TW202416928A - Dispenser configured for aseptic transfer of a liquid product - Google Patents

Abstract

A drug delivery system includes a container comprising a luer compartment and a fluid compartment, a luer fitting arranged within the luer compartment and in fluidic communication with the fluid compartment, and a dispenser in fluidic communication with the fluid compartment. A method of aseptically transferring a drug to such a drug delivery system may include providing a vial comprising the drug to be transferred, withdrawing a volume of the drug from the vial with a syringe, coupling the syringe to a drug delivery system via the luer fitting, transferring the drug from the syringe to the drug delivery system, and decoupling the syringe from the drug delivery system.

Description

Dispensers configured for aseptic transfer of liquid products

The present invention generally relates to the field of storage and/or delivery of fluids, such as drugs.

In many instances, a drug or other medication is delivered and/or stored in a form different from the form in which it is administered to a patient and must be prepared in a particular manner before it is administered to a patient. For example, a freeze-dried drug can be reconstituted into a liquid, or a frozen drug can be thawed. This drug preparation typically occurs in a separate vial, and the prepared drug can then be accessed with a syringe or other suitable device.

In some instances, prepared medications must be administered to a patient in a specific manner using a designated type of medication delivery device (e.g., eyedropper, nasal spray pump). In such instances, the medication is typically prepared in a separate medicine bottle and then must be transferred to the medication delivery device for administration. However, this transfer process is risky and can present challenges to a user. For example, if the transfer process is not handled properly, it can result in contamination and/or other degradation of the prepared medication. Accordingly, special training is required to properly transfer medication from a medicine bottle to a medication delivery device. Untrained patients or other consumers may find it difficult or confusing to properly handle medications, which can result in contamination, reduced efficacy, harm to patients, and/or waste of medication.

Therefore, there is a need for new and improved systems and methods for aseptically transferring a liquid product for drug delivery and/or the like.

In general, in some variations, a drug delivery system may include: a container including a luer compartment and a fluid compartment; a luer connector disposed within the luer compartment and in fluid communication with the fluid compartment; and a dispenser in fluid communication with the fluid compartment. The luer connector may, for example, include a luer valve configured to receive fluid from a syringe or other fluid dispensing device. The luer connector may be coupled to the luer compartment via a fluid seal. In some variations, the system may further include a cap configured to seal the luer connector within the luer compartment. For example, the cap may be configured to couple to the container.

The luer compartment and the fluid compartment may be disposed in any suitable portion or location of the container. For example, in some variations, the luer compartment and the fluid compartment may be disposed on opposite ends of the container (e.g., the luer compartment is proximate a base portion of the container, and the fluid compartment is proximate a neck portion of the container). In some variations, the container may include a conduit extending between the luer compartment and the fluid compartment, such as for conveying fluid from the luer compartment to the fluid compartment. For example, at least a portion of the luer connector may be disposed within the conduit to convey fluid from the luer compartment to the fluid compartment.

In some variants, the dispenser may be coupled to the container. For example, the dispenser may be directly coupled to the container, such as via a snap or threaded interface between the container and the dispenser. Alternatively, the dispenser may be indirectly coupled to the container via an adapter configured to intervene between the container and the dispenser, wherein the adapter includes a first interface configured to be coupled to the container and a second interface configured to be coupled to the dispenser. In some variants, the first interface and the second interface may be different. For example, one of the first and second interfaces may include a snap interface, and the other of the first and second interfaces may include a threaded interface.

The drug delivery system may include any suitable type of dispenser. For example, in some variations, the dispenser may include an eyedropper. As another example, the dispenser may include a nasal spray pump. Other aspects of the container may be configured depending on the type of dispenser. For example, in some variations, the container may include a flexible material (e.g., in variations in which the dispenser includes an eyedropper such that the container can be squeezed to cause fluid to drip from the eyedropper).

Generally, a method of aseptically transferring a drug to a drug delivery system may include: preparing and/or otherwise providing a vial containing the drug to be transferred; withdrawing a quantity of the drug from the vial with a syringe; coupling the syringe to a drug delivery system via a luer connector; transferring the drug from the syringe to the drug delivery system; and uncoupling the syringe from the drug delivery system. In some variations, the method may further include covering the luer connector of the drug delivery system with a cap, such as after the syringe is uncoupled from the drug delivery system. The drug delivery system may include a container and a dispenser, wherein the container includes a luer compartment and a fluid compartment, and wherein the luer connector is disposed within the luer compartment and is in fluid communication with the fluid compartment. In some variations, the dispenser may be directly coupled to the container, while in other variations, the dispenser may be indirectly coupled to the container via an adapter that includes a first interface coupled to the container and a second interface coupled to the dispenser. The drug delivery system may include any suitable type of dispenser. For example, in some variations, the dispenser may include an eye dropper. As another example, the dispenser may include a nasal spray pump.

Non-limiting examples of various aspects and variations of the invention are described herein and shown in the accompanying drawings.

Described herein are systems and methods for aseptically transferring a liquid product (e.g., a drug) to a device that is configured to administer the liquid product in a specific manner. For example, a liquid drug (or other suitable fluid product) can be prepared in a suitable preparation vial (e.g., configured to allow reconstitution of a freeze-dried drug or thawing of a frozen drug such as a biologic or small molecule) and then transferred to a drug delivery system configured with a product dispenser. The drug delivery system is simple to operate and includes one or more features to help reduce the risk of contamination of the liquid product during transfer, as described herein. Additionally or alternatively, the drug delivery system can reduce manufacturing constraints. For example, if a medication is to be stored and delivered within its associated medication dispenser from the time of manufacture, a customized process is required to properly fill the medication dispenser with the medication prior to shipment. Properly sterilizing the entire assembled product with the medication and medication dispenser is also challenging because the medication and medication dispenser have different material properties and sterilization requirements (e.g., a typical sterilization process for a medication dispenser may adversely affect the medication). To facilitate an easy way for a user (e.g., a clinician or a patient at home) to aseptically transfer a medication from a vial to a medication delivery system, the vials and medication delivery system may be separately assembled and/or sterilized. In other words, the medication delivery system may be sterilized through a learned process without medication, while allowing a vial to be filled with medication and sterilized separately through a learned and rigorously reviewed process.

In general, in some variations, a drug delivery system may include: a container including a fluid compartment, a luer compartment; a luer connector disposed within the luer compartment and in fluid communication with the fluid compartment; and a dispenser in fluid communication with the fluid compartment. The luer connector may include, for example, a luer lock having a one-way or resealable valve to aseptically transfer a fluid from a source outside the container (e.g., a syringe) into the fluid compartment. In some variations, both the fluid compartment and the luer compartment may be inside the container. However, the luer compartment may be located in any suitable portion of the drug delivery system in fluid communication with the fluid compartment, such as in a separate component coupled to the container. For example, a drug delivery system may include a collar interposed between the container and the dispenser, wherein at least a portion of the Luer compartment may be within the collar.

Furthermore, in some variations, the dispenser may be directly connected to the container, or may be indirectly coupled to the container and in fluid communication via an adapter (e.g., an adapter that converts between different interface types in the container and the dispenser, such as snap-on or threaded interfaces). The dispenser may be any suitable type of drug delivery dispenser, such as an eyedropper, a nasal spray pump, and/or the like.

The drug delivery system can receive a liquid product (e.g., a reconstituted freeze-dried product, a thawed product, etc.) via the Luer connector. For example, a syringe containing the liquid product (e.g., drawn from a separately prepared vial) can engage the Luer connector. When the syringe is engaged with the Luer connector, the syringe can be operated by a user to transfer some or all of the liquid product from the syringe through the Luer connector into the fluid compartment. After the liquid product is in the fluid compartment, a user can actuate a dispenser in the drug delivery system to appropriately administer the liquid product (e.g., as eye drops, nasal spray, etc.).

An exemplary variation of a drug delivery system 100 is shown in FIGS. 1A-1D . The drug delivery system 100 may include: a container 110 including a luer compartment 120 and a fluid compartment 130 inside the container 110; and a luer connector 150 disposed within the luer compartment 120 and in fluid communication with the fluid compartment 130 (as shown in FIG. 1C ). The luer connector 150 may be configured to receive a syringe needle for receiving a fluid. The luer connector 150 may include, for example, a luer lock having a one-way or resealable valve. 1D , the luer connector 150 may include a hub 152 and one or more connector interfaces configured to engage the fluid compartment 130 and/or other portions of the drug delivery system, such as a luer barb 154 extending from one end of the hub 152 and/or a threaded interface 156 extending from an opposite end of the hub 152. In some variations, the drug delivery system 100 may further include a cap 140 coupled to the container 110 and configured to close the luer connector 150 within the luer compartment.

The drug delivery system 100 may further include a dispenser 160 coupled directly or indirectly to the container 110 to be in fluid communication with the fluid compartment 130. The dispenser 160 may, for example, include an eye dropper, a nasal spray pump head, and/or the like, as further described below.

The container 110 is depicted as being generally cylindrical. However, in other variations, the container 110 may have any suitable shape (e.g., conical, spherical, pear-shaped, hourglass-shaped, etc.). As shown in FIG. 1C , a portion of the container 110 may include a luer compartment 120 and a fluid compartment 130 configured to receive a luer connector 150. The luer compartment 120 and the fluid compartment 130 may be separated, for example, by a wall 114. The wall 114 may extend into a conduit 132 that helps facilitate fluid communication between the luer compartment 120 and the fluid compartment 130. For example, the conduit 132 may include an inner tube extending from the luer compartment 120 so that fluid can travel from the luer compartment 120 to the fluid compartment 130. In some variations, fluid can travel from the luer compartment 120 to the fluid compartment 130 within the luer connector 150, wherein at least a portion of the luer connector (e.g., the luer barb 154) can be located within the conduit 132. The conduit 132 can have a circular cross-section or any suitable shape (e.g., corresponding to the shape of the luer connector). Although the conduit 132 is shown as being centrally located within the container 110, it should be understood that in other variations, the conduit 132 can be radially offset from a centerline or longitudinal axis of the container 110.

As shown in FIG. 1E , the luer compartment 120 and the fluid compartment 130 are axially aligned, with the luer compartment 120 being disposed closer to a base portion of the container 110 (e.g., the lower end of the container 110, as depicted in FIG. 1E ) and the fluid compartment 130 being disposed closer to a dispenser portion of the container 110 (e.g., the upper end of the container 110, as depicted in FIG. 1E ). However, in other variations, the luer compartment 120 and the fluid compartment 130 may be disposed in any suitable relative manner. For example, the fluid compartment may be in the shape of an annulus, and the luer compartment 120 may be substantially or completely located within the annulus of the fluid compartment 130, such that the fluid compartment 130 surrounds the luer compartment. As another example, the Luer compartment 120 and the fluid compartment 130 may occupy different transverse portions of the container (e.g., a first semicircular portion of the container 110 may include the Luer compartment, and a second semicircular portion of the container 110 may include the fluid compartment).

The luer compartment 120 can include one or more luer engagement features 122 that engage the luer connector 150 within the luer compartment 120. For example, the luer engagement features 122 can include one or more radial inward protrusions that can help center and/or otherwise guide the luer connector 150 to be placed within the luer compartment 120. As shown in FIG. 1E , the inward protrusion can be a longitudinal member disposed around an inner surface of the luer compartment 120 to form a cradle that receives the luer connector 150. The luer engagement features 122 can additionally or alternatively interact with the luer connector 150 to help lock or retain the luer connector 150 within the luer compartment. For example, the luer engagement feature 122 may include a friction surface (e.g., a high friction material), a conformable material (e.g., silicone), a texture feature (e.g., a bump, a ridge), and/or the like. Additionally or alternatively, the luer engagement feature 122 may include one or more interlocking features (e.g., a lip, a shoulder, a notch, a thread, etc.) that are mechanically coupled to the luer connector 150 to help the luer connector 150 remain in a particular position and/or orientation. As another example, the luer engagement feature 122 may additionally or alternatively accommodate a snap-fit engagement between the luer connector 150 and the luer compartment 120. Additionally or alternatively, the luer connector 150 may be sealed within the luer compartment 120 by applying a suitable epoxy, a UV curable sealant, and/or the like around the perimeter of the luer connector 150 and/or a surface in the luer compartment 120.

As shown in FIGS. 1B-1D , the drug delivery system 100 may further include a cap 140 for protecting the luer connector 150 when not in use (e.g., before and/or after a syringe is inserted into the luer connector 150). For example, the cap 140 may be configured to couple to the container in a manner that covers the luer connector 150 or otherwise seals the luer connector 150 within the luer compartment 120. As shown in FIG. 1C , in some variations, the cap 140 may be generally disc-shaped and configured to couple to the container 110 and/or a bottom surface of the luer connector 150. For example, the cap 140 may include an outer rim 142 configured to couple to the container 110 and an inner rim 144 configured to couple to the luer connector 150. In some variations, the cap 140 may be coupled to the container 110 and/or the luer 150 by a mechanical interfit (e.g., via engagement features that couple in a snap-fit manner, threaded engagement features, etc.), fasteners (e.g., clips, threaded fasteners, magnets, etc.), and/or any suitable means. In some variations, the cap 140 may be formed as a separate component that is completely removable from the remainder of the drug delivery system 100 (e.g., removable from the container 110), as shown in FIG. 1D . Alternatively, the cap 140 may remain coupled to the remainder of the drug delivery system 100 (e.g., coupled to the container 110) and may be moved between an open configuration that exposes the luer 150 and a closed configuration that covers the luer 150. For example, the cap 140 can be coupled to the container 110 at a hinge about which the cap 140 can be manipulated between an open configuration and a closed configuration. The cap 140 can be integrally formed with the container 110 (e.g., a living hinge, an integrated tether) or can be formed separately from and attached to the remainder of the drug delivery system 100 (e.g., via a hinge fastener or interlocking feature on the cap 140 and the container 110).

In some variations, the cap 140 can provide a tamper-proof feature for the drug delivery system 100. For example, the cap 140 can be configured so that once it is placed over the luer 150, it is difficult to uncouple from the container 110 (or move to an open configuration) to expose the luer 150. In some variations, such a tamper-proof feature can help reduce the likelihood of contamination of the contents of the container 110 after fluid is transferred into the container 110 by preventing a user from intentionally or accidentally opening the cap 140 and accessing the luer 150 and the contents of the container 110. For example, as shown in FIG. 1C , the cap 140 may include a smooth, planar surface and/or the cap 140 may engage the container 110 such that all of the cap edges are flush with (or recessed relative to) adjacent container edges, thereby making it challenging to grasp and manipulate the cap 140 after it is placed over the luer connector 150. As another example, the cap 140 may be recessed within the luer compartment 120, thereby making it challenging to access the cap 140 after it is placed over the luer connector. As yet another example, the cap 140 may be coupled to the container 110 by one or more fasteners (e.g., Torx fasteners) or one-way security fasteners, etc., that require a specialized tool. However, in other variations, the cap 140 may be easily removably coupled to the container 110.

In some variations (such as variations in which the cap 140 forms a base or bottom surface of the overall drug delivery system 100), the cap 140 may include one or more anti-slip features. For example, an outer surface of the cap 140 that forms a bottom surface of the drug delivery system 100 may include textured features (e.g., a high friction material such as silicone). Thus, the cap 140 can help prevent the drug delivery system 100 from slipping or sliding on a surface on which the system is placed.

The fluid compartment 130 of the container 110 is used to receive and store the fluid transferred through the Luer connector 150 and/or the conduit 132. The fluid compartment 130 can have any suitable volume and/or shape for storing a suitable amount of fluid. For example, the fluid compartment 130 can be configured to accommodate a single dose of a medication for a user or multiple doses of a medication for a user.

The container 110 may further include a dispenser interface 112 for coupling to a dispenser 160. For example, as shown in FIG. 1C , the dispenser 160 may include at least one outer member 162a (e.g., a circular member or a plurality of arcuate members around the periphery of the dispenser 160) configured to couple to the dispenser interface 112. Specifically, the outer member(s) 162a may include an inclined inner surface configured to mate with an inclined rim 112a on the container 110 in a snap-fit manner. To attach the dispenser 160 to the container 110, the dispenser 160 may be pushed onto the dispenser interface until the outer member(s) 162a abut the annular shoulder 112b and mate with the rim 112a in a snap-fit manner. Once engaged in this manner, the dispenser 160 is substantially prevented from moving in the opposite direction due to the ratchet-like features of the (several) outer members 162a and the inclined rim 112a, thereby locking the dispenser 160 in place on the container 110. Although the dispenser interface 112 depicted in FIGS. 1C to 1E is an example of a snap-fit interface for coupling to a dispenser 160, it should be understood that in other variations, the dispenser interface 112 may include other suitable mechanical interfitting features that provide a snap-fit interface. In addition, in some variations, the dispenser interface 112 may include other suitable engagement features (e.g., threads) for coupling to a dispenser 160. The specific properties of the dispenser interface 112 may depend, for example, on the type of interface on the dispenser 160, which may also differ from the example shown in FIG. 1C.

The particular type of dispenser 160 may depend on the particular application of the drug delivery system 100. For example, the dispenser 160 may comprise an eyedropper or a nasal spray pump. Other characteristics of the drug delivery system may vary depending on the application and/or the type of dispenser 160 included. For example, in variations in which the dispenser 160 comprises an eyedropper, the container 110 may be deformed to allow a user to squeeze the container 110 laterally or radially to drive its contents out of the eyedropper dispenser in a suitable droplet. The container 110 may, for example, comprise a flexible material such as silicone and/or a thin-walled rigid polymer or other suitable material. As another example, in variations in which the dispenser 160 comprises a nasal pump, the container 110 may be substantially rigid to provide a sturdy surface that withstands radial handle pressure and/or resists flexing when a user actuates a nasal pump attached to the container 110. However, even in some variations in which the dispenser 160 comprises a nasal pump, the container 110 may deform, similar to the above, for example, if the nasal pump dispenser itself provides a sufficiently rigid structure for allowing a user to actuate the nasal pump.

Additionally, in some variations, different portions of the container 110 may have different stiffnesses. For example, the walls of the container 110 surrounding the fluid compartment 130 may be flexible, while the walls of the container 110 surrounding the Luer compartment 120 may be rigid. The stiffness of the container 110 may vary due to different dimensions (e.g., thin walls that are more flexible than thicker walls), different materials, and/or other construction features.

In general, the container 110 can be manufactured using any suitable process, such as injection molding, casting, 3D printing or other suitable processing. The different parts of the container 110 can be integrally formed or can be formed separately and coupled together via mechanical mutual cooperation, fasteners, overmolding and/or the like.

An exemplary method of aseptically transferring a medication to a medication delivery system 100 is illustrated in FIGS. 1F-1I . As shown in FIG. 1F , a syringe 20 may be used to manually withdraw a quantity of a medication from a vial 10 . In some variations, the medication may be prepared in the vial 10 (e.g., reconstitution of a freeze-dried medication, thawing of a frozen medication, etc.) prior to such withdrawal. In some variations, the medication may be withdrawn with the syringe 20 through a needle connected to the syringe, the needle piercing the septum 12 of the vial. In some variations, the septum 12 may include a luer lock adapter, such that the syringe 20 is able to withdraw the medication through the luer lock adapter without a needle 22 . As shown in FIG. 1G , the syringe may be coupled to a medication delivery system 100 via an exposed luer connector 150 . The luer connector 150 can be exposed as shown because a cap (similar to the cap 140) is not attached to the drug delivery system 100 (e.g., never attached or previously attached but removed by the user) or a cap is in an open configuration to allow access to the luer connector. If the drug is withdrawn from the vial 10 via the needle 22 attached to the syringe, the needle can be removed after withdrawal, making the syringe compatible with the luer connector 150 included in the drug delivery system 100. Once the syringe 20 is engaged with the luer connector 150, the syringe 20 can be depressed to transfer the drug from the syringe 20 through the luer connector 150 to the drug delivery system 100. Once all or a sufficient amount of the medication has been aseptically transferred in this manner, the syringe 20 can be decoupled from the medication delivery system 100 to allow the luer connector 150 to reseal and seal the contents of the fluid compartment in the medication delivery system 100 from external access. As shown in FIG. 1H , the luer connector can then be covered by coupling a cap 140 to the container 110, thereby enclosing the luer connector within the luer compartment. Following the above procedure, the medication is stored in the fluid compartment of the medication delivery system 100 and administered according to the type of dispenser. For example, as shown in FIG. 1L , an eyedropper cap can be removed to reveal an eyedropper dispenser tip, and the container 110 can be squeezed to administer the medication as eye drops accordingly. Alternatively, a nasal spray pump cap can be removed to reveal a nasal spray tip or nozzle, and the nasal spray pump can be actuated to administer the medication accordingly as a nasal spray.

2A and 2B depict an exemplary variation of a drug delivery system 200 configured with an eyedropper similar to the drug delivery system 100 described above. For example, the drug delivery system 200 may include a container 210 that is generally cylindrical and includes a luer compartment 220 located at one end (a bottom end) of the container 210 and a fluid compartment 230 located at an opposite end (an upper end) of the container 210. A luer connector 250 may be disposed and circumferentially sealed in the luer compartment 220 (e.g., with a UV sealant, epoxy, etc.). A Luer barb 254 extending from one end of the Luer connector can be disposed in a central conduit 232 extending from the Luer compartment 220 to the fluid compartment 230, and the fluid compartment 230 can surround the conduit 232. The opposite end of the Luer connector can be covered by a cap 240 coupled to the container 210 to close the Luer connector 250 within the Luer compartment 220.

An eye dropper 260 can be coupled to an open end or neck of the container 210 to be in fluid communication with the fluid compartment 230. For example, as shown in FIG2B , the eye dropper 260 can be coupled to a dispenser interface 212 via interlocking features, similar to that described above with respect to the dispenser 160 and dispenser interface 112 shown in FIG1C .

10A and 10B depict an exemplary variation of a drug delivery system 1000 similar to drug delivery systems 100 or 200 described above, except that container 1010 is shaped and sized as a disposable eyedropper. Container 1010 may include a luer compartment 1020 configured to receive a luer connector 1050 at one end (a bottom end) of container 1010, a fluid compartment 1030 at an opposite end (an upper end) of container 1010. The drug delivery system may include a dispenser 1040 connected to or integrated with container 1010 and fluidly connected to fluid compartment 1030. The dispenser 1040 may include a cap 1045 releasably connected to the distal end of the dispenser 1040 such that the dispenser and the fluid container 1030 are sealed when the cap 1045 is attached, but when the cap is torn off the dispenser, a liquid content of the fluid container 1030 may be squeezed out through the dispenser 1040. A luer connector 1050 may be disposed within the luer compartment 1020 and a luer barb 1054 extending from the luer connector 1050 may be disposed in a central conduit 1032 within the luer compartment 1020 to form a fluid connection with the fluid compartment 1030. Figure 10A depicts a drug delivery system 1000 in which the luer connector is attached to the luer compartment 1020, and Figure 10B depicts a drug delivery system 1000 in which the luer connector is removed from the luer compartment 1020. Figures 10C and 10D show alternative versions of the drug delivery system 1000 in which the luer compartment 1020 of the container 1010 has an external thread 1025, and the luer connector 1050 is configured to receive the thread 1025, thereby strengthening the attachment of the luer connector 1050 to the luer compartment 1020. 10E and 10F show an alternative version of the drug delivery system 1000 in which a container 1010 shaped and sized as a disposable eyedropper has a fluid compartment 1030 that is thinner than the drug delivery system shown in FIGS. 10A-10D .

Although specific component sizes and shapes of a drug delivery system are shown in FIGS. 1A-1I and 2A-2B , it should be understood that in other variations, the entire container, luer compartment, luer connector, fluid compartment, and/or other related features may have other suitable sizes and/or shapes. For example, FIG. 3 depicts an exemplary variation of a container 310 in a drug delivery system. Container 310 is substantially similar to container 110 shown in FIG. 1E (and includes elements numbered in a manner similar to that shown in FIG. 1E ), except that container 310 includes an extended catheter having a length that is longer than catheter 132 in FIG. 1E . Container 310 may include a catheter having a stepped profile such that the diameter of the catheter varies along its length. Specifically, the conduit may include a first conduit portion 332a coupled to the Luer compartment 320 and a second conduit portion 332b extending from the first conduit portion 332a. The second conduit portion 332b has a narrower diameter than the first conduit portion 332a.

As described above, in some variations, a drug delivery system may include a container having a container body formed from multiple container portions coupled together. For example, FIG. 4 depicts an exemplary variation of a drug delivery system 400 including a container 410 including a fluid compartment 430 and a Luer compartment 420 formed by connecting multiple container walls. Specifically, container 410 includes an inner container wall 434 and an outer container wall 436. The inner and outer container walls may be coupled at an end of the container, such as at a base of the container (the lower end of the container as oriented in FIG. 4). In some variations, the inner and outer container walls may be coupled via mechanical interfitting. For example, as shown in FIG. 4, at the base of container 410, inner container wall 434 may expand radially outward to form an annular base having an upturned lip 435 or other suitable radially engaging member. The upturned lip 435 can be received in an annular channel 437 extending from the outer container wall 436, and the upturned lip 435 and the interlocking features in the annular channel 437 can lock the inner container wall 434 and the outer container wall 436 together, such as in a snap-fit manner. Additionally or alternatively, (several) other suitable engagement features coupled to the inner container wall 434 or formed integrally with the inner container wall 434 can be coupled to (several) corresponding engagement features coupled to or formed integrally with the outer container wall 436 to couple the inner and outer container walls together. Moreover, in some variations, the inner and outer container walls can be coupled together via one or more suitable fasteners (e.g., epoxy, mechanical fasteners such as screws, magnets, etc.).

Once coupled together, the inner container wall 434 and the outer container wall 436 may together define the Luer compartment 420 and/or the fluid compartment 430. For example, as shown in FIG. 4 , the inner container wall 434 may include a cylindrical surface defining a cavity that serves as the Luer compartment 420. The outer container wall 436 may include a cylindrical surface that forms at least a portion of the outer surface of the container 410, and the inner container wall 434 may be nested within the outer container wall 436 such that the space between the inner and outer container walls serves as the fluid compartment 430. Thus, the fluid compartment 430 may have a generally annular shape formed around the Luer compartment 420.

A luer connector 450 can be received and retained in the luer compartment 420, similar to that described above with respect to FIGS. 1A-1E , except as described below. In the container 410, a luer end 454 of the luer connector (similar to a luer barb described above) can be disposed within a conduit 432 but extend beyond the conduit 432 into the fluid compartment 430 itself. The luer connector 450 can be recessed into the luer compartment 420 to leave a gap for a cap 440 to lie flush with the annular base of the inner container wall 434. The cap 440 can be coupled to the inner container 434 to cover the luer connector 450 and seal the luer connector 450 within the luer compartment 420.

The open neck portion of the container 410 may include an interface 412 configured for coupling to a dispenser (not shown) such as an eye dropper or nasal spray pump. Similar to the above description, the interface 412 may include one or more engagement features for coupling to the dispenser, such as through mechanical mutual fit (snap, thread, etc.) and/or other attachment methods, such as epoxy, etc.

Variants of the above-mentioned drug delivery system generally include a dispenser that is directly coupled to the container. However, in other variants, the dispenser can be indirectly coupled to the container by an intervening adapter. For example, in a case where the open neck portion of the container has an interface that is not compatible with the interface of a dispenser, an intervening adapter can achieve indirect coupling between the container and the dispenser so that the dispenser is still in fluid communication with the fluid compartment of the container. For example, the container and the dispenser can have different interface types (for example, one can be a snap-on, and the other can be a thread, or the two can have geometrically incompatible snap-on interfaces) or different sizes (for example, the two can be threads but have different pitches, or the container and the dispenser can have different diameters). In such variants, the intervening adapter can have an interface configured to be coupled to the container and another interface configured to be coupled to the dispenser. Accordingly, the adapter can allow a particular container to operate with a variety of dispenser types (e.g., dispenser brand, size, etc.). Similarly, the adapter can allow a particular dispenser type to operate with a variety of containers.

FIGS. 5A-5C depict an exemplary variation of a drug delivery system 500 including an adapter that transitions between a snap-on interface and a threaded interface. The container 510 can be substantially similar to the container 110 described above with respect to FIGS. 1A-1E and have similar numbering. For example, the container 510 can include a fluid compartment 530 and a luer compartment 520 configured to receive a luer connector 550. A cap 540 can be coupled to the container 510 to cover the luer connector 550 and seal the luer connector 550 within the luer compartment 520. Additionally, the container 510 can include a snap-on interface 512 including an annular member similar to the interface 112 described above. However, rather than being coupled directly to a dispenser, the snap interface 512 can be configured to be coupled to an adapter 570. On its container side, the adapter 570 includes at least one outer annular member 572 that engages with the container interface 512 in a snap-fit manner. On its opposing dispenser side, the adapter includes a threaded interface 574 that is configured to engage with a corresponding threaded interface of the dispenser 560. In some variations, the adapter 570 can further include one or more features that help lock the threaded engagement between the adapter 570 and the dispenser 560. For example, as shown in FIG. 5C , the adapter 570 may include one or more ratchet features 576 about its circumference, wherein the ratchet features 576 enable the dispenser 560 to rotate one-way relative to the adapter 570 (to couple the dispenser to the adapter) but substantially prevent the dispenser 560 from rotating in the opposite direction (to help prevent the dispenser from being removed or uncoupled from the adapter).

Accordingly, although the threaded interface of the dispenser 560 is not compatible with and cannot be coupled to the snap interface 512 of the container 510, the dispenser 560 can be indirectly coupled to the container 510 via the adapter 570 interposed therebetween. The adapter 570 can include a lumen through which the fluid in the fluid compartment 530 can be transferred to the dispenser.

In the example shown in Figures 5A and 5B, the dispenser 560 includes an eye dropper. However, in other variations, the dispenser 560 may include a nasal spray pump or other suitable dispenser. In addition, it should be understood that in other variations, the adapter 570 can be configured to interface with any suitable container (e.g., container 310, container 410, etc.) having a snap interface that is geometrically compatible with the container side of the adapter 570. The adapter 570 can also be configured to interface with any suitable dispenser (e.g., eye dropper, nasal spray pump) having a threaded interface that is compatible with the dispenser side of the adapter 570. For example, the specific geometry and size of the interface of the adapter can vary depending on the specific characteristics of the container and dispenser between which the adapter is intended to be placed.

6A-6C depict another example variation of a drug delivery system 600. As with drug delivery system 500, drug delivery system 600 may include a container 610 having a fluid compartment 630 and a luer compartment 620 configured to receive a luer connector 650. A cap 640 may be coupled to container 610 to cover luer connector 650 and seal luer connector 650 within luer compartment 620. Similar to drug delivery system 500, container 610 itself is not configured to couple directly to a threaded interface of dispenser 660. In contrast, an intervening adapter 670 is configured to engage with the container 610 (e.g., in a direct mating manner) via mating features that are attached by a suitable mechanical interfit (e.g., snap fit, press fit) and/or with a suitable fastener (e.g., epoxy, mechanical fastener, etc.). For example, as shown in FIG. 6B , the container may include an annular channel 612 that mates with a corresponding annular ring on a flange 672 of the adapter 670. On a dispenser side end of the adapter 670, the adapter 670 may include a threaded interface 674 that couples to a threaded interface of the dispenser 660. In some variations, as with the adapter 570, the adapter 670 may further include one or more features that assist in locking the threaded engagement between the adapter 670 and the dispenser 660. For example, as shown in FIG. 6C , the adapter 670 may include one or more ratchet features 676 about its circumference, wherein the ratchet features 676 enable the dispenser 660 to rotate one-way relative to the adapter 670 (to couple the dispenser to the adapter) but substantially prevent the dispenser 660 from rotating in the opposite direction (to help prevent the dispenser from being removed or uncoupled from the adapter).

Accordingly, although the threaded interface of dispenser 660 is not compatible with and cannot be coupled to container 610, dispenser 660 can be indirectly coupled to container 610 via an adapter 670 interposed therebetween. Adapter 670 can include a lumen through which the fluid in fluid compartment 630 can be transferred to the dispenser.

In the example shown in Figures 6A and 6B, the dispenser 660 includes an eye dropper. However, in other variations, the dispenser 660 may include a nasal spray pump or other suitable dispenser. In addition, it should be understood that in other variations, the adapter 670 can be configured to interface with any suitable container (e.g., container 310, container 410, etc.) having an interface that is geometrically compatible with the container side of the adapter 670. The adapter 670 can also be configured to interface with any suitable dispenser (e.g., eye dropper, nasal spray pump) having a threaded interface that is compatible with the dispenser side of the adapter 670. For example, the specific geometry and size of the interface of the adapter may vary depending on the specific features of the container and dispenser between which the adapter is intended to be placed.

As discussed above, in some variations, a medication delivery system may include a nasal pump dispenser coupled to a container. For example, as shown in FIGS. 7A and 7B , a medication delivery system 700 may include a container 710 and a nasal pump dispenser 760. Container 710 may, for example, be similar to any of the above-described containers (e.g., container 110, container 210, container 310, container 410, container 510, container 610, and/or the like). Nasal pump dispenser 760 may be configured to couple directly to an interface 712 on container 710, such as by snap-fit, threaded engagement, etc., depending on the type of interface 712. Alternatively, the nasal spray pump dispenser 760 can be indirectly coupled to the container 710, such as by an adapter (not shown), which can be similar to any of the adapters described above (e.g., adapter 570, adapter 670, etc.). The nasal spray pump dispenser 760 can further include a dip tube 762 of suitable length and/or diameter for residing in the container 710 after the dispenser 760 is coupled to the container 710.

Although variations of the drug delivery system are primarily described above as being included in a luer compartment within a container body, it should be understood that the luer compartment may be located in any suitable portion of the drug delivery system that is in fluid communication with the fluid compartment, such as in a separate component coupled to the container. For example, the drug delivery system may include a collar interposed between the container and the dispenser, wherein at least a portion of the luer compartment may be located in the collar.

8A and 8B illustrate an exemplary variation of a drug delivery system 800 including a collar 870 including a luer compartment configured to at least partially receive a luer connector 850. A container side end of the collar 870 can be configured to couple to a container 810, and a dispenser side end of the collar 870 can be configured to couple to a dispenser 860. The container 810 can be, for example, similar to any of the above-described containers (e.g., container 110, container 210, container 310, container 410, container 510, container 610, container 710, and/or the like). The dispenser 860 can include any suitable dispenser, such as an eye dropper, nasal spray pump, etc. The Luer connector 850 is shown in FIGS. 8A and 8B as partially extending outside the collar 870 to be partially exposed.

As shown in FIGS. 8A and 8B , the Luer connector 850 can be oriented transversely to a longitudinal axis of the container 810 and/or dispenser 860. Accordingly, the Luer connector 850 can be accessed by a syringe placed transversely to the drug delivery system 800. For example, as shown in FIG. 8C , a syringe 20 can be held transverse to the drug delivery system 800, and a distal end of the syringe 20 can engage the Luer connector (e.g., the syringe needle can be inserted into a septum of the Luer connector, the distal end of the syringe barrel can be threaded onto a threaded end of the Luer connector, etc.). Once the syringe 20 is engaged with the Luer connector ( FIG. 8C ), the syringe can be actuated to transfer its contents through the Luer connector into the fluid compartment of the container 810. The syringe can then be removed from the Luer connector. After the fluid is aseptically transferred to the drug delivery system 800 in this manner, in some variations, the exposed end of the luer connector can be covered by a separate cap (not shown) to protect the luer connector. The drug delivery system 800 can then be used to apply the fluid contained therein in an appropriate manner according to a dispenser 860 (e.g., an eye dropper, a nasal spray pump, etc.).

In the figure depicting the above-described drug delivery system 800, the luer connector 850 partially extends outside of the collar 870 to be partially exposed. However, it should be understood that in other variations, the luer connector can be completely recessed within the collar and/or covered by a cap that can be substantially flush with the surface of the collar. For example, as shown in FIG. 9, a drug delivery system 900 can include a collar 970 that includes a luer compartment 920 configured to receive a luer connector 950. A container side end of the collar 970 can be configured to couple to a container 910, and a dispenser side end of the collar 970 can be configured to couple to a dispenser 960. Container 910 may, for example, be similar to any of the above-described containers (e.g., container 110, container 210, container 310, container 410, container 510, container 610, container 710, container 810, and/or the like). Dispenser 960 may include any suitable dispenser, such as an eye dropper, a nasal spray pump, etc. The operation of medication delivery system 900 may be similar to the operation described above with respect to medication delivery system 800 with reference to FIGS. 8C and 8D.

The luer connector 950 is shown in FIG. 9 as being completely within the collar 970 and reversibly covered by a cap 940. The cap 940 may be attached to the collar 970 and may be movable between an open configuration (exposing the luer connector 950) and a closed configuration (covering the luer connector 950). For example, the cap 940 may include a flexible flap. Alternatively, the cap 940 may be a separate component that is removably coupled to the collar 970 to selectively cover a window aligned with the luer connector 950. For example, the cap 940 may include a cover that engages the collar 970 to cover the luer connector 950 by a mechanical interfit (e.g., a snap-fit type interface) or another fastener (e.g., epoxy).

Drug delivery systems 800 and 900 are described above primarily as including a collar that interfaces directly between a container and a dispenser of the drug delivery system. In some variations, the collar can further function in a manner similar to adapters 570 and 670 in that the collar can be converted between different interface types on the container and dispenser that are not suitable for direct coupling. For example, in a situation where the open neck portion of the container has an interface that is not compatible with an interface of a dispenser, the collar can achieve indirect coupling of the container and the dispenser so that the dispenser remains in fluid communication with the fluid compartment of the container. For example, the container and dispenser may have different interface types (e.g., one may be snap-on and the other may be threaded, or both may have geometrically incompatible snap-on interfaces) or different sizes (e.g., both may be threaded but with different pitches, or the container and dispenser may have different diameters). In such variations, the collar may have one interface configured to couple to the container and another interface configured to couple to the dispenser. Accordingly, the collar may allow a particular container to operate with a variety of dispenser types (e.g., brands, sizes, etc. of dispensers). Similarly, the collar may allow a particular dispenser type to operate with a variety of containers.

It should also be understood that in other variations, the drug delivery system may appropriately include additional adapters to convert between incompatible interfaces between the container and the collar and/or incompatible interfaces between the collar and the dispenser.

The above description uses specific nomenclature for purposes of explanation to provide a thorough understanding of the present invention. However, it should be understood by those skilled in the art that the specific details are not necessarily required to practice the present invention. Therefore, the above description of specific embodiments of the present invention is presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the present invention to the precise form disclosed; obviously, many modifications and variations are possible in light of the above teachings. The embodiments are selected and described to explain the principles of the present invention and its practical applications, thereby enabling others skilled in the art to utilize the present invention and various embodiments with various modifications suitable for the specific intended use. The following claims and their equivalents are intended to define the scope of the present invention.

10: vial 12: diaphragm 20: syringe 22: needle 100: drug delivery system 110: container 112: dispenser interface 112a: angled rim 112b: annular shoulder 114: wall 120: luer compartment 122: luer engagement feature 130: fluid compartment 132: conduit 140: cap 142: outer rim 144: inner rim 150: luer connector 152: hub 154: luer barb 156: threaded interface 160: dispenser 162a: external component 200: drug delivery system 210: container 212: dispenser interface 220: luer compartment 230: fluid compartment 232: catheter 240: cap 250: luer connector 254: luer hook 260: eyedropper 310: container 320: luer compartment 332a: first catheter section 332b: second catheter section 400: drug delivery system 410: container 412: interface 420: luer compartment 430: fluid compartment 432: catheter 434: inner container wall 435: upturned lip 436: outer container wall 437: annular channel 440: cap 450: luer connector 454: luer end 500: drug delivery system 510: container 512: snap interface 520: luer compartment 530: fluid compartment 540: cap 550: luer connector 560: dispenser 570: adapter 572: outer ring member 574: threaded interface 576: ratchet feature 600: drug delivery system 610: container 612: annular channel 620: luer compartment 630: fluid compartment 640: cap 650: luer connector 660: dispenser 670: adapter 672: flange 676: ratchet feature 700: drug delivery system 710: container 712: interface 760: nasal spray pump dispenser 762: dip tube 800: drug delivery system 810: container 850: luer connector 860: dispenser 870: collar 900: drug delivery system 910: container 920: luer compartment 940: cap 950: luer connector 960: dispenser 970: collar 1000: drug delivery system 1010: container 1020: luer compartment 1025: external thread 1030: Fluid compartment 1032: Central catheter 1040: Dispenser 1045: Cap 1050: Luer connector 1054: Luer hook

1A-1D depict an upper perspective view, a lower perspective view, a longitudinal cross-sectional view, and an exploded view of an exemplary variation of a drug delivery system configured to receive a liquid product via an aseptic transfer.

FIG. 1E depicts a longitudinal cross-sectional view of a container in the drug delivery system depicted in FIGS. 1A to 1D .

Figures 1F-1H depict a method of transferring a liquid product to the drug delivery system depicted in Figures 1A-1D. Figure 1I depicts the drug delivery system depicted in Figures 1A-1H for administering a liquid product contained therein.

2A and 2B depict, respectively, a perspective view and a longitudinal cross-sectional view of an exemplary variation of a medication delivery system having an eyedropper.

3 depicts a longitudinal cross-sectional view of a container in an exemplary variation of a drug delivery system.

FIG4 depicts a longitudinal cross-sectional view of an exemplary variation of a drug delivery system.

5A-5C respectively depict a perspective view, a longitudinal cross-sectional view, and an exploded view of an exemplary variation of a medication delivery system having an adapter and an eyedropper.

6A-6C respectively depict a perspective view, a longitudinal cross-sectional view, and an exploded view of an exemplary variation of a medication delivery system having an adapter and an eyedropper.

7A and 7B depict, respectively, a side view and a partially exploded view of an exemplary variation of a medication delivery system having a nasal spray pump dispenser.

8A and 8B depict a perspective view and an exploded view, respectively, of an exemplary variation of a drug delivery system having a collar including a Luer connector.

8C and 8D depict a method of transferring a liquid product to the drug delivery system depicted in FIGS. 8A and 8B .

FIG. 9 depicts an example variation of a drug delivery system having a collar including a luer connector and a luer cap.

10A-10F depict an exemplary variation of a medication delivery system having a container configured as a tear-open disposable eyedropper.

100:Medication delivery system

112: Dispenser interface

112a: tilted edge

112b: Ring shoulder

114: Wall

120: Ruhl compartment

130: Fluid compartment

132: Catheter

140: Hat

142: Outer Ring Edge

144: Inner Ring Edge

150: Ruhr connector

152:

154: Ruhl hook

156: Thread interface

160: Dispenser

162a: External components

Claims (22)

A drug delivery system includes: a container including a luer compartment and a fluid compartment; a luer connector disposed in the luer compartment and in fluid communication with the fluid compartment; and a dispenser in fluid communication with the fluid compartment. The system of claim 1, further comprising a cap configured to seal the luer connector within the luer compartment. A system as in claim 1, wherein the Luer compartment and the fluid compartment are located at opposite ends of the container. A system as in claim 1, wherein the container comprises a flexible material. The system of claim 1, wherein the luer connector includes a valve. A system as in claim 1, wherein the container includes a conduit between the Luer compartment and the fluid compartment. A system as in claim 6, wherein the Luer connector is at least partially inserted into the catheter. A system as in claim 1, wherein the Luer connector is configured to receive a syringe. A system as in claim 1, wherein the Luer connector is coupled to the Luer compartment via a fluid seal. The system of claim 1, wherein the dispenser is coupled to the container. The system of claim 1, further comprising an adapter, wherein the adapter comprises a first interface configured to couple to the container and a second interface configured to couple to the dispenser. A system as in claim 11, wherein one of the first and second interfaces comprises a snap-fit interface and the other of the first and second interfaces comprises a threaded interface. The system of claim 1, wherein the dispenser comprises an eye dropper. The system of claim 1, wherein the dispenser comprises a nasal spray pump. The system of claim 1, wherein the container and dispenser are configured as a disposable eyedropper. A method for aseptically transferring a drug to a drug delivery system, comprising: providing a vial containing the drug to be transferred; extracting a quantity of the drug from the vial with a syringe; coupling the syringe to a drug delivery system via a luer connector, wherein the drug delivery system comprises a container and a dispenser, wherein the container comprises a luer compartment and a fluid compartment, and wherein the luer connector is disposed within the luer compartment and is in fluid communication with the fluid compartment; transferring the drug from the syringe to the drug delivery system; and decoupling the syringe from the drug delivery system. The method of claim 16, further comprising covering the Luer connector with a cap. The method of claim 16, wherein the dispenser is coupled to a container body. The method of claim 16, wherein the drug delivery further comprises an adapter comprising a first interface coupled to the container and a second interface coupled to the dispenser. The method of claim 16, wherein the dispenser comprises an eye dropper. The method of claim 16, wherein the dispenser comprises a nasal spray pump. The method of claim 16, wherein the container and dispenser are configured as a disposable eyedropper.