JP7489925B2 - Systems and methods for dual component drug delivery - Patents.com - Google Patents

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to (i) the nonprovisional U.S. Provisional Patent Application No. 62/687,340, filed June 20, 2018, and entitled "DUAL CHAMBER BFS DRUG DELIVERY SYSTEM," and (ii) a continuation-in-part (CiP) application of U.S. Provisional Patent Application No. 16/169,983, filed October 24, 2018, and entitled "SYSTEM AND METHODS FOR FLUID DELIVERY," both of which are incorporated by reference in their entireties herein.

FIELD OF THEINVENTION Embodiments of the present invention relate generally to delivery devices for delivering substances such as drugs, and more particularly to a delivery system including a modular delivery assembly configured to enable delivery of a single dose of a therapeutic agent to a patient from a blow-fill-seal (BFS) vial.

Every year, millions of people become infected and die from various diseases, some of which are vaccine-preventable. Although vaccination has dramatically reduced the number of cases of some infectious diseases, some of these diseases are still quite common. Often, large populations of the world, especially developing countries, suffer from the spread of vaccine-preventable diseases due to ineffective immunization programs, either because of poor implementation, lack of available vaccines, or inadequate devices to administer the vaccine, or a combination of these.

Some implementations of immunization programs commonly involve the administration of vaccines with a typical reusable syringe. However, in many situations, especially in developing countries, the administration of vaccines occurs outside of a hospital and may be provided by non-professionals such that injections are administered to patients without careful control of access to the syringe. The use of reusable syringes in such situations increases the risk of infection and spread of blood-borne diseases, especially when subsequent injections are administered with a previously used syringe that is no longer sterile. For example, the World Health Organization (WHO) estimates that blood-borne diseases such as hepatitis and human immunodeficiency virus (HIV) are transmitted by the reuse of such syringes, resulting in the deaths of over a million people each year.

Embodiments of the present invention provide a delivery system that overcomes the shortcomings of current delivery devices and methods. In particular, the delivery system according to some embodiments includes a modular delivery assembly for delivering substances such as medicines, vaccines and/or therapeutics, restoratives, prophylactics and/or therapeutics (collectively "medications" or "medications" herein), and more specifically includes a modular two-component injectable delivery system. The two-component injectable delivery system can be configured, for example, to allow delivery/injection to a patient of a single dose of a drug that is initially stored and transported in the form of two substances: (i) an active substance that is initially stored and transported in a first component of the delivery system (referred to herein as the delivery assembly or hub component) in a dehydrated, lyophilized, cryo-dried, dried or powdered form, and (ii) an inactive substance (e.g., a diluent such as saline) that is initially stored and transported in a second component of the delivery system (e.g., a plastic molded-fill-synthetic (BFS) vial). The active agent may be finally reconstituted into a liquid or fluid form immediately prior to injection into the patient by mixing or combining with a second inactive agent (e.g., when a hub component is attached or connected to the BFS vial and the two agents are mixed).

In some embodiments, the modular delivery assembly may be configured to be coupled to a source containing the fluid agent, including, but not limited to, a BFS vial. The delivery assembly may include a modular design consisting of separately constructed modular components cooperatively arranged and coupled to one another. The components of the delivery assembly may include, for example, a hub member configured to be securely coupled to a BFS vial, a one-way valve member positioned within the hub member and configured to restrict fluid flow in an antegrade direction, and an insert positioned within the hub member and configured to receive and hold an administration member for receiving the fluid agent from the BFS vial and administering the fluid agent to a patient. The administration member may include, for example, a needle (for subcutaneous, intramuscular, intradermal, or intravenous injection of the fluid agent) or a nozzle (e.g., a spray nozzle to facilitate dispersion of the fluid agent into a spray or a droplet nozzle for formation of droplets).

In some embodiments, the hub member may include a proximal end defining an inlet port, a distal end defining an outlet port, and a channel extending completely from the proximal end to the distal end, thereby providing a fluid pathway between the inlet port and the outlet port. The inlet port may include a special non-standard (non-luer type) connection fitting configured to mate with a corresponding special non-standard connection fitting on the BFS vial. For example, the inlet port may include a recess, indentation, or complete opening of a particular shape or geometry that is shaped and/or sized to receive a correspondingly shaped and/or sized protrusion, projection, or the like on the BFS vial. In some embodiments, the inlet port may include two opposing openings on either side of the hub member. The BFS vial may generally include a flexible body having an internal volume sufficient to contain at least a single dose of the fluid agent therein. The BFS vial may generally include a neck extending from the body and terminating at a distal end defining an outlet for dispensing the fluid agent upon squeezing of the vial body. In some embodiments, the vial may include two protrusions defined on either side of the neck adjacent the distal end and having a shape that generally corresponds to the opening on the hub member. When a user inserts the distal end of the vial into the inlet port of the hub member, for example, the protrusions may be shaped to slidingly engage the corresponding openings, but may further be shaped to prevent withdrawal of the BFS vial from the hub member. This allows them to effectively lock themselves within the opening and effectively engage the BFS vial with the delivery assembly. By securing the vial to the hub member, a user can simply apply force (i.e., squeeze) to the vial body to cause the fluid agent to flow from the vial through the delivery assembly to the patient.

The special non-standard connection fitting between the hub member and the BFS vial in some embodiments may allow only approved sources (e.g., single-dose BFS vials) having a corresponding agent to be used with the modular delivery assembly described herein, thereby providing an increased level of security. For example, the delivery method is generally dependent on the type of fluid agent being delivered. For example, some drugs are best delivered intravenously, while some vaccines are best delivered intradermally, and some fluid agents are administered via drops or sprays. Thus, the delivery assembly may be configured for delivery of a specific fluid agent, i.e., the connection fitting on the hub member may be designed to only receive and engage the corresponding connection fitting of the BFS vial containing that specific fluid agent. Thus, the special connection fitting design described herein may ensure that only a matching BFS vial (containing the correct fluid agent for that specific delivery assembly) can be connected to the modular delivery assembly, thereby providing safety and reducing risk.

According to some embodiments, the delivery assembly may include a one-way valve and/or an insert in the hub member. The one-way valve may be positioned, for example, in a channel of the hub member and/or may be configured to restrict fluid flow in an antegrade direction from the inlet port toward the outlet port, thereby ensuring that fluid flows in a single direction when the vial body is squeezed for delivery. The insert may be disposed in the channel adjacent the outlet of the hub member in some embodiments. The insert may include a proximal end, an opposing distal end, and a channel extending entirely through the insert from the proximal end to the distal end. The channel of the insert may be coaxially aligned with the channel of the hub member such that a fluid path extends entirely from the inlet port of the hub member, through the one-way valve, through the channel of the insert, and toward the distal end of the insert. An administration member (e.g., needle, nozzle, etc.) may be received and held in the channel of the insert such that when the fluid agent is delivered from the BFS vial through the fluid path of the delivery assembly, the fluid agent flows out of the administration member, thereby enabling delivery of the fluid agent to the patient.

In some embodiments, the delivery assembly may include a safety cover to cover the dosing member to prevent contamination and further reduce the risk of needlestick injuries and therefore the potential for the spread of blood-borne infections. The delivery assembly may generally be packaged and delivered fully assembled, including a safety cover provided over the needle or nozzle. Thus, the user does not need to handle an exposed needle or nozzle when initially attaching the BFS vial to the delivery assembly. Rather, the user need only remove the safety cover once the BFS vial is securely attached to the delivery assembly, thereby exposing the needle or nozzle for fluid agent delivery. The user may then replace the cover once delivery is complete.

The modular construction of the delivery assembly allows for rapid manufacturing reconfiguration of one or more components at minimal cost to create new delivery assembly configurations that meet specific needs (i.e., different delivery modes depending on the agent being delivered, such as subcutaneous, intramuscular, intradermal, intravenous injection, spray, or drop delivery). For example, the hub member and one-way valve may remain the same construction (dimensions and materials), while the insert may be modified to allow for different needle sizes and/or nozzle types depending on the type of delivery and/or type of fluid agent being delivered.

The delivery assembly itself may not be pre-filled. As such, the delivery assembly does not need to be maintained at a particular temperature (e.g., 2-8 degrees Celsius (2°C-8°C)) during shipping or storage, thus reducing overall costs. Rather than maintaining the delivery assembly at a constant temperature, as is the case with current devices, only the supply containing the fluid agent (e.g., the single-dose supply provided in the BFS vial) needs to be maintained at a constant temperature. Thus, multiple empty delivery assemblies may be shipped and stored at low cost and then filled as needed directly on-site, such that only the single-dose BFS vials need to be stored and maintained. Furthermore, if the delivery device is not pre-filled, the delivery device may be sterilized at any point before being filled with the fluid agent, which further improves bulk shipping and storage of such devices. In some embodiments, the delivery assembly may include a substrate infused with or otherwise carrying a solid form of the active ingredient, which may also or alternatively require less stringent storage or transportation requirements.

According to some embodiments, the delivery assembly may be configured to enable delivery of a medication to a patient in a relatively simple manner without requiring special training to administer the medication. In particular, the delivery assembly may be designed to require only that a person administering the fluid agent (e.g., an administrator) (which may also include self-administration) position the device over the administration site (e.g., shoulder, arm, chest, nose, ear, eye, etc.) and then fully compress the BFS vial body containing the dose of the fluid agent, thereby delivering a precise, predetermined dose to the patient. The delivery assembly may also, or alternatively, be configured such that, if a needle is required (i.e., because the delivery method is an injection), needle penetration is limited to the correct length and orientation within the administration site. For example, in some embodiments, the needle may be positioned approximately perpendicular to the plane in which the distal end of the insert is located, such that the needle is configured to be inserted into the patient's skin at a substantially perpendicular angle and the distal end of the insert is configured to contact the patient's skin to indicate an appropriate penetration depth for injection of the fluid agent. Thus, embodiments of the modular delivery assembly described herein may not require a trained, skilled medical professional for administration of a vaccine or drug. Thus, the delivery assembly may be particularly useful in situations where a vaccine or drug is administered in a non-medical related facility (e.g., outside a clinic or hospital) and given by non-professionals to large numbers of individuals over a short period of time.

The drawings depict embodiments for purposes of illustration only. Those skilled in the art will readily recognize from the following description that alternative embodiments of the systems and methods shown herein may be used without departing from the principles described herein.

FIG. 1 is a perspective view of a BFS vial package according to some embodiments. FIG. 1 is a partial enlarged perspective view of a BFS vial package according to some embodiments. FIG. 1 illustrates a right side view of a fluid delivery system according to some embodiments. FIG. 1 illustrates a right side view of a fluid delivery system according to some embodiments. FIG. 1 illustrates a partial right side view of a fluid delivery system according to some embodiments. FIG. 1 illustrates a partial right side view of a fluid delivery system according to some embodiments. FIG. 13 is an exploded right side view of a hub assembly of a fluid delivery system according to some embodiments. 1 is a right perspective partial cross-sectional view of a portion of a fluid delivery system according to some embodiments. FIG. 13 is a right perspective assembly cross-sectional view of a hub assembly of a fluid delivery system according to some embodiments. FIG. 13 illustrates a right perspective cross-sectional view of a hub assembly of a fluid delivery system according to some embodiments. FIG. 13 is a right rear perspective cross-sectional view of a hub assembly of a fluid delivery system according to some embodiments. 1 is a right perspective partial cross-sectional view of a portion of a fluid delivery system according to some embodiments. 1 illustrates a right-side partial cross-sectional view of a portion of a fluid delivery system according to some embodiments. 1 is a right front perspective partial cross-sectional view of a portion of a fluid delivery system according to some embodiments. 1 illustrates a right-side partial cross-sectional view of a portion of a fluid delivery system according to some embodiments. 1A-1D are top and side views of various substrates for use in fluid delivery systems according to some embodiments. FIG. 1 illustrates a right front perspective view of a modular hub according to some embodiments. FIG. 1 illustrates a top view of a modular hub according to some embodiments. FIG. 13 illustrates a bottom view of a modular hub according to some embodiments. FIG. 1 illustrates a left side view of a modular hub according to some embodiments. FIG. 13 illustrates a right side view of a modular hub according to some embodiments. FIG. 1 illustrates a front view of a modular hub according to some embodiments. FIG. 13 illustrates a rear view of a modular hub according to some embodiments. 1 illustrates a front cross-sectional view of a modular hub according to some embodiments. FIG. 1 illustrates a right-front perspective view of a modular valve according to some embodiments. FIG. 1 illustrates a top view of a modular valve according to some embodiments. FIG. 13 illustrates a bottom view of a modular valve according to some embodiments. FIG. 1 illustrates a left side view of a modular valve according to some embodiments. FIG. 1 illustrates a right side view of a modular valve according to some embodiments. FIG. 1 illustrates a front view of a modular valve according to some embodiments. FIG. 13 is a rear view of a modular valve according to some embodiments. FIG. 1 illustrates a front cross-sectional view of a modular valve according to some embodiments. FIG. 13 illustrates a right front perspective view of a modular insert according to some embodiments. FIG. 1 illustrates a top view of a modular insert according to some embodiments. FIG. 13 illustrates a bottom view of a modular insert according to some embodiments. FIG. 13 illustrates a left side view of a modular insert according to some embodiments. FIG. 13 illustrates a right side view of a modular insert according to some embodiments. FIG. 1 illustrates a front view of a modular insert according to some embodiments. FIG. 13 is a rear view of a modular insert according to some embodiments. 1 illustrates a front cross-sectional view of a modular insert according to some embodiments. FIG. 13 illustrates a right front perspective view of a modular BFS vial according to some embodiments. FIG. 1 illustrates a top view of a modular BFS vial according to some embodiments. FIG. 13 is a bottom view of a modular BFS vial according to some embodiments. FIG. 13 is a left side view of a modular BFS vial according to some embodiments. FIG. 13 is a right side view of a modular BFS vial according to some embodiments. FIG. 1 is a front view of a modular BFS vial according to some embodiments. FIG. 1 is a diagram of a modular BFS vial according to some embodiments. FIG. 13 is a right front perspective view of a modular BFS vial according to some embodiments. FIG. 1 illustrates a top view of a modular BFS vial according to some embodiments. FIG. 13 is a bottom view of a modular BFS vial according to some embodiments. FIG. 13 is a left side view of a modular BFS vial according to some embodiments. FIG. 13 is a right side view of a modular BFS vial according to some embodiments. FIG. 1 is a front view of a modular BFS vial according to some embodiments. FIG. 1 is a diagram of a modular BFS vial according to some embodiments. FIG. 1 is a perspective flow diagram of a method according to some embodiments. FIG. 1 is a flow diagram according to some embodiments. FIG. 13 is a perspective view of a variation of the hub assembly according to some embodiments.

I. Introduction Embodiments of the present invention provide a modular drug delivery system that overcomes the shortcomings of current delivery devices and methods. For example, the delivery system of some embodiments includes a modular drug delivery assembly configured to be coupled to a source containing a fluid agent (e.g., a vaccine, a drug, a medicine, a diluent, etc.), further facilitating the delivery of a single dose of the fluid agent from the source to a patient. The delivery assembly can be configured to be filled with a single dose of the fluid agent on-site while remaining sterile and preventing the possibility of contamination during the filling process. The delivery assembly can also, or alternatively, deliver the fluid agent in a controlled manner and without requiring specialized skills in administering the delivery of such a fluid agent.

According to some embodiments, the modular drug delivery system can be configured to allow for the delivery/injection to a patient of a single dose of a drug that is initially stored and transported in the form of two substances: (i) an active substance that is initially stored and transported in a first component of the delivery system (referred to herein as a delivery assembly or hub component) in a dehydrated, lyophilized, cryogenically dried, desiccated, or powdered form, and (ii) an inactive substance (e.g., a diluent such as saline solution) that is initially stored and transported in a second component of the delivery system (e.g., a BFS vial). The active substance can be eventually reconstituted to a liquid or fluid form immediately prior to injection into the patient by being mixed or combined with the second inactive substance (e.g., when the hub component is attached or connected to the BFS vial and the two substances are mixed).

As described herein, the modular drug delivery system can include a BFS vial, container, or reservoir. BFS technology is a manufacturing technique used to produce small (e.g., 0.1 mL) and large (e.g., 500 mL+) volume liquid-filled containers. During the BFS manufacturing process, containers are formed, filled, and sealed in a continuous process without human intervention in a sterile, enclosed area inside the machine. In particular, the BFS manufacturing process is a multi-step process in which pharmaceutical grade plastic resin is hot extruded vertically through a circular opening to form a hanging tube called a parison. This extruded tube is then enclosed within a two-part mold. A mold is placed in the filling area or sterile filling space, and a filling needle (mandrel) is placed within the parison and used to fill the plastic container within the mold formed by vacuum against the mold wall. After the container is partially formed, the mandrel is used to fill the container with liquid. After filling, the parison is dropped with the mold of the BFS machine, and the second top mold seals the container. All operations take place inside the machine in a sterile shrouded chamber. The product is then ejected into a non-sterile area for labeling, packaging and distribution.

A delivery assembly according to some embodiments can be configured to be coupled to a source containing a fluid agent, including, but not limited to, a BFS vial. The delivery assembly can generally include a modular design consisting of separately constructed components cooperatively arranged and coupled to one another. The components of the delivery assembly can include, for example, a hub member configured to be securely coupled to a BFS vial, a one-way valve member positioned within the hub member and configured to restrict fluid flow in an antegrade direction, and/or an insert positioned within the hub member and configured to receive and hold an administration member for receiving the fluid agent from the BFS vial and administering the fluid agent to a patient. The administration member can include, for example, a needle (for subcutaneous, intramuscular, intradermal, or intravenous injection of the fluid agent) or a nozzle (e.g., a spray nozzle for facilitating dispersion of the fluid agent into a spray or a droplet nozzle for forming droplets). In some embodiments, the hub member can include a substrate into which the active ingredient in solid form is injected or which otherwise contains or carries the active ingredient in solid form, the substrate being operable to be reconstituted when the hub member is coupled to a BFS vial containing a diluent.

The modular construction of the delivery assembly may allow for rapid manufacturing reconfiguration of one or more components at minimal cost to create new delivery assembly configurations that meet specific needs (i.e., different modes of delivery depending on the agent being delivered, such as subcutaneous, intramuscular, intradermal, intravenous injection, spray, or drop delivery). For example, the hub member and one-way valve may remain of the same construction (dimensions and materials), while the insert may be modified to allow for different needle sizes and/or nozzle types depending on the type of delivery and/or type of fluid agent being delivered.

The delivery assembly can be generally configured to enable delivery of a medication to a patient in a relatively simple manner without requiring special training to administer the medication. In particular, the delivery assembly is designed to enable a person (e.g., an administrator) administering the fluid medication (which can also include self-administration) to only need to position the device over the administration site (e.g., shoulder, arm, chest, nose, ear, eye, etc.) and then fully compress the BFS vial body containing the dose of the fluid medication, thereby delivering a precise, predetermined dose to the patient.

The delivery assembly itself may not be pre-filled or may contain a solid form of the active ingredient of the drug. Thus, the delivery assembly according to some embodiments does not need to be maintained at a specific temperature (e.g., 2-8 degrees Celsius (2°C-8°C)) during transportation or storage, thus reducing overall costs. Rather than maintaining the delivery assembly at a constant temperature, as is the case with current devices, only the supply containing the fluid agent (e.g., the single-dose supply provided in the BFS vial) needs to be maintained at a constant temperature, for example. Thus, multiple empty delivery assemblies can be shipped and stored at reduced cost and then filled as needed directly on-site, so that only the single-dose BFS vials need to be stored and maintained. Furthermore, if the delivery device is not pre-filled, the delivery device can be sterilized at any point before being filled with the fluid agent, which further improves bulk transportation and storage of such devices.

II. Drug Delivery System Referring initially to Figures 1A and 1B, a perspective view of a BFS vial package 102 and a partial enlarged perspective view of a BFS vial pack or package 102 are shown, according to some embodiments. The BFS vial package 102 can include, for example, a plastic and/or other molded, extruded, and/or formed manifold 104. In some embodiments, the manifold 104 can include a plurality of attachment points 106 to which a plurality of BFS units, containers, and/or vials 110a-e can be connected, for example, by a break-away detachment design. Figure 1B shows a close-up perspective view of the break-away detachment design of a first BFS vial 110a. As shown, each BFS vial 110a-e can contain a single dose of a fluid agent (e.g., a drug or an inert diluent), and when a user is ready, a single vial, such as the first BFS vial 110a, can be removed from the manifold 104 via a pull-away type connection disposed between a first outlet of the first BFS vial 110a or a proximal end 110a-1 of the first BFS vial 110a (the proximal end 110a-1 is proximal to the manifold 104 and the second or distal end 110a-2 is distal therefrom) and a respective attachment point 106. According to some embodiments as shown, for example, the proximal end 110a-1 of the first BFS vial 110a (which can include and/or define an outlet not separately labeled in FIGS. 1A and 1B) can be coupled to the manifold 104 at the attachment point 106. In some embodiments, by simply pulling the desired first BFS vial 110a away from the attachment point 106, the user can separate the first BFS vial 110a from the remaining BFS vials 110b-e and use only the single dose that is needed and/or desired rather than using a larger source of fluid agent (a multi-dose syringe or vial, not shown), thereby completely avoiding the risk of contaminating the single source of fluid agent (e.g., drug or inert diluent) located within the first BFS vial 110a.

According to some embodiments, each BFS vial 110a-e can include and/or define various features, such as features molded, formed, cut, glued, and/or otherwise coupled thereto. As shown in FIGS. 1A and 1B, for example, the first BFS vial 110a can include a neck 112a (e.g., near the proximal end 110a-1) on which various mating features are formed (or otherwise coupled). In some embodiments, the neck 112a can include a first outer radial flange 114a, a second outer radial flange 116a, and/or a mating tab 118a. According to some embodiments, the mating tab 118a can include a wedge-shaped radial protrusion (e.g., having an increasing slope from near the proximal end 110a-1 toward the distal end 110a-2) disposed on, with, or as part of the second outer radial flange 116a. In some embodiments, the first BFS vial 110a can include a fluid reservoir 120a in communication with the neck 112a. According to some embodiments, the fluid reservoir 120a can store, contain, and/or receive a single dose of fluid (e.g., a drug or an inert diluent) and/or can be coupled to a grip plate 122a. The grip plate 122a can include, for example, a flat element that allows for the application of an axial force to the first BFS vial 110a without applying such a force to the fluid reservoir 120a.

In some embodiments, the package 102 can include indicia (not shown) imprinted on the manifold 104 itself and/or on each individual BFS vial 110a-e (e.g., on the grip plate 122a of the first BFS vial 110a). Exemplary indicia can include, but are not limited to, lot numbers, expiration dates, drug information, security stamps (color change temperature sensors to provide an indication of whether the BFS vials 110a-e have been maintained at the required temperature), and dosing lines provided on each BFS vial 110a-e. Although five BFS vials 110a-e are shown in FIG. 1A as being coupled to the manifold 104, fewer or more BFS vials 110a-e can be coupled to the manifold 104 as desired and/or practical, or as desired and/or practical.

According to some embodiments, one or more of the BFS vial package 102 and/or BFS vials 110a-e (and/or hub devices described herein) can comprise and/or be coupled to one or more electronic devices (not shown explicitly). The electronic devices can comprise, for example, one or more passive inductive devices, radio frequency identification (RFID) devices, near-field communication (NFC) devices, processing devices, power storage devices, and/or memory storage devices. In some embodiments, the electronic devices can store, process, receive, and/or transmit various data elements, such as to track the geographic movement of the BFS vial package 102 and/or to verify or confirm that a particular BFS vial 110a-e should be utilized for administration to a particular recipient.

In some embodiments, for example, when a user (whether a healthcare professional, a patient self-injecting, or a friend or family member injecting a patient) wishes to inject a medication utilizing a first BFS vial 110a that includes a first electronic device, such as an NFC chip, the user may first open an appropriate app on the user's mobile device (not shown) and tap (or bring into close proximity) the first BFS vial 110a and/or the first electronic device to the mobile device to initiate communication between them. This allows the app to, in some embodiments, verify the injection by verifying and/or authenticating one or more of: (i) that the fluid or medication is the correct fluid or medication that the patient is supposed to be receiving (e.g., based on a comparison of fluid data stored by the first electronic device with patient information stored, e.g., in a separate memory device of the user's mobile device); (ii) that the injection is administered within the appropriate time frame (e.g., by comparing the current time and/or date with the time and/or date stored and/or referenced by the data of the first electronic device); and (iii) that the first BFS vial 110a and/or the fluid therein is intact and/or not expired. According to some embodiments, any of the foregoing can be verified based on a patient record stored in the app on the mobile device and/or accessible to the app via the internet or a cloud-based system, and/or data stored in the first electronic device. In some embodiments, if the necessary (or desired) verification is successful, the user may be allowed to perform the injection (e.g., an approval indicator may be output to the user via a screen of the app). The user may be motivated to inject only when approval is received via the app, since the user may receive a reward via the app only if they perform an approved injection. In some embodiments, the user may also be required to upload a photo of the first BFS vial 110a and/or injection site (not shown) after injection (e.g., to confirm eligibility for a reward and/or to qualify for additional rewards). According to some embodiments, a reward may be provided to the user via the user's mobile device, for example, in response to receiving data describing administration of fluid and/or use of the first BFS vial 110a.

According to some embodiments, because BFS manufacturing tolerances are not as precise as injection molding and other manufacturing techniques, the configuration of BFS vials 110a-e, including first outer radial flange 114a, second outer radial flange 116a, and/or mating tab 118a, may enable BFS vials 110a-e to be coupled to a modular delivery system (not shown) as described herein while enabling functionality despite a wide range of manufacturing dimensions. In this manner, costs may be reduced by employing BFS technology, for example, while maintaining modular fluid delivery functionality not achievable with previous systems.

In some embodiments, fewer or more of the components 104, 106, 110a-e, 110a-1, 110a-2, 112a, 114a, 116a, 118a, 120a, 122a, and/or various configurations of the illustrated components 104, 106, 110a-e, 110a-1, 110a-2, 112a, 114a, 116a, 118a, 120a, 122a may be included in the BFS vial package 102 without departing from the scope of the embodiments described herein. In some embodiments, the components 104, 106, 110a-e, 110a-1, 110a-2, 112a, 114a, 116a, 118a, 120a, 122a may be similar in configuration and/or functionality to similarly named and/or numbered components described herein. In some embodiments, the BFS vial package 102 (and/or portions and/or components 104, 106, 110a-e, 110a-1, 110a-2, 112a, 114a, 116a, 118a, 120a, 122a) can be utilized in accordance with the methods 800, 900 and/or portions or combinations thereof of FIG. 8 and/or FIG. 9 herein.

Here, Figures 2A, 2B, 2C, 2D, 2E, 2F, 2G, 2H, 2I, 2J, 2K, 2L, 2M and 2N show various views of a fluid delivery system 200 according to some embodiments. 2A and 2B are right side views of the fluid delivery system 200, FIGS. 2C and 2D are partial right side views of the fluid delivery system 200, FIG. 2E is a partially exploded right side view of the fluid delivery system 200, FIG. 2F is a right side cross-sectional view of the fluid delivery system 200, FIG. 2G is a right side cross-sectional assembly view of a portion of the fluid delivery system 200, FIG. 2H is a partial right side cross-sectional view of the fluid delivery system 200, FIG. 2I is a right rear perspective partial cross-sectional view of the fluid delivery system 200, FIG. 2J is a right side perspective partial cross-sectional view of the fluid delivery system 200, FIG. 2K is a right side partial cross-sectional view of the fluid delivery system 200, FIG. 2L is a right front perspective partial cross-sectional view of a portion of the fluid delivery system 200, FIG. 2M is a right side partial cross-sectional view of the fluid delivery system 200, and FIG. 2N is a top view and a side view of a portion of the fluid delivery system 200.

In some embodiments, the fluid delivery system 200 may include various interconnected and/or modular components, such as a BFS vial 210 (e.g., having a first end 210-1 and a second end 210-2) that includes and/or defines a vial neck 212, a first flange 214, a second flange 216, a plurality of locking tabs 218a-b, a crushable reservoir 220, and/or a grip plate 222. According to some embodiments, the fluid delivery system 200 includes a safety cover or cap 228 (e.g., comprising and/or defining a cylindrical cap body 228-1, an interior void 228-2, a tapered cap body 228-3, and/or a head space 228-4), a hub 230 (e.g., comprising a hub body 232, a hub bore 232-1 defining a hub bore diameter 232-2, a vial bevel 232-3, a plurality of locking slots 234a-b, an assembly flange 236, a valve slot 238, a fluid outlet bore 240 defining a fluid outlet bore diameter 240-1, a valve seat 240-2, an insert bore 242 defining an insert bore diameter 242-1, an insert bevel 242-2, an insert recess 242-3, and/or an insert seat 244), a valve 250 (e.g., a valve body 252, a valve channel 254, and/or ... and/or a vial bevel 232-3, and/or a vial bevel 232-3, and/or a vial bevel 232-3, and/or a via 52-1, valve flap 252-2, mounting wings 254a, riser 256, antegrade gap 258, vial flange 260, and seating surface 262), insert 270 (e.g., comprising and/or defining insert body 272, fluid channel 272-1, channel stop 272-2, outlet funnel 274, inlet funnel 276, seating flange 278, and/or seating flange collar 278-1), dispensing member 280 (e.g., comprising and/or defining elongate body 282, fluid bore 282-1, first end 282-2, second end 282-3, and/or needle, point or tip 284), and/or substrate 290 (e.g., comprising or defining flow profile 292 and/or channel 294), delivery or hub assembly 226. According to some embodiments, the fluid delivery system 200 and/or the hub assembly 226 may include a modular design consisting of separately constructed components 228, 230, 250, 270, 280, 290 cooperatively arranged and coupled to one another. The components 228, 230, 250, 270, 280 of the hub assembly 226 may include, for example, a hub 230 configured to be coupled to a source containing a fluid agent, including but not limited to a BFS vial 210, a one-way valve 250 disposed within the hub 230 and configured to restrict fluid flow in an antegrade direction, an insert 270 disposed within the hub 230 and configured to receive and hold a dispensing member 280 for receiving the fluid agent from the BFS vial 210 and dispensing the fluid agent to a patient (not shown), and a substrate 290 disposed within the hub 230 (which itself may be sealed (not shown), e.g., to maintain the purity and/or efficacy of an active ingredient held by the substrate 290).

In some embodiments, the dispensing member 280 can include a needle 284 for at least one of subcutaneous, intramuscular, intradermal, and intravenous injection of the fluid agent into the patient. For ease of illustration and description, the figures and descriptions herein generally refer to the dispensing member 280 as a needle 284. However, it should be noted that in other embodiments, the dispensing member 280 can include a nozzle (not shown) configured to control dispensing of the fluid agent to the patient. The nozzle can include, for example, a spray nozzle configured to facilitate dispersion of the fluid agent into a spray. Thus, the hub assembly 226 with the spray nozzle attached can be particularly useful in dispensing the fluid agent, for example, to the nasal passages, or other parts of the body that would benefit from a spray application (e.g., ear canal, other orifices). In other embodiments, the nozzle can be configured to facilitate the formation of droplets of the fluid agent. Thus, the hub assembly 226 including the droplet nozzle can be useful for dispensing the fluid agent by droplets, such as for administration to the eye, topical administration, etc.

As is generally understood, a medicament may include any type of agent that may be injected into a patient (e.g., a mammal, either human or non-human) and produce an effect (either alone or in combination with an active ingredient, such as may be held by the substrate 290). Thus, a medicament may include, but is not limited to, a vaccine, a drug, a therapeutic agent, a medicine, a diluent, and/or the like. According to some embodiments, either or both of the fluid agent and the active ingredient (i.e., the drug and/or its components) may be tracked, monitored, checked, etc. for compatibility with one another, such as by utilizing electronic data storage devices (not shown) coupled to various modules or components, such as the BFS vial 210 and the hub 230, as described herein.

According to some embodiments, the hub 230 can include a hub body 232 defining a hub bore 232-1 having a first end defining an inlet port and a second end defining an outlet, for example along axis "A-A" as shown in FIG. 2E. In some embodiments, the hub bore 232-1 can provide a fluid path between the inlet port and the outlet port. The hub 230 can include special non-standard (non-luer type) connection fittings, such as locking slots 234a-b, configured to mate with corresponding special non-standard connection fittings, such as locking tabs 218a-b (shown in FIGS. 2A and 2F), of the BFS vial 210. For example, a portion of the hub body 232 adjacent the first end can include a recess, indentation, or complete opening (e.g., locking slots 234a-b) of a particular shape or geometry that is shaped and/or sized to receive a correspondingly shaped and/or sized protrusion, projection, or the like (e.g., locking tabs 218a-b) of the BFS vial 210. In some embodiments, the hub body 232 can include two locking slots 234a-b on either side of the hub body 232 that define opposing openings adjacent the first end, the locking slots 234a-b being shaped and/or sized to receive and retain corresponding locking tabs 218a-b defined on the neck 212 of the BFS vial 210. According to some embodiments, the hub 230 can include one or more windows or port portions, such as valve slots 238, formed on the hub body 232 and configured to provide a means for receiving and retaining a portion of the valve 250 therein (e.g., mounting wings 254a).

For example, the valve 250 may generally be disposed within the hub bore 232-1 and/or may be formed from a polymeric material, such as rubber, synthetic rubber, latex, and/or other elastomeric polymeric material. In some embodiments, the valve 250 may be press-fitted within the hub bore 232-1 such that a portion of the valve 250 (e.g., the mounting wings 254a) may extend through the valve slot 238 and fill any gaps to provide at least a watertight seal. The exposed portion or portions of the valve 250 (and/or its mounting wings 254a) that extend through the valve slot 238 to the outer surface of the hub 230 may generally provide a friction fit with the inner surface internal void 228-2 of the cap 228 when the cap 228 is disposed over and/or coupled to the hub assembly 226. In other words, the exposed polymeric material of the valve 250 (and/or its mounting wings 254a) may generally provide sufficient friction with the cap 228 to keep the cap 228 on the hub assembly 226. In some embodiments, the valve 250 can include and/or define a valve channel 232-1 extending therethrough and coaxially aligned with the hub bore 252-1, e.g., along axis "A-A." According to some embodiments, the valve 250 can include a valve flap 252-2 disposed within the valve channel 252-1 and configured to restrict fluid flow in an antegrade direction from the hub 230 toward the dispensing member 280, thereby ensuring unidirectional fluid flow when the fluid agent is delivered from the BFS vial 210.

In some embodiments, the insert 270 can be disposed within the hub bore 232-1 adjacent the second end of the hub 230. The insert 270 can comprise and/or define a fluid channel 272-1 that, according to some embodiments, extends completely axially through the insert 270. The fluid channel 272-1 can be coaxially aligned with the hub bore 232-1 and/or the valve channel 252-1, e.g., along axis "A-A", such that a fluid path extends entirely from the first end of the hub 230, through the hub bore 232-1, through the valve channel 252-1 of the valve 250, and through the fluid channel 272-1 of the insert 270. According to some embodiments, the seating flange collar 278-1 of the insert 270 can be configured to fit within the valve channel 252-1, e.g., within the riser 256. The dispensing member 280 (e.g., needle 284) can be received and/or retained within the fluid channel 272-1 of the insert 270 such that as the fluid agent is delivered from the BFS vial 210 through the fluid path of the hub assembly 226, the fluid agent flows out of the fluid bore 282-1 of the needle 284, thereby enabling delivery of the fluid agent to the patient.

According to some embodiments, the hub assembly 226 can include a cap 228 to cover the needle 284 to prevent contamination and further reduce the risk of needlestick injuries and thus the possibility of spreading blood-borne infections. In some embodiments, the hub assembly 226 can be packaged and delivered fully assembled, generally including the cap 228 provided over the needle 284 and/or including a seal (not shown), such as a foil, plastic, and/or shrink-wrap seal, that prevents contaminants from entering the hub 230 (e.g., until the seal is broken and/or until the BFS vial 210 is mated with the hub 230). Thus, the user does not have to handle an exposed needle 284 when initially attaching the BFS vial 210 to the hub assembly 226, and the hub assembly 226 may be sealed to protect any active agent stored therein (e.g., substrate 290 as shown in FIG. 2M). Rather, the user need only remove the cap 228 once the BFS vial 210 is securely attached to the hub assembly 226, thereby exposing the needle 284 for fluid agent delivery. The user can then replace the cap 228 once delivery is complete.

In some embodiments, the hub 230, valve 250, insert 270, substrate 290, and/or cap 228 can be constructed from medical grade materials. In some embodiments, the hub 230, insert 270, substrate 290, and/or cap 228 can be constructed from thermoplastic polymers including, but not limited to, polypropylene, polyethylene, polybenzimidazole, acrylonitrile butadiene styrene (ABS) polystyrene, polyvinyl chloride, PVC, and the like.

2A and 2B, a right side view of the fluid delivery system 200 shows the attachment of the BFS vial 210 to the hub assembly 226. As shown unassembled in FIG. 2A, for example, the hub assembly 226 can be biased axially (e.g., to the left in FIG. 2A) along the axis "A-A" as indicated by the arrow to engage and/or be selectively indexed and/or coupled to the BFS vial 210. In some embodiments, the BFS vial 210 can define a collapsible reservoir 220, which can generally include a flexible body having an internal volume sufficient to accommodate at least one dose of a fluid agent therein. The BFS vial 210, in some embodiments, can include a neck 212 extending from the body of the crushable reservoir 220 and terminating in a first end 210-1 that defines an outlet for dispensing a fluid agent upon squeezing the body of the crushable reservoir 220 (e.g., according to the radially inward arrows in FIG. 2F). According to some embodiments, the BFS vial 210 can be formed by BFS technology. The BFS vial 210 can be formed by BFS technology in that the crushable reservoir 220, the neck 212, and the first and second ends 210-1, 210-2 are formed, filled with a fluid agent, and sealed in a sterile enclosed area inside a machine in a continuous process without human intervention. Thus, this process can be used to aseptically manufacture sterile drug liquid dosage forms. The BFS technology can be particularly attractive in the marketplace because it reduces human intervention, making it a more robust method for the aseptic preparation of sterile pharmaceutical products.

According to some embodiments, the hub body 232 can include special non-standard connection fittings (locking slots 234a-b) generally configured to mate with corresponding special non-standard connection fittings (e.g., locking tabs 218a-b) of the BFS vial 210. For example, the BFS vial 210 can include two locking tabs 218a-b defined on either side of the neck 212 adjacent the first end 210-1 and having a general shape corresponding to the locking slots 234a-b on the hub 230. When a user inserts the first end 210-1 of the BFS vial 210 into the hub 230, the locking tabs 218a-b can be shaped (e.g., wedge-shaped) to slide into engagement with the corresponding locking slots 234a-b, respectively (as shown in FIGS. 2B and 2F). 2F is a perspective view, partially in section, showing the engagement between the connecting fittings (e.g., locking tabs 218a-b and locking slots 234a-b) of the BFS vial 210 and the hub 230 of the hub assembly 226, respectively. As shown, the locking tabs 218a-b on the neck 212 of the BFS vial 210 can engage with corresponding locking slots 234a-b of the hub 230. In some embodiments, the locking tabs 218a-b can be shaped to prevent or inhibit withdrawal of the BFS vial 210 from the hub 230, thereby effectively locking themselves into the locking slots 234a-b and effectively locking the BFS vial 210 into engagement with the hub assembly 226. By securing the BFS vial 210 to the hub assembly 226, the user simply applies force (e.g., squeezes) the crushable reservoir 220, as shown, for example, by the arrows in FIG. 2F, to cause the fluid agent to flow along axis "A-A" and out of the fluid bore 282-1 of the needle 284, from the BFS vial 210, through the hub assembly 226 including the needle 284, and into the patient (not shown).

In some embodiments, a special non-standard connection fitting between the hub assembly 226 and the BFS vial 210 allows only approved sources with a corresponding agent (e.g., single-dose BFS vial 210) to be used with the fluid delivery system 200, thereby providing an increased level of security. For example, the delivery method generally depends on the type of fluid agent being delivered. Some drugs are best delivered intravenously, for example, while some vaccines are best delivered intradermally, and even some fluid agents are administered via drops or sprays. Thus, the hub assembly 226 can be configured for delivery of a particular fluid agent, i.e., the connection fitting on the hub assembly 226 can be designed to only receive and engage the corresponding connection fitting of the BFS vial 210 containing that particular fluid agent. Thus, the special connection fitting design ensures that only a matching BFS vial 210 (containing a fluid agent appropriate for that particular delivery assembly) can be connected to the hub assembly 226, thereby ensuring safety and reducing risk.

2G is an exploded perspective cross-sectional view of the hub assembly 226. FIG. 2H is a perspective cross-sectional view of the hub assembly 226 showing the components assembled together to form a continuous fluid path therebetween, and FIG. 2I is another perspective cross-sectional view of the hub assembly 226 showing the components assembled together. As shown, according to some embodiments, the hub 230 can include and/or define a hub bore 232-1 extending therethrough. The hub 230 can also or alternatively include a fluid outlet bore 240 to which the valve 250 and the insert 270 are coupled. In some embodiments, the riser 256 of the valve 250 can be positioned on one side of the fluid outlet bore 240 (e.g., the left side as shown), and the seating flange collar 278-1 of the insert 270 can generally protrude through or into the fluid outlet bore 240 (and/or through or into the riser 256 of the valve 250) and can be positioned on the other side of the fluid outlet bore 240 (e.g., the right side as shown). According to some embodiments, the seating flange collar 278-1 of the insert 270 may be received within the valve channel 252-1 of the riser 256 of the valve 250 and may generally extend against the valve flap 252-2. In some embodiments, the dispensing member 280 comprises an elongated body 282, which may be hollow and/or may otherwise define a fluid bore 282-1 and/or may comprise a generally blunt second end 282-3, and a piercing tip 284 at the first end 282-2. In some embodiments, the second end 282-3 of the dispensing member 280 may be positioned within the fluid channel 272-1 of the insert 270, which may comprise a channel stop 272-2 or end portion (e.g., an internal flange or tapered to a reduced diameter) that prevents the second end 282-3 of the dispensing member 280 from traveling past the fluid channel 272-1. When fully assembled, a fluid pathway can extend completely through the hub assembly 226, from the hub 230 to the tip 284 of the dispensing member 280, and through each of the components therebetween (e.g., through the hub 230, the valve 250, and the insert 270).

2J is an enlarged perspective view in partial section showing the locking engagement between the connection fittings of the BFS vial 210 and the hub 230 of the hub assembly 226. In some embodiments, the hub body 232 can include special non-standard connection fittings (locking slots 234a-b) generally configured to mate with corresponding special non-standard connection fittings of the BFS vial 210. For example, the BFS vial 210 can include two locking tabs 218a-b and/or other protrusions or features defined on either side of the neck 212 adjacent the first end 210-1 and having a general shape corresponding to the locking slots 234a-b on the hub 230. When a user inserts the first end 210-1 of the BFS vial 210 into the hub 230, the locking tabs 218a-b can be configured to slide into sliding engagement with the corresponding locking slots 234a-b, respectively. As shown, locking tabs 218a-b on the neck of the BFS vial 210 can engage with corresponding locking slots 234a-b in the hub 230. The locking tabs 218a-b may, in some embodiments, be further shaped to prevent withdrawal of the BFS vial 210 from the hub 230, thereby effectively locking themselves into the locking slots 234a-b and effectively locking the BFS vial 210 into engagement with the hub assembly 226.

2K and 2L are enlarged perspective views in partial cross section showing the engagement between the first end 210-1 (and outlet) of the BFS vial 210 and the valve 250 of the hub assembly 226 when the BFS vial 210 is securely coupled to the hub assembly 226. By fastening the BFS vial 210 to the hub 230, the outlet of the first end 210-1 of the BFS vial 210 is placed in direct alignment (e.g., axial alignment) with the valve flap 252-2 of the valve 250, according to some embodiments. Thus, the outlet of the BFS vial 210 may be in direct axial alignment with the fluid path (e.g., along axis "A-A"). It should be noted that the dimensions of the BFS vials may be inaccurate due to some small variations that typically occur during the BFS manufacturing process. For example, the second ends 210-1 of any given BFS vial 210 may have different dimensions when compared to one another (on a microscale). To compensate for such variations, the connection joint between the BFS vial 210 and the hub 230 further ensures that the first end 210-1 of the BFS vial 210 is positioned relative to and engages the valve 250 (e.g., its vial flange 260). In some embodiments, the polymeric material of the valve 250 forms a seal between the first end 210-1 of the BFS vial 210 and the vial flange 260 of the valve 250, thereby allowing for imprecise manufacturing of the BFS vial 210.

According to some embodiments, as shown in FIG. 2A, the fluid delivery system 200 may be assembled by application of opposing axial forces (following the arrows shown) that bias the hub assembly 226 onto the BFS vial 210. In some embodiments, a user (not shown) may grasp the grip plate 222 and the hub 230 (and/or the cap 228) and push the BFS vial 210 into the hub bore 232-1 of the hub assembly 226. If a seal (not shown) is positioned to cover the hub bore 232-1, insertion of the BFS vial 210 (or a portion thereof, such as the first end 210-1) may destroy the seal. According to some embodiments, depending on the configuration of the seal used, the user may need to remove the seal before assembling the fluid delivery system 200. In some embodiments, the grip plate 222 may allow a user to apply an axial force toward the hub assembly 226 without having to apply force to the crushable reservoir 220 (e.g., to prevent accidental release of fluid stored in the crushable reservoir 220). According to some embodiments, a user may apply an axial force to the assembly flange 236 of the hub 230 and an opposing axial force to the grip plate 222 to mate the BFS vial 210 with the hub assembly 226, for example, as shown in FIG. 2B.

2C and 2D, the cap 228 can be selectively engaged to couple to the hub assembly 226. The hub assembly 226 can be disposed, for example, within the internal cavity 228-2 of the cylindrical cap body 228-1, and/or its dispensing member 280 can be disposed within the head space 228-4 of the tapered cap body 228-3, such that the needle 284 is protected and/or covered, for example, for cleanliness and safety. In some embodiments, the outer diameter of the hub body 232 can be sized to fit within the internal cavity 228-2 (e.g., can be configured with an outer diameter smaller than the inner diameter of the internal cavity 228-2). According to some embodiments, one or more portions of the valve 250 can extend through a side of the hub body 232, causing a localized increase in the outer diameter of the hub assembly 226. In some embodiments, this localized maximum outer diameter of the hub assembly 226 can be configured to provide an intermediate fit (e.g., an "H7/j6" or "interference fit") between the hub body 232 and the cap 228, allowing the cap 228 to be selectively removed (e.g., as shown in FIG. 2D) and/or manually installed, if desired. According to some embodiments, if the valve 250 includes a rubber or another friction surface, the coefficient of friction of such material and/or compression of the material inside the interior void 228-2 can provide and/or enhance the fit quality.

According to some embodiments, as shown in the assembly view of FIG. 2E, the fluid delivery system 200 can include a hub assembly 226 comprised of multiple modular components, such as a hub 230, a valve 250, an insert 270, and a dispensing member 280. As shown in FIG. 2F, the modular components 230, 250, 270, 280 can be coupled together and attached to the BFS vial 210 to form the fluid delivery system 200. As shown in the cross-sectional assembly view of FIG. 2G, the modular components 230, 250, 270, 280 can be assembled along axis "A-A" by aligning and/or coupling various portions and/or features thereof. Hub 230 can include a hub body 232 (which in some embodiments may be generally cylindrical) that can include and/or define a hub bore 232-2 having an inner hub bore diameter 232-1 and/or can define a vial bevel 232-3 that engages with the BFS vial upon insertion of the BFS vial 210. First flange 214 and/or locking tabs 218a-b of BFS vial 210 can, for example, extend radially outward beyond hub bore diameter 232-2, i.e., engage a sidewall of hub bore 232-1 as they are inserted deeper into vial bevel 232-3. In some embodiments, such engagement can cause the neck 212 of the BFS vial 210 (and/or its first flange 214 and/or locking tabs 218a-b) to compress radially inward and/or the hub body 232 to expand radially outward (e.g., resiliently), e.g., to allow continued advancement of the BFS vial 210 into the hub 230 pursuant to an interference fit and/or interference fit engagement. According to some embodiments, the radial pressure exerted by forcing the neck 212 of the BFS vial 210 into the hub 230 can impart a radial spring effect to the locking tabs 218a-b such that when axial advancement aligns the locking tabs 218a-b with the corresponding locking slots 234a-b, the locking tabs 218a-b spring radially outward into the corresponding locking slots 234a-b, thereby reducing and/or eliminating the radial pressure exerted thereon by the difference between the inner hub bore diameter 232-2 and the outer diameter and/or radial extent of the locking tabs 218a-b.

In some embodiments, the hub 230 can include a fluid outlet bore 240 having a fluid outlet bore diameter 240-1. According to some embodiments, as shown in FIG. 2G, the fluid outlet bore diameter 240-1 can be smaller than the hub bore diameter 232-2. The difference between the fluid outlet bore diameter 240-1 and the valve bore diameter 232-2 can provide and/or define, for example, the valve seat 240-2 and/or the insert seat 244. In some embodiments, the valve 250 can be inserted into the hub bore 232-1 and can include a valve body 252 having an outer diameter sized to fit within the hub bore 232-1. According to some embodiments, the diameter of the valve body 252 can be larger than the hub bore diameter 232-2, such that the valve 250 must be compressed into the hub bore 232-1 for an interference fit. According to some embodiments, the valve 250 can be seated within the valve seat 240-2 and/or the mounting wings 254a can be matingly engaged within and/or through the valve slot 238 in the sidewall of the hub body 232, e.g., creating a watertight seal between the valve body 252 and the hub body 232. In some embodiments, the hub 230 can include an insert bore 242 having an insert bore diameter 242-1. According to some embodiments, the insert 270 can include a seating flange 278 that can have an outer diameter larger than the insert bore inner diameter 242-1. Axial advancement or insertion of the insert 270 into the insert bore 242 can correspondingly engage the seating flange 278 with the insert bevel 242-2 of the hub 230, which can exert a radially outward force on the insert bevel 242-2, which can cause the hub body 232 to radially expand (e.g., resiliently) to accommodate the seating flange 238. In some embodiments, the insert recess 242-3 of the hub 230 can be sized to accommodate the seating flange 238, i.e., when the insert 270 is advanced into the insert bore 242 such that the seating flange 238 is axially aligned with the insert recess 242-3, the insert 270 can snap into place and the hub body 232 can return to its original diameter. According to some embodiments, the seating flange 278 and/or the seating flange collar 278-1 can engage the insert seat 244 and/or form a watertight seal when the seating flange 238 is seated in the insert recess 242-3. In some embodiments, the insert 270 can include an inlet funnel 276 configured to funnel fluids and/or agents moving in an antegrade direction into the fluid channel 272-1. According to some embodiments, the dispensing member 280 can be inserted into the insert 270 by entering the outlet funnel 274 and extending into the fluid channel 272-1 to the channel stop 272-2.

2H and 2I, the seating and sealing between the hub 230, the valve 250, and the insert 270 are illustrated. For example, in FIG. 2H, the seating flange collar 278-1 of the insert 270 is shown to have an outer diameter smaller than the inner diameter of the valve channel 252-1 in the riser 256 of the valve 250, such that when the seating flange 238 is seated in the insert recess 242-3, the seating flange collar 278-1 is disposed within the valve channel 252-1 in the riser 256 of the valve 250. In some embodiments, the fit between the seating flange collar 278-1, the riser 256, and the fluid outlet bore 240 can be configured to provide a watertight seal, such that any fluid directed axially through the valve 250 in the antegrade direction must pass into the inlet funnel 276 and through the fluid bore 282-1 of the dispensing member 280. As shown in Figures 2H and 2I, according to some embodiments, the valve flap 252-2 is located in the center of the fluid flow path and can include a flexible portion of the valve 250 that is free to bend in the antegrade direction by being unhindered by a free space provided between the valve flap 252-2 and the inlet funnel 276 of the insert 270, and/or can move into the inlet funnel 276 itself.

2J and 2K, the fit and/or seal between the BFS vial 210 and the hub assembly 226 is shown. The first flange 214 of the BFS vial 210 is shown to have an outer diameter and/or radial extent equal to or greater than the hub bore diameter 232-1, i.e., to create a fluid-tight seal within the hub bore 232. The second flange 216 and/or locking tabs 218a-b are shown shaped to prevent retrograde axial movement of the BFS vial 210 relative to the hub 230 by having features that project radially outward to seat within the hub 230 and engage the sidewall of the hub body 232. In some embodiments, as shown, the spatial configuration of locking tabs 218a-b and hub bore 232 may cause first end 210-1 of BFS vial 210 to contact, mate with, and/or seat against vial flange 260 of valve 250, thereby creating a fluid-tight seal therebetween. According to some embodiments, valve 250 may form a seal with valve seat 240-2, and/or insert 270 (and/or its seating flange 238) may form a seal with insert seat 244. In some embodiments, valve flap 252-1 may be positioned over and/or biased against first end 210-1 of BFS vial 210 to prevent any backflow of fluid into BFS vial 210. First end 210-1 of BFS vial 210 may, for example, be positioned relative to valve 250 and seated within vial flange 260 of FIG. 2K to prevent retrograde movement or axial displacement of valve flap 252-2 in the direction of BFS vial 210, thereby preventing any opening in first end 210-1 of BFS vial 210 from being exposed in response to any retrograde force (while valve flap 252-2 is free to flex or move in the antegrade direction, at least by not being blocked by any object in valve channel 252-1). Such a configuration according to some embodiments is shown in FIG. 2L, where the collapsible reservoir 220 can provide fluid through the first end 210-1 of the BFS vial 210 with such fluid flow forcing antegrade displacement of the hinged/flapped valve flap 252-2, but retrograde flow would not be possible due to the nature of the first end 210-1 of the BFS vial 210 that blocks or prevents retrograde displacement of the valve flap 252-2.

2M, a right side partial cross-sectional view of a portion of a fluid delivery system 200 according to some embodiments is shown. The embodiment shown in FIG. 2M can, for example, illustrate the case where a drug to be administered is provided in multiple components or substances. The BFS vial 210 can hold or be filled with a fluid agent (e.g., a first component or substance, not explicitly shown), such as an inert carrier fluid (e.g., saline) or diluent, which is operable to be introduced to a second component or substance (also not explicitly shown), such as a dehydrated, dried, or solid active ingredient, to formulate a drug to be delivered to a patient (not shown). The BFS vial 210 can be pre-filled with a predetermined amount of the first component or substance that is introduced into the BFS vial 210 during the BFS manufacturing extrusion process, for example, in a manner that allows the first component or substance to remain sterile and/or prevent or minimize the possibility of contamination during the filling process. According to some embodiments, the BFS vial 210 (or a first end 210-1 thereof) can include a first flange 214, a second flange 216, and/or a neck 212 on which locking tabs 218a-b are disposed and/or formed. In some embodiments, the BFS vial 210 can be matingly or matingly engaged with the hub 230, such as by inserting the neck 212 into the hub body 232, as shown. According to some embodiments as described herein, an assembly flange 238 can be utilized to provide axial leverage to bias the BFS vial 210 into the hub 230. In some embodiments, the hub 230 can define a fluid exit bore 240, which can be disposed adjacent a valve 250 in the hub 230. According to some embodiments, the valve 250 can define a valve channel 252-1 through which the fluid agent (or first component or substance) can pass in an antegrade direction from the BFS vial 210 into the fluid outlet bore 240 (e.g., upon squeezing the BFS vial 210 as described herein).

In some embodiments, the fluid agent passed into the fluid outlet bore 240 can be prevented from moving retrogradely (e.g., back into the BFS vial 210) through the valve flap 252-2 of the valve 250. In this manner, for example, the fluid agent can be selectively released into the fluid outlet bore 240 and into the insert 270. According to some embodiments, the insert 270 can comprise an insert body 272 that houses the dispensing member 280. In such a configuration, the fluid agent can move in an antegrade direction from the BFS vial 210, through the valve 250 and its valve channel 252-1, into the fluid outlet bore 240, into the insert body 272, and through the dispensing member 280 (e.g., ultimately to the patient). According to some embodiments, a second component or substance of the agent can be disposed along this fluid pathway to enable interaction between the two components of the agent. In some embodiments, the fluid pathway can comprise multiple pathways (not shown) that enable, direct, and/or enhance the introduction or interface of the two components. According to some embodiments, more than two components of the drug can be provided, and/or each fluid pathway may enable, direct, and/or enhance interactions between different components of the drug. A first fluid pathway can, for example, cause the introduction of the first and second components of the drug, and a second fluid pathway can cause the introduction of the third and fourth components of the drug. In some embodiments, these pathways can merge (e.g., after separate multi-component introductions) to allow the introduction of all drug components.

According to some embodiments, the fluid delivery system 200 (and the hub 230) can comprise, house, and/or hold a substrate 290. The substrate 290 can comprise, for example, an active ingredient of a drug (i.e., a second ingredient or substance thereof), or an object that holds, carries, or holds the active ingredient. As shown in FIG. 2M, the substrate 290 can be disposed (e.g., during the manufacturing process) within the fluid outlet bore 240 of the hub 230 and/or configured in a helical shape, for example, to promote interaction between the fluid agent and the active ingredient. In some embodiments, the substrate 290 can include an inert object, such as a bag, pouch, capsule, paper disk, and/or tablet, that contains the second ingredient or substance (e.g., the active ingredient). The second ingredient or substance can be disposed, for example, in a powdered, dried, granulated, dehydrated, lyophilized, cryo-dried, desiccated, powdered, and/or solid form, and can be stored in or on the substrate 290. In some embodiments, the second component or substance may be disposed in a solid and/or aerated form, such as a pill, cake, tablet (e.g., annular tablet), fine powder, and/or aerated form. In some embodiments, the second component or substance may be combined or mixed with other substances (e.g., inert and/or non-reactive substances), such as by combining with a polymeric sugar, thickener, etc. According to some embodiments, the hub 230 may include or define voids, channels, protrusions, grooves, tracks, diffusers, or other features (not shown) that may contain or retain the substrate 290 and/or active ingredient. In some embodiments, the substrate 290 may not include a body separate from the active ingredient and may represent a disposal of the second component or substance within the hub 230 (or its fluid outlet bore 240). The second component or substance may be directly deposited (e.g., printed) on the inner surface of the fluid outlet bore 240, for example, in one or more patterns, such as, for example, a spiral (e.g., rifling) pattern. According to some embodiments, the inner surface of the fluid outlet bore 240 (or a portion thereof) can be coated with a second component or substance (or a mixture containing or carrying a second component or substance). In some embodiments, the printing or deposition can be done in a manner (e.g., raised cross patterns, raised rifling ridges) that increases the surface area of the second component or substance exposed to the flow of the fluid agent. Increasing the contact surface area between the second component or substance and the fluid agent (or other first component or substance) can, for example, increase dissolution of the second component or substance and/or decrease the time required for a desired level of dissolution. A variety of different parameters for the size, shape, thickness, and/or dosage of the active ingredient can be selected for different types of active ingredients, with parameter values selected to meet specific goals. Examples of such goals may include (i) maximizing the surface area of the second component or substance, (ii) minimizing dissolution time, (iii) maximizing the percentage of the second component or substance that is dissolved (e.g., within a particular time and/or given a particular amount or type of diluent), and (iv) a desired concentration of the resulting drug (e.g., a desired curve of concentration ranges). For example, in some embodiments, the amount, pattern, or configuration of the second component or substance may be designed such that ninety percent (90%) of the second component or substance (and/or active ingredient) dissolves in a particular first component or substance (e.g., a fluid drug) within five to six (5-6) seconds of the first component or substance being released from the BFS vial 210 into the fluid outlet bore 240.

In some embodiments, the first component or substance and the second component or substance can be filled or manufactured by two separate manufacturing processes and/or packaged and sold as two separate products. The BFS vial 210 can be filled with the first component or substance during a first manufacturing process at a first facility and/or by a first machine (e.g., a BFS machine, not shown), while the second component or substance and/or substrate 290 can be placed or attached in the hub 230 during a second manufacturing process at a second facility and/or by a second machine (e.g., an active ingredient printing device, not shown). According to some embodiments, the BFS vial 210 and the hub 230 (e.g., housing the substrate) can be stored, transported, and/or sold separately. In some embodiments, the BFS vial 210 and the hub 230 can be manufactured and/or sold together, for example, in a pack or set (e.g., a blister pack), and/or can be partially pre-assembled. In some embodiments, the BFS vial 210 and the hub 230 may be sealed individually or together in a package. The BFS vial 210 may be sealed, for example, during the BFS manufacturing process, and the hub 230 (and/or its fluid exit bore 240) may be sealed separately, such as by a plastic or foil seal (not shown) that closes one or more ends of the hub 230, thereby protecting and/or isolating the substrate 290 (and/or active ingredient) (e.g., sealing its fluid path). The hub 230 and substrate 290 may be assembled, for example, in a clean environment, and then sealed for protection. In some embodiments, the BFS vial 210 and the hub 230 may be pre-assembled, and any seals may include an internal operating seal (paper, foil, air bubble), for example, that maintains separation between the first and second components or substances until the system 200 is activated by a user to mix, reconstitute, and/or form the drug to be delivered to the patient.

According to some embodiments, the hub 230 (and/or components thereof, such as the valve 250) can include an element (not explicitly shown) for piercing the seal (e.g., first end 210-1) of the BFS vial 210. A protrusion, cutter, point, and/or other protrusion (e.g., plastic or metallic, not shown) can be disposed, for example, within the hub 230 and oriented to engage the first end 210-1 of the BFS vial 210 upon coupling of the BFS vial 210 within the hub body 232. The element can penetrate the first end 210-1 of the BFS vial 210, for example, to allow a fluid agent stored therein to flow into the valve channel 252-1 and/or the fluid outlet bore 240 (e.g., to engage and/or interface with the substrate 290 and/or its active ingredient). In some embodiments, such a piercing element can comprise a cutting edge that, for example, pierces or cuts circumferentially into or through any seals thereof upon rotation of the BFS vial 210 within the hub body 232. According to some embodiments, the BFS vial 210 can comprise a cutting or piercing element (not shown) disposed on its first end 210-1, which, when engaged with a seal of the hub 230, can pierce, cut, or otherwise damage the seal such that the BFS vial 210 can enter and/or be coupled to the hub body 232.

Although the first component or substance in the BFS vial 210 is generally referred to as an inactive component, such as saline or other fluid agent, and the second component or substance in or on the substrate 290 is generally referred to as an active ingredient or raw material of the drug, in some embodiments they may be reversed. The first component or substance stored in the BFS vial 210 may include, for example, an active agent, and the substrate 290 may include or hold a second component or substance, which may be an inactive component (such as a sugar compound). According to some embodiments, both the first component or substance and the second component or substance may include, for example, active ingredients that react to form a drug upon introduction or mixing.

2N, top and side views of various substrates 290a-c for use in the fluid delivery system 200 according to some embodiments are shown. The substrates 290a-c can include, for example, plastic and/or paper inserts or structures to which the second component or substance is attached, adhered, injected, and/or otherwise held or supported. The substrates 290a-c can be configured in various manners to facilitate dissolution and/or dispersion of the second component or substance and/or to direct the flow of the fluid agent through the hub 230. The first substrate 290a can include, for example, an axially elongated helical structure that defines a first axial flow profile 292a (e.g., an axially exposed surface area). In some embodiments, the first substrate 290a can comprise and/or define a first channel 294a that allows fluid to flow axially through the fluid pathway without being impeded or redirected by the first substrate 290a. According to some embodiments, the second substrate 290b can include an axially elongated helical structure that defines the second axial flow profile 292b. In some embodiments, the third substrate 290c can include a set of axially distributed annular structures that are bonded together to define the third axial flow profile 292c. The third substrate 290c can define a second channel 294c that, for example, allows a portion of the fluid agent to flow through the third substrate 290c while other portions of the fluid agent can be forced to interact with one or more of the third axial flow profiles 292c. Different substrates 290a-c can be utilized to induce different mixing behaviors and/or dissolution times for different substances that can be disposed or held on the substrates 290a-c or that become known or feasible.

According to some embodiments, the substrates 290a-c can include structures inserted into the hub 230 on which (and/or within) a second component or substance is attached or retained. In some embodiments, the substrates 290a-c can include attached instances of the second component or substance, such as structures formed by additive manufacturing utilizing the second component or substance as a printing material. The second component or substance can be attached in a predetermined pattern to define one or more of the substrates 290a-c and/or portions thereof, in combination with a structure promoter, such as, for example, a sugar compound or a protein. As described herein, in some embodiments, such attachment or "printing" can be accomplished directly on one or more interior surfaces of the hub 230 (such as the inner wall of the fluid outlet bore 240). According to some embodiments, the substrates 290a-c and/or the second element or substance can be disposed within and/or attached onto various components of the system 200. Although the fluid outlet bore 240 is generally described as a location for a second component or substance, for example, one or more second components or substances can be, or can be operatively disposed within various other portions of the hub 230, within the insert 270, within the dispensing member 280, and/or within other portions of the system 200.

In some embodiments, one or more of the substrates 290a-c containing and/or carrying a predetermined dose or amount of a second component or substance can be inserted or attached to the hub 230 during the manufacturing process, and the BFS vial 210 can be filled with a predetermined dose or amount of the first component or substance during the BFS manufacturing process. Whether accomplished during manufacturing assembly or on-site, the BFS vial 210 can then be coupled to the hub 230 such that each of the first and second components or substances are exposed to the fluid path and/or each other. Thus, according to some embodiments, it is envisioned that a user actuates the hub 230 and dispensing member 280 (e.g., by "pushing down" on the needle cover (not shown) or on the assembly flange 238 and on the BFS vial 210), thereby causing puncture of the seal (not shown) between the BFS vial 210 and the hub 230 and causing arming of the delivery system 200. The user can then insert the injection cannula into the correct body location after cleaning the injection site if necessary and removing the needle cover, and deploy the system 200 by pinching the BFS vial 210. The fluid agent flows through the hub 230, dissolving the powder (or other form of second substance) and releasing it through the dispensing member 280 and into the patient's body. This works well with fast dissolving powders. Slower dissolving formulations may require a longer "track" (e.g., a longer or more complex fluid path through the hub 230 and/or dispensing member 280), i.e., interactions, flows, eddies, turbulences to ensure dissolution occurs can be modified as desired. In some embodiments, spray drying or printing fine particles of powdered drug into the hub 230 and/or on or into the substrates 290a-c promotes faster dissolution rates. The user (e.g., the person being injected with the medication, or in the case of self-injection, a medical professional or other person) then, for example, squeezes the BFS vial 210, thereby forcing the first component or substance into the hub 230 having the appropriate dose/dose of the second component or substance (e.g., active ingredient), i.e., as the fluid agent travels through the hub 230 and/or the fluid outlet bore 240 containing the second component or substance, the medication including the active ingredient is reconstituted and the appropriate dose of the medication is injected into the patient via the administration member 280. The system 200 is generally capable of delivering multi-component medications in a controlled manner and without the need for specialized skills in administering delivery of such medications.

In an embodiment in which an active substance (e.g., a vaccine or drug in powder form) is deposited and stored in the hub 230 and an inactive substance (e.g., a diluent) is stored in the BFS vial 210, the modular two-component delivery system 200 described herein overcomes many of the shortcomings of current delivery devices and methods, particularly the shortcomings of known dual-chamber syringe mechanisms. First, the BFS vial 210 is configured to store and deliver precise dosages and doses of fluid to very high tolerances without requiring the user to measure the exact dose of fluid. Furthermore, fluids can be stored in the BFS vial 210 for several years, which has been proven over decades of use. The BFS delivery system is configured to facilitate the desired or recommended single dose of drug agent to a patient by a user requiring little or no training (e.g., a patient in the case of self-injection, or a medical professional requiring little training or working under stressful conditions and therefore susceptible to user error). The modular two-component delivery system 200 described herein allows for reconstitution of a drug agent without the user needing to measure an exact dose of diluent, and the normal act of squeezing fluid from the BFS vial 210 provides a force or action to introduce an inert fluidic substance into the hub 230, i.e., allowing for reconstitution of an active agent stored in or on the substrate 290 (or otherwise disposed within the hub 230) without the need for any additional measurements or actions on the part of the user other than what the user normally does when administering an injection via the BFS vial 210. In today's dual chamber syringes, the drug is provided in a glass vial and liquid is added to the vial with a needle or other device and shaken until completely dissolved. The requirements of the prior art systems include the user measuring an exact amount of liquid by drawing the liquid up through the needle, placing the liquid into another container, and then shaking the resulting mixture for an appropriate amount of time to dissolve the appropriate amount of powder/drug. Each of these steps introduces potential points of user error and contamination that are not present in the embodiments described herein. In addition, prior art devices are more complex to manufacture, typically involving multiple parts, multiple assembly processes, and are difficult to maintain sterility and Good Manufacturing Practices (GMP) with large areas of dead space and large amounts of drug waste.

In some embodiments, fewer or more of the components 210, 210-1, 210-2, 212, 214, 216, 218a-b, 220, 222, 226, 228, 228-1, 228-2, 228-3, 228-4, 230, 232, 232-1, 232-2, 232-3, 234a-b, 236, 238, 240, 240-1, 240-2, 242, 242-1, 242-2, 242-3, 244, 250, 252, 252-1, 252-2, 254a, 256, 258, 260, 262, 270, 272, 272-1, 272-2, 274, 276, 278, 278-1, 280, 282, 282-1, 282-2, 282-3, 284, 290, 290a-c, 292, 292a-c, 294, 294a, 292c, and/or the illustrated components 210, 21 0-1, 210-2, 212, 214, 216, 218a-b, 220, 222, 226, 228, 228-1, 228-2, 228-3, 228-4, 230, 232, 232-1, 232-2, 232-3, 234a-b, 236, 238, 240, 240-1, 240-2, 242, 242-1, 242-2, 242-3, 244, 250, 252, 252-1, 252-2, 254a , 256, 258, 260, 262, 270, 272, 272-1, 272-2, 274, 276, 278, 278-1, 280, 282, 282-1, 282-2, 282-3, 284, 290, 290a-c, 292, 292a-c, 294, 294a, 292c may be included in fluid delivery system 200 without departing from the scope of the embodiments described herein. In some embodiments, components 210, 210-1, 210-2, 212, 214, 216, 218a-b, 220, 222, 226, 228, 228-1, 228-2, 228-3, 228-4, 230, 232, 232-1, 232-2, 232-3, 234a-b, 236, 238, 240, 240-1, 240-2, 242, 242-1, 242-2, 242-3, 244, 250, 252, 252-1, 252-2, 252-3, 254, 256, 258, 259, 260, 261, 262, 263, 264, 265, 266, 267, 268, 269, 270, 271, 272, 273, 274, 275, 276, 277, 278, 279, 280, 281, 282, 283, 284, 285, 286, 287, 288, 289, 290, 291, 300, 301, 302, 303, 304, 305, 306, 307, 308, 309, 310, 311, 312, 313, 314, 315, 316, 317, 318, 319, 320, 2-2, 254a, 256, 258, 260, 262, 270, 272, 272-1, 272-2, 274, 276, 278, 278-1, 280, 282, 282-1, 282-2, 282-3, 284, 290, 290a-c, 292, 292a-c, 294, 294a, 292c may be similar in structure and/or functionality to components of like names and/or numbers described herein. In some embodiments, the fluid delivery system 200 (and/or portions thereof and/or components thereof 210, 210-1, 210-2, 212, 214, 216, 218a-b, 220, 222, 226, 228, 228-1, 228-2, 228-3, 228-4, 230, 232, 232-1, 232-2, 232-3, 234a-b, 236, 238, 240, 240-1, 240-2, 242, 242-1, 242-2, 242-3, 244 , 250, 252, 252-1, 252-2, 254a, 256, 258, 260, 262, 270, 272, 272-1, 272-2, 274, 276, 278, 278-1, 280, 282, 282-1, 282-2, 282-3, 284, 290, 290a-c, 292, 292a-c, 294, 294a, 292c) can be utilized in accordance with methods 800, 900, and/or portions or combinations thereof, of FIG. 8 and/or FIG. 9 herein.

3A, 3B, 3C, 3D, 3E, 3F, 3G, and 3H, which show a right front perspective view, a top cross-sectional view, a bottom cross-sectional view, a left cross-sectional view, a right cross-sectional view, a front cross-sectional view, a rear cross-sectional view, and a front cross-sectional view of a modular hub 330 according to some embodiments. In some embodiments, the modular hub 330 can comprise a modular component of a fluid delivery system as described herein. The modular hub 330 can comprise, for example, a cylindrical hub body 332 defining a hub bore 332-1 therethrough, the hub bore 332-1 having an inner hub bore diameter 332-2. According to some embodiments, the modular hub 330 can comprise a vial bevel 332-3 disposed at the opening of the hub bore 332-1 and/or a plurality of locking slots 334a-b disposed on the side of the hub body 332. In some embodiments, the modular hub 330 can include an assembly flange 336 disposed at the opening of the hub bore 332-1 and/or a number of valve slots 338a-b disposed on the side of the hub body 332.

According to some embodiments, the modular hub 330 can include a fluid outlet bore 340 having an internal fluid outlet bore diameter 340-1. In some embodiments, a valve seat 340-2 can be formed or disposed within the hub bore 332-1 and/or between the hub bore 332-1 and the fluid outlet bore 340. In some embodiments, the modular hub 330 can include an insert bore 342 having an internal insert bore diameter 342-1 and/or can include and/or define an insert bevel 342-2 and/or an insert recess 342-3. According to some embodiments, the insert recess 342-3 can define an insert seat 344 and/or the insert bore 342 can include and/or define an insert seat.

In some embodiments, as best seen in FIG. 3C, hub bore 332-1 can include non-circular cross-sections, such as oval, square, rectangular, triangular, and/or other shapes, such as an "eye" shape as shown. In this manner, for example, only BFS vials having a similarly shaped neck (not shown) can be inserted into hub bore 332-1 and/or can be inserted and seated properly to form a watertight seal therein. According to some embodiments, hub bore diameter 332-2 can be equal to insert bore diameter 342-1, and/or fluid outlet bore diameter 340-1 can be smaller than either or both hub bore diameter 332-2 and insert bore diameter 342-1. In some embodiments, valve seat 340-2 and/or insert seat 344 can be shaped to receive a valve and insert (neither shown), respectively. According to some embodiments, valve seat 340-2 can be positioned axially adjacent to valve slots 338a-b such that a portion of a valve inserted into hub bore 322-1 can seat and/or seal against valve seat 340-2 while another portion of the valve seat protrudes into and/or otherwise engages each respective valve slot 338a-b. According to some embodiments, vial bevel 332-3 and insert bevel 342-2 can be cone-shaped portions that act on an object axially inserted therein. For example, if a flexible and/or compressible object (not shown) having an outer diameter and/or radial extent greater than hub bore diameter 332-2 is forced axially into hub bore diameter 332-1, vial bevel 332-3 may provide or exert an opposing force radially inward thereon, causing the object to increasingly compress, retract, and/or deform, for example, as the diameter of vial bevel 332-3 decreases along the axial insertion path. In some embodiments, fluid outlet bore 340 may contain and/or house an active ingredient (not shown: e.g., substrate 290 of Figures 2M and/or 2N herein). Fluid outlet bore 340 may be lined with a solid active ingredient, may house a solid ingredient tablet, and/or may house an inert substrate to which the active ingredient is transported (e.g., adhered to and/or contained). According to some embodiments, the fluid outlet bore 340 can include one or more features (not shown), such as detents, voids, and/or ridges, that contain, accommodate, and/or retain solid materials that can be dissolved by fluid flowing through the fluid outlet bore 340. In some embodiments, the overall length and/or inner fluid outlet bore diameter 340-1 of the fluid outlet bore 340 can be sized and/or configured to accommodate the active ingredient and/or associated substances or objects.

According to some embodiments, fewer or more of the components 332, 332-1, 332-2, 332-3, 334a-b, 336, 338, 340, 340-1, 340-2, 342, 342-1, 342-2, 342-3, 344, and/or various configurations of the components 332, 332-1, 332-2, 332-3, 334a-b, 336, 338, 340, 340-1, 340-2, 342, 342-1, 342-2, 342-3, 344 shown may be included in the modular hub 330 without departing from the scope of the embodiments described herein. In some embodiments, components 332, 332-1, 332-2, 332-3, 334a-b, 336, 338, 340, 340-1, 340-2, 342, 342-1, 342-2, 342-3, 344 can be similar in configuration and/or functionality to similarly named and/or numbered components described herein. In some embodiments, modular hub 330 (and/or portions thereof and/or components 332, 332-1, 332-2, 332-3, 334a-b, 336, 338, 340, 340-1, 340-2, 342, 342-1, 342-2, 342-3, 344) can be utilized in accordance with methods 800, 900 and/or portions or combinations thereof of FIG. 8 and/or FIG. 9 herein.

4A, 4B, 4C, 4D, 4E, 4F, 4G, and 4H, there are shown a right front perspective view, a top cross-sectional view, a bottom cross-sectional view, a left cross-sectional view, a right cross-sectional view, a front cross-sectional view, a rear cross-sectional view, and a front cross-sectional view of a modular valve 450 according to some embodiments. In some embodiments, the modular valve 450 can comprise a modular component of a fluid delivery system as described herein. The modular valve 450 can comprise, for example, a cylindrical and/or annular shaped valve body 452 defining a valve channel 452-1 therethrough, the valve channel 452-1 having a valve flap 452-2 disposed therein and/or one or more mounting wings 454a-b projecting radially from the valve body 452. According to some embodiments, the modular valve 450 can comprise a cylindrical riser 456 extending axially from the valve body 452 and/or an antegrade gap 458 formed at the base of the riser 456. In some embodiments, the modular valve 450 can include a vial flange 460 formed and/or disposed on an axially facing surface of the valve body 452 and/or can include a seating surface 462 disposed and/or formed on an opposing axially facing surface of the valve body 452.

According to some embodiments, the valve body 452 can be molded to fit within a bore of a modular hub member (not shown). The valve body 452 can be molded, for example, generally cylindrical or circular, or can be "eye" or "almond" shaped, as shown in FIGS. 4A, 4B, and 4C. In some embodiments, the valve flap 452-2 can include a portion of flexible material attached along only a portion of the circumference of the interior of the valve channel 452-1, such that the valve flap can be selectively and temporarily axially displaced when an axial force is applied to the valve flap gap. In some embodiments, the valve flap 452-2 can be constructed utilizing a stiffer rubber or plastic compound such that a greater axial force is required to bend the valve flap 452-2 and/or such that the valve flap 452-2 includes an increased natural spring effect that biases the valve flap 452-2 to a default or "closed" position, e.g., perpendicular to the axis of the modular valve 450.

In some embodiments, fewer or more components 452, 452-1, 452-2, 454a-b, 456, 458, 460, 462, and/or various configurations of the illustrated components 452, 452-1, 452-2, 454a-b, 456, 458, 460, 462, may be included in the modular valve 450 without departing from the scope of the embodiments described herein. In some embodiments, the components 452, 452-1, 452-2, 454a-b, 456, 458, 460, 462, may be similar in configuration and/or functionality to similarly named and/or numbered components described herein. In some embodiments, the modular valve 450 (and/or portions and/or components 452, 452-1, 452-2, 454a-b, 456, 458, 460, 462) may be utilized in accordance with the methods 800, 900 and/or portions or combinations thereof of FIGS. 8 and/or 9 herein.

5A, 5B, 5C, 5D, 5E, 5F, 5G, and 5H, there are shown right front perspective, top, bottom, left, right, front, rear, and front cross-sectional views of a modular insert 570 according to some embodiments. In some embodiments, the modular insert 570 can comprise a modular component of a fluid delivery system as described herein. The modular insert 570 can comprise, for example, a cylindrically shaped insert body 572 defining a fluid channel 572-1 therethrough and having an outlet funnel 574 and/or an inlet funnel 576 disposed at opposing ends thereof. According to some embodiments, the outlet funnel 574 can comprise an inner diameter 574-1 configured for various desired fluid delivery applications as described herein (e.g., for the reception of different gauge needles, nozzles, and/or other delivery methods or applications). In some embodiments, the modular insert 570 can include a seating flange 578 and/or a seating flange collar 578-1. As shown, the seating flange collar 578-1 can accommodate and/or define the inlet funnel 576. According to some embodiments, the seating flange 578 can be rounded in its radial extent to facilitate insertion of the seating flange 578 into a bore (not shown) having a diameter smaller than the diameter of the seating flange 578.

In some embodiments, more components 572, 572-1, 572-2, 574, 574-1, 576, 578, 578-1 than are described herein, and/or various configurations of the components 572, 572-1, 572-2, 574, 574-1, 576, 578, 578-1 shown may be included in the modular insert 570 without departing from the scope of the embodiments described herein. In some embodiments, the components 572, 572-1, 572-2, 574, 574-1, 576, 578, 578-1 may be similar in configuration and/or functionality to similarly named and/or numbered components described herein. In some embodiments, the modular insert 570 (and/or portions and/or components 572, 572-1, 572-2, 574, 574-1, 576, 578, 578-1) can be utilized in accordance with the methods 800, 900 and/or portions or combinations thereof of FIGS. 8 and/or 9 herein.

6A, 6B, 6C, 6D, 6E, 6F, and 6G, there are shown right front perspective, top, bottom, left side, right side, front, and views of a modular BFS vial 610 according to some embodiments. The BFS vial 610 can comprise, for example, a generally flask-shaped element with a bottom 610-2 at one end and a neck 612, a distal or first flange 614, a proximal or second flange 616, and/or a number of indexing or coupling elements 618a-b at an opposite end. The first flange 614, the second flange 616, and/or the coupling elements 618a-b can, in some embodiments, be operable to mate and/or couple with a hub assembly (not shown) for fluid delivery, as described herein. In some embodiments, the modular BFS vial 610 can include a flask-shaped fluid reservoir 620 disposed between the base 610-2 and the neck 612, and/or a compression foot 622 disposed adjacent to and/or at the base of the base 610-2.

According to some embodiments, the flask-shaped fluid reservoir 620 can be axially compressed and/or crushed to release any fluid (e.g., an inert diluent or an active ingredient of a drug) stored therein, such as by applying an axial force that urges the compression legs 622 toward the neck 612. In some embodiments, the flask-shaped fluid reservoir 620 can be advantageously ergonomically made easy to operate by a user (not shown) by placing two or more fingers (not shown) on the top of the flask-shaped fluid reservoir 620 and their thumbs (also not shown) under the compression legs 622 of the bottom 610-2. The squeezing motion of compressing the fingers toward the thumbs can then, in some embodiments, compress and/or deform the flask-shaped fluid reservoir 620, thereby achieving a generally disk-shaped, crushed appearance, i.e., reducing the volume of the flask-shaped fluid reservoir 620 to approximately zero by releasing substantially all of the fluid previously stored therein.

In some embodiments, fewer or more components 610-2, 612, 614, 616, 618a-b, 620, 622, and/or various configurations of the illustrated components 610-2, 612, 614, 616, 618a-b, 620, 622 may be included in modular BFS vial 610 without departing from the scope of the embodiments described herein. In some embodiments, components 610-2, 612, 614, 616, 618a-b, 620, 622 may be similar in configuration and/or functionality to similarly named and/or numbered components described herein. In some embodiments, the modular BFS vial 610 (and/or portions and/or components 610-2, 612, 614, 616, 618a-b, 620, 622) can be utilized in accordance with the methods 800, 900, and/or portions or combinations thereof, of FIGS. 8 and/or 9 herein.

7A, 7B, 7C, 7D, 7E, 7F, and 7G, there are shown right front perspective, top, bottom, left side, right side, front, and views of a modular BFS vial 710 according to some embodiments. The BFS vial 710 can comprise, for example, an accordion or "concertina" shaped element including a top or outlet 710-1 and a bottom 710-2. In some embodiments, the BFS vial 710 can comprise a neck 712, a distal or first flange 714, a proximal or second flange 716, and/or a plurality of indexing or coupling elements 718a-b (e.g., at or adjacent to the outlet 710-1). The first flange 714, the second flange 716, and/or the coupling elements 718a-b may, in some embodiments, be operable to mate and/or couple with a hub assembly (not shown) for fluid delivery, as described herein. In some embodiments, the modular BFS vial 710 may include a "concertina" shaped fluid reservoir 720a-b disposed between the top 710-1 and bottom 710-2, and/or a compression leg 722 disposed adjacent to and/or at the bottom 710-2. In some embodiments, the "concertina" shaped fluid reservoir 720a-b may include and/or define multiple segments, volumes, and/or lobes, such as an upper or first lobe 720a and a lower or second lobe 720b formed and/or joined therebetween. In some embodiments, fewer or more lobes 720a-b may be utilized.

According to some embodiments, the lobes 720a-b can be axially compressed and/or collapsed to expel any fluid stored therein, such as by applying an axial force that biases the compression legs 722 toward the neck 712 and/or top 710-1. In some embodiments, the lobes 720a-b can be advantageously ergonomically configured to be easily manipulated by a user (not shown) by placing two or more fingers (not shown) on the top of the first lobe 720a and a thumb (also not shown) positioned under the compression legs 722 at the bottom 710-2. The squeezing motion compressing the fingers toward the thumb can then, in some embodiments, compress and/or deform each of the lobes 720a-b so that each achieves a substantially disk-shaped collapsed appearance, i.e., reducing the volume of the "concertina" shaped fluid reservoirs 720a-b to approximately zero by expelling substantially all of the fluid previously stored therein.

In some embodiments, fewer or more components 710-1, 710-2, 712, 714, 716, 718a-b, 720a-b, 722 and/or various configurations of the illustrated components 710-1, 710-2, 712, 714, 716, 718a-b, 720a-b, 722 may be included in the modular BFS vial 710 without departing from the scope of the embodiments described herein. In some embodiments, the components 710-1, 710-2, 712, 714, 716, 718a-b, 720a-b, 722 may be similar in configuration and/or functionality to similarly named and/or numbered components described herein. In some embodiments, the modular BFS vial 710 (and/or portions and/or components 710-1, 710-2, 712, 714, 716, 718a-b, 720a-b, 722) can be utilized in accordance with the methods 800, 900 and/or portions or combinations thereof of FIG. 8 and/or FIG. 9 herein.

III. Drug Delivery Methods Figure 8 is a perspective flow diagram of a method 800 according to some embodiments. Method 800 can, for example, illustrate an exemplary use of various drug delivery systems and/or components thereof as described herein. The process and flow diagrams described herein do not necessarily imply a fixed order to any depicted acts, steps, and/or procedures, and embodiments may generally be performed in any order feasible unless otherwise noted. Although the order of acts, steps, and/or procedures described herein is generally not fixed, in some embodiments, acts, steps, and/or procedures may be specifically performed in the order listed, illustrated, and/or described, and/or may be performed in response to any previously listed, illustrated, and/or described acts, steps, and/or procedures.

In some embodiments, as shown in FIG. 8, a drug delivery system can include, at 801, a pack of BFS vials 802 and a corresponding number of fully assembled delivery assemblies 826 (e.g., having a safety cover 828 and/or including a solid or dry active ingredient disposed therein). A user can then simply pull one of the vials 810 away from the pack 802 when ready to deliver a single dose of fluid drug, according to some embodiments, at 803. In some embodiments, a user can then attach the removed vial 810 to one of the delivery assemblies 826, for example, by pressing them together (e.g., axially) until the vial 810 snaps, clicks, and/or locks into place within the delivery assembly 826, at 805. In some embodiments, mating or coupling of one of the vials 810 with the delivery assembly 826 can cause piercing or removal of one or more seals. If the active ingredient is stored in the delivery assembly 826, for example, the insertion of the vial 810 may break or dislodge the seal. Similarly, the delivery assembly 826 may include an element that pierces the seal (or a portion thereof) of the vial 810 to expose the fluid stored therein. In some embodiments, the user may shake the combined vial 810 and delivery assembly 826 to introduce fluid from the vial 810 along with the active ingredient in the delivery assembly 826 (or vice versa). According to some embodiments, the user may then remove the safety cover 828 from the combined vial 810 and delivery assembly 826 at 807, thereby exposing the needle 880 (or other suitable administration member). In some embodiments, the user may then administer the fluid agent (either to self-administer or to another person) at 809. Once complete, the safety cover 828 may be replaced over the delivery assembly 826, and the contents may be discarded at 811 into an appropriate biohazard waste container.

The delivery assembly 826 is generally configured to allow delivery of the medication to a patient in a relatively simple manner without requiring special training to administer the medication. In some embodiments, the delivery assembly 828 is designed to allow a person administering the fluid agent (e.g., an administrator) (which may also include self-administration) to only need to place the device on the administration site (e.g., shoulder, arm, chest, nose, ear, eye, etc.) and then fully compress the BFS vial 810 (and/or its fluid reservoir) containing the dose of the fluid agent, thereby delivering a precise, predetermined dosage to the patient. The delivery assembly 826 can further be configured such that, if a needle 880 is required (i.e., because the delivery method is an injection), needle penetration is limited to the correct length and orientation within the administration site. For example, in some embodiments, the needle 880 is configured to be inserted into the patient's skin at a substantially perpendicular angle and is positioned substantially perpendicular to the plane in which the distal end of the insert is located such that the needle 880 is configured to contact the patient's skin and exhibit an appropriate penetration depth for injection of the fluid agent.

Thus, the delivery assembly 826 may not require a trained, skilled medical professional to administer the vaccine or medication. Thus, the delivery assembly 826 may be particularly useful in situations where the vaccine or medication is administered in a non-medical related facility (e.g., outside of a clinic or hospital) and given to a large number of individuals over a short period of time by a non-professional.

9, a flow diagram of a method 900 according to some embodiments is shown. The method 900 can include, for example, at 902, separating the BFS vial from the BFS manifold. A user can grip an individual vial and twist or bend it to separate it from the BFS manifold, for example, at one or more preconfigured break or splice points. According to some embodiments, the method 900 can include, at 904, coupling the BFS vial to the delivery hub. Coupling can include, for example, applying an axial force (e.g., via a grip plate of the BFS vial and an assembly flange of the assembly hub) that axially urges the BFS vial into a bore of a modular assembly hub (e.g., as described herein) until an engagement element integrated into the BFS vial clicks or snaps into a properly indexed retention feature of the assembly hub. According to some embodiments, one or more seals can be removed or broken during or before coupling, and/or the coupled assembly can be shaken to mix ingredients stored separately in its different components. In some embodiments, the method 900 can include removing the safety cap at 906. An axial force can be applied to separate the cap from the assembly hub, exposing a dosing member, such as a needle, nozzle, dropper, etc. According to some embodiments, the method 900 can include administering a dose of fluid (e.g., a fluid agent or a medicament including an active ingredient reconstituted or dissolved in a carrier fluid or diluent) at 908. The dosing element of the assembly hub can be engaged, for example, with a patient, and the crushable, integral reservoir of the BFS vial can be squeezed (e.g., by applying a radially inward force) to expel fluid therefrom (and/or cause mixing or dissolution of the separately stored active ingredients). According to some embodiments, the fluid can be forced in an antegrade axial direction to displace a valve flap of a one-way valve, thereby allowing the fluid to proceed axially into the dosing element and be delivered to the patient. In some embodiments, the method 900 can include replacing the safety cap at 910. According to some embodiments, the method 900 can include discarding the delivery system at 912. In this way, a low-cost, easily transported, and more easily stored fluid delivery system may be provided that allows for administration and/or self-administration by, for example, unskilled users.

IV. ADDITIONAL EMBODIMENTS Figure 10 shows perspective views of modular delivery or hub assemblies 1026a-d configured for different delivery methods (e.g., intramuscular, subcutaneous, intravenous, and intradermal injections). In some embodiments, each modular hub assembly 1026a-d can include a respective modular hub element 1030a-d (e.g., capable of housing or containing a dry or solid active ingredient), modular valve elements 1050a-d, modular insert elements 1070a-d, and/or modular needle (or other administration) elements 1080a-d. As shown in Figure 10, the various respective needle elements 1080a-d can be configured for different delivery/administration requirements. For example, the needle elements 1080a-d can have various lengths ranging from about one and a half millimeters (1.5 mm) to twenty-five millimeters (25 mm), e.g., the first needle element 1080a being the longest, the second needle element 1080b being shorter than the first needle element 1080a, the third needle element 1080c being shorter than the second needle element 1080b, and/or the fourth needle element 1080d being shorter than the third needle element 1080c. According to some embodiments, the length of the needle elements 1080a-d can range from one-half millimeter (0.5 mm) to fifty millimeters (50 mm). In some embodiments, the only structural difference between the various hub assemblies 1026a-d can be the length (and/or thickness) of the needle elements 1080a-d. Each of the other modular components 1030a-d, 1050a-d, 1070a-d can be identical, for example. Thus, the modular construction of the delivery assemblies 1026a-d can enable rapid manufacturing reconfiguration of one or more components at minimal cost to create new delivery assembly configurations that meet specific needs (i.e., different modes of delivery depending on the agent being delivered, such as subcutaneous, intramuscular, intradermal, intravenous injection, spray, or drop delivery, etc.) For example, the modular hub elements 1030a-d and modular valve elements 1050a-d can remain of the same construction (dimensions and materials), while the modular insert elements 1070a-d can be modified to allow for different size needle elements 1080a-d and/or nozzle types depending on the type of delivery and/or type of fluid agent being delivered.

V. Rules of Interpretation Throughout this description, unless otherwise specified, the following terms may include and/or encompass the exemplary meanings provided. These terms and exemplary meanings are provided to clarify the language chosen to describe the embodiments both in this specification and in the appended claims, i.e., they are not intended to be generally limiting. Although not generally limiting and not limiting to all embodiments described, in some embodiments, terms are specifically limited to the exemplary definitions and/or examples provided. Other terms are defined throughout this specification.

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 way. As is readily apparent from this disclosure, the disclosed invention is broadly applicable to many embodiments. Those skilled in the art will recognize that the disclosed invention can be implemented with various changes and modifications, such as structural, logical, software, and electrical modifications. Although certain features of the disclosed invention may be described with reference to one or more specific embodiments and/or drawings, it should be understood that such features are not limited to use in the one or more specific embodiments or drawings in which they are described, unless expressly specified otherwise.

Devices that communicate with each other do not need to communicate with each other continuously, unless otherwise specified.

The description of an embodiment having several components or features does not imply that all or 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 invention. Unless expressly specified otherwise, no component and/or feature is essential or required.

Furthermore, although process steps, algorithms, and the like may be described in a sequence, such processes may be configured to operate in different orders. In other words, any order or sequence of steps that may be explicitly described does not necessarily indicate a requirement that the steps be performed in that order. Steps of processes described herein may be performed in any order that is practical. Furthermore, some steps may be performed simultaneously despite being described or implied as occurring non-concurrently (e.g., because one step is described after the other). Furthermore, illustration of a process by its depiction in a drawing does not imply that the illustrated process is exclusive of other variations and modifications, does not imply that the illustrated process or any of its steps are required for the invention, and does not imply that the illustrated process is preferred.

This disclosure provides one of ordinary skill in the art with a working description of several embodiments and/or inventions. Some of these embodiments and/or inventions may not be claimed in this application, but may nevertheless be claimed in one or more continuing applications claiming benefit of priority to this application. Applicant intends to file additional applications to pursue patents of subject matter disclosed and enabled but not claimed in this application.

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

Although several embodiments of the present disclosure have been described and illustrated herein, those skilled in the art will readily envision various other means and/or structures for performing the functions and/or obtaining one or more of the results and/or advantages described herein, and each such variation and/or modification 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 on the particular application in which the teachings of the present disclosure are used.

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 present disclosure described herein. Accordingly, the foregoing embodiments are presented by way of example only, and it is to be understood that, within the scope of the appended claims and equivalents thereof, the present 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 is included within the scope of the present disclosure, where such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent.

All definitions and definitions used herein should be understood to control for any dictionary definitions, definitions in documents incorporated by reference, and/or ordinary meanings of the defined terms.

The indefinite articles "a" and "an," as used in this specification and the claims, should be understood to mean "at least one," unless clearly indicated to the contrary.

The term "and/or" as used in the specification and 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. Unless expressly indicated to the contrary, other elements than the elements specifically identified by the "and/or" clause may optionally be present, whether or not related to those elements specifically identified.

Throughout this specification, a reference to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with an embodiment is included in at least one embodiment. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification do not necessarily all refer to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

The terms and expressions used in this specification are used as terms of description and not of limitation, and in the use of such terms and expressions there is no intention to exclude any equivalents of the features (or portions thereof) shown and described, recognizing that various modifications are possible within the scope of the claims. Accordingly, the claims are intended to encompass all such equivalents.

Various modifications of the invention and many further embodiments thereof, in addition to those shown and described herein, will become apparent to those skilled in the art from the entire contents of this specification, including references to the scientific and patent literature cited herein. The subject matter of this specification contains important information, examples and guidance that can be adapted to the practice of the invention in its various embodiments and equivalents thereof.

Claims (15)

1. A delivery system for delivery of a pharmaceutical agent, the delivery system comprising:
a molded-and-filled vial (BFS vial) containing a single dose of a fluid agent and including a neck defining at least one of a protrusion and a projection;
and a delivery assembly securely coupled to the BFS vial and configured to deliver the single dose of the fluid agent, the delivery assembly comprising:
a hub member including a proximal end defining a hub bore and a distal end defining an insert bore, the hub member having a channel providing a fluid path extending between the hub bore and the insert bore, the channel defining an internal dimension, the hub member having at least one of a recess, a recessed portion, and an opening configured to receive and retain at least one of the protrusion and the projection of the neck of the BFS vial when the neck of the BFS vial is disposed within the hub bore to secure the BFS vial to the hub member;
a substrate disposed within the channel of the hub member and intersecting the fluid pathway, the substrate being configured to extend across a majority of the internal dimension of the channel, the substrate having an active ingredient, the active ingredient operable to interact with the fluid agent passing through the substrate and the fluid pathway to generate a medicament for delivery to a patient;
an insert member disposed within the insert bore of the hub member, the insert member having a channel aligned with the fluid path;
an administration member for administering the medicament to the patient, the administration member being coupled to the insert member ;
A delivery system , wherein the substrate is elongated and defines a substrate passageway for passage of the fluid agent through the substrate to facilitate interaction of the fluid agent with the active ingredient . The delivery system of claim 1, wherein the BFS vial has an internal volume configured to release the fluid agent into the fluid pathway, through the channel of the insert member, and into the dispensing member in response to an applied compressive force. 2. The delivery system of claim 1, wherein the BFS vial has an internal volume configured to release the fluid agent into the fluid pathway of the hub member, cause an interaction between the fluid agent and the active ingredient of the substrate , and release the resulting agent through the channel of the insert member and into the dosing member in response to a compressive force applied thereto. The delivery system of claim 1, wherein the dispensing member comprises a nozzle configured to control dispensing of the medication to the patient. The delivery system of claim 1, wherein the recess, the indentation, or the opening is shaped and sized to receive a corresponding shape of the protrusion or projection. The delivery system of claim 5, wherein the protrusion or projection is shaped and sized to prevent withdrawal of the distal end of the BFS vial from the hub bore of the hub member when the protrusion or projection is received within and engages the recess, the indentation, or the opening. The delivery system of claim 1, wherein the BFS vial comprises an electronic device that stores data describing the fluid agent. The delivery system of claim 7, wherein the electronic device includes a near field communication device (NFC device). The delivery system of claim 8, wherein the NFC device is operable to facilitate processing of data defining geographic movement of the BFS vial. The delivery system of claim 1, wherein the hub member includes an electronic device that stores data describing the active ingredient. The delivery system of claim 10, wherein the electronic device includes a near field communication (NFC) device. The delivery system of claim 1 , wherein the substrate defines an elongated spiral shape. 2. The delivery system of claim 1, wherein the substrate comprises at least two spaced apart substrates, each of the at least two substrates comprising the active ingredient and having the substrate passageway. The delivery system of claim 1, wherein the substrate further comprises an insert structure into which the active ingredient is deposited, attached, injected, and/or retained. The delivery system of claim 1, including a valve member attached to the hub member in alignment with the fluid path, the substrate being at a distal end of the valve member.

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