Multi-barrel syringe for sequential delivery of liquids and method of using the same

Abstract

A multi-barrel syringe for sequentially discharging a second fluid following a first fluid includes an outer barrel that houses the first fluid and an inner barrel that is slidably inserted into the outer barrel and houses the second fluid. The outer barrel includes an opening proximal end, a distal end that includes a fluid port, a side wall that extends between the proximal end and the distal end, and a protrusion that extends from the inner surface of the outer barrel into the outer barrel. The inner barrel includes an opening proximal end, a closed distal end, and a side wall that extends between the proximal end and the distal end. Moving the inner barrel through the outer barrel causes the piercing-penetrable portion of the inner barrel to contact the protrusion of the outer barrel and pierce through the inner barrel, whereby the second fluid flows from the inner barrel into the outer barrel.

Description

Technical Field

[0001] The present disclosure generally relates to a syringe for discharging a plurality of fluids. Specifically, it relates to a syringe for sequentially discharging a second fluid such as a flush solution following a first fluid such as a medical fluid.

Background Art

[0002] (Cross - reference to related applications) This application claims priority to Indian Patent Application No. 202211036491, filed on June 24, 2022, under the title "Multi - Barrel Syringe for Sequential Delivery of Fluids and Methods of Use", which is hereby incorporated by reference in its entirety as part of this specification.

[0003] (Background Art) Vascular access devices (VADs) are commonly used medical devices including intravenous (IV) catheters such as peripheral catheters or central venous catheters. If not properly maintained or exposed to a non - sterile environment, VADs can become contaminated, leading to occlusion by thrombus and / or spread of infection. In many healthcare facilities, sterile techniques or protocols are introduced to properly use VADs and prevent occlusion and infection. Often, these protocols include sterilization of VADs and flushing of catheters with a flush solution. Specifically, the practice guidelines for VADs typically recommend performing a flush procedure after catheter insertion, before infusion, and before and after drug administration, blood sampling, blood transfusion, and / or parenteral nutrition administration.

[0004] These flushing procedures aim to confirm the patency of the catheter, avoid drug incompatibilities, ensure the administration of the full dose of the drug to the patient, prevent thrombosis, and minimize the risk of bloodstream infection due to VAD contamination. Additionally, flushing can prevent the accumulation of blood, blood residues, and IV drugs within the catheter or other VAD devices. Such accumulation can cause partial or complete occlusion of the fluid pathway within the catheter system, in which case the personnel are required to perform certain expensive and potentially dangerous processes to purge the affected catheter or replace the blocked catheter with a new one. In many cases, such occlusions result in treatment interruptions and may compromise the patient's treatment. Also, the accumulation of residues within the catheter may increase the risk of infection.

[0005] During the administration of a drug or other medical fluid, the catheter or VAD is typically flushed both before and after the delivery of the fluid from a syringe or another drug delivery device to the VAD. In some cases, various fluids (referred to herein as flush solutions) can be pre-filled and a syringe assembly can be used to flush the catheter. The size of the pre-filled syringe used to flush the catheter varies, for example, based on the size and length of the catheter. Typically, a pre-filled syringe for flushing a catheter or IV line contains a flush solution with a volume of about 1 mL, about 3 mL, about 5 mL, or about 10 mL. Many separate syringes commercially available from different manufacturers can be used to supply the flush solution through the patient's catheter or IV line, and such syringes include, for example, the BD PosiFlush™ pre-filled saline syringe from Becton, Dickinson and Company.

[0006] To perform the flush procedure, the practitioner connects a pre-filled flushing syringe to the VAD, advances the plunger rod into the barrel of the pre-filled syringe, and discharges a flush solution into the VAD from the nozzle or fluid port of the pre-filled syringe. After flushing, the pre-filled syringe is disconnected from the VAD, and the practitioner can then administer medical fluid. Conventionally, the medical fluid is contained in a vial, removed into a separate syringe, and after being filled with the medical fluid, is connected to the VAD. Thereafter, the plunger rod is advanced through the syringe filled with the medical fluid to inject the medical fluid into the VAD. After the medical fluid has been injected into the VAD, the syringe is disconnected from the VAD, and a second pre-filled flushing syringe is used to flush the VAD. Flushing of the VAD after administration of the medical fluid verifies the patency of the catheter and delivers any residual medical fluid in the catheter to the patient, ensuring delivery of the full dose of medical fluid to the patient.

SUMMARY OF THE INVENTION

PROBLEMS TO BE SOLVED BY THE INVENTION

[0007] Connecting or disconnecting a syringe or other instrument to the VAD introduces a portion of the VAD into a non-sterile external environment, increasing the potential for the VAD to become contaminated and / or a source of bloodstream infection. To reduce the risk of bloodstream infection and properly use and maintain the VAD, standard practice requires disinfecting and flushing all fluid ports or connectors of the VAD each time a new syringe is connected to the VAD. Thus, reducing the number of syringes that must be connected to the VAD during a drug delivery procedure can simplify drug administration by reducing the number of times a portion of the VAD must be disinfected and flushed. Also, reducing the number of syringes or other fluid delivery devices used during a procedure reduces the opportunity for a portion of the VAD to become contaminated, thereby reducing the risk of bloodstream infection. The syringe and method of the present disclosure provide a simplified drug administration procedure by reducing the number of syringes used during such procedures, thereby reducing the risk of contamination and bloodstream infection.

Means for Solving the Problem

[0008] According to one aspect of the present disclosure, a multi-barrel syringe for sequentially discharging a second fluid following at least a first fluid includes an outer barrel configured to contain the first fluid, and an inner barrel configured to contain the second fluid and slidably inserted into the outer barrel. The outer barrel includes an opening proximal end, a distal end including a fluid port, a side wall extending between the proximal end and the distal end, and at least one protrusion extending from the inner surface of the outer barrel into the interior of the outer barrel. The inner barrel includes an opening proximal end, a closed distal end, and a side wall extending between the proximal end and the distal end. Movement of the inner barrel through the outer barrel brings the piercing-penetrable portion of the inner barrel into contact with at least one protrusion of the outer barrel, piercing through the inner barrel, thereby enabling the second fluid to flow from the inner barrel into the outer barrel. The syringe further includes a plunger at least partially inserted into the inner barrel for moving the inner barrel through the outer barrel and for moving through the inner barrel to discharge the second fluid from the inner barrel through the piercing-penetrable portion of the inner barrel.

[0009] According to another aspect of the present disclosure, a pre-filled flushing syringe includes any of the previously described syringes of the present disclosure, wherein the inner barrel is at least partially inserted into the outer barrel and the plunger is at least partially inserted into the inner barrel. The pre-filled syringe further includes a predetermined amount of the second fluid sealed within the inner barrel by the plunger.

[0010] According to another aspect of the present disclosure, a method of sequentially discharging fluid from one of the previously described syringes includes applying a pressure directed in the distal direction to the plunger, thereby moving the inner barrel through the outer barrel to discharge the first fluid from the outer barrel through the fluid port. The method further includes continuing to apply a pressure directed in the distal direction to the plunger when the piercing-penetrable portion of the inner barrel is pierced by at least one protrusion of the outer barrel and moving the plunger through the inner barrel, thereby discharging the second fluid from the inner barrel into the outer barrel and further discharging it through the fluid port.

[0011] Non-limiting exemplary embodiments of the present disclosure will be described in the following numbered items.

[0012] (Item 1) A multi-barrel syringe for sequentially discharging a second fluid following at least a first fluid, the syringe comprising: an outer barrel configured to contain the first fluid, the outer barrel including an opening proximal end, a distal end including a fluid port, a side wall extending between the proximal end and the distal end, and at least one protrusion extending from the inner surface of the outer barrel into the interior of the outer barrel; an inner barrel configured to contain the second fluid, the inner barrel being slidably inserted into the outer barrel and including an opening proximal end, a closed distal end, and a side wall extending between the proximal end and the distal end, wherein moving the inner barrel through the outer barrel causes the piercing-penetrable portion of the inner barrel to contact at least one protrusion of the outer barrel and pierce through the inner barrel, thereby enabling the second fluid to flow from the inner barrel into the outer barrel; and a plunger at least partially inserted into the inner barrel, configured to move the inner barrel through the outer barrel and discharge the second fluid from the inner barrel through the piercing-penetrable portion of the inner barrel.

[0013] (Item 2) The syringe according to Item 1, wherein when the piercing-penetrable portion of the inner barrel is intact, applying pressure to the plunger causes the inner barrel to move through the outer barrel.

[0014] (Item 3) The syringe according to Item 1 or 2, wherein when the piercing-penetrable portion of the inner barrel is intact, applying proximal pressure to the plunger causes the inner barrel to move proximally through the outer barrel and suck the first fluid into the outer barrel through the fluid port.

[0015] (Item 4) The syringe according to any one of Items 1 to 3, wherein when the piercing-penetrable portion of the inner barrel is intact, applying distal pressure to the plunger causes the inner barrel to move distally through the outer barrel and discharge the first fluid from the outer barrel through the fluid port.

[0016] (Item 5) The syringe according to any one of Items 1 to 4, wherein after the penetrable portion of the inner cylinder is penetrated by at least one protrusion, a distal direction pressure is applied to the plunger, and the plunger moves through the inner cylinder.

[0017] (Item 6) The syringe according to any one of Items 1 to 5, wherein the inner cylinder and the outer cylinder include at least one of polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile-butadiene-styrene.

[0018] (Item 7) The syringe according to any one of Items 1 to 6, wherein the inner cylinder includes a finger flange extending radially from the proximal end of the opening of the inner cylinder, and the outer cylinder includes a finger flange extending radially outward from the outer cylinder.

[0019] (Item 8) The syringe according to any one of Items 1 to 7, wherein the distal end of the inner cylinder includes an annular flange configured to contact the inner surface of the outer cylinder.

[0020] (Item 9) The syringe according to any one of Items 1 to 8, wherein the inner cylinder includes a stopper attached to the distal end of the inner cylinder, and the stopper has a size to seal in contact with the inner surface of the side wall of the outer cylinder.

[0021] (Item 10) The syringe according to Item 9, wherein the stopper includes a full stopper covering the distal end of the inner cylinder and a part of the side wall of the inner cylinder.

[0022] (Item 11) The syringe according to Item 9 or 10, wherein the stopper includes an annular partial stopper covering the distal end of the inner cylinder partially.

[0023] (Item 12) The syringe according to any one of Items 1 to 11, wherein the penetrable portion of the inner cylinder includes a groove at the closed distal end of the inner cylinder.

[0024] (Item 13) The syringe according to Item 12, wherein the thickness of the groove is smaller than the thickness of other parts of the closed distal end of the inner cylinder.

[0025] (Item 14) The syringe according to item 12 or 13, wherein the groove includes an annular groove arranged such that a plurality of protrusions extending inward from the distal end of the outer cylinder come into contact therewith.

[0026] (Item 15) The syringe according to any one of items 1 to 14, wherein the plunger includes a stopper slidably arranged within the inner cylinder and a plunger rod connected to the stopper and extending in the proximal direction from the stopper.

[0027] (Item 16) The syringe according to item 15, wherein the stopper includes a thermoplastic elastomer such as isoprene.

[0028] (Item 17) The syringe according to item 15 or 16, wherein the plunger rod is provided with a pressing plate at the proximal end of the plunger rod.

[0029] (Item 18) The syringe according to any one of items 15 to 17, wherein the stopper includes a conical distal surface and at least one annular rib configured to seal in contact with the inner surface of the side wall of the inner cylinder.

[0030] (Item 19) The syringe according to any one of items 1 to 18, wherein at least one of the protrusions includes at least one of a spike, a needle, a raised portion, a sharp portion, a pointed end, or a post.

[0031] (Item 20) The syringe according to any one of items 1 to 19, wherein at least one of the protrusions is integral with another part of the outer cylinder.

[0032] (Item 21) The syringe according to item 20, wherein the outer cylinder including at least one of the protrusions is an integrally molded product.

[0033] (Item 22) The syringe according to any one of items 1 to 21, wherein at least one of the protrusions extends inward from the inner surface of the distal end of the outer cylinder.

[0034] (Item 23) The syringe according to Item 22, wherein the outer cylinder includes a plurality of protrusions extending inward from the distal end of the outer cylinder.

[0035] (Item 24) The syringe according to any one of Items 1 to 23, wherein at least one protrusion includes at least one channel for fluid flow from the inner cylinder to the outer cylinder when the piercing-through portion of the inner cylinder is pierced.

[0036] (Item 25) The syringe according to Item 24, wherein at least one channel includes at least one of a groove, a notch, an opening, a slot, a cut, a cavity, or a lumen that at least partially extends through at least one protrusion.

[0037] (Item 26) The syringe according to any one of Items 1 to 25, further including a detachable cap that engages with the outer cylinder and / or the inner cylinder to prevent the inner cylinder from being fully inserted into the outer cylinder while the cap is engaged.

[0038] (Item 27) The syringe according to Item 26, wherein the detachable cap prevents the piercing-through portion of the inner cylinder from contacting and being pierced by at least one protrusion of the outer cylinder when engaged with the inner cylinder and / or the outer cylinder.

[0039] (Item 28) The syringe according to Item 26 or 27, wherein the detachable cap detachably engages with a finger flange extending radially outward from the proximal end of the outer cylinder.

[0040] (Item 29) A pre-filled flushing syringe including the syringe according to any one of Items 1 to 28, wherein the inner cylinder is at least partially inserted into the outer cylinder and the plunger is at least partially inserted into the inner cylinder, and a predetermined volume of a second fluid sealed within the inner cylinder by the plunger.

[0041] (Item 30) The pre-filled syringe according to Item 29, wherein the second fluid is a physiological saline flush solution.

[0042] (31) The prefilled syringe according to claim 29 or 30, further comprising a detachable cap that engages with the outer cylinder and / or the inner cylinder to prevent the inner cylinder from being fully inserted into the outer cylinder while the cap is engaged.

[0043] (32) A method of sequentially discharging fluid from a syringe according to any one of claims 1 to 28, the method comprising: applying a pressure directed distally to the plunger, thereby moving the inner cylinder through the outer cylinder and discharging a first fluid from the outer cylinder through a fluid port; and continuing to apply a pressure directed distally to the plunger when the pierceable portion of the inner cylinder is pierced by at least one protrusion of the outer cylinder, moving the plunger through the inner cylinder, thereby discharging a second fluid from the inner cylinder to the outer cylinder and further discharging the second fluid through the fluid port.

[0044] (33) The method according to claim 32, further comprising initially applying a pressure directed proximally to the plunger, thereby moving the inner cylinder proximally through the outer cylinder to aspirate a first fluid into the outer cylinder.

[0045] (34) The method according to claim 33, wherein the step of aspirating the first fluid further comprises attaching a needle to the fluid port of the fluid container, inserting the needle into the fluid container, and aspirating the first fluid from the fluid container into the outer cylinder.

[0046] (35) The method according to any one of claims 32 to 34, wherein the syringe is provided in a partially prefilled state containing a predetermined volume of a second fluid in the inner cylinder.

[0047] (36) The method according to any one of claims 32 to 35, further comprising attaching at least one patient line to the fluid port of the syringe before discharging the first fluid from the outer cylinder through the fluid port.

[0048] (Item 37) The method according to any one of Items 32 to 36, wherein the second fluid includes a flush solution such as physiological saline and / or a heparin lock flush solution, and the first fluid includes a therapeutic agent.

Brief Description of the Drawings

[0049]

Figure 1A

Figure 1B

Figure 1C

Figure 2A

Figure 2B

Figure 2C

Figure 2D

Figure 3A

Figure 3B

Figure 3C

Figure 4A

Figure 4B

Figure 5

DETAILED DESCRIPTION OF THE INVENTION

[0050] The following description is provided to enable one of ordinary skill in the art to make and use the described embodiments contemplated for carrying out the present invention. However, various modifications, equivalents, variations, and alternatives will still be readily apparent to one of ordinary skill in the art. All such modifications, variations, equivalents, and alternatives are intended to be included within the spirit and scope of the present invention.

[0051] In the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and derivatives thereof shall relate to the invention as oriented in the figures. As used herein, the term "proximal" refers to a part or end of a device, such as a syringe or catheter, that is grasped, manipulated, or used by a practitioner or other user. The term "distal" refers to the end or part of the device that is furthest from the part of the device that the practitioner grasps, manipulates, or uses. For example, the "proximal end" of a catheter or IV line refers to the end that includes a fluid port connected to a fluid container, such as an IV bag or syringe. The "distal end" of a catheter or IV line refers to the end that is connected to a patient. However, it should be understood that the present invention may contemplate alternative variations and sequences of steps, except where a contrary is explicitly specified. Also, it should be understood that the specific devices and steps shown in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. Accordingly, the specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered limiting.

[0052] Referring to the drawings, the present disclosure is directed to a multi-barrel syringe (10, 210) that discharges a second fluid F2 following a first fluid F1 from a chamber or barrel of the syringe (10, 210) through a fluid port or nozzle of the syringe (10, 210), for example, into a vascular access device. The first fluid F1 can be a medical fluid, and as used herein, a medical fluid can refer to a drug, total parenteral nutrition (TPN) solution, or another therapeutic agent used in the treatment of chronic or acute conditions, as is known in the art. Exemplary therapeutic agents can include, for example, drugs, chemicals, or biological or biochemical substances that achieve a desired therapeutic effect when delivered to a patient in a therapeutically effective amount. The second fluid F2 can be a flush solution such as saline and / or a heparin lock flush solution. An example of a saline flush solution is 0.9% sodium chloride USP for injection. An example of a heparin lock flush solution is 0.9% sodium chloride containing 100 USP units of sodium heparin per mL or 10 USP units of sodium heparin per mL. Also, other flush solutions as are known in the art can be used with the syringes (10, 210) of the present disclosure. Also, the syringes (10, 210) can also be used to sequentially deliver a different second drug or therapeutic agent following a first drug or therapeutic agent.

[0053] The syringes (10, 210) of the present disclosure enable a practitioner to administer, for example, a flush solution following drug administration without the need to exchange the syringe between the delivery of a first fluid and the delivery of a second fluid. Practitioners are people such as medical technicians, nurses, physician assistants, physicians, or other trained or untrained clinicians or healthcare providers. Advantageously, the sequential administration of the drug and the flush solution is automatically performed, for example, by the advancement of the plunger rod of the syringe (10, 210). As used herein, "advancement" of the plunger rod means that a practitioner can, with a single stroke, push the plunger rod distally through the barrel of the syringe (10, 210) to discharge a second fluid F2 following a first fluid F1 from the syringe (10, 210). The practitioner does not need to remove the syringe or other device from the VAD, for example, between the delivery of the first and second fluids. Further, when using the syringes (10, 210) of the present disclosure, a practitioner does not need to change the direction of movement of the plunger rod and press another component or mechanism of the syringe (10, 210) to perform the sequential delivery of the first and second fluids.

[0054] In some examples, the syringes (10, 210) are provided as partially pre-filled syringes, and the chambers or barrels of the syringes (10, 210) are filled with a flush solution during manufacture. The partially pre-filled syringes (10, 210) can include caps, clips, retainers, and / or other packaging members to hold the plunger rod in a predetermined position and ensure that the flush solution does not leak from the partially pre-filled syringes (10, 210) at an unexpected time, such as during transportation.

[0055] Also, the syringes (10, 210) of the present disclosure are configured such that a practitioner can aspirate a medical fluid into the syringes (10, 210) before delivering the fluid to a patient. For example, the practitioner can insert the nozzle or needle of the syringe (10, 210) into a vial containing the medical fluid and then aspirate the medical fluid into the fluid chamber or barrel of the syringe (10, 210) by moving the plunger rod of the syringe (10, 210) in the proximal direction. After the medical fluid has been aspirated into the fluid chamber or barrel of the syringe (10, 210), the syringe (10, 210) can be connected to the fluid port of the VAD, and then the plunger rod of the syringe (10, 210) can be moved in the distal direction, thereby discharging a first fluid and subsequently a second fluid from the syringe (10, 210) to the VAD, enabling sequential delivery of the first fluid F1 and subsequently the second fluid F2.

[0056] By eliminating the need to flush or disinfect a portion of the VAD between the delivery of the first fluid and the delivery of the second fluid, the syringes (10, 210) of the present disclosure provide a simplification of the fluid administration procedure and a significant time savings compared to conventional fluid administration practices. Further, the syringes (10, 210) of the present disclosure can reduce the risk of infection, enable flushing of the VAD immediately after administration of the medical fluid, thereby preventing occlusion of the drug within the VAD. Additionally, in the syringes (10, 210) of the present disclosure, the dead space is zero, which means that when the second fluid (e.g., flush solution) moves through the syringe (10, 210) to the VAD, all of the medical fluid contained in the first chamber of the syringe (10, 210) is flushed from the syringe (10, 210).

[0057] [Sequential Drug Administration Multi-Barrel Syringe] Figures 1A - 2D show an example of a multi - barrel syringe 10 for sequentially discharging a second fluid F2 following at least a first fluid F1. As described above, the first fluid F1 can be a medical fluid, and the medical fluid can be a drug or another therapeutic agent intended to be delivered to a patient via a VAD such as a catheter or an IV line. The second fluid F2 can be a flush solution such as physiological saline and / or an anticoagulant such as heparin. The type and amount of the flush solution contained in the syringe 10 can be varied, for example, according to the specific type of catheter or IV line used. In some examples, the syringe 10 is configured to contain or be configured to contain a second fluid F2 between about 1 mL and about 20 mL, or preferably between about 5 mL and about 10 mL.

[0058] The syringe 10 includes an outer barrel 12 configured to contain the first fluid F1 and an inner barrel 14 slidably inserted within the outer barrel 12 and configured to contain the second fluid F2. The outer barrel 12 can include a proximal end 16 near the opening, a distal end 18 including a fluid port 20, and a side wall 22 extending between the proximal end 16 and the distal end 18. The fluid port 20 of the outer barrel 12 can be a connector (such as a luer connector, a screw connector, or a snap connector) configured to be connected to a needle for accessing the interior of a medical vial containing a medical fluid, for example. Also, the fluid port 20 of the outer barrel 12 can be configured to be directly or indirectly connected to a fluid port, a valve, or other end - access portion of a VAD. For example, a common type of fluid port of a VAD is a penetrable septum or a press - lit septum made of rubber or other elastomeric material that allows the insertion of a sharp - tip cannula or a blunt - tip cannula for injecting fluid or withdrawing fluid from the catheter of the VAD. Another common fluid port of a VAD is a valve that does not require a needle to access the VAD. Instead, the valve can be activated by the frustoconical tip of the syringe barrel and provides fluid communication between the interior of the barrel and the VAD.

[0059] Further, the outer cylinder 12 includes one or more protrusions 24 that extend from the inner surface of the side wall 22 of the outer cylinder 12 into the interior of the outer cylinder 12. As will be described in more detail herein, the protrusions 24 can be, for example, spikes, needles, ridges, sharp portions, pointed ends, posts, or similar protruding members that extend into the interior of the outer cylinder 12 and penetrate through the inner cylinder. In some embodiments, the protrusions 24 extend proximally from the inner surface of the distal end 18 of the outer cylinder 12. In other examples, one or more of the protrusions 24 can extend radially inwardly from the inner surface of the side wall 22 of the outer cylinder 12.

[0060] In some examples, the outer cylinder 12 of the syringe 10 can have a shape, size, and configuration that is substantially similar to that of a syringe barrel used in the art to administer a flush solution to a VAD. For example, the outer cylinder 12 can be a cylindrical structure formed from a rigid thermoplastic material such as polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, acrylonitrile-butadiene-styrene, or other injection-moldable or moldable resin materials, as is known in the art. An exemplary barrel for a flush syringe is described, for example, in U.S. Patent Application Publication No. 2020 / 0061297, entitled "Flush Syringe Assembly with Controlled Pulsatile Flushing," which is hereby incorporated by reference in its entirety.

[0061] The inner cylinder 14 of the syringe 10 can have the same shape and configuration as the outer cylinder 12, but is slightly narrower than the outer cylinder 12. Specifically, the inner cylinder 14 has an outer diameter that is slightly smaller than the inner diameter of the outer cylinder 12, allowing the inner cylinder 14 to slide within the outer cylinder 12. The inner cylinder 14 includes an open proximal end 26, a closed distal end 28, and a side wall 30 extending between the proximal end 26 and the distal end 28. The inner cylinder 14 is configured to extrude the first fluid F1 within the outer cylinder 12 through the fluid port 20 by moving the inner cylinder 14 through the outer cylinder 12, and to penetrate the inner cylinder 14 by bringing the piercing-penetrable portion 32 of the inner cylinder 14 into contact with the protrusion 24 of the outer cylinder 12. If the inner cylinder 14 is pierced through, the second fluid F2 within the inner cylinder 14 flows from the inside of the inner cylinder 14 through the piercing-penetrable portion 32 to the outer cylinder 12.

[0062] To ensure that the inner cylinder 14 moves all or substantially all of the first fluid F1 within the outer cylinder 12 towards the fluid port 20, the inner cylinder 14 can include an annular flange 34 configured to contact and / or seal against the inner surface of the side wall 22 of the outer cylinder 12. For example, as shown in FIGS. 1A - 1C, the inner cylinder 14 includes a flange 34 extending radially outward from the distal end 28 of the inner cylinder 14. In other examples, an annular flange 34 extending radially from the side wall 30 of the inner cylinder 14 can be provided. In some embodiments, a plurality of annular flanges 34 extending from the distal end 28 and / or the side wall 30 of the inner cylinder 14 can be provided to enhance the stability of the inner cylinder 14 when moving within the outer cylinder 12 and / or to strengthen the seal between the inner cylinder 14 and the inner surface of the side wall 22 of the outer cylinder 12.

[0063] Continuing to refer to FIGS. 1A - 2D, the barrels 12, 14 can include grips, flanges, supports, and the like to facilitate holding and manipulation of the syringe 10 by the practitioner. For example, the inner barrel 14 can include a finger flange 36 that extends radially outwardly from the proximal end 26 of the opening of the inner barrel 14. Similarly, the outer barrel 12 includes a finger flange 38 that extends radially outwardly from the outer barrel 12. The practitioner can grip the finger flanges 36, 38, for example, between the ring finger and the middle finger, for aspiration of fluid into the syringe 10 and expulsion of fluid from the syringe 10.

[0064] The syringe 10 further includes a plunger 40 slidably inserted into the inner cylinder 14. The plunger 40 includes a stopper 42 slidably disposed within the inner cylinder 14 and a plunger rod 44 connected to the stopper 42 and extending proximally from the stopper 42. As described above, the stopper 42 and the plunger rod 44 are configured to move the inner cylinder 14 through the outer cylinder 12 and discharge the first fluid F1 through the fluid port 20 from the outer cylinder 12. Further, the plunger rod 44 and the stopper 42 are configured to move through the inner cylinder 14 and discharge the second fluid F2 from the inside of the inner cylinder 14 to the outer cylinder 12 through the piercing-penetrable portion 32 of the inner cylinder 14. More specifically, as will be described in more detail herein with reference to FIGS. 2A-2D, when the piercing-penetrable portion 32 of the inner cylinder 14 is intact, the inner cylinder 14 and the plunger 40 can be arranged to move the inner cylinder 14 through the outer cylinder 12 by applying pressure to the plunger rod 44. In particular, when the piercing-penetrable portion 32 of the inner cylinder 14 is intact, applying proximal pressure to the plunger rod 44 causes the inner cylinder 14 to move proximally through the outer cylinder 12 and suck the first fluid F1 into the outer cylinder 12 through the fluid port 20. Similarly, when the piercing-penetrable portion 32 of the inner cylinder 14 is intact, applying distal pressure to the plunger rod 44 causes the inner cylinder 14 to move distally through the outer cylinder 12 and discharge the first fluid F1 from the outer cylinder 12 through the fluid port 20. After the piercing-penetrable portion 32 of the inner cylinder 14 has been pierced through by the protrusion 24, applying distal pressure to the plunger rod 44 causes the plunger rod 44 and the stopper 42 to move through the inner cylinder 14.

[0065] As is known in the art, the stopper 42 can include many features of conventional syringe stoppers or plungers. For example, the stopper 42 can be formed from a thermoplastic elastomer material such as polypropylene or polyethylene, as well as synthetic rubber or natural rubber (e.g., isoprene). The stopper 42 can include a proximal face 46 or end, a distal face 48 or end, and an outer peripheral surface 50 extending between the proximal face 46 and the distal face 48. In some examples, the distal face 48 or end of the stopper 42 can be conical or frustoconical to assist in discharging the second fluid F2 from the inner cylinder 14 through the pierceable portion 32 of the inner cylinder 14. Alternatively, the distal face 48 or end of the stopper 42 can be substantially flat. The stopper 42 can further include one or more annular ribs 52 protruding from the outer peripheral surface 50. The annular ribs 52 are configured to seal against the inner surface of the side wall 30 of the inner cylinder 14, such that when the pierceable portion 32 of the inner cylinder 14 is intact, the inner cylinder 14 moves together with the plunger rod 44, and after the pierceable portion 32 of the inner cylinder 14 has been pierced, the second fluid F2 moves through the inner cylinder 14 in a predictable manner. In some embodiments, the stopper 42 can include multiple annular ribs 52 to improve stability and prevent tilting, displacement, and other forms of deformation as the stopper 42 moves within the inner cylinder 14.

[0066] The plunger rod 44 is connected to the stopper 42 and extends in the proximal direction from the stopper 42. The plunger rod 44 can be, for example, an injection molded product formed from a rigid thermoplastic material such as polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or other thermoplastic materials, as is known in the art. The plunger rod 44 includes a distal end 54 that engages the stopper 42. For example, the distal end 54 of the plunger rod 44 can include a connector 56 that is inserted into a corresponding cavity 58 or slot on the proximal face 46 of the stopper 42. Further, the plunger rod 44 includes a proximal end 60 that projects in the proximal direction from the proximal end 26 of the inner cylinder 14. The proximal end 60 of the plunger rod 44 can include a thumb press plate 62 for operating the plunger rod 44 to move the stopper 42 and / or the inner cylinder 14. The plunger rod 44 can have various cross-sectional shapes and configurations within the scope of the present disclosure. For example, the plunger rod 44 can have a generally cross-shaped cross-section. In other examples, the cross-section of the plunger rod 44 can be an I-beam shape, a hollow circle, a hollow square, a hollow rectangle, or an L-shape.

[0067] As most clearly shown in FIGS. 1A and 1C, the syringe 10 can also include a removable cap 64 that engages the outer barrel 12 or the inner barrel 14 to prevent the inner barrel 14 from being fully inserted into the outer barrel 12 until the cap 64 is removed. Specifically, the cap 64 can be configured to maintain the separation between the piercing - through - capable portion 32 of the inner barrel 14 and the protrusion 24 of the outer barrel 12 until the cap 64 is removed. Thus, when the removable cap 64 engages the inner barrel 14 and / or the outer barrel 12, it prevents the piercing - through - capable portion 32 of the inner barrel 14 from contacting and being pierced through the protrusion 24 of the outer barrel 12. As shown in FIG. 1C, the removable cap 64 can have a C - shaped structure that includes a central opening 66 sized to fit around the outer barrel 12 or the inner barrel 14. Also, the cap 64 includes a vertical wall 68 or tab that extends vertically to contact a portion of the inner barrel 14 or the outer barrel 12 to maintain the spacing between the inner barrel 14 and the outer barrel 12. Further, the cap 64 can include a slot 70 or opening sized to fit over one of the finger flanges 36, 38 of the inner barrel 14 or the outer barrel 12. For example, as shown in FIG. 1A, the removable cap 64 is inserted over the finger flange 38 of the outer barrel 12, and the vertical wall 68 or tab contacts the finger flange 36 of the inner barrel 14 and is arranged to prevent the inner barrel 14 from being fully inserted into the outer barrel 12.

[0068] Figures 3A-3C show enlarged views of the distal portion of the syringe 10 focusing on the protrusion 24 of the outer barrel 12 and the piercing-allowable portion 32 of the inner barrel 14. As described above, the inner barrel 14 includes a closed distal end 28. As shown in FIGS. 3B and 3C, the closed distal end 28 may be substantially flat or may include a slight taper that slopes towards the center of the inner barrel 14. Also, as shown in FIGS. 3B and 3C, the inner barrel 14 includes a flange 34 that extends radially outward from the closed distal end 28 of the inner barrel 14 and contacts the inner surface of the side wall 22 of the outer barrel 12. Also, as described above, the inner barrel 14 includes a piercing-allowable portion 32 that can be disposed on the closed distal end 28 of the inner barrel 14 as shown in FIGS. 3B and 3C. In some embodiments, the piercing-allowable portion 32 is a groove on the closed distal end 28 of the inner barrel 14 and is thinner than other portions of the closed distal end 28. This groove can be an annular or circular groove arranged to be contacted by a plurality of protrusions 24 that extend inward from the distal end 18 of the outer barrel 12.

[0069] As shown in FIGS. 3A-3C, the protrusions 24 of the outer barrel 12 extend in the proximal direction from the distal end 18 of the outer barrel 12. For example, as shown in FIG. 3A, the outer barrel 12 includes a plurality of pointed ends or spikes that extend in the proximal direction from the inner surface of the distal end 18 of the outer barrel 12. The plurality of protrusions 24 are disposed around or surround the fluid port 20 of the outer barrel 12. The protrusions 24 such as pointed ends or spikes can be integrated with other parts of the outer barrel 12. For example, the outer barrel 12 including the protrusions can be an integrally formed product formed by, for example, a single injection molding process. In some embodiments, the protrusion 24 includes a channel 72 such as a groove, notch, opening, slot, cut, cavity, or lumen that at least partially extends through the protrusion 24. The channel 72 is configured to allow fluid from the inner barrel 14 to flow to the outer barrel 12 when the piercing penetrable portion 32 of the inner barrel 14 is pierced. Specifically, as described above and shown in FIGS. 3A-3C, in the initial state, the distal end 28 of the inner barrel 14 is spaced from the distal end 18 of the outer barrel 12. As shown in FIG. 3B, the inner barrel 14 moves distally through the outer barrel 12 such that the protrusion 24 of the outer barrel 12 contacts and pierces the piercing penetrable portion 32 (e.g., an annular groove) of the distal end 28 of the inner barrel 14. As shown in FIG. 3C, after the inner barrel 14 is pierced, the fluid can flow through the channel 72 of the protrusion 24 and pass from the inner barrel 14 to the outer barrel 12. Once inside the outer barrel 12, the fluid can be ejected from the syringe 10 through the fluid port 20 of the outer barrel 12.

[0070] [Method of ejecting fluid from a multi-chamber syringe] As described above, the syringe 10 is used for sequential ejection of fluids such that a flush solution is ejected from the syringe 10 to the VAD following ejection of the medical fluid. FIG. 5 shows a flowchart illustrating the steps of a sequential fluid ejection process using the syringe 10 of the present disclosure.

[0071] As shown in FIG. 5, in step 110, the operator first obtains a partially filled syringe 10, where the inner cylinder 14 of the syringe 10 is filled with a predetermined amount of a second fluid F2, such as a flush solution. For example, the partially filled syringe 10 can contain from about 1 mL to about 20 mL, preferably from about 5 mL to about 10 mL of the flush solution. The syringe 10 in this initial or partially filled state is shown in FIG. 2A. In step 112, the operator prepares the syringe 10 for use, for example, by removing the packaging such as the tip cap 74 (shown in FIG. 1B) from the syringe 10. Also, the operator can move the plunger rod 44 in the distal direction indicated by arrow D in FIG. 2A to move the inner cylinder 14 as far as possible within the outer cylinder 12 without contacting the projection 24 extending from the outer cylinder 12. In particular, as described above, the detachable cap 64 attached to the finger flange 38 of the outer cylinder 12 in FIG. 2A prevents the inner cylinder 14 from contacting the projection 24. In step 114, the operator positions the outer cylinder 12 in fluid communication with the interior of a container that is to hold the medical fluid to be delivered to the patient. For example, the operator can attach a needle (not shown) to the fluid port 20 at the distal end 18 of the outer cylinder 12 and insert the needle into a container such as a medical vial that holds the medical fluid to be injected into the patient.

[0072] In step 116, the operator aspirates a medical fluid (e.g., the first fluid F1) into the outer cylinder 12. For example, the operator holds the outer cylinder 12 and the plunger rod 44 (e.g., two fingers contact the finger flange 38 of the outer cylinder 12 and the thumb contacts the press plate 62 of the plunger rod 44) and moves the plunger rod 44 in the proximal direction indicated by arrow P in FIG. 2A, thereby moving the inner cylinder 14 in the proximal direction, and thereby aspirating or drawing fluid from the interior of the container into the interior of the outer cylinder 12 as indicated by arrow A1 in FIG. 2A. In FIG. 2B, the syringe 10 is shown in a fully filled position where the first fluid F1 is inside the outer cylinder 12 and the second fluid F2 is inside the inner cylinder 14.

[0073] If the dose of the medical fluid (first fluid F1) to be delivered to the patient has been drawn into the outer cylinder 12, in step 118, the operator removes the needle from the fluid port 20 of the outer cylinder 12 and connects the fluid port 20 to the VAD. For example, the operator can insert the nozzle of the outer cylinder 12 into the corresponding port or valve of the VAD, thereby establishing fluid communication between the outer cylinder 12 and the lumen of the VAD. In step 120, if the syringe 10 is properly connected to the VAD, the operator grips the plunger rod 44 (for example, by placing the thumb on the press plate 62 and the fingers on the finger flange 38 of the outer cylinder 12), and presses the plunger rod 44 in the distal direction (indicated by arrow D in FIG. 2B), thereby moving the inner cylinder 14 distally through the outer cylinder 12. The distal movement of the inner cylinder 14 discharges the first fluid F1 (for example, medical fluid) within the outer cylinder 12 into the VAD through the fluid port 20 of the outer cylinder 12, as indicated by arrow A2 in FIG. 2B. The operator continues to move the plunger rod 44 in the distal direction until the inner cylinder 14 is pressed against the detachable cap 64 engaged with the finger flange 38 of the outer cylinder 12, indicating that most or all of the first fluid F1 has been discharged from the outer cylinder 12. In FIG. 2C, the syringe 10 is shown in this position where the inner cylinder 14 contacts the cap 64.

[0074] In step 122, the person skilled in the art removes the cap 64 from the finger flange 38 of the outer cylinder 12, for example, by sliding the cap 64 away from the finger flange 38 as indicated by arrow A3 in FIG. 2C. Once the cap 64 is removed, the inner cylinder 14 is free to move within the outer cylinder 12. In step 124, with the inner cylinder 14 free to move to the most distal position within the outer cylinder 12, the operator applies a distal pressure to the plunger rod 44 (indicated by arrow D in FIG. 2C), thereby bringing the piercing - penetrable portion 32 of the inner cylinder 14 into contact with and piercing through the protrusion 24 of the outer cylinder 12.

[0075] In procedure 126, once the inner cylinder 14 has been penetrated, the operator continues to push the plunger rod 44 in the distal direction (shown by arrow D), whereby the stopper 42 moves through the inner cylinder 14. The movement of the stopper 42 through the inner cylinder 14 causes a second fluid F2, such as a flush solution within the inner cylinder 14, to pass through the channel 72 within the projection 24 and into the outer cylinder 12. Next, the second fluid F2 passes through the outer cylinder 12 and is discharged from the outer cylinder 12 through the fluid port 20 into the VAD, as shown by arrow A4 in FIG. 2C. In FIG. 2D, the syringe 10 is shown in an end-of-use or final position, with the penetrated inner cylinder 14 fully seated against the inner surface of the distal end 18 of the outer cylinder 12, and both the first fluid F1 and the second fluid F2 having been discharged from the syringe 10.

[0076] [Multi-barrel syringe including a stopper mounted on the inner cylinder] FIGS. 4A and 4B show an additional example of a multi-barrel syringe 210 for sequentially delivering a first fluid F1, such as a medical fluid, followed by a second fluid F2, such as a flush solution. The syringe 210 includes many of the components and features of the syringe 10 shown in FIGS. 1A-3C. Specifically, the syringe 210 includes an outer cylinder 212, an inner cylinder 214 inserted within the outer cylinder 212, and a plunger (not shown in FIGS. 4A and 4B) at least partially inserted within the inner cylinder 214. The syringe 210 operates in the same manner as the syringe 10 shown in FIGS. 1A-3C. Specifically, the operator can move the inner cylinder 214 through the outer cylinder 212 by gripping and pulling or pushing the plunger while the penetrable portion 232 of the inner cylinder 214 remains intact. Once the penetrable portion 232 of the inner cylinder 214 has been penetrated by the projection of the outer cylinder 212, applying pressure in the distal direction to the plunger causes the plunger to move through the inner cylinder 214, discharging the second fluid F2 from the inner cylinder 214 through the penetrable portion 232 and into the outer cylinder 212.

[0077] The syringes 210 of FIGS. 4A and 4B differ from the foregoing embodiments in that the flange at the distal end of the inner cylinder shown in FIGS. 1A-3C is replaced by a seal or stopper 250 disposed over the closed distal end 228 of the inner cylinder 214. The seal or stopper 250 can include many of the features of conventional syringe stoppers or plungers known in the art. For example, the seal or stopper 250 can be formed from a thermoplastic elastomer material such as polypropylene or polyethylene, as well as synthetic or natural rubber (e.g., isoprene). The seal or stopper 250 can include a proximal surface 252 or proximal end that contacts the outer surface of the sidewall 230 of the inner cylinder 214, as well as the closed distal end 228. The stopper 250 also includes a distal surface 254 or end opposite the proximal surface 252. In some examples, the distal surface 254 or distal end of the stopper 250 can be conical or frustoconical to assist in discharging the first fluid F1 from the outer cylinder 212. Alternatively, the distal surface 254 or distal end of the stopper 250 can be substantially flat. The stopper 250 can further include an annular sealing surface 256 configured to seal against the inner surface of the sidewall 220 of the outer cylinder 212 to ensure that the first fluid F1 moves through the outer cylinder 212 in the expected manner.

[0078] In some embodiments, as shown in FIG. 4A, the stopper 250 is a full stopper that covers the distal end 228 of the inner cylinder 214. The sealing surface 256 of the stopper 250 extends around the periphery of the closed distal end 228 of the inner cylinder 214 and contacts the outer surface of the sidewall 230. As shown in FIG. 4A, the stopper 250 covers the piercing - capable portion 232 of the inner cylinder 214. Thus, the protrusion (not shown in FIGS. 4A and 4B) of the outer cylinder 212 must be modified from the protrusions shown in FIGS. 1A - 3C. Specifically, when used with the full stopper 250, the protrusion must be sharp enough to pierce through the elastomeric material of the stopper 250. Also, the protrusion must be long enough to pierce through the stopper 250 and the piercing - capable portion 232 of the inner cylinder 214 and project into the interior of the inner cylinder 214.

[0079] In some embodiments, as shown in FIG. 4B, the stopper can be an annular or partial stopper 250. The annular or partial stopper 250 partially covers the distal end 228 of the inner cylinder 214, extends around the periphery of the distal end 228, and contacts a portion of the outer surface of the side wall 230 of the inner cylinder 214. Specifically, for the partial or annular stopper 250, the piercing - possible portion 232 of the inner cylinder 214 is not covered by the stopper 250. Thus, unlike the full stopper 250 shown in FIG. 4A, the protrusion of the outer cylinder 212 does not need to pierce through the elastomeric material of the stopper 250. However, in the partial or annular stopper 250 of FIG. 4B, the protrusion of the outer cylinder 212 needs to be long enough to pierce through and protrude from the piercing - possible portion 232 of the inner cylinder 214, taking into account the thickness of the stopper 250.

[0080] Embodiments of the multi - barrel syringe and method of the present disclosure are shown in the accompanying drawings and described in detail herein. However, other embodiments will be apparent to those skilled in the art and will be readily made by those skilled in the art without departing from the scope and spirit of the invention. Accordingly, the foregoing description is intended to be illustrative rather than restrictive. The invention described herein is defined by the appended claims, and all modifications of the invention that come within the meaning and range of equivalency of the claims are embraced within their scope.

Claims

1. A multi-barrel syringe for sequentially discharging a second fluid following at least a first fluid, the syringe comprising: An outer barrel configured to contain a first fluid, the outer barrel including a proximal end at an opening, a distal end including a fluid port, a side wall extending between the proximal end and the distal end, and at least one protrusion extending from an inner surface of the outer barrel into the interior of the outer barrel; An inner barrel configured to contain a second fluid, the inner barrel being slidably inserted into the outer barrel and including a proximal end at an opening, a closed distal end, and a side wall extending between the proximal end and the distal end, wherein moving the inner barrel through the outer barrel causes a penetrable portion of the inner barrel to contact at least one protrusion of the outer barrel and penetrate the inner barrel, thereby enabling the second fluid to flow from the inner barrel into the outer barrel; A plunger at least partially inserted into the inner barrel, configured to move the inner barrel through the outer barrel and discharge the second fluid from the inner barrel through the penetrable portion of the inner barrel; A multi-barrel syringe including the above components.

2. The syringe according to claim 1, wherein when the penetrable portion of the inner barrel is intact, applying pressure to the plunger causes the inner barrel to move through the outer barrel.

3. The syringe according to claim 1, wherein when the penetrable portion of the inner barrel is intact, applying proximal pressure to the plunger causes the inner barrel to move proximally through the outer barrel and suck the first fluid into the outer barrel through the fluid port.

4. The syringe according to claim 1, wherein when the penetrable portion of the inner barrel is intact, applying distal pressure to the plunger causes the inner barrel to move distally through the outer barrel and discharge the first fluid from the outer barrel through the fluid port.

5. The syringe according to claim 1, wherein after the penetrable portion of the inner barrel is penetrated by at least one protrusion, applying distal pressure to the plunger causes the plunger to move through the inner barrel.

6. The syringe according to claim 1, wherein the distal end of the inner barrel includes an annular flange configured to contact an inner surface of the outer barrel.

7. The syringe according to claim 1, wherein the inner barrel includes a stopper attached to the distal end of the inner barrel, the stopper having a size to seal in contact with an inner surface of a side wall of the outer barrel.

8. The syringe according to claim 7, wherein the stopper includes a full stopper covering a distal end of the inner barrel and a part of a side wall of the inner barrel.

9. The syringe according to claim 7, wherein the stopper includes an annular partial stopper covering a distal end of the inner barrel partially.

10. The syringe according to claim 1, wherein the piercing-through portion of the inner cylinder includes a groove at the closed distal end of the inner cylinder.

11. The syringe according to claim 1, wherein the plunger includes a stopper slidably disposed within the inner cylinder and a plunger rod connected to the stopper and extending in the proximal direction from the stopper.

12. The syringe according to claim 1, wherein the at least one protrusion includes at least one of a spike, a needle, a raised portion, a sharp portion, a pointed end, or a post.

13. The syringe according to claim 1, wherein the at least one protrusion is integral with another portion of the outer cylinder.

14. The syringe according to claim 13, wherein the outer cylinder includes a plurality of protrusions extending inwardly from the distal end of the outer cylinder.

15. The syringe according to claim 1, wherein the at least one protrusion includes at least one channel for fluid flow from the inner cylinder to the outer cylinder when the piercing-through portion of the inner cylinder is pierced.

16. The syringe according to claim 15, wherein the at least one channel includes at least one of a groove, a notch, an opening, a slot, a cut, a cavity, or a lumen that at least partially extends through the at least one protrusion.

17. The syringe according to claim 1, further comprising a detachable cap that engages with the outer cylinder and / or the inner cylinder to prevent the inner cylinder from being fully inserted into the outer cylinder while the cap is engaged.

18. The syringe according to claim 17, wherein the detachable cap, when engaged with the inner cylinder and / or the outer cylinder, prevents the piercing-through portion of the inner cylinder from contacting and being pierced by at least one protrusion of the outer cylinder.

19. The syringe according to claim 1, wherein the inner cylinder is at least partially inserted into the outer cylinder and the plunger is at least partially inserted into the inner cylinder, and a second fluid of a predetermined volume within the inner cylinder sealed by the plunger, comprising a pre-filled flushing syringe.

20. A method of sequentially discharging fluid from the syringe according to claim 1, the method comprising: applying a pressure directed in the distal direction to the plunger, thereby moving the inner cylinder through the outer cylinder and discharging the first fluid through the fluid port from the outer cylinder; When the piercing-through portion of the inner cylinder is pierced through by at least one protruding portion of the outer cylinder, continue to apply a pressure directed in the distal direction to the plunger to move the plunger through the inner cylinder, thereby discharging a second fluid from the inner cylinder to the outer cylinder and further discharging the second fluid through the fluid port; A method comprising.

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