Drug storage and dispensing system for pre-filled containers

Abstract

A drug storage and dispensing system is provided that includes a packaging unit for a prefilled container containing a medication and an injection device, the packaging unit having a needle shield. The disclosed drug storage and dispensing system provides drug administration while minimizing the space occupied by the container in the cold chain. The packaging unit minimizes the risk of needlestick injuries because healthcare professionals do not need to manually remove the needle shield. The injection device offers a novel scheme to automatically disable a container, such as a syringe, when the plunger rod is not engaged with the container until the container is actually used.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the benefit of U.S. Provisional Application No. 62 / 104,130, filed on January 16, 2015, which is hereby incorporated by reference in its entirety.

[0002] The present disclosure generally relates to drug storage and dispensing systems. More specifically, the present disclosure relates to drug storage and dispensing systems for pre - filled containers (filled containers).

Background Art

[0003] Conventional syringes are well known in the medical field and are used in connection with vials of drugs. Immediately prior to injection and delivery of the fluid to a patient, the user collects or draws the fluid into the syringe. Generally, subcutaneous syringes can be packaged as "prefilled" devices, and prior to packaging and prior to delivery to the patient, the syringe is pre - filled with the drug. Thus, the user does not need to fill the device prior to injection, thereby saving time and maintaining a consistent volume for delivery.

[0004] However, the packaging of such pre - filled syringes tends to be bulky and difficult to ship and store. Pre - filled syringes are typically packaged with a cap over an opening at the front end of the barrel, and the plunger rod is retracted from the rear end of the syringe barrel with the fluid pre - filled in the syringe barrel. Such packaging creates an elongated package, and the elongated package can be difficult to handle with respect to shipping and storage.

[0005] Pre-filled syringes and pre-filled metered-dose syringes are often filled with fluids such as drugs at production facilities, packaged, and then shipped to healthcare facilities. Once shipped to facilities, these syringes are often placed in controlled storage facilities and / or locked cabinets to reduce theft of the syringes themselves and / or their contents. Space in these controlled storage locations is often limited, and therefore there is a need for storage formats for pre-filled drug containers that minimize the space occupied by such containers in the cold chain. Cold chain space is one of the factors that restrains the adoption of pre-filled containers, particularly in developing regions.

[0006] Furthermore, drug containers must include information to help healthcare professionals identify the contents of the container. If the contents of the drug container cannot be actively identified from the moment the medication is transferred to the container until the moment of administration, errors such as administering the wrong medication or dosage can easily occur.

[0007] The consequences of incorrect and unintended drug use include adverse effects on patients and significant costs to the healthcare industry. Potential causes of these errors include unclear contents of drug containers due to unlabeled or poorly labeled drug containers, and inadequate record-keeping of which drugs were administered, as well as the concentration and amount of drugs administered.

[0008] Identifying the contents of a drug container based on its appearance is unreliable. Since some drugs are identical or nearly identical in appearance, visual identification of drugs is extremely difficult.

[0009] Furthermore, protecting the needle tip of the syringe used is crucial to reduce the risk of accidental needle stick injuries. Due to concerns about disease transmission and infection, methods and devices for surrounding the needles used are extremely important and in high demand. [Overview of the Initiative]

[0010] This disclosure provides a drug storage and dispensing system having a packaging unit and an injection device for pre-filled containers containing a drug, each having a needle shield. The drug storage and dispensing system of this disclosure provides drug administration while minimizing the space occupied by such containers in the cold chain. The packaging unit of the drug storage and dispensing system includes a container holding portion, which is adapted to automatically remove the needle shield of the pre-filled container when the pre-filled container is removed from the packaging unit. In this way, the drug storage and dispensing system minimizes the risk of needle stick injury because healthcare workers do not need to manually remove the needle shield. The injection device of the drug storage and dispensing system provides a novel method of automatically disabling a container, such as a syringe, when the plunger rod is not engaged with the container until the container is actually used. The drug storage and dispensing system provides a reduction in the number of steps required to administer an injection and therefore provides improved productivity and efficiency in mass immunization campaigns. The drug storage and dispensing system provides an automated and secure method for recording, storing, and transmitting information about each injection. The system also provides real-time matching of patient ID, vaccine container ID, vaccination location and time, and the ability to transmit the above information to a central repository in real time. The drug storage and dispensing system of this disclosure is particularly useful in pandemic situations where timely and frequent reporting of the progress of immunization in large populations is required.

[0011] According to embodiments of the present invention, a packaging unit for a plurality of prefilled containers, each having a needle shield, includes a tab member defining a receiving cavity sized and adapted to receive the plurality of prefilled containers therein, and a nesting member fixed within the tab member, having a plurality of container holding portions adapted to receive each prefilled container therein, each of the container holding portions having an engaging member, the engaging member being adapted to automatically remove the needle shield of each prefilled container when the respective prefilled container is removed from the container holding portion of the packaging unit.

[0012] In one configuration, the packaging unit further includes a sealing member that can be removably secured to a tab member. In another configuration, the sealing member is a cover. In yet another configuration, each prefilled container contains a drug disposed therein. In one configuration, the engaging member includes a plurality of elastically deformable fins.

[0013] According to another embodiment of the present invention, a drug storage and dispensing system for a plurality of prefilled containers, each having a needle shield and containing a drug, includes a packaging unit comprising a nesting member comprising a tab member defining a receiving cavity sized and fitted to receive the plurality of prefilled containers therein, and a nesting member fixed within the tab member having a plurality of container holding portions fitted therein, each of the container holding portions having an engaging member, the engaging member fitted to automatically remove the needle shield of each prefilled container when the respective prefilled container is removed from the container holding portion of the packaging unit, and an injection device for automatically injecting the drug from each prefilled container, the injection device having an engaging portion fitted to be removablely engaged with each of the respective prefilled containers, the injection device having a plunger rod movably disposed within the injection device, and with the injection device engaged with each prefilled container, the injection device is fitted to automatically actuate the plunger rod to expel the drug from each prefilled container.

[0014] In one configuration, each prefilled container includes a readable information portion. In another configuration, at least a portion of the readable information portion is a barcode. In another configuration, at least a portion of the readable information portion is a radio frequency identification tag. In yet another configuration, the injection device includes a scanner portion adapted to read the readable information portion of each prefilled container. In one configuration, each prefilled container includes a safety shield, which is adapted to automatically shield the needle tip of each prefilled container after injection is complete. In another configuration, the engaging portion of the injection device includes a threaded portion.

[0015] According to another embodiment of the present invention, a drug storage and dispensing system for a first prefilled container having a first needle shield and containing a first drug, and a second prefilled container having a second needle shield and containing a second drug, comprises a tab member defining an receiving cavity sized and adapted to receive the first prefilled container and the second prefilled container therein, and a nesting member fixable within the tab member having a first container holding portion adapted to receive the first prefilled container therein, and a second container holding portion adapted to receive the second prefilled container therein, wherein the first container holding portion has a first engaging member, the first engaging member adapted to automatically remove the first needle shield of the first prefilled container when the first prefilled container is removed from the first container holding portion of the packaging unit, and the second container holding portion has a second engaging member, the second engaging member is adapted to automatically remove the first needle shield of the first prefilled container when the first prefilled container is removed from the first container holding portion of the packaging unit, and the second container holding portion has a second engaging member, the second engaging member is adapted to A packaging unit including a nesting member adapted to automatically remove the second needle shield of the second prefilled container when the second prefilled container is removed from the second container holding portion of the packaging unit; and an injection device for automatically injecting a first drug from a first prefilled container and a second drug from a second prefilled container, wherein the injection device has an engaging portion adapted to be removablely engaged with the first and second prefilled containers, the injection device has a plunger rod movably disposed within the injection device, and is adapted to automatically actuate the plunger rod to release the first drug from the first prefilled container when the injection device is engaged with the first prefilled container, and is adapted to automatically actuate the plunger rod to release the second drug from the second prefilled container when the injection device is engaged with the second prefilled container.

[0016] In one configuration, the first prefilled container and the second prefilled container each include a readable information portion. In another configuration, at least a portion of the readable information portion is a barcode. In yet another configuration, the injection device includes a scanner portion adapted to read the readable information portions of the first and second prefilled containers. In one configuration, the first and second prefilled containers each include a safety shield, which is adapted to automatically shield the needle tips of the first and second prefilled containers after injection is complete. In another configuration, the engaging portion of the injection device includes a threaded portion. In yet another configuration, at least a portion of the readable information portion is a radio frequency identification tag.

[0017] According to another embodiment of the present invention, an injection device for a first prefilled container having a first drug and a second prefilled container having a second drug, comprising an engagement assembly adapted to be removablely engaged with the first prefilled container and the second prefilled container, the injection device having a plunger rod movably disposed within the injection device, configured such that when the injection device is engaged with the first prefilled container, the injection device automatically acts on the plunger rod to release the first drug from the first prefilled container, and configured such that when the injection device is engaged with the second prefilled container, the injection device automatically acts on the plunger rod to release the second drug from the second prefilled container.

[0018] In one configuration, the engagement assembly includes multiple syringe grip members. In another configuration, the multiple syringe grip members are elastically deformable. In yet another configuration, the injection device includes a retraction assembly adapted to retract a prefilled container into the injection device. In one configuration, the retraction assembly is movable between a first position and a second position, in which the multiple syringe grip members are outside the injection device to engage with the prefilled container, and in the second position, the prefilled container is inside the injection device. In another configuration, the retraction assembly includes a rail and a carriage movably mounted on the rail. In yet another configuration, with the retraction assembly in the second position and the prefilled container inside the injection device, the injection device further includes a locking assembly adapted to lock the multiple syringe grip members into the prefilled container. In one configuration, the prefilled container includes a barcode, and the syringe device further includes a scan assembly adapted to scan the barcode with the prefilled container in the second position. In another configuration, the injection device includes a rotating assembly for rotating the prefilled container when the prefilled container is in a second position. In yet another configuration, the injection device further includes an actuator assembly, which, when the injection device is engaged with a first prefilled container, automatically acts on the plunger rod to release a first drug from the first prefilled container, and when the injection device is engaged with a second prefilled container, automatically acts on the plunger rod to release a second drug from the second prefilled container. In one configuration, the injection device includes an ejection assembly adapted to automatically eject the prefilled container from the injection device.

[0019] According to another embodiment of the present invention, the system includes an injection device for a drug and a prefilled container having a barcode containing information, the injection device comprising an engagement assembly adapted to be removablely engaged with the prefilled container, a scanning assembly adapted to scan the barcode while the prefilled container is contained within the injection device, and a transmitter for transmitting information; and an electronic database that receives information transmitted from the injection device, adapted to verify the information, and adapted to transmit signals to the injection device that provide positive feedback regarding injections using the injection device. [Brief explanation of the drawing]

[0020] The features and advantages of this disclosure described above, as well as other features and advantages, and the ways in which they are obtained, will become clearer, and the disclosure itself will be better understood by looking at it together with the accompanying drawings and referring to the following description of embodiments of this disclosure. [Figure 1] This is an exploded perspective view of a packaging unit for a drug storage and dispensing system for multiple pre-filled containers according to an embodiment of the present invention. [Figure 2] This is an assembly perspective view of a packaging unit for a drug storage and dispensing system for multiple pre-filled containers according to an embodiment of the present invention. [Figure 3] This is an assembly perspective view of a packaging unit for a drug storage and dispensing system for a plurality of pre-filled containers, according to an embodiment of the present invention, in which a sealing member is fixed to the packaging unit. [Figure 4] This is a perspective view of a packaging unit and injection device for a drug storage and dispensing system for multiple pre-filled containers according to embodiments of the present invention. [Figure 5A] This is a side elevation view of a pre-filled container according to an embodiment of the present invention. [Figure 5B] Cross-sectional view of a prefilled container according to another embodiment of the present invention. [Figure 6] Cross-sectional view of an injection device of a drug storage and dispensing system engaged with a prefilled container according to an embodiment of the present invention. [Figure 7A] Side elevation view of a container holding portion of a packaging unit of a drug storage and dispensing system according to an embodiment of the present invention. [Figure 7B] Cross-sectional view of a container holding portion of a packaging unit of a drug storage and dispensing system engaged with a needle shield of a prefilled container according to an embodiment of the present invention. [Figure 8] Cross-sectional view of an injection device of a drug storage and dispensing system engaged with a prefilled container having a safety shield surrounding the needle tip of the prefilled container to protect it before injection according to an embodiment of the present invention. [Figure 9] Cross-sectional view of an injection device of a drug storage and dispensing system engaged with a prefilled container having a safety shield during injection according to an embodiment of the present invention. [Figure 10] Cross-sectional view of an injection device of a drug storage and dispensing system engaged with a prefilled container having a safety shield surrounding the needle tip of the prefilled container to protect it after injection is completed according to an embodiment of the present invention. [Figure 11] Perspective view of an injection device according to an embodiment of the present invention. [Figure 12] Elevation view of an injection device according to an embodiment of the present invention. [Figure 13] Elevation view of an injection device according to an embodiment of the present invention. [Figure 14] Elevation view of an injection device according to an embodiment of the present invention. [Figure 15] Elevation view of an injection device according to an embodiment of the present invention. [Figure 16]This is an elevation view of an injection device according to an embodiment of the present invention. [Figure 17] This is an elevation view of an injection device according to an embodiment of the present invention. [Figure 18] This is a perspective view of an injection device according to an embodiment of the present invention, in which a portion of the housing has been removed. [Figure 19] This is a perspective view of a first step using the injection device of the present disclosure according to an embodiment of the present invention. [Figure 20] This is a perspective view of a second step using the injection device of the present disclosure according to an embodiment of the present invention. [Figure 21] This is a perspective view of a third step using the injection device of the present disclosure according to an embodiment of the present invention. [Figure 22] This is a perspective view of a fourth step using the injection device of the present disclosure according to an embodiment of the present invention. [Figure 23] This is a perspective view of a first step using the injection device of the present disclosure according to an embodiment of the present invention. [Figure 24] This is a perspective view of a second step using the injection device of the present disclosure according to an embodiment of the present invention. [Figure 25] This is a perspective view of an injection device according to an embodiment of the present invention. [Figure 26] This is an elevation view of an injection device according to an embodiment of the present invention. [Figure 27] This is a partial cross-sectional view of a portion of the engagement assembly of an injection device according to an embodiment of the present invention. [Figure 28] This is a perspective view of an engagement assembly for an injection device according to an embodiment of the present invention. [Figure 29] This is a perspective view of an engagement assembly for an injection device according to an embodiment of the present invention. [Figure 30] This is a perspective view of an engagement assembly of an injection device engaged with a container in a packaging unit, according to an embodiment of the present invention. [Figure 31]This is a perspective view of an injection device in a first position according to an embodiment of the present invention, with the housing concealed to illustrate the retracted assembly. [Figure 32] This is a perspective view of an injection device in a second position according to an embodiment of the present invention, with the housing concealed to illustrate the retracted assembly. [Figure 33] This is a perspective view of an injection device in a first position according to an embodiment of the present invention, with the housing concealed to illustrate the retracted assembly. [Figure 34] This is a perspective view of an injection device in a second position according to an embodiment of the present invention, with the housing concealed to illustrate the retracted assembly. [Figure 35] This is a partial perspective cross-sectional view of an injection device in a first position, with the housing concealed to illustrate the locking assembly according to an embodiment of the present invention. [Figure 36] This is a partial perspective cross-sectional view of an injection device in a second position, with the housing concealed to illustrate the locking assembly, according to an embodiment of the present invention. [Figure 37] This is a partial perspective cross-sectional view of an injection device in a third position, with the housing concealed to illustrate the locking assembly according to an embodiment of the present invention. [Figure 38] This is a cross-sectional view of a scan assembly of an injection device according to an embodiment of the present invention. [Figure 39] This is a perspective view of a rotating assembly of an injection device according to an embodiment of the present invention. [Figure 40] This is a perspective view of a rotating assembly of an injection device according to an embodiment of the present invention. [Figure 41] This is a partial side cross-sectional view of a rotating assembly of an injection device according to an embodiment of the present invention. [Figure 42] This is an exploded perspective view of a rotating assembly of an injection device according to an embodiment of the present invention. [Figure 43]This is a perspective view of an actuator assembly for an injection device according to an embodiment of the present invention. [Figure 44] This is a partial cross-sectional view of a plunger rod of an injection device according to an embodiment of the present invention. [Figure 45] This is a cross-sectional view of an actuator assembly for an injection device according to an embodiment of the present invention. [Figure 46] This is a cross-sectional view of an actuator assembly for an injection device according to an embodiment of the present invention. [Figure 47] This is a partial perspective view of an injection assembly of an injection device according to an embodiment of the present invention. [Figure 48] This is a perspective view of a system according to an embodiment of the present invention. [Figure 49A] This is a side view of a first container for an injection device according to an embodiment of the present invention. [Figure 49B] This is a side view of a second container for an injection device according to an embodiment of the present invention. [Figure 50A] This is a perspective view of a first container for an injection device according to an embodiment of the present invention. [Figure 50B] This is a perspective view of a second container for an injection device according to an embodiment of the present invention. [Modes for carrying out the invention]

[0021] Corresponding reference letters indicate the corresponding parts through several figures. The illustrations described herein illustrate exemplary embodiments of the disclosure, and such illustrations should not be construed as limiting the scope of the disclosure in any way.

[0022] The following description is provided to enable those skilled in the art to fabricate and use the described embodiments intended for carrying out the present invention. However, various modifications, equivalents, variations, and alternatives will still be readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.

[0023] For the purposes of the following description, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” and “longitudinal,” and their derivatives, will be relevant to the present invention when they are oriented in the drawings. However, it should be understood that the present invention can take on a variety of alternative modifications unless the opposite is explicitly specified. Also, it should be understood that the particular devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. Therefore, the specific dimensions and other physical characteristics related to the embodiments disclosed herein should not be considered limiting.

[0024] Figures 1 to 10 illustrate exemplary embodiments of the present disclosure. Referring to Figures 1 to 10, a drug storage and dispensing system 10 for a plurality of pre-filled containers 12 includes a packaging unit 14 and an injection device 16, as will be described in more detail below. The drug storage and dispensing system 10 of the present disclosure provides drug storage and administration while minimizing the space occupied by such containers in the cold chain. The packaging unit 14 of the drug storage and dispensing system 10 includes a container holding portion, which is adapted to automatically remove the needle shield of the pre-filled container 12 when the pre-filled container 12 is removed from the packaging unit 14. In this way, the drug storage and dispensing system 10 minimizes the risk of needle stick injury because healthcare workers do not need to manually remove the needle shield. The injection device 16 of the drug storage and dispensing system 10 provides a novel mechanism for automatically disabling the container 12, such as a syringe 100, when the plunger rod is not engaged with the container 12, until the container 12 is actually used. The drug storage and dispensing system 10 provides a reduction in the number of steps required to administer an injection, and therefore provides improved productivity and efficiency in mass immunization campaigns.

[0025] The drug storage and dispensing system 10 provides an automated and secure method for recording, storing, and transmitting information about each injection. The drug storage and dispensing system 10 also provides real-time matching of patient ID, vaccine container ID, vaccination location and time, and the ability to transmit the above information to a central repository in real time. The drug storage and dispensing system 10 of this disclosure is particularly useful in pandemic situations where timely and frequent reporting of the progress of immunization in large populations is required.

[0026] The drug storage and dispensing system 10 of this disclosure is compatible with several different prefilled containers. In one embodiment, the drug storage and dispensing system 10 is compatible with syringes 100. For example, the drug storage and dispensing system 10 is compatible with conventionally available syringes from Becton, Dickinson and Company. In some embodiments, the drug storage and dispensing system 10 may be compatible with steakd needle syringes and / or Luer-lock syringes commercially available from Becton, Dickinson and Company. In other embodiments, the drug storage and dispensing system 10 is compatible with other forms of prefilled containers.

[0027] The drug storage and dispensing system 10 of this disclosure may be used, for example, for subcutaneous, intramuscular, or intradermal injection, and in the case of a syringe equipped with Accuspray, it may be used for nasal administration or for other types of injection.

[0028] As discussed above, in one embodiment, the pre-filled container 12 is a syringe 100. In one embodiment, a plurality of syringes 100 each include a needle shield 102 and contain a drug 104 disposed therein. Referring to Figures 5A and 7B, in one embodiment, the needle shield 102 includes an opening 106 for engaging with a portion of the packaging unit 14, as will be described in more detail below.

[0029] Referring to Figures 5A and 5B, in one embodiment, the syringe 100 includes a syringe barrel 124, a needle hub 126, a cannula 128 having a sharp tip 129, a needle shield 102 having an opening 106, and a safety shield 108. The safety shield 108 is adapted to automatically shield the needle tip of each pre-filled container after injection is complete. The syringe 100 is adapted for dispensing and delivering fluids. For example, the syringe 100 may be used to inject or inject fluids, such as drugs, into a patient.

[0030] Referring to Figures 5A and 5B, the syringe barrel 124 generally includes a side wall portion 130 extending between a first or distal end 132 and a second or proximal end 134. The side wall portion 130 defines the elongated opening or internal chamber 136 of the syringe barrel 124. In one embodiment, the internal chamber 136 may extend over the entire length of the syringe barrel 124, so that a cannula is inserted along its entire length. In one embodiment, the syringe barrel 124 may be in a common form of an elongated cylindrical barrel, as is known in the art, and may be in a common form of a subcutaneous injection syringe. In an alternative embodiment, the syringe barrel 124 may be in other forms for containing fluid to be delivered, such as a common form of an elongated rectangular barrel. The syringe barrel 124 may be formed from glass or injection molded from thermoplastic materials such as polypropylene and polyethylene according to techniques known to those skilled in the art, but it should be recognized that the syringe barrel 124 may be made from other suitable materials according to other applicable techniques. In certain configurations, the syringe barrel 124 may include a flange 140 extending outward around at least a portion of the proximal end 134.

[0031] The distal end 132 of the syringe barrel 124 includes an outlet opening 138, which is in fluid communication with the chamber 136. The outlet opening 138 may be sized and fitted to engage with a cannula 128. In one embodiment, the cannula 128 includes a needle hub 126 for engagement with the distal end 132 of the syringe barrel 124.

[0032] The proximal end 134 of the syringe barrel 124 is generally an open end, but is intended to be closed and sealed to the external environment, as discussed herein. The syringe barrel 124 may also include markings to provide an indication of the level or volume of fluid contained in the internal chamber 136 of the syringe barrel 124, such as a scale located on the side wall portion 130. Such markings may be provided on the external surface of the side wall portion 130, on the internal surface of the side wall portion 130, or integrally formed, or otherwise provided within the side wall portion 130 of the syringe barrel 124. In other embodiments, or, or in addition thereto, the markings may also provide a description of the contents of the syringe, or other identifying information that may be known in the art, such as a maximum fill line and / or minimum fill line.

[0033] The syringe 100 of this disclosure may be a pre-filled syringe and may therefore be provided for end use with a fluid such as a drug or medicine contained in an internal chamber 136 of a syringe barrel 124, which has been pre-filled by the manufacturer. Thus, the syringe 100 may be manufactured, pre-filled with the drug, sterilized, and packaged in a packaging unit 14 for delivery, storage, and use by the end user. In such embodiments, the syringe 100 may include a sealing member, which is disposed at the proximal end 134 of the syringe barrel 124 and seals the fluid such as the drug in the internal chamber 136 of the syringe barrel 124.

[0034] In some embodiments, the syringe barrel 124 may include a stopper, which is movably or slidably disposed within an internal chamber 136 and in sealing contact with the inner surface of the side wall 130 of the syringe barrel 124. The stopper may be sized relative to the syringe barrel 124 and may provide a sealing engagement with the inner surface of the side wall 130 of the syringe barrel 124. Additionally, the stopper may include one or more annular ribs extending around the periphery of the stopper to increase the sealing engagement between the stopper and the inner surface of the side wall 130 of the syringe barrel 124. In alternative embodiments, one or more O-rings may be circumferentially disposed around the stopper to increase the sealing engagement with the inner surface of the side wall 130.

[0035] In another embodiment, the stopper may engage with a plunger rod 64 that is movably disposed within the injection device 16.

[0036] Referring to Figures 5A and 5B, the syringe 100 includes a needle shield 102, which surrounds and covers the sharp tip 129 of the cannula 128 to protect it. In this way, no part of the cannula 128 is exposed, thereby significantly reducing the risk of accidental needle stick injury. The needle shield 102 is engageable with a portion of the packaging unit 14, and when each prefilled container 12 is removed from the packaging unit 14, as described in more detail below, the needle shield 102 of each prefilled container 12 is automatically removed.

[0037] Furthermore, the syringe 100 includes a safety mechanism which is automatically triggered when the injection is complete, preventing access to the sharp tip 129 of the cannula 128 and thus preventing needle-related injuries. In one embodiment, the safety mechanism is part of the syringe 100. Referring, for example, to Figures 5B and 8-10, the syringe 100 includes a safety shield 108 which is connected to the syringe 100 and is adapted to automatically shield the sharp tip 129 of the cannula 128 in each prefilled container after the injection is complete. The safety shield 108 surrounds and covers the sharp tip 129 of the cannula 128 to protect it. In this way, no part of the cannula 128 is exposed, thereby significantly reducing the risk of accidental needle stick injuries. In one embodiment, the safety shield 108 is engaged with a spring 110. Thus, as the sharp tip 129 of the cannula 128 is removed from the patient's skin surface S, the spring 110 exerts a biasing force on the safety shield 108, moving it to surround and cover the sharp tip 129 of the cannula 128 as it exits the patient's skin surface S, as shown in Figures 8 to 10.

[0038] In another embodiment, the safety mechanism can be part of the injection device 16.

[0039] In one embodiment, each of the prefilled containers 12 includes a readable information portion. In one embodiment, at least a portion of the readable information portion is a barcode. In other embodiments, the readable information portion may include any unique identifier, such as, but is not limited to, a barcode, QR code®, data matrix, radio frequency identification (RFID) tag, or other identifier. For example, in one embodiment, at least a portion of the readable information portion is an RFID tag. The RFID tag may include an integrated circuit chip, which can provide information such as a container identification number, temperature information, shock or abuse detection, or similar information. In some embodiments, the readable information portion may be placed on a portion of the packaging unit 14.

[0040] The injection device 16 may include a scanner, which is adapted to read the readable information portion of each prefilled container 12. Thus, the injection device 16 can read the information contained therein, such as the drug type, lot number, expiration date, or other identifying information of the prefilled container 12, and either store it in its onboard non-volatile memory or transmit it to a nearby smartphone or a distant data management system. Similarly, the prefilled container 12 may be equipped with sensors, such as a temperature / humidity sensor or a shock / abuse sensor. Signals from these sensors, once picked up, can be read by the injection device 16. If abnormal conditions are detected, an indicator on the injection device 16 will alert the user, and an optional interlock can prevent the injection from proceeding. Once the syringe 100 is picked up and no abnormal container conditions are detected, the healthcare worker proceeds with the injection.

[0041] Furthermore, the drug storage and dispensing system 10 may include a data management platform that stores and processes data transmitted from the injection device.

[0042] The packaging unit 14 of the drug storage and dispensing system 10 provides drug storage and administration while minimizing the space occupied by such containers in the cold chain, and also minimizes the risk of needle stick injuries because healthcare workers do not need to manually remove the needle shield 102 when removing the pre-filled container 12 from the packaging unit 14. In this way, the packaging unit 14 provides improved productivity and efficiency in mass immunization campaigns.

[0043] Referring to Figures 1 to 3, the packaging unit 14 includes a tub member 20, a nest member 22, and a sealing member 24. The tub member 20 defines a receiving cavity 26, which is sized and adapted to receive multiple prefilled containers 12 into it. The tub member 20 generally includes a first end or upper end 28, a second end or bottom end 30, and a side wall portion 32 extending between the upper end 28 and the bottom end 30. The side wall portion 32 defines the receiving cavity 26 of the tub member 20.

[0044] Referring to Figure 1, the tab member 20 includes a locking lip 34 at its upper end 28. The upper tray portion 36 is positioned below the locking lip 34 and has a larger cross-section than the cross-section positioned below it (i.e., the receiving cavity portion 38), with the shoulder portion 40 defined between them. The upper tray portion 36 receives and supports the nest member 22, as will be described in more detail below.

[0045] The nesting member 22 generally includes a nesting plate 42 having an upper surface 44 and a lower surface 46, and a plurality of container holding portions 48 adapted to receive each prefilled container 12 therein. The nesting member 22 is fixable within the tab member 20, and the nesting plate 42 abuts against the upper tray portion 36 of the tab member 20, as shown in Figure 2. Each of the container holding portions 48 includes an engaging member 50 (Figures 7A and 7B), which is adapted to automatically remove the needle shield 102 of each prefilled container 12 when removing each prefilled container 12 from the container holding portion 48 of the packaging unit 14.

[0046] Referring to Figures 7A and 7B, in one embodiment, the engaging member 50 includes a plurality of elastically deformable fins 52. The deformable fins 52 enable the automatic removal of the needle shield 102 of each prefilled container 12 when each prefilled container 12 is removed from the container holding portion 48 of the packaging unit 14. With each prefilled container 12 installed in its respective container holding portion 48 of the packaging unit 14, the deformable fins 52 engage with the opening 106 of the needle shield 102 of the prefilled container 12, as shown in Figure 7B. In this way, the prefilled container 12 is fixed in the container holding portion 48 of the packaging unit 14. Furthermore, the engagement of the deformable fins 52 with the opening 106 of the needle shield 102 enables the automatic removal of the needle shield 102 when the prefilled container 12 is removed from its respective container holding portion 48 of the packaging unit 14. When the prefilled container 12 is removed from the packaging unit 14, the needle shield 102 is automatically removed from the prefilled container 12 via the deformable fins 52 and held in the container holding section 48. In this way, the packaging unit 14 minimizes the risk of needle stick injuries because healthcare workers do not need to manually remove the needle shield 102 when removing the prefilled container 12 from the packaging unit 14.

[0047] The sealing member 24 is removablely fixed to the tab member 20 and provides a mechanism for reliably sealing and protecting multiple prefilled containers 12 within the tab member 20 of the packaging unit 14. In one embodiment, the sealing member 24 includes a cover 54 (Figure 3).

[0048] The packaging unit 14 may include a temperature control unit. In one embodiment, the packaging unit 14 may have a temperature control unit specifically designed to fit into a single tab member 20. This type of temperature control unit is used with the tab and can limit (either passively or actively) temperature deviations related to the pre-filled drug container 12 inside the tab member 20. This type of temperature control unit may be best used when the drug storage and dispensing system 10 is used outside of a traditional medical setting.

[0049] In another embodiment, the packaging unit 14 may have a temperature control unit specifically designed to fit a plurality of tab members 20. This type of temperature control unit is used to store the plurality of tab members 20 in a temperature-controlled environment. This temperature control unit may be best used when the drug storage and dispensing system 10 is used in a traditional medical setting.

[0050] The drug storage and dispensing system 10 of this disclosure can be used either in or outside of a traditional healthcare setting and is capable of delivering drugs on demand in a safe and rapid manner. The drug storage and dispensing system 10 can also be used by patients with chronic diseases, who can self-administer their injectable medications.

[0051] The injection device 16 of the drug storage and dispensing system 10 provides a smart injection assistance device used to administer drugs together with pre-filled drug containers 12. The injection device 16 enables the automatic injection of drugs from each pre-filled container 12 and includes an engaging portion 58 (Figures 6 and 8-10) that is adapted to be removablely engaged with each of the pre-filled containers 12. With the injection device 16 engaged with each pre-filled container 12, the injection device 16 is adapted to automatically actuate a plunger rod 64 to release the drug from each pre-filled container 12. Such automatic actuation can be achieved by either a mechanical or electromechanical actuator present within the injection device 16. For example, an electric motor 68 (Figures 6 and 8-10) may be used.

[0052] Referring to Figures 6 and 8-10, the injection device 16 includes a housing 60 having a first end 62 and a second end 63, a plunger rod 64 movably disposed within the housing 60 of the injection device 16, a lead screw 66, an electric motor 68, a rigid axial coupler 70, and an engagement portion 58 adapted to be removablely engaged with each of the respective prefilled containers 12. In one embodiment, the engagement portion 58 includes a locking member 72 for securing a portion of the prefilled container 12 to the injection device 16. In another embodiment, the engagement portion 58 includes a threaded portion for securing a portion of the prefilled container 12 to the injection device 16. In one embodiment, the plunger rod 64 may include a threaded portion 74. In one embodiment, the injection device 16 may include a scanner portion, which is adapted to read a readable information portion of each prefilled container 12 as described above.

[0053] The plunger rod 64 may be attached to the injection device 16 and movably disposed within the injection device 16. The plunger rod 64 may be permanently attached to the injection device 16 or may be inserted into the injection device 16 by a healthcare professional before picking up each syringe. When in use, a healthcare professional may secure or snap the injection device 16 onto the selected syringe 100, and may also activate the injection device 16 by pressing an activation button, which extends the plunger rod 64 and secures or screws it onto a portion of the syringe 100. In some embodiments, the plunger rod 64 may be a reusable part. In other embodiments, the plunger rod 64 may be a disposable part.

[0054] The injection device 16 is a smart device and is capable of acquiring, storing, and transmitting information about its usage. The injection device 16 is equipped with an onboard electronic module that includes non-volatile memory, which can record and store container-specific identification information and time stamping information regarding the usage of the pre-filled container 12. The injection device electronic module is also equipped with a Global Positioning System (GPS) receiver, which can record and store the latitude and longitude coordinates of the location of use. When used indoors, the injection device electronic module is compatible with existing indoor positioning systems that use triangulation from a wireless signal receiver.

[0055] Furthermore, the injection device electronic module is equipped with a wireless communication module that can establish distance communication by one or more of the following methods: Near Field Communication (NFC), Bluetooth Low Energy (BLE), Wi-Fi, ZigBee, and / or GSM®. The injection device electronic module includes an embedded piece of software that can encrypt the collected information before its transmission. Thus, information collected by the injection device can be reliably transmitted to a distant recipient by any of the above means. Examples of recipients are smartphones, tablets, and / or data management platforms. Application software has been developed for all of the above hardware platforms to visualize the transmitted data. In the case where the information is sent to a distant data management platform, visualization can occur on a smartphone, tablet, or web portal that can also be accessed from a computer connected to the internet.

[0056] In one embodiment, the injection device may incorporate an electrically operated darting mechanism, which inserts the selected syringe 100 into the patient's skin surface to the correct preset depth. The preset depth of insertion is derived from reading a syringe identifier that has information about the type of injection associated with the syringe.

[0057] Referring to Figures 1 to 10, the use of the drug storage and dispensing system 10 is described here.

[0058] Referring to Figures 1 to 3, a healthcare worker ready to administer treatment can first peel off the sealing member 24 of the packaging unit 14 to expose the pre-filled drug containers 12. The injection device 16 can then be used to pick up and remove individual pre-filled containers 12, for example, pre-filled syringes 100. While removing the pre-filled containers 12 from the container holding portion 48 of the packaging unit 14, the deformable fins 52 of the nesting member 22 of the packaging unit 14 allow for the automatic removal of the needle shield 102 of each pre-filled container 12. Thus, when picking up a pre-filled container 12, for example, a syringe 100, the packaging unit 14 allows the needle shield 102 to be automatically removed and remain inside the nesting member 22.

[0059] As discussed above, the plunger rod 64 is attached to the injection device 16. When in use, the healthcare worker can secure or snap the injection device 16 onto the selected syringe 100, and can also activate the injection device 16 by pressing an activation button, which extends the plunger rod 64 and secures or screws it onto a portion of the syringe 100. The healthcare worker can then remove the selected syringe 100 from the tab member 20 of the packaging unit 14 and proceed with the injection. As discussed earlier, the needle shield 102 is automatically removed when the selected syringe 100 is removed from the packaging unit 14 and remains inside the nest member 22.

[0060] As discussed above, the syringe may contain a unique identifier, and as a result, the injection device 16 may read the information contained therein and either store it in its onboard non-volatile memory or transmit it to a nearby smartphone or a distant data management system. Similarly, the pre-filled container may be equipped with sensors such as a temperature / humidity sensor or a shock / abuse sensor. Signals from these sensors may be picked up and read by the injection device 16. If abnormal conditions are detected, an indicator on the injection device 16 will alert the user, and an optional interlock may prevent the injection from proceeding. Once the syringe is picked up and no abnormal container conditions are detected, the healthcare worker proceeds with the injection using the injection device 16.

[0061] As described above, the injection device 16 enables the automated injection of medication from selected pre-filled containers 12. With the injection device 16 engaged with each pre-filled container 12, the injection device 16 is adapted to automatically activate the plunger rod 64 and release medication from each pre-filled container 12.

[0062] Completion of the injection may optionally be detected by the injection device 16, and the corresponding event may be stored in its onboard non-volatile memory, or transmitted to a nearby smartphone or a remote data management system.

[0063] Once the injection is complete, a safety mechanism is triggered to prevent access to the sharp tip 129 of the cannula 128, thus preventing needle-related damage. For example, referring to Figures 8-10, the safety shield 108 is adapted to automatically shield the needle tip of each prefilled container 12, for example, the sharp tip 129 of the cannula 128, after the injection is complete.

[0064] The drug storage and dispensing system 10 of this disclosure can be used either in or outside of a traditional healthcare setting and is capable of delivering drugs on demand in a safe and rapid manner. The drug storage and dispensing system 10 can also be used by patients with chronic diseases, who can self-administer their injectable medications.

[0065] The drug storage and dispensing system 10 of this disclosure is particularly useful when used to carry out vaccination. Vaccination campaigns may be carried out in traditional medical settings, such as clinics, hospitals, medical offices, minute clinics, pharmacies, vaccination centers, or similar settings, or in non-traditional settings, such as retail stores like supermarkets, schools, or offices, or in unspecified settings, as is common in developing countries, in relation to a target population.

[0066] The pandemic situation requires physicians to be able to vaccinate large numbers of people in a very short amount of time. In all non-traditional vaccination sites, the drug storage and dispensing system 10 of this disclosure is particularly useful for the following reasons: (1) The drug storage and dispensing system 10 provides a faster and safer way to vaccinate more people per unit time; (2) The drug storage and dispensing system 10 provides a means to optimize cold chain space by providing denser packaging compared to other packaging systems relating to prefilled containers; and (3) The drug storage and dispensing system 10 provides automated acquisition and real-time transmission of vaccination data, thus enabling precise tracking of vaccination rates at the population level, or enabling accurate information in individual vaccination logs or electronic medical records at the individual level.

[0067] The drug storage and dispensing system 10 is envisioned to be part of a novel service of an on-demand mobile vaccination system. People wishing to be vaccinated can apply online after answering a few questions about their current health status. A dispatch unit, which may be housed in a nearby pharmacy, will then prepare and sort the orders coming from their service area. The orders can then be loaded onto a van or truck driven by a healthcare worker who will deliver the vaccine. Delivery plans and schedules can be optimized by specific software and can be hastily updated to accommodate any last-minute change requests from customers.

[0068] Figures 11 to 50B illustrate another exemplary embodiment of the injection device 200 of the present disclosure. The injection device 200 provides a novel method for automatically disabling a container 12, such as a syringe 100, when the plunger rod is not engaged with the container 12, until the container 12 is actually used.

[0069] The injection device 200 of the drug storage and dispensing system 10 provides a smart injection assistance device used to administer drugs together with pre-filled drug containers 12. The injection device 200 enables the automatic injection of drugs from each pre-filled container 12 and includes an engagement assembly 210 that is adapted to be removablely engaged with each of the pre-filled containers 12. With the injection device 200 engaged with each pre-filled container 12, the injection device 200 is adapted to automatically actuate a plunger rod 264 to release drugs from each pre-filled container 12. Such automatic actuation can be achieved by either a mechanical or electromechanical actuator present within the injection device 200. For example, an electric motor 268 (Figure 42) may be used.

[0070] Referring to Figures 11 to 50B, the injection device 200 includes an engagement assembly 210, a retraction assembly 212, a locking assembly 214, a scan assembly 216, a rotation assembly 218, an actuator assembly 220, and an ejection assembly 222.

[0071] Referring to Figures 11 to 26, the injection device 200 includes a housing 260 having a first end 262 and a second end 263, a plunger rod 264 movably disposed within the housing 260 of the injection device 200, an upper button or first button 270, a side button or second button 272, a battery compartment 274 (Figure 38), a transparent window 276, an indicator portion 278, a gripping portion 280, an angled portion 282, and a bottom counter 284.

[0072] In one embodiment, the housing 260 may include an upper housing portion 266 and a bottom housing portion 268. The upper housing portion 266 may be removablely fixed to the bottom housing portion 268.

[0073] In one embodiment, the top button or first button 270 is a container retract and / or eject button located on the rear end of the injection device 200, for example, on the second end 263. Thus, the location of the first button 270 is ideal to prevent unintended activation of the first button 270. In one embodiment, the side button or second button 272 is an injection button.

[0074] Referring to Figures 25 and 26, the transparent window 276 provides the user with a viewing window to see the container 12 inside the injection device 200 before injection. In one embodiment, an indicator portion 278 includes an LED to indicate the status of the syringe to the user. In one embodiment, the injection device 200 includes a gripping portion 280, which provides a surface and configuration that is easy for the user to grip the injection device 200. For example, in one embodiment, the gripping portion 280 includes an overmolded rubber or soft-touch bottom for enhanced grip for the user of the injection device 200. In one embodiment, the injection device 200 includes an angled portion 282 at the front end, for example, the first end 262, which allows for a better view of the injection site during injection and / or a view with fewer obstructions. In one embodiment, the injection device 200 includes a bottom counter 284 designed to match the shape of the user's hand as they grip the injection device 200 during injection.

[0075] Referring to Figure 38, in one embodiment, the battery compartment 274 may be located in the bottom portion of the injection device 200. In other embodiments, the battery compartment 274 may be located at the rear end, for example, at the second end 263, allowing for a less obstructed line of sight with respect to the barcode scanner 350 of the scan assembly 216 of the injection device 200.

[0076] Referring to Figures 27 to 30, the injection device 200 includes an engagement assembly 210 that is adapted to be removablely engaged with each of the pre-filled containers 12. With the injection device 200 engaged with each of the pre-filled containers 12, the injection device 200 is adapted to automatically actuate the plunger rod 264 and release the drug from each of the pre-filled containers 12.

[0077] Referring to Figures 27 to 30, in one embodiment, the engagement assembly 210 includes a connecting element 300, which includes a main body portion 302 through which a cavity 303 is defined, and a connecting ring 304 which includes a plurality of syringe grip members 306 having a locking hook projection 308 and an angled wall portion 310, respectively.

[0078] Referring to Figures 27 to 30, in one embodiment, a plurality of syringe grip members 306 each have a locking hook projection 308 and an angled wall portion 310. In one embodiment, the syringe grip members 306 are elastically deformable. For example, the syringe grip members 306 can snap onto the flange 140 of the container 12 and securely grip and / or engage with each container 12. The syringe grip members 306 are attachable to the container 12 and secure the container 12 to the injection device 200 via a connecting element 300. Each syringe grip member 306 includes a locking hook projection 308, which is positioned to engage with the corresponding flange 140 on the container 12 (Figures 5A and 5B), as shown in Figures 28 and 30.

[0079] The connecting element 300 of the engagement assembly 210 of the injection device 200 may be sized to fit containers of any size and volume. In other embodiments, the connecting element 300 of the engagement assembly 210 of the injection device 200 may include other connecting mechanisms for securing the container 12 to the injection device 200, such as threaded portions, snap-fit ​​mechanisms, locking tabs, or other similar mechanisms.

[0080] Referring to Figure 27, each syringe grip member 306 includes an angled wall portion 310, which is arranged to provide a first retraction surface 312 for aligning and positioning the connecting element 300 on the container 12 during the initial engagement of the container 12 to the injection device, and a second retraction surface 314 for ejecting the container 12 after the injection is complete.

[0081] Referring to Figures 29 and 30, in one embodiment, the number of syringe grip members 306 is designed to fit into the gap 316 between each container 12 in the packaging unit 14 (Figure 4). Additionally, the number of syringe grip members 306 is designed to grip the container by rounded flanges. The connecting element 300 of the engagement assembly 210 of the injection device 200 allows the injection device 200 to be secured to the container 12 while the container 12 is contained within the packaging unit 14 (Figure 4). Furthermore, the container 12 can be easily removed from the packaging unit 14 using the injection device 200.

[0082] Referring to Figures 31 to 34, the injection device 200 includes a retraction assembly 212. The retraction assembly 212 is adapted to retract the prefilled container 12 into the injection device 200 after the container 12 has been removed from the packaging unit 14, via the fixed engagement of the container 12 to the engagement assembly 210 of the injection device 200.

[0083] In one embodiment, the retraction assembly 212 is movable between a first position (Figures 31 and 33) and a second position (Figures 32 and 34), in which the multiple syringe grip members 306 are outside the injection device 200 to engage with the prefilled container 12, and in the second position, the prefilled container 12 is contained within the injection device 200. In one embodiment, the movement of the retraction assembly 212 between the first and second positions is activated by the user pressing an upper button or a first button 270 (Figure 20).

[0084] Referring to Figures 31 to 34, in one embodiment, the retraction assembly 212 includes a rail 320, a carriage 322, a connecting element 324, a carriage lead screw 326, an adapter 328, a motor 330, and a limit switch 332.

[0085] In one embodiment, the rail 320 is positioned between the upper housing portion 266 and the bottom housing portion 268. In one embodiment, the rail 320 is linear and also provides guidance for the components of the retraction assembly 212, which are movable to retract the container 12 into the injection device 200.

[0086] The carriage 322 is movably mounted on the rail 320. For example, in one embodiment, the carriage 322 is movably mounted on the rail 320 via a sliding connecting element 324 on the rail 320. In one embodiment, motion of the carriage 322 along the rail 320 is provided by a carriage lead screw 326. In one embodiment, an adapter 328 communicates with the carriage lead screw 326 and a motor 330. Thus, the motor 330 is capable of turning the carriage lead screw 326, which moves the carriage 322 between a first position and a second position. In one embodiment, a limit switch 332 is provided to control how far the carriage 322 can travel within the injection device 200.

[0087] In one embodiment, a portion of the engagement assembly 210 is connected to a portion of the retraction assembly 212. Thus, the retraction of the carriage 322 from a first position (Figures 31 and 33) to a second position (Figures 32 and 34) retracts the container 12, which is fixed to the engagement assembly 210 within the injection device 200.

[0088] Referring to Figures 35 to 37, the injection device 200 includes a locking assembly 214. The locking assembly 214 is fitted to lock the multiple syringe grip members 306 into the container 12 after the container 12 has been removed from the packaging unit 14 using the injection device 200 via a fixed engagement of the container 12 to the engagement assembly 210 of the injection device 200, and after the retraction assembly 212 has been used to retract the prefilled container 12 into the injection device 200.

[0089] The locking assembly 214 is adapted to lock the multiple syringe grip members 306 to the container 12 by the retraction assembly 212 in a second position (Figures 32 and 34), for example, with the container 12 inside the injection device 200.

[0090] Referring to Figures 35 to 37, in one embodiment, the locking assembly 214 includes a locking ring 340, a boss 342, and a compression spring 344. Referring to Figure 35, in one embodiment, the boss 342, positioned within the injection device 200, stops the locking ring 340 and / or abuts against the locking ring 340. Referring to Figure 35, with the retraction assembly 212 in a first position (Figures 31 and 33) (for example, in the first position, the multiple syringe grip members 306 are outside the injection device 200 to engage with the prefilled container 12), the locking ring 340 is stopped against the boss 342. Thus, the syringe grip members 306 are outside the injection device 200 and can also flex freely to engage with the prefilled container 12.

[0091] Referring to Figures 36 and 37, with the retraction assembly 212 moved to the second position, the compression spring 344 moves the locking ring 340 onto the syringe grip member 306 of the engagement assembly 210. In this way, with the locking ring 340 engaged with the syringe grip member 306, the syringe grip member 306 is prevented from bending outward, thereby locking the multiple syringe grip members 306 onto the container 12. This prevents the container 12 from being inadvertently pulled out of the injection device 200 by the user, or from being pushed out of the injection device 200 due to the force applied to the plunger rod 264 during injection.

[0092] Referring to Figures 38 to 42, the injection device 200 includes a scan assembly 216 and a rotation assembly 218. Referring to Figures 38 to 42 and Figures 49A to 49B, in one embodiment, the container 12 includes a barcode 290 containing information, and the syringe device 200 includes a scan assembly 216 adapted to scan the barcode 290 when the container 12 is in a second position. The injection device 220 also includes a rotation assembly 218 for rotating the container 12 when the container 12 is in a second position. The rotation assembly 218 ensures that the rotation assembly 218 is adapted to rotate the container 12 until the scan assembly 216 can properly scan the barcode 290 on the container 12, regardless of whether the initial position of the container 12 is securely received within the injection device 200. Since the barcode 290 on container 12 can be located at any position around the periphery of container 12, the rotating assembly 218 can rotate container 12 at least once during the barcode scanning process, ensuring that the barcode 290 can be seen by the scanning assembly 216.

[0093] Referring to Figures 39 and 40, in one embodiment, the rotating assembly 218 includes a rotating gear 360 that communicates with the motor 362. The rotating gear 360 also communicates with the engagement assembly 210. Thus, when the motor 362 is actuated, the rotating gear 360 is rotated, thereby rotating the engagement assembly 210 and the container 12. Referring to Figures 41 and 42, in one embodiment, the rotating assembly 218 is rotatable while the engagement assembly 210 is securely held, so that the container 12 remains stable and does not rattle or vibrate.

[0094] After container 12 is locked inside the injection device 200, the scan assembly 216 can scan the barcode 290 on container 12. In one embodiment, the scan assembly 216 includes a barcode scanner 350, a mirror 352, a scanner optical path 354, and a transmitter 356 for transmitting the information scanned from the barcode 290. Thus, after the barcode scanner 350 of the scan assembly 216 scans the barcode 290 on container 12, the transmitter 356 of the scan assembly 216 can transmit the information from the barcode 290 to a remote system or electronic database, such as a computer 500 (Figure 48). The electronic database and / or computer 500 receives the information transmitted from the transmitter 356 of the scan assembly 216 to the injection device 200. The electronic database and / or computer 500 is then adapted to verify the information contained on the barcode 290 and to transmit signals to the injection device 200 that provide positive feedback regarding injections using the injection device 200. In one embodiment, the injection device 200 cannot inject the drug contained in the container 12 until positive feedback is received from the electronic database and / or computer 500. This provides an important safety feature of the present disclosure. The electronic database and / or computer 500 is capable of determining whether the drug is incorrect or expired, in which case the electronic database and / or computer 500 will not send positive feedback to the injection device 200, thereby preventing the injection of an unwanted drug into the patient.

[0095] The scan assembly 216 of the injection device 200 enables the injection device 200 to become a smart device, which can acquire, store, and transmit information about its usage. In one embodiment, the injection device 200 is equipped with an onboard electronic module including non-volatile memory, which can record and store container-specific identification information and time stamping information regarding the usage of the pre-filled container 12. The injection device electronic module is also equipped with a Global Positioning System (GPS) receiver, which can record and store the latitude and longitude coordinates of the location of use. When used indoors, the injection device electronic module is compatible with existing indoor positioning systems that use triangulation from a wireless signal receiver.

[0096] In one embodiment, the injection device electronic module is equipped with a wireless communication module that can establish distance communication by one or more of the following methods: Near Field Communication (NFC), Bluetooth Low Energy (BLE), Wi-Fi, ZigBee, and / or GSM. The injection device electronic module includes an embedded piece of software that can encrypt the collected information before its transmission. Thus, information collected by the injection device can be reliably transmitted to a distant recipient by any of the above means. Examples of recipients are smartphones, tablets, and / or data management platforms. Application software has been developed for all of the above hardware platforms to visualize the transmitted data. In the case where the information is sent to a distant data management platform, visualization can occur on a smartphone, tablet, or web portal that can also be accessed from a computer connected to the internet.

[0097] As discussed above, container 12 may contain a unique identifier, such as a barcode 290, and as a result, the injection device 200 may read the information contained therein and either store it in its onboard non-volatile memory or transmit it to a nearby smartphone or a distant data management system, such as a computer 500. Similarly, pre-filled containers may be equipped with sensors, such as temperature / humidity sensors or shock / abuse sensors. Signals from these sensors may be read by the injection device 200 once picked up. If abnormal conditions are detected, an indicator on the injection device 200 will alert the user, and an optional interlock may prevent the injection from proceeding. Once the container is picked up and no abnormal container conditions are detected, the healthcare worker proceeds with the injection using the injection device 200.

[0098] Referring to Figures 43 to 46, the injection device 200 includes an actuator assembly 220. When positive feedback regarding the contents of container 12 is received by the injection device 200, the actuator assembly 220 automatically activates the plunger rod 264 of the injection device 200 to release the drug from the pre-filled container 12.

[0099] Referring to Figures 43 to 46, in one embodiment, the actuator assembly 220 includes a plunger rod 264, a plunger lead screw 370, a plunger lead screw nut 372, a plunger lead screw gear 374, and a motor 376. The plunger lead screw 370 communicates with the plunger rod 264. Referring to Figure 43, in one embodiment, the plunger lead screw 370 is fixed to a portion of the plunger rod 264. For example, the plunger lead screw 370 may be bonded to a portion of the plunger rod 264.

[0100] In one embodiment, the motor 376 drives the gear 374, which rotates the nut 372. Referring to Figures 45 and 46, as the nut 372 rotates, it moves the plunger lead screw 370 linearly, acting the plunger rod 264 and releasing the agent from the container 12. Referring to Figures 45 and 46, the plunger rod 264 travels linearly through the center of the engagement assembly 210.

[0101] Referring to Figures 49A-49B and 50A-50B, the first pre-filled container 400 contains a first drug 402 and a first barcode 404, and the second pre-filled container 410 contains a second drug 412 and a second barcode 414. While Figures 49A-49B and 50A-50B illustrate typical containers, any container may be used with the injection device of this disclosure in relation to injection procedures. For example, containers and / or syringes as shown in Figures 1, 4, 5A, and 5B, or similar containers or syringes, may be used with the injection device of this disclosure.

[0102] The engagement assembly 210 of the injection device 200 is adapted to be removablely engageable with the first prefilled container 400 and the second prefilled container 410.

[0103] With the injection device 200 engaged with the first prefilled container 400, the injection device 200 is configured to automatically activate the plunger rod 264 to release the first drug 402 from the first prefilled container 400.

[0104] With the injection device 200 engaged with the second prefilled container 410, the injection device 200 is configured to automatically activate the plunger rod 264 to release the second drug 412 from the second prefilled container 410.

[0105] With the first container 400 contained within the injection device 200, the scan assembly 216 is adapted to scan the first barcode 404.

[0106] With the second container 410 contained within the injection device 200, the scan assembly 216 is adapted to scan the second barcode 414.

[0107] Referring to Figure 47, the injection device 200 includes an ejection assembly 222, which is adapted to automatically eject the container 12 from the injection device 200. After the injection is complete, the injection device 200 has the ability to automatically eject the container 12 after it has moved back to a first position. Thus, the user does not need to grasp any part of the container 12 in order to manually remove it. In one embodiment, as shown in Figure 47, when the container 12 is positioned outside the syringe device 200, the plunger rod 264 extends to push the container 12 slightly away from engagement with the syringe grip member 306, thereby automatically ejecting the container 12 from the injection device 200.

[0108] Referring to Figures 19 to 24, the use of the injection device 200 is described here.

[0109] Referring to Figures 4 and 19, a user or healthcare professional ready to administer treatment can first select a pre-filled drug container 12 contained within the packaging unit 14 for injection using the injection device 200. A downward vertical motion is used to attach the container to the injection device 200. As described above, the engagement assembly 210 is used to securely engage the container 12 with the injection device 200. Once the container 12 is securely engaged with the injection device 200, the injection device 200 is used to pick up and remove the container 12 from the packaging unit 14.

[0110] In one embodiment, as described above, while removing a prefilled container 12 from the container holding portion 48 of the packaging unit 14, the deformable fins 52 of the nesting member 22 of the packaging unit 14 allow for the automatic removal of the needle shield 102 of each prefilled container 12. Thus, when picking up a prefilled container 12, for example a syringe 100, the packaging unit 14 allows the needle shield 102 to be automatically removed and remain inside the nesting member 22.

[0111] Next, referring to Figure 20, the user can press the first button or the upper button 270 to activate the retraction assembly 212 (Figures 31-34), which automatically retracts the container 12 into the injection device 200 as described above. Subsequently, with the retraction assembly 212 in the second position (Figures 32 and 34) and the prefilled container 12 inside the injection device 200, the locking assembly 214 (Figures 35-37) locks the multiple syringe grip members 306 into the prefilled container 12.

[0112] Next, the scan assembly 216 (Figures 38-42) and the rotating assembly 218 (Figures 38-42) automatically scan the barcode on the container 12 as described above. Thus, after the barcode scanner 350 of the scan assembly 216 scans the barcode 290 on the container 12, the transmitter 356 of the scan assembly 216 can transmit the information from the barcode 290 to a remote system or electronic database, such as a computer 500 (Figure 48). The electronic database and / or computer 500 accepts the information transmitted from the transmitter 356 of the scan assembly 216 of the injection device 200. The electronic database and / or computer 500 is then adapted to verify the information contained on the barcode 290 and to transmit a signal to the injection device 200 that provides positive feedback regarding the injection using the injection device 200. In one embodiment, the injection device 200 cannot inject the drug contained in the container 12 until the positive feedback is accepted from the electronic database and / or computer 500. This provides an important safety feature of the present disclosure. For example, referring to Figure 21, in one embodiment, after positive feedback is received by the injection device 200, an indicator part 278, such as an indicator light, is activated to inform the user of the correct barcode scan and the status of the syringe. An electronic database and / or computer 500 can determine whether the drug is incorrect or expired, in which case the electronic database and / or computer 500 will not send positive feedback to the injection device 200, thereby preventing unwanted drugs from being injected into the patient.

[0113] The scan assembly 216 of the injection device 200 enables the injection device 200 to become a smart device, which can acquire, store, and transmit information about its usage. In one embodiment, the injection device 200 is equipped with an onboard electronic module including non-volatile memory, which can record and store container-specific identification information and time stamping information regarding the usage of the pre-filled container 12. The injection device electronic module is also equipped with a Global Positioning System (GPS) receiver, which can record and store the latitude and longitude coordinates of the location of use. When used indoors, the injection device electronic module is compatible with existing indoor positioning systems that use triangulation from a wireless signal receiver.

[0114] Referring to Figure 21, after positive feedback is received by the injection device 200, the transparent window 276 allows the user to present the injection device 200 with the container 12 to the patient for viewing before injection.

[0115] Next, referring to Figure 22, in one embodiment, after successfully reading the barcode 290 on container 12, the container may be translated to the needle attachment / injection position. The user can then remove the safety cap and attach a needle to the container, such as a syringe. Thus, having a container, such as a syringe, extending from the injection device 200 during injection reduces the risk of splash contamination.

[0116] Referring to Figure 23, the configuration of the user's hand relative to the injection device 200 during injection is shown. In this position, the injection device 200 can be securely held, and the side button or the second button 272 can be pressed to activate the actuator assembly 220 (Figures 43-46) for the injection of drug or vaccine.

[0117] Referring to Figure 24, after the injection is complete, the top button or the first button 270 can be pressed to activate the ejection assembly 222 (Figure 47), which will eject the container from the injection device 200.

[0118] In one embodiment, the injection device 200 may incorporate an electrically operated darting mechanism, which inserts the selected syringe into the patient's skin surface to the correct preset depth. The preset depth of insertion is derived from reading a syringe identifier that has information about the type of injection associated with the syringe.

[0119] In one embodiment, as discussed above, the syringe or container may contain a unique identifier, and as a result, the injection device 200 may read the information contained therein and either store it in its onboard non-volatile memory or transmit it to a nearby smartphone or a distant data management system. Similarly, the pre-filled container may be equipped with sensors, such as a temperature / humidity sensor or a shock / abuse sensor. Signals from these sensors may be picked up and read by the injection device 200. If abnormal conditions are detected, an indicator on the injection device 200 will alert the user, and an optional interlock may prevent the injection from proceeding. Once the syringe is picked up and no abnormal container conditions are detected, the healthcare worker proceeds with the injection using the injection device 200.

[0120] Completion of the injection can optionally be detected by the injection device 200, and the corresponding event can be stored in its onboard non-volatile memory, or transmitted to a nearby smartphone or a remote data management system.

[0121] The drug storage and dispensing system 10 of this disclosure can be used either in or outside of a traditional healthcare setting and is capable of delivering drugs on demand in a safe and rapid manner. The drug storage and dispensing system 10 can also be used by patients with chronic diseases, who can self-administer their injectable medications.

[0122] The drug storage and dispensing system 10 of this disclosure is particularly useful when used to carry out vaccination. Vaccination campaigns may be carried out in traditional medical settings, such as clinics, hospitals, medical offices, minute clinics, pharmacies, vaccination centers, or similar settings, or in non-traditional settings, such as retail stores like supermarkets, schools, or offices, or in unspecified settings, as is common in developing countries, in relation to a target population.

[0123] As described above, the injection device 200 enables the automated injection of medication from selected pre-filled containers 12. With the injection device 200 engaged with each pre-filled container 12, the injection device 200 is adapted to automatically activate the plunger rod 264 and release the medication from each pre-filled container 12.

[0124] In one embodiment, the completion of an injection may optionally be sensed by the injection device 200, and the corresponding event may be stored in its onboard non-volatile memory or transmitted to a nearby smartphone or a remote data management system.

[0125] Once the injection is complete, a safety mechanism is triggered to prevent access to the sharp tip 129 of the cannula 128, thus preventing needle-related damage. For example, referring to Figures 8-10, the safety shield 108 is adapted to automatically shield the needle tip of each prefilled container 12, for example, the sharp tip 129 of the cannula 128, after the injection is complete.

[0126] The drug storage and dispensing system 10 of this disclosure can be used either in or outside of a traditional healthcare setting and is capable of delivering drugs on demand in a safe and rapid manner. The drug storage and dispensing system 10 can also be used by patients with chronic diseases, who can self-administer their injectable medications.

[0127] The drug storage and dispensing system 10 of this disclosure is particularly useful when used to carry out vaccination. Vaccination campaigns may be carried out in traditional medical settings, such as clinics, hospitals, medical offices, minute clinics, pharmacies, vaccination centers, or similar settings, or in non-traditional settings, such as retail stores like supermarkets, schools, or offices, or in unspecified settings, as is common in developing countries, in relation to a target population.

[0128] The pandemic situation requires physicians to be able to vaccinate large numbers of people in a very short amount of time. In all non-traditional vaccination sites, the drug storage and dispensing system 10 of this disclosure is particularly useful for the following reasons: (1) The drug storage and dispensing system 10 provides a faster and safer way to vaccinate more people per unit time; (2) The drug storage and dispensing system 10 provides a means to optimize cold chain space by providing denser packaging compared to other packaging systems relating to prefilled containers; and (3) The drug storage and dispensing system 10 provides automated acquisition and real-time transmission of vaccination data, thus enabling precise tracking of vaccination rates at the population level, or enabling accurate information in individual vaccination logs or electronic medical records at the individual level.

[0129] The drug storage and dispensing system 10 is envisioned to be part of a novel service of an on-demand mobile vaccination system. People wishing to be vaccinated can apply online after answering a few questions about their current health status. A dispatch unit, which may be housed in a nearby pharmacy, will then prepare and sort the orders coming from their service area. The orders can then be loaded onto a van or truck driven by a healthcare worker who will deliver the vaccine. Delivery plans and schedules can be optimized by specific software and can be hastily updated to accommodate any last-minute change requests from customers.

[0130] While this disclosure has been described as having exemplary designs, this disclosure may be further modified within the gist and scope of this disclosure. Accordingly, this application is intended to cover any variations, uses, or adaptations of the disclosure using its general principles. Furthermore, this application is intended to cover any deviations from this disclosure as falling within prior art or practice in the art to which this disclosure relates, and as falling within the limitations of the appended claims.

Claims

1. An injection device for a drug and a prefilled container having a readable information portion containing information, comprising: an engagement assembly that removably engages with the prefilled container; a scanning assembly that scans the readable information portion while the prefilled container is contained within the injection device; a transmitter for transmitting the information contained on the readable information portion; a plunger rod movably disposed within the injection device; an indicator portion that illuminates to inform the user of positive feedback and / or the status of the injection device; and an actuator assembly, An external electronic database that receives information contained in the readable information portion transmitted from the injection device, verifies the information contained in the readable information portion to determine whether the drug is correct or expired, and while the injection device is engaged with the prefilled container, the injection device cannot inject the drug in the prefilled container until positive feedback is received from the external electronic database, if an abnormal condition is detected, the indicator portion of the injection device alerts the user, an interlock prevents the injection from proceeding, and when the injection device receives the positive feedback regarding the injection using the injection device, the actuator assembly works in conjunction with the motor to automatically actuate the plunger rod, and transmits a signal to the injection device to provide the positive feedback. A system characterized by including

2. The system according to claim 1, characterized in that the readable information portion is at least one of a barcode, a QR code, a data matrix, and an RFID tag.

3. The system according to claim 1, wherein the injection device includes a transparent window that allows the user to view the prefilled container before injection.

4. The system according to claim 1, wherein the injection device is equipped with an onboard electronic module that includes a memory capable of recording and storing container-specific identification information and stamping information relating to the use of the pre-filled container.

5. The system according to claim 4, characterized in that the onboard electronic module is equipped with a Global Positioning System receiver capable of recording and storing the latitude and longitude coordinates of the place of use.

6. The system according to claim 5, characterized in that the electronic module is compatible with an indoor positioning system that uses triangulation from a wireless signal receiver.

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