Systems and methods for pre-filled modular multi-stage product delivery

Abstract

A pre-filled, single-dose, modular multi-stage medical agent delivery system assembled and configured to allow delivery of a single dose of a combined therapeutic agent (e.g., vaccine, drug, medicament, etc.) from a Blow-Fill-Seal (BFS) vial to a patient. The delivery assembly generally includes a modular design consisting of separately constructed components cooperatively arranged and coupled to one another, such as to facilitate delivery of a reconstituted lyophilized agent to a patient.

Description

SYSTEMS AND METHODS FOR PRE-FILLED MODULAR MULTI-STAGE PRODUCT DELIVERYCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims benefit and priority under 35 U.S.C. §1 19(e) to, and is a Non-provisional of, U.S. Provisional Patent Application No. 63 / 562,701 filed on March 8, 2024 and titled “MEDICAL DELIVERY DEVICE FOR DELIVERING A LYOPHILIZED PRODUCT’’, which is hereby incorporated by reference herein in its entirety.BACKGROUND

[0002] Staggering numbers of people become infected, severely ill and / or die from a variety of diseases each year, some of which are preventable (or the severity of which could have been mitigated) through injectable medicines, medicaments, vaccines, drug products or other fluid agents (collectively “injectable medicines” herein, injectable medicines referring to fluid agents delivered via use of a syringe or other needle-type medical delivery device). Although injectable medicines have led to a decline in the number of cases of several infectious diseases (or the severity of symptoms or instances of death resulting therefrom) and / or ability to better manage ongoing health conditions such as diabetes, and have also become useful for administration of other medicaments such as contraceptives, the need for additional innovation in injectable medicines remains because the demand for effective contraceptive programs and control of existing and emerging diseases continues to grow and existing solutions leave room for further improvements. Applicant has previously invented various methods and systems intended to address the growing demand for injectable medicines through single-dose, pre-filled Blow-Fill-Seal (BFS) injector devices that comprise one or more benefits, such as (i) being manufacturable in a cost effective manner, in large quantities and at short notice to meet unanticipated peaks in demand; (ii) incorporating simplicity of design that lends itself to administration by users who have little or no medical training (e.g., are suitable for self-injection); and / or (iii) including features that minimize risk of re-use or otherwise prioritize safety concerns. Applicant continues to innovate in this field by developing various new and beneficial systems, devices and components that will provide additional options and opportunities for drug manufacturers to select a single-dose, pre-filled delivery system that best fits their needs.BRIEF DESCRIPTION OF THE DRAWINGS

[0003] An understanding of embodiments described herein and many of the attendant advantages thereof may be readily obtained by reference to the following detailed description when considered with the accompanying drawings, wherein:FIG. 1A, FIG. 1 B, and FIG. 1C are perspective assembly and side cross-section views of a pre-filled modular multi-stage medical agent delivery system according to some embodiments;FIG. 2A, FIG. 2B, FIG. 20, FIG. 2D, FIG. 2E, FIG. 2F, and FIG. 2G are various views of a first component of a pre-filled modular multi-stage medical agent delivery system according to some embodiments;FIG. 3A, FIG. 3B, FIG. 30, FIG. 3D, FIG. 3E, and FIG. 3F are various views of a second component of a pre-filled modular multi-stage medical agent delivery system according to some embodiments;FIG. 4A, FIG. 4B, FIG. 4C, FIG. 4D, FIG. 4E, and FIG. 4F are perspective, left, right, top, bottom, and side cross-section views of an axially-compressible BFS vial according to some embodiments;FIG. 5A, FIG. 5B, FIG. 5C, FIG. 5D, and FIG. 5E are side, top, bottom, side cross-section, and perspective cross-section views of a BFS housing according to some embodiments;FIG. 6A, FIG. 6B, FIG. 60, FIG. 6D, FIG. 6E, and FIG. 6F are perspective, left, right, top, bottom, and perspective cross-section views of BFS compression piston according to some embodiments;FIG. 7A, FIG. 7B, FIG. 70, FIG. 7D, and FIG. 7E are perspective, side, top, bottom, and perspective crosssection views of a mixing connector according to some embodiments;FIG. 8A, FIG. 8B, FIG 8C, FIG. 8D, and FIG. 8E are perspective, side, top, bottom, and perspective crosssection views of a chamber plug according to some embodiments;FIG. 9A, FIG. 9B, FIG. 90, FIG. 9D, and FIG. 9E are perspective, side, top, bottom, and perspective crosssection views of an outlet cap according to some embodiments;FIG. 10A, FIG. 10B, FIG. 10C, FIG 10D, FIG. 10E, FIG. 10F, FIG. 10G, FIG. 10H, FIG. 101, FIG. 10J, FIG. 10K, FIG. 10L, FIG. 10M, FIG. 10N, FIG. 10o, and FIG. 10P are various views of a pre-filled modular multi-stage medical agent delivery system being utilized according to some embodiments; andFIG. 11 is a flow diagram of a method according to some embodiments.DETAILED DESCRIPTIONI. Introduction

[0004] Embodiments of the present invention provide systems and methods for pre-filled, single-dose, and / or modular multi-stage medical agent delivery that overcome drawbacks of current delivery devices and methods. For example, the pre-filled, single-dose, and / or modular multi-stage medical agent delivery systems or assemblies of some embodiments may include a plastic [e.g., a Blow-Fill-Seal (BFS)) vial or bottle coupled within a specialized housing that facilitates axial compression of the BFS vial and / or coupling of an administration member (e.g., a needle / canula) to the BFS vial. In some embodiments, such a pre-filled, single-dose, and / or modular multi-stage medical agent delivery assembly may be selectively actuated by application of axial force to a piston or plunger inserted into the housing. In some embodiments, the BFS vial may be formed with an integral tear-activation valve, permitting in-housing opening of the BFS vial, e.g., during the activation process. According to some embodiments, a modular mixing component [e.g., defining a mixing chamber) may be coupled to be in fluid communication withthe BFS vial (e.g., by coupling to the housing thereof) such that a medicament and / or agent stored or housed in the modular mixing component may be activated, diluted, reconstituted, etc., when introduced to fluid flow from the BFS vial. Utilization of such systems that employ BFS vials, BFS connectors, tear-activation valves, and / or modular mixing chambers may be advantageous and may address various shortcomings of previous systems.

[0005] BFS vials may, for example, offer a less expensive alternative to typical vials or devices created via other manufacturing techniques. In some embodiments, BFS vials or modules (e.g., due to the nature of the BFS manufacturing process) may not require separate sterilization (e.g., and may accordingly be compatible with a wider array of fluids), may provide enhanced production rates of, for example, approximately thirty thousand (30,000) sterile / aseptic units per hour, and / or may be provided to an end-user for a smaller per dose / unit cost than other manufacturing techniques. In some embodiments, these advantages may come with an attendant drawbacks of reduced manufacturing tolerances and other disadvantages of utilizing a “soft” plastic (e.g., having a Shore / Durometer “OO” hardness of between 60 and 70 and / or a Shore / Durometer “A” hardness between 20 and 50). BFS processes may, for example, offer less precise manufacturing tolerances in the range of five hundredths of an inch (0.05-in; 1 .27 mm) to fifteen hundredths of an inch (0.15-in; 3.81 mm) - for linear dimensions, e.g., in accordance with the standard ISO 2768-1 “General tolerances for linear and angular dimensions without individual tolerance indications” published by the International Organization for Standardization (ISO) of Geneva, Switzerland (November 15, 1989).II. Pre-filled Modular Multi-Stage Medical Agent Delivery Systems

[0006] FIG. 1A, FIG. 1 B, and FIG. 10 are perspective assembly and side cross-section views of a pre-filled modular multi-stage medical agent delivery system 100 according to some embodiments. In some embodiments, the pre-filled modular multi-stage medical agent delivery system 100 may comprise various inter-connected and / or modular components. As depicted, for example, the pre-filled modular multi-stage medical agent delivery system 100 may comprise a first component “A” that is operable to be selectively mated with a second component “B”, that in turn is operable to be selectively coupled to a third component “C”. According to some embodiments, the prefilled modular multi-stage medical agent delivery system 100 (and / or the first component “A”) may comprise a BFS vial 1 10 comprising and / or defining a vial neck 112, a fluid seal 1 14, mounting flanges 1 16, side flanges 118, a fluid reservoir 120, a bellows 122, a label flange 124 (e.g., comprising a label 124-1), and / or a tear-activation or “twist” valve 126, e.g., comprising twist valve side flanges 128. In some embodiments, the first component “A” and / or the BFS vial 1 10 and / or a portion thereof may be referred to as a “first chamber” (e.g., containing a first fluid and / or first medical substance - not explicitly shown or labeled). In some embodiments, the fluid or fluid-like medicament stored in the BFS vial 110 (e.g., within the fluid reservoir 120 and / or bellows 122 thereof) may comprise a diluent, first active ingredient fluid, or a sterile powder produced by an Aseptic Spray Drying (ASD) process. A liquid solution containing a medicament and / or active ingredient may be subjected to an ASD process, for example, to produce anon-frozen, sterile powder containing a biologic, antibiotic, and / or other powdered medicament. According to some embodiments, the ASD powder may be produced at a granularity level and / or with a particle geometry that permits the powder to have movement qualities similar to a fluid. In such a manner, for example, the ASD powdered medicament may be injected into the BFS vial 1 10 (e.g., within the fluid reservoir 120 and / or bellows 122 thereof) during the filling stage of the typical BFS process (e.g., through the same filling mandrels and / or conduits typically utilized for liquids).

[0007] According to some embodiments, the BFS vial 110 may comprise a plastic and / or synthetic vial that is constructed via any practicable manufacturing techniques, although in cases that a BFS manufacturing technique is not employed, should be referred to as a "plastic vial”. In some embodiments the BFS manufacturing technique may be utilized, and the “BFS vial” terminology should be utilized. According to some embodiments, the pre-filled modular multi-stage medical agent delivery system 100 may comprise and / or the BFS vial 110 may be selectively inserted into and / or housed in a housing 130. In some embodiments, the pre-filled modular multi-stage medical agent delivery system 100 (and / or the first component “A”) may comprise the housing 130. The housing 130 may comprise and / or define a BFS chamber 130-1 extending axially inward from a first end thereof, for example, and into which the BFS vial 1 10 is configured to be inserted. In some embodiments, the housing 130 may comprise and / or define an interior projection 132 emanating from a distal extent of the BFS chamber 130-1 and toward the first (e.g., open) end of the housing 130. According to some embodiments, the interior projection 132 may comprise and / or define an interior projection socket 132-1 within which are disposed interior projection threads 132-2 and / or a twist valve socket 132-3. The interior projection threads 132-2 may be configured to receive, mate with, and / or guide the mounting flanges 116 of the BFS vial 110, for example, and / or the twist valve socket 132-3 may be configured to receive and / or activate (e.g., tear off) the twist valve 126 of the BFS vial 1 10. In some embodiments, the housing 132 may comprise and / or define a grip flange 134 disposed and / or formed at the first end thereof. According to some embodiments, the housing 130 may comprise and / or define an outlet coupling 136 formed at a second end of the housing 130 and extending axially distal from the BFS chamber 130-1. In some embodiments, the outlet coupling 136 may be in fluid communication (e.g., may define a fluid pathway therebetween; not separately labeled) with the interior projection socket 132-1 and / or the BFS chamber 130-1 In some embodiments, the outlet coupling 136 may comprise and / or define an outlet coupling socket 136-1 comprising outlet coupling threads 136-2 therein. According to some embodiments, the outlet coupling 136 may comprise and / or define an outlet projection 138 extending axially outward / distal from the housing 130 (e.g., from an interior extent of the outlet coupling socket 136-1. In some embodiments, the outlet projection 138 may comprise and / or define one or more outlet ports 138-1 in fluid communication with the interior projection socket 132-1 and / or the BFS chamber 130-1 , e.g., open at the distal end of the outlet projection 138 and / or housing 130. In such a manner, for example, fluid / medicament from the BFS vial 110 that is introduced into the interior projection socket 132-1 (and / or the BFS chamber 130-1) may flow through the outlet projection 138 (via the one or more outlet ports 138-1) and be expelledfrom the second end of the housing 130.

[0008] According to some embodiments, the pre-filled modular multi-stage medical agent delivery system 100 (and / or the first component “A”) may comprise a piston 140 that comprises and / or defines a piston bore 140-1 configured to receive a rear end (e.g., proximate to and / or including the label flange 124) of the BFS vial 1 10. The piston 140 may also or alternatively be configured to fit within the BFS chamber 130-1 of the housing 130. As shown in FIG. 1C, for example, the BFS vial 1 10 may be inserted into the BFS chamber 130-1 and the piston 140 may also be inserted into the BFS chamber 130-1 such that it enshrouds (via the piston bore 140-1) a back / rear portion of the BFS vial 110. According to some embodiments, the piston 140 may comprise and / or define one or more key slots 142a-b disposed at an open end of the piston bore 140-1 . The key slots 142a-b may be configured to mate with and / or drive (e.g., rotationally), for example, the side flanges 118 of the BFS vial 110. In some embodiments, the piston 140 may comprise and / or define a piston grip 144 that may function as a tactile push and / or rotational drive surface operable to be engaged by a human hand to, e.g. , selectively activate the pre-filled modular multistage medical agent delivery system 100 (and / or the first component “A”). According to some embodiments, the pre-filled modular multi-stage medical agent delivery system 100 (and / or the first component “A”) may comprise an outlet cap 148 that selectively engages or mates with, plugs, and / or seals the outlet coupling 136 and / or the outlet port 138-1 thereof. The outlet cap 148 may comprise and / or define outlet cap threads 148-2 that are configured to engage and / or mate with corresponding outlet coupling threads 136-2 of the outlet coupling 136. In such a manner, for example, with the outlet cap 148 installed and the piston 140 engaged with the housing 130 to encase the BFS vial 110, the pre-filled modular multi-stage medical agent delivery system 100 (and / or the first component “A”) may comprise and / or define a sterile sealed package, e.g., for shipping, handling, storage, and / or distribution.

[0009] In some embodiments, the pre-filled modular multi-stage medical agent delivery system 100 (and / or the second component “B”) may comprise a mixing connector 150 comprising and / or defining a mixing chamber 150- 1 therein. The mixing connector 150 may, for example, house a plug 152 within the mixing chamber 150-1 adjacent to and / or at a first or open end thereof and / or may be closed by a temporary and / or removable seal 154 covering the open end of the mixing connector 150 (and / or mixing chamber 1501- thereof). According to some embodiments, the mixing connector 150 may comprise and / or define an outlet coupling 156 at a second end of the mixing connector 150. In some embodiments, the outlet coupling 156 may comprise and / or define an outlet coupling socket 156-1 within which are disposed and / or formed outlet coupling threads 156-2. According to some embodiments, the outlet coupling 156 and / or the outlet coupling socket 156-1 may be in fluid communication with the mixing chamber 150-1 via an outlet port 156-3 e.g., may define a fluid pathway therebetween; not separately labeled). According to some embodiments, the pre-filled modular multi-stage medical agent delivery system 100 (and / or the second component “B”) may comprise an outlet cap 158 that selectively engages or mates with, plugs, and / or seals the outlet coupling 156. The outlet cap 158 may comprise and / or define outlet cap threads 158-2 that are configured to engage and / or mate with corresponding outlet coupling threads 156-2 of the outlet coupling 156. In such amanner, for example, with the outlet cap 158 installed and the seal 154 covering the open end of the mixing connector 150, the pre-filled modular multi-stage medical agent delivery system 100 (and / or the second component “B”) may comprise and / or define a sterile sealed package, e.g., for shipping, handling, storage, and / or distribution. According to some embodiments, within this sterile sealed package of the second component “B”, e.g., within the mixing chamber 150-1 , a medical substrate 160 may be disposed. According to some embodiments, the medical substrate 160 may be disposed in the mixing chamber 150-1 (e.g., during the manufacturing process) and / or may be configured in various shapes (e.g. , disk, spiral, sphere, tablet), e.g., to promote interaction of a fluid agent (e.g., from the BFS vial 110) with the active ingredient. In some embodiments, the medical substrate 160 may comprise an inactive object such as a bag, pouch, capsule, paper disk, and / or tablet that contains a second medical component or substance (e.g., the active ingredient). The second component or substance may, for example, be disposed in a powdered, dry, granulated, dehydrated, lyophilized, cryodesiccated, desiccated, powdered, and / or solid form and may be stored in or on the medical substrate 160. In some embodiments, the medical substrate 160 and / or the active ingredient thereof may be provided as an ASD powder.

[0010] According to some embodiments, the pre-filled modular multi-stage medical agent delivery system 100 (and / or the third component “C”) may comprise an administration housing or connector 170 that couples to and / or houses an administration member 180, and / or a cap 190 that at least partially and selectively covers a portion of the administration member 180. In some embodiments, the second component “B” and / or the mixing connector 150 and / or a portion thereof may be referred to as a “second chamber” (e.g., containing a second medical substance such as the medical substrate 160). According to some embodiments, the pre-filled modular multi-stage medical agent delivery system 100 may include a modular design consisting of separately constructed components “A”, “B”, and “C” cooperatively arranged and coupled to one another to provide an injectable reconstituted, dualsubstance, and / or multi-stage medicament delivery solution. According to some embodiments, some of the components “A”, “B”, and “C” and / or portions thereof may be manufactured, created, molded, and / or otherwise formed together.

[0011] In some embodiments, the BFS vial 110 (and / or the fluid reservoir 120 and / or bellows 122 thereof) may be filled (fully or partially) with a fluid or other agent (not separately shown) such as a diluent, ASD powder, and / or air. According to some embodiments, the fluid / powder may be injected into the BFS vial 1 10 in a sterile environment during manufacture via a BFS process and sealed within the BFS vial 110 via the fluid seal 114. The fluid seal 114 may comprise a portion of the molded BFS vial 110 for example that is configured to be pierced to expel the fluid, e.g., such as by providing a flat or planar piercing surface and / or by being oriented normal to an axis of the BFS vial 1 10 (and / or the pre-filled modular multi-stage medical agent delivery system 100). In some embodiments, the fluid seal 114 may comprise a foil, wax, paper, and / or other thin, pierceable object or layer coupled to the BFS vial 110. In some embodiments, the neck 1 12 of the BFS vial 110 may comprise the mounting flanges 1 16 such as, e.g., the angled exterior flanges depicted (and / or one or more other tabs, detents, protrusions, and / or otherfeatures). According to some embodiments, and as depicted, the neck 112 may be cylindrically shaped. In some embodiments, the neck 112 may comprise one or more other cross-sectional shapes or configurations such as a triangle, square, rectangle, pentagon, hexagon, star, and / or octagon shape. In some embodiments, the shape of the neck 112 may correspond to a type of fluid / powder agent stored in the BFS vial 110. According to some embodiments, the BFS vial 110 may be formed with the twist valve 126. The twist valve 126 may, for example, comprise a tear-activation valve such as that described in co-pending International Patent Application No. PCT / US24 / 52752 filed on October 24, 2024 and titled "SYSTEMS AND METHODS FOR BLOW-FILL-SEAL (BFS) TEAR-ACTIVATION VALVES”, the tear-activation / twist valve concepts and descriptions of which are hereby incorporated by reference herein.

[0012] According to some embodiments, the housing 130 may be axially engaged to couple with the BFS vial 110 via application of an axial mating force. The housing 130 may be urged onto the neck 1 12 of the BFS vial 110, for example, such that the neck 112 is accepted into the interior projection socket 132-1 . In some embodiments, once the neck 112 of the BFS vial 110 is introduced into the interior projection socket 132-1 , the mounting flanges 116 may be rotationally engaged with the interior projection threads 132-2, thereby removably coupling the BFS vial 110 and the housing 130. According to some embodiments, the housing 130 and / or the interior projection socket 132-1 thereof may be shaped to correspond to and / or cooperatively mate with the shape of the neck 112 of the BFS vial 110. In the case that the neck 112 is cylindrically or triangularly shaped, for example, the interior projection socket 132-1 may comprise a cylindrical or triangular opening and / or cross-section or geometry, respectively. In some embodiments, uncoupling of the BFS vial 110 and the housing 130 may be mechanically prohibited. The mounting flanges 116 may effectively lock into the interior projection threads 132-2 once engaged, for example, preventing or inhibiting removal thereafter. In some embodiments, once the BFS vial 110 is inserted into the housing 130, the piston 140 may be inserted into the housing 130 (e.g., into the BFS chamber 130-1 thereof). According to some embodiments, the piston 140 (e.g., the key slots 142a-b thereof) may engage with the side flanges 118 (and / or portions thereof) of the BFS vial 1 10 such that rotation of the piston 140 with respect to the housing 130 causes / im parts rotation of the BFS vial 110.

[0013] In some embodiments, the BFS vial 110 may be engaged with the housing 130 in two positions or stages. In a first stage or position (e.g., a transport and / or storage stage or position), the BFS vial 110 may be partially inserted into the housing 130 such that the mounting flanges 1 16 are partially engaged with the interior projection threads 132-2. In a second stage or position (e.g., an activation stage or position), the piston 140 may be rotationally engaged to complete the threading of the mounting flanges 116 with the interior projection threads 132-2, thereby causing the twist valve 126 to advance axially into / through the twist valve socket 132-3 such that the twist valve side flanges 128 are rotationally blocked by the twist valve socket 132-3. In such a manner, the BFS vial 110 continues to rotate as the axial advancement continues, but the twist valve 126 is retained at a particular rotational orientation, causing the twist valve 126 to separate or shear from the neck 112 of the BFS vial 110. According tosome embodiments, the shearing of the twist valve 126 may cause a rupture of the fluid seal 1 14, thereby exposing the contents of the BFS vial 110 to be in communication with the BFS chamber 130-1 , the interior projection socket 132-1 , the outlet coupling socket 136-1 , and / or the outlet port 138-1.

[0014] In some embodiments, e.g., while the first component “A” is in the first state, the mixing connector 150 may be selectively coupled to the distal end of the housing 130, e.g., upon removal of the outlet cap 148 and the seal 154 of the mixing connector 150. The outlet projection 138 of the housing 130 may be urged axially through the plug 152, for example, opening a fluid pathway between the housing 130 and the mixing chamber 150-1 (e.g., by exposing the outlet port 138-1 into the mixing chamber 150-1. According to some embodiments, once the mixing connector 150 is coupled to the housing 130 (e.g., the first component “A” is coupled to the second component “B”), the piston 140 may be engaged to transition the BFS vial 110 from the first state to the second state by rotationally engaging the mounting flanges 1 16 with the interior projection threads 132-2 and thereby axially advancing the BFS vial 110 further into the interior projection socket 132-1 . Complete rotational engagement may, as described herein, activate the twist valve 126, thereby opening the BFS vial 1 10. In some embodiments, the BFS vial 110 may be transitioned to a third stage (e.g., an expelling or mixing stage) by axially advancing the piston 140 to compress the bellows 122, thereby expelling the contents of the BFS vial 1 10 through the outlet port 138-1 and into the mixing chamber 150-1. According to some embodiments, the fluid / powder / substance from the BFS vial 110 may interact with the medical substrate 160 in the mixing chamber 150-1 In some embodiments, the prefilled modular multi-stage medical agent delivery system 100 (and / or the coupled first and second components "A" and “B” thereof) may be shaken, agitated, vibrated, and / or otherwise manipulated to cause, promote, and / or enhance the interaction of the two medical substances. In some embodiments, the mixing of the two medical substances may be conducted in accordance with designed mixing and / or reconstitution parameters. The mixing / shaking may be conducted for a number of seconds or minutes, for example, and / or may comprise an amount of agitation such as five (5) seconds of shaking repeated over a specific time period, e.g., every five (5) minutes, for a total of fifteen (15) minutes.

[0015] According to some embodiments, the outlet cap 158 may be removed from the second component “B” and / or the mixing connector 150 and the third component “C” may be coupled in its place. The administration connector 170 may, for example, be engaged with the outlet coupling threads 156-2 to secure the third component “C" onto the combined first and second component “A”, “B” combination. In some embodiments, the cap 190 may be removed, exposing an administration or distal end of the administration member 180. According to some embodiments, the pre-filled modular multi-stage medical agent delivery system 100 may be transitioned to a fourth state in which the combined, mixed, and / or reconstituted medical agent(s) is expelled from the pre-filled modular multi-stage medical agent delivery system 100. The first component "A” may be advanced further axially into the mixing connector 150 (and / or the second component “B”), for example, pushing the plug 152 toward the outlet port 156-3 and thereby causing the combined agent to be expelled through the administration member 180.

[0016] In some embodiments, the administration member 180 may include a needle or canula for at least one of subcutaneous, intramuscular, intradermal, and intravenous injection of a combination of the fluid agent from the BFS vial 110 and the medical substrate 160 (and / or an agent deposited, injected, and / or formed or printed thereon; e.g., a combined agent) into a patient (not shown) For ease of explanation and description, the figures and the description herein generally refer to the administration member 180 as a needle. However, it should be noted that, in other embodiments, the administration member 180 may include a nozzle (not shown) configured to control administration of the combined agent to the patient. The nozzle may include a spray nozzle, for example, configured to facilitate dispersion of the combined agent into a spray. Accordingly, an administration connector 170 fitted and / or formed with a spray nozzle may be particularly useful in the administration of a combined agent into the nasal passage, for example, or other parts of the body that benefit from a spray application [e.g., ear canal, other orifices). In other embodiments, the nozzle may be configured to facilitate formation of droplets of the combined fluid agent. Thus, an administration connector 170 including a droplet nozzle may be useful in the administration of a combined agent by way of droplets, such as administration to the eyes, topical administration, and the like. In such embodiments, the administration member 180 may be integral to the administration connector 170 or may not be included in the pre-filled modular multi-stage medical agent delivery system 100.

[0017] As generally understood, the combined agent or drug may include any type of combined agent to be injected into a patient (e.g., mammal, either human or non-human) and capable of producing an effect (alone, or in combination with an active ingredient). Accordingly, the combined agent may include, but is not limited to, a vaccine, a drug, a therapeutic agent, a medicament, a diluent, and / or the like. In some embodiments, the medical substrate 160 may comprise, for example, the active ingredient of the drug agent (i.e., the second component or substance thereof) or an object that retains, carries, or holds the active ingredient.

[0018] In some embodiments, the medical substrate 160 [e.g., the second component or substance) may be disposed in a solid and / or compressed shape such as a pill, cake, tablet (e.g., an annular-shaped tablet), a fine powder, an ASD powder, and / or in aerated form. In some embodiments, the medical substrate 160 (e.g., the second component or substance) may be combined or mixed with other substances (e.g., inactive and / or non-reactive substances) such as by being combined with large molecule sugars, thickeners, etc. According to some embodiments, the mixing chamber 150-1 may comprise or define a void, channel, projection, groove, track, diffuser, or other feature (not shown) that may house or retain the medical substrate 160 (e.g., the second component or substance). In some embodiments, the medical substrate 160 may not comprise a separate object from the active ingredient but may be representative of a disposing of the second component or substance in the mixing chamber 150-1. The medical substrate 160 (e.g., the second component or substance) may, for example, be directly deposited (e.g., sprayed and / or printed) on the inside surface of the mixing chamber 150-1 , e.g., in one or more patterns such as a spiral (e.g., rifle) pattern. According to some embodiments, the inside surface of the mixing chamber 150-1 (or a portion thereof) may be coated with the medical substrate 160 (e.g., the second componentor substance; or a mixture containing or carrying the second component or substance). In some embodiments, the printing or depositing may be conducted in a manner that increases the surface are of the medical substrate 160 (e.g., the second component or substance) exposed to the fluid agent flow (e.g., a raised crisscross pattern, raised rifling ridges) An increased surface area of contact between the medical substrate 160 (e.g., the second component or substance) and the fluid agent (or other first component or substance) may, for example, increase dissolution of the medical substrate 160 (e.g., the second component or substance) and / or reduce an amount of time required for a desired dissolution, mixing, and / or reconstitution level. Various different parameters for the dimension, shape, thickness, and / or dosage of the active ingredient may be selected for different types of active ingredients, the parameter values selected to meet certain goals. Examples of such goals may include, without limitation: (i) maximizing the surface area of the medical substrate 160 (e.g., the second component or substance); (II) minimizing the dissolution, mixing, and / or reconstitution time; (iii) maximizing the percentage of the medical substrate 160 (e.g., the second component or substance) that is dissolved / mixed / reconstituted (e.g., within a certain amount of time and / or given a certain amount or type of diluent); and (iv) a desired concentration of the resulting drug agent (e.g., a desired curve of concentration range). For example, in some embodiments the amount, pattern or configuration of the medical substrate 160 (e.g., the second component or substance) may be designed such that ninety percent (90%) of the medical substrate 160 (e.g., the second component or substance; and / or active ingredient) is dissolved in a particular first component or substance (e.g., fluid agent) within five to six (5 - 6) seconds of the first component or substance being released into the mixing chamber 150-1 from the BFS vial 110.

[0019] According to some embodiment, either or both of the combined agent and the active ingredient ( / .e., the drug agent and / or components thereof) may be tracked, monitored, checked for compatibility with each other, etc., such as by utilization of electronic data storage devices (not shown) coupled to the various modules or components such as the BFS vial 1 10, the housing 130, the piston 140, and / or the mixing connector 150.

[0020] According to some embodiments, the housing 130, the piston 140, the mixing connector 150, the administration connector 170, and / or the cap 190 may be composed of a medical grade material. In some embodiments, the housing 130, the piston 140, the mixing connector 150, the administration connector 170, and / or the cap 190, may be composed of a thermoplastic polymer or other “hard” plastic (e.g., greater than 80 on the Rockwell “R” scale), including, but not limited to, polybenzimidazole, acrylonitrile butadiene styrene (ABS), polystyrene, polyvinyl chloride, or the like.

[0021] In some embodiments, the pre-filled modular multi-stage medical agent delivery system 100 may be advantageously manufactured (in mass quantities), assembled, and / or provided in separate parts or portions, namely, at least (i) the BFS vial 1 10, housing 130, piston 140, and outlet cap 148 portion (e.g., the first component “A”), (ii) the mixing connector 150, plug 152, seal 154, outlet cap 158, and medical substrate 160 portion (e.g., the second component “B”), and / or (iii) the administration connector 170, administration member 180, and cap 190 portion (e.g., the third component “C”), with such different plastic parts / portions being selectively coupled toadminister a medication (e.g., a combined medical agent) to a patient. In practice, for example, some or all of the following procedures may be followed to utilize the pre-filled modular multi-stage medical agent delivery system 100 to administer a combined medication to a patient.

[0022] In some embodiments, an area of injection may be cleaned and / or otherwise prepared. According to some embodiments, the second component "B” (e.g., a mixing, lyophilized, or second agent assembly) may be unsealed (e.g., removal of the seal 154) and the first component “A” (e.g., a BFS or first agent assembly) may be uncapped (removal of the outlet cap 148) and inserted into the open end of the second component “B”. The first and second components “A” and “B” may be axially aligned and the distal end of the first component “A” (e.g., including the outlet projection 138) may be urged through a slit or hole in the plug 152 to enter the mixing chamber 150-1. According to some embodiments, the first component “A" may be activated by application of a rotational force (e.g., by rotating the piston 140) that forces the BFS vial 110 from the first and partially-engaged mating position with the interior projection threads 132-2 to the second and fully-engaged mating position, whereby a shearing of the twist valve 126 from the BFS vial 110 causes an opening or rupturing of the fluid seal 114. In such a manner, for example, the piston 140 may advance the BFS vial 110 to snap-off the twist valve 126 to activate the first component "A7BFS assembly. In some embodiments, the piston 140 may be pushed-in to apply an axial compressive force to the bellows 122, thereby squeezing the first fluid / agent through the outlet port 138-1 and into the mixing chamber 150- 1 such that it comes in contact with, mixes with, dissolves, reconstitutes, and / or otherwise activates any desired ingredient on the medical substrate 160, thereby creating the combined agent. In some embodiments, the pre-filled modular multi-stage medical agent delivery system 100 may be shaken to more fully and / or more quickly introduce the fluid and the medical substrate 160 (and / or any substance thereof).

[0023] According to some embodiments, the cap 190 may be removed to reveal the administration member 180 and / or the administration end thereof. In some embodiments, the administration member 180 (e.g., the administration end thereof) may be inserted into (and / or otherwise engaged with) the patient and the housing 130 / first component “A” may be axially advanced deeper into the mixing chamber 150-1 / the second component “B”, thereby expelling the combined agent through the administration member 180 and into the patient. In some embodiments, the administration member 180 may be withdrawn from the patient and / or the pre-filled modular multi-stage medical agent delivery system 100 may be properly disposed of. While the housing 130, the mixing connector 150, and the administration connector 170 are depicted as separate couplable objects, in some embodiments they may be manufactured (e.g., molded) as a single object or piece or may comprise additional pieces or parts. Similarly, while the cap 190 is depicted as a separate component, in some embodiments the cap 190 may be integral to (e.g., comprise a portion of) one or more of the administration connector 170, the mixing connector 150, and / or the housing 130.

[0024] In some embodiments, fewer or more components 1 10, 112, 1 14, 116, 118, 120, 122, 124, 124-1 , 126, 128, 130, 130-1 , 132, 132-1 , 132-2, 132-3, 134, 136, 136-1 , 136-2, 138, 138-1 , 140, 140-1 , 142a-b, 144, 148, 148-2, 150, 150-1 , 152, 154, 156, 156-1 , 156-2, 156-3, 158, 158-2, 160, 170, 180, 190 and / or various configurations of the depicted components 1 10, 112, 114, 1 16, 118, 120, 122, 124, 124-1 , 126, 128, 130, 130-1 , 132, 132-1 , 132-2, 132-3, 134, 136, 136-1 , 136-2, 138, 138-1 , 140, 140-1 , 142a-b, 144, 148, 148-2, 150, 150-1 , 152, 154, 156, 156- 1 , 156-2, 156-3, 158, 158-2, 160, 170, 180, 190 may be included in the pre-filled modular multi-stage medical agent delivery system 100 without deviating from the scope of embodiments described herein. In some embodiments, the components 110, 112, 114, 116, 118, 120, 122, 124, 124-1 , 126, 128, 130, 130-1 , 132, 132-1 , 132-2, 132-3, 134, 136, 136-1 , 136-2, 138, 138-1 , 140, 140-1 , 142a-b, 144, 148, 148-2, 150, 150-1 , 152, 154, 156, 156-1 , 156- 2, 156-3, 158, 158-2, 160, 170, 180, 190 may be similar in configuration and / or functionality to similarly named and / or numbered components as described herein. In some embodiments, the pre-filled modular multi-stage medical agent delivery system 100 (and / or portions thereof) may comprise a disposable, single-dose, modular, multi-stage delivery assembly operable to be utilized to execute, conduct, and / or facilitate the method 1 100 of FIG. 11 herein, and / or portions thereof.

[0025] Turning to FIG. 2A, FIG. 2B, FIG. 2C, FIG. 2D, FIG. 2E, FIG. 2F, and FIG. 2G, various views of a first component “A” of a pre-filled modular multi-stage medical agent delivery system 200 according to some embodiments are shown. In some embodiments, the pre-filled modular multi-stage medical agent delivery system 200 may be similar in configuration to the pre-filled modular multi-stage medical agent delivery system 100 of FIG. 1 A, FIG. 1 B, and FIG. 1 C herein. According to some embodiments, the pre-filled modular multi-stage medical agent delivery system 200 may comprise a mass-produced, modular, single-dose, multi-stage / agent vaccine and / or other medical treatment delivery device and / or assembly. In some embodiments, the first component “A” of a pre-filled modular multi-stage medical agent delivery system 200 may comprise a BFS and / or first medical agent assembly. The first component "A” of the pre-filled modular multi-stage medical agent delivery system 200 may comprise, for example, a BFS vial 210 comprising and / or defining a vial neck 212, a fluid seal 214, mounting flanges 216, side flanges 218, a fluid reservoir 220, a bellows 222, a label flange 224 (e.g., comprising a label 224-1 ), and / or a tearactivation or “twist” valve 226, e.g., comprising twist valve side flanges 228. In some embodiments, the first component “A” of the pre-filled modular multi-stage medical agent delivery system 200 and / or the BFS vial 210 and / or a portion thereof may be referred to as a “first chamber” (e.g., containing a first fluid and / or first medical substance - not explicitly shown or labeled). In some embodiments, the fluid or fluid-like medicament stored in the BFS vial 210 (e.g., within the fluid reservoir 220 and / or bellows 222 thereof) may comprise a diluent, first active ingredient fluid, or a sterile powder produced by an ASD process. In some embodiments, the combined volume of the neck 212, the fluid reservoir 220, and / or the bellows 222 may be partially filled with the first fluid such as a liquid diluent and / or first medical agent 262 (as depicted in FIG. 2G) and partially filled with a second fluid such as a gas (e.g., air; not separately shown). According to some embodiments, at least the bellows 222 may be compressible by application of human-applied axial inward force.

[0026] According to some embodiments, the first component “A” of the pre-filled modular multi-stage medicalagent delivery system 200 may comprise and / or the BFS vial 210 may be selectively inserted into and / or housed in a housing 230. In some embodiments, the housing 230 may comprise and / or define a BFS chamber 230-1 extending axially inward from a first end thereof, and into which the BFS vial 210 is configured to be inserted. In some embodiments, the housing 230 may comprise and / or define an interior projection 232 emanating from a distal extent of the BFS chamber 230-1 and toward the first (e.g., open) end of the housing 230. According to some embodiments, the interior projection 232 may comprise and / or define an interior projection socket 232-1 within which are disposed interior projection threads 232-2 and / or a twist valve socket 232-3. The interior projection threads 232-2 may be configured to receive, mate with, and / or guide the mounting flanges 216 of the BFS vial 210, for example, and / or the twist valve socket 232-3 may be configured to receive and / or activate (e.g., tear off) the twist valve 226 of the BFS vial 210. In some embodiments, the housing 230 may comprise and / or define a grip flange 234 disposed and / or formed at the first end thereof. According to some embodiments, the housing 230 may comprise and / or define an outlet coupling 236 formed at a second end of the housing 230 and extending axially distal from the BFS chamber 230-1 . In some embodiments, the outlet coupling 236 may be in fluid communication (e.g., may define a fluid pathway therebetween; not separately labeled) with the interior projection socket 232-1 and / or the BFS chamber 230-1. In some embodiments, the outlet coupling 236 may comprise and / or define an outlet socket 236-1 comprising outlet coupling threads 236-2 therein. According to some embodiments, the outlet coupling 236 may comprise and / or define an outlet projection 238 extending axially outward / distal from the housing 230 (e.g., from an interior extent of the outlet socket 236-1 . In some embodiments, the outlet projection 238 may comprise and / or define one or more outlet ports 238-1 in fluid communication with the interior projection socket 232-1 and / or the BFS chamber 230-1 , e.g., open at the distal end of the outlet projection 238 and / or housing 230. In such a manner, for example, first fluid / medicament from the BFS vial 210 that is introduced into the interior projection socket 232-1 (and / or the BFS chamber 230-1 ) may flow through the outlet projection 238 (via the one or more outlet ports 238-1) and be expelled from the second end of the housing 230.

[0027] According to some embodiments, the first component “A" of the pre-filled modular multi-stage medical agent delivery system 200 may comprise a piston 240 that comprises and / or defines a piston bore 240-1 configured to receive a rear end (e.g., proximate to and / or including the label flange 224) of the BFS vial 210. The piston 240 may also or alternatively be configured to fit within the BFS chamber 230-1 of the housing 230. The BFS vial 210 may be inserted into the BFS chamber 230-1 and the piston 240 may also be inserted into the BFS chamber 230- 1 such that it enshrouds (via the piston bore 240-1) a back / rear portion of the BFS vial 210. According to some embodiments, the piston 240 may comprise and / or define one or more key slots 242a-b disposed at an open end of the piston bore 240-1 . The key slots 242a-b may be configured to mate with and / or drive (e.g., rotationally), for example, the side flanges 218 of the BFS vial 210. In some embodiments, the piston 240 may comprise and / or define a piston grip 244 that may function as a tactile push and / or rotational drive surface operable to be engaged by a human hand to, e.g., selectively activate the first component “A” of the pre-filled modular multi-stage medicalagent delivery system 200. According to some embodiments, the first component “A" of the pre-filled modular multistage medical agent delivery system 200 may comprise an outlet cap 248 that selectively engages or mates with, plugs, and / or seals the outlet coupling 236 and / or the outlet port 238-1 thereof. The outlet cap 248 may comprise and / or define outlet cap threads 248-2 that are configured to engage and / or mate with corresponding outlet coupling threads 236-2 of the outlet coupling 236. In such a manner, for example, with the outlet cap 248 installed and the piston 240 engaged with the housing 230 to encase the BFS vial 210, the first component “A" of the pre-filled modular multi-stage medical agent delivery system 200 may comprise and / or define a sterile sealed package, e.g., for shipping, handling, storage, and / or distribution.

[0028] In some embodiments, fewer or more components 210, 212, 214, 216, 218, 220, 222, 224, 224-1 , 226, 228, 230, 230-1 , 232, 232-1 , 232-2, 232-3, 234, 236, 236-1 , 236-2, 238, 238-1 , 240, 240-1 , 242a-b, 244, 248, 248- 2, 262 and / or various configurations of the depicted components 210, 212, 214, 216, 218, 220, 222, 224, 224-1 , 226, 228, 230, 230-1 , 232, 232-1 , 232-2, 232-3, 234, 236, 236-1 , 236-2, 238, 238-1 , 240, 240-1 , 242a-b, 244, 248, 248-2, 262 may be included in the first component “A” of the pre-filled modular multi-stage medical agent delivery system 200 without deviating from the scope of embodiments described herein. In some embodiments, the components 210, 212, 214, 216, 218, 220, 222, 224, 224-1 , 226, 228, 230, 230-1 , 232, 232-1 , 232-2, 232-3, 234, 236, 236-1 , 236-2, 238, 238-1 , 240, 240-1 , 242a-b, 244, 248, 248-2, 262 may be similar in configuration and / or functionality to similarly named and / or numbered components as described herein. In some embodiments, the first component "A” of the pre-filled modular multi-stage medical agent delivery system 200 (and / or portions thereof) may comprise a disposable, single-dose, modular, multi-stage delivery assembly operable to be utilized to execute, conduct, and / or facilitate the method 1 100 of FIG. 11 herein, and / or portions thereof.

[0029] Referring now to FIG. 3A, FIG. 3B, FIG. 3C, FIG. 3D, FIG. 3E, and FIG. 3F, various views of a second component "B” of a pre-filled modular multi-stage medical agent delivery system 300 according to some embodiments are shown. In some embodiments, the pre-filled modular multi-stage medical agent delivery system 300 may be similar in configuration to the pre-filled modular multi-stage medical agent delivery system 100 of FIG. 1 A, FIG. 1 B, and FIG. 1 C herein. According to some embodiments, the pre-filled modular multi-stage medical agent delivery system 300 may comprise a mass-produced, modular, single-dose, multi-stage / agent vaccine and / or other medical treatment delivery device and / or assembly. In some embodiments, the second component “B” of the prefilled modular multi-stage medical agent delivery system 300 may comprise a mixing connector 350 comprising and / or defining a mixing chamber 350-1 therein. The mixing connector 350 may, for example, house a “bung” or plug 352 within the mixing chamber 350-1 adjacent to and / or at a first or open end thereof and / or may be closed by a removable seal 354 covering the open end of the mixing connector 350 (and / or mixing chamber 3501 - thereof). According to some embodiments, the mixing connector 350 may comprise and / or define an outlet coupling 356 at a second end of the mixing connector 350. In some embodiments, the outlet coupling 356 may comprise and / or define an outlet coupling socket 356-1 within which are disposed and / or formed outlet coupling threads 356-2.According to some embodiments, the outlet coupling 356 and / or the outlet coupling socket 356-1 may be in fluid communication with the mixing chamber 350-1 via an outlet port 356-3 (e.g., may define a fluid pathway therebetween; not separately labeled). According to some embodiments, the second component “B” of the prefilled modular multi-stage medical agent delivery system 300 may comprise an outlet cap 358 that selectively engages or mates with, plugs, and / or seals the outlet coupling 356. The outlet cap 358 may comprise and / or define outlet cap threads 358-2 that are configured to engage and / or mate with corresponding outlet coupling threads 356- 2 of the outlet coupling 356. In such a manner, for example, with the outlet cap 358 installed and the seal 354 covering the open end of the mixing connector 350, the second component “B” of the pre-filled modular multi-stage medical agent delivery system 300 may comprise and / or define a sterile sealed package, e.g., for shipping, handling, storage, and / or distribution. According to some embodiments, within this sterile sealed package of the second component “B”, e.g., within the mixing chamber 350-1 , a medical substrate 360 may be disposed. According to some embodiments, the medical substrate 360 may be disposed in the mixing chamber 350-1 (e.g., during the manufacturing process) and / or may be configured in various shapes (e.g., disk, spiral, sphere, tablet), e.g., to promote interaction of a fluid agent (e.g., from the BFS vial 1 10 of FIG. 1A, FIG. 1 B, and / or FIG. 1 C herein) with the active ingredient. In some embodiments, the medical substrate 360 may comprise an inactive object such as a bag, pouch, capsule, paper disk, and / or tablet that contains a second medical component or substance (e.g., the active ingredient). The second component or substance may, for example, be disposed in a powdered, dry, granulated, dehydrated, lyophilized, cryodesiccated, desiccated, powdered, and / or solid form and may be stored in or on the medical substrate 360. In some embodiments, the medical substrate 360 and / or the active ingredient thereof may be provided as an ASD powder.

[0030] In some embodiments, fewer or more components 350, 350-1 , 352, 354, 356, 356-1 , 356-2, 356-3, 358, 358-2, 360 and / or various configurations of the depicted components 350, 350-1 , 352, 354, 356, 356-1 , 356-2, 356- 3, 358, 358-2, 360 may be included in the first component “B” of the pre-filled modular multi-stage medical agent delivery system 300 without deviating from the scope of embodiments described herein. In some embodiments, the components 350, 350-1 , 352, 354, 356, 356-1 , 356-2, 356-3, 358, 358-2, 360 may be similar in configuration and / or functionality to similarly named and / or numbered components as described herein. In some embodiments, the first component “B” of the pre-filled modular multi-stage medical agent delivery system 300 (and / or portions thereof) may comprise a disposable, single-dose, modular, multi-stage delivery assembly operable to be utilized to execute, conduct, and / or facilitate the method 1100 of FIG. 11 herein, and / or portions thereof.

[0031] Turning now to FIG. 4A, FIG. 4B, FIG. 40, FIG. 4D, FIG. 4E, and FIG. 4F, perspective, left, right, top, bottom, and side cross-section views of an axially-compressible BFS vial 410 according to some embodiments are shown. In some embodiments, as described herein, the BFS vial 410 may be constructed of various types of plastic and / or resin and may advantageously be produced in some embodiments utilizing a BFS manufacturing process. In some embodiments, the BFS vial 410 may be molded to comprise and / or define an elongate body comprising avial neck 412 adjacent to a first end thereof, with the neck 412 comprising and / or being sealed by a fluid seal 414. According to some embodiments, the neck 412 may comprise and / or define one or more mounting flanges 416 such as the symmetrically-paired angled exterior flanges shown. According to some embodiments, the BFS vial 410 may comprise and / or define side flanges 418, e.g., formed from extra and / or non-molded, fused parison material along a side-seam of the BFS vial 410 (e.g., where mold halves utilized in the BFS process come together). In some embodiments, the BFS vial 410 may comprise and / or define a fluid reservoir 420 formed at and end of the neck 412 distal form the first end and / or a bellows 422 formed adjacent to the fluid reservoir 420 and proximate to a second end of the BFS vial 410. In some embodiments, the BFS vial 410 may comprise and / or define a label flange 424 at the second end thereof.

[0032] According to some embodiments, the BFS vial 410 may comprise and / or define a tear-activation or "twist” valve 426, e.g., comprising twist valve side flanges 428. The twist valve 426 may, as described herein for example, be operable to be rotationally twisted off from the BFS vial 410 via mechanical separation inside of a delivery component such that the opening of the BFS vial 410 (e.g., breaking of the seal 414) occurs within a sealed and / or sterile environment. In some embodiments, the twist valve side flanges 428 may engage with tracks, slots, and / or projections within delivery device (not shown; e.g., the housing 130 of FIG. 1A, FIG. 1 B, and / or FIG. 1 C herein) such that rotation of the twist valve 426 is prevented. In such a manner, should the BFS vial 410 be rotated within the delivery device while the twist valve 426 is prevented from rotation, the twist valve 426 will be sheared off of the neck 412, thereby breaking the fluid seal 414 and exposing the contents (e.g., a first medical agent) of the fluid reservoir 420. A tear-line and / or breakpoint may be formed between the twist valve 426 and the neck 412, for example, such that failure of the seal 414 can be expected at the junction where the twist valve 426 meets the neck 412 (e.g., at a reduced diameter portion of the neck 412).

[0033] In some embodiments, a fluid or fluid-like medicament stored in the BFS vial 410 (e.g., within the fluid reservoir 420 and / or bellows 422 thereof) may comprise a diluent, first active ingredient fluid, or a sterile powder produced by an ASD process. According to some embodiments, as the fluid reservoir 420, the neck 412, and / or the bellows 422 may be in fluid communication (e.g., share a continuous volume or void), the fluid / first agent may be disposed within the BFS vial 410 (e.g., injected during manufacture prior to the formation of the fluid seal 414) and may freely travel between the fluid reservoir 420, the neck 412, and / or the bellows 422, e.g., depending upon an orientation of the BFS vial 410 with respect to gravity and / or other forces. In some embodiments, the BFS vial 410 may contain a single dose of first medical agent as well as a volume of air. In such a manner, for example, an axial compression of the bellows 422 may pressurize the volume of air (e.g. , by reducing an interior volume of the BFS vial 410) and may accordingly exert pressure on the fluid / agent stored therein. In a case where the fluid seal 414 has been breached, such pressure may cause the fluid / agent to be expelled from the BFS vial 410, e.g., past the twist valve 426 at the first end thereof.

[0034] In some embodiments, fewer or more components 412, 414, 416, 418, 420, 422, 424, 426, 428 and / orvarious configurations of the depicted components 412, 414, 416, 418, 420, 422, 424, 426, 428 may be included in the axially-compressible BFS vial 410 without deviating from the scope of embodiments described herein. In some embodiments, the components 412, 414, 416, 418, 420, 422, 424, 426, 428 may be similar in configuration and / or functionality to similarly named and / or numbered components as described herein. In some embodiments, the axially-compressible BFS vial 410 (and / or portions thereof) may comprise a portion of a disposable, singledose, modular, multi-stage delivery assembly operable to be utilized to execute, conduct, and / or facilitate the method 1 100 of FIG. 11 herein, and / or portions thereof.

[0035] Referring now to FIG. 5A, FIG. 5B, FIG. 5C, FIG. 5D, and FIG. 5E, side, top, bottom, side cross-section, and perspective cross-section views of a BFS housing 530 according to some embodiments. The BFS housing 530 may comprise similar features and / or configurations and / or may be similar to the housing 130, 230 of FIG. 1 A, FIG. 1 B, FIG. 1 C, FIG. 2A, FIG. 2B, FIG. 2C, FIG. 2D, FIG. 2E, FIG. 2F, and FIG. 2G herein. The BFS housing 530 may comprise, for example, a generally cylindrical body defining an interior volume or BFS chamber 530-1. In some embodiments, the BFS chamber 530-1 may extend axially inward from a first end of the BFS housing 530 (e.g., the first end accordingly being open). In some embodiments, the BFS housing 530 may comprise and / or define an interior projection 532 emanating from a distal extent of the BFS chamber 530-1 and toward the first (e.g., open) end of the BFS housing 530. According to some embodiments, the interior projection 532 may comprise and / or define an interior projection socket 532-1 within which are disposed interior projection threads 532-2 and / or a twist valve socket 532-3. The interior projection threads 532-2 may be configured to receive, mate with, and / or guide portions of a BFS vial (not shown; e.g., the mounting flanges 116 of FIG. 1A, FIG. 1 B, and / or FIG. 1 C herein), for example, and / or the twist valve socket 532-3 may be configured to receive and / or activate (e.g., tear off) a twist valve of the BFS vial (also not shown; e.g., the twist valve 126, 226 of FIG. 1A, FIG. 1 B, FIG. 1C, FIG. 2A, FIG. 2B, FIG. 2C, FIG. 2D, FIG 2E, FIG. 2F, and FIG. 2G herein). In some embodiments, the BFS housing 530 may comprise and / or define a grip flange 534 disposed and / or formed at the first end thereof. According to some embodiments, the BFS housing 530 may comprise and / or define an outlet coupling 536 formed at a second end of the BFS housing 530and extending axially distal from the BFS chamber 530-1. In some embodiments, the outlet coupling 536 may be in fluid communication (e.g., may define a fluid pathway therebetween; not separately labeled) with the interior projection socket 532-1 and / or the BFS chamber 530-1. In some embodiments, the outlet coupling 536 may comprise and / or define an outlet socket 536-1 comprising outlet coupling threads 536-2 therein. According to some embodiments, the outlet coupling 536 may comprise and / or define an outlet projection 538 extending axially outward / distal from the BFS housing 530 (e.g., from an interior extent of the outlet socket 536-1). In some embodiments, the outlet projection 538 may comprise and / or define one or more outlet ports 538-1 in fluid communication with the interior projection socket 532-1 and / or the BFS chamber 530-1 , e.g., open at the distal end of the outlet projection 538 and / or BFS housing 530. In such a manner, for example, first fluid / medicament from the BFS vial (not shown) that is introduced into the interior projection socket 532-1 (and / or the BFS chamber 530-1) may flow through the outlet projection 538 (via the one or more outlet ports 538-1) and be expelled from the second end of the BFS housing 530.

[0036] In some embodiments, fewer or more components 530-1 , 532, 532-1 , 532-2, 532-3, 534, 536, 536-1 , 536- 2, 538, 538-1 and / or various configurations of the depicted components 530-1 , 532, 532-1 , 532-2, 532-3, 534, 536, 536-1 , 536-2, 538, 538-1 may be included in the BFS housing 530 without deviating from the scope of embodiments described herein. In some embodiments, the components 530-1 , 532, 532-1 , 532-2, 532-3, 534, 536, 536-1 , 536- 2, 538, 538-1 may be similar in configuration and / or functionality to similarly named and / or numbered components as described herein. In some embodiments, the BFS housing 530 (and / or portions thereof) may comprise a portion of a disposable, single-dose, modular, multi-stage delivery assembly operable to be utilized to execute, conduct, and / or facilitate the method 1100 of FIG. 11 herein, and / or portions thereof.

[0037] Turning now to FIG. 6A, FIG. 6B, FIG. 6C, FIG. 6D, FIG. 6E, and FIG. 6F, perspective, left, right, top, bottom, and perspective cross-section views of BFS compression piston 640 according to some embodiments are shown. The BFS compression piston 640 may comprise similar features and / or configurations and / or may be similar to the piston 140, 240 of FIG. 1A, FIG. 1 B, FIG. 1 C, FIG. 2A, FIG. 2B, FIG. 2C, FIG. 2D, FIG. 2E, FIG. 2F, and FIG. 2G herein. The BFS compression piston 640 may comprise, for example, a generally cylindrical body defining an interior volume or piston bore 640-1 . In some embodiments, the piston bore 640-1 may extend axially inward from a first end of the BFS compression piston 640 (e.g., the first end accordingly being open). In some embodiments, the BFS compression piston 640 may be configured to receive a rear end of a BFS vial (not shown; e.g., the BFS vial 110, 210 of FIG. 1A, FIG. 1 B, FIG. 1 C, FIG. 2A, FIG. 2B, FIG. 2C, FIG. 2D, FIG. 2E, FIG. 2F, and FIG. 2G herein). The BFS compression piston 640 may also or alternatively be configured to fit within a BFS chamber (also not shown; e.g., the BFS chamber 130-1 , 230-1 of FIG. 1A, FIG. 1 B, FIG. 1 C, FIG. 2A, FIG. 2B, FIG. 20, FIG. 2D, FIG. 2E, FIG. 2F, and FIG. 2G herein). In some embodiments, the BFS vial may be inserted into the BFS chamber and the BFS compression piston 640 may also be inserted into the BFS chamber such that it enshrouds (via the piston bore 640-1 ) a back / rear portion of the BFS vial. According to some embodiments, the BFS compression piston 640 may comprise and / or define one or more key slots 642a-b disposed at an open end of the piston bore 640-1 . The key slots 642a-b may be configured to mate with and / or drive (e.g., rotationally), for example, side flanges of the BFS vial (not shown; e.g., the side flanges 1 18, 218 of FIG. 1A, FIG. 1 B, FIG. 1 C, FIG. 2A, FIG. 2B, FIG. 2C, FIG. 2D, FIG. 2E, FIG. 2F, and FIG. 2G herein). In some embodiments, the BFS compression piston 640 may comprise and / or define a piston grip 644 that may function as a tactile push and / or rotational drive surface operable to be engaged by a human hand to, e.g., selectively activate the BFS vial engaged within and / or by the BFS compression piston 640.

[0038] In some embodiments, fewer or more components 640-1 , 642a-b, 644 and / or various configurations of the depicted components 640-1 , 642a-b, 644 may be included in the BFS compression piston 640 without deviating from the scope of embodiments described herein. In some embodiments, the components 640-1 , 642a-b, 644 maybe similar in configuration and / or functionality to similarly named and / or numbered components as described herein. In some embodiments, the BFS compression piston 640 (and / or portions thereof) may comprise a portion of a disposable, single-dose, modular, multi-stage delivery assembly operable to be utilized to execute, conduct, and / or facilitate the method 1100 of FIG. 11 herein, and / or portions thereof.

[0039] Referring now to FIG. 7A, FIG. 7B, FIG. 7C, FIG. 7D, and FIG. 7E, perspective, side, top, bottom, and perspective cross-section views of a mixing connector 750 according to some embodiments are shown. The mixing connector 750 may comprise similar features and / or configurations and / or may be similar to the mixing connector 150, 350 of FIG. 1 A, FIG. 1 B, FIG. 1 C, FIG. 3A, FIG. 3B, FIG 3C, FIG. 3D, FIG. 3E, and FIG. 3F herein. The mixing connector 750 may comprise, for example, a generally cylindrical body defining an interior volume or mixing chamber 750-1 . In some embodiments, the mixing chamber 750-1 may extend axially inward from a first end of the mixing connector 750 (e.g., the first end accordingly being open). In some embodiments, the mixing connector 750 may comprise and / or define an outlet coupling 756 at a second end of the mixing connector 750. In some embodiments, the outlet coupling 756 may comprise and / or define an outlet coupling socket 756-1 within which are disposed and / or formed outlet coupling threads 756-2. According to some embodiments, the outlet coupling 756 and / or the outlet coupling socket 756-1 may be in fluid communication with the mixing chamber 750-1 via an outlet port 756-3 (e.g., may define a fluid pathway therebetween; not separately labeled).

[0040] In some embodiments, fewer or more components 750-1 , 756, 756-1 , 756-2, 756-3 and / or various configurations of the depicted components 750-1 , 756, 756-1 , 756-2, 756-3 may be included in the mixing connector 750 without deviating from the scope of embodiments described herein. In some embodiments, the components 750-1 , 756, 756-1 , 756-2, 756-3 may be similar in configuration and / or functionality to similarly named and / or numbered components as described herein. In some embodiments, the mixing connector 750 (and / or portions thereof) may comprise a portion of a disposable, single-dose, modular, multi-stage delivery assembly operable to be utilized to execute, conduct, and / or facilitate the method 1 100 of FIG. 1 1 herein, and / or portions thereof.

[0041] Turning now to FIG. 8A, FIG. 8B, FIG. 8C, FIG. 8D, and FIG. 8E, perspective, side, top, bottom, and perspective cross-section views of a chamber plug 852 according to some embodiments are shown. The chamber plug 852 may comprise similar features and / or configurations and / or may be similar to the plug 152, 352 of FIG. 1A, FIG. 1 B, FIG. 1 C, FIG. 3A, FIG. 3B, FIG. 3C, FIG. 3D, FIG. 3E, and FIG. 3F herein. The chamber plug 852 may comprise, for example, a generally cylindrical body defining an interior volume or plug bore 852-1 . In some embodiments, the plug bore 852-1 may extend axially inward from a first end of the chamber plug 852 (e.g., the first end accordingly being open). In some embodiments, the chamber plug 852 may comprise and / or define a slit 852-2 disposed in an end wall and / or extent of the plug bore 852-1. As depicted, the slit 852-2 may comprise multiple cuts through the end wall of the plug bore 852-1 , e.g., formed in a two-dimensional “X” pattern as shown. In some embodiments, the slit 852-2 may be partially or fully disposed and / or extending through the wall of the plug 852. In a case where the slit 852-2 is formed through a majority of the wall thickness but a portion of uncut wallremains, the remaining wall portion may be pierced, torn, and / or otherwise ruptured when an object (e.g., the outlet projection 138, 238 of FIG. 1 A, FIG. 1 B, FIG. 1 C, FIG. 2A, FIG. 2B, FIG. 20, FIG. 2D, FIG. 2E, FIG. 2F, and FIG. 2G herein) is forced axially therethrough. According to some embodiments, such as in the case that the chamber plug 852 is constructed of pliable material such as rubber or soft plastic, the slit 852-2 may act as a seal to the plug bore 852-1 unless elastically deformed, e.g., in response to an object (not shown; e.g., the outlet projection 138, 238 of FIG. 1A, FIG. 1 B, FIG. 10, FIG. 2A, FIG. 2B, FIG. 20, FIG. 2D, FIG. 2E, FIG. 2F, and FIG. 2G herein) being urged axially through the slit 852-2. According to some embodiments, the chamber plug 852 may comprise and / or define a plurality of circumferential detents or grooves 852-3 spaced along a length of the chamber plug 852. The grooves 852-3 may, for example, reduce friction in a case where the chamber plug 852 is axially forced through a tight-fitting tube (not shown; e.g., the mixing connector 150-1 , 350-1 of FIG. 1A, FIG. 1 B, FIG. 10, FIG. 3A, FIG. 3B, FIG. 30, FIG. 3D, FIG. 3E, and FIG. 3F herein). In some embodiments, a radial notch 852-4 may be disposed at a radial extent of the first end of the chamber plug 852.

[0042] In some embodiments, fewer or more components 852-1 , 852-2, 852-3, 852-4 and / or various configurations of the depicted components 852-1 , 852-2, 852-3, 852-4 may be included in the chamber plug 852 without deviating from the scope of embodiments described herein. In some embodiments, the components 852- 1 , 852-2, 852-3, 852-4 may be similar in configuration and / or functionality to similarly named and / or numbered components as described herein. In some embodiments, the chamber plug 852 (and / or portions thereof) may comprise a portion of a disposable, single-dose, modular, multi-stage delivery assembly operable to be utilized to execute, conduct, and / or facilitate the method 1100 of FIG. 11 herein, and / or portions thereof.

[0043] Referring now to FIG. 9A, FIG. 9B, FIG. 90, FIG. 9D, and FIG. 9E, perspective, side, top, bottom, and perspective cross-section views of an outlet cap 948 according to some embodiments are shown. The outlet cap 948 may comprise similar features and / or configurations and / or may be similar to the outlet caps 148, 158, 248, 358 of FIG. 1A, FIG. 1 B, FIG. 10, FIG. 2A, FIG. 2B, FIG. 20, FIG. 2D, FIG. 2E, FIG. 2F, FIG. 2G, FIG. 3A, FIG. 3B, FIG. 30, FIG. 3D, FIG. 3E, and FIG. 3F herein. The outlet cap 948 may comprise, for example, a generally cylindrical body defining a first or threaded portion 948-1 extending from a first end of the outlet cap 948 and having a first diameter and comprising external threads 948-2. According to some embodiments, the outlet cap 948 may comprise and / or define a second or grip portion 948-3 having a second diameter that is larger than the first diameter. In some embodiments, the external threads 948-2 may be configured to cooperatively mate with internal threads of other devices (not shown; e.g., the outlet coupling threads 136-2, 156-2, 236-2, 356-2 of FIG. 1A, FIG. 1 B, FIG. 1 C, FIG. 2A, FIG. 2B, FIG. 20, FIG. 2D, FIG. 2E, FIG. 2F, FIG. 2G, FIG. 3A, FIG. 3B, FIG. 30, FIG. 3D, FIG. 3E, and FIG. 3F herein) and / or may be configured in accordance with a threading standard such as the ISO 80369-7 “Small-bore connectors for liquids and gases in healthcare applications: Part 7: Connectors for intravascular or hypodermic applications” or “Luer lock fittings” standard published by the International Organization for Standardization (ISO) of Geneva, Switzerland (2021 ). The outlet cap 948 and / or the threaded portion 948-1 maycomprise and / or define, for example, a taper bore 948-4 configured to accept a projection (not shown; e.g., the outlet projection 138, 238 and / or the outlet port 156-3, 356-3 of FIG. 1 A, FIG. 1 B, FIG. 10, FIG. 2A, FIG. 2B, FIG. 20, FIG. 2D, FIG. 2E, FIG. 2F, FIG. 2G, FIG. 3A, FIG. 3B, FIG. 30, FIG. 3D, FIG. 3E, and FIG. 3F herein) such as a Luer-style taper projection.

[0044] In some embodiments, fewer or more components 948-1 , 948-2, 948-3, 948-4 and / or various configurations of the depicted components 948-1 , 948-2, 948-3, 948-4 may be included in the outlet cap 948 without deviating from the scope of embodiments described herein. In some embodiments, the components 948-1 , 948-2, 948-3, 948-4 may be similar in configuration and / or functionality to similarly named and / or numbered components as described herein. In some embodiments, the outlet cap 948 (and / or portions thereof) may comprise a portion of a disposable, single-dose, modular, multi-stage delivery assembly operable to be utilized to execute, conduct, and / or facilitate the method 1100 of FIG. 11 herein, and / or portions thereof.

[0045] Referring additionally to FIG. 10A, FIG. 10B, FIG. 10C, FIG. 10D, FIG. 10E, FIG. 10F, FIG. 10G, FIG. 10H, FIG. 101, FIG. 10J, FIG. 10K, FIG. 10L, FIG. 10M, FIG. 10N, FIG. 10o, and FIG. 10P, various views of a pre-filled modular multi-stage medical agent delivery system 1000 being utilized according to some embodiments are shown. In some embodiments, the pre-filled modular multi-stage medical agent delivery system 1000 may utilize and / or employ a specially-designed BFS vial 1010 to safely, inexpensively, reliably, and / or conveniently administer a combined medicament to a patient or other target “T” (shown in FIG. 10M, FIG. 10N, FIG. 10o, and FIG 10P). The BFS vial 1010 may comprise and / or define, for example, a vial neck 1012, a fluid seal 1014, mounting flanges 1016, side flanges 1018, a fluid reservoir 1020, a bellows 1022, a label flange 1024, and / or a twist valve 1026 {e.g., comprising twist valve side flanges 1028; disposed at a first end of the BFS vial 1010). In some embodiments, the fluid reservoir 1020 may be filled (fully or partially) with a fluid or other agent {e.g., an ASD powder; not separately shown) such as a diluent or a first active ingredient {e.g., a single dose thereof). According to some embodiments, the fluid may be injected into the BFS vial 1010 in a sterile environment during manufacture via a BFS process and sealed within the BFS vial 1010 via the fluid seal 1014. The fluid seal 1014 may comprise a portion of the molded BFS vial 1010 for example that is configured to be broken / ruptured to expel the fluid, e.g., such as by providing a break line and / or narrow cross-sectional area between the neck 1012 and the twist valve 1026, such that rotational forces developed between the twist valve 1026 and the remainder of the BFS vial 1010 cause the twist valve 126 to tear-off from the BFS vial 1010 at the fluid seal 1014. In some embodiments, the neck 1012 of the BFS vial 1010 may comprise the mounting flanges 1016 that are configured to be threaded {e.g., permitting rotational movement of the BFS vial 1010).

[0046] According to some embodiments, the BFS vial 1010 may be inserted {e.g., via application of a first axial force) into a housing 1030. The housing 1030 may define a BFS chamber 1030-1 at a second end thereof into which the first end of the BFS vial 1010 is inserted, for example. In some embodiments, the housing 1030 may comprise an interior projection 1032 extending toward the BFS vial 1010 within the BFS chamber 1030-1 . Theinterior projection 1032 may comprise an interior projection socket (not readily visible) into which the first end of the BFS vial 1010 is inserted. According to some embodiments, the mounting flanges 1016 of the BFS vial 1010 may be partially rotationally engaged with interior projection threads (not shown) disposed within the interior projection socket. In some embodiments, the interior projection socket may comprise a twist valve socket (not readily visible) into which the twist valve 1026 portion of the BFS vial 1010 is partially inserted. According to some embodiments, the housing 1030 may comprise a grip flange 1034 and / or an outlet coupling 1036. The outlet coupling 1036 may, in some embodiments, define an outlet coupling socket 1036-1 comprising outlet coupling threads 1036-2, at a first end of the housing 1030. According to some embodiments, the housing 1030 may comprise an outlet projection 1038 emanating from within the outlet coupling socket 1036-1 and / or comprising one or more outlet ports 1038-1 in fluid communication with the interior projection socket into and / or the BFS chamber 1030-1 .

[0047] In some embodiments, the pre-filled modular multi-stage medical agent delivery system 1000 may comprise a piston 1040 inserted into the BFS chamber 1030-1 and housing a second end of the BFS vial 1010. The piston 1040 may comprise a piston bore 1040-1 at a first end thereof into which the second end of the BFS vial 1010 is inserted, for example, and the piston 1040 may comprise a body having a geometry configured to slide into the BFS chamber 1030-1 of the housing 1030. According to some embodiments, the piston 1040 may comprise one or more key slots 1042 (only one of which is visible) disposed in an outer wall thereof at the first end, and oriented to engage with the side flanges 1018 of the BFS vial 1010, e.g. , within the BFS chamber 1030-1. In some embodiments, the piston 1040 may comprise a piston grip 1044 disposed at a second end of the piston 1040. The piston grip 1044 may be selectively manipulated, for example, to transition the pre-filled modular multi-stage medical agent delivery system 1000 between different stages and / or states.

[0048] The BFS vial 1010 may be engaged with the housing 1030, for example, in three positions or stages (e.g., corresponding to first, second, and third states of the pre-filled modular multi-stage medical agent delivery system 1000). In a first stage or position (e.g., corresponding to the first state of the pre-filled modular multi-stage medical agent delivery system 1000) as housing 1030 such that the mounting flanges 1016 become partially engaged (e.g., rotationally engaged) with the interior projection threads. As depicted in FIG. 10A and FIG. 10B, for example, the BFS vial 1010 may be inserted into the housing 1030 to an extent until the mounting flanges 1016 are engaged to a first extent, e.g., half of a turn or one hundred and eighty degrees (180°) with the interior projection threads. In the first stage, the twist valve 1026 may become positioned in a first portion of the twist valve socket. According to some embodiments, the piston 1040 may be engaged to cover the second end of the BFS vial 1010 and to couple within the BFS chamber 1030-1. In some embodiments, the piston 1040 may be inserted into the BFS chamber 1030-1 to a first extent where the side flanges 1018 of the BFS vial 1010 enter into the key slot(s) 1042 of the piston 1040. According to some embodiments, the first stage may comprise an assembly, storage, and / or transport stage where the BFS vial 1010, the housing 1030, and the piston 1040 are coupled together without having activated or exposed the contents of the BFS vial 1010. In some embodiments, an outlet cap 1048 may be coupled to block,close, or seal the outlet port 1038-1 , e.g., as part of the first stage or state.

[0049] According to some embodiments, in a second stage or position (e.g., corresponding to the second state of the pre-filled modular multi-stage medical agent delivery system 1000) as depicted in FIG. 10G, the BFS vial 1010 may be fully inserted into the housing 1030 such that the twist valve 1026 is ripped from the BFS vial 1010, exposing the contents of the BFS vial 1010. In some embodiments, a rotational force may be applied (e.g., via the piston 1040 and / or the piston grip 1044 thereof) to further advance the threading of the mounting flanges 1016 with the interior projection threads, thereby further axially advancing the BFS vial 1010 into the housing 1030 (e.g., causing a transition from the first stage to the second stage) In such embodiments, the twist valve 1026 may be prevented from rotation by the twist valve socket, e.g., by the twist valve side flanges 1028 engaging with one or more features and / or geometries (e.g., tracks, grooves, and / or rotational blocking projections; not separately shown) of the twist valve socket and accordingly develop a rotational shear force between the twist valve 1026 and the rotating remainder of the BFS vial 1010. As described herein, the rotational shear force may cause the fluid seal 1014 between the twist valve 1026 and the neck 1012 of the BFS vial 1010 to tear, break, and / or rupture, thereby opening the BFS vial 1010.

[0050] In some embodiments, in a third stage or position (e.g., corresponding to the third state of the pre-filled modular multi-stage medical agent delivery system 1000) as depicted in FIG. 10H, after the BFS vial 1010 is opened, the BFS vial 1010 may be compressed to expel the contents thereof. According to some embodiments, an axial force may be applied (e.g., via the piston 1040 and / or the piston grip 1044 thereof) to further advance the piston 1040 into the BFS chamber 1030-1 , thereby causing the bellows 1022 to compress (e.g., causing a transition from the second stage to the third stage). In such embodiments, one or more fluids such as air within the bellows 1022 may be compressed to cause an increase in pressure within the BFS vial 1010 (e.g., within the fluid reservoir 1020 thereof), thereby forcing the first medical agent out of the BFS vial 1010 at the location of the broken fluid seal 1014. While the bellows 1022 is depicted as having four (4) collapsible segments for exemplary illustration herein, in some embodiments, fewer or more segments and / or sizes or configurations of the segments may be provided.

[0051] According to some embodiments, the pre-filled modular multi-stage medical agent delivery system 1000 may comprise multiple modules and / or components "A”, “B”, and “C” that are advantageously and selectively coupled to provide an injectable multi-component medical substance (e.g., a combined ad / or reconstituted active ingredient(s)) to the target “T” . In some embodiments, each of the modules / components “A”, “B”, and “C" may be separately or individually sealed, packaged, and / or sterilized. According to some embodiments, a first module or component "A” may comprise the BFS vial 1010, the housing 1030, the piston 1040, and / or the outlet cap 1048. The first module / component "A” may be sterile and sealed, for example, by being filled and assembled in a sterile environment and by being sealed by the outlet cap 1048 on a first end thereof and by the fitting of the piston 1040 into the BFS chamber 1030-1 at a second end thereof. In some embodiments, additional and / or alternate sealingand / or packaging measures may be employed. According to some embodiments, a second module or component “B” may comprise a mixing connector 1050 defining a mixing chamber 1050-1 extending from a second end and a standoff assembly 1050-2 extending from a first end thereof. In some embodiments, the mixing chamber 1050-1 may comprise a plug 1052 (e.g. comprising a slit 1052-2) disposed therein and / or may be sealed by a seal 1054. In some embodiments, the mixing connector 1050 may comprise an outlet coupling 1056 defining an outlet socket 1056-1 comprising outlet socket threads 1056-2. According to some embodiments, the mixing connector 1050 may comprise an outlet port 1056-3 emanating from the outlet socket 1056-1 . In some embodiments, the outlet port 1056-3 may be closed and / or sealed by coupling of an outlet cap 1058 with the outlet coupling 1056. In some embodiments, a medical substrate 1060 may be disposed within the mixing chamber 1050-1. According to some embodiments, the second module or component “B” may accordingly comprise the mixing connector 1050 (with the plug 1052 and / or the medical substrate 1060), the seal 1054, and / or the outlet cap 1058. The second module / component “B” may be sterile and sealed, for example, by being filled (e.g., with the medical substrate 1060) assembled in a sterile environment and by being sealed by the outlet cap 1058 on a first end thereof and by the seal 1054 at a second end thereof. In some embodiments, additional and / or alternate sealing and / or packaging measures may be employed. According to some embodiments, a third module or component “C” may comprise an administration connector 1070 that retains an administration member 1080 that is shielded by a cap 1090. Although not depicted, the third module / component "C” may be packaged, wrapped, and / or sealed, e.g., such seal requiring removal before the third module / component “C” may be coupled to the second module / component “B” as depicted in FIG. 10K.

[0052] In some embodiments, the pre-filled modular multi-stage medical agent delivery system 1000 may be provided to a user (not shown; e.g., a nurse, doctor, or patient - e.g., in the case of self-injection) as the three (3) separate modules or components “A", “B”, and “C”, and with the first component "A” in the first state, such that the BFS vial 1010 is inserted into the housing 1030 (e.g., the first axial force has already been applied during a manufacturing assembly process) and the piston 1040 has been installed so that the BFS vial 1010 is fully covered / housed. According to some embodiments, once the pre-filled modular multi-stage medical agent delivery system 1000 is provided and / or transitioned to the first state, a first step for employing the pre-filled modular multistage medical agent delivery system 1000, as depicted in FIG. 10A, may be to align the first end second components “A" and “B”. In some embodiments, a second step for employing the pre-filled modular multi-stage medical agent delivery system 1000, as depicted in FIG. 10B, may be to remove the seal 1054 covering the plug 1052 in the mixing chamber 1050-1. According to some embodiments, a third step for employing the pre-filled modular multi-stage medical agent delivery system 1000, as depicted in FIG 10C, may be to remove (e.g., twist- off) the outlet cap 1048 of the housing 1030, thereby exposing the outlet projection 1038 and the outlet port(s) 1038-1. In some embodiments, a fourth step for employing the pre-filled modular multi-stage medical agent delivery system 1000, as depicted in FIG. 10D, FIG. 10E, and FIG. 10F, may be to insert the first end of the first component“A” into the second end of the second component “B”, e.g., by applying a second axial force to urge the first end of the housing 1030 into the mixing chamber 1050-1 (e.g., and / or into a plug bore 1052-1 of the plug 1052). As depicted, the coupling of the first and second components “A” and “B” may cause the outlet projection 1038 of the housing 1030 to force or pierce through the plug 1052 (e.g., the slit 1052-2 at an extent of the plug bore 105211 thereof) such that the outlet port(s) 1038-1 are exposed within the mixing chamber 1050-1 .

[0053] According to some embodiments, a fifth step for employing the pre-filled modular multi-stage medical agent delivery system 1000, as depicted in FIG. 10G, may comprise transitioning the first component “A” to the second state. In the fifth step, for example, the piston 1040 may be rotated (e.g., clockwise), causing the key slot(s) 1042 to rotationally engage with the side flanges 1018 of the BFS vial 1010, thereby imparting rotational force to the BFS vial 1010. The rotational force may accordingly, for example, cause an advancement of the mounting flanges 1016 with the interior projection threads, causing the BFS vial 1010 (and the piston 1040) to advance axially further into the BFS chamber 1030-1. According to some embodiments, the twist valve socket may prevent the twist valve 1026 portion of the BFS vial 1010 from rotating, thereby causing a rotational shear force to develop in the BFS vial 1010 (e.g., at the fluid seal 1014). The fifth step may accordingly cause the twist valve 1026 to shear or tear (wholly or partially) from the BFS vial 1010, exposing the contents of the BFS vial 1010, e.g., to the outlet port(s) 1038-1 within the mixing chamber 1050-1 .

[0054] In some embodiments, a sixth step for employing the pre-filled modular multi-stage medical agent delivery system 1000, as depicted in FIG. 10H, may comprise transitioning the first component "A” to the third state. In the sixth step, for example, the piston 1040 (e.g., via the piston grip 1044) may be pushed axially into the housing 1030, e.g., by application of a third axial force). According to some embodiments, the axial force may cause the bellows 1022 of the BFS vial 1010 to collapse and / or compress, pressurizing any air within the BFS vial 1010 and thereby causing the first medical agent to be expelled from the outlet port(s) 1038-1 , e.g., into the mixing chamber 1050-1. As depicted in FIG. 10H, for example, each of the medical substrate 1060 and a volume of first medical agent 1062 may be introduced within the mixing chamber 1050-1 . In some embodiments, a seventh step for employing the prefilled modular multi-stage medical agent delivery system 1000, as depicted in FIG. 101, may comprise mixing the first medical agent 1062 and the medical substrate 1060. The combined first and second components “A” and “B” may be shaken or otherwise agitated, for example, to cause and / or facilitate the mixing. As depicted in FIG. 101, the resulting combined medical agent 1064 may be formed and / or reside within the mixing chamber 1050-1 . While reference is made to “combining” different substances in the mixing chamber for ease of description and illustration, in some embodiments a single medical agent may be reconstituted (e.g., from a lyophilized and / or otherwise dried state) with an inert ingredient such as saline solution. In some embodiments, the “combining” or “mixing” may comprise a chemical reaction in which two separate active ingredients react to form a new or third medical agent.

[0055] According to some embodiments, an eighth step for employing the pre-filled modular multi-stage medical agent delivery system 1000, as depicted in FIG. 10J, may comprise removing the outlet cap 1058, e.g., to exposethe outlet port 1056-3. In some embodiments, a ninth step for employing the pre-filled modular multi-stage medical agent delivery system 1000, as depicted in FIG. 10K, may comprise installing or coupling the third component “C” to the combined first and second components “A” and “B”, e.g., by engaging the administration connector 1070 with the outlet coupling threads 1056-2. In some embodiments, a tenth step for employing the pre-filled modular multi-stage medical agent delivery system 1000, as depicted in FIG. 10L, may comprise removing the cap 1090 (e.g., via application of an axial separation force), According to some embodiments, the cap 1090 may be discarded or set aside for later reinstallation to minimize hazards. Removal of the cap 1090 may, for example, expose the administration member 1080 and / or an administration end thereof According to some embodiments, an eleventh step for employing the pre-filled modular multi-stage medical agent delivery system 1000, as depicted in FIG. 10M, may comprise positioning the activated pre-filled modular multi-stage medical agent delivery system 1000 for injection into the desired target “T”. In some embodiments, a twelfth step for employing the pre-filled modular multistage medical agent delivery system 1000, as depicted in FIG. 10N, may comprise engaging the administration member with the target “T”. The engaging may comprise, for example, applying the administration member 1080 to the target “T” (with the non-limiting example of a needle being stuck into a patient depicted in FIG. 10N) and applying a fourth axial force that causes the first component “A” to travel deeper into the mixing chamber 1050-1 of the second component “B", pushing the plug 1052 axially within the mixing chamber 1050-1 and thereby reducing the volume of the mixing chamber 1050-1 and forcing the combined medical agent 1064 through the outlet port 1056-3, through the administration member 1080, and to (or, as depicted, into) the target “T”.

[0056] In some embodiments, a thirteenth step for employing the pre-filled modular multi-stage medical agent delivery system 1000, as depicted in FIG. 10P, may comprise removing the administration member 1080 from the patient / target “T”, such as by backing the administration member 1080 (and / or the entire pre-filled modular multistage medical agent delivery system 1000) out of the target site “T”. According to some embodiments, although not explicitly shown, the expended pre-filled modular multi-stage medical agent delivery system 1000 may then be disposed of properly. According to some embodiments, should someone attempt to refill the pre-filled modular multi-stage medical agent delivery system 1000, e.g., by reversing the piston 1040 and / or reversing the first component "A” from within the second component “B”, the refill attempt may be hindered or thwarted in two (2) ways. First, axial reversal of the piston 1040 and / or of the first component "A” from within the second component “B” may be mechanically prohibited. Once engaged, for example, the nested components may slide past and / or engage one or more catches (not shown) that mechanically prevent reverse movement. Second, even if a vacuum were able to be created within the collapsed BFS vial 1010, fluid entering the outlet coupling 1036 of the housing 1030 would be prevented from entering (or re-entering) the BFS vial 1010 may mechanical and / or fluid interference of the fluid flow by the remnants of the twist valve 1026 lodged within the twist valve socket. In such a manner, for example, the pre-filled modular multi-stage medical agent delivery system 1000 may be rendered disabled from reuse as soon as the twist valve 1026 is activated within the housing 1030.

[0057] In some embodiments, fewer or more components 1010, 1012, 1014, 1016, 1018, 1020, 1022, 1024, 1026, 1028, 1030, 1030-1 , 1032, 1034, 1036, 1036-1 , 1036-2, 1038, 1038-1 , 1040, 1040-1 , 1042, 1044, 1048, 1050, 1050-1 , 1050-2, 1052, 1052-2, 1054, 1056, 1056-1 , 1056-2, 1056-3, 1058, 1060, 1062, 1064, 1070, 1080, 1090 and / or various configurations of the depicted components 1010, 1012, 1014, 1016, 1018, 1020, 1022, 1024, 1026, 1028, 1030, 1030-1 , 1032, 1034, 1036, 1036-1 , 1036-2, 1038, 1038-1 , 1040, 1040-1 , 1042, 1044, 1048, 1050, 1050-1 , 1050-2, 1052, 1052-2, 1054, 1056, 1056-1 , 1056-2, 1056-3, 1058, 1060, 1062, 1064, 1070, 1080, 1090 may be included in the pre-filled modular multi-stage medical agent delivery system 1000 without deviating from the scope of embodiments described herein. In some embodiments, the components 1010, 1012, 1014, 1016, 1018, 1020, 1022, 1024, 1026, 1028, 1030, 1030-1 , 1032, 1034, 1036, 1036-1 , 1036-2, 1038, 1038-1 , 1040, 1040- 1 , 1042, 1044, 1048, 1050, 1050-1 , 1050-2, 1052, 1052-2, 1054, 1056, 1056-1 , 1056-2, 1056-3, 1058, 1060, 1062, 1064, 1070, 1080, 1090 may be similar in configuration and / or functionality to similarly named and / or numbered components as described herein. In some embodiments, the pre-filled modular multi-stage medical agent delivery system 1000 (and / or portions thereof) may comprise a portion of a disposable, single-dose, modular, multi-stage delivery assembly operable to be utilized to execute, conduct, and / or facilitate the method 1100 of FIG. 11 herein, and / or portions thereof.

[0058] While threads and / or other specific coupling mechanisms between different components are described for purposes of example herein, fewer, more, and / or different types and / or configurations of coupling mechanisms may be utilized without deviating from some embodiments. While different types and / or configurations of coupling mechanisms may be utilized, in some embodiments those specifically described types and / or configurations of coupling mechanisms may provide advantages such as facilitating the execution of the method 1100 of FIG. 11 herein, and / or portions thereof. Additionally, while some components that are coupled together are depicted and / or described as being separate and / or distinct components, in some embodiments two or more coupled and / or mated components may be manufactured, assembled, and / or provided as a single joint and / or integral component, as is or becomes desirable and / or practicable. Similarly, while various seals are depicted and referenced, different amounts, sizes, and / or types of seals and / or sterile packaging may be utilized. All modular components may simply be packaged together, for example, without requiring any seals and / or transport or outlet caps. In some embodiments, a mixing chamber and / or module may be provided with or without a standoff assembly or other skinengaging structure.III. Pre-filled Modular Multi-Stage Medical Agent Delivery Methods

[0059] Referring now to FIG. 1 1 , a flow diagram of a method 1 100 according to some embodiments is shown. In some embodiments, the method 1100 may be performed and / or implemented by and / or otherwise associated with one or more users such as doctors, nurses, government workers, patients, family members, caregivers, and / or combinations thereof. In some embodiments, the method 1100 may be embodied in, facilitated by, and / or otherwiseassociated with various components and / or systems as described herein. The process diagrams and flow diagrams described herein do not necessarily imply a fixed order to any depicted actions, steps, and / or procedures, and embodiments may generally be performed in any order that is practicable unless otherwise and specifically noted. 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 action, step, and / or procedure.

[0060] In some embodiments, the method 1 100 may comprise removing a transport cap from a BFS module (e.g., from a first end thereof), at 1 102. The BFS module may comprise a pre-packaged, sterile component housing a specially-designed BFS vial, for example, that is manufactured to contain a first medical agent. According to some embodiments, the transport cap may maintain the sterility of the BFS module through storage and transportation, and unit use. Once removed, the transport cap may expose and / or provide access to a first coupling and / or an outlet port. In some embodiments, the method 1 100 may comprise removing a seal from a mixing module (e.g., from a second end thereof), at 1 104. The mixing module may comprise a pre-packaged, sterile component, for example, that is manufactured to contain a second medical agent and / or to provide a volume in which medical agents may be combined, mixed, reconstituted, reacted, and / or otherwise introduced. According to some embodiments, the seal may maintain the sterility of the mixing module through storage and transportation, and unit use. Once removed, the seal may expose and / or provide access to an inlet port of a mixing chamber of the mixing module.

[0061] According to some embodiments, the method 1100 may comprise coupling the BFS module to the mixing module, at 1106. The first end of the BFS module may, for example, be inserted into the inlet port of the mixing chamber. In some embodiments, the coupling may introduce the outlet port of the BFS module into the mixing chamber. According to some embodiments, the second medical agent may be disposed in the mixing chamber. In some embodiments, once the two modules are coupled, the method 1 100 may comprise activating a twist valve of the BFS vial, at 1108. The twist valve may comprise an integral tear-away portion of the BFS vial, for example, that is configured to be mechanically sheared off from the BFS vial, thereby releasing the first medical agent stored therein. According to some embodiments, the activation of the twist valve may be advantageously accomplished by physical manipulation of the BFS module. A rear section (or piston) of the BFS module at a second end thereof may be rotatable with respect to the remainder of the module at the first end, for example, and may be keyed to cause the BFS vial to rotate therewith. In such a manner, a rotation of the rear section may cause the BFS vial to rotate within the BFS module. In some embodiments, the interior of the BFS module may comprise threads that interact with the BFS vial in response to a rotation thereof, to cause the BFS vial to advance axially within the BFS module. According to some embodiments, the BFS module may comprise one or more interior features that prevent the twist valve portion of the BFS vial from rotating (e.g., with respect to the front end of the BFS module).Accordingly, imparting rotation to the BFS vial while the twist valve is prevented from rotating causes a rotational shear force to develop in the BFS vial. The shear force may cause the twist valve to tear or rip away from the BFS vial, thereby opening the BFS vial within the BFS module (e.g., activating the twist valve).

[0062] In some embodiments, the method 1100 may comprise mixing the medical agents, at 1110. The piston or rear end of the BFS module may be manipulated, for example, to compress the BFS vial and expel the first medical agent into the mixing chamber. According to some embodiments, the piston may be axially forced deeper within the front end of the BFS module, thereby imparting an axial force on the BFS vial therewithin. In some embodiments, the BFS vial may be configured to expel the first medical agent upon receiving the axial compression force. The BFS vial may comprise, for example, a bellows or other axially-compressible geometric feature and / or construction that permits the BFS vial to collapse, thereby pressurizing the contents which are accordingly expelled via the outlet port. In some embodiments, the mixing chamber may house, store, and / or comprise a dry, solid, or gelatinous agent that is disposed within the interior volume thereof. According to some embodiments, the BFS vial (and / or a reservoir thereof) may be squeezed or compressed, forcing any liquid in the BFS vial to be ejected through the outlet port of the BFS module and into the mixing chamber. In some embodiments, any fluid displaced by the entering (e.g., liquid) agent from the BFS vial may move into the BFS vial. According to some embodiments, the first medical agent from the BFS vial may interact and / or engage with the agent stored in the mixing module, thereby forming and / or defining a combined agent. In the case that the agent stored in the mixing module comprises a freeze dried or lyophilized agent and the agent from the BFS vial comprises a liquid diluent, for example, the lyophilized agent may be reconstituted by engagement with the liquid diluent. In some embodiments, any two agents may interact due to the coupling of the mixing module and the BFS module (and / or the connector thereof) and may accordingly define and / or form a combined and / or resultant agent (e.g., a solution, combination, resultant of a chemical reaction, etc.). According to some embodiments, once the first medical agent is introduced into the mixing chamber with the second medical agent, the system may be shaken, vibrated, stirred, and / or otherwise agitated to facilitate and / or cause a mixing, reaction, reconstitution, and / or other interaction between the medical agents. The mixing may comprise a single action or event over a first period of time (e.g., seconds or minutes) or may comprise multiple actions and / or events repeated and / or conducted over multiple periods of time (e.g., five seconds of mixing every five minutes for fifteen minutes).

[0063] According to some embodiments, the method 100 may comprise removing a transport cap from the mixing module, at 11 12. While second end of the mixing module may be engaged with the BFS module, for example, a first end thereof may be protected and / or shielded by a seal, cap, and / or cover. In some embodiments, the cover may be disposed to block or seal an outlet port (and / or second coupling) of the mixing module, such that containments are prevented from entering the mixing module from the first end. The outlet port may, for example, connect with a fluid passage into the mixing chamber of the mixing module, thereby providing fluid communication all the way from the BFS vial to the outlet port of the mixing module.

[0064] In some embodiments, the method 1100 may comprise installing an administration module onto the mixing module, at 11 14. An administration module may comprise, for example, a pre-packaged, sterile unit comprising a needle hub, needle, and protective cap. In some embodiments, the administration module may comprise an administration member such as a nozzle, spout, dropper, and / or needle that defines an administration channel to provide a flow (or mist, droplet, spray, etc.) of the combined agent to a target such as a patient. According to some embodiments, the installation may comprise (or begin by) removing a seal from the administration module. A mating and / or coupling portion of the administration assembly may be protected by the seal, for example, to prevent contamination of a second end thereof. According to some embodiments, once the seal is removed from the administration module, the coupling portion may be engaged with the second coupling of the mixing module to couple the administration module to the mixing module. The exposed second end of the administration module may, for example, comprise threads and / or other mating features that correspond to threads and / or mating features disposed on the first end of the second coupling of the mixing module.

[0065] According to some embodiments, the method 1100 may comprise removing the safety cap, at 1 116. The safety cap covering the needle (and / or other administration member) may be removed, disengaged, pivoted, rotated, and / or otherwise manipulated to expose the distal or administration end of the administration member, for example. In some embodiments, the method 1 100 may comprise engaging the administration member with a target, at 1 118. In the case that the administration member comprises a needle, for example, the needle (e.g., the distal and / or engaging end thereof) may be inserted into a target such as a human patient. In the case that the administration member comprises a nozzle or dropper, the administration member may be positioned proximate to the application target (e.g., in a nasal passage, ear, or near any eye). According to some embodiments, the method 1100 may comprise ejecting the combined agent, at 1120. The BFS module may be forced deeper into the mixing module by application of an axial force, for example, compressing the mixing chamber and expelling the combined agent e.g., a single dose thereof) to the target. In some embodiments, air in a compressible reservoir of the BFS vial and / or in the mixing chamber may be compressed by an axial compressive action which forces any combined agent through an outlet nozzle of the mixing chamber and into the administration module, which in turn directs the single dose of the combined agent to the target.

[0066] According to some embodiments, the method 1100 may comprise disengaging the administration member from the target, at 1 122. Once the dose of combined agent has been delivered, for example, the administration member may be withdrawn from the target - e.g., uninserted from the target in the case that a needle is employed. In some embodiments, the compressive and / or ejection pressure or force may be maintained from a predetermined period of time (e.g., five (5) or ten (10) seconds) between engaging and disengaging, to ensure that the single dose is properly and fully dispensed / applied. In some embodiments, the amounts of first agent and second agent (e.g., liquids, powders, gels, solids, and / or gases) may be configured to ensure delivery of a threshold single dose amount of combined agent to the target with the expectation that a designed amount of residual agent (and / or dry ingredientand / or fluids) may remain in the administration module and / or mixing chamber after application. In other words, some additional agents and / or constituents may be stored in the administration module and / or BFS module to account for residuals expected to be retained in the administration module and / or BFS module. According to some embodiments, the method 1100 may comprise properly discarding the administration module, the mixing module, and the BFS module (e.g., as a combined single-dose delivery device), at 1124. In some embodiments, the safety cap may be reengaged and / or reattached to cover the used needle (or other administration member) tip, e.g., to prevent contamination and / or unintended needle sticks. In some embodiments, the entire system may be discarded into a proper receptacle such as a biohazard and / or sharps disposal unit.IV. Rules of Interpretation

[0067] Throughout the description herein and unless otherwise specified, the following terms may include and / or encompass the example meanings provided. These terms and illustrative example meanings are provided to clarify the language selected to describe embodiments both in the specification and in the appended claims, and accordingly, are not intended to be generally limiting. While not generally limiting and while not limiting for all described embodiments, in some embodiments, the terms are specifically limited to the example definitions and / or examples provided. Other terms are defined throughout the present description.

[0068] 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 presently disclosed invention(s) are widely applicable to numerous embodiments, as is readily apparent from the disclosure. One of ordinary skill in the art will recognize that the disclosed invention(s) may be practiced with various modifications and alterations, such as structural, logical, software, and electrical modifications. Although particular features of the disclosed invention(s) 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 usage in the one or more particular embodiments or drawings with reference to which they are described, unless expressly specified otherwise.

[0069] The present disclosure is neither a literal description of all embodiments of the invention(s) nor a listing of features of the invention(s) that must be present in all embodiments.

[0070] Neither the Title (set forth at the beginning of the first page of this patent application) nor the Abstract (set forth at the end of this patent application) is to be taken as limiting in any way as the scope of the disclosed inven tion(s).

[0071] The term "product" means any machine, manufacture and / or composition of matter as contemplated by 35 U.S.C. §101 , unless expressly specified otherwise.

[0072] The terms "an embodiment", "embodiment", "embodiments", "the embodiment", "the embodiments", "one or more embodiments", "some embodiments", "one embodiment" and the like mean "one or more (but not all) disclosed embodiments", unless expressly specified otherwise.

[0073] A reference to "another embodiment" in describing an embodiment does not imply that the referenced embodiment is mutually exclusive with another embodiment e.g., an embodiment described before the referenced embodiment), unless expressly specified otherwise.

[0074] The terms "a", "an" and "the" mean "one or more", unless expressly specified otherwise.

[0075] The term "plurality" means "two or more", unless expressly specified otherwise.

[0076] The term "herein" means "in the present application, including anything which may be incorporated by reference", unless expressly specified otherwise.

[0077] The phrase "at least one of", when such phrase modifies a plurality of things (such as an enumerated list of things) means any combination of one or more of those things, unless expressly specified otherwise. For example, the phrase at least one of a widget, a car and a wheel means either (i) a widget, (ii) a car, (iii) a wheel, (iv) a widget and a car, (v) a widget and a wheel, (vi) a car and a wheel, or (vii) a widget, a car and a wheel.

[0078] The phrase "based on" does not mean "based only on", unless expressly specified otherwise. In other words, the phrase "based on" describes both "based only on" and "based at least on".

[0079] Where a limitation of a first claim would cover one of a feature as well as more than one of a feature (e.g., a limitation such as "at least one widget" covers one widget as well as more than one widget), and where in a second claim that depends on the first claim, the second claim uses a definite article "the" to refer to the limitation (e.g., "the widget"), this does not imply that the first claim covers only one of the feature, and this does not imply that the second claim covers only one of the feature (e.g., "the widget" can cover both one widget and more than one widget).

[0080] Each process (whether called a method, algorithm or otherwise) inherently includes one or more steps, and therefore all references to a "step" or "steps" of a process have an inherent antecedent basis in the mere recitation of the term 'process' or a like term. Accordingly, any reference in a claim to a 'step' or 'steps' of a process has sufficient antecedent basis.

[0081] When an ordinal number (such as "first", "second", "third" and so on) is used as an adjective before a term, that ordinal number is used (unless expressly specified otherwise) merely to indicate a particular feature, such as to distinguish that particular feature from another feature that is described by the same term or by a similar term. For example, a "first widget" may be so named merely to distinguish it from, e.g., a "second widget". Thus, the mere usage of the ordinal numbers "first" and "second" before the term "widget" does not indicate any other relationship between the two widgets, and likewise does not indicate any other characteristics of either or both widgets. For example, the mere usage of the ordinal numbers "first" and "second" before the term "widget" (1 ) does not indicate that either widget comes before or after any other in order or location; (2) does not indicate that either widget occurs or acts before or after any other in time; and (3) does not indicate that either widget ranks above or below any other, as in importance or quality. In addition, the mere usage of ordinal numbers does not define a numerical limit to the features identified with the ordinal numbers. For example, the mere usage of the ordinal numbers "first" and"second" before the term “widget" does not indicate that there must be no more than two widgets.

[0082] When a single device or article is described herein, more than one device or article (whether or not they cooperate) may alternatively be used in place of the single device or article that is described. Accordingly, the functionality that is described as being possessed by a device may alternatively be possessed by more than one device or article (whether or not they cooperate).

[0083] Similarly, where more than one device or article is described herein (whether or not they cooperate), a single device or article may alternatively be used in place of the more than one device or article that is described. For example, a plurality of computer-based devices may be substituted with a single computer-based device. Accordingly, the various functionality that is described as being possessed by more than one device or article may alternatively be possessed by a single device or article.

[0084] The functionality and / or the features of a single device that is described may be alternatively embodied by one or more other devices which are described but are not explicitly described as having such functionality and / or features. Thus, other embodiments need not include the described device itself, but rather can include the one or more other devices which would, in those other embodiments, have such functionality / features.

[0085] Devices that are in communication with each other need not be in continuous communication with each other, unless expressly specified otherwise. On the contrary, such devices need only transmit to each other as necessary or desirable, and may actually refrain from exchanging data most of the time. For example, a machine in communication with another machine via the Internet may not transmit data to the other machine for weeks at a time. In addition, devices that are in communication with each other may communicate directly or indirectly through one or more intermediaries.

[0086] A description of an embodiment with several components or features does not imply that all or even any of such components and / or features are required. On the contrary, a variety of optional components are described to illustrate the wide variety of possible embodiments of the present inven tion(s). Unless otherwise specified explicitly, no component and / or feature is essential or required.

[0087] Further, although process steps, algorithms or the like may be described in a sequential order, such processes may be configured to work in different orders. In other words, any sequence or order of steps that may be explicitly described does not necessarily indicate a requirement that the steps be performed in that order. The steps of processes described herein may be performed in any order practical. Further, some steps may be performed simultaneously despite being described or implied as occurring non-simultaneously (e.g., because one step is described after the other step). Moreover, the illustration of a process by its depiction in a drawing does not imply that the illustrated process is exclusive of other variations and modifications thereto, does not imply that the illustrated process or any of its steps are necessary to the relevant embodiment, and does not imply that the illustrated process is preferred.

[0088] Although a process may be described as including a plurality of steps, that does not indicate that all oreven any of the steps are essential or required. Various other embodiments within the scope of the described invention(s) include other processes that omit some or all of the described steps. Unless otherwise specified explicitly, no step is essential or required.

[0089] Although a product may be described as including a plurality of components, aspects, qualities, characteristics and / or features, that does not indicate that all of the plurality are essential or required. Various other embodiments within the scope of the described invention(s) include other products that omit some or all of the described plurality.

[0090] An enumerated list of items (which may or may not be numbered) does not imply that any or all of the items are mutually exclusive, unless expressly specified otherwise. Likewise, an enumerated list of items (which may or may not be numbered) does not imply that any or all of the items are comprehensive of any category, unless expressly specified otherwise. For example, the enumerated list "a computer, a laptop, a PDA" does not imply that any or all of the three items of that list are mutually exclusive and does not imply that any or all of the three items of that list are comprehensive of any category.

[0091] Headings of sections provided in this patent application and the title of this patent application are for convenience only, and are not to be taken as limiting the disclosure in any way.

[0092] "Determining" something can be performed in a variety of manners and therefore the term "determining" (and like terms) includes calculating, computing, deriving, looking up (e.g., in a table, database or data structure), ascertaining and the like

[0093] The terms "including", "comprising" and variations thereof mean "including but not limited to", unless expressly specified otherwise. As used herein, "comprising” means “including,” and the singular forms "a” or "an” or “the” include plural references unless the context clearly dictates otherwise. The term “or” refers to a single element of stated alternative elements or a combination of two or more elements, unless the context clearly indicates otherwise

[0094] A description of an embodiment with several components or features does not imply that all or even any of such components and / or features are required. On the contrary, a variety of optional components are described to illustrate the wide variety of possible embodiments of the present inven tion(s). Unless otherwise specified explicitly, no component and / or feature is essential or required.

[0095] Further, although process steps, algorithms or the like may be described in a sequential order, such processes may be configured to work in different orders. In other words, any sequence or order of steps that may be explicitly described does not necessarily indicate a requirement that the steps be performed in that order. The steps of processes described herein may be performed in any order practical. Further, some steps may be performed simultaneously despite being described or implied as occurring non-simultaneously (e.g., because one step is described after the other step). Moreover, the illustration of a process by its depiction in a drawing does not imply that the illustrated process is exclusive of other variations and modifications thereto, does not imply that theillustrated process or any of its steps are necessary to the relevant embodiment, and does not imply that the illustrated process is preferred.

[0096] The present disclosure provides, to one of ordinary skill in the art, an enabling description of several embodiments and / or inventions. Some of these embodiments and / or inventions may not be claimed in the present application, but may nevertheless be claimed in one or more continuing applications that claim the benefit of priority of the present application. Applicants intend to file additional applications to pursue patents for subject matter that has been disclosed and enabled but not claimed in the present application.

[0097] It will be understood that various modifications can be made to the embodiments of the present disclosure herein without departing from the scope thereof. Therefore, the above description should not be construed as limiting the disclosure, but merely as embodiments thereof. Those skilled in the art will envision other modifications within the scope of the invention(s) as defined by the claims appended hereto.

[0098] While several embodiments of the present disclosure have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and / or structures for performing the functions and / or obtaining the results and / or one or more of the advantages described herein, and each of such variations and / or modifications is deemed to be within the scope of the present disclosure. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and / or configurations will depend upon the specific application or applications for which the teachings of the present disclosure is / are used.

[0099] Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the disclosure described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, the disclosure may be practiced otherwise than as specifically described and claimed. The present disclosure is directed to each individual feature, system, article, material, kit, and / or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and / or methods, if such features, systems, articles, materials, kits, and / or methods are not mutually inconsistent, is included within the scope of the present disclosure.

[0100] All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0101] The indefinite articles “a” and "an,” as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean "at least one.” This rule applies even within the body of a claim where a first instance of an element utilizes "a” or "an” and a second or subsequent instance of the element necessarily utilizes (e.g., for purposes of proper grammar and required antecedent basis) the definite article “the” to refer to the element. The use of the definite article “the” does not limit the element to a single object merely because it is utilized to refer back to a previous mention of the element. The original reference to the elementcontrols with respect to the plurality (or lack thereof) of the element.

[0102] The phrase “and / or,” as used herein in the specification and in the claims, should be understood to mean “either or both" of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Other elements may optionally be present other than the elements specifically identified by the “and / or" clause, whether related or unrelated to those elements specifically identified, unless clearly indicated to the contrary.

[0103] Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0104] The disclosure of numerical ranges should be understood as referring to each discrete point within the range, inclusive of endpoints, unless otherwise noted. Unless otherwise indicated, all numbers expressing quantities of components, molecular weights, percentages, temperatures, times, and so forth, as used in the specification or claims are to be understood as being modified by the term “about.” Accordingly, unless otherwise implicitly or explicitly indicated, or unless the context is properly understood by a person of ordinary skill in the art to have a more definitive construction, the numerical parameters set forth are approximations that may depend on the desired properties sought and / or limits of detection under standard test conditions / methods, as known to those of ordinary skill in the art. When directly and explicitly distinguishing embodiments from discussed prior art, the embodiment numbers are not approximates unless the word “about” is recited. Whenever “substantially,” “approximately,” “about,” or similar language is explicitly used in combination with a specific value, variations up to and including ten percent (10%) of that value are intended, unless explicitly stated otherwise.

[0105] Directions and other relative references may be used to facilitate discussion of the drawings and principles herein, but are not intended to be limiting. For example, certain terms may be used such as “inner," “outer,", “upper,” “lower,” “top," “bottom," “interior,” “exterior,” “left,” right,” “front,” “back," “rear,” and the like. Such terms are used, where applicable, to provide some clarity of description when dealing with relative relationships, particularly with respect to the illustrated embodiments. Such terms are not, however, intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, an “upper” part can become a “lower” part simply by turning the object over. Nevertheless, it is still the same part and the object remains the same.

[0106] The terms and expressions which have been employed herein are used as terms of description and not of limitation, and there is no intention, in the use of such terms and expressions, of excluding any equivalents of the features shown and described (or portions thereof), and it is recognized that various modifications are possible within the scope of the claims. Accordingly, the claims are intended to cover all such equivalents.

[0107] Various modifications of the invention(s) and many further embodiments thereof, in addition to those shownand described herein, will become apparent to those skilled in the art from the full contents of this document, including references to the scientific and patent literature cited herein. The subject matter herein contains important information, exemplification and guidance that can be adapted to the practice of the invention(s) in the various embodiments and equivalents thereof.

Claims

What is claimed is:1 . A pre-filled, single-dose, modular multi-stage medical agent delivery system, comprising:(a) a first module, comprising:(1) a housing defining an interior volume and the housing defining a first housing end and a second housing end, the first housing end comprising an outlet projection in fluid communication with the interior volume, the second housing end being open to the interior volume, and an interior projection extending within the interior volume from proximate to the first housing end toward the second housing end, the interior projection comprising an interior threaded portion and a twist valve socket;(2) a blow-fill-seal (BFS) vial defining a first BFS end and a second BFS end, the BFS vial defining a neck portion adjacent to the first BFS end, the neck portion comprising one or more exterior angled flanges, a twist valve disposed at a first BFS end and forming a seal at the end of the neck portion, a fluid reservoir containing a first medical agent, a bellows portion disposed adjacent to the second BFS end, and side flanges extending radially outward from opposing sides of the BFS vial;(3) a piston defining a piston bore and a first piston end and a second piston end, the first piston end being open to the piston bore and the second piston end comprising a grip surface; and(4) wherein the BFS vial is inserted into the interior volume of the housing such that the one or more angled exterior flanges engage with the interior threaded portion of the interior projection, the twist valve is disposed within the twist valve socket, and the first piston end is inserted into the interior volume of the housing such that the second BFS end is disposed within the piston bore;(b) a second module, comprising:(5) a mixing body defining a mixing chamber and a first mixing body end and a second mixing body end, the first mixing body end comprising an outlet coupling and an outlet port, and the second mixing body end being open to the mixing chamber but covered by a temporary seal;(6) a plug disposed within the mixing chamber, the plug defining a slit therethrough;(7) a second medical agent disposed within the mixing chamber;(c) a third module, comprising:(8) a needle;(9) a needle hub comprising a hub flange that is operable to be cooperatively mated with the outlet coupling of the mixing body, the needle hub retaining the needle; and(10) a cap covering an administration end of the needle; and(d) wherein the first module is operable to be coupled to the second module by removal of the temporary seal and insertion of the first housing end into the mixing chamber to a first extent such that the outlet projection pushes through the slit of the plug, the twist valve is operable to expose the first medical agent by being twisted off of the BFS vial via application of a rotational force to the piston, the first medical agent is operable to be expelled into the mixing chamber by application of an axial force to the piston that compresses the bellows of the BFS vial, the needle hub is operable to be attached to the outlet coupling of the mixing body, and a combined medical agent is operable to be expelled through the needle by application of an axial force forcing the first module into the mixing chamber to a second extent that is greater than the first extent.

2. The pre-filled, single-dose, modular multi-stage medical agent delivery system of claim 1, wherein the second medical agent comprises a substrate comprising an active ingredient.

3. The pre-filled, single-dose, modular multi-stage medical agent delivery system of claim 2, wherein the active ingredient comprises a lyophilized medical agent deposited on the substrate.

4. The pre-filled, single-dose, modular multi-stage medical agent delivery system of claim 2, wherein the first medical agent comprises a first fluid.

6. The pre-filled, single-dose, modular multi-stage medical agent delivery system of claim 4, wherein the first fluid comprises air.

7. The pre-filled, single-dose, modular multi-stage medical agent delivery system of claim 4, wherein the first medical agent comprises a second fluid.

8. The pre-filled, single-dose, modular multi-stage medical agent delivery system of claim 7, wherein the second fluid comprises a diluent.

9. The pre-filled, single-dose, modular multi-stage medical agent delivery system of claim 7, wherein an introduction of at least one of the first fluid and the second fluid with the substrate produces the combined medical agent.

10. A method for deploying a pre-filled, single-dose, modular multi-stage medical agent delivery system, comprising:coupling a BFS module to a mixing module, (a) wherein the BFS module comprises (i) a housing within which a BFS vial is disposed, the BFS vial containing a first medical agent, a twist valve, and a bellows, (ii) a piston encasing the BFS vial within the housing, and (iii) an outlet projection emanating axially from a first end of the housing, (b) wherein the mixing module comprises (iv) an interior mixing chamber, (v) an outlet port at a first end of the mixing module, (vi) a plug element disposed at a second end within the mixing chamber, and (vii) a second medical agent disposed within the mixing chamber, and (c) wherein the coupling causes the outlet projection to extend into the mixing chamber by causing the first end of the housing to enter the mixing chamber by a first amount; activating the twist valve of the BFS vial by imparting a rotational force to the piston with respect to the housing; introducing the first medical agent into the mixing chamber by imparting an axial force on the piston, causing an axial compression of the bellows of the BFS vial, wherein the introducing creates a combined medical agent; coupling an administration module to the outlet port of the mixing module; and administering the combined medical agent into a target by applying an axial force that causes the first end of the housing to advance within the mixing chamber by a second amount, forcing the combined medical agent through the administration module11 . The method of claim 10, further comprising: removing, prior to the coupling of the administration module to the outlet port of the mixing module, a transport cap from the outlet port of the mixing module.

12. The method of claim 10, further comprising: removing, prior to the coupling of the BFS module to the mixing module, a transport cap from the first end of the BFS module and a seal from the second end of the mixing module.

13. The method of claim 10, wherein the activating of the twist valve of the BFS vial by imparting the rotational force to the piston with respect to the housing comprises rotationally engaging one or more key slots of the piston with one or more exterior side flanges of the BFS vial.

14. The method of claim 10, wherein the administering of the combined medical agent into the target comprises injecting the combined medical agent into the target.

15. The method of claim 10, further comprising:mixing, after the introducing, the first and second medical agents to create the combined medical agent by agitating the mixing chamber.

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