region 324. According to some embodiments, the pre-filled medical delivery assembly 300 may include an application (e.g., injection) module or component 330 manufactured, assembled, and / or supplied as a separate unit from the BFS vial 310. In some embodiments, the application assembly 330 may include a mounting collar 332, which itself includes, connects to, and / or defines various features and / or elements. The mounting collar 332 and / or application component 330 can be maintained as closed and / or sterile components, for example, by a seal 334 (e.g., foil, wax, paper, and / or other thin, puncture-resistant, tearable, and / or removable object or layer attached to the application component 330 and / or mounting collar 332) disposed at its first end, the seal 334 sealing the internal volume of the mounting collar 332 or the support 332-1 (labeled in FIG. 3G). In some embodiments, the mounting collar 332 may include and / or define a needle interface support 332-3 disposed at its second end. According to some embodiments, the mounting collar 332 may include one or more connection or mounting features 336 (e.g., internal recesses and / or seats), an internal seat 338 (e.g., configured to receive a mounting flange 316 of the BFS vial when the mounting collar 332 and / or the administration component 330 are inserted into the neck 312 of the BFS vial 310), a puncture seal 340, and / or internal threads 342 (e.g., arranged and / or formed within the needle interface support 332-3). In some embodiments, the mounting collar 332 may include and / or define an external flange 344 (e.g., a radial flange) operable to receive, engage, and / or otherwise engage the needle interface 350. According to some embodiments, the needle interface 350 may be coupled to the mounting collar 332 via its external threads 352, which correspond to and / or engage the internal threads 342 of the mounting collar 332. In some embodiments, the needle interface 350 may include an external recess, a protrusion, and / or a drive surface 354-1, which is rotatably engaged to manipulate the connection of threads 342, 352. According to some embodiments, the needle interface 350 (and / or its raised portion 356) may include, connect, and / or accommodate a needle, cannula, and / or other application member 370, and / or a cap 380 (e.g., selectively engaged and / or connected to the needle interface 350 to cover, accommodate, and / or protect the application member 370).

[0043] In some embodiments, the application member 330 may include and / or be connected to a safety shield 390. The safety shield 390 may include, for example, a shield base 392 mounted on and / or around the neck 312 of the BFS vial 310. According to some embodiments, the shield base 392 may include and / or be connected to a hinge element 392-1 and / or may include one or more mounting features 394. The hinge element 392-1 may flexibly connect the shield base 392 to a shield element 396, for example, the shield element 396 including molded and / or shaped elements configured to selectively cover the application member 370. In some embodiments, the shield element 396 may include and / or define a shield volume or space 398, the size and / or shape of which is designed to receive and / or accommodate the application member 370. In some embodiments, the shield space 398 may include, define, and / or accommodate a needle holder 398-1, for example, in cases where the application member 370 includes a needle and / or cannula. According to some embodiments, the prefilled medical delivery assembly 300 may include a modular design comprising separately constructed components 310, 330, 332, 350, 370, 380, and 390 arranged and connected in cooperation with each other.

[0044] In some embodiments, the shrinkable reservoir 320 may be (fully or partially) filled with fluid or other reagents (not shown separately) for delivery to, for example, a patient (not shown). According to some embodiments, fluid may be injected into the BFS vial 310 in a sterile environment during manufacturing via a BFS process and sealed within the BFS vial 310 by a fluid seal 314. The fluid seal 314 may include a portion molded from the BFS vial 310, for example, a portion configured to be punctured to expel fluid, for example by providing a flat or smooth puncture surface and / or by an axis perpendicular to the BFS vial 310 (and / or the pre-filled medical delivery assembly 300). In some embodiments, the fluid seal 314 may include foil, wax, paper, and / or other thin, punctureable objects or layers attached to the BFS vial 310. In some embodiments, the neck 312 of the BFS vial 310 may include a mounting flange 316, such as the “annular” shaped outer flange shown. For example, mounting flange 316 may provide a radially resilient mating surface that is operable to provide selective engagement or fitting within the bracket 332-1 of application assembly 330.

[0045] According to some embodiments, fluid can generally pass between the retractable reservoir 320 and the connected dispensing reservoir 322. In some embodiments, the junction, valve, and / or passage (not separately labeled) between the dispensing reservoir 322 and the retractable reservoir 320 may restrict flow, allowing fluid to easily enter one of the dispensing reservoir 322 and the retractable reservoir 320, but not necessarily return to the other reservoir 320, 322. In some embodiments, such retraction can provide the advantages described herein. In some embodiments, retraction may not be necessary or desirable, for example, when the retractable reservoir 320 and the dispensing reservoir 322 are formed and / or combined into a single unobstructed reservoir, such as a single fluid reservoir (not shown).

[0046] In some embodiments, the prefilled medical delivery assembly 300 may include a modular design comprising separately constructed components 310, 330 arranged and connected in a cooperative manner. As shown in FIG3A, for example, the BFS vial 310 and the application assembly 330 may be manufactured, packaged, transported, stored, and / or supplied as separate components. In this way, the application assembly 330 may not need to be stored or transported according to frequently restrictive requirements imposed on the medication, and the amount of space required for such dedicated storage and / or transport can be reduced accordingly. The application assembly 330 may also or alternatively be manufactured, stored, and / or transported in advance (e.g., at a first time), while the prefilled fluid-filled BFS vial 310 may be manufactured, stored, and / or transported at a later time (e.g., at a second time). In some embodiments, the delay between the first and second times may be long without having a decisive impact, as in some embodiments the application assembly 330 may be stored indefinitely. In this way, units of the application assembly 330 can be provided on hand before the BFS vial 310 becomes available and / or arrives, reducing supply chain constraints in the case of proactive procurement of the application assembly 330.

[0047] According to some embodiments, components 310, 330 can be connected, for example, in the field and / or in situ, to provide an active pre-filled (e.g., injectable) medical delivery device. As shown in FIG3B, for example, the seal 334 can be removed from the application component 330 (and / or the shield base 392; at “A”), and the application component 330 (and / or the support 332-1 and / or its shield base 392) can be aligned with the neck 312 of the BFS vial 310. According to some embodiments, the application component 330 (and / or the mounting collar 332 and / or its shield base 392) can be axially engaged with the BFS vial 310 by applying a mating axial force, as shown in FIG3C (at “B”). The application component 330 (and / or mounting collar 332 and / or its shroud base 392) can be pushed onto the neck 312 of the BFS vial 310, for example, such that a co-shaped inner seat 338 (e.g., an internal groove or channel) receives the mounting flange 316, thereby removably connecting the BFS vial 310 and the application component 330 (and / or mounting collar 332 and / or its shroud base 392). In some embodiments, the inner seat 338 (and / or other internal features) and / or the mounting flange 316 can be shaped such that the BFS vial 310 and the application component 330 (and / or mounting collar 332 and / or its shroud base 392) are mechanically prevented from disengaging. In some embodiments, the mounting flange 316 can be shaped as an axially elongated circular outer flange (e.g., a depicted "ring" shape) and / or the inner seat 338 can include co-shaped and / or mirrored axially elongated circular internal grooves or tracks. According to some embodiments, without the use of the safety shield 390, one or more mounting features 336 (e.g., the depicted internally radially spaced grooves) can engage with the bottle flange 318 (and / or a portion of the BFS vial 310) such that rotation of the application member 330 (and / or its mounting collar 332) relative to the BFS vial 310 is restricted when they are connected. In some embodiments, one or more mounting features 336, such as the depicted internally radially spaced grooves, when the safety shield 390 is utilized and disposed between the BFS vial 310 and the application member 330, can engage with mounting features 394 of the safety shield 390 (and / or a portion of the shield base 392) such that rotation of the application member 330 (and / or its mounting collar 332) relative to the BFS vial 310 is unrestricted when they are connected. In some embodiments, such as when the mounting feature 394 of the safety shield 390 engages with, is housed within, and / or is held by the corresponding mounting feature 336 of the mounting collar 332, axial rotation of the mounting collar 332 relative to the safety shield 390 can be mechanically prevented.In some embodiments, the mounting feature 396 of the safety guard 390 may not be used (or may include one or more continuous and / or non-rotational limiting features), and free rotation between the mounting collar 332 and the safety guard 390 may be mechanically permissible. According to some embodiments, the connection between the BFS vial 310 and the application component 330 (and / or the mounting collar 332 and / or its safety guard 390) may be configured to explicitly allow free rotation of the BFS vial 310 relative to the application component 330 (and / or its mounting collar 332 and / or its safety guard 390) (e.g., about a common axis). For example, in some embodiments, the mounting feature 336 may not engage with the BFS vial 310 (and / or its mounting flange 316), thereby allowing rotation therebetween.

[0048] As shown in Figure 3D, in some embodiments, the neck 312 of the BFS vial 330 may be pushed into and / or forced into the support 332-1 of the mounting collar 332 (and / or through the shield base 392, which may be annular as shown) until the mounting flange 316 is positioned (and / or engaged or mated) in the inner seat 338 (e.g., in a seated position). In this way, the fluid seal 314 can be advantageously positioned adjacent to the puncture seal 340. According to some embodiments, the mounting flange 316 may be configured as annular (as shown) to provide various advantages for the pre-filled medical delivery assembly 300. For example, axial elongation of the mounting flange 316 may provide a smooth, uniform, and / or less stressful mating process that is less likely to deform the soft plastic neck 312 of the BFS vial 310, and / or provide an extended mating surface that is more likely to prevent fluid leakage. In some embodiments, the mounting flange 316 and the shape- and size-matched internal seat 338 allow for simple, efficient, and / or economical attachment of the application component 330 to the BFS vial 310. According to some embodiments, for example, when ready to apply and / or use the pre-filled medical delivery assembly 300, the shield element 396 of the safety shield 390 can be rotated, flipped, and / or otherwise repositioned by activation of the hinge element 392-1 (at “D”).

[0049] In some embodiments, the needle interface 350 may be connected to the mounting collar 332 via engagement of the internal thread 342 of the mounting collar 332 with the external thread 352 (or thread) of the needle interface 350. The external thread 352 corresponds to and engages with the internal thread 342, such that they are rotatably and / or detachably connected. According to some embodiments, the application member 330 may be provided with a partially engaged mounting collar 332 and needle interface 350 (e.g., threads 342, 352 are partially connected), as shown in FIG3D. In some embodiments, the partial engagement (or first engagement state) may result in the application member 370 (e.g., its second end or proximal end) being positioned adjacent to (and / or in contact with) the puncture seal 340 of the mounting collar 332. In such a first engagement state, the application member 330 may be connected to the BFS vial 310, but the BFS vial 310 (and / or the puncture seal 340) has not yet been punctured and / or destroyed by the application member 370.

[0050] According to some embodiments, the needle interface 350 may be connected to and / or retain the application member 370. The application member 370 may be inserted into and / or through the needle interface 350 (and / or its raised portion 356), for example, such that it includes a first or application end extending axially distally from the BFS vial 310 and a second or puncture end disposed within the needle interface 350. In some embodiments, the application end and / or distal portion of the application member 370 may be received, covered, and / or concealed by a cap 380. According to some embodiments, the cap 380 may be configured to receive the application member 370 and removably connected to the housing 350 (e.g., by fitting it externally and / or by engaging with an external flange 344).

[0051] According to some embodiments, the combination of the mounting collar 332 and the needle interface 350 (and cap 380) can be used to connect and / or mate the application member 370 with the BFS vial 310 to provide a mechanism by which the application member 370 can be reliably connected to the soft plastic BFS vial 310. Due to the nature of the BFS plastic and / or the processing and / or the small shape factor of the BFS vial 310, providing a standard external thread (not shown) directly on the neck 312 would not be a viable option, as it would result in an imprecise, unreliable, and / or non-watertight connection between the BFS vial 310 and, for example, the needle interface 350 (i.e., even if the thread can be properly manufactured within the required tolerances, the thread will deform, which is not a desirable result in itself). The applicant has recognized, for example, that the “soft” plastic required for the BFS process is not susceptible to the effects of machining due to thermal deformation of machining features during molding attempts, and deformation due to mechanical stress during use. Therefore, the standardized screw-in needle interface (not shown) is not easily compatible with the connection of the BFS vial 310 (e.g., without the collar 332 installed).

[0052] In some embodiments, the application member 370 may include a needle whose shape and / or size are adapted to inject a fluid medication into a patient via at least one subcutaneous, intramuscular, intradermal, and intravenous route. For ease of explanation and description, the application member 370 is generally referred to as a needle or cannula in the accompanying drawings and description. However, it should be noted that in other embodiments, the medication delivery member 370 may include a nozzle (not shown) configured to control the administration of a fluid medication to a patient. The nozzle may include a spray nozzle, for example, configured to facilitate the dispersion of the fluid medication into a spray. Thus, a needle interface 350 equipped with a spray nozzle may be particularly suitable for administering a fluid medication to, for example, the nasal passages or other sites of the body that benefit from spray application (e.g., ear canals, other orifices). In other embodiments, the nozzle may be configured to facilitate the formation of fluid medication droplets. Thus, a needle interface 350 including a droplet nozzle may be used for administering fluid medications by droplets, such as for application to the eyes, topical application, etc.

[0053] As commonly understood, a fluid or pharmaceutical agent (e.g., stored in a BFS vial 310 and / or one or more of its reservoirs 320, 322) may include an agent intended to be injected into a patient (e.g., an animal, such as a mammal, human, or non-human) and capable of producing an effect (alone or in combination with an active ingredient). Therefore, the agent may include, but is not limited to, vaccines, drugs, therapeutic agents, pharmaceutical preparations, diluents, etc. According to some embodiments, one or both of the fluid agent and the active ingredient (i.e., a pharmaceutical formulation and / or its components) may be tracked, monitored, and their compatibility checked, for example, by utilizing electronic data storage devices (not shown) connected to various modules or components such as the BFS vial 310 (e.g., at identification area 324, on identification area 124, or in identification area 124) and / or the application component 330.

[0054] According to some embodiments, the mounting collar 332, needle interface 350, and / or cap 380 may be made of medical-grade materials. In some embodiments, the mounting collar 332, needle interface 350, and / or cap 380 may be composed of thermoplastic polymers or other “hard” plastics (e.g., greater than 80 on the Rockwell “R” scale), including, but not limited to, polybenzimidazole, ABS, polystyrene, polyvinyl chloride, etc. In some embodiments, the prefilled medical delivery assembly 300 may advantageously be manufactured (in large quantities) as separate parts or portions, i.e., at least a “soft” plastic BFS vial 310 portion (e.g., a “first” portion) and a “hard” plastic drug delivery component 330 (e.g., a “second” portion), these different plastic parts / portions being selectively connected for drug delivery to a patient.

[0055] According to some embodiments, the pre-filled medical delivery assembly 300 can be advanced from a first engaged state to a second engaged state, in which the application member 370 has pierced the BFS vial 310 and the fluid therein can be readily expelled through the application member 370 (e.g., into the patient's body). As shown in FIG3D, partial engagement of the mounting collar 332 and the needle interface 350 (e.g., partial connection of threads 342, 352) can be transformed, for example, by applying a rotational force to the cap 380 to a more advanced, fully advanced, or fully advanced state, for example, as shown in FIG3D (“C”). In some embodiments, further advancement and / or full engagement (or the second engaged state; as shown in FIG3E) can cause the application member 370 (e.g., its second end or proximal end) to advance through the puncture seal 340 of the mounting collar 332 and through the seal 314 of the BFS vial 310. In this manner, for example, the continuous rotational engagement of threads 342, 352 can cause the application member 370 (e.g., its second or proximal end) to open a fluid passage between the BFS vial 310 (e.g., and / or neck 312 and / or its reservoirs 320, 322) and the first or distal end of the application member 370. In some embodiments, the cap 380 can serve as a rotational force actuator to transmit rotational force to the needle interface 350 to induce engagement of threads 342, 352 (and, for example, puncture the puncture seal 340 and the seal 314 of the BFS vial 310). The interior of the cap 380 may include a drive element (not shown), for example, sized and / or shaped to engage with the drive surface 354-1 of the needle interface 350, such that the rotational force applied to the cap 380 is transmitted to the needle interface 350 and rotationally advances the needle interface 350. In this way, for example, cap 380 can be used to complete the insertion / fitting of threads 342, 352, thereby allowing the second end or proximal end of application member 370 to pierce and perforate each of seal 340 and seal 314 of BFS vial 310. According to some embodiments, one or more reservoirs 320, 322 can be compressed (e.g., by applying a radially inward force) to expel fluid therein through application member 370. In some embodiments, once application is complete, shield element 396 of safety shield 390 can be repositioned (e.g., by activation and / or utilization of hinge element 392-1), for example by flipping shield element 396 (at “E” in FIG. 3E) to cover application member 370—for example, as shown in FIG. 3F.

[0056] In some embodiments, fewer or more components 310, 312, 314, 316, 318, 320, 322, 324, 330, 332, 332-1, 334, 336, 338, 340, 342, 344, 350, 352, 354-1, 356, 370, 380, 390, 392, 392-1, 394, 396, 398, 398-1 and / or the illustrated components 310, 312, 314 Various configurations of 316, 318, 320, 322, 324, 330, 332, 332-1, 334, 336, 338, 340, 342, 344, 350, 352, 354-1, 356, 370, 380, 390, 392, 392-1, 394, 396, 398, 398-1 may be included in the prefilled medical delivery assembly 300 without departing from the scope of the embodiments described herein. In some embodiments, components 310, 312, 314, 316, 318, 320, 322, 324, 330, 332, 332-1, 334, 336, 338, 340, 342, 344, 350, 352, 354-1, 356, 370, 380, 390, 392, 392-1, 394, 396, 398, 398-1 may be similar in configuration and / or function to components with similar naming and / or numbering as described herein. According to some embodiments, the pre-filled medical delivery assembly 300 may include a mounting flange 316 but not a retractable reservoir 320. In some embodiments, the pre-filled medical delivery assembly 300 may include a mounting flange 316 but not a dispensing reservoir 322. According to some embodiments, the administration component 330 may be provided without (and / or separately from) the BFS vial 310. In some embodiments, the safety shield 390 may be omitted and / or not used.

[0057] Referring now to Figures 4A, 4B, 4C, 4D, 4E, 4F, and 4G, several views are shown of a pre-filled medical delivery assembly connector 432 (e.g., a connector made of “hard” plastic and configured to securely mate with a “soft” plastic BFS object / container) according to some of the embodiments shown. Connector 432 may include similar features and / or construction and / or may be similar to the mounting collar 332 of Figures 3A, 3B, 3C, 3D, 3E, 3F, and / or 3G herein. Connector 432 may include and / or define, for example, chambers, voids, volumes, and / or mounting brackets 432-1, needle interface brackets 432-3, and / or one or more mounting features 436. In some embodiments, mounting bracket 432-1 may, for example, be shaped to receive and / or retain the neck of the BFS vial (not shown; e.g., the neck 312 of Figures 3A, 3B, 3C, 3D, 3E, 3F and / or 3G) by defining various internal dimensions and / or features. Mounting bracket 432-1 may include and / or define, for example, various internal diameters, each defining a different portion of the mounting bracket 432-1. According to some embodiments, mounting bracket 432-1 may include and / or define an inner seat 438 whose position, size, and / or shape are specifically designed to receive a mounting flange (not shown; e.g., the “annular” mounting flange 316 of Figures 3A, 3B, 3C, 3D, 3E, 3F and / or 3G). In some embodiments, the inner seat 438 may include an internal recess, channel, and / or seat that includes and / or defines various physical dimensions and / or features, such as mating length, seat depth, and / or rounding radius. In some embodiments, the inner seat 438 may include an internal channel (e.g., a circumferential channel) rounded with a radius in the range of four to five millimeters (4 mm-5 mm). In some embodiments, the inner seat 438 extends radially outward into the inner wall of the mounting bracket 432-1 by a protrusion, and wherein the length of the inner seat 438 is in the range of four and three-tenths (4.3x) to five and three-tenths (5.3x) of the protrusion. According to some embodiments, the mounting bracket 432-1 may include an outflow channel arranged, formed, and / or cut into its second end but blocked and / or interrupted by the seal 440.

[0058] According to some embodiments, connector 432 can be axially engaged by the application of an axial engaging force to connect to a BFS vial (not shown; e.g., BFS vial 310 of Figures 3A, 3B, 3C, 3D, 3E, 3F and / or 3G herein). A seal (not shown; e.g., seal 334 of Figures 3A, 3B, 3C, 3D, 3E, 3F and / or 3G herein) covering the mounting bracket 432-1 (and / or covering the opening of the safety shield base connected to connector 432) can, for example, be removed, and connector 432 can be pushed onto the neck of the BFS vial such that a co-shaped inner seat 438 receives the mounting flange of the BFS vial, thereby selectively and / or removably connecting the BFS vial to connector 432. In some embodiments (not shown), the inner seat 438 (and / or other internal features) and / or mounting flange may be shaped such that the BFS vial and connector 432 are mechanically prevented from disengaging. According to some embodiments, the neck of the BFS vial may advance into the mounting bracket 432-1 at a first portion having a first inner diameter. In some embodiments, the neck may continue to advance into a second portion of the mounting bracket 432-1 at a second portion having a second inner diameter. As shown, the second inner diameter may be smaller than the first inner diameter. According to some embodiments, the second inner diameter may be sized to accommodate the outer diameter of the neck of the BFS vial, which may continue to be inserted into the mounting socket 432-1.

[0059] In some embodiments, once the mounting flange of the BFS vial (e.g., an outer circular and / or axially elongated flange) reaches the second portion having a second inner diameter, the mounting flange may engage with the sidewall at a junction / transition between the first and second inner diameters. The first inner diameter may be larger than the radial extent of the mounting flange, but the second inner diameter may be smaller than the radial extent, resulting in engagement. In some embodiments, such as those depicted (but not separately labeled), an internal taper may be provided between the first and second inner diameters, such that the mounting flange may engage along the taper before reaching the second portion having a second inner diameter.

[0060] According to some embodiments, the BFS vial may be made of a softer material than the connector 432 (e.g., having a lower hardness rating and / or being resilient), which may cause the mounting flange to deflect radially inward when engaging with the inner wall / surface of the mounting bracket 432-1 (and under continuous axial force). The mounting flange may deform, compress, and / or flatten to pass through, for example, a second portion having a second inner diameter, and may advance into the inner seat 438.

[0061] According to some embodiments, once the mounting flange of the BFS vial enters the inner seat 438, the mounting flange may expand radially outward to (or near) its original axial range (e.g., releasing elastic potential energy stored by its elastic deformation). In some embodiments, such as when the inner seat 438 is designed to be slightly smaller than the mounting flange (e.g., 0.5% to 2% (0.5%-2.0%)), the mounting flange may be able to reform only to near its original range, resulting in the mounting flange retaining some of its stored elastic energy due to its continued (albeit small) deformation. This retained deformation can, for example, result in an interference pressure between the mounting flange and the inner wall of the inner seat 438, ensuring a tight fit between the materials and a substantially leak-proof seal. In some embodiments, the configuration of the inner seat 438 and / or mounting bracket 432-1 may be defined with BFS vials or bottles of a specific size (e.g., BFS vials 310 of Figures 3A, 3B, 3C, 3D, 3E, 3F and / or 3G herein) such that their mating can be achieved by applying mating forces in a stable and uniform manner, which reduces strain on the components and provides a successful and repeatable user experience.

[0062] According to some embodiments, the first inner diameter may be between 7.45 mm and 9 mm (7.45 mm to 9 mm). In some embodiments, the second inner diameter may be between 6.5 mm and 7 mm (6.5 mm to 7 mm). According to some embodiments, the third inner diameter may be equal to or smaller than the second inner diameter. The third inner diameter may, for example, be between 6 mm and 6.5 mm (6 mm to 6.5 mm). In some embodiments, the dimensions of the mating length, base depth, and / or fillet radius may mate with the mounting flange of the BFS vial. According to some embodiments, the mating length may be between 3 and 4 mm (3 mm to 4 mm), the base depth may be between 65 mm and 9 / 10 mm (0.65 mm to 0.8 mm), and / or the fillet radius may be between 4 and 5 mm (4 mm to 5 mm).

[0063] In some embodiments, connector 432 may include and / or define internal threads 442 in and / or around a needle interface holder 432-3 located at a second end of connector 432. According to some embodiments, the path into and / or through the mounting holder 432-1 and into the inner seat 438 may be adjusted from a simple circular cross-section to facilitate easier access of the inserted mounting flange. In some embodiments, for example, the internal channel may include a plurality of radially spaced undercuts that locally increase the inner diameter of the channel to provide less friction against the mounting flange, which is pushed inward toward the inner seat 438.

[0064] According to some embodiments, connector 432 may include and / or define one or more external flanges 444. The depicted external flanges 444 may, for example, define a stop surface that restricts engagement of connector 432 with other objects and / or components (not shown; e.g., caps 380 of Figures 3A, 3B, 3C, 3D, 3E, 3F, and / or 3G). For example, when a needle interface is screwed into connector 432 (e.g., its needle interface support 432-3) and / or a cap (not shown) is fitted onto connector 432, the external flanges 444 may engage a portion of the cap to prevent axial advance beyond the external flanges 444.

[0065] In some embodiments, one or more mounting features 436 may be configured (e.g., size, shape, and / or positioning / spaced) to accommodate one or more corresponding mounting features of the safety shield base (not shown; e.g., mounting feature 394 of the safety shield base 392 of Figures 3A, 3B, 3C, 3D, 3E, 3F, and / or 3G herein). In this way, for example, the safety shield (not shown; e.g., safety shield 390 of Figures 3A, 3B, 3C, 3D, 3E, 3F, and / or 3G) may be connected to the connector 432. In some embodiments, such as where the attached and / or mating safety shield base includes an opening and / or is annular in shape, the safety shield base may be connected to the mounting feature 436 without obstructing the neck insertion mounting bracket 332-1 of the BFS vial.

[0066] According to some embodiments, fewer or more components 432-1, 432-3, 436, 438, 440, 442, 444 and / or various configurations of illustrated components 432-1, 432-3, 436, 438, 440, 442, 444 may be included in the pre-filled medical delivery assembly connector 432 without departing from the scope of the embodiments described herein. In some embodiments, components 432-1, 432-3, 436, 438, 440, 442, 444 may be similar in configuration and / or function to similarly named and / or numbered components described herein.

[0067] Turning to Figures 5A, 5B, 5C, 5D, 5E, 5F, and 5G, various views of a prefilled medical delivery assembly needle interface 550 according to some embodiments are shown. The needle interface 550 (e.g., an application component housing) may include similar features and / or configurations and / or may be similar to the needle interfaces 350 of Figures 3A, 3B, 3C, 3D, 3E, 3F, and / or 3G herein. The needle interface 550 may include and / or define, for example, an interface hole 550-1, at least one external thread 552, one or more drive grooves 554 (e.g., including and / or defining at least one drive surface 554-1 and / or at least one angled surface 554-2), a riser 556, and / or one or more protrusions 558. In some embodiments, the interface hole 550-1 may accept and / or accommodate an application member (not shown; e.g., application member 370 of Figures 3A, 3B, 3C, 3D, 3E, 3F and / or 3G herein) such as a needle. According to some embodiments, the thread 552 may be formed and / or configured to engage with a corresponding threaded engagement with a BFS connector or mating collar (not shown; e.g., connectors 330, 430 of Figures 3A, 3B, 3C, 3D, 3E, 3F, 3G, 4A, 4B, 4C, 4D, 4E, 4F and / or 4G herein), such that the needle interface 550 can be securely, detachably or non-detachably connected thereto. In some embodiments, one or more drive grooves 554 (and / or their drive surfaces 554-1) may be shaped and / or configured to engage in a first rotational direction and receive rotational force from a key (not shown), and / or allow the key to rotate freely in a second rotational direction (e.g., not engage and / or receive rotational force therefrom).

[0068] According to some embodiments, a key may be disposed and / or formed on the inner surface of the cap (not shown; e.g., cap 380 of Figures 3A, 3B, 3C, 3D, 3E, 3F, and / or 3G herein) as an actuator to apply rotational force to the needle interface 550. The needle interface 550 itself may be disposed, for example, at least partially within a volume defined inside the cap, such that the key of the cap first enters the drive groove 554. In some embodiments, the clockwise wall surface of the drive groove 554 may define a drive surface 554-1 that allows the key of the cap to advance the needle interface 550 in a clockwise (e.g., rightward / tightening) direction. According to some embodiments, at least a portion of the counterclockwise wall surface of the drive groove 554 may define an angled surface 554-2 that, upon application of a counterclockwise (e.g., leftward / loosening) rotation, causes the key to be pushed axially outward from the drive groove 554. In this way, for example, the cap / key can be used to engage and / or mate thread 552 with a corresponding thread (e.g., the thread of a BFS connector; not shown), but cannot be used to disengage thread 552 from the corresponding thread. In some embodiments, as shown, thread 552 may include a single turn of thread that spans 180° or less of the circumference of the needle interface 550, and / or is bisected and / or interrupted by one or more drive slots 554.

[0069] In some embodiments, fewer or more components 550-1, 552, 554, 554-1, 554-2, 556, 558 and / or various configurations of the illustrated components 550-1, 552, 554, 554-1, 554-1, 554-2, 556, 558 may be included in the needle interface 550 of the pre-filled medical delivery assembly without departing from the scope of the embodiments described herein. In some embodiments, components 550-1, 552, 554, 554-1, 554-2, 556, 558 may be similar in configuration and / or function to similarly named and / or numbered components described herein.

[0070] Referring now to Figures 6A, 6B, 6C, 6D, 6E, and 6F, various views of a prefilled medical delivery assembly cap 680 according to some embodiments are shown. The cap 680 may include similar features and / or configurations and / or may be similar to the caps 380 of Figures 3A, 3B, 3C, 3D, 3E, 3F, and / or 3G herein. The cap 680 may include and / or define any or all of, for example, a collar gap 680-1, a needle interface gap 680-2, a needle gap 680-3, and / or a gripping surface 680-4. In some embodiments, the collar gap 680-1 may include an internal volume defined at a first end (e.g., an open end) of the cap 680. According to some embodiments, the size and / or shape of the collar gap 680-1 may be designed to accept, accommodate and / or retain (e.g., may define a first diameter and / or a first inner surface profile) at least a portion of the BFS collar and / or connector (not shown), such as the mounting collar 332 of Figures 3A, 3B, 3C, 3D, 3E, 3F and / or 3G herein. In some embodiments, the needle interface gap 680-2 may be formed and / or arranged adjacent to and / or adjacent to the collar gap 680-1 and / or its size and / or shape may be determined to receive, accommodate and / or retain (e.g., may define a second diameter and / or a second inner surface profile) at least a portion of a needle interface (not shown), such as the needle interfaces 350, 450 of Figures 3A, 3B, 3C, 3D, 3E, 3F, 3G, 4A, 4B, 4C, 4D, 4E, 4F and / or 4G herein. According to some embodiments, the needle gap 680-3 may be formed and / or configured to be adjacent to and / or adjacent to the needle interface gap 680-2, and / or its size and / or shape may be determined to receive, accommodate and / or retain (e.g., may define a third diameter and / or a third inner surface profile) at least a portion of a needle or other application member (not shown), such as application member 370 of Figures 3A, 3B, 3C, 3D, 3E, 3F and / or 3G herein.

[0071] In some embodiments, the gripping surface 680-4 may include one or more planar, flat, textured, and / or parallel (e.g., in the case of two (2) or more) surfaces through which a user grips the cap 680 to apply a rotational force. According to some embodiments, this rotational force may be used to drive a needle interface within the needle interface recess 680-2 into (or further into) a mounting collar (e.g., a BFS collar) disposed within the collar recess 680-1. In some embodiments, the cap 680 and / or the needle interface recess 680-2 may include one or more internal protrusions, features, and / or keys 682 operable to engage one or more features of the needle interface. The keys 682 may, for example, enable a user to twist the cap 680 to apply a rotational force to the engaged needle interface and / or the BFS connector attached thereto, for example, selectively advancing an application member (not shown) into a BFS vial (also not shown) according to embodiments described herein. In this way, for example, cover 680 can be used as a rotary actuator to complete threaded (and / or other rotary coupling) components of prefilled medical delivery assemblies as described herein.

[0072] In some embodiments, fewer or more components 680-1, 680-2, 680-3, 680-4, 682 and / or various configurations of the illustrated components 680-1, 680-2, 680-3, 680-4, 682 may be included in the pre-filled medical delivery assembly cover 680 without departing from the scope of the embodiments described herein. In some embodiments, components 680-1, 680-2, 680-3, 680-4, 682 may be similar in configuration and / or function to the similarly named and / or numbered components described herein.

[0073] Referring now to Figures 7A, 7B, 7C, 7D, 7E, and 7F, various views of a pre-filled medical delivery assembly safety shield 790 according to some embodiments are shown. The safety shield 790 may include similar features and / or construction and / or a cover 380 that may be similar to those in Figures 3A, 3B, 3C, 3D, 3E, 3F, and / or 3G herein. The safety shield 790 may include and / or define, for example, a shield base 792, a hinge element 792-1, one or more mounting features 794, a shield element 796 defining and / or including a shield space 798, and / or a needle holder 798-1. In some embodiments, the shield base 792 may include a circular and / or annular ring through which the neck (not shown) of the BFS vial or bottle passes (the neck, for example, the neck 312 of the BFS vial 310 in Figures 3A, 3B, 3C, 3D, 3E, 3F and / or 3G herein). In such a manner, for example, the shield base 792 may be selectively and / or removably attached to the BFS vial. According to some embodiments, the shield base 792 may be connected to and / or include a hinge element 792-1 that can connect and / or link the shield base 792 to the shield element 796. In this manner, for example, when the shield base 792 is attached to and / or mounted on the BFS vial, the shield element 796 may also be connected to the BFS vial by means of the connection via the hinge element 792-1. Hinge element 792-1 may include any type, configuration, and / or number of resilient connectors between hinges and / or shield base 792 and shield element 796, allowing shield base 792 and shield element 796 to be selectively positioned relative to each other in multiple different orientations. Where hinge element 792-1 comprises flexible and / or resilient plastic elements (e.g., as shown), for example, hinge element 792-1 may be attached to the respective shield base 792 and shield element 796 at two different points (or lines—e.g., hinge lines) and may allow repositioning around one or more such points / lines.

[0074] In some embodiments, the shroud base 792 may be connected to a BFS mounting collar and / or connector (not shown), such as the mounting collar 332 of Figures 3A, 3B, 3C, 3D, 3E, 3F and / or 3G herein. According to some embodiments, the size, shape and / or position or spacing of one or more mounting features 794 may be designed to match corresponding features (not shown), such as one or more mounting features 336 of the mounting collar 332 of Figures 3A, 3B, 3C, 3D, 3E, 3F and / or 3G herein. As depicted, for example, one or more mounting features 794 may include axial projections configured to settle within corresponding axial recesses and / or seats of the mounting collar. In some embodiments, the mounting features 794 may be provided with different configurations (e.g., a single annular flange; not shown) or may not be used. According to some embodiments, the size and / or shape of the shield space 798 may be designed to accommodate a needle (and / or other application member; neither is shown; e.g., application member 370 of Figures 3A, 3B, 3C, 3D, 3E, 3F and / or 3G) and / or other application components and / or module objects (also not shown). In some embodiments, a needle holder 798-1 may be disposed in the shield space 798 to position, retain and / or receive or guide the needle / cannula, for example, where the application member to be protected includes a needle and / or cannula.

[0075] In some embodiments, fewer or more components 792, 792-1, 794, 796, 798, 798-1 and / or various configurations of the depicted components 792, 792-1, 794, 796, 798, 798-1 may be included in a pre-filled medical delivery assembly safety shield 790 without departing from the scope of the embodiments described herein. In some embodiments, components 792, 792-1, 794, 796, 798, 798-1 may be similar in configuration and / or function to similarly named and / or numbered components described herein.

[0076] IV. Prefilled Medical Delivery Methods

[0077] In some embodiments, various methods and / or processes may be performed and / or implemented to administer a single dose to a patient / target using a BFS vial and / or bottle filled with a single-dose medication. In some embodiments, a method may connect a BFS vial to an application component that engages to puncture the BFS vial, which can then be used to inject (or otherwise administer) the medication to a patient / target. The methods and / or processes described herein (and / or their diagrams and / or flowcharts) do not necessarily imply a fixed order of any of the described actions, steps, and / or procedures, and embodiments may generally be performed in any order unless otherwise specifically stated. While the order of actions, steps, and / or procedures described herein is generally not fixed, in some embodiments, actions, steps, and / or procedures may be specifically performed in the order listed, depicted, and / or described and / or may be performed in response to any previously listed, depicted, and / or described actions, steps, and / or procedures.

[0078] In practice, for example, some or all of the following procedures may be followed to administer medication (and / or other fluids) to a patient / target using a pre-filled medical delivery assembly. In some embodiments, the injection area may be cleaned and / or otherwise prepared. The neck and / or fluid seal of the BFS vial (e.g., the "first" portion and / or component) may be cleaned (e.g., wiped with alcohol) to prepare the BFS vial for attachment to the application component and / or assembly. In some embodiments, the "second" portion and / or component, including the pre-packaged mounting collar / connector, needle interface (with application component), cap, and / or safety shield, may include a seal that maintains the internal volume / fluid passage in a sterile state, which may be removed for repapering to attach to the BFS vial. According to some embodiments, the application component may be axially aligned with the neck of the BFS vial, and the neck may be inserted into the mounting collar and / or through the bottom member of the safety shield to engage a mounting flange having mating internal features of a mating shape. According to some embodiments, the application component (and / or mounting ring and / or its safety shield) can "click" or snap onto the BFS vial.

[0079] According to some embodiments, the needle interface, as a component of, for example, a pre-packaged "second" part / application assembly, may only partially engage (e.g., partially threaded to) the mounting collar. For example, only a portion of the thread may be engaged, such that the "second" part is at least loosely or partially connected as a single object / assembly, but the application member is not axially advanced enough to pierce the BFS vial when the "second" part / assembly mates with the BFS vial. In this way, for example, a user can connect the "first" and "second" parts and then selectively engage the application member to pierce the BFS vial (e.g., by applying a rotational force to advance the threads / their engagement).

[0080] In some embodiments, a user can hold the mounting collar with one hand / finger and fully screw (e.g., continue screwing) the needle interface into the mounting collar by applying rotational force to the cap. The cap may include an internal key that engages one or more stop and / or drive features of the needle interface, for example, to transmit rotational force to the needle interface and accordingly advance the threaded engagement. As the threaded engagement is advanced, a second end or piercing end of the application member may be axially advanced to pierce the mounting collar (e.g., its sealing portion) and through the fluid seal of the BFS vial, thereby activating the prefilled medical delivery assembly. In some embodiments, the stop / drive features may be shaped to include one or more surfaces that engage with the internal key of the cap when the cap is rotated clockwise, but may include opposing surfaces or features that allow (and / or force) the internal key to disengage from the stop / drive features when the cap is rotated counterclockwise. In this way, for example, a user can easily connect (or complete the connection) the needle interface and the mounting collar, but prevents the use of the cap to loosen or separate the needle interface and the mounting collar. In some embodiments, the internal key may be configured to accept a threshold amount of torque prior to design failure, allowing the user to easily tighten the threads, but any attempt to overtighten will cause the internal key to disengage or break, thereby preventing the cap from further acting as a driver in the mating process and correspondingly preventing overtightening between the needle interface and the mounting ring. In some embodiments, an audible "click" or other sound of internal key failure may include an indication designed for the user that the pre-filled medical delivery assembly has been correctly and / or fully assembled / activated.

[0081] According to some embodiments, the cap can be removed to expose the application member and / or its first end or application tip. In some embodiments, the application member (e.g., its application tip) can be inserted into the patient, and the retractable reservoir of the BFS vial can be squeezed (e.g., applied in a radially inward force) to expel fluid through the application member and into the patient. In some embodiments, the application member can be withdrawn from the patient and / or the safety shield (e.g., attached to the application member / assembly and / or a portion thereof) can be selectively moved (e.g., flipped and / or rotated) to a position covering the application member / needle. The pre-filled medical delivery assembly can then be appropriately processed. While the mounting collar and needle interface are generally described and depicted as separate connectable objects, in some embodiments they can be manufactured (e.g., molded) as a single object or part, or may include additional parts or components.

[0082] V. Rule Interpretation

[0083] Throughout this description, unless otherwise stated, the following terms may include and / or encompass the illustrative meanings provided. The meanings of these terms and illustrative examples are provided to clarify the language chosen to describe embodiments in the specification and appended claims, and are therefore not intended to be generalized. While not generally limiting and while not limiting all described embodiments, in some embodiments, terms are specifically limited to the illustrative definitions and / or examples provided. Other terms are defined throughout this specification.

[0084] Numerous embodiments are described in this patent application and are presented for illustrative purposes only. The described embodiments are not, and are not intended to be, limiting in any sense. The invention disclosed herein is broadly applicable to many embodiments, as will be apparent from the disclosure. Those skilled in the art will recognize that the disclosed invention can be practiced with various modifications and variations, such as structural, logical, software, and electrical modifications. Although specific features of the disclosed invention may be described with reference to one or more particular embodiments and / or drawings, it should be understood that such features are not limited to the one or more particular embodiments or drawings described below with reference to them, unless otherwise expressly stated.

[0085] Devices that communicate with each other do not need to communicate continuously unless otherwise expressly stated.

[0086] The description of embodiments having multiple components or features does not imply the need for all or even any of these components and / or features. Rather, various optional components are described to illustrate various possible embodiments of the invention. Unless expressly stated otherwise, no component and / or function is essential or required.

[0087] Furthermore, while process steps, algorithms, etc., can be described sequentially, such a process can be configured to operate in different orders. In other words, any order or sequence of steps that can be explicitly described does not necessarily imply that these steps must be performed in that order. The steps of the process described herein can be performed in any actual order. Moreover, some steps may be performed simultaneously, although they are described or implied to occur non-simultaneously (e.g., because one step is described after another). Furthermore, the illustration of the process in the accompanying drawings does not imply that the illustrated process does not include other variations and modifications thereof, nor does it imply that the illustrated process or any of its steps are essential to the invention, and does not imply that the illustrated process is preferred.

[0088] This disclosure provides a description of implementations of several embodiments and / or inventions to those skilled in the art. Some of these embodiments and / or inventions may not be claimed in this application but may still be claimed in one or more continuing applications that claim priority to this application. The applicant intends to file additional applications to seek patents on subject matter disclosed and enabled but not claimed in this application.

[0089] It should be understood that various modifications can be made to the embodiments disclosed herein without departing from the scope of this disclosure. Therefore, the above description should not be construed as limiting this disclosure, but merely as examples thereto. Those skilled in the art will envision other modifications within the scope of the invention as defined by the appended claims.

[0090] Although several embodiments of this disclosure have been described and illustrated herein, those skilled in the art will readily conceive of various other means and / or structures for performing functions and / or obtaining results and / or one or more of the advantages described herein, and each such variation and / or modification is considered to be within the scope of this disclosure. More generally, those skilled in the art will readily understand that all parameters, dimensions, materials, and configurations described herein are exemplary, and actual parameters, dimensions, materials, and / or configurations will depend on the specific application or the application for which the teachings of this disclosure have been used.

[0091] Those skilled in the art will recognize or be able to identify many equivalents of the specific embodiments of the disclosure described herein using only conventional experiments. Therefore, it should be understood that the foregoing embodiments are presented by way of example only, and that this disclosure may be practiced in ways different from the specific descriptions and claims within the scope of the appended claims and their equivalents. This disclosure relates to each individual feature, system, article, material, kit, and / or method described herein. Furthermore, any combination of two or more such features, systems, articles, materials, kits, and / or methods, provided that such features, systems, articles, materials, kits, and / or methods are not inconsistent with each other, is included within the scope of this disclosure.

[0092] All definitions defined and used herein should be understood as control dictionary definitions, definitions incorporated by reference in other files, and / or the general meaning of the defined terms.

[0093] The indefinite articles “a” and “an” used in the specification and claims shall be understood as “at least one” unless expressly indicated to the contrary.

[0094] The phrase “and / or” as used in the specification and claims should be understood as “one or both” of the elements that are combined in such a way that they exist together in some cases and separately in others. Other elements may optionally exist in addition to those specifically identified by the “and / or” clause, whether or not they are related to those specifically identified elements, unless there is an explicit indication to the contrary.

[0095] Throughout this specification, references to "an embodiment" or "an embodiment" mean that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Therefore, the phrases "in an embodiment" or "in one embodiment" appearing throughout this specification do not necessarily refer to the same embodiment. Furthermore, particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0096] The terms and expressions used herein are for description and not limitation, and their use is not intended to exclude any equivalents of the features shown and described (or portions thereof), and it is recognized that various modifications may be made within the scope of the claims. Therefore, the claims are intended to cover all such equivalents.

[0097] In addition to those shown and described herein, various modifications to the invention and many further embodiments thereof will become apparent to those skilled in the art from the entirety of this document, including references to the scientific and patent literature cited herein. The subject matter contains important information, examples, and guidance applicable to the practice of various embodiments of the invention and their equivalents.

Claims

1. A prefilled medical delivery assembly comprising: a blow-fill-seal (BFS) bottle defining a collapsible reservoir, a neck, and an external flange formed on the neck; a collar defining a first end and a second end, the first end defining a mounting seat including an internal seat into which the external flange is axially fitted, the second end defining an interface seat including internal threads, wherein the internal seat extends radially outward into an inner wall of the mounting seat by an overhang, and wherein a length of the internal seat is in a range of four and three tenths to five and three tenths times the overhang; a needle hub including at least one external thread cooperatively engaged with the internal threads of the collar for a first degree of advancement, the needle hub connected to a double-ended needle disposed through the needle hub; and a cap covering a delivery end of the needle, the cap including an internal key operable to drive the needle hub to advance the at least one external thread of the needle hub relative to the internal threads of the interface seat of the collar to a second degree of advancement, wherein advancement of the threads toward the second degree of advancement causes a piercing end of the double-ended needle to pierce a seal of the collar and to pierce a seal of the BFS bottle.

2. The prefilled medical delivery assembly of claim 1, further comprising a safety shield connected to the BFS bottle.

3. The prefilled medical delivery assembly of claim 2, wherein the safety shield includes a shield base connected to the BFS bottle and a hinge element connecting the shield base to a shield member.

4. The prefilled medical delivery assembly of claim 1, further comprising a safety shield connected to the collar.

5. The prefilled medical delivery assembly of claim 1, further comprising a safety shield including an annular shield base through which the neck of the BFS bottle is inserted.

6. The prefilled medical delivery assembly of claim 5, wherein the shield base includes one or more mounting features axially connected to corresponding features of the collar.

7. The prefilled medical delivery assembly of claim 1, wherein the internal seat includes an interior channel that is radiused in a range of four to five millimeters.

8. A medical administration assembly comprising: a collar defining a first end and a second end, the first end defining a mounting seat including an internal seat operable to receive an axially fitted external flange of a blow-fill-seal (BFS) bottle, and the second end defining an interface seat including internal threads, wherein the internal seat extends radially outward into an inner wall of the mounting seat by an overhang, and wherein a length of the internal seat is in a range of four and three tenths to five and three tenths times the overhang; a needle hub including at least one external thread cooperatively engaged with the internal threads of the collar for a first degree of advancement, the needle hub connected to a double-ended needle disposed through the needle hub; and a cap covering a delivery end of the needle, the cap including an internal key operable to drive the needle hub to advance the at least one external thread of the needle hub relative to the internal threads of the interface seat of the collar to a second degree of advancement, wherein advancement of the threads toward the second degree of advancement causes a piercing end of the double-ended needle to pierce a seal of the collar and to pierce a seal of the BFS bottle. a cap covering a delivery end of the needle and comprising an internal key operable to drive the needle hub so that at least one external thread of the needle hub is advanced relative to the needle hub receptacle of the collar to a second advancement extent, wherein advancement of the thread toward the second advancement extent causes the piercing end of the double-ended needle to pierce the seal of the collar.

9. The medical administration assembly of claim 8, wherein advancement of the thread toward the second advancement extent further causes the piercing end of the double-ended needle to pierce a seal of the BFS bottle.

10. The medical administration assembly of claim 8, further comprising a seal covering the opening of the mounting receptacle.

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