Patent Description:
While IntraDermal ("ID") injections are preferable for the administration of various medicaments, difficulties in administration and in providing effective injection devices have limited the practical application of ID injections. <CIT> proposes a single use injector. <CIT> proposes a system and method for dual-component drug agent delivery. <CIT> proposes packaged products, inserts, and compartments for aseptic mixing of substances. <CIT> proposes a prefilled disposable injection device. <CIT> proposes a prefilled medical injection device.

In a first aspect, embodiments of the invention provide a pre-filled blow-fill-seal intradermal injection system as set out in claim <NUM>.

An understanding of embodiments described herein and many of the attendant advantages thereof may be readily obtained by reference to the following detailed description when considered with the accompanying drawings, wherein:.

Embodiments of the present invention provide systems and methods (not claimed) for pre-filled, single-dose, and/or IntraDermal ("ID") medical agent delivery that overcome drawbacks of current delivery devices and methods. For example, the pre-filled, single-dose, and/or ID medical delivery systems or assemblies of some embodiments may include a plastic (e.g., a Blow-Fill-Seal (BFS)) vial or bottle coupled to a specialized collar, coupling, or connector that facilitates coupling of an administration member (e.g., an ID needle/canula) to the BFS vial. In some embodiments, such a pre-filled, single-dose, and/or ID medical delivery assembly may be selectively actuated by application of an axial or longitudinal force to a shield and/or piston covering the administration member, causing the administration member to axially advance and pierce a fluid reservoir of the BFS vial. In some embodiments, a specialized BFS coupling, connector, or collar may be utilized to seat the BFS vial in a position for puncturing. According to some embodiments, a pre-filled BFS ID delivery system may comprise one or more auto-disable features that permit the system to be utilized for a single dose delivery, after which the system becomes inoperable to administer additional doses (e.g., preventing needle reuse). In some embodiments, the disabling of the device may be accomplished by providing an eccentrically-disposed needle/canula that becomes automatically misaligned with an administration port following use. According to some embodiments, the device may be self-actuating in response to applied axial/longitudinal force such as by employing a plurality of elastic legs that engage with cooperative beveled and/or angled surfaces to displace the legs, thereby imparting an elastic deformation force to the internal components of the device.

Referring initially to <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, various views of a pre-filled BFS ID injection system <NUM>. The pre-filled BFS ID injection system <NUM> may comprise various inter-connected and/or modular components such as a BFS vial <NUM> (or bottle, unit, ampule, etc.) comprising and/or defining a vial neck <NUM>, a fluid seal <NUM>, a mounting flange <NUM>, and/or a collapsible reservoir <NUM> (e.g., comprising an upper reservoir surface <NUM>, a lower reservoir surface <NUM>, and/or a push surface <NUM>). The BFS vial <NUM> may comprise a plastic and/or synthetic vial that is constructed via any practicable manufacturing techniques. The BFS manufacturing technique may be utilized. Where the BFS vial <NUM> is constructed utilizing BFS manufacturing techniques, special characteristics may necessarily be imparted to the BFS vial <NUM> due to the BFS manufacturing technique and may accordingly be inherent in the BFS vial <NUM>. Such characteristics may include, but are not limited to (and indeed may not require), the BFS vial <NUM> (i) being manufactured in an aseptic and/or sterile environment, (ii) being automatically filled and sealed in the aseptic/sterile environment, (iii) being comprised of a soft plastic, e.g., having a Shore/Durometer "D" hardness of between <NUM> and <NUM>, (iv) being formed in two conjoined halves along an axial seam, (v) being geometrically limited to symmetrically moldable features, and/or (vi) being limited to formation in particular temperature ranges (e.g., above freezing). While a particular shape and configuration of the BFS vial <NUM> is depicted for ease of illustration and explanation, other shapes and/or configurations may be utilized. The BFS vial <NUM> may not include, for example, the mounting flange <NUM> and/or may comprise a side or seam flange (not shown; e.g., formed between different co-manufactured units of BFS vials <NUM> and providing and/or defining a cut or punch surface at which the different units are separated post-manufacture).

The pre-filled BFS ID injection system <NUM> may comprise a mounting collar or connector <NUM> in which the BFS vial <NUM> is seated. The connector <NUM> may comprise and/or define, for example, a BFS chamber <NUM>-<NUM>, a BFS detent <NUM>-<NUM>, a hub bore <NUM>-<NUM>, an interior cone <NUM>, a cone lip <NUM>-<NUM>, an interior surface <NUM>, a seat <NUM>, and/or a track <NUM>. The pre-filled BFS ID injection system <NUM> may comprise a hub <NUM> comprising an annular, circular, and/or cylindrical base <NUM>, an administration seat <NUM>, one or more legs <NUM>, one or more feet <NUM>-<NUM>, and/or one or more rails <NUM>. The pre-filled BFS ID injection system <NUM> may comprise an injection shield <NUM> comprising a cylindrical body <NUM>, an administration bore <NUM>, and/or one or more legs <NUM> and/or one or more feet <NUM>-<NUM>. The pre-filled BFS ID injection system <NUM> may comprise an administration member <NUM> and/or a cap <NUM>. The pre-filled BFS ID injection system <NUM> may comprise a modular design consisting of separately constructed components <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> cooperatively arranged and coupled to one another. Some of the components <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may be manufactured, created, molded, and/or otherwise formed together.

The collapsible reservoir <NUM> of the BFS vial <NUM> may be filled (fully or partially) with a fluid or other agent (not separately shown) such as a medicament. The fluid may be injected into the BFS vial <NUM> in a sterile environment during manufacture via a BFS process and sealed within the BFS vial <NUM> via the fluid seal <NUM>. The fluid seal <NUM> may comprise a portion of the molded BFS vial <NUM> for example that is configured to be pierced to expel the fluid, e.g., such as by providing a flat or planar piercing surface, being selectively formed with a particular material thickness, and/or by being oriented normal to an axis of the BFS vial <NUM> (and/or the pre-filled BFS ID injection system <NUM>). The fluid seal <NUM> may comprise a foil, wax, paper, and/or other thin, pierceable object or layer coupled to the BFS vial <NUM>. The neck <NUM> of the BFS vial <NUM> may comprise the mounting flange <NUM> such as, e.g., the "doughnut"-shaped exterior flange depicted (and/or one or more other tabs, detents, protrusions, and/or other features). The mounting flange <NUM> may also or alternatively comprise a side or seam flange (not depicted), e.g., whether disposed/formed on the neck <NUM> or elsewhere on the BFS vial <NUM>. As depicted, the neck <NUM> may be cylindrically shaped. The neck <NUM> may comprise one or more other cross-sectional shapes or configurations such as a triangle, square, rectangle, pentagon, hexagon, star, and/or octagon shape. The shape of the neck <NUM> may correspond to a type of fluid agent stored in the BFS vial <NUM>.

The connector <NUM> may be axially engaged to couple with the BFS vial <NUM> via application of an axial mating force. The connector <NUM> (and/or the BFS chamber <NUM>-<NUM> thereof) may be urged onto the neck <NUM> of the BFS vial <NUM>, for example (or vice versa), such that it accepts and/or selectively couples to the mounting flange <NUM> (e.g., via the seat <NUM>), thereby removably coupling the BFS vial <NUM> and the mounting collar <NUM>. The BFS chamber <NUM>-<NUM> (and/or the BFS detent <NUM>-<NUM>) may be shaped to correspond to and/or cooperatively mate with the shape of the neck <NUM> and/or of the collapsible reservoir <NUM> of the BFS vial <NUM>. In the case that the neck <NUM> is cylindrically or triangularly shaped, for example, the BFS chamber <NUM>-<NUM> may comprise a cylindrical or triangular opening and/or passage, respectively. Uncoupling of the BFS vial <NUM> and the connector <NUM> may be mechanically prohibited. The mounting flange <NUM> may effectively lock into the seat <NUM> connector <NUM> once inserted, for example, preventing or inhibiting removal thereafter. When seated in the BFS chamber <NUM>-<NUM> (and/or the BFS detent <NUM>-<NUM>), the BFS vial <NUM> may be substantially shrouded by the connector <NUM>. As depicted, for example, in a seated configuration, only the upper reservoir surface <NUM> and the push surface <NUM> may be externally exposed and/or accessible. A first end of the connector <NUM> (and/or of the pre-filled BFS ID injection system <NUM>) may be referred to as a distal end, as it is distal from a site of injection (not separately labeled). Utilizing such terminology, the BFS vial <NUM> may be coupled to and/or seated in the connector <NUM> at the distal end thereof.

The hub <NUM> may be selectively coupled to and/or seated in the hub bore <NUM>-<NUM> of a proximal end of the connector <NUM>. The legs <NUM> of the hub <NUM> may extend into the hub bore <NUM>-<NUM> and engage with the interior cone <NUM> and/or the cone lip <NUM>-<NUM> thereof. Each leg <NUM> (and/or a foot <NUM>-<NUM> thereof) may comprise a pliable member that is elastically and radially offset as the hub <NUM> is inserted axially deeper into the hub bore <NUM>-<NUM> such that the legs <NUM> (and/or feet <NUM>-<NUM> thereof) travel along the increasing outer diameter of the interior cone <NUM>. In such a manner, for example, elastic and/or axial resistance may increase as the hub <NUM> is inserted axially deeper into the hub bore <NUM>-<NUM>. The hub <NUM> may couple to and/or retain the administration member <NUM>. The administration member <NUM> may be inserted into the administration seat <NUM> of the hub <NUM>, for example, such that a first or piercing end (not separately labeled) is disposed within the hub bore <NUM>-<NUM>, e.g., in the case that the hub <NUM> is seated in the hub bore <NUM>-<NUM>, and a second or administration end (not separately labeled) extends axially distal from the BFS vial <NUM>. In a first state or engagement position, the administration member <NUM> and/or the piercing end thereof may be positioned adjacent to (e.g., axially adjacent to) the interior surface <NUM> (and/or a specific portion thereof). The administration end and/or a distal portion of the administration member <NUM> may be housed, shrouded, and/or covered by the shield <NUM> and/or the cap <NUM>.

When seated in the hub bore <NUM>-<NUM>, the rails <NUM> of the hub <NUM> may engage with and/or seat in the track <NUM>. As depicted, the track <NUM> and corresponding rails <NUM> may be shaped in a triangular and/or otherwise cammed or disjointed track pattern such that axial insertion of the hub <NUM> into the hub bore <NUM>-<NUM> causes an axial rotation of the hub <NUM> with respect to the connector <NUM>. Such a rotation may cause the administration member <NUM> and/or the piercing end thereof to attain a piercing position with respect to the interior surface <NUM> (and/or a specific portion thereof). As depicted, for example, the administration member <NUM> (and the corresponding administration seat <NUM>) may be axially offset (e.g., eccentrically positioned) from a central axis of the pre-filled BFS ID injection system <NUM>. Rotation of the hub <NUM> may cause the piercing end of the administration member <NUM> to travel along a circular path over or on the interior surface <NUM>. In the case that a particular portion of the interior surface <NUM> is thinner and/or otherwise configured to accept the administration member <NUM>, the administration member <NUM> may pierce the interior surface <NUM> and travel into and pierce the fluid seal <NUM> of the BFS vial <NUM> upon achievement of a particular axial insertion distance (and corresponding axial rotation due to engagement of the track <NUM> and rails <NUM>). The pre-filled BFS ID injection system <NUM> may be configured such that a rotation in the range of three degrees (<NUM>°) to seven degrees (<NUM>°) of the hub <NUM> (and/or the shield <NUM>) may cause the administration member <NUM> to become misaligned with the administration bore <NUM> and/or a desired portion of the interior surface <NUM> (e.g., a puncture area - not separately shown or labeled).

The shield <NUM> may be selectively coupled to and/or seated in the hub bore <NUM>-<NUM> of the proximal end of the connector <NUM>. The legs <NUM> of the shield <NUM> may extend into the hub bore <NUM>-<NUM> and engage with the interior cone <NUM> and/or the cone lip <NUM>-<NUM> thereof. Each leg <NUM> (and/or a foot <NUM>-<NUM> thereof) may comprise a pliable member that is elastically and radially offset as the shield <NUM> is inserted axially deeper into the hub bore <NUM>-<NUM> such that the legs <NUM> (and/or feet <NUM>-<NUM> thereof) travel along the increasing outer diameter of the interior cone <NUM>. In such a manner, for example, elastic and/or axial resistance may increase as the shield <NUM> is inserted axially deeper into the hub bore <NUM>-<NUM>. As depicted, each of the hub <NUM> and the shield <NUM> may be coupled to the connector <NUM>. The legs <NUM> of the shield <NUM> may, for example, extend through and/or past the hub <NUM> such that all legs <NUM>, <NUM> (and/or feet <NUM>-<NUM>, <NUM>-<NUM>) simultaneously engage with the interior cone <NUM>. The number, size, and/or shape of the legs <NUM>, <NUM> (and/or feet <NUM>-<NUM>, <NUM>-<NUM>) and the angle of the interior cone <NUM> may be adjusted to achieve a desired axial insertion resistance profile.

As depicted in <FIG>, the shield <NUM> and the hub <NUM> may be axially advanced into the hub bore <NUM>-<NUM> by engaging (e.g., pressing) the proximal end of the shield <NUM> against an injection surface (e.g., human skin). Such advancement/engagement may cause the piercing end of the administration member <NUM> to advance through the interior surface <NUM> (and/or a specific portion thereof and pierce the fluid seal <NUM> of the BFS vial <NUM>. The advancement/engagement may also cause the administration end of the administration member <NUM> to become aligned with and advance through the administration bore <NUM> and into the target. Once the administration member <NUM> has entered the target, the push surface <NUM> of the BFS vial <NUM> may be axially forced toward the injection site, causing the collapsible reservoir <NUM> to compress against the BFS detent <NUM>-<NUM> and thereby causing any fluid therein to advance through the administration member <NUM> and into the target (e.g., forming an ID "bleb"). Release of the axial pressure/force from the shield <NUM> may cause the elastic force of the legs <NUM>, <NUM> (and/or feet <NUM>-<NUM>, <NUM>-<NUM>) to release, thereby causing the legs <NUM>, <NUM> (and/or feet <NUM>-<NUM>, <NUM>-<NUM>) to retreat from the interior cone <NUM>. The legs <NUM>, <NUM> (and/or feet <NUM>-<NUM>, <NUM>-<NUM>) may stop retreating upon engagement with the cone lip <NUM>-<NUM>, e.g., preventing uncoupling of the hub <NUM> and the shield <NUM> from the connector <NUM>.

The reverse travel or retreating of the legs <NUM>, <NUM> (and/or feet <NUM>-<NUM>, <NUM>-<NUM>) may cause the rails <NUM> riding in the track <NUM> to urge the hub <NUM> (and/or the shield <NUM>) to rotate axially. Such rotation may cause the axially-offset administration member <NUM> to become misaligned from the hole made by the piercing of the BFS vial <NUM> and/or from the administration bore <NUM>. In such a manner, for example, the pre-filled BFS ID injection system <NUM> may become deactivated and/or rendered unusable (e.g., for reuse). This rotational misalignment and/or the collapsing of the collapsible reservoir <NUM> may selectively and automatically disable the pre-filled BFS ID injection system <NUM>.

Hub <NUM> and shield <NUM> combination may be utilized to couple and/or mate the administration member <NUM> with the connector <NUM>. The connector <NUM> may provide a mechanism via which the administration member <NUM> may be coupled to be in fluid communication with a soft plastic BFS vial <NUM> in a reliable manner. Due to the nature of the BFS plastic and/or process and/or the small form-factor of the BFS vial <NUM>, providing external machine-type threads (not shown) directly on the neck <NUM> may not be a viable option for it would result in an imprecise, unreliable, and/or non-water tight coupling (i.e., the threads may be deformable even if they could be properly manufactured to within the desired tolerances) between the BFS vial <NUM> and, e.g., the connector <NUM>.

The administration member <NUM> may include a needle or canula for at least one of ID, subcutaneous, intramuscular, and intravenous injection of a combination of the fluid agent from the BFS vial <NUM> into a patient. The pre-filled BFS ID injection system <NUM> may be configured such that, e.g., for IDS injections, approximately one and one half millimeters (<NUM>-mm) of exposure of the administration end of the administration member <NUM> may be exposed for insertion into the target. For ease of explanation and description, the figures and the description herein generally refer to the administration member <NUM> as a needle and are described for convenience with respect to an ID injection. However, it should be noted that the injection may be other than ID and/or the administration member <NUM> may include a nozzle (not shown) configured to control administration of the combined agent to the patient. The nozzle may include a spray nozzle, for example, configured to facilitate dispersion of the combined agent into a spray. Accordingly, a pre-filled BFS ID injection system <NUM> fitted with a spray nozzle may be particularly useful in the administration of a combined agent into the nasal passage, for example, or other parts of the body that benefit from a spray application (e.g., ear canal, other orifices). The nozzle may be configured to facilitate formation of droplets of the combined fluid agent. Thus, a pre-filled BFS ID injection system <NUM> including a droplet nozzle may be useful in the administration of a combined agent by way of droplets, such as administration to the eyes, topical administration, and the like. In each of these cases, the pre-filled BFS ID injection system <NUM> would more appropriately be referred to as a pre-filled BFS "administration" system <NUM>.

As generally understood, the fluid agent or drug may include any type of agent to be injected into a patient (e.g., mammal, either human or non-human) and capable of producing an effect (alone, or in combination with an active ingredient). Accordingly, the agent may include, but is not limited to, a vaccine, a drug, a therapeutic agent, a medicament, a diluent, and/or the like. The fluid in the BFS vial <NUM> may comprise, for example, the active ingredient of the drug agent or an object that retains, carries, or holds the active ingredient.

The connector <NUM>, the hub <NUM>, the shield <NUM>, and/or the cap <NUM> may be composed of a medical grade material such as Polylactic Acid (PLA) and/or another thermoplastic elastomer. The connector <NUM>, the hub <NUM>, the shield <NUM>, and/or the cap <NUM>, may be composed of a thermoplastic polymer or other "hard" plastic (e.g., greater than <NUM> on the Rockwell "R" scale), including, but not limited to, polybenzimidazole, acrylonitrile butadiene styrene (ABS), polystyrene, polyvinyl chloride, or the like. The BFS vial <NUM> may be formed of one or more polyolefins such as Low-Density PolyEthylene (LDPE), High-Density PolyEthylene (HDPE), and/or PolyPropylene (PP) and/or one or more other thermoplastics such as Thermoplastic PolyUrethane (TPU).

Fewer or more components <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>, <NUM>-<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>-<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>-<NUM>, <NUM>, <NUM> and/or various configurations of the depicted components <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>, <NUM>-<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>-<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>-<NUM>, <NUM>, <NUM> may be included in the pre-filled BFS ID injection system <NUM>. The components <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>, <NUM>-<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>-<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>-<NUM>, <NUM>, <NUM> may be similar in configuration and/or functionality to similarly named and/or numbered components as described herein. The pre-filled BFS ID injection system <NUM> (and/or portions thereof) may comprise a disposable, auto-disabled, single-dose delivery assembly operable to be utilized to execute, conduct, and/or facilitate various methods.

Turning to <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, front perspective, rear perspective, front perspective cross-section, front, back, left, right, top, and bottom views of an ID injection hub <NUM> are shown. The ID injection hub <NUM> may comprise similar features and/or configurations and/or may be similar to the hub <NUM> of <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG> herein. The ID injection hub <NUM> may comprise and/or define, for example, a circular, annular, and/or cylindrical base <NUM>. An administration seat <NUM> may extend through the cylindrical base <NUM> (and/or through a center portion thereof; not separately labeled) from a first side to a second side thereof. As depicted the administration seat <NUM> may be eccentric to a central axis of the ID injection hub <NUM>, e.g., to facilitate and/or enable auto-disable functionality as described herein. The ID injection hub <NUM> may comprise one or more legs <NUM> extending axially away from the cylindrical base <NUM> (e.g., in a first axial direction). The legs <NUM> may comprise pliable and/or elastic or semi-elastic elongated members that extend from the cylindrical base <NUM> from respective locations radially disposed between the center of the cylindrical base <NUM> and the radial extents of the cylindrical base <NUM>. Each leg <NUM> may comprise and/or define a foot <NUM>-<NUM> disposed on a radially interior side of the respective legs <NUM>. The feet <NUM>-<NUM> may comprise, for example, radially inwardly projections disposed proximate to the axial extents of the respective legs <NUM>. The cylindrical base <NUM> may comprise and/or define one or more cam features or rails <NUM> disposed radially about the cylindrical base <NUM>. As depicted, for example, the rails <NUM> may comprise one or more circumferential features such as detents, projections, and/or other shaped portions. The rails <NUM> may comprise sloped, tapered, cammed, and/or otherwise disjointed and/or uneven surface features, e.g., operable to rotate the hub <NUM> in the case that the rails <NUM> are axially engaged with a corresponding track (not shown).

Fewer or more components <NUM>, <NUM>, <NUM>, <NUM>-<NUM>, <NUM> and/or various configurations of the depicted components <NUM>, <NUM>, <NUM>, <NUM>-<NUM>, <NUM> may be included in the ID injection hub <NUM>. The components <NUM>, <NUM>, <NUM>, <NUM>-<NUM>, <NUM> may be similar in configuration and/or functionality to similarly named and/or numbered components as described herein. The ID injection hub <NUM> (and/or portions thereof) may comprise a disposable, auto-disabled, single-dose delivery assembly operable to be utilized to execute, conduct, and/or facilitate various methods.

Referring additionally to <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, front perspective, perspective cross-section, front, back, left, right, top, and bottom views of a BFS ID injection connector <NUM>. The BFS ID injection connector <NUM> may comprise similar features and/or configurations and/or may be similar to the connector <NUM> of <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG> herein. The BFS ID injection connector <NUM> may comprise, for example, a generally cylindrical body defining a BFS chamber <NUM>-<NUM>, a BFS detent <NUM>-<NUM>, and/or a hub bore <NUM>-<NUM>. A pathway into the BFS chamber <NUM>-<NUM> may be modified from a simply circular (or other chosen geometry) cross-section to provide for easier entry of an inserted mounting flange of a BFS vial (not shown). The hub bore <NUM>-<NUM> may also or alternatively be shaped and/or sized to receive and/or engage with various components (not shown) such as a hub and/or a shield. As depicted for example, the hub bore <NUM>-<NUM> may comprise and/or define an interior cone <NUM> (e.g., a frustoconical shape) comprising and/or defining a cone detent, exterior channel, and/or lip <NUM>-<NUM>. An axial terminus of the interior cone <NUM> may comprise and/or define an interior surface <NUM>. The interior surface <NUM> may comprise a planar surface oriented normally to the longitudinal axis of the BFS ID injection connector <NUM>. One or more portions of the interior surface <NUM> may comprise and/or define a puncture surface <NUM>-<NUM>. As depicted in <FIG>, for example, the puncture surface <NUM>-<NUM> may comprise a circular or cylindrical portion of the interior surface <NUM> that comprises an axial thickness that is less than an axial thickness of the remainder of the interior surface <NUM>. In such a manner, for example, a needle or other puncturing member (not shown) may be limited to successfully puncturing the interior surface <NUM> through the puncture surface <NUM>-<NUM>, while engagement with other portions of the interior surface <NUM> would frustrate puncturing. As depicted, the puncture surface <NUM>-<NUM> may be eccentrically situated such that it is offset from a central portion or axis of the BFS ID injection connector <NUM>. In such a manner, for example, a needle and/or other puncture member that is itself eccentric to the central axis must be rotationally aligned with the puncture surface <NUM>-<NUM> to permit puncturing/breaching of the interior surface <NUM> (and attendant puncturing and/or engagement with a BFS vial (not shown) seated in the BFS chamber <NUM>-<NUM>).

The BFS ID injection connector <NUM> and/or the BFS chamber <NUM>-<NUM> thereof may comprise an internal groove or seat <NUM> that is cooperatively sized and configured to receive a mounting flange of a BFS vial (neither shown; e.g., the mounting flange/feature <NUM> of the BFS vial <NUM> of <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG> herein). In such a manner, for example, a BFS vial may be selectively and/or removably coupled to the BFS ID injection connector <NUM>. A cooperatively shaped BFS vial may comprise a neck and/or exterior flange that fit within the BFS chamber <NUM>-<NUM> and/or may comprise a conical and/or frustoconical reservoir portion that seats in the BFS detent <NUM>-<NUM>. The BFS ID injection connector <NUM> may comprise and/or define a track <NUM>, e.g., within the hub bore <NUM>-<NUM>. The track <NUM> may comprise and/or define, for example, a plurality of circumferentially arranged and/or offset projections, grooves, channels, and/or shaped elements that are configured to accept and/or guide one or more corresponding features (not shown) of an object inserted into the hub bore <NUM>-<NUM>.

Fewer or more components <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>, <NUM>-<NUM>, <NUM>, <NUM>-<NUM>, <NUM>, <NUM> and/or various configurations of the depicted components <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>, <NUM>-<NUM>, <NUM>, <NUM>-<NUM>, <NUM>, <NUM> may be included in the BFS ID injection connector <NUM>. The components <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>, <NUM>-<NUM>, <NUM>, <NUM>-<NUM>, <NUM>, <NUM> may be similar in configuration and/or functionality to similarly named and/or numbered components as described herein. The BFS ID injection connector <NUM> may comprise a disposable, auto-disabled, single-dose delivery assembly operable to be utilized to execute, conduct, and/or facilitate various methods.

Turning now to <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, front perspective, perspective cross-section, front, back, left, right, top, and bottom views of an ID injection shield <NUM> are shown. The ID injection shield <NUM> may comprise similar features and/or configurations and/or may be similar to the shield <NUM> of <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG> herein. The ID injection shield <NUM> may comprise and/or define, for example, a circular, annular, and/or cylindrical body <NUM> defining an interior volume <NUM>-<NUM>. An administration bore <NUM> may extend through the cylindrical body <NUM> (and/or through a center portion thereof; not separately labeled) from a first side to a second side thereof. As depicted, the administration bore <NUM> may be eccentric to a central axis of the ID injection shield <NUM>, e.g., to facilitate and/or enable auto-disable functionality as described herein. The ID injection shield <NUM> may comprise one or more legs <NUM> extending axially away from the cylindrical body <NUM> (e.g., in a first axial direction). The legs <NUM> may comprise pliable and/or elastic or semi-elastic elongated members that extend from the cylindrical body <NUM> from respective locations radially disposed between the center of the cylindrical body <NUM> and the radial extents of the cylindrical body <NUM>. Each leg <NUM> may comprise and/or define a foot <NUM>-<NUM> disposed on a radially interior side of the respective legs <NUM>. The feet <NUM>-<NUM> may comprise, for example, radially inwardly projections disposed proximate to the axial extents of the respective legs <NUM>.

Fewer or more components <NUM>, <NUM>-<NUM>, <NUM>, <NUM>, <NUM>-<NUM> and/or various configurations of the depicted components <NUM>, <NUM>-<NUM>, <NUM>, <NUM>, <NUM>-<NUM> may be included in the ID injection shield <NUM>. The components <NUM>, <NUM>-<NUM>, <NUM>, <NUM>, <NUM>-<NUM> may be similar in configuration and/or functionality to similarly named and/or numbered components as described herein. The ID injection shield <NUM> may comprise a disposable, auto-disabled, single-dose delivery assembly operable to be utilized to execute, conduct, and/or facilitate various methods.

Referring additionally to <FIG>, <FIG>, front perspective, front, top, and bottom views of pre-filled BFS vial <NUM>. Pre-filled BFS vial <NUM> may comprise similar features and/or configurations and/or may be similar to the BFS vial <NUM> of <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG> herein. The pre-filled BFS vial <NUM> may comprise and/or define, for example, a vial neck <NUM>, a fluid seal <NUM>, a mounting flange <NUM>, and/or a collapsible reservoir <NUM> (e.g., comprising an upper reservoir surface <NUM>, a lower reservoir surface <NUM>, and/or a push surface <NUM>). The neck <NUM> may comprise a cylindrical and longitudinally extended feature that is sealed at a proximal end by the fluid seal <NUM>, comprises the mounting flange <NUM> disposed on an exterior surface and along the length thereof, and/or is coupled to and/or in communication with the collapsible reservoir <NUM> at a distal end. The collapsible reservoir <NUM> may comprise an (e.g., one or more) ellipsoid, disc, conical, and/or frustoconical shape or volume defining the upper reservoir surface <NUM> and the lower reservoir surface <NUM>). As depicted, for example, the collapsible reservoir <NUM> may comprise a shape configured such that the upper reservoir surface <NUM> may be collapsed into or onto the lower reservoir surface <NUM>, thereby substantially collapsing the collapsible reservoir <NUM>. In the case that the fluid seal <NUM> is punctured (as described herein), application of axial compressive force to the push surface <NUM> and/or the upper reservoir surface <NUM> may cause the collapsible reservoir <NUM> to fold inward upon itself, thereby expelling a volume of fluid that was previously housed within the collapsible reservoir <NUM>. In such a manner, for example, the collapsible reservoir <NUM> may be compressed to expel a vaccine and/or other medicament from the BFS vial <NUM> (e.g., and into a patient; not shown). The collapsing may not be readily reversible. The push surface <NUM> may not comprise a large enough grip surface, for example, to permit human gripping for application of reverse or axially outward expansive force.

Fewer or more components <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and/or various configurations of the depicted components <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may be included in the pre-filled BFS vial <NUM>. The components <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may be similar in configuration and/or functionality to similarly named and/or numbered components as described herein. The pre-filled BFS vial <NUM> may comprise a disposable, auto-disabled, single-dose delivery assembly (or portion thereof) operable to be utilized to execute, conduct, and/or facilitate various methods.

Referring initially to <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG>, various views of a pre-filled BFS ID injection system <NUM> according to some embodiments are shown. In some embodiments, the pre-filled BFS ID injection system <NUM> may comprise various inter-connected and/or modular components such as a BFS vial <NUM> (or bottle, unit, ampule, etc.) comprising and/or defining a vial neck <NUM>, a fluid seal <NUM>, a mounting flange <NUM>, and/or one or more collapsible reservoirs 620a-b (e.g., comprising an upper reservoir surface 622a-b, a lower reservoir surface 624a-b, and/or a push surface <NUM>). According to some embodiments, the BFS vial <NUM> may comprise a plastic and/or synthetic vial that is constructed via any practicable manufacturing techniques. In some embodiments the BFS manufacturing technique may be utilized. In embodiments where the BFS vial <NUM> is constructed utilizing BFS manufacturing techniques, special characteristics may necessarily be imparted to the BFS vial <NUM> due to the BFS manufacturing technique and may accordingly be inherent in the BFS vial <NUM>. Such characteristics may include, but are not limited to (and indeed may not require), the BFS vial <NUM> (i) being manufactured in an aseptic and/or sterile environment, (ii) being automatically filled and sealed in the aseptic/sterile environment, (iii) being comprised of a soft plastic, e.g., having a Shore/Durometer "D" hardness of between <NUM> and <NUM>, (iv) being formed in two conjoined halves along an axial seam, (v) being geometrically limited to symmetrically moldable features, and/or (vi) being limited to formation in particular temperature ranges (e.g., above freezing). While a particular shape and configuration of the BFS vial <NUM> is depicted for ease of illustration and explanation, other shapes and/or configurations may be utilized without deviating from some embodiments. The BFS vial <NUM> may not include, in some embodiments for example, the mounting flange <NUM> and/or may comprise a side or seam flange (not shown; e.g., formed between different co-manufactured units of BFS vials <NUM> and providing and/or defining a cut or punch surface at which the different units are separated post-manufacture).

According to some embodiments, the pre-filled BFS ID injection system <NUM> may comprise a mounting collar or connector <NUM> in which the BFS vial <NUM> is seated. The connector <NUM> may comprise and/or define, for example, a BFS chamber <NUM>-<NUM>, a BFS detent <NUM>-<NUM>, a hub bore <NUM>-<NUM>, an interior flange <NUM>-<NUM>, an exterior flange <NUM>-<NUM>, an interior cone <NUM>, an interior surface <NUM>, one or more puncture surfaces <NUM>-1a, <NUM>-1b, a seat <NUM>, and/or a flange seat <NUM>-<NUM>. In some embodiments, the pre-filled BFS ID injection system <NUM> may comprise a hub <NUM> comprising an annular, circular, and/or cylindrical base <NUM>, one or more base guides <NUM>-1a, <NUM>-1b, an administration seat <NUM>, one or more upper legs <NUM>, and/or one or more lower legs <NUM>. According to some embodiments, the pre-filled BFS ID injection system <NUM> may comprise a piston <NUM> that may selectively engage with the hub <NUM>. The piston <NUM> may comprise and/or define, for example, a piston body <NUM>-<NUM> (e.g., cylindrical as shown) with one or more leg tracks 654a, 654d formed and/or disposed thereupon. The leg tracks 654a, 654d may be configured, for examples, such that a coupling of the piston <NUM> and the hub <NUM> engages the one or more lower legs <NUM> with the leg tracks 654a, 654d. According to some embodiments, engagement of the one or more lower legs <NUM> with the leg tracks 654a, 654d via application of axial/longitudinal force (e.g., applied and/or received along an axis "A" of the pre-filled BFS ID injection system <NUM>) may urge the lower legs <NUM> radially outward, thereby generating a radial elastic force.

In some embodiments, the pre-filled BFS ID injection system <NUM> may comprise an injection stopper or shield <NUM> comprising a cylindrical body <NUM> defining an interior volume <NUM>-<NUM>, an administration bore <NUM> disposed at a proximal end of the interior volume <NUM>-<NUM>, and/or one or more shoulders <NUM> disposed and/or formed within the interior volume <NUM>-<NUM>. In some embodiments, the injection shield <NUM> may comprise and/or define one or more axial slots or slits <NUM> (e.g., on or through an exterior wall of the cylindrical body <NUM>). According to some embodiments, the pre-filled BFS ID injection system <NUM> may comprise an administration member <NUM> and/or a cap <NUM>. The administration member <NUM> may, for example, be coupled to and/or retained by the administration seat <NUM> of the hub <NUM> and/or the cap <NUM> may be seated with the exterior flange <NUM>-<NUM> of the connector <NUM> (e.g., selectively covering and/or housing portions of the connector <NUM>, the injection shield <NUM>, and/or the piston <NUM>). According to some embodiments, the pre-filled BFS ID injection system <NUM> may comprise a modular design consisting of separately constructed components <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> cooperatively arranged and coupled to one another. According to some embodiments, some of the components <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may be manufactured, created, molded, and/or otherwise formed together.

In some embodiments, the collapsible reservoirs 620a-b of the BFS vial <NUM> may together (in the case there are more than one) define a fluid volume that may be filled (fully or partially) with a fluid or other agent (not separately shown) such as a medicament. According to some embodiments, the fluid may be injected into the BFS vial <NUM> in a sterile environment during manufacture via a BFS process and sealed within the BFS vial <NUM> via the fluid seal <NUM>. The fluid seal <NUM> may comprise a portion of the molded BFS vial <NUM> for example that is configured to be pierced to expel the fluid, e.g., such as by providing a flat or planar piercing surface, being selectively formed with a particular material thickness, and/or by being oriented normal to an axis of the BFS vial <NUM> (and/or the pre-filled BFS ID injection system <NUM>). In some embodiments, the fluid seal <NUM> may comprise a foil, wax, paper, and/or other thin, pierceable object or layer coupled to the BFS vial <NUM>. In some embodiments, the neck <NUM> of the BFS vial <NUM> may comprise the mounting flange <NUM> such as, e.g., the "doughnut"-shaped exterior flange depicted (and/or one or more other tabs, detents, protrusions, and/or other features). In some embodiments, the mounting flange <NUM> may also or alternatively comprise a side or seam flange (not depicted), e.g., whether disposed/formed on the neck <NUM> or elsewhere on the BFS vial <NUM>. According to some embodiments, and as depicted, the neck <NUM> may be cylindrically shaped. In some embodiments, the neck <NUM> may comprise one or more other cross-sectional shapes or configurations such as a triangle, square, rectangle, pentagon, hexagon, star, and/or octagon shape. In some embodiments, the shape of the neck <NUM> may correspond to a type of fluid agent stored in the BFS vial <NUM>.

According to some embodiments, the connector <NUM> may be axially engaged to couple with the BFS vial <NUM> via application of an axial mating force. The connector <NUM> (and/or the BFS chamber <NUM>-<NUM> thereof) may be urged onto the neck <NUM> of the BFS vial <NUM>, for example (or vice versa), such that it accepts and/or selectively couples to the mounting flange <NUM> (e.g., via the seat <NUM> and/or the flange seat <NUM>-<NUM>), thereby removably coupling the BFS vial <NUM> and the mounting collar <NUM>. According to some embodiments, the BFS chamber <NUM>-<NUM> (and/or the BFS detent <NUM>-<NUM>) may be shaped to correspond to and/or cooperatively mate with the shape of the neck <NUM> and/or of at least one of the collapsible reservoirs 620a-b (e.g., a second or proximal reservoir 620b) of the BFS vial <NUM>. In the case that the neck <NUM> is cylindrically or triangularly shaped, for example, the BFS chamber <NUM>-<NUM> may comprise a cylindrical or triangular opening and/or passage, respectively. In some embodiments, uncoupling of the BFS vial <NUM> and the connector <NUM> may be mechanically prohibited. The mounting flange <NUM> may effectively lock into the seat <NUM> (and/or the flange seat <NUM>-<NUM>) connector <NUM> once inserted, for example, preventing or inhibiting removal thereafter. According to some embodiments, when seated in the BFS chamber <NUM>-<NUM> (and/or the BFS detent <NUM>-<NUM>), the BFS vial <NUM> may be substantially shrouded by the connector <NUM>. As depicted, for example, in a seated configuration, only a first or distal reservoir 620a and/or the upper reservoir surface 622a thereof and/or the push surface <NUM> may be externally exposed and/or accessible. According to some embodiments, a first end of the connector <NUM> (and/or of the pre-filled BFS ID injection system <NUM>) may be referred to as a distal end, as it is distal from a site of injection (not separately labeled). Utilizing such terminology, the BFS vial <NUM> may be coupled to and/or seated in the connector <NUM> at the distal end thereof.

In some embodiments, the hub <NUM> may be selectively coupled to and/or seated in the hub bore <NUM>-<NUM> of a proximal end of the connector <NUM>. According to some embodiments, the upper legs <NUM> of the hub <NUM> may extend into the hub bore <NUM>-<NUM> and engage with the interior cone <NUM> thereof. Each upper leg <NUM> may, in some embodiments, comprise a pliable member that is elastically and radially offset as the hub <NUM> is inserted axially deeper into the hub bore <NUM>-<NUM> such that the upper legs <NUM> travel along the increasing outer diameter of the interior cone <NUM>. In such a manner, for example, elastic and/or axial resistance may increase as the hub <NUM> is inserted axially deeper into the hub bore <NUM>-<NUM>. According to some embodiments the hub <NUM> may couple to and/or retain the administration member <NUM>. The administration member <NUM> may be inserted into the administration seat <NUM> of the hub <NUM>, for example, such that a first or piercing end (not separately labeled) is disposed within the hub bore <NUM>-<NUM>, e.g., in the case that the hub <NUM> is seated in the hub bore <NUM>-<NUM>, and a second or administration end (not separately labeled) extends axially distal from the BFS vial <NUM>. According to some embodiments, in a first state or engagement position, the administration member <NUM> and/or the piercing end thereof may be positioned adjacent to (e.g., axially adjacent to) the interior surface <NUM> (and/or a specific portion thereof such as the puncture surface(s) <NUM>-1a, <NUM>-1b). In some embodiments, the administration end and/or a distal portion of the administration member <NUM> may be housed, shrouded, and/or covered by the piston, <NUM>, the shield <NUM> and/or the cap <NUM> (e.g., in the case that the latter has been installed and/or has not yet been removed).

According to some embodiments, the pre-filled BFS ID injection system <NUM> may be assembled and/or provided in the first state or engagement position where the cap <NUM> is coupled to the connector <NUM> and the administration member <NUM> is completely or substantially aligned (e.g., axially) with a guide hole <NUM>-<NUM> at a proximal end of the piston. In some embodiments, in the first state or engagement position the base guides <NUM>-1a, <NUM>-1b may comprise radially protruding tabs or features that are coupled to and/or held by the injection shield <NUM> in a first radial orientation. According to some embodiments, in the first state or engagement position the upper legs <NUM> of the hub <NUM> may be engaged to a first amount or degree with the interior cone <NUM> of the connector <NUM> and the lower legs <NUM> may be engaged to a first amount or degree with the leg tracks 654a, 654d of the piston <NUM>.

In some embodiments, the cap <NUM> may be removed, exposing the proximal end of the piston <NUM> (and, e.g., the proximal portions of the injection shield <NUM>). In the first state or engagement position, the administration end of the administration member <NUM> may be shrouded by the piston <NUM>, e.g., to prevent accidental injury once the cap <NUM> is removed. According to some embodiments, a user (e.g., self-administration patient, doctor, nurse, etc.) may transition the pre-filled BFS ID injection system <NUM> from the first state or engagement position to a second state or engagement position whereby the BFS vial <NUM> is pierced and the fluid (or a portion thereof, such as a liquid portion, while a gas portion remains) therein is injected into the target area. As depicted in <FIG>, for example, the proximal end of the piston <NUM> may be placed normal to the target surface and pushed against the target surface. As depicted in <FIG>, initial axial movement (in response to applied axial force) may cause the distal end of the piston <NUM> to advance with respect to the lower legs <NUM> (e.g., a third lower leg 648c and a fourth lower leg 648d). The lower legs <NUM> may, for example, engage with or further engage with respective leg tracks 654c-d of the piston <NUM>. According to some embodiments, the shoulders <NUM> may limit or prevent radial deflection/bending of the lower legs <NUM> and thereby cause the piston <NUM> and the hub <NUM> (and the administration member <NUM>) to move together. This may, for example, cause the administration member <NUM> to remain shrouded within the piston <NUM> despite the overall axial compression of the pre-filled BFS ID injection system <NUM>.

In some embodiments, as continued axial force or pressure is applied, the lower legs <NUM> may be forced to flex radially outward by the shape of the respectively engaged leg tracks 654c-d, thereby creating or enhancing an elastic and/or radial force and increasing the axial resistance between the hub <NUM> and the piston <NUM>. The increased resistance may, in some embodiments, become equal to or greater than a resistance between the upper legs <NUM> and the interior cone <NUM>, thereby causing the upper legs <NUM> (and the hub <NUM> and the piston <NUM>) to advance with respect to the upper cone <NUM>, e.g., as depicted in <FIG>. According to some embodiments, as the base guides <NUM>-1a, <NUM>-1b advance axially toward the interior cone <NUM> they may encounter and/or engage with respective internal tracks (not shown) within the hub bore <NUM>-<NUM>. In some embodiments, the base guides <NUM>-1a, <NUM>-1b may be beveled such that as they advance axially (e.g., upward as shown) from the first state or engagement position, the bevel engages with the track, thereby causing the hub <NUM> to rotate with respect to the connector <NUM>. In some embodiment, such rotation may be approximately three degrees (<NUM>°). In some embodiments, such a rotation may cause the administration member <NUM> and/or the piercing end thereof to attain a piercing position with respect to the interior surface <NUM> (and/or one or more puncture surfaces <NUM>-1a, <NUM>-1b thereof). As depicted, for example, the administration member <NUM> (and the corresponding administration seat <NUM>) may be axially offset (e.g., eccentrically positioned) from the central axis "A" of the pre-filled BFS ID injection system <NUM>. In such embodiments, rotation of the hub <NUM> may cause the piercing end of the administration member <NUM> to travel along a circular path over or on the interior surface <NUM>. In the case that a particular portion of the interior surface <NUM> is thinner and/or otherwise configured to accept the administration member <NUM>, such as one or more of the puncture surfaces <NUM>-1a, <NUM>-1b, the administration member <NUM> may pierce the interior surface <NUM> and travel into and pierce the fluid seal <NUM> of the BFS vial <NUM> upon achievement of a particular axial insertion distance. According to some embodiments, the pre-filled BFS ID injection system <NUM> may be configured such that a rotation in the range of three degrees (<NUM>°) to seven degrees (<NUM>°) of the hub <NUM> may cause the administration member <NUM> to become aligned for piercing the BFS vial <NUM>.

As depicted in <FIG>, the second state or engagement position may be achieved once sufficient axial force has been applied to engage the upper legs <NUM> with the interior cone <NUM> to an extent where the administration member pierces the BFS vial <NUM> and the lower legs <NUM>, freed from the shoulders <NUM> due to axial movement away from the injection shield <NUM>, are able to radially deflect and fully engage with the leg tracks 654c, 654d such that the lower extents of the lower legs <NUM> engage with and are stopped by the stop tabs <NUM> of the piston <NUM>. The advancement/engagement may also cause the administration end of the administration member <NUM> to become aligned with and advance through the guide hole <NUM>-<NUM> and into the target. According to some embodiments, once the administration member <NUM> has entered the target, the push surface <NUM> of the BFS vial <NUM> may be axially forced toward the injection site, causing the collapsible reservoir(s) 620a-b to compress against the BFS detent <NUM>-<NUM> (as depicted in <FIG>) and thereby causing any or all fluid therein to advance through the administration member <NUM> and into the target (e.g., forming an ID "bleb"; not shown). In some embodiments, the BFS detent <NUM>-<NUM> acting as a compression surface for the collapsible reservoir(s) 620a-b to compress against may be provided by a different configuration of a connector <NUM> coupled to the BFS vial <NUM>. The different/alternate configuration of the connector <NUM> may, for example, not comprise an ID injector and/or may not comprise or utilize the hub <NUM>, the piston <NUM>, and/or the shield <NUM>. According to some embodiments, the different/alternate configuration of the connector <NUM> may comprise a snap-on (or other mating style) injection hub (not shown) that mates the administration member <NUM> with the BFS vial <NUM> and provides the BFS detent <NUM>-<NUM> acting as a compression surface for the collapsible reservoir(s) 620a-b to compress against.

In some embodiments, the pre-filled BFS ID injection system <NUM> may be advanced (e.g., automatically) to a third state or engagement position upon and/or in response to a release of the axial pressure/force from the piston <NUM>. Removal or decreasing the axial force or pressure may cause the elastic (e.g., spring) force of the legs <NUM>, <NUM> to release, thereby causing the upper legs <NUM> to retreat from the interior cone <NUM> and/or the lower legs <NUM> to retreat from the respective leg tracks 654c, 654d (as depicted in <FIG>). According to some embodiments, the reverse axial travel or retreating of the legs <NUM>, <NUM> may cause the base guides <NUM>-1a, <NUM>-1b to exit the interior tracks of the connector <NUM>, e.g., in their shifted radial positions, and engage with a distal edge or perimeter of the injection shield <NUM> at an engagement location that differs from the original engagement or seat location of the base guides <NUM>-1a, <NUM>-1b with respect to the injection shield <NUM>. According to some embodiments, such engagement may cause the base guides <NUM>-1a, <NUM>-1b to rotate the hub <NUM> with respect to the injection shield <NUM> and the piston <NUM>. In some embodiments, the rotation of the hub <NUM> may cause the administration member <NUM> to become radially offset by approximately forty-five degrees (<NUM>°), e.g., thereby misaligning the administration member with the puncture surfaces <NUM>-1a, <NUM>-1b and/or with the guide hole <NUM>-<NUM>.

The rotation may also or alternatively cause the lower legs 648c-d to fall off of or disengage with the leg tracks 654c-d such that further attempts to axially engage the pre-filled BFS ID injection system <NUM> may fail to bend the lower legs <NUM> outward, e.g., rendering the pre-filled BFS ID injection system <NUM> inoperable in the third state or engagement position (as depicted in <FIG>). In some embodiments, the rotation may also or alternatively cause the axially-offset administration member <NUM> to become misaligned from the hole made by the piercing of the BFS vial <NUM> and/or from the guide hole <NUM>-<NUM>. In such a manner, for example, the pre-filled BFS ID injection system <NUM> may become deactivated and/or rendered unusable (e.g., for reuse). In some embodiments, these rotational misalignments and/or the collapsing of the collapsible reservoir(s) 620a-b may selectively and automatically disable the pre-filled BFS ID injection system <NUM> after use. According to some embodiments, an automatic visual indication of the third state or engagement position may be provided via the axial slits <NUM>. Upon attaining the third state or engagement position due at least in part to and/or resulting in the rotation of the hub <NUM> inside of the pre-filled BFS ID injection system <NUM> for example, one of the lower legs <NUM> such as the fourth lower leg 648d depicted in <FIG> may become visible due to the achieved rotational alignment of the hub <NUM> subsequent to the administration/injection. In the case that the pre-filled BFS ID injection system <NUM> is in the first and/or second state or engagement position, no lower leg <NUM> may be visible through the axial slots <NUM>. In the case that the lower legs <NUM> are provided in a highly visible color such as red, a user may readily identify the used/third state of the pre-filled BFS ID injection system <NUM> by simply viewing the fourth lower leg 648d through the axial slit <NUM>.

According to some embodiments, hub <NUM>, piston <NUM>, and shield <NUM> combination may be utilized to couple and/or mate the administration member <NUM> with the connector <NUM>. In some embodiments, the connector <NUM> may provide a mechanism via which the administration member <NUM> may be coupled to be in fluid communication with a soft plastic BFS vial <NUM> in a reliable manner. Due to the nature of the BFS plastic and/or process and/or the small form-factor of the BFS vial <NUM>, in some embodiments for example, providing external machine-type threads (not shown) directly on the neck <NUM> may not be a viable option for it may result in an imprecise, unreliable, and/or non-water tight coupling (i.e., the threads may be deformable even if they could be properly manufactured to within the desired tolerances) between the BFS vial <NUM> and, e.g., the connector <NUM>.

In some embodiments, the administration member <NUM> may include a needle or canula for at least one of ID, subcutaneous, intramuscular, and intravenous injection of a combination of the fluid agent from the BFS vial <NUM> into the target/patient. According to some embodiments, the pre-filled BFS ID injection system <NUM> may be configured such that, e.g., for ID injections, approximately one and one half millimeters (<NUM>-mm) of exposure of the administration end of the administration member <NUM> may be exposed for insertion into the target. In some embodiments, the pre-filled BFS ID injection system <NUM> may be configured such that, e.g., for subcutaneous injections, approximately eight millimeters (<NUM>-mm) of exposure of the administration end of the administration member <NUM> may be exposed for insertion into the target.

For ease of explanation and description, the figures and the description herein generally refer to the administration member <NUM> as a needle and are described for convenience with respect to an ID injection. However, it should be noted that, in other embodiments, the injection may be other than ID and/or the administration member <NUM> may include a nozzle (not shown) configured to control administration of the combined agent to the patient. The nozzle may include a spray nozzle, for example, configured to facilitate dispersion of the combined agent into a spray. Accordingly, a pre-filled BFS ID injection system <NUM> fitted with a spray nozzle may be particularly useful in the administration of a combined agent into the nasal passage, for example, or other parts of the body that benefit from a spray application (e.g., ear canal, other orifices). In other embodiments, the nozzle may be configured to facilitate formation of droplets of the combined fluid agent. Thus, a pre-filled BFS ID injection system <NUM> including a droplet nozzle may be useful in the administration of a combined agent by way of droplets, such as administration to the eyes, topical administration, and the like. In each of these cases, the pre-filled BFS ID injection system <NUM> would more appropriately be referred to as a pre-filled BFS "administration" system <NUM>.

As generally understood, the fluid agent or drug may include any type of agent to be injected into a patient (e.g., mammal, either human or non-human) and capable of producing an effect (alone, or in combination with an active ingredient). Accordingly, the agent may include, but is not limited to, a vaccine, a drug, a therapeutic agent, a medicament, a diluent, and/or the like. In some embodiments, the fluid in the BFS vial <NUM> may comprise, for example, the active ingredient of the drug agent or an object that retains, carries, or holds the active ingredient.

According to some embodiments, the connector <NUM>, the hub <NUM>, the piston <NUM>, the shield <NUM>, and/or the cap <NUM> may be composed of a medical grade material such as Polylactic Acid (PLA) and/or another thermoplastic elastomer. In some embodiments, the connector <NUM>, the hub <NUM>, the piston <NUM>, the shield <NUM>, and/or the cap <NUM>, may be composed of a thermoplastic polymer or other "hard" plastic (e.g., greater than <NUM> on the Rockwell "R" scale), including, but not limited to, polybenzimidazole, acrylonitrile butadiene styrene (ABS), polystyrene, polyvinyl chloride, or the like. In some embodiments, the BFS vial <NUM> may be formed of one or more polyolefins such as Low-Density PolyEthylene (LDPE), High-Density PolyEthylene (HDPE), and/or PolyPropylene (PP) and/or one or more other thermoplastics such as Thermoplastic PolyUrethane (TPU).

In some embodiments, fewer or more components <NUM>, <NUM>, <NUM>, <NUM>, 620a-b, 622a-b, 624a-b, <NUM>, <NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>, <NUM>, <NUM>-1a, <NUM>-1b, <NUM>, <NUM>-<NUM>, <NUM>, <NUM>, <NUM>-1a, <NUM>-1b, <NUM>, <NUM>, 646a-d, <NUM>, 648a-d, <NUM>, <NUM>-<NUM>, 654a, 654c-d, <NUM>, <NUM>-<NUM>, <NUM>, <NUM>, <NUM>-<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>-<NUM>, <NUM>-<NUM> and/or various configurations of the depicted components <NUM>, <NUM>, <NUM>, <NUM>, 620a-b, 622a-b, 624a-b, <NUM>, <NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>, <NUM>, <NUM>-1a, <NUM>-1b, <NUM>, <NUM>-<NUM>, <NUM>, <NUM>, <NUM>-1a, <NUM>-1b, <NUM>, <NUM>, 646a-d, <NUM>, 648a-d, <NUM>, <NUM>-<NUM>, 654a, 654c-d, <NUM>, <NUM>-<NUM>, <NUM>, <NUM>, <NUM>-<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>-<NUM>, <NUM>-<NUM> may be included in the pre-filled BFS ID injection system <NUM> without deviating from the scope of embodiments described herein. In some embodiments, the components <NUM>, <NUM>, <NUM>, <NUM>, 620a-b, 622a-b, 624a-b, <NUM>, <NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>, <NUM>, <NUM>-1a, <NUM>-1b, <NUM>, <NUM>-<NUM>, <NUM>, <NUM>, <NUM>-1a, <NUM>-1b, <NUM>, <NUM>, 646a-d, <NUM>, 648a-d, <NUM>, <NUM>-<NUM>, 654a, 654c-d, <NUM>, <NUM>-<NUM>, <NUM>, <NUM>, <NUM>-<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>-<NUM>, <NUM>-<NUM> may be similar in configuration and/or functionality to similarly named and/or numbered components as described herein. In some embodiments, the pre-filled BFS ID injection system <NUM> (and/or portions thereof) may comprise a disposable, auto-disabled, single-dose delivery assembly (or portion thereof) operable to be utilized to execute, conduct, and/or facilitate various methods such as one or more BFS ID injection methods that utilize internal elastic forces to automatically enable and/or disable an injection system based on application of axial force thereto.

Turning now to <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, front left perspective, top left perspective, top right perspective, bottom left perspective, front, left, top, and bottom views of an ID injection shield <NUM> according to some embodiments are shown. In some embodiments, the ID injection shield <NUM> may comprise similar features and/or configurations and/or may be similar to the injection shield <NUM> of <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> herein. The ID injection shield <NUM> may comprise and/or define, for example, a circular, annular, and/or cylindrical body <NUM> defining an interior volume <NUM>-<NUM>. In some embodiments, an outer rounded flange or rib <NUM>-<NUM> may be disposed around the cylindrical body <NUM> near a distal/upper end of the ID injection shield <NUM>. The outer rib <NUM>-<NUM> may, for example, be selectively and cooperatively mated with a groove (not shown) of a connector component (not shown; e.g., the connector <NUM> of <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> herein). According to some embodiments, the ID injection shield <NUM> may comprise and/or define a piston bore <NUM> at a proximal end thereof. The piston bore <NUM> may be sized to accommodate, for example, the passing of a body of a piston (not shown; e.g., the cylindrical body <NUM> of <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> herein). In some embodiments, such as in the case that the piston comprises side or axial flanges (not shown), the ID injection shield <NUM> and/or the piston bore <NUM> may comprise and/or define corresponding flange guides <NUM>-1a, <NUM>-1b, e.g., that may act as anti-rotation devices with respect to the piston and the ID injection shield <NUM>.

According to some embodiments, the interior volume <NUM>-<NUM> of the ID injection shield <NUM> may comprise and/or define a plurality of protrusions or shoulders <NUM> that are sized, spaced, and/or shaped to guide and/or limit radial movement/bending of elastic legs (not shown; e.g., the lower legs <NUM> of the hub <NUM> of <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> herein). In some embodiments, the ID injection shield <NUM> may comprise and/or define a circumferential track <NUM>. The circumferential track <NUM> may, for example, comprise a distal perimeter or end surface of the cylindrical body <NUM> that is shaped to form a particular profile. As well depicted in <FIG>, <FIG>, <FIG>, and <FIG>, for example, while certain portions of the cylindrical body <NUM> at the distal end may extend to a maximum or full cylindrical extent (axially), other portions may comprise and/or be formed or cut to reduced heights and/or profiles. In some embodiments, two (<NUM>) symmetrical circumferential tracks <NUM> may be formed on opposite sides of the ID injection shield <NUM>. According to some embodiments, the circumferential track(s) <NUM> may define and/or comprise a first or start portion <NUM>-<NUM> and/or a second or rotation portion <NUM>-<NUM>. The start portion <NUM>-<NUM> may comprise, for example, a trap or catch profile that is shaped and sized to hold or retain a base guide/tab of a hub component (not shown; e.g., the base guides <NUM>-1a, <NUM>-1b of <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> herein). Any base guide/tab engaged to sit within the start portion <NUM>-<NUM> (e.g., at or during a first state or engagement position) may, for example, only be free to move from the start portion <NUM>-<NUM> in a single axial (e.g., upward as depicted) direction and may be restrained from rotational movement by the start portion <NUM>-<NUM>. In some embodiments, the rotation portion <NUM>-<NUM> may comprise a sloped portion of the perimeter where, in the case that a base guide/tab engages axially (e.g., downward as depicted) toward the perimeter, the base guide/tab may be urged to slide along the sloped rotation portion <NUM>-<NUM> thereby causing a rotation of the base guide/tab and any corresponding hub component.

In some embodiments, the ID injection shield <NUM> may comprise one or more axial slots or slits <NUM>. The axial slits <NUM> may, for example, extend from the distal end of the cylindrical body <NUM> toward the proximal end of the cylindrical body <NUM>. In some embodiments, the axial slits <NUM> may provide viewing windows through which lower leg members of a hub nested within the interior volume <NUM>-<NUM> may be visible, e.g., in the case that they align radially with the axial slits <NUM> (e.g., in the case that a second or third state or engagement position is attained - e.g., during and/or after use/injection).

In some embodiments, fewer or more components <NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>, <NUM>-1a, <NUM>-1b, <NUM>, <NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM> and/or various configurations of the depicted components <NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>, <NUM>-1a, <NUM>-1b, <NUM>, <NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM> may be included in the ID injection shield <NUM> without deviating from the scope of embodiments described herein. In some embodiments, the components <NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>, <NUM>-1a, <NUM>-1b, <NUM>, <NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM> may be similar in configuration and/or functionality to similarly named and/or numbered components as described herein. In some embodiments, the ID injection shield <NUM> (and/or portions thereof) may comprise a disposable, auto-disabled, single-dose delivery assembly (or portion thereof) operable to be utilized to execute, conduct, and/or facilitate various methods such as one or more BFS ID injection methods that utilize internal elastic forces to automatically enable and/or disable an injection system based on application of axial force thereto.

Turning now to <FIG>, <FIG>, <FIG>, top left perspective, bottom left perspective, front, left, top, and bottom views of a BFS ID injection piston <NUM> according to some embodiments are shown. In some embodiments, the BFS ID injection piston <NUM> may comprise similar features and/or configurations and/or may be similar to the piston <NUM> of <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> herein. The BFS ID injection piston <NUM> may comprise and/or define, for example, a circular, annular, and/or cylindrical body <NUM>-<NUM> defining a piston bore <NUM>-<NUM> therethrough. In some embodiments, the BFS ID injection piston <NUM> and/or the cylindrical body <NUM>-<NUM> thereof may comprise and/or define one or more axial flanges 852a-b extending from a proximal end of the cylindrical body <NUM>-<NUM> and axially along an outer surface of the cylindrical body <NUM>-<NUM>, and protruding radially outward along the length thereof. In some embodiments, the axial flanges 852a-b may terminate at and/or comprise respective flange stops <NUM>-1a, <NUM>-1b. According to some embodiments, the BFS ID injection piston <NUM> and/or the cylindrical body <NUM>-<NUM> thereof may comprise and/or define one or more leg tracks 854a-d extending from a distal end of the cylindrical body <NUM>-<NUM> and axially along the outer surface of the cylindrical body <NUM>-<NUM>.

According to some embodiments, the leg tracks 854a-d may comprise a number of symmetrical and/or symmetrically radially spaced areas of the cylindrical body <NUM>-<NUM> that are configured to accept and/or guide hub legs (not shown; e.g., the lower legs <NUM> of the hub <NUM> of <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> herein). According to some embodiments, each leg track 854a-d may comprise first or upper portion <NUM>-1a, <NUM>-1b, <NUM>-1d, a lower portion <NUM>-2a, <NUM>-2b, <NUM>-2c, <NUM>-2d, an edge portion <NUM>-3a, <NUM>-3b, <NUM>-3d, and/or a bottom portion <NUM>-4a, <NUM>-4b, <NUM>-4d. In some embodiments, the upper portions <NUM>-1a, <NUM>-1b, <NUM>-1d may comprise axial surfaces along the cylindrical body <NUM>-<NUM> that accept and/or guide corresponding hub legs edge portion <NUM>-3a, <NUM>-3b, <NUM>-3d axially along the cylindrical body <NUM>-<NUM>. In some embodiments, the upper portions <NUM>-1a, <NUM>-1b, <NUM>-1d may increase the diameter of the cylindrical body <NUM>-<NUM> but may be substantially parallel and/or planar to the outer surface of the cylindrical body <NUM>-<NUM>. According to some embodiments, the lower portions <NUM>-2a, <NUM>-2b, <NUM>-2c, <NUM>-2d may comprise contiguous areas along the cylindrical body <NUM>-<NUM> that defines a ramp that constantly increases the outer diameter of the cylindrical body <NUM>-<NUM> along the length of the lower portions <NUM>-2a, <NUM>-2b, <NUM>-2c, <NUM>-2d. In such a manner, continued axial engagement of the hub legs along the leg tracks 854a-d may increasingly deflect and/or bend the hub legs radially outward. In some embodiments, each of the leg tracks 854a-d may be radially disposed about the circumference of the cylindrical body <NUM>-<NUM> to engage with and/or guide the respective hub legs in the case that the hub legs are disposed in a first state or engagement position (e.g., first rotational positions).

According to some embodiments, in the case that the hub legs are rotated to a second or third state or engagement position (e.g., second and/or third rotational positions), the hub legs may rotate off of the leg tracks 854a-d and may become disposed between the leg tracks 854a-d. In some embodiments, the edge portions <NUM>-3a, <NUM>-3b, <NUM>-3d may be shaped to facilitate the falling off/de-railing of the hub legs, e.g., by comprising rounded or chamfered edges or surfaces. According to some embodiments, the edge portions <NUM>-3a, <NUM>-3b, <NUM>-3d may define radial stop surfaces that prevent further rotational movement of the hub legs (e.g., locking the hub legs between the leg tracks 854a-d and accordingly preventing subsequent radial deflection/bending of the hub legs by the BFS ID injection piston <NUM>. In some embodiments, the BFS ID injection piston <NUM> and/or the cylindrical body <NUM>-<NUM> may comprise one or more 856a-b that comprise radial protrusions that similarly prevent or limit radial movement of the hub legs around the circumference of the cylindrical body <NUM>-<NUM>. In some embodiments, the flange stops <NUM>-1a, <NUM>-1b may limit axial advancement of the hub legs in one or more of the areas between the leg tracks 854a-d.

According to some embodiments, the proximal end of the cylindrical body <NUM>-<NUM> and the axial flanges 852a-b may be inserted into a shield component and/or a piston bore thereof (not shown; e.g., the piston bore <NUM> of the injection shield <NUM> of <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> herein). In such cases, the limit of axial insertion of the cylindrical body <NUM>-<NUM> into and/or through the piston bore of the shield component may be limited by the bottom portions <NUM>-4a, <NUM>-4b, <NUM>-4d. The bottom portions <NUM>-4a, <NUM>-4b, <NUM>-4d may engage with stop surfaces of the injection shield, for example, preventing insertion of the BFS ID injection piston <NUM> beyond the extent of the axial flanges 852a-b.

In some embodiments, the proximal or administration end of the BFS ID injection piston <NUM> may comprise an end surface <NUM> defining and/or comprising one or more administration or guide holes <NUM>-1a, <NUM>-1b. According to some embodiments, the end surface <NUM> may comprise a concave surface, e.g., for ID injections, such that an ID bleb may be formed in the concave cavity thereof when the end surface <NUM> is pressed against the skin for ID injection, thereby allowing the bleb to form without pressure being exerted thereupon by the end surface <NUM>. In some embodiments, the guide holes <NUM>-1a, <NUM>-1b may be disposed eccentric to a central axis "A" of the BFS ID injection piston <NUM> such that an administration member/needle disposed within the piston bore <NUM>-<NUM> may be selectively aligned or misaligned with the guide holes <NUM>-1a, <NUM>-1b by radial displacement of the axis of the administration member/needle. In some embodiments, two (<NUM>) guide holes <NUM>-1a, <NUM>-1b spaced equidistant from the central axis "A" along a common line or axis "B" and may be utilized such that during assembly of a BFS ID injection system including the BFS ID injection piston <NUM>, an administration member/needle may be advantageously positioned in one of two one hundred and eight degree (<NUM>°) offset positions/orientations while still permitting proper alignment (or misalignment) with one of the guide holes <NUM>-1a, <NUM>-1b. In such a manner, for example, assembly of system parts may be simplified, reducing system costs.

According to some embodiments, fewer or more components <NUM>, <NUM>-<NUM>, <NUM>-<NUM>, 852a-b, <NUM>-1a, <NUM>-1b, 854a-d, <NUM>-1a, <NUM>-1b, <NUM>-1d, <NUM>-2a, <NUM>-2b, <NUM>-2c, <NUM>-2d, <NUM>-3a, <NUM>-3b, <NUM>-3d, <NUM>-4a, <NUM>-4b, <NUM>-4d, 856a-b, <NUM>, <NUM>-1a, <NUM>-1b and/or various configurations of the depicted components <NUM>, <NUM>-<NUM>, <NUM>-<NUM>, 852a-b, <NUM>-1a, <NUM>-1b, 854a-d, <NUM>-1a, <NUM>-1b, <NUM>-1d, <NUM>-2a, <NUM>-2b, <NUM>-2c, <NUM>-2d, <NUM>-3a, <NUM>-3b, <NUM>-3d, <NUM>-4a, <NUM>-4b, <NUM>-4d, 856a-b, <NUM>, <NUM>-1a, <NUM>-1b may be included in the BFS ID injection piston <NUM> without deviating from the scope of embodiments described herein. In some embodiments, the components <NUM>, <NUM>-<NUM>, <NUM>-<NUM>, 852a-b, <NUM>-1a, <NUM>-1b, 854a-d, <NUM>-1a, <NUM>-1b, <NUM>-1d, <NUM>-2a, <NUM>-2b, <NUM>-2c, <NUM>-2d, <NUM>-3a, <NUM>-3b, <NUM>-3d, <NUM>-4a, <NUM>-4b, <NUM>-4d, 856a-b, <NUM>, <NUM>-1a, <NUM>-1b may be similar in configuration and/or functionality to similarly named and/or numbered components as described herein. In some embodiments, the BFS ID injection piston <NUM> (and/or portions thereof) may comprise a disposable, auto-disabled, single-dose delivery assembly (or portion thereof) operable to be utilized to execute, conduct, and/or facilitate various methods such as one or more BFS ID injection methods that utilize internal elastic forces to automatically enable and/or disable an injection system based on application of axial force thereto.

Turning to <FIG>, <FIG>, <FIG>, <FIG>, top left perspective, bottom left perspective, front, left, top, and bottom views of an ID injection hub <NUM> according to some embodiments are shown. In some embodiments, the ID injection hub <NUM> may comprise similar features and/or configurations and/or may be similar to the hub <NUM> of 6A, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> herein. The ID injection hub <NUM> may comprise and/or define, for example, a circular, annular, and/or cylindrical base <NUM>. In some embodiments, the base <NUM> may comprise one or more radially protruding tabs or base guides <NUM>-1a, <NUM>-1b extending outwardly from an outer radius of the base <NUM>. According to some embodiments, the base guides <NUM>-1a, <NUM>-1b may be shaped with one flat side and one beveled side as depicted, e.g., to effectuate selective rotation of the ID injection hub <NUM> upon entry and/or exit of the base guides <NUM>-1a, <NUM>-1b into slots or tracks of a connector component (not shown; e.g., the connector component <NUM> of 6A, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> herein). In some embodiments, an administration seat <NUM> may extend through the base <NUM> from a first side to a second side thereof. As depicted, in some embodiments the administration seat <NUM> may be eccentric to a central axis "A" of the ID injection hub <NUM>, e.g., to facilitate and/or enable auto-disable functionality as described herein. According to some embodiments, the ID injection hub <NUM> may comprise one or more first or upper legs <NUM> extending axially away from the base <NUM> (e.g., in a first axial direction) and/or may comprise one or more second or lower legs <NUM> extending axially away from the base <NUM> (e.g., in a second axial direction). According to some embodiments, the legs <NUM>, <NUM> (of which four (<NUM>) of each type are shown for example purposes, namely, four (<NUM>) upper legs 946a-d and four (<NUM>) lower legs 948a-d) may comprise pliable and/or elastic or semi-elastic elongated members that extend from the base <NUM> from respective locations radially disposed between the center of the base <NUM> and the radial extents of the base <NUM>. In some embodiments, each leg <NUM>, <NUM> may comprise and/or define an outside bevel extending inward axially from the extents/terminus thereof, e.g., to reduce the rigidity of the legs <NUM>, <NUM> and promote a desired level of elastic spring force capability.

In some embodiments, fewer or more components <NUM>, <NUM>-1a, <NUM>-1b, <NUM>, <NUM>, 946a-d, <NUM>, 948a-d and/or various configurations of the depicted components <NUM>, <NUM>-1a, <NUM>-1b, <NUM>, <NUM>, 946a-d, <NUM>, 948a-d may be included in the ID injection hub <NUM> without deviating from the scope of embodiments described herein. In some embodiments, the components <NUM>, <NUM>-1a, <NUM>-1b, <NUM>, <NUM>, 946a-d, <NUM>, 948a-d may be similar in configuration and/or functionality to similarly named and/or numbered components as described herein. In some embodiments, the ID injection hub <NUM> (and/or portions thereof) may comprise a disposable, auto-disabled, single-dose delivery assembly (or portion thereof) operable to be utilized to execute, conduct, and/or facilitate various methods such as one or more BFS ID injection methods that utilize internal elastic forces to automatically enable and/or disable an injection system based on application of axial force thereto.

Referring additionally to <FIG>, <FIG>, <FIG>, and <FIG>, bottom left perspective, side, top, bottom, side cross-section, and perspective side cross-section views of a BFS ID injection connector <NUM> according to some embodiments are shown. In some embodiments, the BFS ID injection connector <NUM> may comprise similar features and/or configurations and/or may be similar to the connector <NUM> of <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> herein. The BFS ID injection connector <NUM> may comprise, for example, a generally cylindrical body defining a BFS chamber <NUM>-<NUM>, a BFS detent <NUM>-<NUM>, a hub bore <NUM>-<NUM>, an interior flange <NUM>-<NUM>, and exterior flange <NUM>-<NUM>, and/or an interior groove <NUM>-<NUM>. In some embodiments, a pathway into the BFS chamber <NUM>-<NUM> may be modified from a simply circular (or other chosen geometry) cross-section to provide for easier entry of an inserted mounting flange of a BFS vial (not shown; e.g., the BFS vial <NUM> of <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> herein). The hub bore <NUM>-<NUM> may also or alternatively be shaped and/or sized to receive and/or engage with various components such as a hub and/or a piston (neither shown; e.g., the hub <NUM> and/or the piston <NUM> of <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> herein).

In some embodiments, the interior flange <NUM>-<NUM> may act as an insertion stop that limits the insertion of an injection shield component such as the ID injection shield <NUM> of <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> herein. According to some embodiments, the exterior flange <NUM>-<NUM> may comprise a lip and/or surface that stops and/or accepts a corresponding surface of a cap (nto shown; e.g., the cap <NUM> of <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> herein) into which the proximal portion of the BFS ID injection connector <NUM> is inserted. In some embodiments, the interior groove <NUM>-<NUM> may be disposed inside the hub bore <NUM>-<NUM> at the proximal end of the BFS ID injection connector <NUM> and be sized and/or shaped to accept a corresponding lip, rib, or rounded flange of an injection shield (not shown; e.g., the ID injection shield <NUM> of <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> herein) coupled to the proximal end of the BFS ID injection connector <NUM>.

According to some embodiment, the hub bore <NUM>-<NUM> may comprise and/or define an interior shaped structure such as a pyramid or cone <NUM> extending from an interior distal surface of the hub bore <NUM>-<NUM> and into the hub bore <NUM>-<NUM>. In some embodiments, an axial terminus of the interior cone <NUM> may comprise and/or define an interior surface <NUM>. According to some embodiments, the interior surface <NUM> may comprise a planar surface oriented normally to a longitudinal axis "A" of the BFS ID injection connector <NUM>. In some embodiments, one or more portions of the interior surface <NUM> may comprise and/or define a puncture surface <NUM>-1a, <NUM>-1b. As depicted in <FIG>, for example, the puncture surface(s) <NUM>-1a, <NUM>-1b may comprise a circular or cylindrical portion of the interior surface <NUM> that comprises an axial thickness that is less than an axial thickness of the remainder of the interior surface <NUM>. While the interior surface <NUM> may comprise and/or define an axial thickness of approximately one millimeter (<NUM>-mm) between the hub bore <NUM>-<NUM> and the BFS chamber <NUM>-<NUM>, for example, the thickness at the puncture surface(s) <NUM>-1a, <NUM>-1b may be lesser, such as approximately four tenths of a millimeter (<NUM>-mm) in thickness. In such a manner, for example, a needle or other puncturing member (not shown) may only successfully puncture the interior surface <NUM> through the puncture surface(s) <NUM>-1a, <NUM>-1b, while engagement with other portions of the interior surface <NUM> would frustrate puncturing, such as by damaging the needle and/or preventing communication from being established between the hub bore <NUM>-<NUM> and the BFS chamber <NUM>-<NUM>. According to some embodiments, and as depicted, the puncture surface(s) <NUM>-1a, <NUM>-1b may be eccentrically situated such that it is offset from the central portion or axis "A" of the BFS ID injection connector <NUM>. In such a manner, for example, a needle and/or other puncture member that is itself eccentric to the central axis "A" must be rotationally aligned with one of the puncture surface(s) <NUM>-1a, <NUM>-1b to permit puncturing/breaching of the interior surface <NUM> (and attendant puncturing and/or engagement with a BFS vial (not shown) seated in the BFS chamber <NUM>-<NUM>). In some embodiments, two (<NUM>) puncture surfaces <NUM>-1a, <NUM>-1b spaced equidistant from the central axis "A" along a common line or axis "B" and may be utilized such that during assembly of a BFS ID injection system including the BFS ID injection connector <NUM>, an administration member/needle may be advantageously positioned in one of two one hundred and eight degree (<NUM>°) offset positions/orientations while still permitting proper alignment (or misalignment) with one of the puncture surfaces <NUM>-1a, <NUM>-1b. In such a manner, for example, assembly of system parts may be simplified, reducing system costs.

According to some embodiments, the BFS ID injection connector <NUM> and/or the BFS chamber <NUM>-<NUM> thereof may comprise an internal groove or seat <NUM> and/or one or more flange seats <NUM>-<NUM> that is/are cooperatively sized and configured to receive a mounting flange of a BFS vial (neither shown; e.g., the mounting flange/feature <NUM> of the BFS vial <NUM> of <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> herein). In such a manner, for example, a BFS vial may be selectively and/or removably coupled to the BFS ID injection connector <NUM> and, e.g., positioned for selective piercing by an administration member that becomes aligned with and breaches the puncture surface(s) <NUM>-1a, <NUM>-1b. According to some embodiments, a cooperatively shaped BFS vial may comprise a neck and exterior flange that fit within the BFS chamber <NUM>-<NUM> and/or may comprise a conical and/or frustoconical reservoir portion that seats in the BFS detent <NUM>-<NUM>.

In some embodiments, the BFS ID injection connector <NUM> may comprise and/or define one or more slots or tracks <NUM>, e.g., within the hub bore <NUM>-<NUM>. The track(s) <NUM> may comprise and/or define, for example, one or more axial grooves, channels, and/or shaped elements that are configured to accept and/or guide one or more corresponding features inserted into the hub bore <NUM>-<NUM> such as corresponding base guides of a hub component (not shown; e.g., the base guides <NUM>-1a, <NUM>-1b of the hub <NUM> of <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> herein). According to some embodiments, the track(s) <NUM> may interrupt and/or traverse the interior flange <NUM>-<NUM>, thereby defining an axial pathway through the track(s) <NUM> and, e.g., into an engagement with an injection shield inserted into the hub bore <NUM>-<NUM> (not shown; e.g., the injection shield <NUM> of <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> herein). In some embodiments, either or both of the tracks <NUM> and the interior cone <NUM> may comprise and/or define spiral, helix, diagonal, and/or other non-lineal axial paths, shapes, and/or features that are operable to cause rotation of elements axially engaged therewith.

In some embodiments, fewer or more components <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>, <NUM>, <NUM>-1a, <NUM>-1b, <NUM>, <NUM>-<NUM>, <NUM> and/or various configurations of the depicted components <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>, <NUM>, <NUM>-1a, <NUM>-1b, <NUM>, <NUM>-<NUM>, <NUM> may be included in the BFS ID injection connector <NUM> without deviating from the scope of embodiments described herein. In some embodiments, the components <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>-<NUM>, <NUM>, <NUM>, <NUM>-1a, <NUM>-1b, <NUM>, <NUM>-<NUM>, <NUM> may be similar in configuration and/or functionality to similarly named and/or numbered components as described herein. In some embodiments, the BFS ID injection connector <NUM> (and/or portions thereof) may comprise a disposable, auto-disabled, single-dose delivery assembly (or portion thereof) operable to be utilized to execute, conduct, and/or facilitate various methods such as one or more BFS ID injection methods that utilize internal elastic forces to automatically enable and/or disable an injection system based on application of axial force thereto.

Turning to <FIG>, top and bottom perspective views of a BFS ID injection cap <NUM> according to some embodiments are shown. In some embodiments, the BFS ID injection cap <NUM> may comprise similar features and/or configurations and/or may be similar to the cap <NUM> of 6A, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> herein. The BFS ID injection cap <NUM> may comprise and/or define, for example, a circular, annular, and/or cylindrical cap body <NUM>-<NUM> that defines an interior cap volume <NUM>-<NUM> that is open at a first or distal end thereof. In some embodiments, the interior cap volume <NUM>-<NUM> may be sized and/or shaped to cover, house, and/or mate with a BFS connector component (not shown; e.g., the connector component <NUM> of 6A, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> herein). In some embodiments, the BFS connector component (or a portion threof) may, for example, slide into the interior cap volume <NUM>-<NUM> and an end wall or edge of the BFS ID injection cap <NUM> may be stopped by, seated and/or mated with a corresponding flange surface (not shown; e.g., the exterior flange <NUM>-<NUM> of 6A, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> herein) of the BFS connector component (e.g., to selectively shield, cover, and/or house the portion of the BFS connector component, an administration member, injection shield, and/or piston component (none of which are shown; e.g., the connector <NUM>, the administration member <NUM>, the injection shield <NUM>, and/or the piston <NUM> of 6A, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> herein).

In some embodiments, fewer or more components <NUM>-<NUM>, <NUM>-<NUM> and/or various configurations of the depicted components <NUM>-<NUM>, <NUM>-<NUM> may be included in the BFS ID injection cap <NUM> without deviating from the scope of embodiments described herein. In some embodiments, the components <NUM>-<NUM>, <NUM>-<NUM> may be similar in configuration and/or functionality to similarly named and/or numbered components as described herein. In some embodiments, the BFS ID injection cap <NUM> (and/or portions thereof) may comprise a disposable, auto-disabled, single-dose delivery assembly (or portion thereof) operable to be utilized to execute, conduct, and/or facilitate various methods such as one or more BFS ID injection methods that utilize internal elastic forces to automatically enable and/or disable an injection system based on application of axial force thereto.

Various systems and/or components described herein, either alone or in various combinations, may be utilized to execute, conduct, and/or facilitate various methods such as one or more BFS ID injection methods that utilize internal elastic forces to automatically enable and/or disable an injection system based on application of axial force thereto. As described herein, for example, a BFS injection system may comprise internal elastic or semi-elastic legs that are selectively deformed, bent, and/or urged axially outward (e.g., flared) in response to axial compressive force applied to the system components. This may establish internal forces that are utilized to automatically (i) align an administration member with one or more puncture surfaces and/or components such as holes, ports, guides, and/or seals, (ii) puncture one or more seals (e.g., of a BFS vial), and/or (iii) cause a misalignment of one or more components such as the administration member and/or an internal hub component, such misalignment preventing reuse of the system for medical injection (e.g., auto-disable).

In practice, for example, a user may remove a BFS injection system/device from a package and/or seal, remove a cap thereof to expose an injection shield and/or proximal end of an injection piston, and place the proximal end of the injection piston against a target site, such as a human skin area. The user may place a BFS vial in a distal reeving end of the device or the BFS vial may come pre-installed. The user may exert axial force or pressure upon the device by urging the device against the target/skin. In response to the axial force/pressure, the injection piston may move inward into the device, e.g., along with an administration member and/or hub element therein, e.g., keeping the administration member shrouded and/or disengaged from the target. Internal axial movement of the hub element may cause the hub element to undergo a first degree of rotational shift, which may for example, align the administration member with an internal puncture surface, seal, and/or with a seal of the BFS vial. Elastic legs within the device may be forced against one or more radial deflections surfaces such as an interior shaped element and thereby establish an elastic and/or spring force within the device.

Sufficient pressure may be applied by the user to cause the administration member to pierce the internal seal and/or the seal of the BFS vial, thereby placing the contents (e.g., a medication) in fluid communication with the administration member. Continued applied force/pressure may cause the piston element to retract further, exposing an administration end of the administration member. In the case of an ID injection, the administration member/needle may be exposed to approximately one and one half millimeters (<NUM>-mm). The user may then press a collapsible reservoir of the BFS vial, e.g., against the device (e.g., a detent thereof), thereby forcing the fluid stored therein (or at least a desired dosage portion thereof) through the administration member and into the target/skin. In the case of an IDS injection, the proximal end of the piston may comprise a concave surface that permits an ID bleb to form withint he concave volume while the piston element remains engaged with the target/skin.

The user may withdrawal the device from the target/skin, causing a release of the internal elastic/spring force. The force may be released, for example, by urging guide portions of the hub element to rotate, e.g., by engaging axially with one or more sloped and/or shaped tracks and/or guides that cause the hub to rotate with respect to the piston element. This rotation (which may occur automatically in response to the user removing the axial pressure of the device against the target/skin) may cause the administration member and/or the internal elastic legs to become misaligned, thereby preventing reuse of the device. The device may no longer compress to reveal the administration member due to the elastic legs becoming disengaged and/or locked, for example, and/or the administration member may become misaligned with one or more holes or passages such that it cannot exit the device. In such a manner, for example, the device may automatically manage the internal forces developed by radial deflection of the elastic legs to apply at least one rotational offset that (i) enables the device and/or (ii) disables the device.

Some embodiments may comprise and/or define various systems, methods, articles of manufacture, apparatus, and/or devices that are either stand-alone or may be utilized together. If described as stand-alone, this does not necessarily preclude interoperability with the other disclosed embodiments. Indeed, by being included in the same disclosure, Applicant has anticipated some degree of relation between the disclosed embodiments. If described as cooperative, this does not necessarily preclude stand-alone or alternative operability. Particularly with respect to described systems, for example, while various components are described in relation to their interoperability in some embodiments, in other embodiments one or more of such components may be operative to function without the other (and/or with another component, whether disclosed or not).

Different objects disclosed in different numbered figure sets, for example, may in some cases comprise different inventive components that alone constitute the broadest extents of the disclosure herein (e.g., with or without the other different numbered figure set components). In some embodiments, the combination and/or interaction of a subset of the components may comprise inventive subject matter. The interaction of the hub legs with the cone and/or piston leg tracks may, for example, be inventive with or without any of the other components. Similarly, the automatic misalignment of the needle and/or the legs may be effectuated by a subset of the components without the others being necessary.

While a BFS container having certain features is described and depicted as being part of an injection system, non-BFS vials or different shaped/configured BFS vials may be utilized and/or the BFS vial itself may be inventive without the other components of the system. The BFS vial may be utilized with a different injection connector and/or system, for example. Similarly, the system itself may be utilized without the BFS vial in some embodiments (e.g., the medicament may be otherwise incorporated into the system). In some embodiments, the system may be novel and functional without certain components such as the cap. Similarly, and as noted herein, while some components are described as comprising single or multiple objects, in some embodiments components may be combined to provide the same or similar features in fewer objects or may be split or segmented into more objects. The hub and the piston may be combined to retain the needle, for example, and/or the connector may be incorporated with the shield, without deviating from some embodiments.

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

Numerous embodiments are described in this patent application, and are presented for illustrative purposes only. The described embodiments are not, and are not intended to be, limiting in any sense. The presently disclosed invention(s) are widely applicable to numerous embodiments, as is readily apparent from the disclosure. One of ordinary skill in the art will recognize that the disclosed invention(s) may be practiced with various modifications and alterations, such as structural, logical, software, and electrical modifications. Although particular features of the disclosed invention(s) may be described with reference to one or more particular embodiments and/or drawings, it should be understood that such features are not limited to usage in the one or more particular embodiments or drawings with reference to which they are described, unless expressly specified otherwise.

Devices that are in communication with each other need not be in continuous communication with each other, unless expressly specified otherwise.

While threads and/or other specific coupling mechanisms between different components are described for purposes of example herein, fewer, more, and/or different types and/or configurations of coupling mechanisms may be utilized without deviating from some embodiments. While different types and/or configurations of coupling mechanisms may be utilized, in some embodiments those specifically described types and/or configurations of coupling mechanisms may provide advantages such as facilitating the execution of various methods. Additionally, while some components that are coupled together are depicted and/or described as being separate and/or distinct components, in some embodiments two or more coupled and/or mated components may be manufactured and/or provided as a single joint and/or integral component, as is or becomes desirable and/or practicable.

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

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

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

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

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

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

Other elements may optionally be present other than the elements specifically identified by the "and/or" clause, whether related or unrelated to those elements specifically identified, unless clearly indicated to the contrary.

Claim 1:
A pre-filled blow-fill-seal (BFS) intradermal (ID) injection system (<NUM>), comprising:
a BFS bottle (<NUM>) defining a collapsible fluid chamber, a neck portion, an exterior flange, and a BFS seal at an end of the neck portion;
a connector (<NUM>) defining a first connector end and a second connector end, the first connector end comprising an interior seat into which the exterior flange is axially mated, the second connector end comprising a hub bore in which an interior cone and at least one axial track is disposed;
a hub member (<NUM>) disposed in the hub bore, the hub member comprising a hub body from which a first plurality of elongate legs extend axially outward in a first direction and from which a second plurality of elongate legs extend axially outward in a second direction, the hub member comprising an administration member seat disposed axially therethrough and defining at least one circumferential tab cooperatively shaped and engaged with the axial track of the connector, and the first plurality of elongate legs being engaged with the interior cone in a first position;
an administration member (<NUM>) retained by the administration member seat and extending through the hub body, the administration member comprising a piercing end and an administration end, with the piercing end being disposed within the hub bore;
a piston (<NUM>, <NUM>) defining a piston bore within which the administration end of the administration member is disposed and comprising a plurality of axial leg tracks with which the second plurality of elongate legs are engaged; and
a shield (<NUM>) comprising a body and defining an interior volume in which the piston is slidably disposed, the shield defining an administration member bore therethrough and the shield comprising a plurality of internal shoulder elements aligned with the second plurality of elongate legs;
wherein axial force applied to the piston causes the piston and the hub member to advance axially into the hub bore which thereby causes the respective first plurality of elongate legs to travel along an increasing diameter of the interior cone and causes the second plurality of elongate legs to engage with an increasing diameter of the axial leg tracks, which thereby causes the first and second elongate legs to be elastically biased in a radially outward direction, and wherein the advancing of the piston and the hub member causes the piercing end of the administration member to pierce the fluid seal of the BFS bottle.