Syringe with an integrated easy-open cap

Abstract

The syringe includes a barrel having a proximal end, a distal end including a distal opening, and a sidewall extending between the proximal end and the distal end. The syringe further includes a plunger disposed within the barrel for discharging fluid from the barrel through the distal opening, and a cap including a connector connected to the distal end of the barrel and defining a flow channel through the cap. The cap is movable relative to the barrel between a first position in which fluid is prevented from flowing through the distal opening of the barrel into the flow channel of the connector and a second position in which fluid flow through the distal opening of the barrel into the flow channel of the connector can occur.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to Indian Patent Application No. 202211035493, filed on June 21, 2022, entitled "Syringe with Integrated Easy - Open Cap", the entire disclosure of which is incorporated herein by reference in its entirety.

[0002] Field of the Invention The present disclosure generally relates to syringes, such as pre - filled syringes, and more particularly to syringes having an integrated cap that can be easily opened by a user, preferably with one hand.

Background Art

[0003] Description of Related Art Conventional syringes comprise a barrel having an open proximal end and an opposing distal end. The distal tip sometimes referred to as a luer, protrudes from the distal end of the syringe barrel and includes a narrow passage or channel that is in fluid communication with the interior of the syringe barrel. These conventional syringes are often pre - filled with a medical fluid, such as a flush solution or a therapeutic agent, during manufacture. When pre - filled with a medical fluid, the syringe barrel can be sealed to prevent contamination or loss of the medical fluid prior to use. The seal also prevents the operator from being unnecessarily exposed to the medicament contained in the syringe barrel, which can be particularly important for toxic or other harmful agents.

[0004] Some prefilled syringes have a stopper or closure, often referred to as a tip cap, attached to the distal tip of the syringe barrel to seal the syringe barrel, prevent leakage, and avoid contamination of the medical fluid contained therein. Prior art tip caps are removed from the distal tip of the syringe barrel by the operator by grasping the tip cap and axially pulling the tip cap away from the syringe immediately prior to use of the syringe. When the prefilled syringe is fitted with a tip cap, it is particularly important that a good seal is maintained. This is usually achieved by firmly fixing the tip cap to the distal end of the syringe barrel. However, if tightened too much, the tip cap can be difficult to remove and can be damaged. Further, the prefilled syringe is autoclaved after filling and plugging, and the prefilled syringe is contained within a sterile package. The autoclaving procedure causes an interaction between the tip cap and the syringe barrel, which can further increase the difficulty of removing the tip cap from the distal tip of the syringe barrel.

[0005] Due to the tight connection between the tip cap and the distal tip of the syringe barrel, the operator may be required to apply a significant gripping force to remove the tip cap from the distal end of the syringe barrel. In particular, considering the small size of a typical tip cap, it can be difficult for a significant number of operators, who may lack the physical strength and dexterity required to correctly grasp the tip cap, to firmly grip the tip cap. Further, when firmly gripping the tip cap, the operator's finger is in close proximity to the distal tip of the syringe barrel. Thus, there is a risk that the operator will contact the distal tip of the barrel while removing the tip cap, which can contaminate the distal tip of the syringe barrel.

[0006] Just before the procedure is performed, but when the tip cap is removed, the luer tip at one end of the syringe barrel is exposed to a non-sterile environment, which provides an additional opportunity for unwanted contamination. Further, in some cases, the operator may remove the tip cap to perform preparatory work (e.g., to flush air from the syringe barrel) and then reattach the same tip cap to the distal tip of the syringe before performing the fluid delivery procedure. This reattachment of the tip cap is yet another opportunity for contamination of the distal tip of the syringe barrel.

[0007] Prefilled syringes are often connected to vascular access devices (VADs), such as intravenous (IV) catheters like peripheral catheters and central venous catheters, and are used to deliver fluid to a patient through these. If not properly maintained, or if exposed to a non-sterile environment, which can occur when the operator manipulates or removes the tip cap from the syringe barrel as described above, the VAD can become contaminated and occluded with thrombus and / or can spread infection. Many healthcare facilities implement sterilization procedures and protocols to avoid contamination and ensure that the VAD is properly used and not occluded or infected. These protocols often include sterilizing medical devices including the VAD and flushing the catheter with a flush solution. Specifically, the implementation criteria for VADs typically recommend that a flush procedure be performed after catheter placement, before fluid infusion, and before and after drug administration, blood sampling, blood transfusion, and / or enteral nutrition administration. These flush procedures are intended to confirm catheter patency, avoid drug incompatibilities, ensure that the full dose of the drug is administered to the patient, prevent thrombus formation, and minimize the risk of bloodstream infection caused by contamination of the VAD.

Prior Art Documents

Patent Documents

[0008]

Patent Document 1

[0009] Sterilization procedures performed in medical facilities do, to some extent, address the risk of contamination, but there is a need for an improved design for medical devices that reduces the opportunity for contamination and simplifies the use of the devices. In particular, throughout the fluid delivery procedure using a VAD, a syringe design that ensures that the distal tip of the syringe barrel remains sterile and uncontaminated will address many of the current contamination problems. Further, a syringe and cap design that is easy to open or remove and can be operated without touching the distal tip of the syringe will reduce the common contamination risks associated with conventional prefilled syringes. The syringe and integrated cap designs of the present disclosure address these problems. MEANS FOR SOLVING THE PROBLEMS

[0010] SUMMARY OF THE INVENTION According to one aspect of the present disclosure, a syringe includes a barrel having a proximal end, a distal end including a distal opening, and a sidewall extending between the proximal end and the distal end. The syringe further includes a plunger disposed within the barrel and configured to expel fluid from the barrel through the distal opening, and a connector defining a flow channel through the cap and coupled to the distal end of the barrel, the cap including a cap coupled to the distal end of the barrel. The cap is movable relative to the barrel between a first position in which fluid is prevented from flowing through the distal opening of the barrel into the flow channel of the connector and a second position in which fluid flow through the distal opening of the barrel into the flow channel of the connector can occur.

[0011] According to another aspect of the present disclosure, a prefilled flushing syringe includes the aforementioned syringe and a predetermined amount of fluid disposed within the barrel of the prefilled syringe. The cap of the aforementioned syringe is initially in a first position, thereby preventing the fluid within the barrel from passing through the open distal end of the barrel into the flow channel of the connector.

[0012] According to another aspect of the present disclosure, a method of discharging fluid from the aforementioned syringe includes moving the cap of the aforementioned syringe from a first position to a second position, whereby fluid flow from the barrel into the flow channel of the connector is permitted; attaching the connector of the cap to a vascular access device; and moving the plunger through the barrel to discharge fluid from the barrel through the flow channel of the connector into the vascular access device.

[0013] Next, non-limiting exemplary examples of embodiments of the present disclosure will be described in the following numbered items.

[0014] Item 1: A syringe comprising a barrel having a proximal end, a distal end having a distal opening, and a sidewall extending between the proximal end and the distal end; a plunger disposed within the barrel for discharging fluid from the barrel through the distal opening; and a cap connected to the distal end of the barrel, the cap comprising a connector defining a flow channel therethrough, wherein the cap is movable relative to the barrel between a first position preventing fluid from flowing through the distal opening of the barrel into the flow channel of the connector and a second position allowing fluid flow from the distal opening of the barrel into the flow channel of the connector.

[0015] Item 2: The syringe of Item 1, wherein the cap rotates relative to the barrel to move from the first position to the second position.

[0016] Item 3: The syringe of Item 1 or Item 2, wherein the cap rotates about the longitudinal axis of the barrel to move from the first position to the second position.

[0017] Item 4: A syringe of any one of Items 1 - 3, wherein the cap is configured to be manually moved from a first position to a second position.

[0018] Item 5: The syringe of Item 4, wherein the syringe can be operated with one hand both to move the cap from the first position to the second position and to discharge fluid from the barrel through the flow channel of the connector by moving the plunger through the barrel.

[0019] Item 6: The syringe according to any one of Items 1 - 5, wherein the barrel comprises at least one of polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene.

[0020] Item 7: The syringe of any one of Items 1 - 6, wherein the barrel further comprises an annular flange around the proximal end of the barrel for gripping the barrel and the plunger to move the plunger through the barrel.

[0021] Item 8: The syringe of any one of Items 1 - 7, wherein the plunger comprises a stopper disposed within the barrel and a plunger rod extending proximally from the stopper through the proximal end of the barrel.

[0022] Item 9: The syringe of Item 8, wherein the stopper comprises a thermoplastic elastomer such as isoprene.

[0023] Item 10: The syringe of Item 8 or Item 9, wherein the stopper comprises a proximal end, a distal end, and an outer surface extending between the proximal end and the distal end and sealingly contacting the inner surface of the barrel.

[0024] Item 11: A syringe of any of Items 8 - 10, wherein the plunger rod is inserted into the cavity of the stopper and includes a connector portion that engages with the cavity of the stopper to fix the stopper to the plunger rod.

[0025] Item 12: A syringe of any of Items 1 - 11, wherein the connector of the cap includes at least one of a luer connector, a screw connector, or a snap connector.

[0026] Item 13: A syringe of any of Items 1 - 12, wherein the connector is tapered and the outer diameter of the proximal end of the connector is wider than the outer diameter of the distal end of the connector.

[0027] Item 14: A syringe of any of Items 1 - 13, further comprising a barrel seal disposed between the distal opening of the barrel and the cap, the barrel seal including at least one hole for the flow of fluid from the barrel to the flow channel of the connector.

[0028] Item 15: The syringe of Item 14, wherein the barrel seal includes a disk portion disposed on the distal end of the barrel and an annular wall portion extending from the disk portion and in contact with the inner surface of the barrel, and the at least one hole penetrates the disk portion.

[0029] Item 16: The syringe of Item 15, wherein the outer surface of the annular wall portion includes a groove configured to receive a corresponding protrusion of the barrel to limit rotation of the seal with respect to the barrel.

[0030] Item 17: The syringe of Item 16, wherein the groove includes an axial groove extending between the proximal end and the distal end of the annular wall of the barrel seal.

[0031] Item 18: A syringe of any one of Items 15 - 17, wherein the barrel seal comprises an annular ridge extending proximally from the proximal face of the disk portion and is received within a corresponding annular groove at the distal end of the barrel.

[0032] Item 19: A syringe of any one of Items 15 - 18, wherein the barrel seal further comprises a lip extending radially inwardly from the annular wall portion of the barrel seal, and the lip is configured to engage with the cap to hold the proximal portion of the cap within the barrel seal.

[0033] Item 20: A syringe of any one of Items 15 - 19, further comprising a plug that engages with the cap, the plug moves when the cap moves from a first position to a second position, and when the cap is in the first position, the plug is over at least one hole of the barrel seal to prevent fluid from flowing through at least one hole of the barrel seal into the flow channel of the connector, and when the cap is in the second position, the plug is spaced apart from at least one hole of the barrel seal to allow fluid to flow from the barrel through at least one hole of the barrel seal into the flow channel of the connector.

[0034] Item 21: The syringe of Item 20, wherein the plug comprises a seal portion that moves over at least one hole of the barrel seal and at least one arm extending from the seal portion and engaged with a part of the cap.

[0035] Item 22: The syringe of Item 20 or Item 21, wherein the end of at least one arm of the plug is pivotally connected to the inner surface of the cap, and when the cap moves from the first position to the second position, the plug can move to expose at least one hole of the barrel seal.

[0036] Item 23: A syringe according to any one of Items 20 - 22, wherein the cap comprises at least one pair of protrusions extending radially inward from the inner surface of the cap, and the end of at least one arm of the plug is disposed between the pair of protrusions, and when the cap rotates from the first position to the second position, the protrusions move the plug.

[0037] Item 24: A syringe according to any one of Items 20 - 23, wherein the plug further comprises a strut inserted into a hole in the disk portion of the seal that forms a rotation point when the cap moves from the first position to the second position.

[0038] Item 25: A syringe according to any one of Items 20 - 24, wherein the plug is configured to be disposed over at least one hole of the barrel seal to seal at least one hole of the barrel seal when the cap is in the first position.

[0039] Item 26: A syringe according to Item 25, wherein the plug further comprises a body containing a rigid thermoplastic material, and the elastomeric seal is attached or adhered to the body of the plug.

[0040] Item 27: A syringe according to any one of Items 14 - 26, wherein at least one hole of the barrel seal is axially aligned with the distal opening of the barrel, and the diameter of at least one hole of the barrel seal is smaller than the diameter of the distal opening of the barrel.

[0041] Item 28: A syringe according to any one of Items 14 - 27, wherein the barrel seal comprises a thermoplastic elastomer material.

[0042] Item 29: A syringe according to any one of Items 14 - 28, wherein the barrel seal remains stationary when the cap moves from the first position to the second position.

[0043] Item 30: A syringe according to any one of Items 1 - 29, wherein the cap further comprises a shield extending around the connector, the shield having an inner surface with threads configured to engage the threads of the female connector, the syringe and the cap being fixed to the female connector.

[0044] Item 31: A syringe according to Item 30, wherein the distal end of the connector projects beyond the distal end of the shield.

[0045] Item 32: A syringe according to Item 30 or Item 31, wherein the direction of rotation for connecting the syringe to the female connector is opposite to the direction of rotation for moving the cap from the first position to the second position.

[0046] Item 33: A syringe according to any one of Items 30 - 32, wherein the barrel further comprises an extension extending distally from the distal end of the barrel, the cap being connected to the extension and at least partially surrounded by the extension.

[0047] Item 34: A syringe according to Item 33, wherein the extension comprises a proximal end extending from the distal end of the barrel, an open distal end, and an annular sidewall extending between the proximal end and the distal end.

[0048] Item 35: A syringe according to Item 33 or Item 34, wherein the sidewall of the barrel comprises a tapered portion between the distal end of the barrel and the other part of the barrel for guiding the fluid in the barrel towards the distal opening of the barrel.

[0049] Item 36: A syringe according to any one of Items 33 - 35, wherein the cap comprises at least one tab extending radially outward from the shield for rotating the cap relative to the barrel.

[0050] Item 37: A syringe according to any one of Items 33 - 36, wherein the cap further comprises a rotating ring with at least one tab, the rotating ring extends around the shield of the cap and the extension of the barrel, and the rotating ring is configured to be rotated by a user to move the cap between a first position and a second position.

[0051] Item 38: A syringe according to Item 37, wherein the cap comprises a plurality of tabs extending radially outward from the shield, and the plurality of tabs are connected to the rotating ring at different positions around the circumference of the ring to support the rotating ring.

[0052] Item 39: A syringe according to any one of Items 36 - 38, wherein the extension comprises at least one slot, at least one tab of the cap extends through the slot, and at least one tab can be grasped by a user to rotate the cap relative to the barrel.

[0053] Item 40: A syringe according to Item 39, wherein at least one slot extending from the distal end of the extension comprises an axial portion for inserting the cap into the extension and a circumferential portion for rotating the cap relative to the barrel between a first position and a second position.

[0054] Item 41: A syringe according to Item 39 or Item 40, wherein at least one slot comprises at least one protrusion protruding from the surface of the slot, and the protrusion restricts the sliding of at least one tab through the slot to lock the cap to the extension.

[0055] Item 42: A syringe according to any one of Items 33 - 41, wherein the extension further comprises a protrusion on the inner surface of the extension to limit the rotation of a barrel seal disposed on the distal opening of the barrel.

[0056] Item 43: The syringe of Item 42, wherein the protrusion comprises a ridge, rib, or columnar body that extends axially on the inner surface of the extension.

[0057] Item 44: A prefilled flushing syringe, the prefilled flushing syringe comprising the syringe of any of Items 1-43 and a predetermined amount of fluid disposed within the barrel of the prefilled syringe, wherein the cap is initially in a first position, thereby preventing the fluid within the barrel from passing through the open distal end of the barrel into the flow channel of the connector.

[0058] Item 45: The prefilled syringe of Item 44, wherein the fluid comprises a saline flush solution.

[0059] Item 46: The prefilled syringe of Item 44 or Item 45, wherein the fluid comprises a therapeutic agent.

[0060] Item 47: The prefilled syringe of any of Items 44-46, wherein the barrel contains from about 1 mL to about 50 mL of fluid.

[0061] Item 48: A method of discharging fluid from the syringe of any of Items 1-43, the method comprising moving the cap from a first position to a second position, allowing fluid to flow from the barrel into the flow channel of the connector, attaching the connector of the cap to a vascular access device, and moving the plunger through the barrel to discharge fluid from the barrel and through the flow channel of the connector into the vascular access device.

[0062] Item 49: The method of Item 48, wherein the fluid contained within the barrel of the syringe comprises a saline flush solution.

[0063] Item 50: The method according to item 48 or 49, wherein the fluid contained within the barrel of the syringe comprises a therapeutic agent.

[0064] Item 51: The method according to any one of items 48 - 50, wherein the barrel contains from about 1 mL to about 50 mL of fluid.

[0065] Item 52: The method according to any one of items 48 - 51, wherein the cap is manually moved from a first position to a second position by grasping a portion of the cap and rotating the cap about the longitudinal axis of the syringe.

[0066] Item 53: The method according to item 52, wherein the cap is manually moved from a first position to a second position by grasping a portion of the cap with one hand.

[0067] Item 54: The method according to any one of items 48 - 53, further comprising advancing the plunger a small amount through the barrel prior to attaching the syringe to the VAD to remove air from the interior of the barrel.

[0068] Item 55: The method according to any one of items 48 - 54, wherein the step of attaching the cap to the VAD comprises inserting the distal end of the connector through the septum of the fluid port of the VAD and twisting the syringe such that the threads of the syringe engage the corresponding threads of the female connector of the VAD.

[0069] Item 56: The method according to item 55, wherein the cap is moved from a first position to a second position by rotating the cap in a first direction relative to the barrel, and the cap is attached to the VAD by rotating the syringe in a second direction opposite to the first direction.

[0070] Item 57: A method according to any one of Items 48-56, wherein the connector comprises a male Luer connector, and the cap is attached to the female Luer connector of the VAD by inserting the male Luer connector into the female Luer connector.

Brief Description of the Drawings

[0071]

Figure 1A

Figure 1B

Figure 2A

Figure 2B

Figure 2C

Figure 3A

Figure 3B

Figure 3C

Figure 4A

Figure 4B

Figure 4C

Figure 4D

Figure 5A

Figure 5B

Figure 6A

Figure 6B

Figure 6C

Figure 7A

Figure 7B

Figure 7C

Figure 8

[0072] Description of the Invention The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the present invention. However, various modifications, equivalents, variations, and alternatives will remain readily apparent to those skilled in the art. All such modifications, variations, equivalents, and alternatives are intended to be included within the spirit and scope of the present invention.

[0073] In the following, for purposes of explanation, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and derivatives thereof will relate to the present invention as it is oriented in the drawings. As used herein, the term "proximal" refers to a part or end of a device, such as a syringe or catheter, that is grasped, manipulated, or used by an operator or other user. The term "distal" refers to the end or part of a device that is furthest from the part of the device that is grasped, manipulated, or used by an operator. For example, the "proximal end" of a catheter or IV line refers to the end that includes a fluid port connected to a fluid container, such as an IV bag or syringe. The "distal end" of a catheter or IV line refers to the end that is connected to a patient. However, it should be understood that the present invention may employ alternative, modifications, and process sequences, except where specifically stated otherwise. Also, it should be understood that the specific devices and methods shown in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. Accordingly, the specific dimensions and other physical characteristics related to the embodiments disclosed herein should not be considered as limiting.

[0074] Referring to the figures, the present disclosure relates to a syringe 10, such as a prefilled syringe, configured to be used by an operator to deliver a medical fluid to a patient, e.g., via a vascular access device (VAD). The operator can be, for example, a medical technician, a nurse, a physician's assistant, a physician, or other trained or untrained clinician or healthcare provider. The medical fluid can be, for example, saline and / or a flush solution such as a heparin lock flush solution. An example of a saline flush solution is 0.9% sodium chloride USP for injection. An example of a heparin lock flush solution is 0.9% sodium chloride containing 100 USP units of sodium heparin per mL, or 10 USP units of sodium heparin per mL. Other flush solutions known in the art can also be used with the syringe 10 of the present disclosure. The medical fluid can also be, as is known in the art, a drug, a total parenteral nutrition (TPN) solution, or other therapeutic agent used in the treatment of chronic or acute diseases. Exemplary therapeutic agents can include, for example, drugs, chemicals, biological or biochemical substances that achieve a desired therapeutic effect when delivered to the patient in a therapeutically effective amount.

[0075] As described above, the syringe 10 of the present disclosure is intended to reduce the risk of contamination and ensure that the distal end of the syringe barrel remains sterile and free of contamination before and during connection to a VAD. Further, the syringe 10 of the present disclosure is designed for easy operation and, in particular, to avoid the difficulties associated with removing the tip cap of a conventional prefilled syringe. In some particularly advantageous examples, the syringe 10 of the present disclosure can be operated with one hand by an operator. Specifically, the operator can open and close the syringe cap with one hand by, for example, pressing, sliding, pulling, or otherwise manipulating a tab of the syringe cap, as described in more detail herein. In contrast, as described above, in the case of a conventional prefilled syringe, the operator is required to hold the syringe barrel with one hand and grasp the tip cap with the other hand to pull the tightly fitted tip cap away from the distal end of the syringe barrel. Once the syringe cap is opened, the operator can expel the medical fluid from the syringe barrel of the syringe 10 with one hand, for example, by pushing a plunger or stopper through the syringe barrel.

[0076] In some examples, the syringe 10 of the present disclosure is provided as a prefilled syringe containing a flush solution or other medical fluid. The prefilled syringe 10 may also include a cap, clip, retainer, and / or other packaging to hold the plunger rod in place and ensure that the flush solution or other medical fluid does not leak from the prefilled syringe 10 during unexpected times such as during transportation.

[0077] Syringe with an integrated cap Referring to FIGS. 1A and 1B, syringe 10 of the present disclosure includes a barrel 12, which can include a proximal end 14, a distal end 16 having a distal opening 18 (most clearly shown in FIG. 2C), and a side wall 20 extending between the proximal end 14 and the distal end 16. Syringe 10 further includes a plunger 22 disposed within barrel 12 for discharging medical fluid F (shown in FIGS. 6A, 6B, 7A, and 7B) from barrel 12 through the distal opening 18. Syringe 10 further includes a cap 24, valve, cover, sealing device, or similar structure connected to the distal end 16 of barrel 12 for sealing medical fluid F within barrel 12 and for guiding the flow of fluid from the interior of barrel 12 and discharging medical fluid F from barrel 12. In some examples, cap 24 includes a connector 26 or stem extending distally from the distal end 16 of barrel 12. Connector 26 can be an elongated and / or tubular member defining a flow path or flow path channel 28 extending from the proximal end 30 of cap 24 to the distal end or distal tip 32 of connector 26. As described in more detail herein, connector 26 can be a male needleless connector configured to be inserted into a female needleless connector, such as a female connector forming a fluid port or opening of a VAD. For example, cap 24 can be configured to be used with a female needleless connector, such as a female luer connector, within a range of dimensions acceptable by various design protocols, such as ISO80369-7:2016 or ISO80369-7:2021 (dimensions of a female luer lock connector). In some specific examples, cap 24 can be sized to engage a female needleless connector having threads with a width of about 0.3 mm to about 1.0 mm at the top of each thread and a width of about 0.5 mm to about 1.2 mm at the base of each thread.

[0078] When the connector 26 is inserted into the female connector, fluid communication is established between the VAD and the interior of the barrel 12 via the cap 24. Further, the cap 24 is in a closed position or a first position (shown in FIGS. 6A-6C) with respect to the barrel 12 that prevents fluid flow from the barrel 12 through the distal opening 18 of the barrel 12 to the flow channel 28 of the connector 26, and an open position or a second position (shown in FIGS. 7A-7C) where fluid flow to the VAD through the distal opening 18 of the barrel 12 and the flow channel 28 of the connector 26 can occur. For example, the cap 24 can be configured to twist or rotate about the longitudinal axis L1 of the barrel 12 and the syringe 10 (shown in FIGS. 1A, 6A, 6B, 7A, and 7B), which moves the cap 24 from the closed position (shown in FIGS. 6A-6C) to the open position (shown in FIGS. 7A-7C).

[0079] In some examples, the cap 24 is configured to be manually movable, which means that the operator can grasp a portion of the cap 24 and rotate, twist, slide, or move the cap 24 from the closed position to the open position. Further, as described above, the cap 24 can be configured to be operated with one hand. In particular, the operator can preferably move the cap 24 from the closed position to the open position using one hand and can also discharge the medical fluid F from the barrel 12 through the flow channel 28 of the connector 26 by moving the plunger 22 through the barrel 12.

[0080] Continuing to refer to FIGS. 1A and 1B, as well as FIGS. 2A-2C, barrel 12 can be a conventional fluid delivery syringe barrel for use in medical procedures, which is manufactured, for example, by an injection molding process. For example, barrel 12 can be substantially similar in shape, size, and configuration to the barrel of a syringe used to administer a flush solution to a VAD, as is known in the art. In some examples, barrel 12 can be a cylindrical or elliptical columnar structure formed from a rigid thermoplastic material such as polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, acrylonitrile butadiene styrene, or other injection molding or moldable resin materials known in the art. An exemplary barrel 12 for a flush syringe similar to barrel 12 of the present disclosure is described, for example, in Patent Document 1 titled "Flush Syringe Assembly with Controlled Pulsatile Flushing", which is hereby incorporated by reference in its entirety. The dimensions of syringe barrel 12 can be determined based on the type of fluid injection being performed. In particular, barrel 12 can be configured to contain various fluid volumes depending on the type and amount of fluid delivered from barrel 12 to the patient. For example, barrel 12 can define an interior that houses from about 1 mL to about 50 mL of medical fluid, or preferably from about 5 mL to 20 mL of medical fluid.

[0081] In some examples, the sidewall 20 of the barrel 12 comprises a tapered portion 34 (shown in FIGS. 2A-2C) near the distal end 16 of the barrel 12. For example, the tapered portion 34 can be disposed between the distal end 16 of the barrel 12 and other portions of the sidewall 20 of the barrel 12. The tapered portion 34 is configured to direct fluid within the barrel 12 toward the distal opening 18 of the barrel 12 and to discharge the medical fluid within the barrel 12 through the distal opening 18 toward the flow path or flow channel 28 of the connector 26. The tapered portion 34 has an inclined surface or angled surface corresponding to the distal face of a stopper or plunger 22 that moves through the interior of the barrel 12 and is shaped to reduce dead space and ensure that fluid moves through the barrel 12 to the distal opening 18. Reducing or eliminating the dead space between the stopper or plunger 22 and the distal end 16 of the barrel 12 helps ensure that an appropriate or expected amount of fluid is discharged from the barrel 12 and delivered to the patient. In some examples, the barrel 12 further comprises a finger flange 36 or grip. For example, as shown in FIGS. 1A and 1B, the finger flange 36 can extend around the proximal end 14 of the barrel 12 to grasp the barrel 12 and the plunger 22 and move the plunger 22 through the barrel 12.

[0082] Continuing to refer to FIGS. 1A and 1B, syringe 10 further includes a plunger 22 configured to move through the interior of syringe barrel 12 to draw medical fluid into the interior of syringe barrel 12 (if syringe 10 is not a prefilled syringe) and / or to expel fluid F from barrel 12 through the flow path or flow channel 28 of connector 26. Plunger 22 may include a stopper 38 and a plunger rod 40 connected to stopper 38 and extending from stopper 38 through the proximal end 14 of barrel 12. Stopper 38 may have many aspects of conventional syringe stoppers or plungers known in the art. For example, stopper 38 may include a thermoplastic elastomer material such as polypropylene or polyethylene, as well as synthetic or natural rubber (e.g., isoprene). Further, stopper 38 may include a proximal surface 42 or proximal end, a distal surface 44 or distal end, and an outer peripheral surface 46 extending between proximal surface 42 and distal surface 44. Outer peripheral surface 46 may be configured to seal against the inner surface of side wall 20 of barrel 12 to move medical fluid F through barrel 12. In some examples, the distal end or distal surface 44 of stopper 38 may be tapered with an inclination or angle that matches the tapered portion 34 of side wall 20 of barrel 12, as described above.

[0083] The plunger 22 also includes a plunger rod 40 connected to the stopper 38. The plunger rod 40 can be an injection molded part formed from a rigid thermoplastic material such as, for example, polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or other thermoplastic materials known in the art. The plunger rod 40 can include a distal end 48 that engages the stopper 38. For example, the distal end 48 of the plunger rod 40 can include a corresponding cavity in the proximal face 42 of the stopper 38 or a connector (not shown) that is inserted into a slot. The plunger rod 40 can also include a proximal end 50 that projects proximally through the proximal end 14 of the barrel 12, and a body that extends between the proximal end 50 and the distal end 48 of the plunger rod 40. The proximal end 50 of the plunger rod 40 can include a thumb press plate 52 for operating the plunger rod 40 to move the plunger rod 40 and the stopper 38 through the syringe barrel 12. The body of the plunger rod 40 can have various cross-sectional shapes and structures within the scope of the present disclosure. For example, the body can have a generally cross-shaped cross-section. In other examples, the cross-section of the plunger rod 40 can be an I-beam shape, a hollow circle, a hollow square, a hollow rectangle, or an L-shape.

[0084] Continuing to refer to FIGS. 1A and 1B, and FIGS. 3A - 3C, the syringe 10 further includes a barrel seal 54 or gasket for sealing the distal opening 18 of the barrel 12 to ensure that fluid passing through the distal opening 18 of the barrel 12 passes through the flow path or flow channel 28 of the connector 26. As shown in FIG. 3C, the barrel seal 54 can be disposed near the distal opening 18 of the barrel 12 between the distal end 16 of the barrel 12 and the cap 24. The barrel seal 54 can be formed from an elastomeric material such as silicon, rubber, isoprene, or a similar flexible elastomer, and seals the distal end 16 and the distal opening 18 of the barrel 12.

[0085] In some examples, the barrel seal 54 includes a substantially flat sheet or disk portion 57 disposed on the distal end 16 of the barrel 12, and an annular wall portion 59 that extends distally from the disk portion 57 and is disposed in contact with a portion of the annular inner surface of the barrel 12. The barrel seal 54 also includes an opening, perforation, or fluid port, such as a through-hole 56, that extends through the disk portion 57 and that enables fluid to flow from the barrel 12 into the flow channel 28 of the connector 26.

[0086] As shown in FIG. 3C, the hole 56 of the barrel seal 54 can be axially aligned with the distal opening 18 of the barrel 12 along the longitudinal axis L1 of the syringe 10 (shown in FIGS. 1A, 6A, 6B, 7A, and 7B), which means that the axis L1 passes through the center of the hole 56 and the center of the distal opening 18. For example, as shown in FIG. 3C, the hole 56 of the barrel seal 54 can be smaller than the distal opening 18 of the barrel 12 (e.g., can have a smaller diameter and / or area). In some examples, the barrel seal 54 also includes a structure for maintaining the position of the barrel seal 54 on the distal opening 18 of the barrel 12. For example, the barrel seal 54 can include a proximal ridge 58 or O-ring that extends from the proximal face of the barrel seal 54 and that is disposed within a corresponding groove 62 of the distal end 16 of the barrel 12. The engagement between the ridge 58 or O-ring and the groove 62 can ensure that the barrel seal 54 stays in place and does not slide relative to the distal end 16 or the distal opening 18 of the barrel 12. The ridge 58 can also seal the distal opening 18 and prevent fluid from accumulating in the space between the distal end 16 of the barrel 12 and the barrel seal 54.

[0087] Referring to FIGS. 3A - 3C, the barrel seal 54 may also include a lip 61 or an inwardly directed ridge that extends radially inwardly from the annular wall portion 59 of the barrel seal 54. The lip 61 may be arranged to engage the cap 24 and hold the proximal portion of the cap 24 within the barrel seal 54. Thus, the engagement between the lip 61 and the cap 24 ensures that the cap 24 remains seated within the barrel seal 54 and restricts distal movement of the cap 24 away from the barrel seal 54 when the cap 24 rotates between the closed and open positions. However, in some examples, it should be noted that when the cap 24 moves from the closed position to the open position, the cap 24 may lift slightly from the barrel seal 54, creating a gap between the disk portion 57 of the barrel seal 54 and the cap 24. However, the width of the gap between the barrel seal 54 and the cap 24 is restricted by the engagement between the cap 54 and the lip 61.

[0088] Referring to FIGS. 1A and 1B, and FIGS. 5A and 5B, the syringe 10 further includes a plug 63 or valve that engages the cap 24. The plug 63 is configured to move away from the aperture 56 of the barrel seal 54 when the cap 24 moves from the closed position to the open position. In particular, when the cap 24 is in the closed position (shown in FIGS. 6A - 6C), the plug 63 is over the aperture 56 of the barrel seal 54, preventing fluid from flowing through the aperture 56 into the flow path or flow channel 28 of the connector 26. When the cap 24 is in the open position, the plug 63 is at least partially spaced from the aperture 56 of the barrel seal 54, allowing fluid to flow from the barrel 12 through the aperture 56 into the flow path or flow channel 28 of the connector 26.

[0089] In some examples, the plug 63 has a seal portion 64 sized to move over and cover the hole 56 to prevent fluid flow through the hole 56. The plug 63 also includes one or more elongate members or arms 65a, 65b extending from the seal portion 64, which can be configured to engage or be connected to a portion of the cap 24 to rotate the plug 63 as indicated by arrow A5 (in FIGS. 6C and 7C). For example, as shown in FIGS. 5A and 5B, the plug 63 includes a first arm 65a extending from the seal portion 64 in a first direction and a second arm 65b extending from the seal portion 64 in a second direction. The arms 65a, 65b of the plug 63 include free ends 67a, 67b, which can contact and / or be pivotally connected to the inner surface of the cap 24. Engagement between one or both of the free ends 67a, 67b and the cap 24 causes movement of the cap 24 to result in movement of the plug 63 to expose the hole 56 of the barrel seal 54.

[0090] In some examples, the cap 24 can include a structure, such as a protrusion 68, rib, slot, notch, gap, or other structure, that contacts the plug 63 to transmit movement of the cap 24 to the plug 63. For example, as shown in FIGS. 4B, 6C, and 7C, the cap 24 includes a pair of protrusions 68. The free end 67a of the first arm 65a is positioned between the protrusions 68 such that rotation of the cap 24 is transmitted to the plug 63, which results in movement of the plug 63 away from the hole 56 as the cap 24 moves from a closed position to an open position. The plug 63 can also include a post 70 or pivot point that is received within a hole 71 in the distal surface 66 of the barrel seal 54. The plug 63 is configured to rotate about the post 70 or pivot point (shown by arrow A3 in FIG. 5B), which moves the seal portion 64 of the plug 63 towards or away from the hole 56.

[0091] Continuing to refer to FIGS. 5A and 5B, the plug 63 can be formed from separate components that are adhesively joined together to form the plug 63. For example, the plug 63 can include an elastomeric seal 72 at a seal portion 64 of the plug 63, which is configured to be disposed over a hole 56 of the barrel seal 54 to seal the hole 56 of the barrel seal 54 when the cap 24 is in the closed position. The elastomeric seal 72 can be formed from an elastomeric material such as silicon, polypropylene, polyethylene, isoprene, or natural rubber. The plug 63 can further include a body 73, which comprises a more rigid material such as a rigid thermoplastic material to support the elastomeric seal 72. In particular, the body 73 is preferably sufficiently rigid to rotate and move towards or away from the hole 56 of the barrel seal 54 when the cap 24 moves or rotates.

[0092] Referring to FIGS. 1A and 1B, and FIGS. 4A and 4B, syringe 10 further includes a cap 24 that is connected to the distal end 16 of barrel 12 and is received within barrel seal 54. For example, as described in more detail herein, barrel 12 may include a locking structure such as a slot, groove, detent, protrusion, ridge, or similar structure to provide a mechanical engagement between cap 24 and barrel 12, thereby securing cap 24 to barrel 12 near the distal opening 18 of barrel 12. Cap 24 includes a stem or connector 26 that defines a flow path or flow channel 28, which permits fluid flow from barrel 12 through connector 26. As described above, in some examples, connector 26 of cap 24 includes a male Luer connector. As used herein, a "Luer connector" refers to a connector that includes a tapered portion (i.e., a Luer taper) to create a frictional engagement between connector 26 and a tapered cavity, such as a cavity of a female Luer connector configured to receive and engage a tapered connector 26. For example, connector 26 may be a tapered, elongated structure where the outer diameter of the proximal end of connector 26 is larger than the outer diameter of the distal tip 32 of connector 26. Connector 26 may be configured to be directly or indirectly connected to a fluid port, valve, or other terminal access portion of a VAD, including a female Luer connector. For example, a common type of fluid port of a VAD is a pierceable septum or pre-slit septum made of rubber or other elastomeric material, which permits insertion of a blunt, elongated member such as distal tip 32 of connector 26 or a frustoconical tip to inject fluid or draw fluid from a catheter of the VAD. Connector 26 of the present disclosure may be sized to be inserted through a septum of a VAD, which establishes fluid communication between barrel 12 and the VAD through connector 26.

[0093] In some examples, the cap 24 further includes a shield 74 that extends around the connector 26. The shield 74 can be an annular or tubular structure having a proximal end connected to the proximal end of the connector 56 and an open distal end 76 that surrounds or encloses the connector 26. The shield 74 includes an inner surface having threads 78 configured to engage the threads of the female connector to secure the syringe 10 and the cap 24 to the female connector. As described above, the threads 78 of the shield 74 can be configured to mate with female connectors having different thread arrangements, such as a female connector having threads with a width of about 0.3 mm to about 1.0 mm at the top of each thread and a width of about 0.5 mm to about 1.2 mm at the base of the thread.

[0094] The distal tip 32 or distal end of the connector 26 can extend distally beyond the open distal end 76 of the shield 74 such that the distal end or distal tip 32 of the connector 26 can be inserted through an opening or a cover or septum on a fluid port of the female connector. In some examples, the cap 24 can be configured to rotate in a first direction (shown by arrow A1 in FIG. 1A) to move the cap 24 from a closed position to an open position. The threads 78 on the inner surface of the shield 74 can be arranged such that the cap 24 and the syringe 10 are rotated in an opposite direction or a second direction (shown by arrow A2 in FIG. 1A) to secure the cap 24 and the syringe 10 to the female connector and to discharge fluid from the syringe 10 to the VAD.

[0095] Continuing to refer to FIGS. 1A and 1B, as well as FIGS. 2A-2C, the barrel 12 may further comprise a structure for securing a cap 24 over the distal opening 18 of the barrel 12, and fluid flows through the distal opening 18 into the flow path or flow channel 28 of the connector 26. For example, the barrel 12 may include an extension 80 that extends distally from the distal end 16 of the barrel 12. As shown in FIGS. 1A and 1B, the cap 24 is connected to the extension 80 and at least partially surrounded by the extension 80. The extension 80 may be an annular or tubular structure having a proximal end 82 that extends from the distal end 16 of the barrel 12, an open distal end 84, and an annular sidewall 86 that extends between the proximal end 84 and the distal end 84. In some examples, the cap 24 may be inserted or press-fit into the extension 80 through the open distal end 84 of the extension 80. The extension 80 may be integrally formed with the remainder of the barrel 12 or may be a separate component that is connected to the remainder of the barrel 12 by an adhesive, ultrasonic welding, or other suitable connection process, as is known in the art.

[0096] As described above, the cap 24 is configured to be manually operated by an operator and moved from a closed position to an open position. To enable such manual operation, in some examples, the extension portion 80 includes one or more slots 88 or openings that extend through the side wall 86 of the extension portion 80. The cap 24 may include a beam or tab 92 that extends through the slot 88 of the extension portion 80 and rotates the cap 24 relative to the syringe barrel 12. The cap 24 may further include a rotating ring 90 connected to the beam or tab 92, which surrounds the shield 74 of the cap 24. For example, as shown in FIGS. 4A and 4B, the cap 24 includes two tabs 92 or beams that extend from opposite sides of the shield 74. The rotating ring 90 is attached to the tab 92 and surrounds the shield 74. When operating the cap 24, the operator can grasp any portion of the rotating ring 90 and move the cap 24 from a closed position to an open position. In some examples, the rotating ring 90 may include a grip portion such as a ridge 94 to make it easier to grasp and operate the ring 90. In particular, the rotating ring 90 may be configured such that the operator can grasp the ring 90 between the thumb and index finger to rotate the cap 24. As described above, rotating the cap 24 causes the tab 92 or beam to slide through the slot 88, which causes the cap 24 to rotate relative to the barrel 12. Further, rotation of the cap 24 activates the plug 63, causing the plug 63 to move away from the hole 56, allowing fluid to flow out of the barrel 12 of the syringe 10 through the cap 24.

[0097] In some examples, the slot 88 may include an axial portion or axial segment that extends axially through the side wall 86 from the distal end 84 of the extension portion 80. The axial portion or axial segment allows the cap 24 to be inserted onto the extension portion 80, and the tab 92 or beam projects through the slot 88. The slot 88 also includes a circumferential portion or circumferential segment for rotating the cap 24 relative to the barrel 12 between a first position and a second position.

[0098] Referring back to FIGS. 2A-2C, in some examples, the slot 88 of the barrel 12 may include a bump 77 or protrusion that projects from one substantially flat surface of the slot 88. The bump 77 may be disposed in the slot 88 to limit or block the tab 92 or beam from easily sliding through the slot 88. In some examples, the bump 77 may be disposed to effectively lock the cap 24 to the extension 80, preventing the tab 92 or beam from sliding through the axial segment of the slot 88 to remove the cap 24 from the extension 80.

[0099] Referring particularly to FIG. 2C, the inner surface of the extension 80 may include a structure for fixing the barrel seal 54 in its seated position at the proximal end of the extension 80. For example, as shown in FIG. 2C, the extension 80 may include a protrusion, such as an axially extending ridge 96, rib, column, or similar structure, on the inner surface of the extension 80 to limit rotation of the barrel seal 54 disposed on the distal opening 18 of the barrel 12. As shown in FIGS. 3A and 3B, the barrel seal 54 may include a notch 55, slot, or groove disposed to receive the ridge 96 on the inner surface of the extension 80. The engagement between the ridge 96 and the notch 55 of the barrel seal 54 maintains the positioning of the barrel seal 54 and, in particular, prevents the barrel seal 54 from rotating as the cap 24 rotates between its closed and open positions.

[0100] As shown in FIG. 2C, the extension 80 may also include raised circumferential protrusions such as protruding ridges or locking rings 98. The locking ring 98 may be arranged to ensure that the barrel seal 54 remains seated against the distal end 16 of the barrel 12 and to prevent the barrel seal 54 from lifting out of the distal opening 18 of the barrel 12 as the cap 24 rotates between the first and second positions. As previously described, the distal end 16 of the barrel 12 may also include an annular groove 62 (shown in FIG. 2C) that receives a ridge 58 or O-ring extending from the proximal face of the barrel seal 54. The ridge 58 or O-ring also contributes to maintaining the positioning of the barrel seal 54 within the extension portion 80 of the barrel 12, for example, by preventing the barrel seal 54 from sliding relative to the extension 80 or distal end 16 of the barrel 12. The ridge 58 or O-ring also effectively seals the distal opening 18 of the barrel 12 and prevents fluid from accumulating between the barrel seal 54 and the distal end 16 of the barrel 12.

[0101] Method of discharging fluid from a syringe with an integrated cap A flowchart showing the steps of discharging fluid to a VAD using the syringe 10 is shown in FIG. 8. As shown in FIG. 8, in step 110, the operator first obtains a prefilled syringe 10 in which the interior of the syringe barrel 12 is filled with a predetermined amount of medical fluid F. For example, the prefilled syringe 10 may contain from about 1 mL to about 50 mL, preferably from about 5 mL to about 20 mL of medical fluid F. The cap 24 of the prefilled syringe 10 is initially in the closed position, and the medical fluid F remains within the barrel 12 to prevent fluid contamination and / or fluid leakage. In this initial or prefilled position, the stopper 38 is positioned near the proximal end 14 of the barrel, and the plunger rod 40 extends proximally through the proximal end 14 of the barrel 12 from the stopper 38.

[0102] In step 112, the operator prepares the syringe 10 for use, for example, by removing any packaging from the syringe 10 and, if present, removing the plunger cap that holds the plunger rod 40 in a predetermined position. In the initial position, the cap 24 is in the closed position, meaning that fluid cannot pass through the connector 26. Instead, as shown by arrow A4 in FIG. 6B, the fluid F is prevented from passing into the flow channel 28 of the connector 26 by the plug 63 that covers the hole 56 of the barrel seal 54.

[0103] In step 114, when ready to perform the flush or injection procedure, the operator moves the cap 24 to the open position. For example, the operator grasps the rotation ring 90 of the cap 24 between the thumb and index finger and rotates the ring 90 (as shown by arrow A1 in FIG. 1A), which causes the beam or tab 92 of the cap 24 to move through the slot 88 of the extension 80. As the beam or tab 92 slides through the slot 88, the cap 24 rotates from the closed position to the open position. As described above, moving the cap 24 to the open position causes the plug 63 to rotate around the post 70 and move away from the hole 56, as shown by arrow A5 in FIGS. 6C and 7C. The movement of the plug 63 away from the hole 56 of the barrel seal 54 establishes fluid communication between the interior of the syringe barrel 12 and the flow path or flow channel 28 of the connector 26, allowing the medical fluid F to be discharged from the syringe 10.

[0104] In step 116, the operator then advances the stopper 38 slightly distally through the barrel 12 (as indicated by arrow D in FIG. 1) by, for example, pressing on the thumb plate 52 of the plunger rod 40 while grasping the finger flange 36 of the barrel 12, for example, between the ring finger and the index finger. This slight distal movement of the stopper 38 removes air from the interior of the syringe barrel 12. In step 118, once all of the air has been removed from the interior of the syringe barrel 12, the operator then attaches the connector 26 of the cap 24 to the VAD. For example, the operator may insert the distal end or tip 32 of the connector 26 into the corresponding port or valve of the VAD, particularly the port or valve of a female luer connector. To push the connector 26 into the septum of the female connector, the operator may move the syringe 10 distally while simultaneously rotating the syringe 10 and the integral cap 24 in the direction indicated by arrow A2 (shown in FIG. 1A), such that the threads 78 on the inner surface of the shield 74 engage the corresponding threads of the female connector, securing the syringe 10 and the integral cap 24 to the female connector. As described above, the direction of rotation (indicated by arrow A2 in FIG. 1A) for securing the shield 74 of the cap 24 to the female connector may be opposite to the direction of movement (indicated by arrow A1 in FIG. 1A) for moving the cap 24 from the closed position to the open position.

[0105] In step 120, with the cap 24 in the open position and attached to the VAD, the operator can use the plunger rod 40 to move the stopper 38 distally (indicated by arrow D in FIG. 1A) through the interior of the syringe barrel 12, discharging the medical fluid F from the syringe barrel 12 through the flow path or flow channel 28 of the connector 26. For example, as described above, the operator can grasp the finger flange 36 of the syringe barrel 12 and push the thumb press 52 of the plunger rod 40 with the thumb to move the plunger rod 40 distally (indicated by arrow D in FIG. 1A), which causes the stopper 38 to move distally through the syringe barrel 12 and expels the medical fluid F from the syringe barrel 12 as indicated by arrow A6 (shown in FIG. 7B). The operator continues to move the stopper 38 distally through the barrel 12 until all or substantially all of the medical fluid F has been discharged from the barrel 12 through the flow path or flow channel 28 of the connector 26 into the VAD.

[0106] In step 122, after the fluid F has been discharged from the syringe barrel 12 through the connector 26, the syringe 10 can be removed from the VAD by rotating the syringe 10 in direction A1 (shown in FIG. 1A) and disengaging the threads 78 of the shield 74 from the corresponding threads of the female connector.

[0107] As described above, the prefilled syringe 10 of the present disclosure is filled with a flush solution and can be used to perform a primary flush or preflush of the patient line of a VAD. In that case, after the flush solution is discharged from the syringe 10, the syringe 10 is removed from the female connector, and another syringe containing another medical fluid such as a therapeutic agent is connected to the female connector to provide the therapeutic agent to the patient. In other examples, the prefilled syringe 10 of the present disclosure can contain a dosage of a therapeutic agent to be delivered to a patient through a VAD. In that case, to provide the therapeutic agent to the patient, the syringe 10 can be attached to the female connector after flushing. In other examples, the prefilled syringe 10 of the present disclosure can contain a flush solution and can be used for post-flush operations. For example, after a therapeutic agent has been delivered to a patient through a VAD, the prefilled syringe 10 can be connected to the VAD. The flush solution can be discharged from the prefilled syringe 10 through the connector 26 and the VAD to flush the therapeutic agent remaining in the VAD to ensure that the entire dosage of the therapeutic agent is supplied to the patient. The post-flush procedure can also ensure that the patient line is clean by removing any precipitate or other foreign matter from the patient line.

[0108] The syringe 10 with the integrated cap 24 of the present disclosure, and examples of the method, are shown in the accompanying figures and described in detail above, but other examples will be apparent to and readily obtained by those skilled in the art without departing from the scope and spirit of the invention. Accordingly, the foregoing description is intended to be illustrative rather than limiting. The invention described above is defined by the appended claims, and all changes to the invention that come within the meaning and range of equivalency of the claims are to be embraced within the scope of the claims.

Claims

**Claim 1** A syringe, wherein the syringe comprises a barrel having a proximal end, a distal end with a distal opening, and a side wall extending between the proximal end and the distal end, a plunger disposed within the barrel for discharging fluid from the barrel through the distal opening, a cap connected to the distal end of the barrel, the cap comprising a connector defining a flow channel therethrough, the cap being movable relative to the barrel between a first position in which fluid is prevented from flowing from the distal opening of the barrel into the flow channel of the connector and a second position in which fluid flow from the distal opening of the barrel into the flow channel of the connector can occur. **Claim 2** The syringe according to claim 1, wherein the cap rotates about the longitudinal axis of the barrel to move from the first position to the second position. **Claim 3** The syringe according to claim 1, further comprising a barrel seal disposed between the distal opening of the barrel and the cap, the barrel seal comprising at least one hole for fluid flow from the barrel into the flow channel of the connector the barrel seal comprising a disk portion disposed on the distal end of the barrel and an annular wall portion extending from the disk portion and in contact with the inner surface of the barrel, the at least one hole extending through the disk portion. **Claim 4** The syringe according to claim 3, wherein the barrel seal comprises an annular ridge extending proximally from the proximal face of the disk portion and received within a corresponding annular groove in the distal end of the barrel, a lip extending radially inwardly from the annular wall portion of the barrel seal, the lip being configured to engage the cap and hold the proximal portion of the cap within the barrel seal. **Claim 5** ​ The syringe according to claim 3, further comprising a plug that engages with the cap, wherein the plug moves when the cap moves from the first position to the second position, and when the cap is in the first position, the plug is over at least one hole of the barrel seal to prevent fluid from flowing through the at least one hole of the barrel seal into the flow channel of the connector, and when the cap is in the second position, the plug is spaced apart from the at least one hole of the barrel seal to allow fluid to flow from the barrel through the at least one hole of the barrel seal into the flow channel of the connector.

6. The syringe according to claim 5, wherein the plug comprises a seal portion that moves over at least one hole of the barrel seal and at least one arm that extends from the seal portion and engages a part of the cap.

7. The syringe according to claim 5, wherein an end of the at least one arm of the plug is pivotally connected to the inner surface of the cap, and when the cap moves from the first position to the second position, the plug can move to expose at least one hole of the barrel seal.

8. The syringe according to claim 5, wherein the cap comprises at least one pair of protrusions that extend radially inward from the inner surface of the cap, an end of the at least one arm of the plug is disposed between the pair of protrusions, and when the cap rotates from the first position to the second position, the protrusions move the plug.

9. The syringe according to claim 5, wherein the plug comprises an elastomeric seal configured to be disposed over at least one hole of the barrel seal to seal the at least one hole of the barrel seal when the cap is in the first position.

10. The syringe according to claim 4, wherein the at least one hole of the barrel seal is axially aligned with the distal opening of the barrel, the diameter of the at least one hole of the barrel seal is smaller than the diameter of the distal opening of the barrel, and when the cap moves from the first position to the second position, the barrel seal remains stationary.

11. The syringe according to claim 1, wherein the cap further comprises a shield extending around the connector, the shield having an inner surface with threads configured to engage the threads of the female connector, and fixing the syringe and the cap to the female connector.

12. The syringe according to claim 11, wherein the barrel further comprises an extension extending distally from the distal end of the barrel. The cap is connected to the extension and at least partially surrounded by the extension, and the cap comprises at least one tab extending radially outward from the shield for rotating the cap relative to the barrel.

13. The syringe according to claim 12, wherein the cap further comprises a rotating ring having the at least one tab, the rotating ring extending around the shield of the cap and the extension of the barrel. The rotating ring is configured to be rotated by a user to move the cap between the first position and the second position.

14. The syringe according to claim 12, wherein the extension comprises at least one slot, the at least one tab of the cap extends through the slot, and the at least one tab can be grasped by a user to rotate the cap relative to the barrel.

15. The syringe according to claim 14, wherein the at least one slot comprises at least one protrusion protruding from the surface of the slot, the protrusion restricting at least the sliding of the at least one tab through the slot and locking the cap to the extension.

16. The syringe according to claim 12, wherein the extension further comprises a protrusion on the inner surface thereof to limit rotation of a barrel seal disposed on the distal opening of the barrel. The syringe, wherein the protrusion comprises a ridge, rib, or columnar body extending axially on the inner surface of the extension.

17. A prefilled flushing syringe, the prefilled flushing syringe comprising the syringe according to claim 1, and a predetermined amount of fluid disposed within the barrel of the prefilled flushing syringe. The prefilled flushing syringe, wherein the cap is initially in the first position, thereby preventing the fluid within the barrel from passing through the open distal end of the barrel into the flow channel of the connector.

18. The prefilled flushing syringe according to claim 17, wherein the fluid comprises a saline flush solution or a therapeutic agent.

19. A method of discharging fluid from the syringe according to claim 1, the method comprising moving the cap from the first position to the second position, allowing fluid flow from the barrel into the flow channel of the connector; attaching the connector of the cap to a vascular access device; and moving the plunger through the barrel to discharge the fluid from the barrel and through the flow channel of the connector into the vascular access device.

20. The method according to claim 19, wherein the cap is manually moved from the first position to the second position by grasping a portion of the cap with one hand and rotating the cap about the longitudinal axis of the syringe.

Images