Multi-chamber syringe with multiple plungers for sequential delivery of fluids and methods of use

Abstract

A multi-chamber syringe for sequentially discharging a first fluid and a subsequent second fluid includes a container having a proximal end and a distal end, the distal end including a fluid port for discharging the fluid out of the container. The container defines a first chamber for containing the first fluid and a second chamber for containing the second fluid. The syringe further comprises: a first plunger for discharging the first fluid from the first chamber; a second plunger for discharging the second fluid from the second chamber; and a valve positioned in the container. The valve is configured to transition between a first position in which fluid is prevented from flowing through the valve from the first chamber and a second position in which fluid is permitted to flow through the at least one valve from the first chamber to the fluid port to discharge the first fluid from the container.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to Indian patent application No. 202211036490 filed on June 24, 2022, titled “Multi-Chamber Syringe with Multiple Plungers for Sequential Delivery of Fluids and Methods of Use”, the entire disclosure of which is incorporated herein by reference in its entirety.

[0003] Background of the Invention

[0004] Field of the Invention

[0005] The present disclosure relates generally to syringes for expelling multiple fluids, and more particularly to syringes for sequentially expelling flushing solutions and medical fluids.

[0006] Description of related technologies

[0007] Vascular Access Device (VAD) is a commonly used medical device that may include an intravenous (IV) catheter, such as a peripheral catheter or a central venous catheter. If improperly maintained or exposed to a non-sterile environment, the VAD may be contaminated, blocked by blood clots, and / or may spread infection. Many medical institutions implement aseptic techniques and procedures to ensure that the VAD is used correctly and will not be blocked or infected. These procedures typically include disinfecting the VAD and flushing the catheter with a flushing solution. Specifically, VAD operating standards typically recommend flushing procedures after catheter placement, before fluid infusion, and before and after drug administration, before and after blood sampling, before and after blood transfusion, and / or before and after parenteral nutrition administration.

[0008] These flushing procedures are designed to confirm catheter patency, avoid medication incompatibilities, ensure that a complete medication dose is administered to the patient, prevent thrombosis, and minimize the risk of bloodstream infection caused by contamination of the VAD. In addition, flushing can prevent the accumulation of blood, blood residue, and IV medications within the catheter or other VAD device. Such accumulation may cause the fluid pathway in the catheter system to become partially or completely blocked, which may require the practitioner to perform certain expensive and potentially dangerous procedures to clear the affected catheter, or may require the practitioner to replace the blocked catheter with a new catheter. Often, such blockages result in interruptions in treatment, which may impact patient care. The accumulation of residue within the catheter may also increase the risk of infection.

[0009] During the administration of a drug or another medical fluid, the catheter or VAD is typically flushed before and after the fluid is delivered to the VAD from a syringe or another drug delivery device. In some cases, a syringe assembly prefilled with various fluids (referred to herein as flushing solutions) can be used to flush the catheter. The size of the prefilled syringe for flushing the catheter varies based on, for example, the size and length of the catheter. Typically, the prefilled syringe for flushing the catheter or IV line contains about 1 mL, 3 mL, 5 mL, or 10 mL of flushing solution. Many different syringes available from different manufacturers can be used to provide flushing solutions through the patient's catheter or IV line, including, for example, the BD PosiFlush from Becton, Dickinson and Company. TM Pre-filled saline syringe.

[0010] In order to perform the flushing procedure, the practitioner connects the pre-filled flushing syringe to the VAD and advances the plunger rod into the barrel of the pre-filled syringe, which discharges the flushing solution to the VAD through the nozzle or fluid port of the pre-filled syringe. After flushing, the pre-filled syringe is disconnected from the VAD so that the practitioner can apply a dose of medical fluid. The medical fluid is usually contained in a vial and drawn into a separate syringe, which is connected to the VAD after being filled with the medical fluid. Then, the medical fluid is injected into the VAD by advancing the plunger rod through the syringe containing the medical fluid. After the medical fluid is injected into the VAD, the syringe is disconnected from the VAD and the VAD is flushed using a second pre-filled flushing syringe. Flushing the VAD after applying the medical fluid confirms the patency of the catheter, and any remaining medical fluid in the catheter is delivered to the patient, thereby ensuring that the full dose of the medical fluid is delivered to the patient.

[0011] Connecting or disconnecting a syringe or other device to a VAD introduces portions of the VAD to a non-sterile external environment, which increases the likelihood that the VAD will be contaminated and / or become a source of bloodstream infection. In order to reduce the risk of bloodstream infection and ensure proper use and maintenance of the VAD, operating standards require that any fluid ports or connectors of the VAD be disinfected and cleaned each time a new syringe is connected to the VAD. Thus, by reducing the number of times portions of the VAD must be disinfected and cleaned, reducing the number of syringes that must be connected to the VAD during drug delivery simplifies drug administration. Reducing the number of syringes or other fluid delivery devices used during a procedure also reduces the chances that portions of the VAD will become contaminated, thereby reducing the risk of bloodstream infection. The syringes and methods of the present disclosure simplify the process by reducing the number of syringes used during a drug administration procedure, thereby reducing the risk of contamination and bloodstream infection. Summary of the invention

[0012] According to one aspect of the present disclosure, a multi-chamber syringe for sequentially discharging at least a first fluid and a subsequent second fluid includes a container having a proximal end and a distal end, the distal end including a fluid port for discharging the first fluid and the second fluid from the container. The container defines a first chamber for accommodating the first fluid and a second chamber for accommodating the second fluid. The syringe also includes: a first plunger, the first plunger is used to discharge the first fluid from the first chamber; a second plunger, the second plunger is used to discharge the second fluid from the second chamber; and at least one valve, the at least one valve is positioned in the container. The at least one valve is configured to switch between a first position and a second position, in which the fluid is prevented from flowing from the first chamber through the valve, and in which the fluid is allowed to flow from the first chamber through the at least one valve to the fluid port to discharge the first fluid from the container.

[0013] According to another aspect of the present disclosure, a prefilled flushing syringe includes any of the foregoing syringes and a predetermined volume of a first fluid disposed in a first chamber of the prefilled syringe. The valve is initially in a first position, thereby preventing the first fluid disposed in the first chamber from flowing through at least one valve from the first chamber.

[0014] According to another aspect of the present disclosure, a method for sequentially expelling fluid from any of the aforementioned syringes includes: moving a valve to a second position to allow fluid to flow from a first chamber through the valve to a fluid port; moving a first plunger through the first chamber to expel a first fluid from the first chamber through the fluid port; moving at least one valve to a first position to allow fluid to flow from a second chamber through the at least one valve to the fluid port; and moving a second plunger through the second chamber to expel a second fluid from the second chamber through the fluid port.

[0015] According to another aspect of the present disclosure, a syringe includes a housing having an upper barrel and a lower barrel. The upper barrel includes an open proximal end, a distal end, a sidewall extending between the proximal end and the distal end, and a partition extending axially through the barrel to divide the barrel into a first chamber configured to accommodate a first fluid and a second chamber configured to accommodate a second fluid. The lower barrel is connected to the distal end of the upper barrel, and the lower barrel includes a fluid port. The syringe also includes: a first plunger, the first plunger is used to discharge the first fluid from the first chamber; a second plunger, the second plunger is used to discharge the second fluid from the second chamber; and a manually operable valve, the valve is positioned in the lower barrel. The manually operable valve is configured to move between a first position and a second position, in which the first position allows fluid to flow from the second chamber through the valve to the fluid port to discharge the second fluid from the syringe, and in which the second position allows fluid to flow from the first chamber through the valve to the fluid port to discharge the first fluid from the syringe.

[0016] According to another aspect of the present disclosure, a syringe includes a barrel having an open proximal end, a distal end including a frustoconical portion and a fluid port, a cylindrical sidewall between the proximal end and the distal end, and a partition extending axially through the barrel to divide the barrel into a first chamber configured to accommodate a first fluid and a second chamber configured to accommodate a second fluid. The syringe also includes a first plunger for discharging the first fluid from the first chamber, a second plunger for discharging the second fluid from the second chamber, and a compressible bellows disposed in the first chamber. The compressible bellows is configured to move between an unbiased position and a biased position, in which the fluid is prevented from flowing from the first chamber and in which the fluid is allowed to flow from the first chamber to the fluid port.

[0017] Non-limiting illustrative examples of embodiments of the present disclosure will now be described in the following numbered items.

[0018] Article 1: A multi-chamber syringe for sequentially discharging at least a first fluid and subsequently a second fluid, the syringe comprising: a container, the container comprising a proximal end and a distal end, the distal end comprising a fluid port for discharging the first fluid and the second fluid from the container, wherein the container defines a first chamber for containing the first fluid and a second chamber for containing the second fluid; a first plunger, the first plunger for discharging the first fluid from the first chamber; a second plunger, the second plunger for discharging the second fluid from the second chamber; and at least one valve, the at least one valve positioned in the container, the valve being configured to switch between a first position and a second position, in which the first position prevents fluid from flowing from the first chamber through the at least one valve, and in which the second position allows fluid to flow from the first chamber through the at least one valve to the fluid port to discharge the first fluid from the container.

[0019] Clause 2: The syringe of clause 1, wherein the first chamber and the second chamber extend axially through the container, wherein the longitudinal axis of the first chamber is substantially parallel to the longitudinal axis of the second chamber.

[0020] Clause 3: A syringe according to Clause 1 or Clause 2, wherein, when the at least one valve is in the first position, fluid is allowed to flow from the second chamber through the at least one valve to the fluid port to discharge the second fluid from the container, and when the at least one valve is in the second position, fluid is prevented from flowing from the second chamber through the at least one valve.

[0021] Clause 4: The syringe of any one of Clauses 1 to 3, wherein, with the at least one valve in the first position, proximal movement of the second plunger through the second chamber draws the second fluid into the second chamber.

[0022] Article 5: The syringe according to any one of Articles 1 to 4, wherein the container comprises an upper barrel and a lower barrel, the upper barrel comprising the first chamber and the second chamber, and the lower barrel is connected to the distal end of the upper barrel to enclose the at least one valve.

[0023] Article 6: A syringe according to Article 5, wherein the upper barrel includes: an open proximal end, a distal end, an annular side wall extending between the open proximal end and the open distal end, and an axially extending partition extending from the open proximal end of the upper barrel to the distal end to separate the first chamber from the second chamber.

[0024] Article 7: According to the syringe described in Article 5 or Article 6, the syringe also includes at least one seal covering the open distal end of the upper barrel, the at least one seal including a first opening and a second opening, the first opening is used to allow the first fluid to flow from the first chamber to the at least one valve when the at least one valve is in the second position, and the second opening is used to allow the second fluid to flow from the second chamber through the at least one valve when the at least one valve is in the first position.

[0025] Clause 8: The syringe of Clause 7, wherein the at least one seal comprises a proximal seal positioned between the distal end of the upper barrel and the at least one valve and a distal seal positioned between the at least one valve and the distal end of the lower barrel.

[0026] Article 9: A syringe according to Article 7 or Article 8, wherein the first plunger and / or the second plunger includes a stopper having a flat distal surface and a protrusion extending from the flat distal surface, the protrusion being positioned to be inserted into the first opening or the second opening to completely discharge the first fluid from the first chamber or to completely discharge the second fluid from the second chamber.

[0027] Clause 10: The syringe of any one of clauses 5 to 9, wherein the upper barrel is connected to the lower barrel by ultrasonic welding.

[0028] Item 11: The syringe of any one of Items 1 to 10, wherein the upper barrel and the lower barrel comprise at least one of polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene.

[0029] Clause 12: The syringe of any one of Clauses 1 to 11, wherein the first plunger comprises a first stopper located in the first chamber and a first plunger rod connected to and extending from the first stopper through the proximal end of the container.

[0030] Clause 13: The syringe of Clause 12, wherein the first plunger rod comprises a tab configured to contact a portion of the container as the first rod moves through the first chamber, thereby providing feedback that an initial volume of the first fluid has been expelled from the first chamber.

[0031] Clause 14: The syringe of clause 12 or clause 13, wherein the second plunger comprises a second stopper located in the second chamber and a second plunger rod connected to and extending from the second stopper through the proximal end of the container.

[0032] Clause 15: The syringe of Clause 14, wherein the first chamber and the second chamber have a semicircular cross-sectional shape, and wherein the first stopper and the second stopper have a semicircular flat distal surface corresponding to the cross-sectional shape of the first chamber or the second chamber.

[0033] Article 16: The syringe according to Article 14 or Article 15, further comprising at least one removable cap engaged between the container and the first plunger rod and / or the second plunger rod to prevent movement of the plunger rods until the at least one removable plunger cap is removed from the syringe.

[0034] Clause 17: The syringe of any one of Clauses 14 to 16, wherein the first stopper and / or the second stopper comprises a thermoplastic elastomer, such as isoprene.

[0035] Article 18: A syringe according to any one of Articles 14 to 17, wherein the first stopper and / or the second stopper comprises a proximal end, a distal end, and an outer surface extending between the proximal end and the distal end, the outer surface being sealed against the inner surface of the container.

[0036] Article 19: A syringe according to any one of Articles 14 to 18, wherein the first plunger rod and / or the second plunger rod includes a connector portion, which is inserted into and engaged with the cavity of the first stopper and / or the second stopper for fixing the first stopper and / or the second stopper to the first plunger rod and / or the second plunger rod.

[0037] Article 20: A syringe according to any one of Articles 14 to 19, wherein the at least one valve includes a body, the body including a channel, when the at least one valve is in the first position, the channel is fluidly connected to the second chamber, and when the at least one valve is in the second position, the channel is fluidly connected to the first chamber.

[0038] Clause 21. The syringe of clause 20, wherein the body comprises a rotating disk and a knob extending through the opening of the container for rotating the disk between the first position and the second position.

[0039] Clause 22: The syringe of clause 21, wherein the disk is rotated 80 to 120 degrees between the first position and the second position.

[0040] Clause 23: A syringe according to any one of Clauses 1 to 4, wherein the container comprises a barrel comprising an annular sidewall, a frustoconical portion extending from the annular sidewall to the fluid port, and a partition extending through the barrel to separate the first chamber from the second chamber.

[0041] Clause 24: The syringe of Clause 23, wherein the first plunger comprises a first stopper comprising a substantially planar distal surface and a first plunger rod connected to and extending proximally from the first stopper.

[0042] Clause 25: The syringe of Clause 24, wherein the second plunger comprises a second stopper comprising a semi-conical distal surface sized to be received within the frustoconical portion of the barrel and a second plunger rod connected to and extending proximally from the second stopper.

[0043] Clause 26: The syringe of Clause 25, wherein the first plunger rod comprises a first protrusion positioned proximate to the distal end of the first plunger rod, the first protrusion being configured to contact the barrel to prevent the first plunger rod from moving distally through the first chamber to expel the first fluid from the first chamber.

[0044] Clause 27: The syringe of Clause 26, wherein the second plunger rod comprises a second protrusion positioned proximate to the proximal end of the second plunger rod, the second protrusion being configured to contact and depress the first protrusion such that the first plunger rod can move through the first chamber.

[0045] Article 28: A syringe according to any one of Articles 23 to 27, wherein the at least one valve includes a compressible body that prevents fluid from flowing from the first chamber to the fluid port in an expanded position and allows fluid to flow from the first chamber to the fluid port in a compressed position.

[0046] Article 29: A syringe according to Article 28, wherein the barrel includes at least one slot defining a flow channel for fluid to flow from the first chamber to the fluid port, and wherein the at least one slot is positioned so that when the compressible body is in the expanded position, fluid is prevented from flowing through the at least one slot, and when the compressible body is in the compressed position, fluid is allowed to flow through the at least one slot to the fluid port.

[0047] Clause 30: The syringe of Clause 29, wherein the at least one slot is an opening extending through the partition of the barrel, and wherein, when the second stop is in the distal-most position in the second chamber, the second stop seals a portion of the at least one slot to prevent the first fluid from flowing into the second chamber.

[0048] Article 31: A syringe according to any one of Articles 28 to 30, wherein the compressible body includes a semi-conical distal surface and at least one radially extending rib, the semi-conical distal surface is configured to be positioned in the frustoconical portion of the barrel, and the at least one radially extending rib is configured to contact the inner surface of the cylindrical side wall of the barrel to seal the first fluid within the first chamber.

[0049] Article 32: A prefilled flushing syringe comprising: a syringe as described in any one of Articles 1 to 31; and a predetermined volume of a first fluid, the predetermined volume of the first fluid being disposed in a first chamber of the prefilled syringe, wherein the at least one valve is initially in the first position, thereby preventing the first fluid disposed in the first chamber from flowing through the at least one valve from the first chamber.

[0050] Clause 33: The prefilled syringe of clause 32, wherein the first fluid is a saline flush solution.

[0051] Clause 34: A prefilled syringe according to Clause 32 or 33, further comprising a removable plunger cap engaged between the first plunger and / or the second plunger and the container to prevent movement of the plungers until the cap is removed.

[0052] Article 35: A method for sequentially expelling fluid from a syringe as described in any one of Articles 1 to 31, the method comprising: moving the at least one valve to the second position to allow fluid to flow from the first chamber through the at least one valve to the fluid port; moving the first plunger through the first chamber to expel the first fluid from the first chamber through the fluid port; moving the at least one valve to the first position to allow fluid to flow from the second chamber through the at least one valve to the fluid port; and moving the second plunger through the second chamber to expel the second fluid from the second chamber through the fluid port.

[0053] Clause 36: The method of clause 35, further comprising: initially with the at least one valve in the first position, drawing the second fluid into the second chamber by moving the second plunger distally through the second chamber.

[0054] Clause 37: The method of Clause 36, wherein drawing the second fluid further comprises: attaching a needle to the fluid port of the container, inserting the needle into the fluid container, and drawing the second fluid from the fluid container into the second chamber of the syringe.

[0055] Clause 38: The method of any one of Clauses 35 to 37, wherein the syringe is provided partially pre-filled, the syringe containing a predetermined volume of the first fluid in the first chamber.

[0056] Clause 39: The method of any one of Clauses 35 to 38, further comprising: attaching at least one patient line to the fluid port of the syringe before expelling the second fluid from the second chamber through the fluid port.

[0057] Clause 40: The method of any one of Clauses 35 to 39, wherein the first fluid comprises a flushing solution, such as a saline solution and / or a heparin lock flushing solution, and the second fluid comprises a therapeutic agent.

[0058] Article 41: A method according to any one of Articles 35 to 40, wherein the first plunger includes a plunger rod, the plunger rod including a protrusion, the protrusion being configured to contact a portion of the container when the first plunger rod moves through the first chamber, thereby providing feedback that an initial volume of the first fluid has been discharged from the first chamber, and wherein moving the first plunger through the first chamber to discharge the first fluid from the first chamber through the fluid port includes: before discharging the second fluid, moving the first plunger through the first chamber to discharge the initial volume of the first fluid until the protrusion contacts the container; and after discharging the second fluid from the second chamber, continuing to move the first plunger through the first chamber to discharge the remaining volume of the first fluid from the first chamber.

[0059] Article 42: A syringe comprising: a housing comprising (i) an upper barrel and (ii) a lower barrel, the upper barrel comprising an open proximal end, a distal end, a sidewall extending between the proximal end and the distal end, and a partition extending axially through the barrel to divide the barrel into a first chamber configured to accommodate a first fluid and a second chamber configured to accommodate a second fluid, the lower barrel being connected to the distal end of the upper barrel, the lower barrel comprising a fluid port; a first plunger for expelling the first fluid from the first chamber; a second plunger for expelling the second fluid from the second chamber; and a manually operable valve positioned in the lower barrel, the valve being configured to move between a first position and a second position, in which the first position allows fluid to flow from the second chamber through the valve to the fluid port to expel the second fluid from the syringe, and in which the second position allows fluid to flow from the first chamber through the valve to the fluid port to expel the first fluid from the syringe.

[0060] Clause 43: The syringe of clause 42, wherein the first chamber and the second chamber extend axially through the upper barrel, wherein the longitudinal axis of the first chamber is substantially parallel to the longitudinal axis of the second chamber.

[0061] Article 44: A syringe according to Article 42 or Article 43, wherein when the manually operable valve is in the first position, fluid is prevented from flowing through the valve from the first chamber, and when the valve is in the second position, fluid is prevented from flowing through the valve from the second chamber.

[0062] Article 45: According to the syringe described in Article 44, the syringe also includes at least one seal covering the open distal end of the upper barrel, the at least one seal including a first opening and a second opening, the first opening is used to allow the first fluid to flow from the first chamber to the valve when the valve is in the second position, and the second opening is used to allow the second fluid to flow from the second chamber through the valve when the valve is in the first position.

[0063] Clause 46: The syringe of Clause 45, wherein the at least one seal comprises a proximal sheet positioned between the distal end of the upper barrel and the valve and a distal sheet positioned between the valve and the distal end of the lower barrel.

[0064] Clause 47: The syringe of any one of Clauses 42 to 46, wherein the upper barrel is connected to the lower barrel by ultrasonic welding.

[0065] Article 48: A syringe according to any one of Articles 42 to 47, wherein the first plunger includes a first stopper and a first rod, the first stopper is located in the first chamber, and the first rod is connected to the first stopper and extends from the first stopper through the proximal end of the upper barrel.

[0066] Article 49: A syringe according to Article 48, wherein the first plunger rod includes a protrusion extending from the first plunger rod, and when the first plunger rod moves from the first chamber, the protrusion contacts a portion of the upper barrel to provide feedback that the initial volume of the first fluid has been expelled from the first chamber.

[0067] Article 50: A syringe according to any one of Articles 42 to 49, wherein the manually operable valve includes a body, the body including a through hole defining a flow channel, when the valve is in the first position, the flow channel is fluidly connected to the second chamber, and when the valve is in the second position, the flow channel is fluidly connected to the first chamber.

[0068] Clause 51: The syringe of clause 50, wherein the body comprises a rotating disk and a protrusion extending through the opening of the lower barrel for rotating the disk between the first position and the second position.

[0069] Article 52: A syringe comprising: a barrel including an open proximal end, a distal end including a frustoconical portion and a fluid port, a cylindrical sidewall between the proximal end and the distal end, and a partition extending axially through the barrel to divide the barrel into a first chamber configured to accommodate a first fluid and a second chamber configured to accommodate a second fluid; a first plunger for expelling the first fluid from the first chamber; a second plunger for expelling the second fluid from the second chamber; and a compressible bellows portion configured to move between an unbiased position and a biased position, in which the unbiased position prevents fluid from flowing from the first chamber and in which the biased position allows fluid to flow from the first chamber to the fluid port.

[0070] Clause 53: The syringe of clause 52, wherein the first chamber and the second chamber extend axially through the barrel, wherein the longitudinal axis of the first chamber is substantially parallel to the longitudinal axis of the second chamber.

[0071] Article 54: A syringe according to Article 52 or Article 53, wherein the first plunger includes a first stopper including a substantially flat distal surface and a first rod, the first stopper being located in the first chamber, and the first rod being connected to the first stopper and extending from the first stopper through the proximal end of the barrel.

[0072] Article 55: A syringe according to Article 54, wherein the second plunger includes a second stopper including a semi-conical distal surface and a second rod, the second stopper being located in the second chamber, and the second rod being connected to the second stopper and extending from the second stopper through the proximal end of the barrel.

[0073] Article 56: A syringe according to Article 55, wherein the barrel includes at least one slot for allowing the first fluid to flow from the first chamber to the fluid port, and wherein the at least one slot is positioned so that when the compressible bellows is in the unbiased position, fluid is prevented from flowing into the at least one slot, and when the compressible bellows is in the biased position, fluid is allowed to flow through the at least one slot to the fluid port.

[0074] Clause 57: The syringe of Clause 56, wherein the at least one slot is an opening extending through a partition of the barrel, and wherein, when the second stop is in a distal-most position in the second chamber, the second stop seals a portion of the at least one slot to prevent the first fluid from flowing into the second chamber.

[0075] Article 58: A syringe according to any one of Articles 52 to 57, wherein the compressible bellows includes a semi-conical distal surface and at least one radially extending rib, the semi-conical distal surface is configured to be positioned in the frustoconical portion of the barrel, and the at least one radially extending rib is configured to contact the inner surface of the cylindrical side wall of the barrel to seal the first fluid within the first chamber. BRIEF DESCRIPTION OF THE DRAWINGS

[0076] Figure 1A is a perspective view of a multi-chamber syringe according to one aspect of the present disclosure.

[0077] Figure 1B yes Figure 1A Exploded view of the syringe.

[0078] Figure 2A According to one aspect of the present disclosure Figure 1A A perspective view of the lower part of the stopper of a syringe.

[0079] Figure 2B According to one aspect of the present disclosure, Figure 1A A stereoscopic view of the seal of a syringe valve.

[0080] Figure 2C According to one aspect of the present disclosure Figure 1A A stereoscopic view of the valve of a syringe.

[0081] Figure 2D According to one aspect of the present disclosure Figure 1A A perspective view of the distal or lower portion of the barrel of a syringe.

[0082] Figure 3A is in the initial position Figure 1A Cross-sectional view of a syringe.

[0083] FIG. 3B to FIG. 3E is in use Figure 1A Cross-sectional view of a syringe.

[0084] Figure 3F After the fluid is expelled from the syringe Figure 1A Cross-sectional view of a syringe.

[0085] Figure 4A and Figure 4B According to one aspect of the present disclosure Figure 1A sectional view of portions of the side wall of a syringe showing the welded joints between portions of the barrel.

[0086] Figure 5 is a flow chart illustrating a method of using a multi-chamber syringe for sequential fluid discharge according to an aspect of the present disclosure.

[0087] Fig. 6A is a perspective view of another example of a multi-chamber syringe according to an aspect of the present disclosure.

[0088] Figure 6B yes Fig. 6A A perspective view of the distal or lower portion of the barrel of a syringe.

[0089] Figure 6C yes Fig. 6A A perspective view of the distal or lower portion of a syringe illustrating the force exerted on a valve of the syringe by fluid in a first chamber of the syringe.

[0090] Fig.6D yes Fig. 6A A cross-sectional view of the distal end of a syringe showing the valve of the syringe in a compressed position.

[0091] Fig. 7A is in the initial position Fig. 6A Cross-sectional view of a syringe.

[0092] Figure 7B and Figure 7C is used to draw and expel fluid from a syringe Fig. 6A Cross-sectional view of a syringe.

[0093] Fig.7D After the fluid is expelled from the syringe Fig. 6A Cross-sectional view of a syringe.

[0094] Fig. 8A and Figure 8B According to one aspect of the present disclosure Fig. 6A A stereoscopic view of a stopper of a syringe.

[0095] Fig. 9A and Fig. 9B According to one aspect of the present disclosure Fig. 6A View of the valve of a syringe.

[0096] Fig. 10A and Fig. 10B According to one aspect of the present disclosure Fig. 6A A cross-sectional view of a proximal portion of a syringe showing a locking protrusion extending between the plunger rods of the syringe. DETAILED DESCRIPTION

[0097] The following description is provided to enable those skilled in the art to make and use the described embodiments intended for implementing the present invention. However, various modifications, equivalents, variations and substitutes will be apparent to those skilled in the art. Any and all such modifications, variations, equivalents and substitutes are intended to fall within the spirit and scope of the present invention.

[0098] Hereinafter, for the purpose of description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and their derivatives shall relate to the present invention as oriented in the accompanying drawings. As used herein, the term "proximal" refers to the portion 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 portion of a device that is farthest from the portion of the device that is grasped, manipulated, or used by a practitioner. 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 a syringe). The "distal end" of a catheter or IV line refers to the end that is connected to the patient. However, it should be understood that the present invention may employ alternative variations and step sequences unless otherwise expressly stated. It should also be understood that the specific devices and processes shown in the drawings and described in the following specification are merely exemplary embodiments of the present invention. Therefore, specific dimensions and other physical characteristics associated with the embodiments disclosed herein should not be considered limiting.

[0099] Referring to the accompanying drawings, the present disclosure relates to multi-chamber syringes 10, 210 that discharge a first fluid F1 and a second fluid F2 from a container or barrel through a fluid port or nozzle of the syringe 10, 210 to, for example, a vascular access device (VAD). The first fluid F1 can be a flushing solution, such as saline and / or a heparin lock flushing solution. An example of a saline flushing solution is 0.9% sodium chloride USP for injection. An example of a heparin lock flushing solution is 0.9% sodium chloride containing 100 USP units of heparin sodium per milliliter or 0.9% sodium chloride containing 10 USP units of heparin sodium per milliliter. Other flushing solutions known in the art can also be used with the syringes 10, 210 of the present disclosure. The second fluid F2 can be a medical fluid, which, as used herein, can refer to a drug, a total parenteral nutrition (TPN) liquid, or another therapeutic agent known in the art for treating a chronic or acute condition. 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 therapeutically effective amounts.

[0100] In some examples, the syringe 10, 210 is configured to perform two steps or aspects of the injection procedure, specifically injecting a medical fluid and then injecting a flushing solution. In other examples, the syringe 10, 210 can be used to perform three steps or aspects of the injection procedure, specifically injecting a first volume of flushing solution (first fluid F1) to prime and / or confirm the patency of the patient's line (referred to herein as the primary flush or pre-flush), followed by injecting a certain volume of medical fluid (second fluid F2), and then injecting a second volume of flushing solution (first fluid F1) to clean the patient's line and confirm that all medical fluids flow from the patient's line to the patient (referred to herein as post flush). The syringe 10, 210 of the present disclosure can also be used to sequentially deliver a first drug or therapeutic agent and a subsequent different second drug or therapeutic agent.

[0101] The syringes 10, 210 of the present disclosure allow practitioners (such as medical technicians, nurses, physician assistants, physicians, or other trained or untrained clinicians or medical caregivers) to administer, for example, medication and subsequent flushing solutions without having to change syringes between the delivery of the first fluid and the second fluid. Thus, pre-flushing, medication injection, and post-flushing can be performed one after the other, thereby avoiding delays caused by switching between different syringes or injection devices.

[0102] In some examples, the syringe 10, 210 is provided as a partially pre-filled syringe, wherein the chamber of the syringe 10, 210 is filled with a flushing solution during manufacture. The partially pre-filled syringe 10, 210 may include a cap, a clip, a retainer, and / or other packaging to hold the plunger rod in place and ensure that the flushing solution does not leak from the partially pre-filled syringe 10, 210 at an unexpected time (such as during shipping).

[0103] The syringe 10, 210 of the present disclosure is also configured to allow a practitioner to draw a medical fluid into the syringe 10, 210 before delivering the medical fluid to a patient. For example, a practitioner can insert the nozzle or needle of the syringe 10, 210 into a bottle containing the medical fluid, and then draw the medical fluid into the fluid chamber of the syringe 10, 210 by moving the plunger rod of the syringe 10, 210 in a proximal direction. After the medical fluid is drawn into the fluid chamber of the syringe 10, 210, delivery of the first fluid F1 and subsequently the second fluid F2 can be performed by connecting the syringe 10, 210 to the fluid port of the VAD and then discharging the first fluid and the second fluid in sequence.

[0104] Compared to conventional fluid application operations, the syringe 10, 210 of the present disclosure simplifies the fluid application procedure and saves a great deal of time because there is no need to clean or disinfect some parts of the VAD between the delivery of the first fluid and the second fluid. The syringe 10, 210 of the present disclosure also reduces the risk of infection and allows the VAD to be flushed immediately after the medical fluid is applied, which can prevent the drug from being blocked in the VAD. In addition, the syringe 10, 210 of the present disclosure has a low dead space or zero dead space, which means that when the second fluid (e.g., flushing solution) moves to the VAD through the syringe 10, 210, all the medical fluid contained in the first chamber of the syringe 10, 210 is flushed out of the syringe 10, 210.

[0105] Multi-chamber syringes for sequential drug delivery

[0106] Figures 1A to 4BAn example of a multi-chamber syringe 10 for sequentially discharging a first fluid F1 contained in a first fluid chamber 12 and a second fluid F2 contained in a second fluid chamber 14 is shown. For example, the syringe 10 may be configured to perform a two-step fluid delivery, which includes discharging a predetermined volume of the second fluid F2 from the second chamber 14, and then discharging a predetermined volume of the first fluid F1 from the first chamber 12. In other examples, the syringe 10 may be configured for a three-step fluid delivery, which includes ejecting a predetermined volume of the first fluid F1 from the first chamber 12, then ejecting a predetermined volume of the second fluid F2 from the second chamber 14, and then ejecting the remaining volume of the first fluid F1 from the first chamber 12.

[0107] As described above, in some examples, the first fluid F1 can be a flushing solution, such as a saline solution and / or an anticoagulant (such as heparin). The type of flushing solution contained in the first chamber 12 and the amount of the flushing solution can vary according to, for example, the specific type of catheter or IV line being used. In some examples, the syringe 10 is partially prefilled to accommodate, for example, the first fluid F1 between about 1 mL and 20 mL, or preferably the first fluid F1 between about 5 mL and about 10 mL. The second fluid F2 can be a medical fluid, such as a drug or another therapeutic agent intended to be delivered to the patient through a VAD (such as a catheter or IV line).

[0108] In some examples, the syringe 10 includes a container 16 or a housing that defines or encloses a first chamber 12 and a second chamber 14. The container 16 may include an open proximal end 18 and a distal end 20, the distal end 20 including a fluid port 22 or a nozzle for discharging fluids F1 and F2 from the container 16. The fluid port 22 of the container 16 may be a connector (such as a Luer connector, a threaded connector, or a snap connector) configured to be connected to a needle that is used to access the interior of a medical bottle containing, for example, a medical fluid. The fluid port 22 may also be configured to be directly or indirectly connected to a fluid port, a valve, or another end access portion of a VAD. For example, a common type of fluid port of a VAD is a pierceable septum or pre-slit septum made of rubber or another elastic material that allows the insertion of a sharp or blunted needle cannula to infuse or extract fluids 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. Alternatively, the valve may be activated by the frustoconical end of the syringe barrel 16 to provide fluid communication between the interior of the container 16 and the VAD.

[0109] In some examples, the first chamber 12 and the second chamber 14 are parallel or substantially parallel cavities or spaces extending axially through the container 16. For example, the longitudinal axis L1 of the first chamber 12 (at Figure 3A ) may be parallel or substantially parallel to the longitudinal axis L2 of the second chamber 14 (shown in Figure 3A ). As used herein, "substantially parallel" means that axis L1 is nearly parallel to axis L2. For example, axis L1 may be angled relative to axis L2 by only a nominal amount (such as less than 5 degrees). Chambers 12, 14 may be any convenient shape based on the size of container 16 and / or other components of syringe 10. For example, first chamber 12 and second chamber 14 may have a semicircular cross-sectional shape as well as an elliptical, circular, square, triangular or rectangular shape.

[0110] In some examples, the container 16 is a syringe barrel, such as a barrel of a conventional fluid delivery syringe for medical procedures, which is made by, for example, an injection molding process. For example, the container 16 or barrel can be roughly similar in shape, size, and construction to the barrel of a syringe for administering a flushing solution to a VAD as known in the art. The container 16 or barrel can be a cylindrical or elliptical prismatic structure formed by a rigid thermoplastic material, such as polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, acrylonitrile butadiene styrene, or other injection moldable or formable resin materials as known in the art. For example, an exemplary barrel for flushing a syringe is described in U.S. patent application No. 2020 / 0061297, entitled "Flush Syringe Assembly with Controlled Pulsatile Flushing", which is incorporated herein by reference in its entirety.

[0111] In other examples, the container 16 can be formed from a plurality of separately molded components that are joined together to form the container 16. For example, the container 16 can include an upper barrel 24 enclosing the first chamber 12 and the second chamber 14, and a lower barrel 26 connected to the upper barrel 24. As with more conventional syringe barrels, the upper barrel 24 and the lower barrel 26 of the container 16 can be made of at least one of polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene.

[0112] In some examples, the upper barrel 24 of the container 16 includes an open proximal end 28, a distal end 30, and an annular sidewall 32 extending between the open proximal end 28 and the distal end 30. The distal end 30 of the upper barrel 24 can be open, or can be substantially closed, but can include an opening that allows the fluid contained in the chambers 12, 14 to pass from the chambers 12, 14 through the distal end 30 of the upper barrel 24. The upper barrel 24 also includes an axially extending partition 34 (such as a wall or baffle) extending from the open proximal end 28 of the upper barrel 24 to the distal end 30 to separate the first chamber 12 from the second chamber 14. In some examples, the partition 34 is centrally located within the container 16 to divide the container 16 into the first chamber 12 and the second chamber 14 having the same or substantially the same fluid volume. In other examples, the divider 34 can be off-center or spaced from the longitudinal axis of the container 16, which means that the chambers 12, 14 can contain different fluid volumes. The lower barrel 26 of the container 16 can include an open proximal end 36, a closed distal end 38 including the fluid port 22 of the container 16, and an annular sidewall 40 extending between the proximal end 36 and the distal end 38. As is known in the art, the upper barrel 24 can be joined to the lower barrel 26 by any suitable fastener or adhesive. In some examples, the upper barrel 24 and the lower barrel 26 are joined by ultrasonic welding. For example, as Figure 4A and Figure 4B As shown, the proximal end 36 of the lower barrel 26 can be welded at an ultrasonically welded joint 70 (at Figure 4B ) is coupled to the distal end 30 of the upper cylinder 24.

[0113] In some examples, the syringe 10 also includes a seal (referred to herein as a proximal seal 42) covering the distal end 30 of the upper barrel 24 to seal the fluid within the chambers 12, 14 of the container 16. The proximal seal 42 can be a generally flat sheet of fluid-impermeable material (such as silicone) that is slightly smaller than the cross-section of the upper barrel 24. The proximal seal 42 can be positioned at the distal end 30 of the upper barrel 24 and held in place by a valve 44 positioned distal to the seal 42 or by contact between the seal 42 and, for example, the inner surface of the sidewall 40 of the lower barrel 26. In some examples, the proximal seal 42 includes a first opening 46 (at Figure 2B The first opening 46 is used to allow the first fluid F1 to flow from the first chamber 12 through the valve 44 to the fluid port 22. The proximal seal 42 may also include a second opening 48 (in Figure 2B), the second opening 48 is used to allow the second fluid F2 to flow from the second chamber 14 through the valve 44. The syringe 10 may also include a distal seal 50 positioned between the valve 44 and the distal end 38 of the lower barrel 26, and the size and shape of the distal seal 50 are similar or identical to the size and shape of the proximal seal 42.

[0114] The syringe 10 also includes a plurality of plungers configured to move through the chambers 12, 14 of the container 16 for drawing the second fluid F2 into the second chamber 14 and / or for expelling the fluid F1, F2 from the chambers 12, 14 through the fluid port 22 at the distal end 20 of the container 16. For example, the syringe 10 may include a first plunger 52 that moves through the first chamber 12 and a second plunger 54 that moves through the second chamber 14. The first plunger 52 may include a first stopper 56 (at Figure 2A 14 and a first plunger rod 58 connected to and extending from the first stopper 56 through the proximal end 18 of the container 16. The second plunger 54 may include a second stopper 60 located in the second chamber 14 and a second plunger rod 62 connected to and extending from the second stopper 60 through the proximal end 18 of the container 16.

[0115] The first stopper 56 and the second stopper 60 can have many features of conventional syringe stops or plungers as known in the art. For example, the stops 56, 60 can be formed from a thermoplastic elastomer material (such as polypropylene or polyethylene) and from a synthetic or natural rubber (e.g., isoprene). The first stopper 56 and / or the second stopper 60 can include a proximal surface 64 or proximal end, a distal surface 66 or distal end, and a peripheral surface 68 extending between the proximal surface 64 and the distal surface 66. The peripheral surface 68 can be configured to seal against the inner surface of the side wall 32 of the upper barrel 24 to allow the fluid F1, F2 to move through the chambers 12, 14 of the container 16. In some examples, the distal end or distal surface 66 of the stops 56, 60 can be substantially flat. In addition, the distal surface 66 of the stops 56, 60 can be a semicircular shape corresponding to the cross-sectional shape of the first chamber 12 and / or the second chamber 14. In some examples, as Figure 2AAs most clearly shown in FIG. 1 , the stops 56, 60 may also include a protrusion 72 configured to be inserted into and engage the openings 46, 48 of the proximal seal 42 so as to eliminate dead space in the openings 46, 48. For example, the first stop 56 may include a protrusion 72 that is inserted through the first opening 46 when the first stop 56 is in the most distal position in the first chamber 12 to ensure that all of the first fluid F1 is discharged from the first chamber 12 to the valve 44. In a similar manner, the second stop 60 may include a protrusion 72 that is positioned to be inserted into the second opening 48 when the second stop 60 is in the most distal position to ensure that all of the second fluid F2 is discharged from the second chamber 14.

[0116] As previously described, the second stopper 60 can be configured to move through the second chamber 14 to draw fluid into the container 16. For example, the second stopper 60 moves through the second chamber 14 in the proximal direction (eg, Figure 3B The first stopper 56 moves in the distal direction through the first chamber 12 (as shown by the arrow P in FIG. 1 ). Figure 3D In a similar manner, the second stopper 60 moves distally through the second chamber 14 (as shown by the arrow D in FIG. Figure 3E The second fluid F2 (such as a medical fluid) will be discharged from the second chamber 14 (as shown by the arrow D in FIG. 1 ).

[0117] The plungers 52, 54 may also include plunger rods, such as a first plunger rod 58 connected to the first stop 56 and a second plunger rod 62 connected to the second stop 60. The plunger rods 58, 62 may be, for example, injection molded parts formed of a rigid thermoplastic material, such as polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or another thermoplastic material as known in the art. The plunger rods 58, 62 may include a distal end 78 that is engaged to one of the stops 56, 60. For example, the distal end 78 of the plunger rods 58, 62 may include an annular connector 80 that is inserted into a corresponding cavity 82 (at the proximal surface 64 of the stops 56, 60) Figure 1B) or in a narrow groove. The plunger rod 58, 62 also includes a proximal end 84 that protrudes proximally from the proximal end 18 of the container 16 and a body extending between the proximal end 84 and the distal end 78 of the plunger rod 58, 62. The proximal end 84 of the plunger rod 58, 62 may include a thumb press plate 88, which is used to manipulate the plunger rod 58, 62 to move the stopper 56, 60 through the container 16. Within the scope of the present disclosure, the body of the plunger rod 58, 62 can have a variety of cross-sectional shapes and configurations. For example, the body can have a generally cross-shaped cross-section. In other examples, the cross-section of the plunger rod 58, 62 can be an I-beam, a hollow circle, a hollow square, a hollow rectangle, or an L-shape. In some examples, the syringe 10 may also include a removable plunger cap 90 (in Figure 3A ), the removable plunger cap 90 is engaged between the thumb pressure plate 88 of one or both of the plunger rods 58, 62 and the proximal end 18 of the container 16 to prevent movement of the plunger rods 58, 62 until the removable plunger cap 90 is removed from the syringe 10. For example, Figure 3A As shown, a removable cap 90 may be engaged to the first plunger rod 58 for limiting movement of the first plunger rod 58 through the first chamber 12 .

[0118] In some examples, the first plunger rod 58 may also include a protrusion 92 configured to contact a portion of the container 16 when the first plunger rod 58 moves through the first chamber 12. The protrusion 92 may be positioned on the plunger rod 58 to provide tactile feedback that the initial volume of the first fluid F1 has been discharged from the first chamber 12. As described in further detail herein, the tactile feedback provided by the protrusion 92 assists the practitioner in performing the three-step fluid discharge procedure. In particular, the practitioner may push the first plunger rod 58 and the first stopper 56 through the first chamber 12 of the container 16 until the practitioner feels tactile feedback from the protrusion 92 indicating that the initial volume of the first fluid F1 (such as a volume of flushing solution sufficient to prefill or confirm the patency of the patient's line) is discharged from the container 16. The practitioner may then move the second plunger rod 62 and the second stopper 60 through the second chamber 14 to discharge the second fluid F2 (such as a medical fluid) into the patient's line. Finally, the practitioner may apply sufficient force to the first plunger rod 52 to deform or bend the protrusion 92 , thereby allowing the first plunger rod 52 and the stopper 56 to move through the first chamber 12 to expel the remaining volume of the first fluid F1 from the first chamber 12 .

[0119] The syringe 10 also includes a valve 44 positioned in the container 16, which is configured to control the sequential flow of fluid from the first chamber 12 and from the second chamber 14. The valve 44 can be positioned in the lower barrel 26 of the container 16, between the proximal seal 42 and the distal seal 50. The valve 44 can be configured to allow fluid to flow from the first chamber 12 or the second chamber 14 through the valve 44 to the fluid port 22 of the container 16. More specifically, the valve 44 can be configured to be in a first position (in a closed position) so that the fluid can flow from the first chamber 12 or the second chamber 14 to the fluid port 22 of the container 16. FIG. 3A to FIG. 3C and Figure 3E ) and the second position (shown in Figure 3D and Figure 3F 4 and 5. The valve 44 is shown in the figure, wherein the first position prevents fluid from flowing through the valve 44 from the first chamber 12, and the second position allows fluid to flow from the first chamber 12 through the valve 44 to the fluid port 22 to discharge the first fluid F1 from the container 16. In addition, in some examples, when the valve 44 is in the first position, fluid is allowed to flow from the second chamber 14 through the valve 44 to the fluid port 22 to discharge the second fluid F2 from the container 16. Similarly, when the valve 44 is in the second position, fluid is prevented from flowing through the valve 44 from the second chamber 14. In addition, when the valve 44 is in the first position, the proximal movement of the second plunger 54 through the second chamber 14 will draw the second fluid F2 into the second chamber 14.

[0120] Continue to refer Figures 1A to 3F In some examples, the valve 44 can include a body 74 including a passage 76 that is fluidly connected to the second chamber 14 when the valve 44 is in the first position and that is fluidly connected to the first chamber 12 when the valve 44 is in the second position. The body 74 can be a cylindrical structure, such as a rotating disk. In some examples, the body 74 or the rotating disk is an injection molded component made of a rigid plastic. The body 74 or the rotating disk can include a protrusion or knob 94 that is configured to be grasped by a practitioner to rotate the body 74 or the disk to move the valve 44 between the first position and the second position. Figure 1A As shown, the protrusion or knob 94 can extend through the opening 96 in the side wall 40 of the lower barrel 26. The practitioner can grasp or press against the protrusion or knob 94 to rotate the body 74 in a first direction (such as Figure 1A This moves the body 74 toward the first position. Conversely, the practitioner can grasp or press against the protrusion or knob 94 to rotate the knob in a second direction (eg, Figure 1A), which moves the body 74 of the valve 44 to the second position. In some examples, the protrusion or knob 94 can be rotated a predetermined angular distance (such as an angular distance from 80 degrees to 120 degrees or preferably about 100 degrees) to move the body 74 or the rotating disk between the first position and the second position.

[0121] As described in further detail herein, the syringe 10 may be initially provided in a partially filled state, such as Figure 3A As shown, there is a first fluid F1 (such as a flushing solution) in the first chamber 12. In this initial position or partially filled position, the first stopper 56 is positioned in the first chamber 12 near the proximal end 18 of the container 16 so that the first chamber 12 contains a volume of about 1 mL to 20 mL or preferably about 5 mL to 10 mL of the first fluid F1. The valve 44 is in the first position to prevent the first fluid F1 in the first chamber 12 from being discharged from the first chamber 12. The second stopper 60 can be inserted at any position in the second chamber 14. When ready for use, the practitioner can move the second stopper 60 to the distal-most position against the distal end 30 of the upper barrel 24, wherein the protrusion 72 extending from the distal surface 66 of the second stopper 60 at least partially protrudes through the first opening 46 of the proximal seal 42. The practitioner can then move the second stopper 60 in the proximal direction (such as Figure 3B ), to draw a second fluid F2 (such as a medical fluid) into the second chamber 14, thereby completely filling the syringe 10, as shown by the arrow P in FIG. Figure 3C Once the syringe 10 is completely filled with the first and second fluids F1, F2, the practitioner may use the plungers 52, 54 and the valve 44 to sequentially control the discharge of the first and second fluids F1, F2 from the syringe 10, as described in detail below.

[0122] Method for discharging fluid from a multi-chamber syringe

[0123] As previously described, syringe 10 is used to sequentially expel fluid from syringe 10 into the VAD, such as expelling an initial volume of flush solution, followed by a volume of medical fluid, and then a remaining volume of flush solution. Figure 5 The following flow chart is shown: The flow chart shows the steps of the sequential fluid expulsion process using the syringe 10.

[0124] like Figure 5As shown, at step 110, the practitioner first obtains a partially filled syringe 10, wherein the first chamber 12 of the syringe 10 is filled with a predetermined volume of a first fluid F1 (such as a flushing solution). For example, the partially filled syringe 10 can contain about 1 mL to 20 mL or preferably about 5 mL to 10 mL of the first fluid F1 or flushing solution. The valve 44 is in a first position to prevent the first fluid F1 or flushing solution from flowing out of the first chamber 12. Figure 3A The syringe 10 is shown in an initial or partially filled position. At step 112, the practitioner prepares the syringe 10 for use by, for example, removing any packaging from the syringe 10 and removing the plunger cap 90 (if present) that holds the plunger rods 58, 62 in place. The practitioner may also move the second plunger rod 62 in a distal direction (e.g., Figure 3A 10 ) to fully position the second stopper 60 of the syringe 10 in its most distal position. At step 114, the practitioner places the container 16 in fluid communication with the interior of a container containing a medical fluid to be delivered to the patient. For example, the practitioner can attach a needle (not shown) to the fluid port 22 at the distal end 20 of the container 16 and insert the needle into a medical container or bottle containing a medical fluid to be injected into the patient.

[0125] At step 116, the practitioner draws the medical fluid into the second chamber 14 of the container 16. For example, the practitioner may grasp the second plunger rod 62 and move the second plunger rod 62 in a proximal direction (e.g., Figure 3B This causes the second stopper 60 to move in the proximal direction, thereby aspirating or drawing the fluid into the second chamber 14, as shown by the arrow P in FIG. Figure 3B As shown by arrow A3 in FIG. Figure 3C 1 is shown in its fully filled position, with the first fluid F1 being located in the first chamber 12 and the second fluid F2 being located in the second chamber 14 .

[0126] Once a dose of the medical fluid to be delivered to the patient is drawn into the second chamber 14, the practitioner removes a needle (not shown) from the fluid port 22 of the container 16 and connects the fluid port 22 to the VAD at step 118. For example, the practitioner may insert the nozzle of the container 16 into a corresponding port or valve of the VAD, thereby establishing fluid communication between the chambers 12, 14 of the container 16 and the lumen of the VAD.

[0127] At step 120, once the syringe 10 is properly connected to the VAD, the practitioner can perform an initial flush or priming of the patient circuit. To perform an initial flush or priming, the practitioner first presses the knob 94 (in the Figure 1A , Figure 1B and Figure 2C ) moves the valve 44 to the second position, which establishes fluid communication between the first chamber 12 and the fluid port 22 of the container 16. Specifically, as Figure 3C As shown, the valve 44 can be rotated in the direction of arrow A2 so that the passage 76 moves from being in fluid communication with the second chamber 14 to being in fluid communication with the first chamber 12. The practitioner then grasps the first plunger rod 58 and pushes the first plunger rod 58 in the distal direction (e.g., Figure 3D This causes the first stopper 56 to move distally through the first chamber 12, thereby forcing the first fluid F1 to flow out of the first chamber 12, as shown in FIG. Figure 3D The practitioner continues to move the first stopper 56 distally through the first chamber 12 until the protrusion 92 of the first plunger rod 58 contacts the container 16, as shown in FIG. Figure 3D As previously described, contact between the protrusion 92 and the container 16 provides a tactile feedback to the practitioner indicating that a predetermined initial volume of the first fluid F1 has been expelled from the syringe 10 through the patient line.

[0128] Once the initial flush or pre-flush has been performed, the practitioner then discharges the second fluid F2 drawn from the container 16 (such as a medical bottle) into the second chamber 14 into the patient circuit at step 122. To discharge the second fluid F2, the practitioner first moves the valve 44 to the first position (such as Figure 3D The practitioner then grasps the second plunger rod 62 and pushes the second plunger rod 62 in the distal direction (as shown by arrow A1 in FIG. 1 ), which establishes fluid communication between the second chamber 14 and the fluid port 22 of the container 16 through the valve 44. Figure 3E The distal movement of the second stopper 60 causes the second fluid F2 (e.g., medical fluid) in the second chamber 14 to be discharged from the container 16 to the VAD through the fluid port 22 or nozzle of the container 16, as shown in FIG. Figure 3E As shown by arrow A5 in FIG. 1 . The practitioner continues to move the second plunger rod 62 in the distal direction until the second stopper 60 abuts the proximal seal 42 at the distal end 30 of the upper barrel 24. Figure 3E The second stop 60 is shown in this distal-most position.

[0129] At step 124, after draining the second fluid F2 from the container 16, the practitioner then performs a second flush or post-flush to ensure that the entire volume of the second fluid F2 has passed from the container 16 through the patient circuit and to clean the patient circuit and / or remove debris from the patient circuit. To perform the second flush or post-flush, the practitioner moves the valve 44 back to the second position (e.g., Figure 3Eand Figure 3F ), which establishes fluid communication from the first chamber 12 to the fluid port 22 of the container 16 through the valve 44. The practitioner then grasps the first plunger rod 58 and pushes the first plunger rod 58 in the distal direction with sufficient force (as shown in FIG. Figure 3F The first plunger rod 58 is pushed further into the first chamber 12 by the practitioner (as indicated by arrow D in the figure) to deform the protrusion 92 so that the first plunger rod 58 can be further inserted into the first chamber 12. Once the protrusion 92 is depressed or deformed, the practitioner continues to push the first plunger rod 58 in the distal direction, which causes the first stopper 56 to move distally through the first chamber 12, thereby discharging the first fluid F1 from the first chamber 12 through the fluid port 22, as shown in FIG. Figure 3F The practitioner continues to move the first plunger rod 58 in the distal direction until the first stop 56 abuts the proximal seal 42 at the distal end 30 of the upper barrel 24, indicating that the entire remaining volume of the first fluid F1 or flushing solution has been expelled from the first chamber 12 and the fluid port 22 to the patient line. After the entire volume of the first fluid F1 and the entire volume of the second fluid F2 have been expelled from the container 16, the syringe 10 is Figure 3F 2 is shown in this final or end-of-use position, wherein the distal surfaces 66 of the first stopper 56 and the second stopper 60 contact or nearly contact the distal end 30 of the upper barrel 24 and / or the proximal seal 42.

[0130] 6A to 7D Another example of a multi-chamber syringe 210 is shown, which is used to sequentially deliver a first fluid F1 (such as a flushing solution) and a second fluid F2 (such as a medical fluid). The syringe 210 includes Figures 1A to 4B Many of the components and features of the syringe 10 shown. In particular, the syringe 210 includes a container enclosing or defining a first chamber 212 and a second chamber 214. The container can be a syringe barrel 216 having an open proximal end 218, a distal end 220 including a fluid port 222, and a sidewall 224 extending between the proximal end 218 and the distal end 220 of the barrel 216. The barrel 216 also includes a partition 234 or wall that divides the interior of the barrel 216 into the first chamber 212 and the second chamber 214. For example, Fig. 7A As shown, the first chamber 212 and the second chamber 214 are parallel or substantially parallel cavities or spaces extending axially through the barrel 216. For example, the longitudinal axis L1 of the first chamber 212 (at Fig. 7A ) may be parallel or substantially parallel to the longitudinal axis L2 of the second chamber 214 (in Fig. 7A ).

[0131] Unlike in the previous examples, the syringe barrel 216 can be a single molded component that is structurally similar to the barrel of a conventional fluid delivery syringe. In addition, the distal end 220 of the syringe barrel 216 can include a tapered portion 221 extending from the side wall 224 of the barrel 216 to the fluid port 222 (at Fig.6D and 7A to 7D ), the tapered portion 221 is used to guide the fluid from the chambers 212 , 214 to the fluid port 222 .

[0132] The syringe 210 also includes a first plunger 252 for discharging the first fluid F1 from the first chamber 212 and a second plunger 254 for discharging the second fluid F2 from the second chamber 214. As in the previous example, the first plunger 252 includes a first stopper 256 (at Fig. 8A ) and a first plunger rod 258. The second plunger 254 includes a second stopper 260 (shown in Figure 8B 260 and a second plunger rod 262. The first stopper 256 includes a proximal surface 264, a distal surface 266, and an annular outer peripheral surface 268 extending between the proximal surface 264 and the distal surface 266. The distal surface 266 of the first stopper 256 is flat. In contrast, the second stopper 260 includes a partially conical or truncated conical distal surface 266, which corresponds to the curvature or angle of the tapered portion 221 of the distal end 220 of the barrel 216. In particular, the partially or semi-conical distal surface 266 of the second stopper 260 can be configured to push the second fluid F2 through the tapered portion 221 of the second chamber 214, thereby ensuring that all or substantially all of the second fluid F2 is directed to the fluid port 222, and that no second fluid F2 or only a nominal amount of the second fluid F2 remains in the second chamber 214 after the use of the syringe 210 is completed.

[0133] As in the previous examples, the syringe 210 also includes a valve 244 that controls the orderly discharge of the first fluid F1 and the second fluid F2 from the syringe 210. Unlike in the previous examples, the valve 244 is an automatic valve that is activated due to the force (such as force) applied to the valve 244 when the first plunger rod 258 and the first stopper 256 move through the first chamber 212. Figure 6C In addition, for the syringe 210, the valve 244 controls only the flow of the first fluid F1 from the first chamber 212. Specifically, when the valve 244 is in the first position or the closed position (in 7A to 7C ), preventing fluid from flowing from the first chamber 212 to the fluid port 222 of the cylinder 216 through the valve 244. When the valve 244 is in the second position or open position (in Fig.6D and Fig.7D), allowing fluid to flow from the first chamber 212 to the fluid port 222 through the valve 244. 6A to 7D In the syringe 210, the fluid flow from the second chamber 214 is not controlled by the valve 244, which means that the second fluid F2 is allowed to flow out of the second chamber 214 whenever the second plunger rod 262 moves the second stopper 260 through the second chamber 216 with sufficient force to move the fluid F2 through the fluid port 222 of the barrel 216.

[0134] like 6A to 7D as well as Fig. 9A and Fig. 9B As shown, the valve 244 includes a compressible body 274 or bellows that prevents fluid from flowing from the first chamber 212 to the fluid port 222 in an unbiased or expanded position, and allows fluid to flow from the first chamber 212 to the fluid port 222 in a biased or compressed position. Similar to the stoppers 256, 260, the compressible body 274 can be formed of a thermoplastic elastomer material such as polypropylene or polyethylene and formed of a synthetic or natural rubber (e.g., isoprene). The compressible body 274 of the valve 244 includes a half or partial frustoconical portion 276 that is positioned in the frustoconical portion or conical portion 221 of the barrel 216. The compressible body 274 also includes a partial cylindrical portion or semi-cylindrical portion 278 extending proximally from the frustoconical portion 276. The semi-cylindrical portion 278 may include one or more peripheral ribs 280 configured to contact and seal against the inner surface of the sidewall 224 of the cylinder 216 to ensure that the first fluid F1 only passes through the valve 244 when the valve 244 is in a compressed position or an open position.

[0135] In some examples, the cylinder 216 includes a structure, such as a channel or groove, for directing the first fluid F1 through the valve 244 when the body 274 is compressed. Figure 6B and Figure 6C As best shown in FIG. 1 , the barrel 216 may include a slot 282 that defines a flow passage for fluid to flow from the first chamber 212 to the fluid port 222. The slot 282 may be positioned such that when the compressible body 274 is in the expanded position, fluid is prevented from flowing through the slot 282. When the compressible body 274 is in the compressed position, as shown in FIG. Fig.6D As shown, fluid is allowed to flow through slot 282 to fluid port 222. In some examples, such as Figure 6B and Figure 6CAs shown, the slot 282 is an opening, cutout portion, or through hole extending through the partition 234 of the barrel 216. When the compressible body 274 of the valve 244 is in the expanded state, the compressible body 274 prevents the fluid F1 from entering the slot 282 and / or flowing from the first chamber 212 to the second chamber 214. The compressible body 274 also prevents any second fluid F2 from entering the first chamber 212 through the slot 282 and / or mixing with the first fluid F1. When the second stop 260 is in the most distal position in the second chamber 214 (e.g., as shown in FIG. 2A ), the second stop 260 is in the most distal position in the second chamber 214 (e.g., as shown in FIG. 2B ). Fig. 7A , Figure 7C and Fig.7D ), the second stopper 260 seals a portion of the slot 282 to prevent the first fluid F1 from flowing into the second chamber 214. For example, a distal surface 266 of the second stopper 260 positioned in the frustoconical portion 221 of the barrel 216 may contact the partition 234 to seal the slot 282 to separate the first chamber 212 from the second chamber 214.

[0136] As in the previous examples, the syringe 210 may initially be in a partially filled state ( Fig. 7A ) is provided, wherein the first chamber 212 is filled with a first fluid F1 (such as a fluid solution), and the second chamber 214 may be empty. The second chamber 214 is filled by moving the second plunger rod 260 ( Figure 7B The second fluid F2 is drawn from a container (such as a medical bottle) into the second chamber 214 through the fluid port 222, as shown by the arrow P in ( Figure 7B Once the syringe 210 is completely filled (wherein the first chamber 212 is filled with the first fluid F1 and the second chamber 214 is filled with the second fluid F2) (as shown by arrow A8 in FIG. Figure 7B ), by moving the second plunger rod 262 ( Figure 7C The second fluid F2 is discharged from the syringe 210 as shown by the arrow D in FIG. 2 , which discharges the second fluid F2 from the second chamber 214. Figure 7C As shown by arrow A9 in FIG. 1 , the practitioner continues to move the second plunger rod 262 through the second chamber 214 until the second stopper 260 abuts against the distal end 220 of the barrel 216 to ensure that all or substantially all of the second fluid F2 is discharged from the second chamber 214. Figure 7C The second stop 260 is shown in the distal-most position.

[0137] After draining the second fluid F2 from the second chamber 214, the practitioner performs a post-flush by draining the first fluid F1 from the first chamber 212. To drain the first fluid F1, the practitioner grasps the first plunger rod 258 and pushes the first plunger rod 258 in the distal direction (eg, Fig.7D ), which causes the first stopper 256 to move through the first chamber 212. The movement of the first stopper 256 through the first chamber 212 increases the fluid pressure in the first chamber 212, thereby compressing the compressible body 274 of the valve 244. As previously described, Fig.6D The compressible body 274 is shown in a compressed position. When the body 274 is compressed, the fluid flows through the channel or flow path (such as FIG. 6B to FIG. 6D The practitioner continues to push the first plunger rod 258 and the first stop 256 through the first chamber 212 until the distal surface 266 of the first stop 256 contacts or nearly contacts the compressible body 274, as shown. Fig.7D As shown, thereby ensuring that all or substantially all of the first fluid F1 in the first chamber 212 flows through the slot 282, flows through the valve 244 and flows to the fluid port 222, where the first fluid F1 is discharged from the syringe 210. Thus, the syringe 210 provides an orderly discharge of the second fluid F2 and subsequently the first fluid F1. Fig.7D The syringe 210 is shown in its final position, wherein both the first fluid F1 and the second fluid F2 are expelled from the syringe 210 .

[0138] refer to Fig. 10A and Fig. 10B In some examples, the plungers 252, 254 of the syringe 210 may include locking features for ensuring that the plunger rods 258, 262 are used in the correct sequence. Fig. 10A and Fig. 10B As shown, the first plunger 252 may include a first protrusion 284 that is positioned proximate to the distal end of the first plunger rod 258 and / or proximate to the stop 256. As used herein, "proximate to" the distal end and / or "proximate to" the stop 256 may mean that the first protrusion 284 extends from a portion of the first plunger rod 258 that is closer to the distal end of the plunger rod 258 than to the proximal end of the plunger rod 258. Fig. 10AAs shown, the first protrusion 284 extends radially from the plunger rod 258 and is positioned to contact a portion of the barrel 216 to prevent the first plunger rod 258 from moving distally through the first chamber 212 to discharge the first fluid F1 from the first chamber 212 before discharging the second fluid F2 from the second chamber 214. Similarly, the second plunger 254 may include a second protrusion 286 extending from the second plunger rod 262. The second protrusion 286 may be positioned close to the proximal end of the second plunger rod 262. For example, the second protrusion 286 may be positioned on the second plunger rod 262 closer to the proximal end of the plunger rod 262 than to the distal end of the plunger rod. The second protrusion 286 is configured to contact and depress the first protrusion 282 so that the first plunger rod 258 can move through the first chamber 212.

[0139] More specifically, in use, the plunger rods 258, 262 are Fig. 10A In its most proximal position, this means that the syringe 210 is filled with the first fluid F1 in the first chamber 212 and with the second fluid F2 in the second chamber 214. Fig. 10A As shown, due to the contact between the first protrusion 284 and the partition 234 of the barrel 216, the practitioner cannot insert the first plunger rod 258 further into the first chamber 212. As previously described, the practitioner first moves the second plunger rod 262 in the distal direction through the second chamber 214 (such as Fig. 10A The second plunger rod 262 moves in the distal direction through the second chamber 214 (as shown by arrow D) causing the second protrusion 286 to contact the first protrusion 284. Fig. 10B As shown, the contact between the first protrusion 284 and the second protrusion 286 depresses the first protrusion 284. Once the first protrusion 284 is depressed, the practitioner can move the first plunger rod 258 in the distal direction through the first chamber 212 (eg, Fig. 10B ), which causes the first fluid F1 to be discharged from the first chamber 212 as described above.

[0140] Although examples of the multi-chamber syringe and method of the present disclosure are shown in the drawings and described in detail above, other examples will be apparent to those skilled in the art and are easily made by those skilled in the art without departing from the scope and spirit of the present invention. Therefore, the foregoing description is intended to be illustrative rather than restrictive. The invention described above is defined by the appended claims, and all changes to the invention that fall within the equivalent meaning and scope of the claims will be included within the scope of the claims.

Claims

1. A multi-chamber syringe for sequentially discharging at least a first fluid and subsequently a second fluid, the syringe comprising: a container comprising a proximal end and a distal end, the distal end comprising a fluid port for discharging the first fluid and the second fluid from the container, wherein the container defines a first chamber for containing the first fluid and a second chamber for containing the second fluid; a first plunger, the first plunger being used to discharge the first fluid from the first chamber; a second plunger for expelling the second fluid from the second chamber; and At least one valve is positioned in the container, the at least one valve being configured to switch between a first position in which fluid is prevented from flowing from the first chamber through the at least one valve, and a second position in which fluid is allowed to flow from the first chamber through the at least one valve to the fluid port to discharge the first fluid from the container.

2. The syringe according to claim 1, wherein: The first chamber and the second chamber extend axially through the container, wherein a longitudinal axis of the first chamber is substantially parallel to a longitudinal axis of the second chamber.

3. The syringe according to claim 1, wherein: When the at least one valve is in the first position, fluid is allowed to flow from the second chamber through the at least one valve to the fluid port to discharge the second fluid from the container, and when the at least one valve is in the second position, fluid is prevented from flowing from the second chamber through the at least one valve.

4. The syringe according to claim 1, wherein: The container includes an upper cylinder including the first chamber and the second chamber and a lower cylinder connected to a distal end of the upper cylinder to enclose the at least one valve.

5. The syringe according to claim 4, wherein: The upper cylinder includes: an open proximal end, a distal end, an annular side wall extending between the open proximal end and the open distal end, and an axially extending partition extending from the open proximal end of the upper cylinder to the distal end of the upper cylinder to separate the first chamber from the second chamber.

6. The syringe according to claim 5 further comprises at least one seal covering the open distal end of the upper barrel, the at least one seal comprising a first opening and a second opening, the first opening being used to allow the first fluid to flow from the first chamber to the at least one valve when the at least one valve is in the second position, and the second opening being used to allow the second fluid to flow from the second chamber through the at least one valve when the at least one valve is in the first position.

7. The syringe according to claim 6, wherein: The first plunger and / or the second plunger include a stopper having a flat distal surface and a protrusion extending from the flat distal surface, the protrusion being positioned to be inserted into the first opening or the second opening to completely discharge the first fluid from the first chamber or to completely discharge the second fluid from the second chamber.

8. The syringe according to claim 1, wherein: The first plunger includes a first stopper located in the first chamber and a first plunger rod connected to and extending from the first stopper through the proximal end of the container.

9. The syringe according to claim 8, wherein: The first plunger rod includes a protrusion configured to contact a portion of the container when the first plunger rod moves through the first chamber, thereby providing feedback that an initial volume of the first fluid has been expelled from the first chamber.

10. The syringe according to claim 1, wherein: The at least one valve includes a body including a passageway that is fluidly connected to the second chamber when the at least one valve is in the first position and that is fluidly connected to the first chamber when the at least one valve is in the second position.

11. The syringe according to claim 10, wherein: The body includes a rotating disk and a knob extending through an opening of the container for rotating the disk between the first position and the second position.

12. The syringe according to claim 1, wherein: The container includes a barrel including an annular sidewall, a frustoconical portion extending from the annular sidewall to the fluid port, and a divider extending through the barrel to separate the first chamber from the second chamber.

13. The syringe according to claim 12, wherein: The first plunger includes a first stopper including a substantially planar distal surface and a first plunger rod connected to and extending proximally from the first stopper, and wherein the second plunger comprises a second stopper and a second plunger rod, the second stopper comprising a semi-conical distal surface dimensioned to be received within the frustoconical portion of the barrel, the second plunger rod being connected to and extending proximally from the second stopper.

14. The syringe according to claim 13, wherein: The first plunger rod includes a first protrusion positioned proximate a distal end of the first plunger rod, the first protrusion being configured to contact the barrel to prevent the first plunger rod from moving distally through the first chamber to expel the first fluid from the first chamber, and Wherein, the second plunger rod includes a second protrusion positioned proximate to the proximal end of the second plunger rod, the second protrusion being configured to contact and depress the first protrusion so that the first plunger rod can move through the first chamber.

15. The syringe according to claim 12, wherein: The at least one valve includes a compressible body that prevents fluid flow from the first chamber to the fluid port in an expanded position and allows fluid flow from the first chamber to the fluid port in a compressed position.

16. The syringe according to claim 15, wherein The barrel includes at least one slot defining a flow passage for fluid to flow from the first chamber to the fluid port, and wherein the at least one slot is positioned such that when the compressible body is in the expanded position, fluid is prevented from flowing through the at least one slot, and when the compressible body is in the compressed position, fluid is allowed to flow through the at least one slot to the fluid port.

17. A prefilled flushing syringe comprising: a container comprising a proximal end and a distal end, the distal end comprising a fluid port for discharging the first fluid and the second fluid from the container, wherein the container defines a first chamber for containing the first fluid and a second chamber for containing the second fluid; a first plunger, the first plunger being used to discharge the first fluid from the first chamber; a second plunger, the second plunger being used to discharge the second fluid from the second chamber; at least one valve positioned in the container, the at least one valve configured to transition between a first position in which fluid is prevented from flowing from the first chamber through the at least one valve and a second position in which fluid is allowed to flow from the first chamber through the at least one valve to the fluid port to discharge the first fluid from the container; and a predetermined volume of the first fluid disposed in the first chamber of the prefilled syringe, The at least one valve is initially in the first position, thereby preventing the first fluid disposed in the first chamber from flowing from the first chamber through the at least one valve.

18. The prefilled syringe of claim 17, wherein: The first fluid is a saline flush solution.

19. A syringe comprising: A housing comprising: (i) an upper barrel comprising an open proximal end, a distal end, a sidewall extending between the proximal end and the distal end, and a divider extending axially through the barrel to divide the barrel into a first chamber configured to contain a first fluid and a second chamber configured to contain a second fluid; and (ii) a lower barrel connected to the distal end of the upper barrel, the lower barrel comprising a fluid port; a first plunger, the first plunger being used to discharge the first fluid from the first chamber; a second plunger for expelling the second fluid from the second chamber; and A manually operable valve is positioned in the lower barrel, the valve being configured to move between a first position to allow fluid to flow from the second chamber through the valve to the fluid port to expel the second fluid from the syringe, and a second position to allow fluid to flow from the first chamber through the valve to the fluid port to expel the first fluid from the syringe.

20. The syringe of claim 19, wherein: The first chamber and the second chamber extend axially through the upper barrel, wherein a longitudinal axis of the first chamber is substantially parallel to a longitudinal axis of the second chamber.

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