Compact pre-filled syringe and method of using the same

Abstract

A compact pre-filled syringe that is at least 35% smaller in length than traditional pre-filled syringes, without sacrificing the liquid / medication holding capacity. The compact pre-filled syringe features an accidental leak safety design. This feature provides superior dosage stability / guarantee and adds a level of safety for the user. With the help of this feature, the user will always receive the right amount of dose at every' instance.

Description

COMPACT PRE-FILLED SYRINGE AND METHOD OF USING THE SAMECROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the priority benefit of U.S. Provisional Patent Application No. 63 / 447,464, filed February 22, 2023, which is hereby incorporated herein by reference in its entirety.TECHNICAL FIELD

[0002] The present disclosure relates to the field of syringes, and, more particularly, to a prefilled syringe that utilizes a plunger system that allows for the syringe to be smaller in length than a conventional pre-filled syringe.BACKGROUND

[0003] Pre-filled syringes provide affordability, accuracy, sterility, and safety, which makes them very convenient in the medical industry. They do not require preservatives, they bring certain manufacturing advantages, and marketing advantages as they are more user-friendly and practical. Studies have been conducted that show nine out of ten healthcare professionals prefer pre-filled syringes over conventional syringes that need dosed out from a vial of medicine.

[0004] However, one of the disadvantages of traditional pre-filled syringes is that they are relatively large because they a require large plunger system. The large size of traditional pre-filled syringes makes them take up valuable space that is inconvenient to both end users and medical facilities.

[0005] Therefore, there is a need in the art for pre-filled syringes that utilize a plunger system that takes up less space while also delivering all the advantages of traditional pre-filled syringes.BRIEF DESCRIPTION OF THE DRAWINGS

[0006] The accompanying drawings are incorporated into and form a part of the specification to illustrate several aspects of the embodiments contemplated, and together with the description, serve to explain the principles of the disclosed embodiments. It being understood that the described embodiments are not limited to the precise arrangements shown. In the drawings, like reference numerals refer to like elements in the several views. In the drawings:1SUBSTITUTE SHEET (RULE 26)

[0007] FIG. 1 is a top view of one embodiment of a compact pre-filled syringe of the present disclosure shown with a plunger member in a pre-use stage

[0008] FIG. 2 is a top view of the compact pre-filled syringe of FIG. 1 with the plunger member pulled to the rear of the syringe;

[0009] FIG. 3 is an exploded view of the compact pre-filled syringe of FIG. 1;

[0010] FIG. 4 is a top view of one embodiment of a compact pre-filled syringe of the present disclosure shown with a plunger member in a pre-use stage

[0011] FIG. 5 is a top view of the compact pre-filled syringe of FIG. 4 with the plunger member pulled to the rear of the syringe;

[0012] FIG. 6 is an exploded view of the compact pre-filled syringe of FIG. 4;

[0013] FIG. 7 is a top view of one embodiment of a compact pre-filled syringe of the present disclosure shown with a plunger member in a pre-use stage;

[0014] FIG. 8 is a top view of the compact pre-filled syringe of FIG. 7 with the plunger member pulled to the rear of the syringe;

[0015] FIG. 9 is an exploded view of the compact pre-filled syringe of FIG. 7;

[0016] FIG. 10 is a top view of one embodiment of a compact pre-filled syringe of the present disclosure shown with a plunger member in a pre-use stage;

[0017] FIG. 11 is a top view of the compact pre-filled syringe of FIG. 10 with the plunger member pulled to the rear of the syringe;

[0018] FIG. 12 is an exploded view of the compact pre-filled syringe of FIG. 10;

[0019] FIG. 13 is a top view of the compact pre-filled syringe of FIG. 10 with the plunger member depressed after having dispensed the fluid contained within a barrel of the compact prefilled syringe;

[0020] FIG. 14 is side view of one embodiment of a stopper and ends of the split plunger of the compact pre-filled syringe of the present disclosure;

[0021] FIG. 15 is side view of one embodiment of a stopper and ends of the split plunger of the compact pre-filled syringe of the present disclosure; and2SUBSTITUTE SHEET (RULE 26)

[0022] FIG. 16 is side view of one embodiment of a stopper and ends of the split plunger of the compact pre-filled syringe of the present disclosure.DETAILED DESCRIPTION

[0023] Various non-limiting embodiments of the present disclosure will now be described to provide an overall understanding of the principles of the structure, function, and use of the apparatuses, systems, methods, and processes disclosed herein. One or more examples of these non-limiting embodiments are illustrated in the accompanying drawings. Those of ordinary skill in the art will understand that systems and methods specifically described herein and illustrated in the accompanying drawings are non-limiting embodiments. The features illustrated or described in connection with one non-limiting embodiment may be combined with the features of other nonlimiting embodiments. Such modifications and variations are intended to be included within the scope of the present disclosure. Like numbers refer to like elements throughout.

[0024] Reference throughout the specification to “various embodiments,” “some embodiments,” “one embodiment,” “some example embodiments,” “one example embodiment,” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with any embodiment is included in at least one embodiment. Thus, appearances of the phrases “in various embodiments,” “in some embodiments,” “in one embodiment,” “some example embodiments,” “one example embodiment,” or “in an embodiment” in places throughout the specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner in one or more embodiments.

[0025] In various embodiments disclosed herein, a single component can be replaced by multiple components and multiple components can be replaced by a single component to perform a given function or functions. Except where such substitution would not be operative, such substitution is within the intended scope of the embodiments.

[0026] Pre-filled syringes of the present disclosure can have a reduced size profile, which allows for multiple benefits for end-users of the pre-filled syringes, manufacturers of the pre-filled syringes, and medical facilities that carry the pre-filled syringes. In one or more embodiments, those benefits can include a reduced packaged size, thus creating a more compact syringe which3SUBSTITUTE SHEET (RULE 26)may be easier to carry, transport, and store. An additional benefit may be a reduction in the size of the shipping container needed to ship the pre-filed syringes which may save on shipping costs or, alternatively, more pre-filled syringes could be included in standard packaging. With unpredictable supply chains and delivery times more efficient use of space may save on cost and improve delivery effectiveness. Another benefit may be a reduction in the storage space needed to store containers of the pre-filled syringes which may reduce the size of the building or storage container needed to store the pre-filled syringes or, alternatively, more pre-filled syringes could be stored in current storage spaces. An additional benefit may be a reduction in shipping and transportation costs associated with the pre-filled syringes which can lead to a lower bottom line cost to manufacturers, which they can pass on to end-users. Another benefit may be a reduction in the size of the cold-storage facility needed to house the containers of the pre-filed syringes which may reduce the size of the cold-storage facility needed to store the pre-filled syringes or, alternatively, more pre-filled syringes could be stored in current cold-storage facilities. For the end user, an additional benefit may be a reduction in the space needed for the end user to store and carry the pre-filed syringes prior to use which may lead the end user to lead a more normal lifestyle when having to store and carry pre-filled syringes. Finally, another benefit of the end user may be a reduction in the overall cost of the pre-filled syringe bom by the end user by getting rid of the dead space needed with conventional pre-filled syringes.

[0027] For example, a conventional pre-filled syringe can be as long as 5.2 inches / 132 mm while the embodiments of the present disclosure can have a 35% or more reduction in their length. A pre-filled syringe in accordance with embodiments described herein may have a length of from 1 inch to 4 inches, from 1 inch to 3.5 inches, from 1 inch to 3 inches, and from 1 inch to 2.5 inches when in a compact state. In one embodiment, a pre-filled syringe of the present disclosure can have a length of 3.44 inches / 87.4 mm.

[0028] While various embodiments of pre-filled syringes envisioned by the present disclosure will be discussed below, they may utilize the following principles. The pre-filled syringes of the present disclosure can generally utilize a body member, a stopper member, and a plunger member, but other configurations may be contemplated. The plunger member can incorporate a more compact design than standard pre-filled syringe plungers, making the whole syringe occupy a significantly smaller space. For example, pre-filled syringes constructed in accordance with versions described herein may be 10% to 20% shorter, from 10% to 30% shorter, 50% shorter, or4SUBSTITUTE SHEET (RULE 26)otherwise more compact than standard pre-filled syringe plungers. A reduced length plunger may improve functionality, portability, and convenience without sacrificing the medication-holding capacity of the pre-filled syringes of the present disclosure. Pre-filled syringes of the present disclosure can also utilize similar components that are used on conventional pre-filled syringes, such as a syringe cap, a syringe cap inner lining, and a syringe needle. It can be appreciated that the systems and methods described herein can be used with original equipment manufacturing (OEM) component or they may be designed as a retrofit to existing standard syringe designs.

[0029] FIGS. 1-3 show an embodiment of a pre-filled syringe 100 of the present disclosure. FIG. 1 shows the syringe 100 in its compact form; FIG. 2 shows the syringe 100 of FIG. 1 with a plunger member 110 pulled to a proximal end 101 of a syringe barrel 106, and FIG. 3 shows an exploded view of the syringe 100 of FIG. 1. As illustrated, the syringe 100 can hold any suitable volume of a fluid, a medication, or the like within the syringe barrel 106, but without the added length of a traditional plunger member projecting proximally from the proximal end 101 of the syringe barrel 106. Such a configuration can allow a standard amount of a fluid, medication, or the like to be provided at a fraction of the size, but with the same functionality as a traditional prefilled syringe. In one or more embodiments, the syringe can hold medicine, oil, lubricants, solvents, mechanical sealants, engine sealants, plant feed, and or glues.

[0030] Pre-filled syringe 100, according to one embodiment, includes a needle cap 102, a needle cap inner lining 104, a syringe barrel 106, an actuation flange 108 located adjacent the proximal end 101 of barrel 106, and a plunger member 110. The needle cap 102 provides protection for the needle 124 while the needle cap inner lining 104 provides an additional layer of protection for the needle 124 while helping to prevent contamination and accidental sticks of needle 124. The syringe barrel 106 includes a proximal end 101 and a distal end 103 defining an inner volume. The inner volume of the syringe barrel 106 can be where the fluid, medicine, or the like may be prefilled. The actuation flange 108 provides a surface for the user to hold onto and apply pressure when actuating the plunger member 110 while also helping prevent the users ’ fingers from slipping off the syringe barrel 106 during operation, ensuring that an intended force can be applied to the plunger member 110.

[0031] The plunger member 110 includes a split plunger guide rod 112, a split plunger 114, and a plunger flange 116. As can be seen in FIGS. 1 -3, the split plunger guide rod 112 and the split5SUBSTITUTE SHEET (RULE 26)plunger 114 can be split into two symmetrical sections, with an end of each symmetrical section of both the split plunger guide rod 112 and the split plunger 114 being connected to the plunger flange 116. It can be appreciated that the sections of the split plunger 114 can be asymmetrical, can include two or more portions, and can have any suitable shape or orientation. In one or more embodiments, the plunger member 110 can also include a motion limiter (example 407 shown in FIGS. 10-12) that can be utilized to limit the maximum rearward motion of the plunger member 110. In one or more embodiments, the motion limiter is in the form of a retainer ring. Limiting the rearward motion of the plunger member 110 provides multiple benefits such as allowing the split plunger 114 to be placed in its armed position (discussed below in more detail) at the proper time and place, by preventing tampering with the fluid held within the syringe barrel and allowing the split plunger guide rod 112 and split plunger 114 to stay in their proper positions for dispensing of the fluid within the syringe barrel. In one or more embodiments, the motion limiter can comprise a plastic ring made from cellulose acetate or polypropylene.

[0032] FIG. 3 is an exploded view of the pre-filled syringe 100 of FIG. 1. FIG. 3 shows additional components of the pre-filled syringe 100 such as a plunger limiter guide 118 located at the ends of the split plunger guide rod 112 of the plunger member 110 which works in conjunction with the motion limiter to limit the maximum rearward motion of the plunger member 110. With the plunger member 110 being pulled rearward, the plunger limiter guide 118 can catch on the motion limiter and halt additional rearward motion of the plunger member 110, which can allow for the split plunger 114 to be utilized, as will be discussed in further detail below. Also shown in FIG. 2 is an optional cover 120 which protects the syringe barrel 106 when present while also protecting the plunger member 110 when in its compact form such as shown in FIG. 1. FIG. 3 also shows a piston / stopper 122, a needle 124, a syringe hub 126, and openings 128 in the syringe barrel 106 and actuation flange 108.

[0033] The piston / stopper 122 provides a structure to contain the fluid within the syringe barrel 106 by creating a barrier that prevents the fluid from leaking out of the proximal end 101 of the syringe barrel 106. The piston / stopper 122 also helps in accurately calibrating the amount of fluid that can eventually be dispelled from the needle 124. In one or more embodiments, the syringe barrel 106 can include a calibrated scale, and by moving the stopper 122 along said scale, users can precisely dispense the desired amount of fluid. With the plunger guide rod 112 pressed against the stopper 122, as will be discussed in detail below, the stopper 122, along with the plunger guide6SUBSTITUTE SHEET (RULE 26)rod 112, can accurately control the release of the fluid. The stopper 122 also provides seal integrity with the syringe barrel 106, preventing air or contaminants from entering the syringe barrel 106.

[0034] The syringe hub 126 can be located at the distal end 103 of the syringe barrel 106 and provides a secure attachment point for the needle 124 to the syringe 100. In one or more embodiments, the syringe hub 126 can have a female fitting that allows the needle to be securely screwed or pressed onto the syringe hub 126. In acting as the secure attachment point for the needle 124, the syringe hub 126 also ensures a tight and leak-proof connection between the two components, preventing any leakage of fluid from the syringe barrel 106.

[0035] The openings 128 allow for the split plunger 114 to enter the syringe barrel 106 and align with the stopper 122 to dispense medication from the syringe 100. As can be seen in FIG. 3, the needle 124 can be located at a distal end portion 103 of the syringe barrel 106, and the stopper 122 can be located at a proximal end portion of the syringe barrel 106.

[0036] In one or more embodiments, the plunger flange 116 contains an open aperture 115. The open aperture 115 in the plunger flange 116 allows for the plunger member 110 to be more easily manufactured utilizing modem manufacturing technology. However, if the manufacturing process does not demand the open aperture 115 on the plunger flange 116, then open aperture 115 can be omitted. If present, the open aperture 115 in the plunger flange 116 also provides an opening for an auto-injector accessory, and the user can auto-inject the medication from the syringe 100 without utilizing the split plunger 114. By having an open aperture 115 in the plunger flange 116, the split plunger 114 can be bypassed. In yet other embodiments, with the open aperture 115 present in the plunger flange 116, the syringe 100 can also utilize a flange sticker (not shown) which covers access to the open aperture 115. Such a sticker may make the plunger flange 116 flatter and more comfortable for use. Additionally, useful information and / or instructions can be added to the flange sticker.

[0037] With syringe 100 in a pre-use / packaged stage (also referred to as a compact stage), such as shown in FIG. 3, the split plunger guide rod 112 and the split plunger 114 are positioned around the syringe barrel 106. The placement of the split plunger guide rod 112 and the split plunger 114 around the syringe barrel 106 and not behind the syringe barrel 106 can be a differentiator from conventional pre-filled syringes while also providing a built-in accurate dose safety system. By removing contact between the plunger member 110 and the piston 122 in the7SUBSTITUTE SHEET (RULE 26)pre-use / packaged stage, even if the syringe 100 comes under accidental pressure, the piston 122 cannot be moved forward to dispense medication accidentally. This feature provides superior dosage stability while adding a level of safety for the end user of syringe 100.

[0038] The split plunger guide rod 112 works by being slidable over the surface of the syringe barrel 106. By splitting the split plunger guide rod 112 and the split plunger 114 into two symmetrical sections connected to the plunger flange 116 at an end thereof, the plunger member 110 can only be moved towards the front and rear along the bore axis of the syringe barrel 106. The split plunger guide rod 112 and the split plunger 114 being placed around the syringe barrel 106 can also reduce the packaged size of syringe 100 while also providing a dependable plunger system during administration with the plunger flange 116 pulled back and the syringe 100 placed in an armed stage.

[0039] With the plunger flange 116 pulled towards the rear of the syringe 100, the split plunger guide rod 112 and the split plunger 114 can be pulled backwards along the syringe barrel 106. In one or more embodiments, the split plunger 114 may have a shorter length than the split plunger guide rod 112 such that with the plunger member 110 pulled back towards the end of the syringe barrel 106, the split plunger 114 can split off of it’s positioning on the syringe barrel 106 and the two arms of the split plunger 114 can meet in the middle of the plunger member 110. Once in this position, plunger flange 116 can be eased forward such that the two arms of the split plunger 114 can be placed in a position to engage the stopper 122. Once positioned against the stopper 122, the plunger flange 116 can be pushed forward such that the combination of the stopper 122 and the two arms of the split plunger 114 can dispense medication from the syringe 100.

[0040] In one or more embodiments, the split plunger 114 may be made of a plastic material such as Polypropylene (PP), Polyethylene (PE), Polycarbonate (PC), or combinations thereof or in yet other embodiments, the split plunger 114 may be made from sheet metal or a combination of over-molded sheet metal and a plastic material. In light of the split plunger 114 being made of a plastic material, the split plunger 114 can snap or spring into an armed position to meet in the middle of the plunger member 110 with the plunger member 110 pulled rearward enough. Plastics have spring-like properties. Plastics have a unique property called viscoelasticity, which allows them to absorb energy, flex, and spring back to their original shape without cracking. This property can be achieved through molecular movement and rearrangement when a stress is applied. The8SUBSTITUTE SHEET (RULE 26)spring-like feature of plastics can often be referred to as their "elastic modulus" or "Young's modulus”. "Viscoelasticity, on the other hand, can be a property of materials that exhibit both viscous (flow) and elastic (spring-like) characteristics when undergoing deformation. This means they deform under stress but also have some degree of recovery with the stress removed. The split plunger 114 of syringes 100 of the present disclosure utilizes these features in order to function. In order to perform the same duty as a regular prefilled syringe at a much more compact size.

[0041] In the embodiment of syringe 100 as shown in FIGS. 1-3, when positioned on the syringe barrel, the split plunger guide rod 112 and the split plunger 114 are located along the syringe barrel 106 in the same plane as the ends of the actuation flange 108. Based on this orientation, the syringe barrel 106 and actuation flange 108 include the openings 128 that provide a pathway for the two arms of the split plunger 114 to travel when the plunger flange 116 is pulled towards the rear of the syringe 100.

[0042] FIGS. 4-6 show a different embodiment of a pre-filled syringe 200 of the present disclosure. In this embodiment, the pre-filled syringe 200 includes all the same elements as the pre-filled syringe 100 of FIGS. 1-3, except when positioned on a syringe barrel 206, a split plunger guide rod 212 and a split plunger 214 are located along the syringe barrel 206 in a different plane than ends of an actuation flange 208. Based on this orientation, only the syringe barrel 206, and not the actuation flange 208 may include an opening 228 that provides a pathway for the two arms of the split plunger 214 to travel with the plunger flange 216 pulled towards the rear of the syringe 200.

[0043] In both the embodiment of FIGS. 1-3 and the embodiment of FIGS. 4-6, both the split plunger guide rod 112 / 212 and the split plunger 114 / 214 are each located in the same plane. However, embodiments of the present disclosure also contemplate embodiments wherein a plunger guide rod can be located in a different plane than a split plunger. In the embodiment of FIGS. 7-9, a split plunger guide rod 312 can be located along a top and bottom of a syringe barrel 306 when looking at a top view of syringe 300, and a split plunger 314 can be located along sides of the syringe barrel 306 when looking at a top view of syringe 300. In embodiment shown in FIGS. 7- 9, the pre-filled syringe 300 includes all the same elements as the pre- filled syringe 100 of FIG. 1- 39SUBSTITUTE SHEET (RULE 26)

[0044] In the embodiment of FIG. 7-9, an actuation flange 308 can be larger in size that the actuation flange 108 of the embodiments shown in FIGS. 1-3, and openings 328 can act as a motion limiter to limit the maximum rearward motion of the split plunger guide rod 312. Specifically, a plunger limiter guides 318 can be caught in the openings 328 to stop the rearward motion of a plunger member 310. As can be seen in FIGS. 7-9, the split plunger 314 can be positioned such that it travels over the actuation flange 308 with the syringe 300 armed. A length of the split plunger 314 may be such that the split plunger 314 can be armed prior to the split plunger guide rod 312 being limited in its rearward motion by the openings 328 and the plunger limiter guides 318.

[0045] Although not shown, the present disclosure also contemplates an embodiment wherein a split plunger can be located along the top and bottom of a syringe barrel when looking at a top view of a syringe, and a split plunger guide rod can be located along sides of the syringe barrel when looking at a top view of the syringe. In such an embodiment, openings may need to be positioned on an actuation flange such that they are in a position to interact with the split plunger guide rod.

[0046] FIGS. 10-13 show a different embodiment of a pre-filled syringe 400 of the present disclosure. In this embodiment, the pre-filled syringe 400 includes all the same elements as the pre-filled syringe 100 of FIGS. 1-3, except when positioned on a syringe barrel 406, a split plunger guide rod 412 and a split plunger 414 are located along the syringe barrel 406 in a different plane than ends of an actuation flange 408, similar to pre-filled syringe 200. Based on this orientation, only the syringe barrel 406, and not the actuation flange 408 may include an opening 428 that provides a pathway for the two arms of the split plunger 414 to travel with the plunger flange 416 pulled towards the rear of the syringe 400. Pre-filled syringe 400 also does not utilize the optional cover 220 as utilized in pre-filled syringe 200. Furthermore, pre-filled syringe 400 shows an embodiment of a motion limiter 407 as discussed above in relation to the pre-filled syringe 100. In the embodiment of FIGS. 10-13, because of the orientation of the split plunger guide rod 412 and split plunger 414, the motion limiter 407 can work in conjunction with an actuation flange 408 to limit the maximum rearward motion of plunger member 410 as shown in FIG. 11. FIG. 13 shows the state of pre-filled syringe 400 once the split plunger 414 has been depressed and fluid within the syringe barrel 406 has been pushed out through the needle 424.10SUBSTITUTE SHEET (RULE 26)

[0047] FIGS. 14-16 show various embodiments for ends 130 of each arm of the split plunger 114 and the stopper 122. Although FIGS. 14-16 only show embodiments of the ends 130 of each arm of the split plunger 114 and stopper 122, these embodiments can also be utilized in the embodiments shown in FIGS. 4-13 described above. In the embodiment of FIG. 14, the ends 130 of each arm of the split plunger 114 are enlarged in size, such that they are larger in diameter than each arm of the split plunger 114, and the end 132 of the stopper 122 can be solid. In the embodiment of FIG. 15, the ends 130 of each arm of the split plunger 114 are pointed such that they are the same diameter as each arm of the split plunger 114, and the end 132 of the stopper 122 contains an aperture 134 which can receive the ends 130 of each arm of the split plunger 114. In the embodiment of FIG. 16, the ends 130 of each arm of the split plunger 114 are jagged and the end 132 of the stopper 122 contains an aperture 134 with jagged walls such that the jagged end 132 of each arm of the split plunger can mate with the jagged walls of aperture 134.

[0048] In one or more embodiments, the following steps can be followed to utilize syringe 100 discussed above. First, the syringe 100 may be removed from its protective packaging. To arm the syringe 100, the user can pull back on plunger flange 116 such that the split plunger 114 can be disengaged from its positioning on the syringe barrel 106 and both arms of the split plunger 114 can meet in the middle of the plunger member 110. In one or more embodiments, the disengaging of the split plunger 114 from its position on the syringe barrel can accompany an audible click. This action of rearward pulling on the plunger flange 116 can cause the split plunger guide rod 112 to also travel rearward, but the combination of the motion limiter and the motion limiter guides 118 can stop the split plunger guide rod 112, and as such, the plunger member 110, from being pulled back farther than it needs to be.

[0049] With both arms of the split plunger 114 having met in the middle of the plunger member, the ends 130 of each arm of the split plunger 114 may now be positioned to align with the stopper 122. The needle cap 102 can then be removed, which exposes the needle 124. With the needle cap 102 exposed, the syringe 100 can be ready to dispense fluid. As with a typical syringe, a user can grip both the plunger flange 116 and the actuation flange 108 to push forward on the plunger member 110 which can cause the split plunger 114 to push against the stopper 122 which can administer the medication within the syringe barrel. The steps described above, although referencing pre-filled syringe 100, the steps may also be utilized to operate pre-filled syringes 200, 300, or 400 or any other embodiment of the pre-filled syringes of the present disclosure.11SUBSTITUTE SHEET (RULE 26)

[0050] The end user of any of the syringes of the present disclosure can see a multitude of benefits from their use. The overall size of the syringes of the present disclosure are smaller than traditional single use syringes, which can lead to a lower cost of obtaining the medication, because the packaging of the syringes can be smaller. Costs can also be lowered because the cold storage space of the syringes of the present disclosure are decreased as compared to the cold storage space required for traditional single use syringes. The end user may now more easily carry the syringes of the present disclosure because they take up less space and they cannot accidently administer a fluid, medication, or other because the steps discussed above have to be undertaken prior to the syringes of the present disclosure being able to administer medication. During long periods of travel, carrying the syringes of the present disclosure in bulk can be easier because they take up less space. The syringes of the present disclosure can provide a leak-proof design because the steps discussed above have to be undertaken prior to the syringes of the present disclosure being able to administer medication. The positioning of the split plunger guide rod of the present disclosure and the split plunger of the present disclosure on the syringe barrel of the present disclosure also can provide an additional benefit of providing protection against shatter if the syringes of the present disclosure are dropped or crushed.

[0051] The syringes of the present disclosure also can provide benefits to healthcare systems due to the reduction in shipping costs and costs associated with cold storage of traditional singleuse syringes. The smaller size of the syringes of the present disclosure can also help healthcare systems function more efficiently while also lowering the overall costs to healthcare facilities when they utilize the syringes of the present disclosure.

[0052] The foregoing description of embodiments and examples has been presented for purposes of illustration and description. It is not intended to be exhaustive or limiting to the forms described. Numerous modifications are possible in light of the above teachings. Some of those modifications have been discussed, and others will be understood by those skilled in the art. The embodiments were chosen and described in order to best illustrate principles of various embodiments as are suited to particular uses contemplated. The scope is, of course, not limited to the examples set forth herein, but can be employed in any number of applications and equivalent devices by those of ordinary skill in the art. Rather it is hereby intended the scope of the invention to be defined by the claims appended hereto.12SUBSTITUTE SHEET (RULE 26)

Claims

WHAT IS CLAIMED IS:

1. A pre-filled syringe for delivering fluid comprising: a. a syringe barrel having a proximal end portion and a distal end portion defining an inner volume, wherein the inner volume contains a fluid; b. a needle secured to the proximal end portion of the syringe barrel; c. a piston movably disposed within the distal end portion of the syringe barrel; and d. a plunger member comprising: i. a split plunger guide rod; and ii. a split plunger; wherein the plunger member transitions from a compact stage wherein the split plunger guide rod and the split plunger are positioned around an exterior of the syringe barrel to an armed stage wherein the split plunger is removed from its positioning on the syringe barrel such that it is engaged with the piston.

2. The pre-filled syringe of claim 1 , wherein the plunger member further comprises a plunger flange.

3. The pre-filled syringe of claim 2, wherein the transition from the compact stage to the armed stage occurs by pulling on the plunger flange such that the split plunger guide rod and the split plunger move from a position adjacent the distal end portion of the syringe barrel to a position adjacent the proximal end portion of the syringe barrel.

4. The pre-filled syringe of claim 1, wherein the syringe barrel further comprises an actuation flange located adjacent to the proximal end portion of the syringe barrel, wherein the actuation flange includes end portions which extend outside a diameter of the syringe barrel, and wherein the end portions of the actuation flange are positioned in a first plane.

5. The pre-filled syringe of claim 4, wherein when the plunger member is in the compact stage, the split plunger guide rod and the split plunger are positioned around the syringe barrel such that the split plunger guide rod and the split plunger lie in the first plane.13SUBSTITUTE SHEET (RULE 26)6. The pre-filled syringe of claim 5, wherein the syringe barrel and the actuation flange each include openings that provide a pathway for the split plunger to transition from the compact stage to the armed stage.

7. The pre-filled syringe of claim 4, wherein when the plunger member is in the compact stage, the split plunger guide rod and the split plunger are positioned around the syringe barrel such that the split plunger guide rod and the split plunger lie in a second plane, wherein the second plane is distinct from said first plane.

8. The pre-filled syringe of claim 7, wherein the syringe barrel includes openings that provide a pathway for the split plunger to transition from the compact stage to the armed stage.

9. The pre-filled syringe of claim 4, wherein when the plunger member is in the compact stage, the split plunger guide rod is positioned around the syringe barrel such that the split plunger guide rod lies in the first plane, and the split plunger is positioned around the syringe barrel such that the split plunger lies in a second plane, wherein the second plane is distinct from said first plane.

10. The pre-filled syringe of claim 4, wherein the actuation flange includes openings that inhibit rearward motion of the split plunger guide rod once the split plunger has transitioned to the armed stage.

11. The pre-filled syringe of claim 1, wherein the split plunger guide rod is defined by a first symmetrical portion and a second symmetrical portion, wherein the first symmetrical portion includes a plunger limiter guide at an end thereof, and wherein the second symmetrical portion includes a plunger limiter guide at an end thereof.

12. The pre-filled syringe of claim 11, wherein the plunger member further includes a motion limiter, and wherein the plunger limiter guides of the split plunger guide rod interact with the motion limiter to inhibit rearward motion of the split plunger guide rod once the split plunger has transitioned to the armed stage.14SUBSTITUTE SHEET (RULE 26)13. The pre-filled syringe of claim 1, further comprising a cover member, wherein the cover member is positionable over the syringe barrel to cover the syringe barrel, the split plunger guide rod, and the split plunger when the plunger member is in the compact stage.

14. The pre-filled syringe of claim 1, further comprising a needle cap and a needle cap inner lining positionable over the needle to protect the needle when in the compact stage.

15. The pre-filled syringe of claim 1, wherein the split plunger is defined by a first symmetrical portion and a second symmetrical portion, wherein the first symmetrical portion includes a first end portion, and wherein the second symmetrical portion includes a second end portion.

16. The pre-filled syringe of claim 15, wherein the piston is solid and when in the armed state, the first and second end portions sit flush against the piston.

17. The pre-filled syringe of claim 15, wherein the piston contains an aperture and when in the armed state, the first and second end portion sit within the aperture of the piston.

18. The pre-filled syringe of claim 15, wherein the piston contains an aperture with jagged walls, wherein the first and second end portions include jagged edges, and when in the armed state, the jagged edges of the first and second end portions mate with the jagged walls of the aperture of the piston.

19. A syringe-based method for delivering fluid, the method comprising the steps of: a. providing a pre-filled syringe, the pre-filled syringe including; i. a syringe barrel having a proximal end portion and a distal end portion defining an inner volume, wherein the inner volume contains the fluid; ii. a needle secured to the proximal end portion of the syringe barrel; iii. a piston movably disposed within the distal end portion of the syringe barrel; and iv. a plunger member comprising:

1. a split plunger guide rod;2. a split plunger; and15SUBSTITUTE SHEET (RULE 26)3. a plunger flange; b. pulling rearward on the plunger flange to transition the plunger member from a compact stage wherein the split plunger guide rod and the split plunger are positioned around an exterior of the syringe barrel to an armed stage wherein the split plunger is removed from its positioning on the syringe barrel such that it is engaged with the piston; and c. pushing forward on the plunger flange such that the split plunger is pushed against the piston and fluid is delivered from the inner volume through the needle.

20. The method of claim 19, wherein the fluid is medication.16SUBSTITUTE SHEET (RULE 26)

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