Dynamic mixing and delivery systems for mixing therapeutic agents in syringes or autoinjectors

Abstract

A mixing device is configured to hold two containers, each container having a separate pharmaceutical component disposed therein. A fluid passageway is configured to establish fluid communication with each container once a seal surrounding each container is opened. A transfer mechanism can then transfer the pharmaceutical component from one container to the other until ready for delivery or transfer via a delivery assembly through the fluid passageway.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 032,311, filed May 29, 2020; which is incorporated herein by reference in its entirety. Technical Field

[0003] The present invention generally relates to dual container devices for reconstitution or sequential delivery of medicament components. Background Art

[0004] Dual-chamber syringes / auto-injectors are known for storing drug components separately until they are reconstituted at the time of use. There are various benefits to treatments that may be preferably provided in a multi-chamber format. The drug may be more thermally stable, have a longer shelf life, or be present in its aqueous form, among other aspects. For similar reasons, it may be desirable to dissolve the drug in a liquid reagent, suspend dry particles in a liquid, or mix a liquid-liquid solution or suspension thereof.

[0005] In the multi-chamber syringe / autoinjector application area, there are also drug formulations that require intensive and / or prolonged mixing after reconstitution of the drug components. This can be due to the drug's low solubility, poor surface energy, or wettability of the powder or microparticles used for dissolution. Other requirements include uniformly dispersing the suspension of particles in the solvent, addressing dry phase agglomeration that requires initial energy for dispersion, or poor miscibility that makes emulsification difficult. In some cases, speed and ease of use can be crucial for emergency treatments that require very fast and minimal steps. In this application area, state-of-the-art devices often rely on the user to shake the drug container to mix, dissolve, or suspend the drug. Preparation can also require multiple steps, including changing needles or manually transferring the drug and diluent from one container to another. Due to these additional user steps, users may experience delayed treatment time, inadequate drug mixing, or generally be dissatisfied with the product experience. In other cases, the drug may be formulated in a less than ideal manner, where the user may need to inject a higher dose volume, tolerate a less comfortable dosage form, a larger than ideal delivery needle, be exposed to additional solubilizers or stabilizers added to the formulation, or be required to perform more frequent injections. There is a significant motivation to create a device that can mix drugs that are otherwise difficult to dissolve, reconstitute, or suspend by reconstitution alone.

[0006] The present application seeks to address some of these identified problems as well as other problems that will become apparent to those skilled in the art. Summary of the Invention

[0007] Several embodiments of drug mixing and drug delivery devices are disclosed herein.

[0008] In one embodiment, a mixing and drug delivery system includes: a housing configured to hold a first container and a second container, wherein the first container contains a first pharmaceutical component and the second container contains a second pharmaceutical component; a first seal; a second seal; a seal-breaking component configured to open, remove, or pierce the first seal and the second seal; a fluid passageway that allows fluid communication between the first container and the second container once the seal-breaking component changes each of the first container and the second container from a sealed state to an open state; a first plunger at least partially disposed within the first container and at least partially disposed within the second container. a second plunger within the second container, wherein pressing the first plunger drives a portion of the first medicament from the first container through the fluid channel into the second container to mix with the second medicament, and wherein when the second plunger is pressed during the second transfer state, a portion of the mixed medicament in the second container is transferred from the second container through the fluid channel to the first container; a delivery seal arranged around a portion of the fluid channel; and a delivery assembly having a delivery seal unsealing component and a delivery component, wherein the delivery seal unsealing component is configured to cause the delivery seal to change from a sealed state to an open state, thereby allowing the delivery assembly to be in fluid communication with the fluid channel.

[0009] It should be noted that the volume of the first container and the volume of the second container may be the same or different in size.

[0010] The above-mentioned mixing and drug delivery system embodiments may further include an actuating device comprising a stored energy source, which upon actuation causes the stored energy source to be released and causes the second plunger to press and force the mixed drug disposed in the second container out of the delivery assembly.

[0011] In some embodiment variations, the actuator is further coupled to a locking mechanism, and upon actuation of the actuator, the actuator engages the locking mechanism with the first plunger, thereby preventing the first plunger from moving inwardly or outwardly relative to the housing.

[0012] In some variations of the embodiments, an actuation device is absent, a locking mechanism is associated with the first plunger, and when the locking mechanism is engaged, the first plunger is prevented from moving inwardly or outwardly relative to the housing during the delivery step.

[0013] The above embodiments may further include a first plunger rod associated with the first plunger and a second plunger rod associated with the second plunger.

[0014] Some variations may include a plunger rod connection mechanism associated with the first and second plunger rods, and causing the first and second plungers to move in unison when the plunger locking mechanism is engaged. This may take the form of a sliding member, or alternatively, each of the plunger rods may have an extending flange that engages each other when rotated and causes depression of one flange to cause the other to be depressed.

[0015] In some configurations, a needle guard assembly may be coupled to the actuation device. The needle guard assembly serves as a strike trigger to actuate the actuation device.

[0016] Alternatively, a side button may be coupled and / or part of the actuation means to cause a locking mechanism to lock the first plunger in place and prevent it from moving inwardly or outwardly.

[0017] The actuation device may also be configured to release a stored energy source associated with the second plunger and configured to drive the second column.

[0018] In some configurations, the needle guard assembly causes the delivery assembly to change the delivery seal from a sealed state to an open state.

[0019] In several embodiments, the first container and the second container are aligned side by side with each other, and both distal ends point in the same direction.

[0020] The first and second medicaments may be in dry or liquid form.

[0021] In another embodiment, the mixing and drug delivery system may further include a safety release device disposed around the proximal end of the first container, wherein the safety release device may cause the transfer spring to release and engage with the driver and force the driver to move the plunger, thereby causing the drug in the container to be transferred out through the fluid channel.

[0022] The mixing and drug delivery system may also include a single plunger rod associated with the second plunger, and when the plunger rod is depressed, a portion of the mixed drug is transferred to the first container and the transfer spring is recompressed. Once the plunger rod is released, the recompressed transfer spring releases energy again, causing the driver to automatically depress the first plunger and transfer a portion of the mixed drug back to the second container. This depression and release of the plunger can cause the drug to transfer back and forth each time it is depressed and released.

[0023] In some configurations, once the delivery seal is in an open state, depression of the first plunger drives a portion of the mixed first and second medicaments disposed in the first container through the delivery assembly.

[0024] Likewise, when the second plunger is depressed, the second plunger can drive a portion of the mixed first and second medicaments disposed in the second container through the delivery assembly. Thus, once the delivery assembly is fluidically connected, depressing the first plunger rod, the second plunger rod, or both plungers can drive any of the medicaments out.

[0025] The seal breaking means may comprise at least one or more mixing needles.

[0026] The mixing needle may be fluidically connected to the fluid channel. The mixing needle may be supported by a mixing needle hub. In some variations, there may be a sterile seal in which the mixing needle is partially disposed during a storage state.

[0027] The seal breaking member may be influenced by a fluid communication mechanism extending outwardly from the housing and, when depressed into the housing, causes fluid communication between the first container and the second container.

[0028] With respect to the first and other embodiments mentioned, the first container, the second container, the first plunger, the second plunger, and the fluid channel are configured to transfer a portion of the mixed drug back and forth to each of the first container and the second container multiple times through multiple transfer states.

[0029] The drug mixing and drug delivery system embodiment may further include a first sterile cover disposed on an upper portion of the first container and a second sterile cover disposed on an upper portion of the second container.

[0030] The drug mixing and drug delivery system embodiments may further include an upper sterile barrier disposed around the first container and the second container and configured to help form a sterile volume. They may also include a lower sterile barrier disposed around the delivery assembly and configured to help form a second sterile volume.

[0031] The first plunger rod or the second plunger rod may have a notch formed therein and configured to engage with a locking mechanism or a release mechanism.

[0032] In another embodiment, a drug mixing system comprises: a housing configured to hold a first container and a second container, wherein the first container contains a first pharmaceutical component and the second container contains a second pharmaceutical component; a first seal; a second seal; a seal-opening component configured to open, remove or pierce the first seal and the second seal; a fluid channel that allows fluid communication between the first container and the second container once the seal-opening component causes each of the first container and the second container to change from a sealed state to an open state; a first plunger at least partially disposed within the first container and a second plunger at least partially disposed within the second container, wherein pressing the first plunger drives a portion of the first medicament from the first container through the fluid channel into the second container to mix with the second medicament, and wherein the second plunger, when pressed during the second transfer state, causes a portion of the mixed medicament in the second container to be transferred from the second container through the fluid channel to the first container; and a transport seal disposed around a portion of the fluid channel.

[0033] This embodiment may also include a delivery assembly having a delivery seal unsealing component and a delivery component, wherein the delivery seal unsealing component is configured to cause the delivery seal to change from a sealed state to an open state, thereby allowing the delivery assembly to communicate with the fluid channel. The delivery assembly can be attached to a delivery connector. In some configurations, the delivery connector is threaded and in some configurations it can be a Luer lock or bayonet type connector.

[0034] For this embodiment, once the delivery seal is in the open state, depressing the first plunger may drive a portion of the mixed first and second medicaments disposed in the first container through the delivery assembly.

[0035] For this embodiment, once the delivery seal is in the open state, upon depression of the second plunger, the second plunger may drive a portion of the mixed first and second medicaments disposed in the second container through the delivery assembly.

[0036] For this embodiment, once the delivery seal is in an open state, the first and second plungers can drive the mixed first and second medicaments disposed in the first and second containers through the delivery assembly when the first and second plungers are depressed simultaneously.

[0037] In some variations, the drug mixing system embodiment may further include a safety release device disposed around the proximal end of the first container, even without an integrated delivery assembly. This may be part of a transfer actuator comprising a safety release device, a transfer spring, a driver, and a plunger rod. The safety release device, the transfer spring, and the driver may be associated with the first container. As mentioned in other embodiments, these may act to drive the medicament out of the first container when the transfer spring is released. Again, when the medicament from the second container is driven back into the first container by pressing the plunger rod associated with the second container, the transfer spring may be recompressed. Once the plunger rod is released, the transfer spring is released again and the transfer from the first container to the second container is achieved again. This step may be repeated multiple times.

[0038] The mentioned transfer connection may be positioned around the fluid channel.

[0039] In yet another embodiment, a pharmaceutical agent mixing system comprises: a housing configured to hold a first container and a second container, wherein the first container contains a first agent component and the second container contains a second agent component; a fluid channel; a fluid communication mechanism, wherein when the fluid communication mechanism is actuated, the fluid communication mechanism causes the first container to be fluidically connected to the second container via the fluid channel; and a transfer actuator.

[0040] In yet another embodiment, a pharmaceutical dose mixing system includes: a housing configured to hold a first container and a second container, wherein the first container contains a first pharmaceutical component and the second container contains a second pharmaceutical component; a fluid channel; a fluid communication mechanism, wherein when the fluid communication mechanism is actuated, the fluid communication mechanism causes the first container to be fluidically connected to the second container via the fluid channel; and a first plunger rod associated with the first container and a second plunger associated with the second container.

[0041] The fluid communication mechanism may partially extend out of the housing and initiate fluid communication between the first container and the second container when the fluid communication mechanism is depressed.

[0042] In yet another embodiment, a drug delivery system is provided, comprising: a housing configured to hold a first container and a second container, wherein the first container contains a first drug component and the second container contains a second drug component; a fluid channel; a delivery assembly having a delivery needle fluidically connected to the fluid channel; a sterile barrier having a delivery end of the delivery needle partially disposed in the sterile barrier; a first puncture needle fluidically connected to the fluid channel and having a first sterile seal disposed around a portion of an end of the first puncture needle; and a second puncture needle fluidically connected to the fluid channel and having a second sterile seal disposed around a portion of an end of the second puncture needle assembly.

[0043] In yet another embodiment, a drug dose delivery system comprises: a housing configured to hold a first container and a second container, wherein the first container contains a first drug component and the second container contains a second drug component; a fluid channel; a first puncture needle, the first puncture needle being fluidically connected to the fluid channel and having a first sterile seal disposed around a portion of an end of the first puncture needle; and a second puncture needle, the second puncture needle being fluidically connected to the fluid channel and having a second sterile seal disposed around a portion of an end of the second puncture needle.

[0044] In another embodiment, a mixing and drug delivery system includes: a housing configured to hold a first container and a second container, wherein the first container contains a first pharmaceutical component and the second container contains a second pharmaceutical component; a first seal; a second seal; a first seal unsealing component, wherein the first seal unsealing component is configured to open, remove or pierce the first seal; a second seal unsealing component, wherein the second seal unsealing component is configured to open, remove or pierce the second seal; and a fluid channel, wherein once the first seal unsealing component causes the first seal to change from a sealed state to an open state, the fluid passage permitting fluid communication between the first container and the delivery needle once the second seal unsealing component causes the second seal to change from a sealed state to an open state, the fluid passage further permitting fluid communication between the second container and the delivery needle; a first plunger at least partially disposed within the first container and a second plunger at least partially disposed within the second container, wherein depressing the first plunger drives a portion of the first medicament from the first container through the delivery needle, and wherein subsequently depressing the second plunger drives a portion of the second medicament from the second container through the delivery needle.

[0045] These and other embodiments are described in more detail below. BRIEF DESCRIPTION OF THE DRAWINGS

[0046] The foregoing and other objects, features and advantages of the present invention will become apparent from the following description of specific embodiments of the present invention, as shown in the accompanying drawings, in which like reference numerals refer to like parts throughout the different views. The drawings are not necessarily drawn to scale, emphasis instead being placed on illustrating the principles of the invention.

[0047] Figures 1A to 1J Illustrate various states of a drug mixing and delivery device configured to have multiple drug transfer states;

[0048] Figures 2A to 2B illustrates drive mechanism housing locking features associated with several embodiments described herein;

[0049] Figures 3A to 3B An enlarged cross-sectional view illustrating an embodiment of a drug mixing device in a storage state and a mixing state;

[0050] Figures 4A to 4D Various enlarged cross-sectional views illustrating embodiments of a medicament mixing device, including the transition of a delivery needle before and after piercing a delivery seal, which enables delivery of a mixed medicament;

[0051] 5A to 5D Illustrate various sterility features and their release states associated with the hybrid frames of several embodiments described herein;

[0052] Figures 6A to 6B Illustrate various sterility features and their release states associated with the delivery hub and mixing frame 134 described herein;

[0053] 7A to 7C Various states of an alternative embodiment of the mixing and conveying device are illustrated, wherein the conveying component is manually operated.

[0054] Figures 8A to 8C illustrates another variation of the mixing device already described, wherein the plunger rod does not have a plunger rod locking feature;

[0055] Figures 9A to 9C illustrates a further variation of the already described mixing device, including a side lock and / or an actuation button;

[0056] 10A to 10C various cross-sectional views illustrating a release slider engaged with a plunger rod detent;

[0057] Figures 11A to 11C illustrating alternative forms of first and second plunger rods including flanges;

[0058] Figures 11D to 11FExample of simultaneously driving the first and second plunger rods Figures 11A to 11C Alternative forms of;

[0059] Figure 12 This is an embodiment in which the first container and the second container are of the same size.

[0060] 13A to 13C A delivery attachment for a mixing device is illustrated, comprising a fluid passageway disposed therein;

[0061] Figures 13D to 13E A delivery attachment device including a fluid mixing feature is illustrated;

[0062] Figure 14 Another embodiment illustrating a delivery needle fully integrated with the fluid channel;

[0063] 15A to 15D illustrates an external view of another embodiment including a single manual plunger rod with a return transfer mechanism;

[0064] 16A to 16D exemplify 15A to 15D The corresponding cross-sectional view of

[0065] Figures 17A to 17G illustrates various states of an apparatus including an attachable and detachable delivery mechanism;

[0066] 18A to 18E An alternative sterile system for a mixing needle and fluid channel for a delivery device having multiple reservoirs is illustrated;

[0067] - Figures 19A to 19B Illustrated is a sterile cap that can be integrated into any of the devices described herein. DETAILED DESCRIPTION

[0068] In the interests of clarity, applicants wish to provide context surrounding certain terms used in this specification, in addition to their ordinary meanings.

[0069] The term "distal" or "proximal" generally refers to the end of the device opposite the end having the plunger rod. Conversely, the term "proximal" or "proximal" refers to the end of the device having the plunger rod. For example, the distal end of a delivery needle would be the end farthest from the plunger rod end of the device, while the proximal end of the delivery needle would be the end closest to the plunger end of the device.

[0070] For the first purpose of this application, the term container may include any component configured to hold a volume. For example, a cartridge, a pre-filled syringe, a vial, etc. will be considered a container.

[0071] As noted above, there is a need for improved pharmaceutical mixing devices to allow for the need for high strength and / or prolonged mixing of pharmaceutical formulations after reconstitution of the pharmaceutical components. The inventors who created the embodiments herein have provided solutions to at least this noted problem, as well as other problems that will become apparent upon reading this description.

[0072] One embodiment for solving the above problems includes a combined drug mixing and delivery device 100, such as Figures 1A to 1J The various states are shown. Figure 1A and Figure 1B Illustrated are side and front views of a mixing and delivery device 100 including a housing 102, a drive mechanism housing 104, a viewing port 105, a cover 106, and plunger rods 108A, 108B.

[0073] Figure 1C 1 is a cross-sectional view of the mixing and delivery device 100 in a storage state. The drive mechanism 110 is disposed in the drive mechanism housing 104, and the drive mechanism 110 includes a transfer spring 116 and a delivery piston 118. A container holder 132 is disposed in the housing 102, and the container holder 132 is configured to hold a first drug container 122A and a second drug container 122B. Each drug container 122A, 122B has a first plunger 120A or a second plunger 120B and a first plunger rod 108A or a second plunger rod 108B associated therewith. Each drug container is configured to hold a first drug component or a second drug component (124A, 124B). When in the storage state, the first drug component and the second drug component (124A, 124B) are not in fluid communication with each other. This state is maintained until 104 is pressed. As Figure 2A As shown, 104 is retained by a snap feature 172 that engages a first notch 170A formed in housing 102. When 104 is pressed, snap feature 172 releases until it snaps into notch 170B, as shown. Figure 2B As shown. The snap feature 172 can be a passive snap or a one-way snap. Figures 2A to 2B The retention and snap-fit ​​mechanism shown can be applied to several embodiments described herein, not just 100 .

[0074] like Figure 1C As shown, the first container 122A and the second container 122B each include a first container seal 126A and a second container seal 126B, respectively. The mixing needle 128A and the mixing needle 128B are configured to pierce 126A and 126B to allow fluid communication between each container through the fluid channel 130. As described above, once 104 is pressed, as shown in FIG. Figure 1DAs shown, mixing needles 128A, 128B pierce the first and second container seals 126A, 126B and enable fluid communication between the first and second containers 122A, 122B. This may be referred to as the mixing initiation phase. Figures 3A to 3B Enlarged cross-sectional views of an embodiment of a medication mixing device are illustrated in a storage state and a mixing state, including before and after mixing needles 128A, 128B pierce respective container seals 126A, 126B.

[0075] Figure 1E The plunger rod 108A is shown pressed against the plunger 120A, which drives the first pharmaceutical component 124A into the second container 122B and begins mixing with the second pharmaceutical component 124B. It should be noted that the second pharmaceutical component 124B can be in liquid or dry form, while the first pharmaceutical component 124A is typically provided in liquid form. The plunger 120B can rise to expand the internal volume of the second container 124B to receive the first pharmaceutical component. This can also be referred to as the first transfer of the pharmaceutical component from one container to another or the first transfer state.

[0076] exist Figure 1F , a second transfer state is illustrated, whereby the plunger rod 108B is depressed, which pushes the plunger 120B in the distal direction and forces at least a portion of the mixed medicament components through the fluid channel 130 back into the first container 122A.

[0077] exist Figure 1G In the next step, another transfer state occurs, this time by pressing the plunger rod 108A to again apply force to the plunger 120A, forcing the mixed drug currently in the first container 122A back into the second container 122B through the fluid channel 130. It should be readily understood that multiple transfers can occur back and forth between the first container and the second container, thereby improving the speed and quality of the drug mixing process. The viewing port can be used to observe one and / or both containers to confirm that the mixed drug is in a state ready for delivery or transfer.

[0078] Once the medicament is fully mixed, dissolved or suspended and ready for administration, the cap 106 can be removed to expose the needle guard 150, which also serves as a trigger to cause or activate several functions in the device 100. First, it locks the first plunger rod in place as the upward or proximal movement of the needle guard pushes the delivery collar 112, which has a delivery collar bevel 160 that causes the release slider 114 to transfer laterally into the plunger rod detent 164, which is then secured into place once the delivery collar protrusion 162 is fully engaged behind 114. This is the step that locks the plunger rod, as shown in FIG. Figure 1H shown.

[0079] Second, it causes the piercing end 148 of the delivery needle 144 to pierce the delivery seal 140, which is held in place by the delivery seal cap 142. Once in the open and / or pierced state, the delivery seal exposes the fluid channel 130 to the delivery needle and can allow the mixed medicament from the second container to flow through and out of the delivery needle 144 at the delivery end 146. In one embodiment of the device 100, a fluid channel delivery interface 154 is formed around a portion of the fluid channel 130 to receive the piercing end 148 of the delivery needle 144, as shown.

[0080] Third, it causes the energy stored in the delivery spring 116 of the drive mechanism 110 to release and drive the mixed medicament now in the second container through the fluid channel and out of the delivery assembly formed by the delivery needle 144, which is held in place by the delivery hub 136. Figure 1I Delivery spring 116 is shown in an extended state, driving or forcing delivery piston 118 distally onto plunger 120B and causing the mixed medicament disposed therein to be expelled through delivery needle 144, as indicated.

[0081] Once the mixed medicament has been delivered from delivery needle 144, needle shield spring 152 can extend the needle shield outward to cover delivery needle. This needle shield can then be locked in place by known methods, which is not the focus of this description.

[0082] Recalling the above embodiments, the device 100 is shown as enabling a user to transfer the drug components from a first drug container to a second drug container multiple times until they are fully mixed and ready for delivery. The additional embodiments described below illustrate variations of the above embodiments while maintaining some of the same principles of the improved drug mixing device. Variant embodiments of the mixing device may include a delivery assembly, or a version configured to receive a delivery assembly, may include features similar to an auto-injector, or may be manually delivered, and may also include semi-automatic mixing features. These and other features are described below.

[0083] Figures 4A to 4D Various enlarged cross-sectional views illustrating embodiments of a drug mixing device, including a delivery needle prior to piercing a delivery seal ( Figure 4A 、 4C ) and after ( Figure 4B 、 4D ) transition, which enables the delivery of mixed medicaments. Here, the delivery seal 140 disposed around the fluid channel delivery interface 154 can be seen. When the piercing end 148 of the delivery needle 144 passes through the delivery seal 140, it engages the fluid channel delivery interface 154 and allows open fluid communication with the fluid channel 130.

[0084] 5A to 5DVarious sterility features and their release states associated with the mixing frame 134 of several embodiments described herein are illustrated. Although the mixing frame 134 is from the mixing device 100 described above, it should be noted that the same mixing frame with related components and functions can be similarly configured in other embodiments described later. Figure 5A As shown, the mixing frame 134 can include an upper sterile seal 180 and a lower sterile seal 182. The upper sterile seal 180 is shown disposed on the inside of the mixing frame 134, while the lower sterile seal 182 is shown disposed on the outside of the mixing frame 134. The mixing frame 134, together with the container holder 132, forms a sealed sterile volume 190 around the mixing hub. The upper sterile seal 180 engages the side walls of the container holder 132 to form a seal. Within the container holder 132 are a plurality of container holder sealing ridges 184A, 184B that engage the lower portions of the first container 122A and the second container 122B and also form a sealed interface. Together, they maintain the sterile volume 190 until the mixing needles each penetrate the container and establish sterile fluid communication. When the first and second containers are compressed into the mixing needles held in place by the mixing needle hub 138, an exhaust path is formed, as shown in FIG. Figure 5B As shown. This vent is formed as a vent ridge 186 formed on the lower portion of the container holder 132 as it translates toward the mixing frame 134 and passes over the upper sterile seal 180 to open or form a vent, through which a portion of the air or gas disposed in the sterile volume 190 can escape. Thus, a sterile interface can be maintained while the mixing device is stored or transported and prior to use.

[0085] Figure 5C Figures 5-D illustrate a cross-sectional view (5C) of the mixing frame 134 and a non-cross-sectional view (5D) of the mixing frame 134 separated from the rest of the mixing device. Here, it is shown how the upper and lower sterile seals are formed around the entire sealing portion of the mixing frame. Of note and discussed below is the optional vent or hole 194 in the lower portion of the mixing frame 134.

[0086] Figures 6A to 6B Various sterility features associated with the delivery hub 136 and mixing frame 134 and their release states are illustrated. Figure 6A 136. This is created by the mixing frame 134 engaging the delivery hub 136 and forming a sealing barrier where the lower seal 182 is located. Figure 5A In the embodiment of -B, when the delivery hub 136 is pressed upwardly into the mixing frame 134, the lower sterile seal 182 can be vented due to the venting area 198 formed by the venting ridge 196. Figure 6B The exhaust region 198 is shown in FIG.

[0087] As contemplated in an alternative embodiment, instead of forming vent ridges 196 in the sidewalls of the delivery hub 136 , air or gas within the sterile volume 192 may escape through vents or holes 194 formed in the bottom of the mixing frame 134 .

[0088] 7A to 7C Various states of an alternative mixing and delivery device 200 are illustrated, wherein the delivery components are manually operated. Figure 7A The delivery device 200 is illustrated in a stored state. Figure 7B The transport device 200 is shown in the transport start state. Figure 7C Delivery device 200 is illustrated in a fully delivered state. Similar to mixing and delivery device 100, 200 includes a first plunger rod 208A and a second plunger rod 208B, which can transfer the medicament components from first container 222A to second container 222B back and forth as needed to prepare for delivery. This back-and-forth fluid communication is enabled once the drive mechanism housing 204 is depressed to establish fluid communication between the first and second containers and the fluid channel. Also similar to 100, device 200 includes a needle shield 250 covered by cap 206. However, when the needle shield is depressed, it only functions to lock plunger rod 208A, as it causes delivery collar 212, with its beveled edge 260 and protruding end 262, to translate release slider 214 into plunger rod detent 264. It does not cause the delivery spring to release, as this embodiment lacks one. When the user is ready to deliver the mixed medicament, they manually depress plunger rod 208B. It should also be noted that the mixing initiation stage and piercing of the delivery seal, in addition to the above-mentioned features for maintaining sterile volume, can all be incorporated into 200, similar to 100.

[0089] Figures 8A to 8CAnother variation of the mixing device (100, 200) already described is illustrated in which the plunger rod does not have a plunger rod locking feature. Device 300 illustrates a release slider 314 similar to those described above, except that the release slider does not engage with the plunger rod pawl, as it does not exist in this embodiment. Instead, the release slider can apply pressure on one side of the plunger rod 308A. Once the delivery assembly, particularly the delivery needle, establishes fluid communication with the fluid communication channel, the pressure combined with the pressure of the plunger can be sufficient to prevent additional backflow into the first container. In another embodiment not shown, the mixing and delivery device does not include a release slider at all and relies on the friction of the plunger to prevent backflow into the first container. This friction does not necessarily need to be very large, as long as it is sufficient to overcome any back pressure of the fluid flow flowing through and out of the delivery needle. In another embodiment, the friction between the plunger and the container and the pressure of the release slider on the plunger rod 308A are not sufficient to prevent backflow, and the user can apply pressure using a finger, thumb or other appendage to maintain direct contact with the plunger rod 308A to ensure that the position of the plunger rod 308A is maintained throughout the duration of the delivery step.

[0090] Figures 9A to 9C Another variation of the mixing device already described is illustrated, including a side actuation button 415 that can be incorporated into any of the above-described embodiments. The function of the side actuation button 415 here is at least twofold. First, it enables the release slider 414 to engage with the rod plunger pawl 464 and lock the plunger rod 408A in place. Second, it enables the delivery spring 416 (for embodiments comprising a delivery spring) to be released and automatically drives the delivery piston 418 to drive the plunger (and plunger rod 408B) to force the mixed drug disposed in the corresponding container to be driven out of the container. This embodiment does not need to lock the plunger rod or trigger the delivery actuation by the needle shield, and can implement many alternative delivery embodiments described below and in other figures. The function of the drive mechanism housing 404 is similar to that of the above-mentioned 104.

[0091] 10A to 10C Different cross-sectional views of the release slide are illustrated in various states of engagement with the plunger rod pawl. Figure 10A , the release slider 114, 414 is positioned to correspond to a storage or mix-priming state, wherein travel of the plunger rod 108A, 408A is unrestricted. Figure 10B Illustrate when the plunger rod pawl 164, 464 enters a position where the release slider 114, 414 can engage. Figure 10A and 10B In the embodiment, the release slider also holds the delivery piston 118, 418 in shear, so the delivery spring 116, 416 cannot be released. Figure 10C, the release slider is translated by the delivery collar 112 to engage the plunger rod 108A, 408A and fully release the delivery piston 118, 418. It should be noted that the version shown here includes the delivery collar 112 as the mechanism for translating the release slider; however, as indicated in parentheses, this can be replaced by the side actuation button 415 previously described and depicted.

[0092] For embodiments where both plunger rods are intended to be depressed simultaneously, Figures 11A to 11C The solution shown in exemplifies an alternative form of first and second plunger rods 1108A, 1108B comprising flanges 1115A, 1115B, respectively. Figure 11A As shown, each plunger rod has its own corresponding flange. 11A-C. Here, the user rotates 1108B and flange 1115B until 1115B is above flange 1115A. The user can now press flange 1115B, which drives both plunger rods 1108A and 1108B to dispense the medication stored in the corresponding container or cartridge associated with each rod. In some variations, a bump catch 1113 can be provided on one or both plunger rods, which can help lock the plunger rods in place when the flanges are rotated. Prior to rotation, the flanges are separated from each other and can assist in pumping the plunger rods to transfer medication between containers until it is in a ready-to-deliver state, in which case the flanges can be rotated and pressed together, as indicated.

[0093] Figures 11D to 11F exemplify Figures 11A to 11C An alternative solution to simultaneously actuate the first and second plunger rods is to rotate flange 1115B on flange 1115A. Instead of rotating flange 1115B on flange 1115A, flange 1115B can include a sliding locking mechanism 1117 that, when the device is in a state ready to deliver a mixed medicament, can slide over a portion of 1115A and lock 1115A relative to 1115B, such that when either side is pressed, it actuates both plunger rods 1108A and 1108B simultaneously. It should be noted that these two examples are illustrative and not restrictive.

[0094] Figure 12 An embodiment is illustrated in which the first container and the second container have the same size, in contrast to the previously shown and described embodiments in which the first container and the second container have different sizes and volumes.

[0095] 13A to 13C A delivery attachment including a fluid channel disposed therein is illustrated. Figure 13A A dual chamber primary drug container assembly is illustrated. Figure 13B exemplify Figure 13A Exploded view of the device comprising the cartridge frame, pre-filled cartridge and needle assembly and sterile barrier. Figure 13CThe needle assembly shown includes a fluid channel for transferring medication back and forth between two cartridges or containers, similar to the above-described embodiment. Here, the needle is embedded in a sterile barrier covering the needle to prevent fluid from escaping from the needle tip until the medication components stored therein are fully mixed and ready for delivery.

[0096] Figures 13D to 13E The example delivery attachment includes a channel in which fluid mixing features are provided. These fluid mixing features can assist in the mixing process of the medicament components as they flow back and forth between each cartridge or container.

[0097] Figure 14 Another example is shown in which the delivery needle is fully integrated into the fluid channel before and throughout the mixing process. Figure 13A , the distal end of the needle will be embedded in a sterile barrier that covers the needle to restrict flow down the delivery needle until the drug components are fully mixed and ready for delivery.

[0098] 15A to 15D (External View) and 16A to 16D (Cross-sectional view) illustrates another embodiment that includes a single manual plunger rod with a return transfer mechanism. The mixing device 500 may include (or not include) the various delivery components described above. The main purpose of this device is to illustrate a single plunger rod transfer mechanism. In the storage state, the mixing device 500 includes a housing 502, which includes a mixing or drive mechanism housing 504, which, similar to the other embodiments, when pressed, fluidically connects the first and second containers disposed therein and places them in place to transfer the pharmaceutical components back and forth between the containers, thereby mixing the pharmaceutical components.

[0099] Similar to the above-described embodiments, the device 500 includes a pair of side flanges 503 , although not explicitly noted above, to assist a user in manually grasping and pumping or depressing the plunger rod 508 . Figure 15A / 16A illustrates device 500 in a storage state. Figure 15B / 16B shows the device 500 in a mixing start state, wherein the pharmaceutical components are ready to be mixed.

[0100] The device 500 includes a safety pin 507 which, when released (pulled out), allows the transfer spring 515 to release energy and force the driver 513 downward or in a distal direction against the plunger and force the medicament component from the first container into the second container associated with the plunger rod 508. The driver includes a pair of driver arms 511 which engage with the release edge 509. When the safety release 507 forces the arms apart, the arms cannot disengage from the boss 509; however, once the safety release 507 is removed, the arms are free to disengage from the ledge 509. This disengagement occurs when Figure 15C / shown in 16C.

[0101] Now that the drug components have been transferred from the first container to the second container, the user can press the plunger rod 508 to return the drug components from the second container to the first container. In this process, the user recompresses and / or re-energizes the transfer spring 515 and, upon releasing the plunger rod 508, automatically transfers the mixed drug components back to the second container. In this embodiment, the user only needs to press the plunger rod once, with the result that the drug components are transferred back and forth with each press and release. Once the drug components are mixed and ready, the user can appropriately deliver the mixed drug components using one of the delivery assemblies or systems discussed above and depicted in the earlier drawings. This can be achieved by manual administration or by triggering the needle shield to deliver via a pre-stored energy source.

[0102] Figures 17A to 17G Various states of the device 600 including the attachable delivery mechanism 645 are illustrated. Figure 17A In -B, the attachable delivery mechanism 645 can be screwed onto the delivery connection 635 of the mixing device 600. Figure 17C -G further illustrates various states of mixing and delivery similar to the above-described embodiments. Here, the device 600 includes a housing 602, and plunger rods 608A and 608B are configured to engage with plungers respectively disposed in containers 622A and 622B. Each container is configured to hold a pharmaceutical component. When the drive mechanism housing 604 is depressed, it causes a container holder 632 disposed within the housing to move distally into a mixing frame 634. As it travels distally, each container 622A and 622B is driven into a respective mixing needle 628A and 628B, which is in fluid communication with a fluid channel 630. Once each container is in fluid communication with another chamber, the plunger rods can be alternately depressed to drive the pharmaceutical component from one container and back to one or more containers until the mixed pharmaceutical component is ready for delivery. Once in the ready state, as Figure 17F As shown, once the cover 606 is removed, the delivery assembly 645 can be connected to the delivery connector 635. The delivery assembly includes a delivery needle 644 having a piercing end 648 and a delivery end 646. The piercing end 648 is configured to pierce the delivery seal 640 and be in fluid communication with the fluid channel 630. At this stage, each plunger rod can be pressed to deliver or transfer the mixed pharmaceutical components. Once again, this embodiment 600 can have features integrated from above and will be within the scope of this description. For example, the device 600 does not include an automatic delivery feature or automatic transfer mechanism, such as some of the embodiments described above, which can be integrated here as a variation of this embodiment.

[0103] 18A to 18EVarious states of alternative systems of mixing needles and fluid channels for a delivery device 700 are illustrated, whereby mixing is not intended, but rather the medicaments from the two containers are expelled independently of each other. Figure 18A The device 700 is illustrated in a collapsed state, where a first container 722A includes a first medicament, a first plunger 720A forming a stopper for the first medicament, a first container seal 726A, a first sterile seal 727A having a first piercing needle 728A partially disposed within the first sterile seal 727A, connected to a fluid pathway 730, and in fluid communication with a delivery needle 744, wherein the delivery needle 744 is partially embedded in a sterile barrier 733. Similarly, a second container 722B includes a second medicament, a second plunger 720B forming a stopper for the second medicament, a second container seal 726B, a second sterile seal 727B having a second piercing needle 728B partially disposed within the second sterile seal 727B, and connected to the fluid pathway 730.

[0104] like Figure 18B As shown, when the first container 722A is pressed into the sterile seal 727A, the first piercing needle 728A extends upward into and through the first container seal 726A to establish fluid communication with the first pharmaceutical component stored therein. The plunger 720A can then be pressed to deliver the first pharmaceutical component through the delivery needle 744. During this first delivery, the second container 722B remains sealed to the fluid channel until the second container 722B is delivered. Figure 18D As shown, the second container is similarly pressed into the piercing needle 728B and causes the second sterile seal and the second container seal to be completely pierced, thereby achieving fluid communication between the second container 722B and the fluid channel 730.

[0105] Figure 18E The second medicament is shown being delivered out of the delivery needle 744 when the second plunger 720B is depressed. Thus, the first and second medicament components can remain sterile until delivery. Although these are delivered sequentially, the same device 700 can be configured for simultaneous delivery and also integrated to transfer fluids back and forth between containers, as long as the sterile barrier 733 is not removed.

[0106] Figures 19A to 19B Sterile caps 168A and 168B are illustrated that may be integrated into any of the devices described herein. Figure 19A and 19B yes Figure 1C and Figure 1E. Set between the plunger rods 108A and 108B and the plungers 120A and 120B are sterile caps 168A and 168B. The function of these sterile caps is to provide a sterile inner surface for the inner sidewalls 166A and 166B in the storage state. Once packaged, the sterile caps prevent debris or any other potential non-sterile contaminants from entering each of the first and second containers. The sterile caps are formed so that the lower portion forms a sealing barrier, while the side surfaces generate a spring-like force to keep the sterile caps in place until they are moved by the plunger rod. In some cases, when the internal pressure reaches a certain threshold value greater than the spring force, any air pockets set in the upper or proximal portion of the container can be released or deflated through the sidewalls of the sterile caps. This may occur when initially transferring a dose from one container to another.

[0107] It should be clear from the above description, but for the sake of clarity, due to the various embodiments disclosed, it will be understood that as a result of transferring all of the medicament components to the first or second container, the medicament can be delivered first from one container and then subsequently from the second container, and then these mixed medicaments can be delivered from the container where the mixed medicament is located. The containers can be dispensed simultaneously or subsequently in any order. The medicament components can also be delivered as a mixed version, or each can be delivered subsequently or simultaneously without prior mixing.

[0108] Although the principles of the present invention have been described herein, it will be understood by those skilled in the art that this description is intended to be illustrative only and not to limit the scope of the invention. In addition to the exemplary embodiments shown and described herein, other embodiments are contemplated within the scope of the invention. Modifications and substitutions by those of ordinary skill in the art are considered to be within the scope of the invention.

Claims

1. A mixing and drug delivery system, comprising: a housing configured to hold a first container and a second container, wherein the first container contains a first pharmaceutical component and the second container contains a second pharmaceutical component; a first seal; a second seal; a seal-opening component configured to open, remove, or pierce the first seal and the second seal; a fluid passageway that allows fluid communication between the first container and the second container once the seal unsealing component changes each of the first seal and the second seal from a sealed state to an open state; a first plunger at least partially disposed within the first container and a second plunger at least partially disposed within the second container, wherein depressing the first plunger drives a portion of the first medicament from the first container through the fluid channel into the second container to mix with the second medicament, and wherein the second plunger, when depressed during a second transfer state, causes a portion of the mixed medicament in the second container to be transferred from the second container through the fluid passage into the first container; conveying components; as well as An actuating device includes a stored energy source, which, when actuated, causes the stored energy source to be released and causes the second plunger to depress and force the mixed medicament disposed in the second container out of the delivery assembly.

2. The mixing and drug delivery system according to claim 1 further comprises a delivery assembly having a delivery seal unsealing component and a delivery component, wherein the delivery seal unsealing component is configured to cause the delivery seal to change from a sealed state to an open state, thereby allowing the delivery assembly to receive the mixed drug.

3. The mixing and drug delivery system of claim 1 , wherein the actuating device is further coupled to a locking mechanism, and when the actuating device is actuated, the actuating device engages the locking mechanism with the first plunger, thereby preventing the first plunger from moving inwardly or outwardly relative to the housing.

4. The mixing and drug delivery system of claim 2, further comprising a needle shield assembly coupled to the actuation device.

5. The mixing and drug delivery system of claim 4, wherein the needle guard assembly serves as a strike trigger to actuate the actuation device.

6. The mixing and drug delivery system of claim 5, wherein the actuation device causes a locking mechanism to lock the first plunger in place and prevent the first plunger from moving inwardly or outwardly.

7. The mixing and drug delivery system of claim 6, wherein the actuation device is configured to release a stored energy source associated with the second plunger and to drive the second plunger.

8. The mixing and drug delivery system of claim 6, wherein depressing the needle shield assembly causes the delivery assembly to change the delivery seal from a sealed state to an open state.

9. The mixing and drug delivery system of claim 1, wherein the first container and the second container are aligned side by side with each other and both distal ends point in the same direction.

10. The mixing and drug delivery system of claim 1, wherein the first medicament is in liquid form.

11. The mixing and drug delivery system of claim 1, wherein the second medicament is in liquid form or dry form.

12. The mixing and drug delivery system of claim 1, further comprising a safety release device disposed about the proximal end of the first container.

13. The mixing and drug delivery system of claim 12, further comprising a transfer spring and a driver, wherein the driver is configured to engage the first plunger.

14. The mixing and drug delivery system of claim 13, wherein upon removal of the safety release the mixing and drug delivery system causes the driver to depress the first plunger.

15. The mixing and drug delivery system of claim 14, further comprising a plunger rod associated with the second plunger and configured such that depression of the plunger rod causes a portion of the mixed medicament to transfer to the first container and recompress the transfer spring.

16. The mixing and drug delivery system of claim 15, wherein releasing the depressed plunger rod causes the recompressed transfer spring to release energy, thereby causing the driver to automatically depress the first plunger and transfer a portion of the mixed drug back into the second container.

17. The mixing and drug delivery system of claim 1, wherein the seal breaking component comprises at least one mixing needle.

18. The mixing and drug delivery system of claim 17, wherein the at least one mixing needle is fluidly connected to the fluid channel.

19. The mixing and drug delivery system of claim 18, wherein the mixing needle is supported by a mixing needle hub.

20. The mixing and drug delivery system of claim 1, wherein the seal breaking feature is influenced by a fluid communication mechanism extending from the housing, wherein the fluid communication mechanism is configured to be pressed into the housing.

21. The mixing and drug delivery system of claim 1 , wherein the first container, the second container, the first plunger, the second plunger, and the fluid channel are configured to transfer a portion of the mixed medicament back and forth to each of the first container and the second container multiple times through multiple transfer states.

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