Blow-fill-seal VIAL with sterile access port

Abstract

A blow-fill-seal vial for storing a fluid agent that includes a sterile access port on one end, which sterile access port may be revealed by twisting or otherwise removing an end cap before allowing a needle to penetrate a surface of the vial that was otherwise maintained in a sterile condition prior to the end cap removal. In one embodiment, the sterile access port element of the vial is molded in a single mold with the remainder of the vial, such that the sterile access port element is a contiguous and integrated element of the vial.

Description

PCT / US25 / 44375 30 August 2025 (30.08.2025)Attorney Docket No.: AJ01 -047-02BLOW-FILL-SEAL VIAL WITH STERILE ACCESS PORTCLAIM OF PRIORITY

[0001] The present application claims priority to U.S. Provisional Application No. 63 / 689,440, filed on August 30, 2025 and titled BLOW-FILL-SEAL VIAL WITH STERILE ACCESS PORT. The entirety of this Provisional Application is incorporated by reference herein for all purposes.BACKGROUND

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

[0003] The present disclosure is directed to further improvements in BFS injector devices, in particular, including improvements in the cartridge or vial assembly portion of such injector devices that function to contain a fluid agent. Specifically, the present disclosure is directed to embodiments comprising a cartridge or vial assembly including aPCT / US25 / 44375 30 August 2025 (30.08.2025)Attorney Docket No.: AJ01 -047-02 first element which minimizes the potential of contaminants from mixing with the fluid agent or contaminating the surface of the vial assembly that is penetrated by a delivery device for purposes of injecting the fluid agent into a user, before and / or during actuation of the BFS injector device. In some embodiments, the first element comprises a sterile access port. In some applications, the first element (e.g., sterile access port feature) as described herein may minimize or even eliminate the need for a user to wipe or swab prior to use (e.g., with alcohol or another disinfectant) a surface, portion or feature of a cartridge or vial assembly that is to be penetrated by a needle, cannula or other administration member in order to access the fluid agent stored in the vial and inject it into a patient. This is because a novel aspect of the vial design as described herein (and particularly of the sterile access port feature of such a vial) comprises a portion of the vial that is twisted off or otherwise removed by a user (referred to as an “end cap” herein even though in many embodiments it is manufactured in a single mold as integral with the body or remainder of the vial), in order to reveal the surface, portion or other feature of the vial that is to come in contact with the administration member. This surface, portion or other feature remains sterile from the time of manufacture until it is so removed by the user and is thus not exposed to contaminants in the interim.

[0004] In some embodiments, the cartridge assembly includes a second element (e.g., a removable end cap) which covers the access port and encloses a third element (e.g., a seal membrane) leading to the internal reservoir of the cartridge assembly. As described herein, the second element (e.g., removable end cap) may be an integrated part of the remainder of the vail in the sense that it is manufactured as a single container in a BFS mold (that includes two halves that come together to mold the shape of the vial, including the removable end cap portion). In accordance with some embodiments, the end cap is “removable” in the sense that it is “attached” to or separated from the sterile access port surface by a relatively thin portion of the vial, such that a user may easily twist or tear it off in order to expose the sterile access port portion of the vial, prior to use (e.g., the force required to twist or tear off the end cap portion may be less than a predetermined threshold). Once the removable end cap is detached, the cartridge assembly is mounted to an administration device or assembly to enable the needle of the device to pierce the seal membrane and access the internal reservoir filled with fluid agent. Commonly-owned PCT Patent Application No. PCT / US23 / 25123 titled MEDICAL DELIVERY ASSEMBLY describes example delivery assembly designs (also called “needle hubs”) that may be used to attach to a vial such as ones described herein in order to assemble an integrated BFS injector device; this PCT Application is incorporated by reference herein for all purposes.

[0005] In certain embodiments, the first element (e.g., sterile access port) defines a chamber which enables the needle to pass through the access port without engaging internal sides of the access port to permit direct penetration through the third element (e.g., seal membrane). In some embodiments, the access port is sterile and is enclosed by the removable end cap. The removable end cap may, in embodiments, be detached from the cartridge body by a twisting action, a tearing action or the like.

[0006] In one illustrative embodiment, a cartridge assembly comprises a cartridge body having an internalPCT / US25 / 44375 30 August 2025 (30.08.2025)Attorney Docket No.: AJ01 -047-02 reservoir for holding a fluid agent and defining a longitudinal axis, an access port adjacent one end of the cartridge body, a seal membrane separating the access port and the internal reservoir of the cartridge body and an end cap mounted to the cartridge body adjacent the access port. The end cap is removable from the cartridge body to enable access to the access port and the seal membrane. In embodiments, at least the seal membrane is sterile.

[0007] In embodiments, the access port defines a port opening upon removal of the end cap. In some embodiments, the access port defines a port interior extending from the port opening to the seal membrane. In other embodiments, the port opening and the port interior are dimensioned to enable passage of a needle therethrough. In embodiments, the seal membrane is configured to be penetrated by a needle to enable access of the needle to the fluid agent within the internal reservoir of the cartridge body.

[0008] In embodiments, the cartridge body defines one or more bellows segment configured to be compressed along at least a longitudinal direction to dispense the fluid agent.

[0009] In other embodiments, the cartridge body is compressible in at least a direction transverse to the longitudinal axis.

[0010] In some embodiments, the end cap is configured to be rotated relative to the cartridge body to effect removal from the cartridge body. In embodiments, the end cap includes indicia representative of the fluid agent within the internal reservoir of the cartridge body.

[0011] In one illustrative embodiment, a delivery system comprises an administration assembly and a cartridge assembly. The administration assembly includes an administration housing defining a longitudinal axis and having a housing chamber and an administration member coupled to the administration housing and having a first end extending within the housing chamber and a second end for application to a patient. The cartridge assembly includes a cartridge body having an internal reservoir for holding a fluid agent and defining a longitudinal axis, an access port adjacent one end of the cartridge body, a seal membrane separating the access port and the internal reservoir of the cartridge body and an end cap mounted to the cartridge body adjacent the access port where the end cap is removable from the cartridge body to enable access to the access port and the seal membrane. Subsequent to removal of the end cap from the cartridge body, the cartridge body is moved relative to the administration housing to cause the first end of the administration member to penetrate the seal membrane to enable access of the administration member to the fluid agent within the internal reservoir of the cartridge body.

[0012] In embodiments, the administration member includes a cannulated needle and wherein the first end is configured to pierce the seal membrane.

[0013] In some embodiments, the access port defines a port opening upon removal of the end cap. In other embodiments, the access port defines a port interior extending from the port opening to the seal membrane. In embodiments, the port opening and the port interior are dimensioned to enable passage of the first end of the cannulated needle therethrough during movement of the cartridge body relative to the administration housing whereby the first end of the cannulated needle penetrates the seal membrane to enable access of the cannulatedPCT / US25 / 44375 30 August 2025 (30.08.2025)Attorney Docket No.: AJ01 -047-02 needle to the fluid agent within the internal reservoir of the cartridge body.

[0014] In certain embodiments, the cartridge body defines one or more bellows segment configured to be compressed along at least a longitudinal direction to dispense the fluid agent. In embodiments, the cartridge body is compressible in a direction transverse to the longitudinal axis.

[0015] In embodiments, the end cap of the cartridge assembly is configured to be rotated to effect removal from the cartridge body.

[0016] In other embodiments, the administration assembly includes a plunger. The plunger is manually actuated to cause movement of the cartridge body relative to the administration housing.

[0017] In accordance with another illustrative embodiment, a method comprises obtaining a cartridge assembly including a cartridge body having an internal reservoir for holding a fluid agent and an end cap mounted to the cartridge body, removing the end cap to enable access to an access port adjacent the cartridge body where the access port defines a port opening leading to a port interior and penetrating, with an administration member, a sterile seal membrane disposed between the port interior of the access port and the internal reservoir of the cartridge body to enable access to the fluid agent for delivery of the fluid agent to a patient.

[0018] In another illustrative embodiment, a method comprises obtaining a cartridge assembly including a cartridge body having an internal reservoir for holding a fluid agent and an end cap mounted to the cartridge body, removing the end cap to enable access to an access port adjacent the cartridge body where the access port defines a port opening leading to a port interior, positioning the cartridge body within an administration housing of an administration assembly where the administration assembly includes an administration member coupled to the administration housing and extending at least within the administration housing, and moving the cartridge body relative to the administration housing to cause an internal end of the administration member to penetrate a sterile seal membrane separating the port interior of the access port and the internal reservoir of the cartridge body to enable access to the fluid agent with the administration member.

[0019] In embodiments, the method includes delivering the fluid agent to a patient with an external end of the administration member. In some embodiments, moving the cartridge body includes enabling the internal end of the administration member to penetrate the sterile seal membrane without contacting internal surfaces of the access port. In other embodiments, removing the end cap includes breaking a coupling segment coupling the end cap to the cartridge body. In certain embodiments, removing the end cap includes exposing the port opening of the access port. In other embodiments, removing the end cap includes rotating the end cap relative to the cartridge body.

[0020] Any of the various innovations and embodiments included in the disclosed subject matter herein can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosed technology willPCT / US25 / 44375 30 August 2025 (30.08.2025)Attorney Docket No.: AJ01 -047-02 become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.BRIEF DESCRIPTION OF THE DRAWINGS

[0021] An understanding of embodiments described herein and many of the attendant advantages thereof may be readily obtained by reference to the following detailed description when considered with the accompanying drawings, wherein:FIG. 1 is a side elevation view of an example cartridge assembly for use with a delivery or administration assembly in accordance with one or more illustrative embodiments of the present disclosure;FIG. 2 is a side elevation view of the cartridge assembly illustrating the removable end cap detached from the cartridge body of the cartridge assembly in accordance with one or more illustrative embodiments of the present disclosure;FIG. 3 is a perspective view of the cartridge assembly in partial cross-section illustrating the sterile access port, the seal membrane and the internal chamber of the cartridge body in accordance with one or more illustrative embodiments of the present disclosure;FIG. 4 is an enlarged perspective view in partial cross-section illustrating a needle positioned through the access port and the seal membrane to access the internal reservoir of the cartridge body in accordance with one or more illustrative embodiments of the present disclosure;FIGS. 5A and 5B are perspective and perspective cross-sectional views respectively of the cartridge assembly positioned within an administration assembly in accordance with one or more illustrative embodiments of the present disclosure;FIG. 5C is an enlarged isolated view of the area of detail identified in FIG. 5B in accordance with one or more illustrative embodiments of the present disclosure;FIG. 6 is an enlarged isolated view in cross-section illustrating the cartridge assembly advanced within the administration assembly with the needle of the administration assembly penetrating the seal membrane of the cartridge assembly in accordance with one or more illustrative embodiments of the present disclosure;FIG. 7 is a flow chart illustrating a method of use of a cartridge assembly in accordance with one or more illustrative embodiments of the present disclosure;FIG. 8 is a flow chart illustrating an example method of forming a cartridge assembly in accordance with one or more illustrative embodiments of the present disclosure;FIG. 9 is a side elevation view of an example cartridge assembly for use with an administration assembly in accordance with one or more illustrative embodiments of the present disclosure;PCT / US25 / 44375 30 August 2025 (30.08.2025)Attorney Docket No.: AJ01 -047-02FIGS. 10 and 11 are side elevation and perspective views respectively of the cartridge assembly illustrating the removable end cap detached from the cartridge body of the cartridge assembly in accordance with one or more illustrative embodiments of the present disclosure;FIG. 12 is an enlarged perspective view in partial cross-section illustrating a needle of an administration assembly positioned through the access port and the seal membrane to access the internal reservoir of the cartridge assembly in accordance with one or more illustrative embodiments of the present disclosure;FIG. 13 is a perspective of the cartridge assembly positioned within the administration assembly in accordance with one or more illustrative embodiments of the present disclosure; andFIG. 14 is an enlarged isolated view in cross-section illustrating the cartridge assembly advanced relative to the administration assembly with the needle of the administration assembly penetrating the seal membrane of the cartridge assembly in accordance with one or more illustrative embodiments of the present disclosure.DETAILED DESCRIPTION

[0022] Embodiments of the present disclosure provide systems and methods for pre-filled medical delivery assemblies that overcome drawbacks of current delivery devices and methods. For example, the system of some embodiments may include a cartridge, vial or bottle module couplable to a delivery syringe device or an administration device. In some embodiments, such a system may be selectively activated by application of a relative longitudinal force of the components causing the needle of the delivery syringe device or administration device to pierce a fluid reservoir of the cartridge or vial. Utilization of such systems may be advantageous and may address various shortcomings of previous systems.

[0023] In some embodiments, the cartridge or vial is formed by Blow Fill Seal (BFS) technologies. BFS cartridges or vials may, for example, offer a less expensive alternative to typical vials or devices created via other manufacturing techniques. In some embodiments, BFS cartridges or vials (e.g., due to the nature of the BFS manufacturing process) may not require separate sterilization (e.g. and may accordingly be compatible with a wider array of fluids), may provide enhanced production rates of sterile / aseptic units per hour, and / or may be provided to an end-user for significantly lower per dose / unit costs. In some embodiments, BFS cartridges or vials reduce the need to meet precise manufacturing tolerances and may be readily adaptable to form certain mating features such as standardized threads.

[0024] Referring now to FIG. 1 , there is illustrated one exemplative embodiment of a cartridge assembly according to the present disclosure. The cartridge assembly 100 includes a cartridge body 102 defining a longitudinal axis “k.” The cartridge body 102 defines a first longitudinal end having a planar tab 104 for engagement by the user and a second longitudinal end having an access port 106. In embodiments, the tab 104 may be any shape or configuration other than planar, and dimensioned to facilitate grasping and manipulation by the user. The tab 104PCT / US25 / 44375 30 August 2025 (30.08.2025)Attorney Docket No.: AJ01 -047-02 also may include visual indicia, identified as reference numeral 108, such as an RFID tag or bar code, to facilitate identification of the treatment agent, cartridge type or size, expiration date etc. One exemplary system utilizing identifiers or indicia for cartridge assemblies and associated delivery devices is disclosed in commonly assigned PCT Application No. PCT / US21 / 30530, filed May 3, 2021 , the entire contents of which is incorporated by reference herein.

[0025] In illustrative embodiments, the cartridge body 102 includes a single dose of the fluid agent or, optionally, may include multiple doses. In accordance with some embodiments, the cartridge body 102 includes a central bellows structure 110 including multiple individual bellows or folds 112 (four (4) are shown) configured to contract upon exertion of longitudinal forces of the cartridge body 102 along longitudinal axis “k.” The contraction of the bellows structure 110 provides sufficient compressive forces to maximize expulsion of the fluid agent from the cartridge body 102. In one illustrative embodiment, compression of the bellows structure 110 corresponds to dispensing of a single dose of a fluid agent, and exhaustion of the fluid agent. In another illustrative embodiment, compression of one or more individual bellows 112 corresponds to delivery of one dose of the fluid agent while additional fluid agent remains in the cartridge body 102 for one or more additional doses, i.e., multiple doses. Continued compression of the additional individual bellows 112 will release the additional doses in sequence. It should be noted that other configurations of BFS vials that are compressible in some manner may be used, and the embodiments described herein are not dependent on a bellows structure 112.

[0026] An end cap 114 is coupled to the second longitudinal end of the cartridge body 102 adjacent the access port 106. In embodiments, the end cap 114 is formed with the cartridge body 102 during the BFS molding process. In some embodiments, the end cap 114 is an extension of the cartridge body 102, and formed via a die cutting process in association with the BFS molding process. For example, and without limitation, the end cap 114 may be formed with the cartridge body 102, and thereafter separated from the cartridge body 102 by slits 116 with exception of the internal area aligned with the access port 106. In accordance with this approach, the end cap 114 is coupled to the cartridge body 102 through one or more segments of material forming the cartridge body 102 and the end cap 114. In certain embodiments, the end cap 114 may be removed from the cartridge body 102 by rotating or twisting the end cap 114 relative to the cartridge body 102 which causes the material connecting the end cap 114 to fracture, rupture, break etc. thereby enabling release of the end cap 114 relative to the cartridge body 102. In some embodiments, the end cap 114 may be removed without rotation or twisting relative to the cartridge body 102. Other arrangements are also envisioned.

[0027] Referring now to FIGS. 2-4, further details of the access port 106 will be described. As noted hereinabove, the access port 106 provides a sterile chamber to enable access of an administration member or needle to the treatment fluid within the cartridge body 102. The sterile access port 106 minimize the potential of contaminants from mixing with the fluid agent during use of the cartridge assembly, and may minimize or even eliminate the need for a user to wipe or swab the access port 106 with a disinfectant like alcohol prior to use. In FIGS. 2-4, the endPCT / US25 / 44375 30 August 2025 (30.08.2025)Attorney Docket No.: AJ01 -047-02 cap 114 is shown removed from the cartridge body 102. The access port 106 is a tapered or a frusto-conical shaped structure and defines a port opening 118 which is exposed upon removal of the end cap 114. The access port 106 further includes a port interior or cavity 120 extending from the port opening 118 and a seal membrane 122. The seal membrane 122 separates the port interior 120 of the access port 106 from the cartridge body 102. In embodiments, the access port 106 and the seal membrane 122 are formed during the BFS process.

[0028] As best depicted in FIGS. 3 and 4, the port interior 120 is defined by an interior wall 124 which tapers inwardly from the port opening 118 toward the seal membrane 122. In embodiments, the interior wall 124 is dimensioned to minimize engagement with an administration device or needle “n” (shown in FIG. 4) introduced through the access port 106 and used to penetrate the seal membrane 122 to access the treatment fluid within the cartridge body 102. Moreover, the interior wall 124 of the port interior 120 decreases in orthogonal relation to the longitudinal axis “k” to facilitate positioning a needle “n” (FIG. 4) within the port opening 118 and enable the needle “n” to advance within the port interior 120 toward the seal membrane 122 without, e.g., engagement with the interior wall 124.

[0029] The access port 106 including the port interior 120 and the seal membrane 122 is sterile. In embodiments, the end cap 114 maintains the sterility of the interior of the access port 116. In embodiments, the BFS process for forming the cartridge body 102 is performed in a sterile environment. Thus, the access port 106 including the port interior 120 and the seal membrane 122 is sterile. Thus, upon removal of the end cap 114, the sterile access port 106 is exposed to enable introduction of the needle “n” through the port opening 118 and the port interior 120 for penetration through the seal membrane 122. In some embodiments, due to the sterile environment provided by the end cap 114 in association with the access port 106, the needle “n” can be introduced within the access port 106 without “swabbing” or cleaning of the access port 106 subsequent to the removal of the end cap 114. More specifically, the seal membrane 122 is isolated within the access port 106 and remains sterile during manipulation and use of the cartridge assembly 100 until the end cap 114 is removed prior to use. This provides significant clinical advantages to a clinician or user whose hands may be otherwise occupied while performing other steps of a surgical procedure.

[0030] In FIG. 4, the seal membrane 122 is shown to have a cross-section or thickness greater than the thickness of the internal wall 124 of the port interior 120 (although in other embodiments the thickness of the seal membrane 122 may be the same or less than the thickness of the internal wall 124). In embodiments, the seal membrane 122 is solid and pierced or penetrated with a pointed end of the needle “n”. In some embodiments, the seal membrane 122 may include a slit, opening or valve dimensioned to permit passage of the needle end of the needle “n” without piercing through the material of the seal membrane 122. FIG. 4 also shows the needle entering the internal reservoir 126 of the cartridge body 102 to access the fluid agent therein.

[0031] FIG. 4 also depicts the cartridge wings 128 extending outwardly relative to the access port 106. The cartridge wings 128 are dimensioned to define a cross-section to approximate an internal housing of anPCT / US25 / 44375 30 August 2025 (30.08.2025)Attorney Docket No.: AJ01 -047-02 administration assembly to which the cartridge body 102 will be position. The cartridge wings 128 may be planar or any other configuration.

[0032] Further details of additional compressible cartridges which may be modified for use with a sterile access port are illustrated in international patent application number PCT / US24 / 25736, filed April 22, 2024 and entitled “BLOW-FILL-SEAL (BFS) SYRINGE CARTRIDGE SYSTEMS AND METHODS,” the entire contents of which disclosure is incorporated by reference herein.

[0033] Referring now to FIGS. 5A-5C, a delivery system which incorporates the cartridge assembly 100 of FIGS. 1-4 is illustrated. The delivery system 250 includes a cartridge assembly 200 and an administration assembly 270. The cartridge assembly 200 may be similar or identical in all respects to the cartridge assembly 100 described hereinabove with like refence numerals of the cartridge assembly 200 identifying like components of the cartridge assembly 100. In FIGS. 5A and 5B, the end cap 114 of the cartridge assembly 200 is removed and the cartridge body 202 is within the administration assembly 270 in a “ready for use” position. The administration assembly 270 including an administration housing 272 having a housing chamber 274 for accommodating the cartridge assembly 200, an administration member 276 (e.g., a needle) coupled to the administration housing 272 and a plunger 278 at least partially positionable within the housing chamber 274. The administration assembly 270 further includes a cover 280 which encapsulates the administration member 276. In embodiments, the administration housing 272 includes a flange 282 for gripping engagement by the user. The administration housing 272 includes a narrow housing neck 284 having an internal hub 286 therein for securing the administration member 276 within the administration housing 272. The internal hub 286 may be secured within the narrow housing neck 284 with the use of adhesives or the like and may include a passage for reception of the administration member 276. The administration member 276 is in turn secured within the passage of the internal hub 286 to secure and / or fix the administration member 276 relative to the administration housing 272.

[0034] The administration member 276 may be, for example, a cannulated needle such as a double edge needle and extends within the interior of the narrow housing neck 284 at one end and beyond the internal hub 286 at the second end. The needle end within the narrow housing neck 284 may be dimensioned to pierce the seal membrane 222 of the cartridge body 202 and the opposed needle end may be dimensioned to pierce the subject or patient. The needle ends may be straight, beveled, multi-beveled, etc. In other embodiments, the opposed needle end may be blunt and dimensioned to penetrate tissue, but rather apply the fluid agent topically to a patient. The cannulated needle may include transverse bores in its outer wall to permit entry of the fluid agent into the passage of the cannulated needle. One suitable needle arrangement for use as an administration member 276 is described in commonly assigned PCT Application Serial No. PCT / US21 / 61991 , filed December 6, 2021 , the entire contents of which is incorporated by reference herein.

[0035] The plunger 278 may include a disc-shaped handle 288 (although any geometric shape or configuration for such handle may be used) and an elongate plunger element 290. The plunger 278 may further include a flagPCT / US25 / 44375 30 August 2025 (30.08.2025)Attorney Docket No.: AJ01 -047-02 segment 292 depending outwardly from the plunger element 290. The plunger 278 may be fabricated from a suitable polymeric material and formed via known methodologies including injection molding techniques or the like. The flag segment 292 functions as an anti-activating mechanism preventing activation or movement of the plunger 278 within the administration housing 272 until it is detached, folded or otherwise removed from the plunger 278. More specifically, the flag segment 292 prevents the cartridge body 202 from being pushed down into the administration housing 272 and pierced by the administration member 276 (e.g., the needle) until it is removed or displaced, (i.e., the flag segment 292, in its first or “pre-acti vation” position, prevents an injection of the fluid agent from being initiated; it is only when the flag segment 292 is removed or placed into a second “activation” position (repositioned, etc.) that the injection of the fluid agent may be initiated.

[0036] FIGS. 5A-5C illustrate the cartridge body 202 positioned within the administration housing 272 with the end cap being removed to open the access port 206. As best depicted in FIG. 5C, once the cartridge body 202 is loaded, one end of the administration member 276 is received within the port opening 218 and at least partially extending within the port interior 220. At this initial state or condition, the needle end is spaced from the seal membrane 222.

[0037] FIG. 6 is a view corresponding to an actuated position of the plunger 278 through removal of the flag segment 292 and advancement of the plunger 278 within the administration housing 272. During actuation of the plunger 278, the needle end of the administration member 276 penetrates the seal membrane 222 to enter the internal reservoir 226 and access the fluid agent therein. As shown, the administration member 276 is spaced from the interior wall 224 of the access port 206 and directly engages and pierces the seal membrane 222 in response to actuation of the plunger 278.

[0038] FIG. 7 is a flow chart illustrating one exemplary method of use of the cartridge assembly 100 of FIGS. 1 -4 of the present disclosure. The process 300 includes obtaining a cartridge assembly 100 having a cartridge body 102 with an internal reservoir 126 for holding a medicant or fluid agent and an end cap 114 mounted to the cartridge body 102. (STEP 302). In STEP 304, the end cap 114 is removed from the cartridge body 102 to enable access to a sterile access port 106 of the cartridge body 102. The access port 106 defines a port opening 118 leading to a port interior 120 and to a sterile seal membrane 122 separating the access port 106 and the cartridge body 102. In embodiments, the end cap 114 is monolithically formed with the cartridge body and is removed via a twisting or rotating action to cause the material connecting the end cap 114 and the cartridge body 102 to fracture. In STEP 306, an administration member or needle extending through the port opening 118 and the port interior 120 of the access port 106 is used to penetrate the sterile seal membrane 122 to enter the internal reservoir 126 of the cartridge body 102 to enable access to the fluid agent for delivery to the patient. Due to the sterile characteristics of the access port 106 and the seal membrane 122, the cartridge assembly may be used without swabbing the components with a disinfectant.

[0039] In embodiments, during the BFS manufacturing process, the cartridge body 102 may be formed, filled, and sealed in a continuous process without human intervention, in a sterile enclosed area inside a machine. ThePCT / US25 / 44375 30 August 2025 (30.08.2025)Attorney Docket No.: AJ01 -047-02BFS manufacturing process is multi-step in which a pharmaceutical-grade plastic resin is vertically heat extruded through a circular opening to form a hanging tube called the parison. This extruded tube is then enclosed within a two-part mold, and the tube is cut above the mold. The mold is transferred to the filling zone, or sterile filling space, where filling needles (mandrels) are lowered and used to inflate the plastic to form the container within the mold. Following the formation of the cartridge assembly 100, the mandrel is used to fill the cartridge body 102 a fluid agent. Following filling, the mandrels are retracted, and a secondary top mold seals the container. All actions take place inside a sterile shrouded chamber inside the machine. The end cap 114 is formed during the BFS extrusion process, and is an extension of the cartridge body 102. The end cap 114 seals the access port 106 and maintains the sterilized environment even upon removal of the end cap 114.

[0040] FIG. 8 is a flow chart illustrating a method of use of the delivery system 250 of FIGS. 5A-5C and 6. In the exemplary method or process 400, a cartridge assembly is provided or obtained where the cartridge assembly 200 includes a cartridge body 202 having an internal reservoir 226 for holding a medicant or fluid agent and an end cap 214 mounted to the cartridge body 202 (STEP 402). In STEP 404, the end cap 214 is removed from the cartridge body 202 to enable access to an access port 206 of the cartridge body 202. In embodiments, removing the end cap 214 includes breaking a coupling segment coupling the end cap 214 to the cartridge body 2O2.The access port 206 defines a port opening 218 leading to a port interior 220 and a sterile seal membrane 222. Thereafter, the cartridge body 202 is positioned within an administration housing 272 of an administration assembly 270, for example, the housing chamber 274 of the administration assembly 270. (STEP 406) The administration assembly 270 includes an administration member 276 coupled to the administration housing 272 and extending at least within the housing chamber 274. In some embodiments, the cartridge body 202 is positioned within the administration housing 272 without swabbing the access port 206 with alcohol and / or a disinfectant. This is made possible at least in part to the sterilized access port 206 which is sealed by the end cap 214. In STEP 408, the cartridge body 202 is moved relative to the administration housing 272 to cause an internal end of the administration member to penetrate the sterile seal membrane 222 separating the port interior 220 of the access port 206 and the internal reservoir 226 of the cartridge body 202 to enable access to the fluid agent or medicant with the cartridge body 202. Thereafter, the fluid agent or medicant is delivered to a patient with an external end of the administration member. In some embodiments, during moving of the cartridge body 202, the internal end of the administration member 276 penetrates the sterile seal membrane 222 without contacting internal surfaces of the access port 206.

[0041] Referring now to FIGS. 9-11, another cartridge assembly in accordance with an exemplary embodiment of the present disclosure is illustrated. The cartridge assembly 500 includes a compressible cartridge body 502 defining a longitudinal axis “m,” a handle 504 extending from one end of the cartridge body 502 and an access port 506 extending from the other end of the cartridge body 502. The handle 504 includes visual indicia 508 similar in function to the visual indicia 108 of the cartridge assembly 100 described hereinabove. The indicia or an indicator (such as an RFID chip) may be representative of the type, lot, expiration date of the fluid agent contained withinPCT / US25 / 44375 30 August 2025 (30.08.2025)Attorney Docket No.: AJ01 -047-02 the cartridge body 502. The cartridge body 502 is compressible through application of a compressive force transverse to the longitudinal axis “m” to dispense the fluid agent contained within the cartridge body 502. In some embodiments, the cartridge body 502 includes a plurality of outer ribs 528 to facilitate engagement with the cartridge boy 502 and compression of the cartridge body 502. In embodiments, the cartridge body 502 includes one or more wings 530 depending radially outwardly with respect to the longitudinal axis “m.” In some embodiments, first and second wings 530 are provided and arranged in diametric opposed relation. The first and second wings 530 are narrow in cross-section defining a thickness, in some embodiments, less than one (1) millimeter. The first and second wings 530 facilitate coupling of the cartridge assembly 500 relative to an administration or delivery assembly. The cartridge body 502 further includes an end cap 514 (FIG. 9) coupled to the cartridge body 502 adjacent the access port 506. The end cap 514 may be similar in configuration and function to the end cap 114 of the cartridge assembly 100.

[0042] FIGS. 10 and 11 illustrate the end cap 514 removed from the cartridge body 502 exposing the port opening 518 leading to the port interior 520 of the access port 506. FIG. 12 is an isolated view of the access port 506 with a needle “n” penetrating the seal membrane 522. The access port 506 is similar to configuration and function to the access port 106 of FIGS. 1-4, and provides a sterile environment for the needle “n” to access the internal reservoir 526 of the cartridge body 502 through penetration of the sterile seal membrane 522. Moreover, the cartridge assembly 500 may be formed via a BFS process in a sterile environment as described hereinabove. Thus, the access port 506 including the port interior 520 and seal membrane 522 is sterilized prior to and subsequent to removal of the end cap 514. Thus, in embodiments, once the end cap 514 is removed, there is no requirement to swab or clean the exposed access port 506 in that the port interior 520 and the seal membrane 522 in in a sterilized state or environment.

[0043] Further details of additional compressible cartridges which may be modified for use with a sterile access port are illustrated in international patent application publication number WO2017 / 186262 A1 , published on 02 November 2017 and entitled “Medical Delivery System,” and in international patent application publication number WO2023 / 244561 A1 , published on 12 December 2023 and entitled “Medical Delivery System,” the entire contents of each disclosure being incorporated by reference herein.

[0044] FIGS. 13 and 14 illustrates a delivery system which incorporates the cartridge assembly 500 of FIGS. 9- 12. The delivery system 650 includes a cartridge assembly 600 and an administration assembly 670. The cartridge assembly 600 may be similar or identical in all respects to the cartridge assembly 500 described hereinabove in connection with FIGS. 10-13 with like reference numerals of the cartridge assembly 600 identifying like components of the cartridge assembly 500. In FIGS. 13 and 14, the end cap of the cartridge assembly 600 is removed and the cartridge body 602 is disposed within the administration assembly 670 in a “ready for use” position. The administration assembly 670 including an administration housing 672 having an internal housing chamber 674 for accommodating the cartridge assembly 600 and an administration member 676 (e.g., a needle) coupled to thePCT / US25 / 44375 30 August 2025 (30.08.2025)Attorney Docket No.: AJ01 -047-02 administration housing 672. The administration assembly 670 may include a cover (not shown) for encapsulating the administration member 676. In embodiments, the administration housing 672 includes a narrow housing neck 684 having an internal hub 686 therein for securing the administration member 676 within the administration housing 672. The internal hub 686 may be secured within the narrow housing neck 684 with the use of adhesives or the like and may include a passage for reception of the administration member 676. The administration member 676 is in turn secured within the passage of the internal hub 686 to secure and / or fix the administration member 276 relative to the administration housing 272. The administration member 676 may be similar to the administration member 276 of FIGS. 1-4.

[0045] In use, the end cap is removed from the cartridge body 602 by twisting the end cap to break the connecting material coupling the end cap to the cartridge body 602. Thereafter, the cartridge body 602 is advanced within the housing chamber 674 of the administration housing 672. During advancement of the cartridge body 602, the needle end of the administration member 676 (e.g., cannulated needle) penetrates the sealed membrane 722 to access the internal reservoir 626 of the cartridge body 602 and the fluid agent therein. In embodiments, the one or more wings 630 compress during entry into the administration housing 672 to facilitate retention and / or locking of the cartridge body 602 within the administration housing 672. The cartridge body 602 is squeezed to eject the fluid agent from the internal reservoir 626 of the cartridge body 602, and through the administration member 676 for application to the patient.

[0046] In some embodiments, the end cap may be manufactured as a separate component and coupled to the cartridge body 602 in a subsequent process step. In accordance with this approach, the port interior 120 of the access port 106 may be exposed and subjected to one or more sterilization processes utilizing a sterilizing agent to sterilize the port interior 120 and the seal membrane 122 of the access port 106. Thereafter, the end cap may be coupled to the access port 106 to enclose the port interior 120. Any mechanisms for coupling the end cap to the access port 106 may be utilized including mechanical couplings, adhesives or the like.Rules of Interpretation

[0047] 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.

[0048] 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 present disclosure is widely applicable to numerous embodiments, as is readily apparent from the disclosure. One of ordinary skill inPCT / US25 / 44375 30 August 2025 (30.08.2025)Attorney Docket No.: AJ01 -047-02 the art will recognize that the disclosure may be practiced with various modifications and alterations. Although particular features of the disclosure 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.

[0049] Devices that are in communication with each other need not be in continuous communication with each other, unless expressly specified otherwise.

[0050] 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 disclosure. Unless otherwise specified explicitly, no component and / or feature is essential or required.

[0051] Further, although process steps 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 disclosure, and does not imply that the illustrated process is preferred.

[0052] The present disclosure provides, to one of ordinary skill in the art, an enabling description of several embodiments and / or disclosures. Some of these embodiments and / or disclosures 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.

[0053] 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 disclosure as defined by the claims appended hereto.

[0054] 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 dependPCT / US25 / 44375 30 August 2025 (30.08.2025)Attorney Docket No.: AJ01 -047-02 upon the specific application or applications for which the teachings of the present disclosure is / are used.

[0055] 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.

[0056] All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0057] The indefinite articles “a” and “an,” as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean “at least one.”

[0058] The phrase “and / or,” as used herein in the specification and in the claims, should be understood to mean “either or both” of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Other elements may optionally be present other than the elements specifically identified by the “and / or” clause, whether related or unrelated to those elements specifically identified, unless clearly indicated to the contrary.

[0059] Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0060] The terms and expressions which have been employed herein are used as terms of description and not of limitation, and there is no intention, in the use of such terms and expressions, of excluding any equivalents of the features shown and described (or portions thereof), and it is recognized that various modifications are possible within the scope of the claims. Accordingly, the claims are intended to cover all such equivalents.

[0061] Various modifications of the disclosure and many further embodiments thereof, in addition to those shown and described herein, will become apparent to those skilled in the art from the full contents of this document, including references to the scientific and patent literature cited herein. The subject matter herein contains important information, exemplification and guidance that can be adapted to the practice of this disclosure in its various embodiments and equivalents thereof.

Claims

Attorney Docket No.: AJ01-047-02CLAIMSWhat is claimed is:

1. A cartridge assembly, which comprises: a cartridge body having an internal reservoir for holding a fluid agent and defining a longitudinal axis; an access port adjacent one end of the cartridge body; a seal membrane separating the access port and the internal reservoir of the cartridge body; and an end cap mounted to the cartridge body adjacent the access port, the end cap being removable from the cartridge body to enable access to the access port.

2. The cartridge assembly according to claim 1 wherein the access port defines a port opening upon removable of the end cap.

3. The cartridge assembly according to claim 2 wherein the access port defines a port interior extending from the opening to the seal membrane.

4. The cartridge assembly according to claim 3 wherein the port opening and the port interior are dimensioned to enable passage of a needle therethrough.

5. The cartridge assembly according to claim 4 wherein the seal membrane is configured to be penetrated by a needle to enable access of the needle to the fluid agent within the internal reservoir of the cartridge body.

6. The cartridge assembly according to claim 1 wherein the cartridge body defines one or more bellows segment configured to be compressed along at least a longitudinal direction to dispense the fluid agent.

7. The cartridge assembly according to claim 1 wherein the cartridge body is compressible along at least a direction transverse to the longitudinal axis.

8. The cartridge assembly according to claim 1 wherein the end cap is configured to be rotated relative to the cartridge body to effect removal from the cartridge body.

9. The cartridge assembly according to claim 8 wherein the end cap includes indicia representative of the fluid agent within the internal reservoir of the cartridge body.Attorney Docket No.: AJ01-047-0210. A delivery system, which comprises: an administration assembly including: an administration housing defining a longitudinal axis and having a housing chamber; and an administration member coupled to the administration housing and having a first end extending within the housing chamber and a second end for application to a patient; and a cartridge assembly, including: a cartridge body having an internal reservoir for holding a fluid agent and defining a longitudinal axis; an access port adjacent one end of the cartridge body; a seal membrane separating the access port and the internal reservoir of the cartridge body; and an end cap mounted to the cartridge body adjacent the access port, the end cap being removable from the cartridge body to enable access to the access port; and wherein subsequent to removal of the end cap from the cartridge body the cartridge body is movable relative to the administration housing to cause the first end of the administration member to penetrate the seal membrane to enable access of the administration member to the fluid agent within the internal reservoir of the cartridge body.

11. The delivery system according to claim 10 wherein the administration member includes a cannulated needle and wherein the first end is configured to pierce the seal membrane.

12. The delivery system according to claim 11 wherein the access port defines a port opening upon removable of the end cap.

13. The delivery system according to claim 12 wherein the access port defines a port interior extending from the port opening to the seal membrane.

14. The delivery system according to claim 13 wherein the port opening and the port interior are dimensioned to enable passage of the first end of the cannulated needle therethrough during movement of the cartridge body relative to the administration housing whereby the first end of the cannulated needle penetrates the seal membrane to enable access of the cannulated needle to the fluid agent within the internal reservoir of the cartridge body.Attorney Docket No.: AJ01-047-0215. The delivery system according to claim 14 wherein the cartridge body defines one or more bellows segment configured to be compressed along at least a longitudinal direction to dispense the fluid agent.

16. The delivery system according to claim 14 wherein the cartridge body is compressible in a direction at least transverse to the longitudinal axis.

17. The delivery system according to claim 14 wherein the end cap is configured to be rotated relative to the cartridge body to effect removal from the cartridge body.

18. The delivery system according to claim 11 wherein the administration assembly includes a plunger, the plunger being manually actuated to cause movement of the cartridge body relative to the administration housing.

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