WO2017001921A1

WO2017001921A1 - Multiple-dose dispensing device

Info

Publication number: WO2017001921A1
Application number: PCT/IB2016/001033
Authority: WO
Inventors: Marc Andrew Koska
Original assignee: Marc Andrew Koska
Priority date: 2015-07-02
Filing date: 2016-07-01
Publication date: 2017-01-05

Abstract

The invention is a multiple-dose dispensing device (200) for dispensing doses of a fluid agent to a plurality of single use delivery devices. The multiple-dose dispensing device includes a body (202) containing a volume of fluid agent within and an outlet in fluid communication with said cavity. The device further includes a cap member (208) coupled to the outlet, thereby sealing the outlet and preventing fluid agent from passing therethrough. The cap member is configured to detach from the outlet upon the application of sufficient force thereto. The device as a whole is formed by way of a blow- fill-seal method, such that the device is initially provided already prefilled and sealed until the seal between the outlet and cap member is broken. The device is used to fill a plurality of single use delivery devices on-site and in the field, while remaining sterile and preventing the potential for contamination during the filling process.

Description

MULTIPLE-DOSE DISPENSING DEVICE

Cross Reference to Related Applications

This application claims the benefit of and priority to U.S. Provisional Application No. 62/188,117, filed July 2, 2015, the content of which is hereby incorporated by reference herein in its entirety.

Field of the Invention

The present invention generally relates to dispensing devices for dispensing fluids, and, more particularly, to a multiple-dose dispensing device for dispensing doses of a fluid agent to a plurality of single use delivery devices.

Background

Every year, millions of people become infected and die from a variety of diseases, some of which are treatable or entirely preventable. For example, many diseases may be prevented via immunization programs which include the administration of vaccines. Although vaccination has led to a dramatic decline in the number of cases of several infectious diseases, some of these diseases remain quite common. In many instances, large populations of the world, particularly in developing countries, suffer from the spread of vaccine-preventable diseases due to ineffective immunization programs, either because of poor implementation, lack of affordable vaccines, or inadequate devices for administering vaccines, or combinations thereof.

Some implementations of immunization programs generally include administration of vaccines via a typical reusable syringe. However, in many situations, particularly in developing countries, the administration of vaccines occur outside of a hospital and may be provided by a non-professional, such that injections are given to patients without carefully controlling access to syringes. The use of reusable syringes under those circumstances increases the risk of infection and spread of blood-borne diseases, particularly when syringes, which have been previously used and are no longer sterile, are used to administer subsequent injections. For example, the World Health Organization (WHO) estimates that blood-borne diseases, such as Hepatitis and human immunodeficiency virus (HIV), are being transmitted due to reuse of such syringes, resulting the death of more than one million people each year. As part of an ongoing effort to address inadequacies of immunization programs globally, there has been increasing focus on the manner in which vaccines are packaged and provided. For example, in many parts of the world, vaccinations may be supplied in multi-dose containers or vials. A multi-dose vial is a vial of liquid that contains more than one dose of medication and may be used for providing multiple doses for a single individual or for providing a single dose for multiple individuals in a group. In contrast, single-dose format generally includes single- dose vials or pre-filled single dose delivery devices.

The multi-dose format may be a more attractive option for various reasons. For example, a multi-dose format may be more cost-effective, as the filling and packaging costs for multi-dose vials are generally cheaper than single-dose vials, and multi-dose vials generally have less cold chain capacity requirements (e.g., less packed volume per dose) when compared to single-dose vials. Furthermore, the distribution of a vaccine within a given population may be improved with the use of multi-dose format, as the multi-dose format has less cold chain requirements and a larger volume of vaccine (e.g. more doses) can be available at a single instance. The multi- dose format is particularly attractive given that a single source of vaccine (e.g., 10-dose, 20-dose, 50-dose, etc. vial) may be used in the vaccination of a large population within a short timeframe (e.g., administer vaccine to a large group of people), thereby providing a better coverage rate than would be available with the single-dose format.

Although the multi-dose format may provide numerous advantages over a single-dose format, there multi-dose format has drawbacks. For example, multi-dose vials or delivery devices must be handled with care so as to protect against cross-contamination, particularly if a multi-dose vial is to be used for more than one patient. If care is not taken by the medical professional administering the vaccine, inadvertent contamination of a multi-dose vial may occur through direct or indirect contact with potentially contaminated surfaces or equipment that could then lead to infections in subsequent patients. For example, a vaccine may be administered via injection with a syringe having a needle. Accordingly, a new, sterile needle and sterile syringe should always be used to access the vaccine in a multi-dose vial. Reuse of needles or syringes to access a vaccine can result in contamination of the vaccine that can be spread to others when the medicine is used again. In many situations, particularly in developing countries, the

administration of vaccines occurs outside of a hospital and may be provided by a nonprofessional. Such non-professionals may not have formal training, or the resources, for the proper handling of a multi-dose vial or delivery device, and contamination may occur, thereby increasing the risk of infection and spread of blood-borne diseases.

Summary

The present invention provides a multiple-dose dispensing device that overcomes the drawbacks of current dispensing devices and methods. In particular, the multiple-dose dispensing device may be used for the storage of multiple doses of a fluid agent (e.g., medication, vaccine, therapeutic, etc.) and is configured to be coupled to single use delivery devices (e.g., single use delivery devices) and dispense an amount (e.g., dose) of fluid agent into such delivery devices for subsequent administration of the dose of fluid agent to a patient.

The multiple-dose dispensing device generally includes a body containing a volume of fluid agent contained within and an outlet in fluid communication with the cavity. The device further includes a cap member coupled to the outlet, thereby sealing the outlet and preventing fluid agent from passing therethrough. The cap member is configured to detach from the outlet upon the application of sufficient force thereto. For example, the device as a whole is formed by way of a blow-fill- seal method, such that the device is initially provided already prefilled and sealed until the seal between the outlet and cap member is broken. Blow-fill-seal technology is a manufacturing technique used to produce liquid-filled containers. Accordingly, the body and cap member may be materially formed with one another in a single, sterile process, such that the cavity may be filled with a fluid agent and sealed in a continuous process without human intervention, in a sterile enclosed area inside a machine. Accordingly, this process can be used to aseptically manufacture sterile pharmaceutical liquid dosage forms. Blow-fill-seal technology may be particularly attractive in the current market, as it reduces personnel intervention making it a more robust method for the aseptic preparation of sterile pharmaceuticals.

When desired, a person need only tear the cap member from the outlet so as to effectively break the seal. The device may then be use to fill a plurality of single use delivery devices on- site and in the field, while remaining sterile and preventing the potential for contamination during the filling process. The multiple-dose dispensing device may be a particularly attractive option in that the source is a disposable dispensing device configured to hold a large volume of fluid agent to allow for dispensing of multiple doses of a fluid agent to a plurality of the delivery devices consistent with the present disclosure. The outlet of the dispensing device may have either a standard connection fitting (an ISO standard (e.g. ISO 594) luer fitting or non-standard connection fittings to be coupled with a non-standard connection fitting of a single use delivery device of the present invention. For example, in some embodiments, the connection fitting of the outlet of the device may be a simple press-fit type design, so as to allow the device to be quickly coupled and de-coupled to and from single use delivery devices.

Brief Description of the Drawings

FIG. 1 is a perspective exploded view of a single use delivery device consistent with the present disclosure.

FIG. 2 is a top elevation view of the single use delivery device of FIG. 1 illustrating the base and top members in an assembled state.

FIG. 3 is side view of the single use delivery device of FIG. 1 illustrating the base and top members in an assembled state.

FIGS. 4 and 5 illustrate coupling of the single use delivery device of FIG. 1 to a source for providing a fluid agent to the single use delivery device.

FIG. 6 is a side view of another embodiment of a multi-dose source for dispensing aliquots of a fluid agent to a delivery device consistent with the present disclosure.

FIG. 7 is a perspective view of an adapter to be fitted on the delivery device and to allow aliquots of a fluid agent to be dispensed into the delivery device from a multi-dose vial.

FIGS. 8A-8C are side views of the single use delivery device of FIG. 1 illustrating different embodiments of needles to be used for intradermal, subcutaneous, and intramuscular delivery of a fluid agent, respectively.

FIG. 9 illustrates intradermal, subcutaneous, and intradermal delivery of a fluid agent with the single use delivery device of FIG. 1.

FIGS. 10A and 10B are perspective views of another embodiment of a needle protector in an open position, in which the penetrating tip of the needle is exposed, and a closed position, in which at least the penetrating tip of the needle is shielded and covered.

Detailed Description

When desired, a person need only tear the cap member from the outlet so as to effectively break the seal. The device may then be use to fill a plurality of single use delivery devices on- site and in the field, while remaining sterile and preventing the potential for contamination during the filling process. The multiple-dose dispensing device may be a particularly attractive option in that the source is a disposable dispensing device configured to hold a large volume of fluid agent to allow for dispensing of multiple doses of a fluid agent to a plurality of the delivery devices consistent with the present disclosure. The outlet of the dispensing device may have either a standard connection fitting (an ISO standard (e.g. ISO 594) luer fitting or non-standard connection fittings to be coupled with a non-standard connection fitting of a single use delivery device of the present invention. For example, in some embodiments, the connection fitting of the outlet of the device may be a simple press-fit type design, so as to allow the device to be quickly coupled and de-coupled to and from single use delivery devices. The multiple-dose dispensing device consistent with the present disclosure may be couplable to any of the single use delivery device embodiments described herein.

FIG. 1 is a perspective exploded view of a single use delivery device 10 consistent with the present disclosure. FIGS. 2 and 3 are top and side elevation views of the single use delivery device 10 of FIG. 1 in an assembled state. As shown, the single use delivery device 10 may include a needle 11 having a tip configured for penetrating a target site and injecting a fluid agent into the target site. As will be described in greater detail herein, the needle may include a micro needle configured to penetrate a patient's skin down to a depth of the dermis and deliver a dosage of fluid agent thereto. In other embodiments, however, the needle 11 may be sized for other injection types (e.g., intravenous, subcutaneous, intradermal, etc.). In some embodiments, the single use delivery device 10 of the present disclosure is not limited solely to the

administration of a fluid agent via injection, and thus may be fitted with other means of delivering a fluid agent (e.g., nozzle tip, spray tip, droplet tip, etc.) in lieu of a needle.

The device 10 further includes a base member 12 and a top member 14 coupled thereto, wherein the combined base and top members 12, 14 are configured to provide the fluid agent into the needle for subsequent injection. As generally understood, the fluid agent may include any type of agent to be injected into a patient (e.g., mammal, either human or non-human) and capable of producing an effect. Accordingly, the agent may include, but is not limited to, a vaccine, a drug, a therapeutic agent, a medicament, or the like.

The base member 12 includes a proximal end 16 having an inlet port 18 configured to receive fluid agent from a source and a distal end 20 having an outlet port 22 coupled to the needle 11 and configured to provide the fluid agent thereto. As described in greater detail herein, the source of the fluid agent may include a filling syringe, for example, configured to be releasably coupled to the inlet port 18 of the base member 16. As shown, the inlet port 18 may include a Luer-type connection 19, such as a Luer-Lok fitting, configured to releasably engage a corresponding Luer-type connection on a hub of the syringe, thereby providing a fluid

connection between the syringe and the inlet port 18 of the base member 12. It should be noted that the inlet port 18 need not be limited to an ISO standard (e.g. ISO 594) luer fitting. In other embodiments, the inlet port 18 may include non-standard connection fittings to be coupled with non-standard connection fitting of a source or adapter, for example. Accordingly, by providing a specialty connection fitting, only approved sources (e.g., multi-dose dispensing devices) can be used with the delivery devices of the present disclosure, thereby adding one more layer of security.

As shown, a seal member 21 may cover the inlet port 18 so as to prevent any

contaminants from entering the inlet port 18 and potentially contaminating the delivery device 10 prior to filing the delivery device 10 with the fluid agent. For example, a single use seal member 21 may be composed of a relatively thin sheet of material (e.g., metal foil, plastic, etc.) may be hermetically sealed to the opening of the inlet port 18, thereby preventing contaminants (e.g., gases, fluids, dirt, debris, etc.) from entering the delivery device 10. The seal member 21 may be coupled to the inlet port 18 by any known sealing techniques (e.g., heat, vibration, or adhesive process). The seal member 21 is configured to be durable in the sense that it provides a sufficient seal with the inlet port 18 and prevent contaminants from entering into the device 10 via the inlet port 18 while also being configured to be pliable and rupture upon coupling of the inlet port 18 to a source (e.g., hub of filler syringe), thereby allowing a fluid to enter into the delivery device 10 via the inlet port 18. Accordingly, the seal member 21 provides a measure of security to ensure that the delivery device 10 remains sterile until it is to be used.

The base member 12 may further include a channel 24 formed within a portion thereof and providing a fluid pathway from the inlet port 18 to the outlet port 22. Accordingly, upon receipt of fluid agent from a source, via the inlet port 18, the fluid agent may flow within the pathway provided by the channel 24. The base member 12 further includes a one-way valve 26 positioned within the fluid pathway of the channel 24. The one-way valve 26 is configured to permit antegrade flow of fluid from the inlet port 18 to the outlet port 22, while preventing retrograde flow (e.g., backflow) of fluid from the outlet port 22 through the valve 26 and through the inlet port 18. For example, the one-way valve 26 may include an open inlet end and an adjustable outlet end configured to move between a normally closed position and an open position. The one-way valve 26 is positioned such that the open inlet end is configured to receive fluid from the inlet port 18, and, upon sufficient application of fluid pressure in a direction away from the inlet port 18 and towards the outlet port 22 (e.g., depressing plunger of filling syringe to fill device 10 with fluid agent) the outlet end of the valve 26 moves from the normally closed position to an open position to allow fluid to flow therethrough in a direction towards the outlet port 22, as indicated by the directional arrow. However, when in a closed position, the outlet provides a substantially leak-proof and/or airtight seal so as to prevent any fluid from entering the valve 26 from the outlet end. Furthermore, the valve 26 is configured such that any application of fluid pressure in a direction away from the outlet port 22 and towards the outlet end of the valve 26, the outlet end remains closed, thereby preventing any fluid from flowing through the valve 26 in a retrograde direction from the outlet port 22 towards the inlet port 18. As generally understood, the one-way valve 26 may include any type of valve configured to permit fluid to flow only in a single direction. The one-way valve 26 may include any type of valve having medical grade material and configured to be used with the flow of fluids. For example, the one-way valve 26 may include a Reed valve or a Heimlich valve.

The top member 14 may be formed separately from the base member 12, which provides advantages, as previously described herein. Accordingly, the top member 14 may be coupled to a portion of the base member 12 along a mounting section 28. For example, the mounting section 28 generally includes a large portion of the base member 12 and includes at least a portion of the channel 24 and the one-way valve 26, such that, upon coupling the top member 14 to the mounting section 28 of the base member 12, the top member substantially encloses the channel 24 and the one-way valve 26.

The top member 14 includes a compressible reservoir member 30 and a compressible valve cover 26, such that, upon coupling the top member 14 to the base member 12, the reservoir member 30 is in fluid communication with the fluid pathway of the channel 24 and the valve cover 36 substantially encloses the one-way valve 26. The top member 14 may further include an inlet 32 and an outlet 34 and defining a fluid pathway extending there between and in fluid communication with the reservoir member 30 and valve cover 36. Accordingly, once coupled to the base member 12, the inlet 34 and outlet 34 and the pathway extending there between may substantially correspond to the fluid pathway of the channel 24, thereby cooperating with one another to form a combined single channel pathway from the inlet port 18 to the outlet port 22.

The top member 14 may be coupled to the base member 12 by any known means so as to create a hermetic seal. For example, the base and top members 12, 14 may be sealed with one another via any known adhesives, cements, ultrasonic welding, or thermoplastic bonding techniques. The base and top members 12, 14 are composed of a medical grade material. In some embodiments, the base member 12, the top member 14, or both, may be composed of a thermoplastic polymer, including, but not limited to, polypropylene, polyethylene, polybenzimidazole, acrylonitrile butadiene styrene (ABS) polystyrene, polyvinyl chloride, PVC, or the like.

The reservoir member 30 includes an interior volume configured to receive and store a fluid agent passing through the one-way valve 26. Upon applying a compression force to the reservoir member 30, the fluid agent is expelled into the fluid pathway of the channel 24 and through the outlet port 22 into the needle 11. Accordingly, the method of delivering the fluid agent into a patient is a relatively simple and straightforward process which simply requires an administrator to apply sufficient pressure to the filled reservoir member 30 so as to deform the reservoir, resulting in expulsion of the stored fluid agent from the interior volume. Due to the one-way valve 26, the fluid agent is force to flow in a direction towards the outlet port 22 and out of the needle 11.

The base member 12 further includes a needle protector member 38 extending from the distal end 20 and adjacent to the outlet port 22. The needle protector member 38 may be coupled to the distal end 20 by way of any known means. In the illustrated embodiment, the needle protector member 38 is coupled to the distal end 20 by way of a living hinge 40, for example. Accordingly, the needle protector member 38 is configured to move between a closed position and an open position, as indicated by arrow 42. When in a closed position, the needle protector member 38 is configured to substantially enclose the penetrating tip of the needle 11, thereby shielding one from inadvertent needle sticks. When in an open position, as shown, the penetrating tip of the needle 11 is exposed and ready for intradermal injection on a target site of a patient. Accordingly, the needle protector member 38 may be in a closed position while the delivery device 10 is being shipped, stored, and handled (e.g., during filling of the delivery device 10). An administrator need only move the needle protector member 38 to an open position to expose the needle 11 for delivering the fluid agent to a target site on a patient. Upon delivering the fluid agent, the administrator may then move the needle protector member 38 to a closed position and discard the delivery device 10, so as to prevent unintentional needle sticks.

The delivery device is configured to allow delivery of the agent to the patient in a relatively simple manner, without requiring specialized training for injecting a needle portion intradermally. In particular, the delivery device is designed such that it may be filled on-site and in the field with a microdose of an agent, while remaining sterile and preventing the potential for contamination during the filling process. For example, FIGS. 4 and 5 illustrate coupling of the single use delivery device 10 to a multi-dose source for dispensing a fluid agent into the delivery device 10. In the illustrated embodiment, the source may include a filler syringe 100, for example. The filler syringe 100 may be embodied as a conventional syringe. Accordingly, the filler syringe 100 includes a barrel 102 having a distal hub 104 configured to be releasably coupled to the inlet port 18 of the base member 12 of the delivery device 10. For example, the inlet port 18 may include a Luer-type connection 19, such as a Luer-Lok fitting, configured to releasably engage a corresponding Luer- type connection on the hub 104 of the syringe 100, thereby providing a fluid connection between the interior volume of the barrel 102 of the syringe 100 and the inlet port 18 and subsequent fluid pathway formed by the channel 24 of the base member 12.

In order to fill the delivery device 10, specifically the reservoir member 30, with a fluid agent 106 contained with the syringe 100, a person need only couple the hub 104 with the inlet port 18. As shown in FIG. 4, the seal member 21 is intact and covering the inlet port 18 so as to prevent any contaminants from entering the inlet port 18 and potentially contaminating the delivery device 10 prior to filing the delivery device 10 with the fluid agent. Upon inserting the hub 104 into engagement with the inlet port 18, the hub 104 is configured to pierce the seal member 21, upon which the seal member 21 ruptures and tears, as indicated by arrow 43, thereby breaking the hermetic seal and allowing fluid to be providing from the syringe 100 into the device 10 through the inlet port 18. For example, upon rotating either the syringe 100 or device 10, as indicated by arrow 44, the hub 104 and inlet port 18 may contact and come into threaded engagement. A person may then fill the reservoir 40 with the fluid agent 106 by applying pressure to a plunger 108 of the filler syringe 100, as indicated by arrow 46. Due to the one-way valve 26, the fluid agent 106 is only permitted to flow in a direction towards the reservoir 30 and prevented from flowing in a retrograde fashion out of the reservoir 30. Furthermore, the interior volume of the reservoir 30 may be within a range considered to be a micro dose, such as 0.05 ml to 1.0 ml. Accordingly, in some embodiments, the delivery device 10 does not require exact measurements when filling the reservoir 30. Instead, a person need only completely fill the reservoir, which includes the correct dosage, and, once completely filled, the correct dosage has been reached and the buildup of pressure will prevent the plunger 108 of the syringe 100 from advancing further. Accordingly, the device 10 allows consistent filling and dosing of the fluid agent 106 from device to device (e.g., filling up tens of hundreds of devices 10 at any one time). Accordingly, when in the field or directly on-site, a person may use a single filling syringe 100 to fill a plurality of empty delivery devices 10 in a consistent manner. The filling syringe 100 essentially acts as a means of storing and dispensing aliquots of the fluid agent.

It should be noted that, although the previous description refers to the multi-dose source as being a large volume standard syringe 100, other multi-dose sources may be used for dispensing aliquots of fluid agent into the delivery devices of the present invention. For example, as shown in FIG. 6, is a side view of another embodiment of a multi-dose source 200 for dispensing aliquots of a fluid agent to a delivery device consistent with the present disclosure. As shown, the multi-dose source 200 generally includes a body 202 having an interior volume sufficient to contain multiple doses of a fluid agent 206 within. The body 202 includes a single outlet 204 configured to dispense a volume of fluid agent 206 therefrom. In the illustrated embodiment, the source 200 is generally formed by blow-fill-seal technology. Blow-fill-seal (BFS) technology is a manufacturing technique used to produce liquid-filled containers. The present invention, source 200 may be formed by BFS technology, in that the body 202 and outlet 204 are formed, filled within a fluid agent 206, and sealed in a continuous process without human intervention, in a sterile enclosed area inside a machine. Accordingly, this process can be used to aseptically manufacture sterile pharmaceutical liquid dosage forms. Blow-fill-seal technology may be particularly attractive in the current market, as it reduces personnel intervention making it a more robust method for the aseptic preparation of sterile

pharmaceuticals.

The outlet 204 may be sealed with a cap member 208, or other extension, that can later be torn or detached from the outlet 204 to allow the fluid agent 206 to be dispensed. For example, a score line or micro perforations in a particular pattern, as indicated by line 210, may be formed between the outlet 204 and cap member 208, such that a person need only tear the cap member 208 away from the body 202 of the source 200 so as to expose the outlet 204 for coupling to the delivery devices 10 for dispensing fluid agent 206 thereto. The multi-dose source 200 may be a particularly attractive option in that the source 200 is a disposable dispensing device configured to hold a large volume of fluid agent to allow for dispensing of multiple doses of a fluid agent to a plurality of the delivery devices consistent with the present disclosure. The outlet 204 may have either a standard connection fitting (an ISO standard (e.g. ISO 594) luer fitting or nonstandard connection fittings to be coupled with a non-standard connection fitting of the device 10. For example, the in some embodiments, the connection fitting of the outlet 204 may be a simple press-fit type design, so as to allow the source 200 to be quickly coupled and de-coupled to and from devices 10. The source 200 may be composed of a medical grade material. In some embodiments, the source 200 may be composed of a thermoplastic polymer, including, but not limited to, polypropylene, polyethylene, polybenzimidazole, acrylonitrile butadiene styrene (ABS) polystyrene, polyvinyl chloride, PVC, or the like.

Yet still, it should be noted that, although the previous description refers to the multi-dose source as being a large volume standard syringe 100 or a BFS-type source 200, other multi-dose sources may be used for dispensing aliquots of fluid agent into the delivery devices of the present invention. For example, in many parts of the world, vaccinations may be supplied in multi-dose containers or glass vials. A multi-dose glass vial is a vial of liquid that contains more than one dose of medication and may be used for providing multiple doses for a single individual or for providing a single dose for multiple individuals in a group. Glass vials are generally sealed with a rubber stopper which has a center area for penetration with a metal cannula or hypodermic needle as used on a syringe. The rubber septum is held and sealed in place with an aluminum band crimped under a ledge on the glass vial neck and above the rubber septum. Currently, only syringes with metal or plastic needles are able penetrate this rubber septum so as to gain access to the fluid within. Further, the fluid has to be drawn out with pressure, as the vial is not compressible.

FIG. 7 is a perspective view of an adapter 300 to be fitted on a delivery device 10 consistent with the present disclosure and to allow accurate dispensing of aliquots of a fluid agent to be dispensed into the delivery device 10 from a multi-dose glass vial 400. As shown, the adapter 300 generally includes a body having a depressible handle that allows a user to manually control dispensing of a dose of fluid agent from the glass vial 400 into the device 10. The body has a first port that is couplable to the inlet port 18 of the device 10, in a similar manner as previously described herein. The body has a second portion that is couplable to the glass vial 400. In particular, the second port of the adapter 300 is configured to clip over the aluminum outer band of the vial 400 in a pressure-type or snap-fit manner firmly hold the vial 400 in place. The adapter 300 further includes a bevel cut needle or hollow tube having a tip configured to pierce and penetrate through the rubber septum. The needle has a lumen that is in fluid communication with the first and second ports of the adapter 300 and may further include a releasable seal that is actuated upon depression of the handle, thereby giving a user control over fluid flow through the needle and through the first port into the device 10, as generally understood. The bevel cut needle may be configured such that it lies in a bottom corner of the vial 400 when coupled thereto so as to allow the needle to access all of the fluid agent within the vial 400. For example, a common drawback with syringes and needles is that such devices are generally lack the ability to access a whole final dose of fluid agent after initial doses are obtained. Accordingly, many multi-dose vials are filled with an extra amount (e.g., 10% or more) of fluid agent so as to account for this drawback, thus leading to waste. The needle or tube would likely be positioned at the bottom corner when the vial is tilted so as to enable the needle to access most, if not all, of the fluid agent within the vial until it is empty, thereby preventing the need to fill a multi-dose vial with additional amounts of fluid agent and thereby reducing wastes. With color coding of the handle and instructions, it may be that two pumps would fill a 0.05 ml to 1 ml dose within tolerance. The adapter 300 may further include a spring or other element configured to provide a biasing force against the handle portion, such that the handle is spring driven to return to a primed position, similar to a pump aerosol or the like. One feature includes the luer fitting which would relate in a number of variations to the single use delivery device (dose and needle size) required for the drug being administered.

Once filled, the delivery device 10 is designed such that a person administering the agent (e.g., administrator) may easily administer a dose of the fluid agent as intended. For example, FIGS. 8A-8C are side views of the single use delivery device 10 illustrating different embodiments of needles to be used for intradermal, subcutaneous, and intramuscular delivery of a fluid agent, respectively. FIG. 9 illustrates intradermal, subcutaneous, and intradermal delivery of a fluid agent with the single use delivery device 10.

The delivery device 10 is configured to allow delivery of the agent to the patient in a relatively simple manner, without requiring specialized training for injecting a needle portion intradermally. In particular, the delivery device is designed such that a person administering the agent (e.g., administrator) need only press the delivery device against the administration site (e.g., shoulder, arm, chest, etc.), in which the device is configured such that needle penetration is limited to the correct length and orientation within the administration site. As shown, the delivery device 10 may be removed from the filler syringe 100 and used to administer the fluid agent as a standalone device. However, it should be noted that the delivery device 10 may remain coupled to the filler syringe 100 during administration of the fluid agent, such that an administrator may use the filler syringe 100 as a handle or means of stabilizing the delivery device 10 during delivery of the fluid agent to a patient.

As shown in FIG. 8 A, the needle 1 la is positioned substantially perpendicular relative to a plane along which the distal end 20 of the base member 12 lies, such that the needle 1 la is configured to be inserted into a patient's skin at a substantially perpendicular angle. This is a much more straightforward process for intradermal delivery of an agent, particularly when compared to the Mantoux procedure. Furthermore, the distal end is configured to contact the patient's skin during penetration of the needle 11a, thereby indicating adequate depth of penetrating for intradermal injection of the fluid agent. For example, the needle 11a may be a micro-needle having a length Li (measured from the distal end 20) in the range of 0.5 mm to 4 mm. Other needles may be used with devices 10 of the present disclosure. For example, as shown in FIG. 8B, the device 10 may include a needle 1 lb specifically designed for

subcutaneous delivery of an agent. For example, the needle 1 lb may have a length L₂ (measured from the distal end 20) in the range of 8 mm to 15 mm. As shown in FIG. 8C, the device 10 may include a needle 1 lc specifically designed for intramuscular delivery of an agent, such that the 1 lc has a length L₃ (measured from the distal end 20) in the range of 18 mm to 30 mm.

Accordingly, as shown in FIG. 9, upon an administrator applying pressure in a direction towards the target site, as indicated by arrow 62, the needle 1 la is configured to penetrate the epidermis and dermis layers of skin. Needle l ib is configured to penetrate the epidermis, dermis and subcutaneous layers. Needle 1 lc is configured to penetrate he epidermis, dermis, subcutaneous, and muscle layers. Upon sufficient contact between the distal end of the base member 12 and the outer layer of skin, as indicated by arrow 64, the needles 1 la, 1 lb, 1 lc have achieved adequate penetration into the dermis for injection of the fluid agent into the appropriate layer. For example, upon the needle 1 la reaching the adequate depth into the dermis, the administrator may then compress the reservoir member 30 containing the dosage of fluid agent so as to deliver the fluid agent into the dermis. For example, the reservoir member 30 is configured to substantially collapse and reduce the interior volume upon substantial compression applied thereto, as indicated by arrow 66. An administrator need only fully compress the reservoir member 30 so as to expel to required dosage. Upon compression of the reservoir member 30, the fluid agent is expelled into the fluid pathway of the channel 24 and out of the outlet port 22 and out of the needle 11, resulting in delivery of the fluid agent into the dermis, as indicated by arrow 68.

In some embodiments, the reservoir member 30 is shaped or sized such that, upon compression applied thereto, the reservoir member 30 is prevented from being reformed and the interior volume is prevented from expanding subsequent to substantial compression.

Additionally, or alternatively, the valve cover 36 may be shaped or sized such that, upon compression applied thereto, the valve cover 36 is configured to substantially collapse upon the one-way valve 26 and render the one-way valve 26 inoperable, thereby blocking fluid flow into or out of the one-way valve 26. Accordingly, the delivery device 10 configured to be rendered incapable of reuse following its delivery of the agent to a patient, thereby preventing reuse of the device and reducing the risk of the spreading blood-borne diseases through reuse.

Accordingly, the delivery device 10 of the present invention does not require a trained, skilled healthcare profession for administration of vaccines or drugs. As such, the delivery device may be particularly useful in situations in which vaccines or drugs are being administered in non-healthcare related facilities (e.g., outside of clinics or hospitals) and given to large numbers of individuals over a short period of time by a non-professional.

It should further be noted that, in order to compensate for the variety of different lengths of needles 1 la-1 lc, the device 10 may further include an alternative embodiment of a needle protector. FIGS. 10A and 10B are perspective views of a needle protector member 70 in an open position, in which the penetrating tip of the needle 11 is exposed, and a closed position, in which at least the penetrating tip of the needle 11 is shielded and covered by the needle protector member 70. Similar to needle protector member 38 previously described herein, needle protector member 70 generally extends from the distal end 20 of the device 10 and is adjacent to the outlet port. The needle protector member 70 may be coupled to the distal end 20 by way of any known means. In the illustrated embodiment, the needle protector member 70 is coupled to the distal end 20 by way of a living hinge, for example. Accordingly, the needle protector member 70 is configured to move between a closed position and an open position. The needle protector member 70 is shaped and/or sized so as to accommodate needles of a specific length (e.g., needles having a length between 0.5 and 30 mm or longer). For example, when in a closed position, as shown in FIG. 10B, the needle protector member 70 is configured to substantially enclose at least the penetrating tip of a needle 11, wherein the needle may have a length between 4 mm and 30 mm or longer, such that the needle protector member 38 would be inadequate and would not accommodate a needle of such length. When in an open position, as shown in FIG. 10A, the penetrating tip of the needle 11 is exposed and ready for intradermal injection on a target site of a patient.

The delivery device is configured to allow delivery of the agent to the patient in a relatively simple manner, without requiring specialized training for injecting a needle portion intradermally. In particular, the delivery device is designed such that it may be filled on-site and in the field with a microdose of an agent, while remaining sterile and preventing the potential for contamination during the filling process. For example, when filling the delivery device with a fluid agent, a person need only couple a filler syringe containing the fluid agent to the inlet port and then fill the reservoir with the fluid agent by applying pressure to a plunger of the filler syringe. Due to the one-way valve, the fluid agent is only permitted to flow within the reservoir and prevented from flowing in a retrograde fashion out of the reservoir. Furthermore, the interior volume of the reservoir may be within a range considered to be a micro dose. Thus, the delivery device does not require exact measurements when filling the reservoir. Instead, a person need only completely fill the reservoir, which includes the correct dosage, and further prevents overfilling, as the interior volume is limited to the dosage amount for any given fluid agent.

Because the delivery device itself is not prefilled, the delivery device of the present invention does not require the maintenance of a certain temperature (e.g., 2 to 8 degrees Celsius) during shipment or storage, thus cutting down on the overall costs. Rather than maintaining the delivery device at a constant temperature, as is the case with current devices, only the source containing the vaccine or drug (e.g., single supply provided in filling syringe) need by maintained at a constant temperature. Additionally, because the delivery device is configured to store and deliver a microdose of agent, the delivery device allows for dose-sparing. Dose- sparing may provide for a successful immunization program, particularly in resource-poor settings, by potentially reducing the per-injection cost (including transport and storage) of vaccines because more doses might be obtained from the existing vaccine presentation. Dose- sparing might also extend the availability of vaccines in cases where supply is limited by manufacturing capacity. Accordingly, a plurality of empty delivery devices may be shipped and stored, at a reduced cost, and then filled directly on-site and on an as-needed basis, such that only a single filler syringe is required for hundreds of doses to be delivered at any given point.

Once filled, the delivery device is designed such that a person administering the agent (e.g., administrator) need only press the delivery device against the administration site (e.g., shoulder, arm, chest, etc.), in which the device is configured such that needle penetration is limited to the correct length and orientation within the administration site. For example, in some embodiments, the needle is positioned substantially perpendicular relative to a plane along which the distal end of the base member lies, such that the needle is configured to be inserted into a patient's skin at a substantially perpendicular angle and the distal end is configured to contact the patient's skin indicating adequate depth of penetrating for intradermal injection of the fluid agent.

Upon needle penetration, the administrator then may fully compress a reservoir containing the micro dose of agent, thereby delivering the correct predefined dosage to the patient. The delivery device is further configured to be rendered incapable of reuse following its delivery of the agent to a patient, thereby preventing reuse of the device and reducing the risk of the spreading blood-borne diseases through reuse. For example, in some embodiments, the reservoir member is configured to substantially collapse and reduce the interior volume upon substantial compression applied thereto. In particular, the top member may include an inelastic material such that the reservoir member is prevented from being reformed and the interior volume prevented from expanding subsequent to substantial compression. In some

embodiments, the top member may further include a valve cover configured to substantially enclose the one-way valve within. Upon substantial compression applied to the valve cover, the valve cover is configured to substantially collapse upon the one-way valve and render the oneway valve inoperable, thereby blocking fluid flow from the inlet port to the reservoir member.

Furthermore, the delivery device may be configured to prevent unintentional needle sticks, and thus reduce the potential for spreading blood-borne diseases. For example, in some embodiments, the base member further includes a needle protector member extending from distal end adjacent to the outlet port. The needle protector member is configured to move between a closed position, in which a penetrating tip of the needle is shielded, and an open position, in which the penetrating tip of the needle is exposed.

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

configurations will depend upon the specific application or applications for which the teachings of the present disclosure is/are used.

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

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.

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."

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.

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.

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.

Incorporation by Reference

References and citations to other documents, such as patents, patent applications, patent publications, journals, books, papers, web contents, have been made throughout this disclosure. All such documents are hereby incorporated herein by reference in their entirety for all purposes.

Equivalents

Various modifications of the invention and many further embodiments thereof, in addition to those shown and described herein, will become apparent to those skilled in the art from the 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 invention in its various embodiments and equivalents thereof.

Claims

Claims What is claimed is:

1. A multiple-dose dispensing device comprising:

a body having a cavity for containing a volume of fluid agent within, said body having a distal end extending from said body and defining an outlet in fluid communication with said cavity; and

a cap member coupled to said distal end and preventing fluid agent from passing through outlet;

wherein said cap member is configured to become detached from said distal end upon sufficient application of force applied thereto, thereby allowing fluid agent to be dispensed from said cavity through said outlet.

2. The multiple-dose dispensing device of claim 1, wherein said distal end comprises at least one score line or micro perforation pattern formed thereon and configured to allow said cap member to tear or detach from said proximal end upon sufficient application of force applied thereto.

3. The multiple-dose dispensing device of claim 1, wherein said body comprises a substantially elastic material, such that, upon a compression force applied to said body, a volume of fluid agent travels from said cavity through said outlet.

4. The multiple-dose dispensing device of claim 1, wherein said body and cap member comprise a medical grade material.

5. The multiple-dose dispensing device of claim 1, wherein said body and cap member comprise a thermoplastic polymer.

6. The multiple-dose dispensing device of claim 5, wherein said thermoplastic polymer is selected from the group consisting of polypropylene, polyethylene, polybenzimidazole, acrylonitrile butadiene styrene (ABS) polystyrene, polyvinyl chloride, PVC, and a combination thereof.

7. The multiple-dose dispensing device of claim 1, wherein said body and cap member are formed from blow-fill- seal methods.

8. The multiple-dose dispensing device of claim 7, wherein said body and cap member are integrally formed from the same material.

9. The multiple-dose dispensing device of claim 1, wherein said distal end and outlet are configured to be releasably coupled to a single use delivery device and dispense an aliquot of fluid agent thereto.

10. The multiple-dose dispensing device of claim 1, wherein said cavity has a volume in the range between 0.5 ml and 500 ml.

11. The multiple-dose dispensing device of claim 10, wherein said cavity has a volume in the range between 1 ml and 100 ml.

12. The multiple-dose dispensing device of claim 11, wherein said cavity has a volume in the range between 5 ml and 50 ml.